PhD thesis Jesper Bak Mechanical Restraint Preventive Factors in Theory and Practice Academic advisor: Mette Brandt-Christensen Submitted: 29/01/15 Title: Mechanical Restraint Subtitle: Preventive Factors in Theory and Practice Subject description: Identifying mechanical restraint factors to generate knowledge of non-medical MR-prevention. Author: Jesper Bak The studies were completed at Mental Health Centre Sct. Hans, Research Institute, Boserupvej 2, 4000 Roskilde, Denmark and St. Olavs University Hospital, Forensic Department Bröset, Centre for Research & Education in Forensic Psychiatry, Norway, while the author was a PhD student at the University of Copenhagen, Faculty of Health, and Medical Science, University of Copenhagen, Denmark. Supervisors: Mette Brandt-Christensen, MD, PhD, Head of Department, Department Q, Mental Health Centre Glostrup, Glostrup, Denmark. Dorte Maria Sestoft, MD, PhD, Head of Clinic, Clinic of Forensic Psychiatry, Ministry of Justice, Copenhagen, Denmark. Vibeke Zoffmann, RN, MPH, PhD, Head of Research, Women and Children’s Health, Juliane Marie Centre, Rigshospitalet, Copenhagen, Denmark. Assessment committee: Ingrid Egerod, Clinical Professor, Department of Clinical Medicine, University of Copenhagen and Trauma Centre, Rigshospitalet, Copenhagen, Denmark (Chair). Lise Hounsgaard, Professor, Odense Patient data Explorative Network, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. Frans Fluttert, Associate Professor, Centre for Research and Education in Forensic Psychiatry, Ullevål University Hospital, Oslo, Norway, and senior researcher, FPC Dr. S. Van Mesdag, Groningen, The Netherlands. This thesis has been submitted to the Graduate School of the Faculty of Health and Medical Sciences, University of Copenhagen. 2015 © All rights reserved. No part of this publication may be reproduced in any form or by any means without clear indication of the source. DOI: 10.13140/RG.2.1.2681.5528 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE 1 Table of Contents 1 2 TABLE OF CONTENTS........................................................................................................... 1 PREFACE................................................................................................................................... 2 2.1 2.2 2.3 2.4 2.5 3 SUMMARIES IN DANISH AND ENGLISH ........................................................................... 5 3.1 3.2 4 5 6 7 Summary in Danish (Dansk Resumé) ..................................................................................................... 5 Summary in English .................................................................................................................................... 7 INTRODUCTION ....................................................................................................................... 8 OBJECTIVE ............................................................................................................................. 13 DESIGN AND METHODS ..................................................................................................... 14 RESULTS ................................................................................................................................. 24 7.1 7.2 7.3 7.4 8 9 Acknowledgements ..................................................................................................................................... 2 List of Papers ................................................................................................................................................ 3 Table of Contents: Figures, Tables, and Appendixes ......................................................................... 3 List of Symbols and Abbreviations ......................................................................................................... 4 Key Definitions .............................................................................................................................................. 4 Summary of Results, Study 1 .................................................................................................................. 24 Summary of Results, Study 2 .................................................................................................................. 27 Summary of Results, Study 3 .................................................................................................................. 29 Summary of Results, Study 4 .................................................................................................................. 31 APPROVAL AND ETHICS .................................................................................................... 35 DISCUSSION ........................................................................................................................... 35 9.1 Discussion of Individual Studies ........................................................................................................... 35 9.2 Design Issues .............................................................................................................................................. 45 9.3 Cause and Effect ........................................................................................................................................ 47 9.3.1 Chance..................................................................................................................................................... 47 9.3.2 Bias........................................................................................................................................................... 48 9.3.3 Confounding ............................................................................................................................................ 50 9.3.4 Strength of the Association ................................................................................................................... 51 9.3.5 Biological Credibility ............................................................................................................................... 51 9.3.6 Generalisability and Consistency ......................................................................................................... 52 9.4 Discussion of International High Quality Research .......................................................................... 52 10 CONCLUSIONS ...................................................................................................................... 54 10.1 10.2 Conclusions from the Individual Studies ............................................................................................. 54 General Conclusions ................................................................................................................................. 55 11 PERSPECTIVES ..................................................................................................................... 56 11.1 11.2 Clinical Implications .................................................................................................................................. 56 Future Research Recommendations ..................................................................................................... 57 12 REFERENCE LIST ................................................................................................................. 58 13 APPENDIX ............................................................................................................................... 68 13.1 Appendix A................................................................................................................................................... 68 Paper 1 Paper 2 Paper 3 Paper 4 1 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE 2 Preface This thesis addresses the mechanical restraint (MR) of adult psychiatric inpatients. I have dealt with this phenomenon for many years, first as a nurse in acute psychiatry later as a clinical nurse manager of closed units, and finally as a worker in the education and development field. I have always tried to minimise the use of MR by delivering empowering and humanistic nursing care and simultaneously introducing safe and secure nursing procedures. Although some reduction in the use of MR has been observed locally, much more progress is needed. The question thus arises of which procedures, interventions or conditions we should develop and implement. When interviewing patients in 2004 to collect their suggestions on how to reduce the number of MR episodes, they gave many suggestions, convincing me that my research should generate knowledge of non-medical MR-prevention. I hereby present this thesis. 2.1 Acknowledgements I thank The Mental Health Centre Sct. Hans, especially Margit Asser, for supporting my PhD education. I would like to thank Mette Brandt-Christensen, Dorte Maria Sestoft and Vibeke Zoffmann for their continual advice and supervision. I would like to thank Thomas Werge and my co-workers at the research institute for helping me with countless questions and for being my colleagues. I would like to thank Roger Almvik and my former colleagues in Norway at the Bröset Centre for Research and Education in Forensic Psychiatry for the interesting discussions and guidance and for “having me around” in autumn 2010. I would like to thank Helle Aggernæs, Mette Dons, Torben Hærslev and Louise Gjørup for their collaboration on the European study. I would like to thank Volkert Siersma for supervising the statistical analyses and enduring my endless questions. I would like to thank the clinical nurse managers of the psychiatric units in Norway and Denmark: this study would not have been possible without you spending time on the questionnaires. 2 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Special thanks are extended to some of the clinical nurse managers of the units at Mental Health Department Østmarka, Mental Health Centre Copenhagen and Mental Health Centre Sct. Hans for helping to pilot the questionnaire. Finally, on a personal level, I would like to thank my family for their patience when the study demanded late hours and months of separation that kept my attention away from them. I would like to thank the following organisations for funding this project: the Mental Health Centre Sct. Hans, the Health Science Research Foundation in the Capital Region of Denmark, the Mental Health Services in the Capital Region of Denmark, Copenhagen University Hospital and the National Board of Health. 2.2 List of Papers 1. Bak, J., Brandt-Christensen, M., Sestoft, D. M., and Zoffmann, V. Mechanical Restraint Which Interventions Prevent Episodes of Mechanical Restraint? - A Systematic Review. Perspectives in Psychiatric Care 48, 83-94. 2011. 2. Bak, J. and Aggernæs, H. Coercion within Danish psychiatry compared with 10 other European countries. Nordic Journal of Psychiatry 66(5), 297-302. 2011. 3. Bak, J., Zoffmann, V., Sestoft, D. M., Almvik, R., and Brandt-Christensen, M. Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish-Norwegian Association Study. Perspectives in Psychiatric Care 50(3), 155-166. 2014. 4. Bak, J., Zoffmann, V., Sestoft, D. M., Almvik, R., Siersma, V. D., and Brandt-Christensen, M. Comparing the effect of non-medical mechanical restraint preventive factors between psychiatric units in Denmark and Norway. Nordic Journal of Psychiatry 23(1), 1-11. 2015. 2.3 Table of Contents: Figures, Tables, and Appendixes Figure 1: Mechanical Restraints in Denmark, 2004-2013 Figure 2: Effect and Recommendation Grade Matrix Table 1: Hierarchy of Mechanical Restraint Preventive Factors Table 2: Background Data Table 3: Applied Methods of Coercion Table 4: Physical Coercion per 100,000 Inhabitants in Denmark and Norway Table 5: Ranking of Coercive Measures With Respect to Perceived Intrusion Table 6: Effects of Potential Mechanical Restraint Preventive Factors on the Annual 3 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Number of Mechanical Restraint Episodes Table 7: Differences in the Effects of Potential Mechanical Restraint Preventive Factors on the Annual Number of Mechanical Restraint Episodes in Denmark and Norway Appendix A: Appraisal, Grading, and Combining the Recommendations of the Mechanical Restraint Preventive Factors 2.4 List of Symbols and Abbreviations B: Estimate of regression coefficient n/No: Number χ2: Chi square N.a.: No available information CI: Confidence interval NICE: National Institute for Health and Clinical Excellence DRPS: Danish Reference Programme Secretariat Pearson’s r: Pearson´s correlation coefficient Δ: Difference p: Probability value EPSO: European Platform of Supervisory Organizations ERM: Early Recognition Method P.n.: Pro necessitate (as needed) Exp: Exponentiated QICC: Corrected Quasi Likelihood under Independence Model Criterion GEE: Generalized Estimating Equations RCT: Randomised controlled trial IM: Intramuscular injection SIGN: The Scottish Intercollegiate Guidelines Network Ken, b: Kendall’s Taub SOI: Second Order Interaction m2: Square meter UEMS: Union Européenne des médicins Spécialistes (Psychiatric Section of the European Union of Medical Specialists) MERGE: Method for Evaluating Research and Guideline Evidence WHO, ICD-10: World Health Organization, International Classification of Diseases, 10th version QIC: Quasi Likelihood under Independence Model Criterion MR: Mechanical restraint 2.5 Key Definitions Mechanical restraint (MR): The use of restraining straps, belts or other equipment to restrict movement (1). Coercion: The action of making somebody do something that they do not want to do (2). 4 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Restraint: The use of physical force to control somebody who is behaving in a violent way (2). Physical restraint/Holding: Physically holding the patient, preventing movement (1). Seclusion/Isolation: Isolated in a locked room (1). Time out: Patient asked to stay in room or area for period of time, without the door being locked (1). Forced admission: An involuntary admitted patient (3). Forced compulsory retention: Forced compulsory retention of a voluntary admitted patient (4). Forced treatment: An involuntarily treated patient, normally by antipsychotic medications (3); sometimes called forced medication/long period (4). Forced acute tranquillising medication/IM medication: Intramuscular injection of sedating drugs given without consent (1); sometimes called forced medication/short period (4). Constant observation/Person-to-person-/face-to-face observation: An increased level of observation, of greater intensity than that which any patient generally receives, coupled with allocation of responsibility to an individual nurse or other worker. Constant: within eyesight or arms reach of the observing worker at all times (1). This type of measure is registered as a coercive measure, in Denmark, if it is involuntary and prolonged for more than 24 hours (5). Unit: The smallest organisational collection of beds, led by a clinical nurse manager. 3 Summaries in Danish and English 3.1 Summary in Danish (Dansk Resumé) Tvangsfiksering af psykiatriske patienter indlagt på psykiatrisk afdeling er et voldsomt indgreb i den enkelte patients autonomi og kan medføre både fysiske og psykiske skader. Det kan dog i særlige situationer være nødvendigt blandt andet for, at beskytte patienten selv, medpatienter eller andre. En sådan situation kan for eksempel opstå hvis en indlagt patient er meget aggressiv, voldelig, selvskadende eller suicidal truet. Selvom også længerevarende tvangsfikseringer udføres i henhold til den danske lovgivning, understregede Den Europæiske Komité for Forebyggelse af Tortur (The European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment) i rapporter fra 5 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE 2002, 2008 og 2014 at, tvangsfiksering af psykiatriske patienter flere dage i træk, ikke har nogen behandlingsmæssig berettigelse og må beskrives som mishandling/fejlbehandling. Der er bred enighed om, at anvendelsen af fysisk magtanvendelse herunder tvangsfiksering i behandlingen af psykiatriske patienter bør mindskes mest muligt, men hvordan dette skal gøres i praksis, hersker der usikkerhed om. Evidensen på området er stigende, men der mangler fortsat sikker evidens. Ingen studier har undersøgt hvilke faktorer, der mest effektivt forebygger anvendelse af tvangsfiksering i praksis i Danmark og Norge. Det overordnede formål med denne afhandling er at generere viden om ikke-medicinsk forebyggelse af tvangsfikseringer. Afhandlingen består af fire individuelle studier: Først gennemførtes et systematisk review af den internationale forskningslitteratur for at identificere evidente og effektive faktorer (forhold og interventioner), der kunne reducere antallet af tvangsfikseringer. Formålet var at skabe grundlag for at udvikle et spørgeskema med henblik på at belyse, i hvilken grad formodede forebyggende faktorer var til stede i de psykiatriske afsnit, som indgik i afhandlingens studie 3 og 4. Dernæst blev psykiatrilovgivning og anvendelse af tvang i 11 europæiske lande beskrevet og sammenlignet i samarbejde med Sundhedsstyrelsen. Resultaterne dannede grundlag for udvælgelse af et egnet andet europæisk land med sammenlignelige forhold som kunne indgå i afhandlingens 3. og 4. studie. Afhandlingens 3. og 4. studie var baseret på en multicenterspørgeskemaundersøgelse, hvor data blev indsamlet fra lukkede psykiatriske afsnit i Danmark og Norge for at belyse i hvilken grad de enkelte tvangsfikseringsforbyggende faktorer var til stede i afsnittene og antallet af tvangsfikseringer det forgange år. Formålet for det 3. studie var, at undersøge hvorvidt tilstedeværelse af formodede tvangsfikseringsforebyggende faktorer i et afsnit var associeret med mindre anvendelse af tvangsfiksering. I afhandlingens 4. studie blev data analyseret med henblik på at identificere, om nogle af de formodede forebyggende faktorer muligvis kunne forklare forskellen i antallet af tvangsfikseringer mellem Danmark og Norge. Der blev identificeret tre forebyggende faktorer, som var signifikant associeret til et lavt antal tvangsfikseringer i Danmark og Norge: Obligatorisk review af tvangsfikseringsepisoder (64 % færre tvangsfikseringer), Patient involvering (58 % færre tvangsfikseringer) og Crowding (46 % færre tvangsfikseringer). Derudover blev identificeret fem faktorer, der havde konfunderende effekt (reducerede forskellen mellem landene), disse kunne være en del af forklaringen på, hvorfor Danmark anvendte 92 % mere tvangsfiksering end Norge. De fem var: Personalets grunduddannelses niveau (51 % af effekten), Anvendelse af afløsnings personale (17 % af 6 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE effekten), Arbejdsmiljø (15 % af effekten), Andelen af personaler per patient (11 % af effekten) og Identifikation af patientens krise-triggere (10 % af effekten). Resultaterne har uddybet vores viden om hvordan specifikke faktorer reducerer antallet af tvangsfikseringer. De er ikke identificeret ved gennemførelse af randomiserede kliniske studier, og selv om nogle svagheder findes i studierne, blev spørgeskemaet udviklet på en grundig måde, der blev justeret for flere mulige konfunderende faktorer i analyserne, og lignende resultater er fundet i tidligere forskning fra andre lande. Derudover er der ikke noget, der tyder på, at de fundne faktorer kan have negative effekter, snarere kunne det tænkes, at den mulige positive effekt, faktorerne har på forebyggelse af tvangsfiksering, kunne være et udtryk for en generel styrkelse af pleje- og behandlingsmiljøet. Det anbefales derfor, yderligere at undersøge effekten af at implementere: obligatorisk review, patient involvering, mindre crowding, højere grunduddannelsesniveau blandt personalet, anvendelsen af færre vikarer, et bedre arbejdsmiljø, højere antal personaler per patient og identificering af patienters krise triggere, i praksis i Danmark og Norge. 3.2 Summary in English Mechanical restraint (MR) is a major infringement on the psychiatric patient’s autonomy. MR can cause physical and mental harm but may be necessary, e.g. to avoid putting an individual’s health at risk. The nursing staff is tasked with protecting the life and health of not only the individual patient but also other patients and relatives. A situation can occur in which staff is obligated to use force and occasionally MR, e.g. if a patient is very aggressive, violent, self-destructive or suicidal. Although MR is legal, the European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment concluded, in two reports from 2002, 2008, and 2014 that no medical justification exists for applying instruments of physical restraint to psychiatric patients for days and that doing so amounts to ill treatment. Although the number of MR episodes should be reduced as much as possible, how this goal should be accomplished is quite unclear. Despite the growth in available research in the area decisive evidence is still lacking. No studies have investigated which of the many MR-preventive factors are the most effective in practice, in Denmark and Norway. Therefore, the overall objective of this thesis was to generate knowledge of non-medical MRprevention. The four studies that contributed to this objective had separate purposes. First, a systematic review of international research papers was conducted to identify evident and effective MR-preventive factors; this review served as a basis for developing a questionnaire examining the degree to which MR-preventive factors have been implemented in psychiatric units and the 7 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE numbers of MR episodes in those units. Second, a comparative investigation of European countries was conducted to identify a country comparable to Denmark to include in the cross-country questionnaire survey. Third, the collected questionnaire data were analysed to identify the associations between the MR-preventive factors and the number of MR episodes. Finally, the data were analysed to identify if the MR-preventive factors could explain the difference in the number of MR episodes between Denmark and Norway. Three MR-preventive factors were significantly associated with a low frequency of MR episodes in Denmark and Norway: a mandatory review of MR episodes (64% fewer MR episodes), patient involvement (58% fewer MR episodes), and crowding (46% fewer MR episodes). Further, we identified five MR-preventive factors with confounding effects (reducing the difference between countries), which may explain in part why Denmark used 92% more MR compared with Norway. These factors included: staff education (51% of the effect), substitute staff (17% of the effect), work environment (15% of the effect), patient-staff ratio (11% of the effect), and identification of patients’ crisis triggers (10% of the effect). These results have increased our understanding of the ability of specific MR-preventive factors to reduce the number of MR episodes in Denmark and Norway, thereby generating knowledge in the field of MR-prevention. These findings have not been identified via randomised controlled trials (RCTs), and although some biases could be present, the questionnaire was thoroughly developed to include several potential confounders. Furthermore, similar results have been demonstrated in previous international studies. These factors are not likely to have adverse effects on the patients or staff. Rather, the potential positive effects of these factors on the prevention of MR episodes may reflect a general strengthening of the care and treatment environments. Therefore, further investigation into the effects of implementing the following within Danish and Norwegian practices is recommended: mandatory review, patient involvement, less crowding, higher staff education, less substitute staff use, better work environment, increased number of staff per patient, and the identification of the patient’s crisis triggers. 4 Introduction In Denmark, MR can legally be performed, e.g. when psychiatric inpatients pose a risk to themselves or to others (6). Other countries do not allow the use of MR: forexample, only the use of seclusion and holding (physical restraint) is allowed (except in exceptional circumstances in Special Hospital environments) in the United Kingdom. Thus, the use of MR differs greatly across Europe 8 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE and the rest of the world. The practical procedure is primarily prescribed by a psychiatrist, is performed by nursing staff and involves using leather or fibre belts to secure the patient to a bed, occasionally with additional straps used around the wrists and ankles. MR using leather belts has been used in Denmark since, at least 1870, when the use of a “straitjacket” was abolished (7). Reiter described the use of MR in 1927 (translated by the author): Of restraints, the belt (ed. MR) is especially used; this is an upholstered girth, that can be locked around the patient … and secured to the bed … It is only used when other measures fail and only after a doctor’s prescription. (7) Unlike most other countries, the use of seclusion is illegal in Denmark. In 1901, Professor Knud Pontopidan argued (translated by the author): These (ed. chains and straitjackets) were abandoned from the asylums armamentarium long ago. However, the medical profession has first achieved its goal in this area, by abandoning the remaining mechanical restraints, which represents themselves in the closed cell. The future solution must involve consistently combating cell treatment. (8) In 1985, the first legislation (9) on the use of specific types of restraint was published, and seclusion was finally abandoned, except in a special high security department (Sikringen). In Denmark other types of coercion can legally be used for psychiatric patients, including forced admissions/compulsory forced retention, forced treatment, forced acute tranquillising medication, holding, person-to-person observation, follow-up after discharge, mail examination, patient rooms, personalised alarm systems, and protective MR (6). Legislation stipulates that the least intrusive type of coercion must be used only after trying everything possible to avoid using coercion. The most intrusive coercive measures used in Denmark are: forced admission/compulsory forced retention, then MR, forced treatment, forced acute tranquillising medication, and holding, and finally person-to-person observation (10). Danish legislation follows the United Nations Principles for the protection of persons with Mental Illness and the improvement of Mental Health Care (11). Thus, as most European Countries also follows these principles, which do not describe the intrusiveness of the different types of coercion, individual countries likely defined them based on their own interpretation of human rights, as influenced by their historic– and cultural development. In Denmark, MR is considered the most intrusive intervention for controlling aggressive or selfmutilating/suicidal inpatients in psychiatric units. 9 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE According to the Danish Mental Health Act, the following conditions must be present to legally initiate MR (translated by the authors): Mechanical restraint may be used only when necessary to prevent a patient from 1. exposing their body or health or the body or health of others to danger, 2. pursuing or grossly molesting fellow patients in any way, or 3. committing significant acts of vandalism. (6) The same conditions must be present to initiate holding. If a patient is very agitated, forced acute tranquillising medications can be used. The same conditions must be present in many other countries to initiate MR, seclusion, holding, or forced acute tranquillising medication (10). The central concept is danger towards self or others, which is the most common reason for using coercive interventions towards psychiatric patients behaving in an aggressive or selfmutilating/suicidal maner. Thus, although the use of MR is legal in many countries, the discussion is ongoing regarding how often this intervention should be used, given the patients’ right to selfdetermination and human rights in general. Following visits to Denmark, the European Committee for the Prevention of Torture and Inhumane or Degrading Treatment or Punishment stated that no medical justification exists for applying instruments of physical restraint to psychiatric patients for days and that doing so amounts to ill treatment (12-14). MR exposes the patient to potential physical injuries such as deep vein thrombosis, pulmonary embolisms, pressure sores, and bone fractures (15-19). For most patients, MR also involves negative psychological effects: feeling helpless, angry, trapped, sad, fearsome, unpleasant, or offended. Individual patients often regard the use of MR as unjust or even as a punishment (20-24), in the worst case developing long-term trauma and possibly features of post-traumatic stress disorder (22-24). In addition to affecting the individual patient, the use of MR has a negative effect on the atmosphere, care, and treatment of the whole unit (20;21). These negative consequences appear inconsistent with health care providers’ basic attitudes regarding “doing good” for patients. However, strong counter-arguments regarding the use of MR suggest that health care professionals are obliged to secure and care for the health and life of the patients and other individuals, while avoiding violence towards fellow patients, relatives, and staff. Some studies indicate that up to 10% of patients request the use of MR to prevent acting out (4). Overall, enhanced efforts are required to reduce the frequency (10). In a textbook on mental health nursing (translated by the author), Jacobsen wrote the following in 1920: 10 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE “Straitjackets”, where the arms were tied to the chest, as used in earlier times, are not currently used in any mental health hospital, and even the afore mentioned milder restraints (ed. MR) are used less frequently and will most likely be rendered superfluous by numerous and careful nursing staff. (25) This goal has not been reached; instead, the numbers of MR episodes in Denmark have remained constant over the previous decade (26) (Figure 1). Figure 1. Mechanical Restraints in Denmark, 2004–2013 The relevant legislation, which was thoroughly revised in 1989 has been continually updated, with a Number of Mechanical Restraint Episodes special focus on efforts to reduce the use of MR. 7000 These efforts have shown no significant effect, 6000 5000 which is consistent with reports in other countries 4000 (27). This finding is most likely because many 3000 2000 factors influence the events that lead to the use of 1000 MR. The factors that influence an individual 0 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 patient’s aggressive or self-destructive behaviour and hence the frequency of MR use in a psychiatric Number of Individuals who Experienced Mechanical Restraint unit could be related to the patient, unit, staff or 2500 “situational/interactional conditions” (28). As 2000 Bowers (29) describes in the very recently 1500 developed “Safewards Model” on conflict and 1000 containment on psychiatric wards, six domains of 500 originating factors exist: the staff team, the physical 0 2004 2005 2006 2007 2008 2009 2010 2011 2012 Note. The numbers does not include the special high security department (Sikringen). 2013 environment, outside of the hospital, the patient community, patient characteristics, and the regulatory framework. All of these domains give rise to potential flashpoints, with the capacity to trigger conflict and/or containment, representing another way to categorise the originating conditions while underpinning the fact that many factors influence how often coercive measures are used in psychiatric units. In Denmark the 6,165 MR episodes recorded in 2013 involved 2,084 individual patients with an average of 3.0 episodes per patient; 14% of these episodes lasted longer than 48 hours. The distribution of MR episodes across the five regions in Denmark was as follows: Capital, 115 per 100,000 inhabitants; Zealand, 67 per 100,000 inhabitants; South Denmark, 78 per 100,000 11 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE inhabitants; Mitt Jutland, 165 per 100,000 inhabitants; and North Jutland, 101 per 100,000 inhabitants. The highest numbers of MR episodes were found in regions with the largest cities; however, despite of including only the second largest city, Mitt Jutland had the highest numbers of MR episodes. A similar tendency was found upon investigating the MR episodes in relation to the number of psychiatric beds, or the number of psychiatric patients across the regions (26). Other conditions in addition to the often-seen urban/rural differences (30) must also influence the regional distribution of MR episodes. In Denmark in 2008, the average length of a MR episode was 27 hours. The average age of the patients subjected to MR was 40 years, and the average age of all inpatients was 42 years, indicating that patients sumitted to MR was younger. More male (58%) than female patients experienced MR, although men represented 51% of all inpatients. The diagnostic distribution of patients experiencing MR were (WHO, ICD-10, principal codes): F00-09, 8.5%; F10-19, 15.3%; F20-29, 46.6%; F30-39, 16.0%; F40-49, 3.9%; F50-59, 0.3%; F60-69, 6.1%; F70-79, 1.6%; F80-89, 0.6%; and F90-99, 0.9%. The diagnostic distribution of all inpatients was as follows: F00-09, 2.4%; F10-19, 16.1%; F20-29, 31.5%; F30-39, 24.8%; F40-49, 15.2%; F50-59, 0.7%; F60-69, 6.4%; F7079, 0.5%; F80-89, 0.4%; and F90-99, 1.2%. Thus, the patients experiencing MR were diagnosed more often with F20-29 and less often with F30-39 or F40-49. Different types of departments had different diagnostic distributions. For example, in special forensic departments, 46% of the patients were diagnosed as F20-29 and 12% as F30-39, whereas these frequencies were 31%, and 25% in acute departments, respectively. In 2008, 22 adult inpatients experienced MR more than 25 times, comprising 1,150 total MR episodes. Nineteen of these inpatients were woman and 17 were diagnosed F20-29. Their average age was 30 years, they were admitted in all regions, and they spend an average of 280 days as inpatients. Thus, few patients experience numerous MR episodes, and whether these patients respond to the same MR-preventive initiatives as other patients is unknown. These 2008 data originate from the Danish Health and Medicines Authorities Register on Coercion and the Danish Psychiatric Central Research Register (31). Between 1999 and 2003, immigrants and refugees experienced more than twice the amount of MR episodes as Danish-born population did (32) perhaps because the rates of psychosis are higher among migrants than non-migrants, because family support systems are lacking, or because language barriers existed between the staff and migrants in the psychiatric units. Although differences in MR rates are known to exist, the reason for the difference remains unknown. The same differences regarding regions, diagnoses, genders, departments, the low number of patients experiencing multiple MR episodes, and ethnicities are found in other countries (33-37). 12 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE More than 30 reviews of the management of agitation, aggression, violence, and coercion (such as MR, seclusion, physical restraint, and forced acute tranquillising medication) were identified. Ten of the reviews explicitly included MR, several of them quite recent (38-42), and all of the reviews described the absence of high-quality research1. No meta-analyses or meta-syntheses2 were identified. Thus, which preventive interventions are effective and which interventions only appear to be effective due to favourable study conditions remain unknown. Physical restraint/holding, constitutes a coercive intervention in itself but is also employed as part of several other procedures e.g. MR, seclusion, and forced acute tranquillising medication. Thus if preventive interventions reduces the number of seclusions, forced acute tranquillising medications or physical restraints, they are likely also effective in reducing MR. After all, each of these modalities represents a staff management strategy towards aggressive or self-mutilating/suicidal patient behaviours. Numerous factors have been recommended to reduce the use of MR, including risk management, physical environment, and alarm systems, staff attitudes and care alliance. In risk prediction, the often highlighted issues include antecedents, warning signs, and risk assessments. The training, education, skills, competencies, and attitudes of the staff who work with psychiatric patients, as well as the de-escalation methods and techniques, post-incident review, staff environmental factors (both mental and physical working environment), medication, effective illness and abuse treatment, effective observation, and physical training have also been considered (43;44). Although some of these actions have been locally proven to reduce the number of times MR is used (45;46), national figures have failed to significantly decrease in some countries, e.g., Denmark and Norway (26;47). 5 Objective As described in the introduction, MR is presumed to be the most intrusive intervention towards aggressive or self-mutilating/suicidal psychiatric inpatients in Denmark. MR is considered a highrisk intervention for both patients and staff, and many preventive interventions, mostly non-medical 1 High quality research may comprise the following types: qualitative such as at least one high-quality meta-synthesis, systematic review, meta-summary, or a body of high-quality evidence; or quantitative such as at least one metaanalysis, systematic review or body of high quality RCTs. 2 A meta-synthesis is similar to a quantitative meta-analysis. Definition: Meta-synthesis “is the bringing together and breaking down of findings, examining them, discovering essential features, and, in some way, combining phenomena into a transformed whole” (Schreiber, R., Crooks, D., and Stern, P. N. Qualitative Meta-analysis. Morse, J. M. Completing a Qualitative Project: Details and Dialogue. 311-326. 1997. Thousand Oaks, Sage). 13 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE in nature, have been suggested in the international literature. Despite political/legislative initiatives, the number of MR episodes does not seem to be decreasing in Denmark; thus, the overall objective of this thesis was to generate knowledge of non-medical MR-prevention. The four studies that contributed to this objective had separate purposes: Study 1: Which conditions in nursing and which nursing interventions have been shown to reduce the frequency of mechanical restraint episodes? Study 2: To compare the use of coercive measures on psychiatric inpatients between Denmark and Sweden, Norway, Finland, Iceland, Belgium, The Netherlands, United Kingdom, Ireland, France, and Italy, in order to share knowledge and learn about what other countries do to minimize coercion. Study 3: How are presumed MR-preventive factors of non-medical origin associated with the frequency of MR episodes in Denmark and Norway? Study 4: To examine how presumed MR-preventive factors of non-medical origin may explain the differing number of MR episodes between Denmark and Norway. 6 Design and Methods To generate knowledge of non-medical MR-prevention, the research was designed in the following manner: 1. A systematic review of international research papers, combining quantitative and qualitative research, was conducted to identify evident and effective MR-preventive factors (Study 1). 2. A descriptive comparative investigation, regarding the use of coercive measures in European countries, was performed to gain knowledge about the use of coercion in other European countries and to identify a comparable country that uses less MR to be included in the subsequent questionnaire survey (Study 2). 3. A questionnaire survey based on the results of the review (Study 1) was conducted to examine the relationship between the number of MR episodes and the degree to which the MR-preventive factors were implemented in “closed” psychiatric units in Denmark and Norway (Studies 3 and 4). 14 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE 4. Finally, two analytic investigations were conducted to identify the potential associations between the number of MR episodes and MR-preventive factors (Study 3) and to determine to what degree the identified MR-preventive factors could explain the different number of MR episodes between Denmark and Norway (Study 4). Regarding the systematic review (Study 1), this particular design was chosen because very few RCTs and no meta-analyses were found. Therefore, searches were not limited to these study designs. Additionally, some of the areas under investigation could not be covered by quantitative papers alone. Therefore, a combination of quantitative and qualitative papers into ranked recommendations was developed to deduce maximal information from the available papers. The systematic review process was based on the principles outlined by, first, the Danish Reference Programme Secretariat (DRPS) (48), and the National Institute for Health and Clinical Excellence (NICE) (43) for the evaluation of the quantitative research, and second, by Sandelowski and Barroso (49) and Kearney (50) for the evaluation of the qualitative research. The Scottish Intercollegiate Guidelines Network (SIGN) (51) inspired the process of the combined evaluation of both qualitative and quantitative research. The combination of principles from the above mentioned sources was necessary because no one source in itself covered both quantitative and qualitative research quantification. The stages of the review process were as follows: developing the scope of the review, drafting review questions with a clinical focus, and inclusion and exclusion criteria, implementing a search strategy and search phrases, identifying sources of evidence, carrying out searches, sifting through the evidence, extracting relevant data from studies meeting both the methodological and clinical criteria, evaluating the methodological quality using relevant checklists, compiling papers into relevant evidence tables, interpreting and grading each paper, abstracting interventions, summarising intervention levels, separately grading the recommendations for the quantitative and qualitative evidence, and summarising the whole body of evidence. The scope of the review was to answer the following question: which conditions in nursing and which nursing interventions have been shown to reduce the frequency of MR episodes? Next, review questions were developed, e.g. “Do communicative de-escalation techniques prevent MR?” or “Do specific types of limit-setting prevent MR?” The searched papers included original peerreviewed papers on the care of adult psychiatric inpatients that were physically restrained. Physical restraints were included in several procedures e.g. MR, seclusion, and forced acute tranquillising medications; as such, if the preventive factors described in the literature reduces the number of 15 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE seclusions, forced acute tranquillising medications, or holdings, they are likely to be effective towards MR reductions as well. Papers were excluded if they were reviews, or if they described interventions and conditions to prevent physical restraint in non-psychiatric inpatient settings, learning disability settings, nursing homes, or prisons. The papers were obtained from 1998 to April 2009. The searches included English, Danish, Norwegian, and Swedish language citations, all with English abstracts. A total of 84 key words were used in different combinations and inflections in the search, e.g. affect, aggression, alliance, coping, debriefing, intervention, and restraint. The structure of the search strategy was as follows: an overarching strategy for conditions and interventions across selected databases, a search to identify guidance and reports (for example, governmental reports, not indexed in the major databases), and topic-specific search strategy on PubMed. For each condition or intervention, evidence supporting effectiveness or harm was sought. A manual search was performed in key areas that were not electronically indexed (e.g., PhD thesis), and the reference lists of the most relevant papers were checked for articles not otherwise found. Sifting through the evidence was completed in three steps. First, we sifted through the material that potentially met the eligibility criteria based on the title/abstract. Second, full papers were reviewed for relevance/eligibility or for vague relevance/eligibility. Third, the papers were critically appraised checked for quality. Checklists for evaluating the methodological quality of the papers, and evidence tables for compiling the studies were gathered (48-50;52-54). Once the individual papers had been assessed by the author for methodological quality and relevance in terms of the clinical questions, they were graded according to the levels of evidence. Grading of the quantitative research papers was conducted as outlined by the DRPS (48). The levels of evidence and grades of recommendation were developed from the DRPS (48), the Method for Evaluating Research and Guideline Evidence (MERGE) (54), and SIGN (51). Grading of the qualitative research was performed according to the levels of complexity in the evidence described by Kearney (50), and the process was inspired by Sandelowski and Barroso (49), Kearney (50), the MERGE (54), the DRPS (48), and the SIGN (51). The evidence for each intervention/condition was then compiled into tables. The quantitative and qualitative grading systems can be found at the end of Appendix A, the different checklists are available upon request from the author. The final synthesis was based on consensus decisions by the four authors of Paper 1 and was guided by the following three questions. Which interventions match the patients’ views and experiences? 16 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Which interventions have yet to be evaluated in clinical settings? Does the effect of the intervention seem plausible from a clinical point of view? The results of the systematic review are displayed in a hierarchy, combining recommendation grades and effects. The recommendation grade describes the ability of an intervention to exert an effect by reducing the number of mechanical restraints in the clinical setting—that is not the degree that such an intervention would reduce the number of mechanical restraints but rather whether the intervention would reduce the number. This procedure is described in five levels from 1 to 5, with 1 being the best. Accordingly, 1 indicates an intervention that most certainly would have an effect on the phenomenon (MR), and 5 indicates a high degree of uncertainty as to whether the intervention would have an impact on or have any relation at all to the phenomenon. Combining the quantitative and qualitative recommendations was achieved by taking the better of the two. The effect is considered as effect of the intervention on MR (MR, seclusion, physical restraint, etc.) reductions, whereas the reduction in the number of MR was divided into five levels from 1 to 5, with 1 being the best and ranging from 80% to 100% reduction, 2 from 60% to 80%, and so on. The effect of the intervention was extrapolated from the quantitative papers and combined in the following manner: with no quantitative papers, the level was set to 5 (0–20% reduction); with one, the level was transferred directly; with two or more the level was first influenced by the paper with the best recommendation grade, second by the paper best describing the intervention, and third by a simple average. Regarding the comparative investigation into the use of coercive measures in European countries (Study 2), this particular design was chosen to screen selected European countries based on their use of coercive measures. This aim was achieved in two ways: first, by reviewing international reports, research literature, and national registers, and second, by performing a survey that asked government officials and medical specialists to complete a questionnaire. Primarily to examine “numbers” on background features and coercive measures, the literature review covered the legislation and coercive measures used in psychiatry across Europe follows: forced medication/long period, forced medication/short period, MR, seclusion, holding, time out, and constant observation. The review was conducted between April and June 2009, with an update in March 2010, and covered the years from 1999 to 2010. The searches included literature in the following languages: English, Danish, Norwegian, Dutch, Finnish, and Swedish. The search strategy was structured as: an overall search for legislation and coercion across selected databases, a 17 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE search to identify registers and reports (e.g. governmental reports not indexed in the major databases), a topic-specific search on PubMed, and lastly, the reference lists of the most relevant papers to identify articles not otherwise found. Once the references were retrieved, sifting process was initiated including a first sift for material that potentially met the eligibility criteria based on title/abstract and a second sift for the full references that appeared relevant and eligible or in which the relevance/eligibility was not clear from the abstract. Finally, a third sift allowed for the critical assessment of the references. The focused search strategy is laid out in Paper 2, Supplementary, Appendix 1. The questionnaire survey was primarily developed to gather knowledge on the legislation across the selected European countries by the two authors and two representatives from the mental health authorities in Denmark. The questions were based on Danish legislation, and on knowledge gained from nationwide reports and papers (e.g. Policies and practices for mental health in Europe (55), including the compulsory admission and involuntary treatment of mentally ill patients - legislation and practice in EU-member states (56), among other (57-62)). The questionnaire covered legislative practices in the same areas mentioned earlier in the literature review. The construction of the questionnaire followed a guide developed by Olsen (63) comprising six phases: guiding the formulation of the problem, understanding the questions, recalling information, evaluating contextual effects, editing answers, and conducting tests. The test-retest validation was primarily internally conducted among the members of the constructed group, but two responders were asked if they understood and were able to answer the questionnaire. The respondents included governmental health staff working with mental health issues/legislation, because they are the most knowledgeable of the mental health legislation in the selected countries. The questionnaires were sent to the members of the European Platform of Supervisory Organisations (EPSO), a body that was formed in 1996 to create a network of supervisory organisations in health care. Additionally, the questionnaire was sent to the members of the Psychiatric Section of the European Union of Medical Specialists (Union Européenne des médicins Spécialistes, UEMS), to gain knowledge regarding possible differences between the current legislation and its translation into practice. These respondents represent medical specialists in psychiatry from each of the different countries. An example from the questionnaire can be found in Paper 2, Supplementary, Appendix 2. The questionnaire survey was administered between May and July 2009. The results are shown as purely descriptive “raw” data. 18 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Studies 3 and 4 were designed as a cluster cross-sectional questionnaire survey based on the results of the review (Study 1). The survey was conducted to examine the relationship between the number of MR episodes and the degree to which the MR-preventive factors were implemented in “closed” psychiatric units in Denmark and Norway (Studies 3 and 4). Norway, which has very similar legislation, was included in the survey to increase the power of the latter analysis and to strengthen its overall transferability. The following conditions must be present to legally initiate MR according to the Danish Mental Health Act (translated by the authors): Mechanical restraint may be used only when necessary to prevent a patient from 1) exposing their body or health or the body or health of others to danger, 2) pursuing or grossly molesting fellow patients in any other way, or 3) committing significant acts of vandalism. (64) These conditions are consistent with Norwegian legislation (translated by the authors): Restraints may be used on a patient only when absolutely necessary to prevent him or her from damaging him/herself or others or to prevent damage to buildings, clothing, inventory or other things. (65) Additionally, Norway had a lower rate of physical coercion (MR, seclusion, and physical restraint/holding) with 29 patients per 100,000 inhabitants experiencing physical coercion compared with 52 patients per 100,000 inhabitants in Denmark (4). Specifically regarding MR, Denmark had 122 episodes of MR per 100,000 inhabitants compared with 87 episodes of MR per 100,000 inhabitants in Norway in 2007 (66;67). The lower frequency of MR episodes in Norway might indicate that more effective MR-preventive factors have been implemented in Norway compared with Denmark or that MR-preventive factors exhibit differing effects between the countries. In the questionnaire MR is defined as the use of restraining straps, belts or other equipment to restrict movement (1). Notably, this definition refers only to the MR of adult (18-65 years) inpatients in psychiatric hospitals and does not refer to the use of MR in prisons or nursing homes. The MR-preventive factors identified by the literature review (Study 1) were included in an online questionnaire and sent to the clinical nurse managers (the respondents) to quantify whether they were implemented in the units. These managers were chosen because they had exclusive access to the requested information. The Danish questionnaire was administered between 23 December 2009 and 28 May 2010, and the collected data pertained to 2008. The Norwegian questionnaire was administered between 29 19 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE October 2010 and 27 January 2011, and the collected data pertained to the previous 12 months, most of which occurred in 2010. The study included all psychiatric hospital units in Denmark (n = 87) and Norway (n = 96) that treated adult inpatients (18-65 years) and used MR for approximately two years prior to the year of the investigation. MR did occur in Norway in settings other than hospitals; however, given that only 1.5% of recorded MR episodes in 2007 occurred in these settings (67) and that hospitals served as the primary focus, these units were not included. The special high-security department in Denmark was excluded due to specific legislation on coercive measures. If MR was used more than 25 times on the same patient during the investigation period, then the episodes of MR > 25 were excluded. Chance determined the units to which these few patients were admitted, but the presence of these patients could significantly affect the MR frequencies of these units, thereby distorting the results, as described in the introduction. The number of 25 times on the same patient during one year was chosen after visually examining a graph of MR episodes per patient in the Danish cohort. The examination showed that the number of times the same patient experienced MR slowly increased until the point of 25 times, were a rapid increase in times was found, i.e. extreme cases. In the development of the questionnaire each MR-preventive factor was “translated” into questions to identify the degree to which the factor was present in the units. Six factors were not included. Combined intervention programmes were also omitted because of the complexities in their measurement and the implications of other factors, e.g. training, work environment, and early recognition of patient triggers. The following three factors: treatment of substance abuse and psychosis, pro necessitate (p.n.)/as-needed medication guided by individual patients, and carealliance, were omitted because they were not considered to be measured appropriately by a questionnaire, leading to the emergence of eventual confounding effects created by the three factors, was covered by other covariates such as the type of unit, type of bed, number of units nested in the departments, or number of MR episodes experienced by patients with a forensic provision. For instance, if care-alliance was associated to the outcome and was poorer between patients with a forensic provision and the staff, because some are involuntarily admitted for long periods of time, this effect would be reduced by the covariate, number of MR episodes experienced by patients with a forensic provision. Finally, two MR-preventive factors: music used as a diversion or for relaxation, and patients perceived as a resource in their own treatment were omitted, as these factors were partially covered by other factors, such as activity-based nursing and patient 20 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE involvement. The omitted MR-preventive factors only represented a problem for the later analyses if they acted as confounders in the association between the other MR-preventive factors and the outcome; thus, at the same time not associated with one of the covariates making them act as proxy covariates. The odds for this situation to occur are very small. Cognitive milieu therapy and patient involvement as well as patient-centred care and patient involvement were separated into three factors: cognitive milieu therapy, patient-centred care, and patient involvement. Although patient involvement is part of cognitive milieu therapy and patientcentred care, patient involvement might also occur by itself. These stipulations left; 22 separate MR-preventive factors to be included in the questionnaire. The questionnaire was developed by conceptualising and operationalising the MR-preventive factors. To increase validity and reliability the Question Appraisal System QAS-99 (68) was utilised to identify problems within the questionnaires, including the cognitive processes inherent in the question-answering process. The construction and pre-testing of the questionnaire involved an eight-step appraisal of each item (QAS-99), as follows: reading, instructions, clarity, assumption, knowledge/memory, sensitivity/bias, response categories, and others. The pre-test was conducted by creating a cognitive-test protocol including probes for each item. The probes covered the aforementioned eight steps and comprised the following types: general, specific, understanding/interpretation, safety, paraphrasing, and memory. The pre-test was performed by cognitively interviewing (69) four clinical nurse managers individually with concurrent probing (70), in which verbal probes were immediately asked after a question. This protocol led to revision of seven questions that were subsequently pre-tested in a group interview. Data collection, administration, processing, error identification, and electronic data file creation (63;71), were conducted using the electronic web-based survey system Enalyzer Survey Solution, Version 2010 (Enalyzer A/S, Copenhagen, Denmark). The questionnaire was checked for test-retest reliability by asking three clinical nurse managers to answer the questionnaire a second time after a three-month interval (the respondents were instructed not to check their previous answers). The estimated mean correlation between all of the first and second answers was reasonable (Kendall’s Taub [Ken, b] = .75). With regard to the Norwegian portion of the study, the questionnaire was translated and retranslated by the author and then checked by two healthcare professionals who were familiar with the subject. A pre-test was conducted to test face validity through cognitive interviews of seven clinical nurse managers. This test led to the revision of eight questions, mostly due to imprecise translations. Moreover, one 21 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE question was added to the questionnaire due to different staff competencies, as psychologists in Norway are partially responsible for their patients’ treatment, which was not the case in Denmark at that time. Later, the outcome variable (i.e., the number of MR episodes) was re-examined. This procedure was necessary due to confusing wording of a heading in the Danish questionnaire and the lack of precise numbers regarding the Norwegian patients who experienced MR more than 25 times (14 answer categories instead of the actual number were provided, causing imprecise exclusion). Reexamination was accomplished by contacting all of the clinical nurse managers in Denmark and four of the clinical nurse managers in Norway. The respondent rate was 94%, and the results lowered the overall frequency of MR by 3.2%. A high correlation coefficient (Ken, b =.89) was found between the two answers, revealing that the confusing heading and the categorisation error did not have an important effect. A description of how the 22 dichotomised MR-preventive factors were measured can be found in Papers 1 and 2. As described in the introduction, several conditions might influence how much MR is used. These conditions include geography (region), type of unit (department), ethnicity other than Danish/Norwegian, gender, diagnoses, and the small number of patients experiencing many MR episodes. In the later analyses unit size, patient flow, bed occupancy, type of bed, reason for the MR, country, and forensic provision, could also possibly have an influence on how often MR is used. The specific background variables included as covariates in the later analyses and the dispersion of MR episodes between the categorised background variables in the subsample (data from the questionnaire survey) can be found within Papers 3 and 4. Finally, two analytic investigations were conducted, the first, to identify the potential associations between the number of MR episodes and the MR-preventive factors (Study 3), and the second, to determine the degree to which the identified MR-preventive factors could explain the different numbers of MR episodes between Denmark and Norway (Study 4). The first analytic investigation was conducted by analysing the data from the questionnaire to identify potential associations between the number of MR and the MR-preventive factors (Study 3). Data analyses were conducted in four steps. We first examined how the factors were individually associated with the number of MR episodes (Model 1), and then how the factors were associated with the number of MR episodes, using a model with all factors included (Model 2). To eliminate 22 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE multicollinearity and the chance that important effects may hide each other from Model 2, a third model was constructed by a forward factor-selection procedure, in which the most significant factors were included stepwise until the corrected quasi-likelihood under the independence model criterion (QICC) value began to rise, denoting no further improvement for the model (Model 3). All of these models were adjusted for potentially confounding variables. Additionally, we adjusted for the nesting of units in departments — 17 departments containing two units each and three departments containing three units each — by a Generalised Estimating Equations (GEE) technique. Finally, we analysed the correlations among the factors by Pearson’s correlation coefficient, adjusted for department, to explore multicollinearity and to justify a reduction of Model 2. In Models 1–3, linear regression was used to assess the associations between the number of MR episodes and the chosen factors. To stabilize the variance, the outcome was logarithmically transformed. Hence, the regression coefficients are reported back-transformed (exponentiated; exp[B]) and must be interpreted multiplicatively. Hence, because the preventive factors were dichotomized, a regression coefficient exp(B) indicates the average number of times MR increased for units in which this factor was present compared with units in which this factor was absent. To account for multiple testing, a p value < .01 was chosen to indicate significance. The second analytic investigation was conducted by analysing the data from the questionnaire to determine the degree to which the identified MR-preventive factors could explain the different number of MR episodes between Denmark and Norway (Study 4). The data analyses were conducted in five steps. First, the difference in the frequency of MR episodes between the countries, was analysed. Second, how the factors were individually associated with the number of MR episodes in Denmark and Norway was separately investigated. Third, we assessed whether an interaction between MR-preventive factors and the country (second order interaction, SOI) existed. Fourth, the difference in the prevalence of MR predictive factors between the two countries was probed using Pearson’s chi-square test (χ2). Fifth, the confounding effects of the MR-preventive factors, i.e., the difference in the effect of the country in models with and without the corresponding MR-preventive factor expressed as a percentage (∆ exp[B]); a percentage greater than 10% was chosen to denote a significant difference. Linear regression was used to estimate the associations among the frequency of MR episodes, countries, and MR-preventive factors. To stabilise the variance, the outcome was logarithmically transformed. Hence, the regression coefficients are backtransformed (exponentiated; exp[B]) and should be interpreted multiplicatively. Because the preventive factors were dichotomised, the regression coefficient exp(B) indicates the average number of times the MR increased for the units in which a factor was present compared with the 23 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE units missing this factor e.g., result of exp(B) = 0.42 should be interpreted as 0.42 times the average number of MR incidents without the MR-preventive factor or 58% fewer MR episodes that occur with the MR-preventive factor than would without it. Except for the first analysis, in which the dichotomised variable was the “country,” the regression coefficient exp(B), indicates the difference between the countries in the average number of MR episodes. Further, all models, except the fourth set of analyses (χ2-test), were adjusted for background variables. Adjustments were made for the nesting of units in the departments (17 departments contained two units each and three departments contained three units each) using a GEE technique. To account for multiple testing, a p-value < .01 was chosen to indicate significance. All analyses were performed using IBM SPSS Statistics for Windows, Version 19.0 (released in 2010; Armonk, NY, IBM Corp.). 7 Results 7.1 Summary of Results, Study 1 Mechanical Restraint – Which Interventions Prevent Episodes of Mechanical Restraint? – A Systematic Review. This systematic literature review was conducted to identify which conditions in nursing and which nursing interventions have been shown to reduce the frequency of mechanical restraint episodes. The search yielded a total of 2,885 papers. After three sifts, a final number of 59 papers were included in the further review process. Of these, 48 papers were quantitative and 11 papers were qualitative (a table presenting the appraisal, grading, and combination of the recommendations regarding the MR-preventive factors can be found in Appendix A). Upon hierarchically displaying the preventive factors (Table 1), the implementation of cognitive milieu therapy e.g. through patient involvement and empowerment; combined intervention programmes e.g. patient participation, patient education, staff education, programmatic changes, high-level administrative endorsement, cultural changes, and data analysis; and implementation of patient-centred care with a high degree of patients´ positive involvement in their own care reduces the number of mechanical restraint episodes. These are among the three highest ranking MRpreventive factors. 24 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Table 1. Hierarchy of Mechanical Restraint Preventive Factors Rank 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Preventive factor (reference) Implementation of cognitive milieu therapy reduces the number of mechanical restraint episodes, among other things through patient involvement and empowerment (72;73) Combined intervention programmes are effective in avoiding mechanical restraints, for example, patient participation, patient education, staff education, programmatic changes, high-level administrative endorsement, cultural changes, data analysis, etc. (45;46;74-76) Implementation of patient-centred care with a higher degree of patients´ positive involvement in their own care reduces the number of mechanical restraint episodes (73;77;78) The identification of the patients’ crisis triggers unique calming techniques and decisions on specific crisis interventions early in the admission procedure, thereby reducing the number of mechanical restraints (79-82) Introduction of validated risk assessment systems including suggestions of care interventions reduce the number of mechanical restraints (83-85) Effective treatment of substance abuse and psychosis reduces the number of mechanical restraint episodes; the treatment of mental illnesses is also described elsewhere in the review (73;77;78;86) Mandatory review from qualified clinical experts, for example, as post-incident review minimizes the number of mechanical restraint episodes (87;88) Better staff training reduces the number of mechanical restraints (longer duration of the training, more staff participating, use of different and involving education methods, higher quality of the content and greater diversity of the topics, for example, legislation, crisis management, physical intervention strategies, antecedents, warning signs, de-escalation techniques etc.) (20;79;89-96) Staff attitudes such as positive care for the patients, respect, collaboration, communication, humanism, empathy and less control and involuntary procedures, reduce the number of mechanical restraints (1;81;95;97-102) Higher patient-staff ratio reduces the number of mechanical restraints (103;104) The higher educated staff, the fewer episodes of mechanical restraints (90;93;95;105;106) The more experienced staff, the fewer episodes of mechanical restraints (90;93;95;105;107;108) If nurses change their focus from considering the patient as deviant to being a resource in their own treatment it would decrease the number of mechanical restraint (109) Early and adequate administration of oral p.n. medication guided by the individual patients´ problems, medication experiences, and preferences leads to fewer mechanical restraint episodes (80;81;97;110;111) Debriefing, defusing and crisis intervention minimize the number of mechanical restraint episodes (20;79;105;112) Patients´ response to rules can be positive and lead to fewer cases of mechanical restraint. For instance, if staff helps patients to understand not only the rules, but also the rationale for the presence of such rules. If the staff manages to make patients understand that the rules are imposed out of concern for their welfare, then patients may be less reluctant to following these rules (81;100-102;113) Activity-based nursing interventions e.g. physical activities are effective in avoiding mechanical restraints (81;114) Several mental and physical working environmental factors influence positively the number of mechanical restraints, for example, good management as a high degree of order, organization, or support; adequate staffing, psychiatric training, rotation, education, no crowding, emergency backup, etc. Several of these factors are described elsewhere in the review (20;115-118) Less crowding, for example, less stimuli, less environmental stress and more personal space decrease the number of mechanical restraints (81;119) Higher regular staff and lower substitute ratio reduce the number of mechanical restraints (20;95;120) Staffs´ opposition towards mechanical restraint, due to the perception that mechanical restraint is ethically problematic, decrease the number of mechanical restraints (121;122) Alarm systems, for example, video surveillance and radio systems and well trained response teams, reduce the number of mechanical restraints (123) Better care-alliance between patients and the nursing staff reduces the number of mechanical restraints (104) Communication especially communicative de-escalation reduces the number of mechanical restraint episodes (124) Well-maintained and familiar surroundings reduce the number of mechanical restraints (125) Music as diversion and relaxation before and after mechanical restraint reduces the number of mechanical restraint episodes (126) Separation of acutely disturbed patients reduces the number of mechanical restraint episodes (81) Note. Rank refers to the number in the hierarchy where 1 is highest/best. p.n. = pro necessitate (as needed). 25 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE The development of the combined recommendation grading system, which describes a single, combined grade for the quantitative and qualitative evidence, allowed studied MR-preventive factors to be displayed within a Figure 2. Effect and Recommendation Grade Matrix matrix of the effect and Effect recommendation grades, in 1 1 2 2,3 which the recommendation grade and effect were weighted as equally important. The 3 6,7 4 9,10 8 recommendation grade describes the evidence 4 5 5 regarding a specific 14,15,16,17, 18,19,20,21, 11,12,13 22,23,24,25, 26 27 5 4 3 intervention level of scientific “truth” or its potential for 2 1 clinical application on a scale Recommendation grade from 1 to 5, for which 1 is the Figure 2. The numbers in the matrix refer to a specific factor (the fist number in the hierarchy of the mechanical restraint preventive factors). Recommendation grade describes the evidence regarding a specific intervention level of scientific “truth” or its potential for clinical application, from 1 to 5, where 1 is the highest/best. Effect refers to the reduction in the number of mechanical restraints, from 1 to 5, with 1 being the best, from 80% to 100% reduction, 2 from 60% to 80%, etc. highest/best. The effect refers to the reduction in the number of MR episodes, from 1 to 5, e.g. with 1 representing an 80% to 100% reduction, 2 a 60% to 80%, and so on (Figure 2). No MR-preventive factors reached the highest degree of recommendation combined with the highest level of effect. One MR-preventive factor reached the highest level of effect, with a decrease in MR use of 87%; however, it received a recommendation grade of only 3. Another factor had a recommendation grade of 2 but a decrease in MR use of only 27%. Almost no papers described negative or harmful effects for patients or staff such as increased numbers of staff or patient injuries or increased use of other types of more intrusive coercive measures. Of the 59 papers included in this review, one study, by Bowers (89) identified that attending briefer update courses in physical restraint/holding techniques, triggered small short-term rises in the rates of physical aggression; however, these results are consistent with a threshold effect, indicating that once adequate numbers of staff have been trained, further training keeps incidents rates low. One study by Khadivi (74), detected an increase in assaults on patients and staff after implementing an intervention that included staff education, early recognition, debriefing, and post incident review. Future initiatives are suggested to be followed by safety monitoring and staff training in the management of violent patients. 26 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Corrigendum: Unfortunately, a few minor reference errors were identified after publication; thus, a corrigendum was published (Paper 1, at the end). 7.2 Summary of Results, Study 2 Coercion within Danish Psychiatry Compared with 10 Other European Countries. This investigation was conducted to compare the use of coercive measures on psychiatric inpatients between Denmark and Sweden, Norway, Finland, Iceland, Belgium, The Netherlands, United Kingdom, Ireland, France, and Italy, to share knowledge and learn about what other countries do to minimise coercion. All members of UEMS responded to the questionnaire, but only a few members of EPSO provided answers. Most of the background data (Table 2) and the physical coercion data (Table 4) were retrieved from the literature review and collected from several sources, including national registers, governmental/specialist reports, and research papers (55;57;59-61;66;67;127-133). Data on legally applied coercive measures (Table 3) and the perception of intrusiveness (Table 5) were retrieved from the questionnaire. For the purpose of this thesis, Norway was included in the later described research (Studies 3 and 4), and the results from Denmark and Norway are shown. Table 2 shows the background data from Denmark and Norway. Table 2. Background Data Psychiatric beds per 100,000 inhabitants (55) (2007) Number of forced admissions per 100,000 inhabitants (56;59;131) (1999-2001) Mean length of stay in days (55;57) (1998 and 2007) Forensic psychiatric beds per 100,000 inhabitants (60;61) (2002-2007) Psychiatric beds in jails per 100,000 inhabitants (60;61) (2002–2007) Year of last revision of the psychiatric code (Questionnaire survey - 2009) National register for coercion (Questionnaire survey - 2009) Psychiatrists per 100,000 inhabitants (55) (2007) Nurses working in Mental Health Care per 100,000 inhabitants (55;132) (2007) Denmark Norway 61 70 30 6.6 0 2006 X 11 64 119 135 29 0 0 2006 X 16 N.a. N.a.: No available information. Year: The available data were recorded from 1998 to 2008. The numbers of forced admissions: Denmark: 2000, Norway: 2001. Mean length of stay was in Denmark from 2007 and Norway 1998. Mean length of stay: The median number of days in mental hospitals and community-based psychiatric inpatient units. Denmark: The number of forced admissions includes forced compulsory retention of voluntarily admitted patients; the number on forced admissions alone would be 34. “Nurses working in Mental Health Care” refers to all nurses, the number of specialized nurses was 9 (55;132). The length of stay is only from community-based psychiatric inpatient units. The number of psychiatric beds was almost twice as high per 100,000 inhabitants in Norway (61, 119). The number of forced admissions was also almost twice as high per 100,000 inhabitants (70, 135). The mean length of stay in days was the same (30, 29). Norway had no specialised psychiatric forensic beds (6.0, 0), and neither Denmark nor Norway had psychiatric beds in jails. The last 27 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE revision of the psychiatric code was the same (2006) in 2009, later revisions has since been published. Both Denmark and Norway had a national register on coercion, although Norway only collected complete data some years. Denmark had fewer psychiatrists than Norway per 100,000 inhabitants (11, 16). The number of nurses working in mental health care in Norway was unavailable. Table 3 shows the applied methods of coercion from the two countries. Table 3. Applied Methods of Coercion Forced medication/long period Forced medication/short period Mechanical restraint Seclusion/isolation Physical restraint/holding Time out Constant observation Are other types of coercion used Denmark Norway X X X X X X X X X X X X X Blank: Coercive measures were not in use, allowed, or perceived as a coercive measure in the country. Denmark: If patients complained about the use of forced medication, it would give 2-3 weeks delayed effect before medication could be initiated. During mechanical restraint, constant observation was required. Seclusion had only been allowed since 2005 and only in a particularly high security department for extraordinarily dangerous psychiatric patients. Physical restraint was only used few minutes in connection with other coercive measures. Time out was not regarded as coercion. Constant observation as a coercive measure was first reported if it was prolonged more than 24 hours. Norway: Seclusion was only allowed in acute situations and was not to be used if patients were under 16 years. Time out was not regarded as coercion. Constant observation was first regarded as a coercive measure after 12 to 24 hours. Denmark and Norway applied the same methods of coercion, except for seclusion, which was only allowed in a special high security department in Denmark. Table 4 shows the usage of the three most frequent physical coercive measures: MR, seclusion, and physical restraint/holding (physical restraint/holding not as part of MR or seclusion, but as the only coercive measure). Table 4. Physical Coercion per 100,000 Inhabitants in Denmark and Norway Mechanical restraint Seclusion/isolation Physical restraint/holding Denmark Norway 34 0 18 21 2 6 Denmark: 2007. The numbers included: geronto-, child/adolescent, and forensic psychiatry (66). In Denmark, it was possible for the patients to be subjected to voluntary mechanical restraint, which occurred in 10% of all incidents. Norway: 2007. The numbers included: geronto-, child/adolescent, and forensic psychiatry (67). In 2007, Denmark used more MR and physical restraint/holding than Norway (34, 21 and 18, 6). Norway used more seclusion/isolation than Denmark, but no numbers from the Danish high security department were available. Table 5 shows the ranking of the coercive measures with respect to perceived intrusion in the two countries. 28 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Table 5. Ranking of Coercive Measures With Respect to Perceived Intrusion Forced medication/long period Forced medication/short period Mechanical restraint Seclusion/isolation Holding/physical restraint Time out Constant observation Mechanically restraint ambulatory Denmark Norway 5 4 7 6 3 1 2 8 8 7 6 4 3 1 2 5 Forced medication/short period: Was defined as medicine given against the patient’s will in an emergency (not medical treatment for a longer time according to treatment plan). Forced medication/long period: Was defined as medicine given against the patient’s will, as treatment (medical treatment for a longer time according to treatment plan). Mechanically restraint ambulatory: Was defined as the use of restraint devices, which allow patients to be out of bed and to walk around. The degrees of intrusion for the coercive measures were perceived differently in the two countries, In Denmark ambulatory MR, MR, and seclusion/isolation are perceived as the most intrusive measures, whereas forced medications were perceived as the most intrusive in Norway. 7.3 Summary of Results, Study 3 Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish– Norwegian Association Study. In this study, a cross-sectional questionnaire was used to identify how the presumed MR-preventive factors of non-medical origin were associated with the frequency of MR episodes in Denmark and Norway. The responding and non-responding clinical nursing managers in the units were equally distributed across the countries (overall response rate = 49%). Data from 43 and 47 units were included in Denmark and Norway receptively. The reasons for non-response were indicated by the clinical nurse managers as “change of clinical nurse manager” (n = 9), “lack of personal resources to accomplish the task” (n = 7), sick leave (n = 5), inability to remember/identify the number of MR episodes (n = 5), and lack of belief that this type of research was beneficial (n = 1). The remaining 63 nurse managers did not provide a reason. The respondents reported 2,361 MR episodes in Denmark and 1,017 MR episodes in Norway during the examined one-year time period (2008 in Denmark and 2010 in Norway); nine units accounted for 451 of the excluded MR episodes (> 25 per individual), leaving 1,938 episodes in Denmark, and 989 in Norway for analysis. Table 6 shows the results from the analyses. 29 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Table 6. Effects of Potential Mechanical Restraint Preventive Factors on the Annual Number of Mechanical Restraint Episodes Model 1 MR-preventive factors Cognitive milieu therapy vs. no cognitive milieu therapy Patient involvement vs. no patient involvement Patient-centred care vs. no patient-centred care Identification of the patient’s crisis triggers vs. no identification Risk assessment vs. no risk assessment Mandatory review vs. no mandatory review Staff training (> 50% vs. less) Positive staff attitudes vs. less positive Patient-staff ratio (> 3 staff per patient vs. less) Staff education (> 3 years vs. less) Staff experience (> 5 years vs. less) Debriefing, defusing vs. none Positive patient responses to rules vs. negative responses Activity-based nursing vs. no activity-based nursing Acceptable work environment vs. poor work environment No crowding vs. crowding Substitute staff (< 50 vs. more) Staff opposition to MR (many vs. some) Alarm systems (many and well-trained responses vs. less well-trained responses) Communication (all staff have communicative skills vs. less than all staff) Well-maintained, clean and tidy surroundings (always vs. seldom) Separation of acutely disturbed patients vs. no separation Model 2 Model 3 exp(B) 95% CIs of exp(B) p exp(B) 95% CIs of exp(B) p exp(B) 95% CIs of exp(B) p 0.75 0.51 0.79 0.73 2.01 0.41 1.08 1.15 0.72 1.16 0.76 1.20 0.82 0.93 0.54 0.56 0.82 0.85 1.12 1.08 0.69 1.55 [0.26, 2.07] [0.29, 0.88] [0.30, 2.06] [0.46, 1.15] [0.84, 4.81] [0.23, 0.73] [0.69, 1.69] [0.61, 2.16] [0.42, 1.24] [0.39, 3.41] [0.47, 1.23] [0.81, 1.70] [0.46, 1.47] [0.51, 1.70] [0.33, 0.90] [0.34, 0.92] [0.51, 1.32] [0.54, 1.34] [0.42, 3.00] [0.66, 1.75] [0.41, 1.17] [0.95, 2.52] .57 .02 .62 .17 .12 .00 .74 .67 .24 .79 .27 .36 .50 .82 .02 .02 .42 .49 .82 .77 .17 .08 0.67 0.14 0.42 0.45 2.91 0.27 3.60 1.15 1.36 0.14 0.40 0.85 0.34 1.65 1.09 0.50 0.57 1.12 2.31 1.53 1.08 1.14 [0.37, 1.18] [0.07, 0.30] [0.17, 1.01] [0.29, 0.72] [1.28, 6.60] [0.18, 0.39] [2.49, 5.20] [0.58, 2.26] [0.83, 2.21] [0.06, 0.32] [0.24, 0.67] [0.59, 1.22] [0.19, 0.62] [1.08, 2.51] [0.76, 1.58] [0.31, 0.80] [0.33, 1.01] [0.77, 1.62] [1.15, 4.63] [0.84, 2.81] [0.71, 1.66] [0.73, 1.78] .17 .00 .05 .00 .01 .00 .00 .69 .22 .00 .00 .39 .00 .02 .64 .00 .05 .56 .02 .17 .72 .57 . 0.42 . . . 0.36 . . . . . . . . . 0.54 . . . . . 1.65 . [0.25, 0.73] . . . [0.21, 0.63] . . . . . . . . . [0.36, 0.81] . . . . . [1.10, 2.49] . .00 . . . .00 . . . . . . . . . .00 . . . . . .02 Note. MR = Mechanical restraint. The exp(B) parameters were estimated using a linear regression, and all three models were adjusted for the background variables: geography, unit size, bed occupancy, type of bed, reason for the MR, forensic provision, ethnicity, and type of unit. Additionally, the nesting of units in departments was adjusted using GEE techniques. In Model 1, the MR-preventive factors were analysed alone. In Model 2, all MR-preventive factors were analysed together. In Model 3, a forward-selection procedure included the most significant MR-preventive factors until the Corrected Quasi Likelihood under Independence Model Criterion (QICC) value began to rise. In all three models, the outcome variable (i.e., the number of MR episodes) was log-transformed. Hence, the parameters should be interpreted multiplicatively (e.g., in Model 1, cognitive milieu therapy results in exp(B) = 0.75 times the average number of MR incidents without cognitive milieu therapy (or 25% fewer MR episodes occur with cognitive milieu therapy compared with without therapy). p < .01. The grey marking denotes the most important values. 30 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Table 6 indicates that in Model 1, which evaluated the associations separately, only one MRpreventive factor was significantly associated with a low frequency of MR episodes: mandatory review (exp[B] = .41, which is interpreted as a 1-.41 = 59% decrease in MR episodes). In Model 2, in which the associations were evaluated jointly, seven MR-preventive factors were significantly associated with a low frequency of MR episodes: patient involvement (exp[B] = .14), staff education (exp[B] = .14); mandatory review (exp[B] = .27); positive patient responses to rules (exp[B] = .34); staff experience (exp[B] = .40); identification of the patient’s crisis triggers (exp[B] = .45); and crowding (exp[B] = .50). Staff training was the only MR-preventive factor that was significantly associated with a high frequency of MR episodes (exp[B] = 3.60). In Model 3, in which we attempted to strike a balance between residual confounding (Model 1) and over-fitting (Model 2), three MR-preventive factors were significantly associated with a low frequency of MR episodes: mandatory review (exp[B] = .36); patient involvement (exp[B] = .42); and crowding (exp[B] = .54). Pearson’s correlation matrix identified one highly correlated (Pearson’s r > .50) pair of MRpreventive factors: communication and positive staff attitudes (Pearson’s r = .77). Furthermore, the following six pairs exhibited a medium correlation (Pearson’s r .30 ≤ .50): patient-centred care and cognitive milieu therapy (Pearson’s r = .49); communication and staff opposition to MR (Pearson’s r = .38); substitute staff and activity-based nursing (Pearson’s r = .36); communication and risk assessment (Pearson’s r = .32); positive patient responses to rules and identification of the patient’s crisis triggers (Pearson’s r = .31); and staff education and cognitive milieu therapy (Pearson’s r = .31). All correlations were significant (p < .01). 7.4 Summary of Results, Study 4 Comparing the effect of non-medical mechanical restraint preventive factors between psychiatric units in Denmark and Norway. The data acquired from the cross-sectional questionnaire (the same as in Study 3) was analysed to examine how presumed MR-preventive factors of non-medical origin may explain the differing numbers of MR episodes between Denmark and Norway. The responding and non-responding clinical nursing managers of the units were equally distributed across the countries (overall response rate = 49%). Data from 43 and 47 units were included in Denmark and Norway respectively. The reasons for non-response were indicated by the clinical nurse managers as “change of clinical nurse manager” (n = 9), “lack of personal resources to 31 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE accomplish the task” (n = 7), sick leave (n = 5), inability to remember/identify the number of MR episodes (n = 5), and lack of belief that this type of research was beneficial (n = 1). The remaining 63 nurse managers did not provide a reason. The respondents reported 2,361 MR episodes in Denmark and 1,017 MR episodes in Norway during the examined one-year period (2008 in Denmark and 2010 in Norway); nine units accounted for 451 of the excluded MR episodes (> 25 per individual), leaving 1,938 episodes in Denmark, and 989 in Norway for analysis. A difference in the number of MR episodes was observed between the countries in the model that included the background variables (exp[B] = 1.92, p = .01); Denmark had 1.92 times as many (92% more) MR episodes than Norway. Table 7 shows the results of the analyses. 32 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Table 7. Differences in the Effects of Potential Mechanical Restraint Preventive Factors on the Annual Number of Mechanical Restraint Episodes in Denmark and Norway Denmark MR-preventive factors Cognitive milieu therapy vs. no cognitive milieu therapy Patient involvement vs. no patient involvement Patient-centred care vs. no patient-centred care Identification of the patient’s crisis triggers vs. no identification Risk assessment vs. almost none or no risk assessment Mandatory review vs. no mandatory review Staff training (> 50% vs. less) Positive staff attitudes vs. less positive Patient-staff ratio (> 3 staff per patient vs. less) Staff education (> 3.5 years vs. less) Staff experience (> 5 years vs. less) Debriefing, defusing vs. none Positive patient responses to rules vs. negative responses Activity-based nursing vs. no activity-based nursing Acceptable work environment vs. poor work environment No crowding vs. crowding Substitute staff (< 50 vs. more) Staff opposition to MR (many vs. some) Alarm systems (many and well-trained responses vs. less well-trained responses) Communication (all staff possess communicative skills vs. less than all staff) Well-maintained, clean and tidy surroundings (always vs. seldom) Separation of acutely disturbed patients vs. no separation No % exp(B) 5 34 5 29 9 8 20 4 2 3 36 28 32 15 6 19 8 11 13 81 13 69 21 19 49 10 5 7 84 72 78 38 14 51 19 27 0.36 0.66 0.41 0.65 2.85 0.38 1.26 1.30 0.96 0.34 0.81 0.79 0.61 0.78 0.52 0.59 0.59 1.09 95% CIs of exp(B) [0.11, 1.16] [0.26, 1.71] [0.12, 1.38] [0.38, 1.10] [1.28, 6.36] [0.15, 0.97] [0.65, 2.46] [0.56, 2.99] [0.45, 2.06] [0.17, 0.66] [0.45, 1.44] [0.46, 1.36] [0.29, 1.29] [0.34, 1.79] [0.22, 1.25] [0.31, 1.13] [0.32, 1.10] [0.47, 2.54] Norway p .09 .40 .15 .11 .01 .04 .49 .54 .91 .00 .47 .40 .20 .56 .14 .11 .10 .84 3 86 10 93 37 15 48 28 53 93 98 65 85 54 40 59 73 39 7.46 0.60 5.01 0.75 1.39 0.53 0.88 1.28 0.62 0.76 0.56 2.04 1.92 0.69 0.55 0.55 0.54 0.70 95% CI p of exp(B) [2.94, 18.89] .00 [0.27, 1.31] .20 [2.03, 12.36] .00 [0.26, 2.17] .59 [0.60, 3.26] .45 [0.21, 1.37] .19 [0.39, 2.01] .76 [0.53, 3.06] .59 [0.32, 1.19] .15 [0.28, 2.04] .59 [0.14, 2.19] .41 [1.07, 3.89] .03 [0.49, 7.44] .35 [0.25, 1.88] .47 [0.30, 1.03] .06 [0.27, 1.14] .11 [0.25, 1.18] .12 [0.30, 1.63] .41 No % exp(B) 1 37 4 40 17 7 21 13 25 43 44 24 34 22 17 20 33 17 SOI χ2 Δ exp(B) Interaction between the MR-preventive factor and the country Difference in the prevalence of the MR predictive factor between countries Difference in the effect of country p p % .00 .80 .00 .67 .13 .97 .22 .75 .56 .05 .84 .02 .80 .53 .93 .22 .33 .65 .09 .53 .72 .01 .11 .60 .92 .03 .00 .00 .02 .52 .42 .14 .01 .53 .00 .25 6 -2 3 -10# 7 -1 0 3 -11# -51# -1 -3 -1 -6 -15# 6 -17# -1 7 0.18 [0.03, 1.17] .07 5 11 3.72 [2.16, 6.41] .00 .00 .50 4 8 20 1.56 23 55 0.89 21 50 1.05 [0.85, 2.85] .15 [0.42, 1.87] .75 [0.46, 2.40] .90 17 36 29 63 38 83 1.03 1.03 1.94 [0.51, 2.10] [0.53, 2.04] [0.92, 4.09] .93 .92 .08 .43 .63 .28 .08 .43 .00 3 0 13# 3 Note. MR = Mechanical restraint. No = the number of units where the factor was present. % = the percentage of units where the factor was present. Exp(B) = the parameter estimate. The outcome variable (i.e., the number of MR episodes) was log-transformed. Hence, the exp(B) should be interpreted multiplicatively (e.g., in Denmark, cognitive milieu therapy results in exp[B] = 0.36 times the average number of MR incidents without cognitive milieu therapy (or 64% fewer MR episodes occur with cognitive milieu therapy compared without therapy). 95% CI of exp(B) = 95% Wald confidence interval for exp(B). p = p-value. SOI = second order interaction, p-value of a test for the interaction between the MRpreventive factor and the country, i.e., whether the effect of the MR-preventive factor differs between the countries. χ2 = p-value of a chi square test for the difference in the prevalence of the MR-preventive factor in the units between the countries. Δ exp(B) = Differences in the effects of the country in models with and without the corresponding MR factor (confounding effect of the MR-preventive factor) expressed as a percentage; negative Δ exp(B) values should be interpreted as a MR-preventive factor that minimises the difference between the countries. In the estimation of exp(B), SOI, and Δ exp(B), we used linear regression and adjusted for the following background variables: unit size, bed occupancy, type of bed, reason for the MR, forensic provision, ethnicity, and type of unit. Additionally, the nesting of units in departments was adjusted using GEE techniques. = p < .01. # = Δ exp(B) > +/- 10%. The grey marking denotes the most important values. 33 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Table 7 indicates the extent to which the MR-preventive factors explain the differences in MR episodes between Denmark and Norway in several steps. The first column of results in Table 7, in which the MR-preventive factors are evaluated in a similar fashion as in Table 6 (Model 1), indicates that a single MR-preventive factor, staff education (exp[B] = 0.34, p = .00), was significantly associated with a lower frequency of MR episodes in Denmark. In Norway, three MRpreventive factors were significantly associated with a higher frequency of MR episodes: cognitive milieu therapy (exp[B] = 7.46, p = .00); patient-centred care (exp[B] = 5.01, p = .00); and alarm systems (exp[B] = 3.72, p = .00). Notably, the confidence intervals for cognitive milieu therapy and patient-centred care were large, reducing the precision of any estimates of an increase in the MR episodes related to these factors. Various effects noticeably differed between the countries. In the column marked SOI in Table 7, we identified three incidences of an interaction between the MR-preventive factor and the countries: cognitive milieu therapy (SOI, p = .00); patient-centred care (SOI, p = .01); and alarm systems (SOI, p = .00). The presence of these factors exhibited a positive effect in Denmark (exp[B]: 0.36, 0.41, and 0.18) and a negative effect in Norway (exp[B]: 7.46, 5.01, and 3.72). As shown in the column marked χ2 in Table 7, the prevalence was significantly different for six MR-preventive factors between the two countries: the identification of a patient’s crisis triggers (χ2, p = .01); patient-staff ratio (χ2, p = .00); staff education (χ2, p = .00); work environment (χ2, p = .01); substitute staff (χ2, p = .00); and separation of acutely disturbed patients (χ2, p = .00). This represents a criterion of the factors to represent a confounder for the association between country and MR episodes. In the last column of Table 7, six MR-preventive factors were identified, and confounding effects were uncovered for the association between the country and the number of MR episodes, i.e., the MR-preventive factor explained part of the difference in the number of MR episodes between Denmark and Norway. A factor was identified as a confounder if the adjustments for this factor changed the effects of the country by more than 10% (∆ exp[B] > 10%), and the identified factors were as follows: identification of the patients’ crisis triggers (∆ exp[B] = -10%); patient-staff ratio (∆ exp[B] = -11%); staff education (∆ exp[B] = -51%); work environment (∆ exp[B] = -15%); substitute staff (∆ exp[B] = -17%); and separation of acutely disturbed patients (∆ exp[B] = 13%). In both countries, the following MR-preventive factors were associated with lower numbers of MR episodes: identification of patients’ crisis triggers (Denmark, exp[B] = 0.65; Norway, exp[B] = 0.75); the patient-staff ratio (Denmark, exp[B] = 0.96; Norway, exp[B] = 0.62); staff education 34 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE (Denmark, exp[B] = 0.34; Norway, exp[B] = 0.76); work environment (Denmark, exp[B] = 0.52; Norway, exp[B] = 0.55); and substitute staff (Denmark, exp[B] = 0.59; Norway, exp[B] = 0.54). In contrast, the separation of acutely disturbed patients was associated with increased MR episodes (Denmark, exp[B] = 1.05; Norway, exp[B] = 1.94). Corrigendum: Unfortunately, a minor error in the abstract of the paper were identified, the one MRpreventive factor not supported by earlier research was, “separation of acutely disturbed patients” and not as written “the identification of the patient’s crisis triggers”. 8 Approval and Ethics Literature reviews such as those in Studies 1 and 2, do not require approval from the scientific ethical committee system (134). Questionnaire surveys such as those included in Studies 2, 3, and 4 do not require approval from the scientific ethical committee systems of the included European countries if, respondents are able to provide informed consent or if sensitive information is not collected. The Danish Data Protection Agency (Journal number: 2007-2058-0015, PSV-2009-2013) approved the studies and we received permission from the Danish Health and Medicines Authorities and the Danish Psychiatric Central Research Register to use the register data on the frequency of MR in Denmark (31) (Journal number: 7-505-29-1246/1). The studies followed the Ethical Guidelines for Nursing Research in the Nordic Countries (135) and the White Paper Regarding a Draft Recommendation on Legal Protection of Persons Suffering From Mental Disorder Especially Those Placed as Involuntary Patients (136). 9 Discussion 9.1 Discussion of Individual Studies Study 1: Cognitive milieu therapy combined with patient involvement was highest ranked MRpreventive factor. To the best of our knowledge, this result has not been identified in prior reviews. One possible explanation for this could be that the cognitive milieu therapy paper (72) was not published in English; the abstract of this study only described a significant effect and did not quote an exact figure such as a staggering 87% reduction. Later research by Chang (137) supported this finding; this before-and-after study showed a reduction in seclusion and restraint episodes following the implementation of a cognitive therapy training program. Cognitive milieu therapy is an active, structured, problem-orientated, psycho-educational, and dynamic type of care. Cognitive care 35 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE models in this environment give the patient the opportunity to implement new alternatives to inappropriate reaction patterns while also developing new skills (138). One of the core issues in cognitive milieu therapy is a schema-focused dialog between the patient and the nursing staff during situations just before potential MR use. In this moment, the patient has the opportunity to try new actions. This type of patient involvement has also been addressed elsewhere (73) as having a positive influence on the incidence of MR. A later paper by Soininen (139) agreed, concluding that patients´ opinions required greater attention in treatment decisions. Several studies have examined the effect of implementing the “six core strategies” (103;140-147), one of which touts patient involvement. The reason for the present high recommendation grade is the combination of cognitive milieu therapy and patient involvement, because, cognitive milieu therapy had a high effect and patient involvement had high evidence. Synthesising these together adding evidence to cognitive milieu therapy is possible the correct deduction, because patient involvement is part of the care model, all though patient involvement could as well be a phenomenon on its own. The second highest ranked MR-preventive factor was not one particular intervention but rather programs including several interventions such as patient participation, patient education, staff education, programmatic changes, high-level administrative endorsement, cultural changes, and data analysis. Several papers have described different programs (45;46;74-76), indicating an average decrease in the number of MR episodes of 76%. The evidence mostly comprises “beforeand-after” papers; because some of these papers are well founded, the recommendation grade is the same as in the first MR-preventive factor. Later research describing combined interventions with a higher evidence grade (145) could move this MR-preventive factor up in the hierarchy. The third highest ranked MR-preventive factor was the implementation of patient-centred care combined with patient involvement. Here, implementation of the Tidal Model reduced the number of mechanical restraints by 68% (77;78). The Tidal Model is a philosophical approach to mental health discovery that focuses on helping people who have experienced a metaphorical “breakdown” to recover their lives as fully as possible by reclaiming their personal stories of distress and difficulty (148). One of the core elements in the Tidal Model is patient empowerment. Empowerment is only possible if the patients are involved in their own care. Elsewhere, patient involvement has also been found (73) to positively influence the occurrence of MR. Thus, the recommendation grade is the same as in the second MR-preventive factor. As in the first MRpreventive factor, the reason for the high recommendation grade was the combination of patientcentred care and patient involvement, where patient-centred care had a high effect and patient involvement had high evidence. Synthesising these together adding evidence to the Tidal Model is 36 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE possible the correct deduction, because patient involvement is part of the care model, all though patient involvement could as well be a phenomenon on its own. The MR-preventive factor with the highest recommendation grade was no. 5, the introduction of validated risk assessment systems. This has later been supported by one additional cluster RCT by van de Sande (149), investigating implementation of crisis monitoring instruments (Kennedy Axis V and Brøset Violence Checklist [BVC]), the result indicated an insignificant difference between the experimental wards and the control wards of -15% in the risk ratio of seclusion incidents (15% lower risk after the implementation). The difference in the duration of seclusion was significant, with a risk ratio = -45%. These findings added further evidence to this MR-preventive factor, although, it did not change its place in the hierarchy, based on the risk of moderately occurring bias in the study (not blinded and small clusters) and the continuously low effect. When introducing MR-preventive initiatives, only two of the 59 papers described adverse effects (negative consequences), concluding that adverse effects very seldom arises. Never the less, following measures of important adverse effects should always be addressed, when introducing new MR-preventive initiatives. The evidence supporting the different MR-preventive factors has improved since April 2009 (when study inclusion in the systematic review ended). Some of these factors were included in the former discussion of the individual MR-preventive factors; these factors will continue to improve over the next few years. A superficial update in December 2014 revealed 64 new papers. Thus, few MRpreventive factors are closing in on the highest recommendation grade, although no MR-preventive factor has reached the highest recommendation grade. Study 2: This study was not planned to be as an analytic study but took on a more descriptive nature, enabling statistical analyses of the differences among the European countries. For the purpose of this thesis, the data regarding Denmark and Norway are discussed. The number of psychiatric beds was almost twice as high per 100,000 inhabitants in Norway (61, 119) as in Denmark. This trend could be due to the actual numbers or to way the numbers were extracted or recorded by the WHO (55). Investigating later data from the countries central statistical population registers and patient registers, the numbers of mental health hospital beds per 100,000 inhabitants were Denmark, 23.96 and Norway, 22.81, pertaining to the years of 2008 and 2010 (the years of the later questionnaire survey). So the data recorded by the WHO, did not seem accurate. The number of forced admissions was almost twice as high per 100,000 inhabitants; this finding could indicate that patients in Norway were admitted earlier, before they became as aggressive or 37 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE suicidal as patients in Denmark. Alternatively, Denmark has many more forensic psychiatric patients (in 2010, 2,638 forensic psychiatric patients (150)) compared with Norway’s maximum of approximately 500 (the exact number is unknown); although they were unwillingly placed in a psychiatric unit, these patients were not included in the numbers of forced admission . In Norway, there are no specialised psychiatric forensic beds. Regional security departments admit the most aggressive or agitated patients. In Denmark, many forensic patients are placed in ordinary beds, and only the most severe patients are placed in the special forensic units. Denmark had fewer psychiatrists than Norway per 100,000 inhabitants, which could indicate that treatment in Norway is more available and of higher quality. In 2007, Denmark used more MR and physical restraint/holding than Norway. This finding is not easily explained due to the many similarities in legislation (64;65) and treatment culture (10) between the two countries. Norway used more seclusion/isolation than Denmark, but no numbers from the Danish high security department were available to further qualify this difference. Overall, the numbers are small and do not sufficiently explain the differences in the MR and physical restraint/holding figures. Regarding the validity of these figures, in both countries registration of coercive measures are compulsory by law. The figures from Norway were scrutinised by Bremmes (67), who collected complete figures from all institutions using coercive measures. Knutzen (151) have validated 98 randomly selected reasons for restraint, finding kappa values between 0.71 and 0.94 (substantial agreement to almost perfect agreement), the scrutinised protocols were obtained from three psychiatric wards. Although, the Danish figures have not been scientifically validated, the nursing heads of the units answered affirmatively when asked whether all coercive measures had been reported. Furthermore, upon comparing the individual numbers of written records from seven randomly selected units with the national register, the highest difference found was less than 3%. Therefore, the differences between the figures are not likely due to imprecise registration practices. A possible explanation could be different medication practises; this does not apply for forced medication/short period, which showed the same tendencies as MR and physical restraint/holding (in 2009, 107 and 39 episodes per 100,000 inhabitants were recorded in Denmark and Norway, respectively (47;152)), but perhaps for forced medication/long period. In 2013, the number of forced medications was 15.7 and 24.0 per 100,000 inhabitants in Denmark (26) and Norway (153), respectively; some of the differences in MR and physical restraint/holding numbers could perhaps be explained by earlier medication use and the inclusion of more patients in a longer medication period; this does not likely explain much of the difference because Denmark more 38 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE frequently uses forced medication/short period. The last difference regarding medication use could involve differences in the overall amount or the number of doses of medicine, which are indicative of different treatment cultures. The only study found that described this condition was “Comparisons of psychotropic drug prescribing patterns in acute psychiatric wards across Europe” (154), which did not describe the actual relationship between coercion and medication but rather described medication practises in general. This study did not show country differences but did show department differences. Thus, the lower frequency of MR and physical restraint/holding in Norway likely indicates that other factors are “responsible” for the differences. The degrees of perceived intrusion of the coercive measures were perceived differently in the two countries. In Denmark, ambulatory MR, MR, and seclusion/isolation are perceived to be the most intrusive, whereas in Norway, forced medications are perceived as the most intrusive. In particular, the difference regarding forced medication/short period is described within the Norwegian legislation in the following order: MR, isolation, forced medication (isolated episode), and finally, physical restraint (lasting for a short period of time) (65). This order is the same as in the Danish legislation, except for isolation (which is only used in a special high security department) (64). Normally, the most intrusive intervention would be listed first; thus, a misunderstanding on behalf of the Norwegian representative of the concepts “short period” vs. “isolated episode” may have occurred, thereby increasing the similarities between the countries. Study 3: Mandatory review was significant in all three models; correspondingly, no significant inter-correlations with the other factors were identified. Thus, no other factors greatly confounded the association between mandatory review and the number of MR episodes. Mandatory review should be interpreted as follows: the units in which the staff audited, reviewed or conducted a similar systematic follow-up period after each MR episode (to analyse and learn from the episodes) experienced an average of .36 times as many (or 64% fewer) MR episodes compared with units in which a review was conducted only after some episodes or the unit did not conduct a review process. This finding is in line with previous research, which also reported that conducting mandatory reviews of MR episodes was associated with a lower number of MR episodes (87;88;155-157). Previous research has suggested that an optimal process should review all MR episodes within a few days and the review board should comprise an interdisciplinary team, including a nurse specialist, a physician, a psychologist, and the clinical department heads with the supervisory authority to change nursing and treatment practices. Additionally, the review process should require a protocol that includes a description of the episode, the environmental conditions that might have provoked the problem behaviour, possible “crisis triggers,” any unique calming 39 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE techniques identified, patient involvement, medications, and any behavioural treatments and milieu therapies, among other items. Later research also supports this, several studies examining the effect of implementing “the six core strategies” (103;140-147), wherein one of the strategies deals with mandatory review (debriefings), a RCT found a difference between the control wards and the intervention wards of 62%, other studies found an even higher effect. Overall, present research of reasonable quality supports mandatory review. Patient involvement was significant in both Models 2 and 3; the fact that patient involvement was not significant in Model 1 could be explained by the correlations with other factors (albeit not strongly or significantly), e.g., staff training and well-maintained, clean and tidy surroundings. The elements of patient involvement are potentially included in some staff training, and patients who are more involved in their own care may have a greater sense of responsibility towards their surroundings. Thus, the non-significant findings presented in the correlation matrix with regard to patient involvement do not precisely explain which factors influence the association between patient involvement and the number of MR episodes. Patient involvement should be interpreted as follows: units in which the patients participated in ward rounds/conferences, influenced the rules applied to the unit, or influenced what was written in the nurse’s journal experienced an average of .42 times as many (or 58% fewer) MR episodes compared with the units in which no such participation occured. Previous research demonstrated that patient involvement might reduce MR episodes (73;141), and more resent research also supports this idea. Soininen (139) concluded that patients´ opinions require more attention during treatment decisions. In several studies examining the effect of implementing the “six core strategies” (103;140-147), one of the strategies represent an approach to address patient involvement, one RCT found a difference between the control wards and the intervention wards of 62% Subsequent studies found an even higher effect. In this study, patient involvement was measured using three items (whether the patients participated in ward rounds/conferences; whether they influenced the rules; and whether they affected what was written in the nurses’ journals). Patient involvement is a very complex phenomenon and, includes the concept that the patient is the expert on his or her life and that the staff members are experts with regard to the patient’s care or treatment. Accordingly actions are negotiated via dialogue. However, units with a recovery-orientated or empowering approach, that integrate patient involvement with the delivery of care and treatment schould include one of the aforementioned items (whether the patients participated in ward rounds/conferences; whether they influenced the rules; and whether they affected what was written in the nurses’ journals). Overall, patient involvement has been strongly supported as a MR-preventive factor by other research. 40 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Crowding was significant in both Models 2 and 3; one minor but significant inter-correlation between crowding and the staff-patient ratio was identified (Pearson’s r = .24, p < .05). This intercorrelation is logical as more staff creates a perception of more crowding. Crowding should be interpreted as follows: units in which two of three conditions were present experienced an average of .54 times (or 46% fewer) MR episodes compared with the units where only one or none of the conditions was present: only one bed in a patient’s room, more than 25 m2 of all-day-accessible space per patient, and the perception of no crowding. Previous research demonstrated that no crowding might influence the number of MR episodes (81;119;158;159), but none of the four studies supports a causal relationship with the number of MR episodes. One of the MR preventive factors identified in the systematic literature review, namely risk assessment, has been supported by some of the strongest evidence, including two cluster RCTs. One study showed a reduction of 27% in coercive measures (83), and the other showed an insignificant difference of -15% between experimental and control wards in the risk ratio of seclusion incidents (149). We have not found a significant relationship between risk assessment and MR reduction in this study due to the combination of risk assessments for self-destructive/suicidal behaviours and aggressive/violent behaviours. The difference in the risk assessments of self- destructive behaviours is most likely impossible to measure because both Denmark and Norway have focused on this factor over the past several years; thus, almost all institutions have implemented this assessment system. The independent assessment of aggressive/violent behaviour has also become more common. Fifty-five per cent of the patients in the units were systematically assessed for the risk of developing aggressive or violent behaviours; however, this assessment system appears to have been initially introduced in units with high numbers of MR episodes. Another explanation could be that the effect of implementing risk assessment tools was not large enough to be identified in this study. Study 4: Three potential MR-preventive factors displayed very different effects in the two countries; these factors were demonstrated by significant interactions between the MR-preventive factor (cognitive milieu therapy, patient-centred care, and alarm systems) and the country. Each factor exhibited a positive effect in Denmark and a negative effect in Norway, but the prevalence did not differ between the countries. Because of the different effects, the degree of confounding (∆ exp[B]) is impossible to interpret. Although this topic is potentially interesting, we cannot provide clear reasons as to why these factors exhibited different effects in the two countries. Further research is required to explore the different effects of these three MR-preventive factors. 41 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Six MR-preventive factors exhibited a significant difference between the countries with regard to the frequency of MR episodes (∆ exp[B]). First, staff education: Differences were observed in units in which the staff received basic training for at least three and a half years vs. units in which the staff had less than three and a half years of training. This factor explains a large portion (∆ exp[B] = -51%) of the difference in MR episodes between the countries. Staff education has been supported by earlier research. Jannsen (108) reported that seclusion was used more often in units with less-educated staff in the long-term wards. Gim (106) found a significant difference between psychiatric-trained and non-psychiatric-trained staff in identifying and managing the precipitants of violence. In a large 20-year analysis of 1,565 mental health workers, Flannery (160) found that staff who were victims of patients aggression were less formally educated and less trained. None of the studies were RCTs, but well designed otherwise, it is reasonable to deduce, that earlier research supports the role of staff education, in the difference in MR use between the two countries. Higher basic education among the staff probably leaves them with higher analytic, and action competences, even in situations of crisis, thereby reducing the number of MR episodes. Second, substitute staff: Differences were observed in units in which substitute staff was used fewer than 50 times (8-hour shifts) over the year vs. units in which these employees were used greater than or equal to 50 times. The factor explains a large proportion (∆ exp[B] = -17%) of the difference in MR episodes between the countries. The effects of substitute staff were supported by earlier research. Bonner (20) found that both patients and staff discriminated between permanent and regular staff. Bowers (120) reported that adverse incidents were more likely to occur in weeks during which the regular staff was absent. In another study, Bowers (161) noted that increased levels of aggression were associated with an increased use of bank and agency staff. None of the studies were RCTs, but all indicated similar results supporting less use of substitute staff. The substitute staff may lack knowledge of the structures, processes, and patients in the units thereby creating insecurity and disturbances among the most vulnerable patients in the unit. This could be a stressing factor for the patients leading to more aggressive or self-destructive behaviours and hence more MR episodes. Third, work environment: Differences were found in units in which a workplace environment assessment was conducted no or only insignificant physical or mental work-environment problems existed, and the overall work environment was evaluated as acceptable vs. units in which the workplace environment was not assessed, more work-environment problems existed, and the 42 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE overall work environment was evaluated as poor. This factor explains a large proportion (∆ exp[B] = -15%) of the differences in MR episodes between the countries. Assessing the work environment is somewhat complex due to the mix of leadership, degree of order, organisation, staffing, training, and crowding, among other factors. De Benedictis (162) reported that several organisational factors, e.g., team climate, staff perception of aggression and interaction of team-members, were associated with an increased use of seclusion and restraint. Hanrahan (163), observed a relationship between psychiatric nurses’ work environments and inpatients’ environments. Van der Schaff (158), reported a number of building design features that affect seclusion and restraint. Virtanen (159), indicated that patient overcrowding was associated with violent assaults towards employees. Huckshorn (143), found that leaders played a critical role in reducing seclusion and restraint. Camarino (164), found a significant association between work-related factors and certain types of violence. Some of the other examined factors such as staff training and the staff/patient ratio also contribute to the overall work environment. Overall, research supporting the association between MR use and the work environment covers many aspects of a healthy work environment supporting the role of the work environment in accounting for the difference in MR use between the two countries. Regardless of which piece creates a positive work environment, the wellbeing of the staff most certainly affects the wellbeing of the patients. Accordingly, if staff members experience a more positive work environment, then the patient likely also experiences a more positive environment. Fourth, patient-staff ratio: Differences were observed in units in which the staff-to-patient ratio was higher than or equal to three-to-one on average vs. those units in which this ratio was lower than three-to-one. In Denmark, the effect was small, possibly due to the small number of units with an average staff-to-patient ratio higher than three-to-one. This factor explains a large proportion (∆ exp[B] = -11%) of the difference in MR episodes between the countries. The effects of the staff-topatient ratio were partially supported by earlier research. Smith (103) found a 66% decrease in restraint episodes. However, because several factors contributed to the observed effect, the proportion of the MR reduction that is attributable to the 50% increase in staffing remains unclear. Jannsen (108) found that seclusion was more commonly used if the number of patients per staff was greater, in this case in long-term wards. Donat (165) reported a significant association between increased staffing levels and decreased MR and seclusion numbers. However, Owen (117) noted that the relative risk of violence increased with more nursing staff. Additionally, Bowers (161) reported that increased levels of aggressive incidents were associated with increased staffing. Nonetheless, these studies with opposite outcomes did not precisely target MR or seclusion and 43 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE instead focused on violence and aggression; thus their results could have been influenced by staff employment policies, which state that staffing levels are to be increased in units with more aggressive incidents. Our study most likely eliminated this problem by introducing “type of unit” and “type of bed” as confounders. Overall, earlier research specifically dealing with the same conditions supports the finding that the staff-to-patient ratio plays a role in explaining the difference in MR use between the two countries. The mechanisms involved in higher staffing levels suggest that, in such scenarios, the staff may be more able to observe, interact, and cooperate with the patients, likely reducing the number of stressed staff members and thereby calming the environment. The presence of more personal resources for positive reinforcement, support, and communication, would hopefully create a more empowering and recovery-orientated environment for patients. Fifth, identification of a patient’s crisis triggers: Differences were found in units in which the initial nurse evaluation of at-risk patients always contained a written evaluation of aggressive, selfmutilating, or suicidal behaviours (e.g., crisis triggers, unique calming techniques, and coping strategies) vs. units in which the initial evaluation only occasionally or never contained a written evaluation. This factor explains a large proportion (∆ exp[B] = -10%) of the difference in MR episodes between the countries. The identification of a patient’s crisis triggers has been supported by earlier research. In a well-designed before-and-after study, Jonikas (79) observed a significant decrease (between 49% and 99%) in physical restraint episodes after patients were interviewed to determine their crisis triggers and personal crisis management strategies. In a well-designed cluster RCT, Putkonen (145) reported the same tendency, in which the difference between the intervention and control wards was a 62% reduction in seclusion and restraint time after implementing “six core strategies” to prevent seclusion and restraint. In both studies, the effect was attributed to variables other than the patients’ crisis triggers. In a one-way case-crossover-designed study, Fluttert (166) reported that implementing the Early Recognition Method (ERM) decreased the number of seclusions by 54%. The ERM is a technique used by patients and staff to systematically work with the patients’ triggers (early warning signs), crisis intervention, and coping strategies; this is the same identification procedure that we asked the clinical nurse managers about in the questionnaire. Overall, earlier research supports the finding that, identification of a patient’s crisis triggers, is a key part of explaining the difference in MR use between the two countries. The mechanism underlying this process is likely that patients and staff recognise earlier signs of a forthcoming crisis and act together to counteract escalation of the crisis, thereby reducing the risk of a MR episode. 44 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Sixth, the separation of acutely disturbed patients: This single factor had opposing results in that units that were able to separate acutely disturbed patients from other patients had more MR episodes vs. units that were unable to separate patients. The factor explains a large proportion (∆ exp[B] = 13%) of the difference in MR episodes between the countries. This negative association has not been supported by earlier research; in fact, the opposite results have been indicated. In a qualitative content analysis study, Meehan (81) noted that the separation of acutely disturbed patients would reduce the number of aggressive incidents. Because this result is not supported by earlier research, more research is needed to explore the mechanisms involved in placing one or a few patients in a separate and isolated part of the unit. 9.2 Design Issues The initial systematic review was conducted to identify evident and effective MR-preventive factors. We quickly realised that no meta-analyses or meta-syntheses were available. Insufficient high-quality studies covering individual MR-preventive factors were also not found; thus, performing our own was not possible, although this approach would have been optimal. Through such an approach, Studies 3 and 4 would have included powerful hypothesis testing for the effects of the MR-preventive factors in practice. Instead a combined systematic review was developed to identify as many evident and effective MR-preventive factors as possible. The combination of quantitative and qualitative research results might be controversial, but this is becoming more common in highly complex research areas involving human interaction (167). Often the qualitative research is only “recognised” as the lowest recommendation grade, in line with the opinions of respected authorities or reports of expert committees, and not as “real” research. To establish the more evident power of qualitative research, Kearney’s (50) qualitative hierarchy was introduced in the model. Still, in the effect and recommendation grade matrix, the effect side of the matrix is “flawed” due to the basic qualitative research methodology, which does not provide an effect as part of the results or findings. For example, if the combined research does not include quantitative research, it is only provided with an effect of five (the lowest effect level). Regardless, this review does provide more evident “power” for the qualitative research and thereby the combined evidence is greater than of earlier reviews regarding complex areas involving human interaction (MRprevention). Unfortunately, none of the identified MR-preventive factors reached the top end of the evidence hierarchy (here the effect size of the matrix was not very important because this would have been the objective of later investigation) and were unable to provide Studies 3 and 4 with the possibility of powerful hypotheses testing for the effects of the MR-preventives factors in practice. Instead, almost all of the results from the systematic review were investigated in the later studies. 45 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Regarding the comparative investigation of the use of coercive measures in Europe, this was designed as a combination of a literature review and a questionnaire survey. This design was chosen because it allowed for the investigation of practices in a large population in an inexpensive and timesaving maner. A more thorough and ”scientific” design would have be required to examine all parties involved in coercive procedures (e.g., health authorities, psychiatrists, nurses, and patients) using large-scale questionnaire survey or personal interviews regarding the procedures, practices, and the actual use of these measures. This approach would have produced data of a more evident character for analytic investigation. However, this approach would have been very comprehensive, difficult, and expensive to undertake, which was not the task at hand. The two last studies were based on a questionnaire survey, designed to investigate the relationship between the number of MR episodes and the degree to which the MR-preventive factors were implemented in the “closed” units, at a single time point (cross-sectional). This design was chosen because it made it possible to investigate large populations (Danish and Norwegian “closed” psychiatry) and complex phenomena (many MR-preventive factors and confounders) in a reasonable, inexpensive and not very time-consuming maner. Theoretically, the best design would have been to conduct RCTs of all individual MR-preventive factors and to compare the results of these trials. Apart from the excessive use of resources and the lack of psychiatric units necessary to obtain sufficient power in the analyses, such a practice would be impossible because most patients who experience MR are under involuntary/forced admission and are therefore not allowed to participate in trials by law. Another approach would have been to allocate the MR-preventive factors to the units in an efficient experimental design, removing the need for many RCTs. However, given the number of MR-preventive factors requiring envestigation, this approach would still require too many units. Furthermore, many units have previously implemented certain MRpreventive factors. A third approach could be to use a case-control design asking outpatients how and to what extent they had experienced MR-preventive factors (using those who had experienced MR as cases, and those who had not experienced MR as controls). In this scheme, investigating many MR-preventive factors would not be possible because the outpatients would not possess the required information, e.g., patient-staff ratio, staff experience, staff education, and risk assessment. The last approach that may have constituted a stronger design would have been to repeat the data collection over time and to examine the changes in the extent to which MR-preventive factors were implemented and in the number of MR episodes. However, this design was not chosen due to the limited study period and problems with organisational changes, thus, some units experience changes in functions and leaders over a short period of time. The changes in organisational factors would 46 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE have confounded the effects, thus minimising the validity of the study outcome. Ultimately, the chosen design was preferred to investigate multiple MR-preventive factors and confounders in a population of this size. The analytic design of Study 3 was used to identify potential associations between the number of MR episodes and the MR-preventive factors. In Study 4 similar analysis was applied to determine the degree which the MR-preventive factors could explain the different numbers of MR episodes between Denmark and Norway. For the main analyses linear regression was chosen because it is a common and well-known statistical model that yiels easily interpretable results, although, categorising the MR-preventive factors and logarithmically transforming the outcome variable (the number of MR episodes) were nessesary. Because the outcome was a count, Generalised Linear Models (GLMs) e.g. Poison regression could have been optimal, however, the logarithmically transformed outcome variable in a linear regression model, provided a better fit for the statistical model for the dataset (GEE, Quasi Likelihood under Independence Model Criterion [QIC]: 83,417), than Poisson regression (GLM, QIC: 215,816). The resulting model investigated the outcome variable and all MR-preventive factors and covariates/confounders (one nested) in a large population. Using the GEE technique for nesting, we were able to include dichotomised, categorised, and linear covariates in the models. 9.3 Cause and Effect A causal association is one in which a change in the exposure frequency results in a corresponding change in the outcome frequency. Making judgments about causality involves a chain of logic: first, whether the statistical association is valid (chance); next, the strength of the association and to its biological credibility; and finally, the generalisability and consistency of the results with those of other investigations. Assessing the statistical validity of the association involves determining the likelihood that alternative explanations such as chance, bias, or confounding could account for the findings (168). 9.3.1 Chance Chance refers to whether the included participants represent the whole population (168). In Study 1, this objective could be translated as whether all of the papers dealing with MRprevention were obtained in the search strategy; the answer is likely not. However, no other literature reviews at the time had coved other MR-preventive issues, and none included other references. As a result, a very large portion of the available MR-preventive literature was found and investigated. 47 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE In Study 2, all EPSO members did answer the questionnaire, but very few UEMS members answered the questionnaire, thus ascertaining any possible differences between the current legislation and how tits transformed into practice, was impossible. Although we believe that the UEMS members represent the whole population of their country, regarding national legislation, we did not consider questions regarding general perceptions of the intrusiveness of coercive interventions, which could be coloured by an individual’s personal beliefs, to represent the whole population. However, most countries have addressed this question within their legislation (using the measure of less intrusiveness) to disconnect this decision from personal beliefs. Overall, the answers represent the whole population regarding the legislation, if not necessarily the actual practise. In Studies 3 and 4, a response rate of 49% was obtained. Therefore, we can only apply our results to the entire population with some measures of certainty due to the risk of systematic differences between responders and non-responders. Regarding the risk of systematic flaws or differences, we reviewed the non-responders’ reasons for not responding. Most reasons appeared to be unrelated to the questions under investigation. If a failure to respond was caused by a failure to implement preventive factors or connected with high numbers of MR episodes, then our results would be strengthen our findings would be underestimated. A proper drop-out analysis has not been conducted; consequently it is unknown whether the high drop-out rate resulted in systematic flaws. 9.3.2 Bias Bias is an alternative explanation for an observed relationship of an exposure with the outcome in which some aspect of the design or execution of a study introduces a systematic error into the results (168). Selection bias is normally described as using non-comparable criteria to enrol participants in an investigation (168). In Study 1, this could be translated, to the use of different criteria for sifting, grading, and synthesising the evidence. Only one person was involved in the initial review process, up to the drafting of evidence statements. Arguably, two or more persons reading all of the material followed by consensus evaluations, would produce more reliable results; however, this could have introduced inter-rater differences. To reduce bias, all of the evidence was gathered and strictly rated according to set schemes in exactly the same manner. In Study 2 the enrolment criteria for the questionnaire survey were the same for all responders; we presume that the staff who responded was knowledgeable in the area of metal health legislation. Regarding the literature review, this process was conducted by several people to screen for background variables and numbers on 48 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE coercion mostly due to the limited data available at the time. In Studies 3 and 4, a type of selection bias sometimes called non-respondent bias might have emerged between the respondent and the non-respondent groups. The non-responders’ reasons for failure to reply were reviewed, and no systematic differences were observed between the responders and non-responders, Still, a proper dropout analysis was not conducted. Reviewing the Danish National Register on coercion, we found that 49% of the responding units were “responsible” for 52% of the MR episodes in the same population, suggesting minimal differences in MR episodes between responders and nonresponders. Recall bias may arise because individuals with particular exposure or adverse health outcome are likely to remember their experiences differently from those who are not similarly affected (168). In Studies 1 and 2, recall bias was not an issue. In Studies 3 and 4, recall bias could have occurred, especially for the Danish data; the clinical nurse manager had to recall all MR-preventive factors as well as the conditions and numbers of MR episodes from two years prior. Although, an earlier study determined that nurse recall is reliable for 4 weeks (169), the clinical nurse managers in these studies were able to support their memories by referring to charts and protocols to answer many of the questions. The outcome variable (i.e., the number of MR episodes) was validated or reexamined revealing that no significant recall bias existed with regard to the outcome variable. Additionally, recall bias could have affected the results if the MR-preventive factors had only been implemented for a portion of the year. Regardless, possible recall bias would likely only increase the effect. Still, we must consider the possibility of recall bias with regard to certain variables. Measurement-/insensitive measures of bias arise if the items in a questionnaire survey are not sensitive enough to detect potential important factors (170). In Study 2, the questionnaire survey only addressed interpretative legislative areas, not revealing any non-detection of important matters. In Studies 3 and 4, such significant non-detection could be of concern. However, the findings were probably quite conservative, underestimating the actual effect, because the questionnaire only roughly covered the MR-preventive factors with questions that could measure all aspects of such a MR-preventive factor. A MR-preventive factor such as the patient-staff ratio is simple and straightforward, but a more complex MR-preventive factor such as cognitive milieu therapy, could lack the sensitivity to identify the most important MR-preventive responses due to the many relevant aspects such as a clear objective, a described philosophy, management support and knowledge, the economy, qualified supervisors, cultural changes, and patient education and involvement, among others. Still, complex MR-preventive factors may have a greater impact on the reduction of MR episodes than those found in Studies 3 and 4. 49 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Expectation bias occurs when participants err in measuring data towards the expected outcome (170). In Studies 3 and 4, the number of MRs was an important outcome, and most of the data regarding outcome were taken from existing electronic or paper charts with no obvious manipulation. Whether the clinical nurse managers err toward the expected outcome when measuring certain preventive factors is unknown. However, clinical nurse managers were urged to describe the conditions of the unit in a neutral manner. Analysis or transfer bias occurs upon transferring the data into organised structures for analysis (170). In Studies 3 and 4, this problem was likely avoided in the design phase, during which definitions, hypotheses, and analyses were prepared and scrutinised. Cognitive dissonance bias occurs if the investigator is convinced that his or her beliefs about the findings are valid, regardless of findings to the contrary (170). Because Studies 3 and 4, reexamines the preventive factors that others have previously described, the risk of cognitive dissonance bias is minimal. Biases in questionnaires, is an important issue in this thesis. A couple has been addressed earlier, but most of the many types of bias must be eliminated in the construct-phase, as follows: in designing questions, in designing the questionnaire, and in administration of the questionnaire. Choi (171) describes in all 48 common types of bias in questionnaires, nearly all eliminated by strictly following the guide by Olsen (63) in Study 2, and following QAS-99 by Willis (68), concurrent probing by Watt (70), and cognitive interviews by Willis (69) in Studies 3 and 4. 9.3.3 Confounding Confounding can be thought of as a mixing of the effect of the exposure on the outcome with a third factor. This third factor must be associated with the exposure and the outcome, independently of that exposure (168). In Studies 1 and 2, confounding was important in the assessment of the individual papers included in the literature reviews, but was otherwise not an issue because the studies were not analytic. In Studies 3 and 4 confounding was a very important issue. In Study 3, certain confounding covariates e.g. patient flow, diagnostic distribution, different population bases of the units and age of the patients who experienced MR, might be missing from the analyses. However, the previously described covariates did not act as confounders in Denmark because the geographic regions and types of the units functioned as proxy covariates. Geographic regions eliminated the confounding effect of the different population base of the units, and the type of unit eliminated the confounding effect of the diagnostic distribution, patient flow, and age of the patients. These effects were determined by analysing data from the Danish National Register on 50 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Coercion and the Danish Psychiatric Research Register. However, these data could not be accessed in the Norwegian sample; therefore, whether these conclusions apply to the entire dataset remains unknown, although it is reasonable to deduce that they do. In Study 4, the same considerations regarding confounding covariates were made, except that, patients who experienced MR were thought to be more aggressive or self-mutilating in one of the countries, which represented a confounder. However, an earlier study that assessed aggressive behavior (172) did not report large differences between Denmark and Norway. Additionally, some of the covariates (number of forensic patients, type of bed, and the reason for MR) could eliminate portions of the difference. Thus, the potential differences in aggressive or self-mutilating patients did not likely influence the results. Overall, the most important covariates either were included or covered the effects of others by proxy (3). 9.3.4 Strength of the Association The magnitude of the observed association is useful to judge the likelihood that the exposure itself affects the outcome and therefore the likelihood of a cause-effect relationship (168). The magnitude of the observed associations only refers to the outcomes of Studies 3 and 4. In Study 3, the three MR-preventive factors that were significantly associated with a reduction in MR episodes varied from exp(B) = 0.36 to 0.54, both of which represents quite large effects, supporting the plausibility of a cause-effect relationship. In Study 4, the six MR-preventive factors that confounded the differing effects on MR use between Denmark and Norway varied between ∆exp(B) = 10% and 51% . Although these data are not as convincing as the MR-preventive factors in Study 3, they do address some reasonable effects. A larger sample would nonetheless have been preferred, as stronger associations and more significantly associated MR-preventive factors would likely have followed. 9.3.5 Biological Credibility The existence of a cause-and-effect relationship is supported if there is a known or postulated biological mechanism by which the exposure might reasonably alter the outcome (168). Although this definition is more relevant when the study concerns the risk of disease, some neurophysiological explanations concerning factors such as anxiety, fear, and aggression have accounted for these emotions as a part of the MR-sequence (173). However, not enough data are available to establish a cause-effect relationship based on biological credibility. 51 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE 9.3.6 Generalisability and Consistency Generalisability refers to whether the results are applicable to other populations (168). The study covered half of the eligible populations in Norway and Denmark: however, because we found no systematic differences between the respondent and non-respondent groups, the results can reasonably be assumed to cover these two populations. If compared to other populations (e.g., other countries), differences in legislation, culture, practise, and other factors might cause overwhelming obstacles to application. As the differences between Norway and Denmark were small, the present results could perhaps be generalised by considering the differences between these countries and other similar countries (e.g. Sweden or Finland). However, applying the results to other countries would require a thorough examination of their cultures, legislation, and other relevant factors. Consistency with other studies calls for comparisons with studies conducted in other populations, by different investigators, at various times, and using alternative methodologies in a variety of geographic and cultural settings (168). The findings of these studies are supported by many international studies using different methodologies and by different investigators. However, if we examine individual MR-preventive factors, the support and variation have not reached the level required for “scientific proof” or consistency, possibly due to the complexity of the MR sequence. 9.4 Discussion of International High Quality Research Five RCTs dealing with MR (coercion, MR, restraint, or seclusion) prevention were identified, as follows: Georgieva (174), “Reducing seclusion through involuntary medication: A randomised clinical trial”: Although the use of involuntary medication was able to successfully reduce the number of seclusions, alternative interventions are required to reduce the overall number and duration of coercive incidents. The intervention involved the use of either seclusion or involuntary medication as the first choice of intervention. This paper has been published after the initial literature review. In Denmark, these guidelines have been described in the Danish Mental Health Act — the use of the least intrusive intervention (6) — and generally medication, preferably voluntary, if not possible, then involuntary, are considered less intrusive and hence the first choice before initiating MR. In Norway, the principle of — the use of the least intrusive intervention — is also described in the Norwegian Mental Healt Act (65), whether involuntary medication in practice are the first choice before initiating MR is unknown, but the conclusion, that alternative interventions are needed to reduce the overall number and duration of coercive incidents, complies to Norway as well. 52 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Berg (175), “A Randomised Controlled Comparison of Seclusion and Mechanical Restraint in Inpatient Settings”: The result did not provide evidence for the use of one intervention over the other. The conclusion was that, clinical decisions should account for patients preferences. The study compared the restrictiveness of seclusion and MR from the patient´s point of view. This paper has been published after the initial literature review. In Denmark, seclusion cannot be used; thus, taking patient´s preferences into account, is not possible at the time being. In Norway patient´s preferences, in this respect, may be taken into account, perhaps reducing the numbers of MR episodes and increase the numbers of seclusion, thereby reducing the patients experiences of restrictiveness. Abderhalden (83), “Structured risk assessment and violence in acute psychiatric wards: randomised controlled trial”: Structured risk assessment during the first days of treatment may contribute to reduced violence and coercion (ed. forced acute tranquillising medication, seclusion and MR) in acute psychiatric wards. The study investigated the implementation of BVC, which has been implemented in more than 80% of “closed” units in Denmark. The amount of units that has implemented the BVC in Norway, is unknown, but it is likely the same. van de Sande (149), “Aggression and seclusion on acute psychiatric wards: effect of short-term risk assessment”: The routine application of structured risk assessment measures was found to possibly help reduce the incidents of aggression and the use of restraint and seclusion in psychiatric wards. The study investigated the implementation of BVC in combination with Kenndy–Axic V. This paper has been published after the initial literature review. As indicated above, more and more units have implemented BVC in Denmark and Norway. Many units, also use the Global Assessment of Functioning Scale, which is rather similar to Kenndy–Axic V, as both are brief clinician-scored global assessment instruments used to measure the functioning of patients (176). Putkonen (145), “Cluster-Randomised Controlled Trial of Reducing Seclusion and Restraint in Secured Care of Men With Schizophrenia”: Seclusion and restraint were prevented without any increase in violence on the wards for men with schizophrenia and violent behaviour. The study investigated the implementation of the “Six Core Strategies”, as follows: leadership toward organisational change, workforce support and development, the use of primary prevention tools, the use of data to inform practice, debriefings, and meaningful consumer roles. This paper has been published after the initial literature review. Parts of the “six core strategies” have been implemented in Denmark and Norway, e.g. the use of risk assessment tools (use of primary prevention tools) and some debriefing techniques, but most parts have not been implemented. 53 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE These studies represent the highest international evidence available at this time. Comparing these with the Danish and Norwegian MR-preventive initiatives in practise, as previously described, the “Six Core Strategies” provide the best potential for developing MR-prevention practices in Denmark and Norway. Comparing these strategies with the findings in Studies 3 and 4 of this thesis, nearly all eight of the MR-preventive factors are components of the “Six Core Strategies”, supporting the suggestion that the high evidence supporting implementation of the “Six Core Strategies” could increase the overall causality of the eight identified MR-preventive factors or that implementing of the “Six Core Strategies” might reduce the MR episodes in Denmark and Norway as in a special setting in Finland (consistency). Although these five RCTs represent the highest evidence available, none reached the highest grade of evidence. Furthermore, the settings in which they were conducted only partially comply with the conditions of Danish and Norwegian psychiatry. 10 Conclusions 10.1 Conclusions from the Individual Studies Study 1: The objective of the first study was to answer the question: Which conditions in nursing and which nursing interventions have been shown to reduce the frequency of mechanical restraint episodes? No interventions reached the highest degree of recommendation combined with the highest effect. Because no interventions reached the highest degree of recommendation (evidence), the question cannot be answered with certainty. Therefore, the studies (Studies 3 and 4) conducted later must include as many MR-preventive factors as possible, testing not only a few factors to be effective in research settings (obtaining the highest recommendation grad), in practice (by hypothesis tests, increasing the power of the later studies). Study 2: The objective of the second study was: To compare the use of coercive measures on psychiatric inpatients between Denmark and Sweden, Norway, Finland, Iceland, Belgium, The Netherlands, United Kingdom, Ireland, France, and Italy, in order to share knowledge and learn about what other countries do to minimize coercion. The study primarily revealed, that the many differences in legislation between the countries and that very few countries, at the time of the study, produced nationwide public data on coercive measures and background data, making the comparison very difficult. Thereby, not reaching the objective on what to learn about what other countries do to minimize coercion. Targeting the comparison between Denmark and Norway, demonstrated a tendency for Norway to use less MR and physical restraint, than Denmark. Most 54 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE other indicators were similar between the two countries. Thus, Norway was included in the later studies (Studies 3 and 4). Overall, caution must be applied in the interpretation and comparison of coercive measures and factors related to coercion between countries. Study 3: The objective of the third study was to answer the question: How are presumed MRpreventive factors of nonmedical origin associated with the frequency of MR episodes in Denmark and Norway? The results suggest that mandatory review, patient involvement, and crowding were associated to a reduced frequency of MR episodes in Denmark and Norway. However, we were unable to establish a causal effect between the reduction in MR episodes and these preventive measures. Given that we included important potential confounders and that MR-preventive factors have not been shown to present any adverse effects on the patients or staff in the literature, the identified MR-preventive factors might be investigated further because they may contribute to a better understanding of the phenomenon of MR. Study 4: The objective of the fourth study was: To examine how presumed MR-preventive factors of non-medical origin may explain the differing number of MR episodes between Denmark and Norway. The results suggest that: the identification of patient’s crisis triggers; an increased number of staff per patient; increased staff education; better work environment; and reduced substitute staff use might explain why MR was initiated more often in Demark than in Norway. We cannot claim that the implementation of these potential preventive measures, primarily in Denmark and in a few units in Norway, would reduce the number of MR episodes. Given that we considered several important potential confounders and that the MR-preventive factors demonstrated no adverse effects on the patients or staff in the literature, the identified MR-preventive factors should be investigated further because they may contribute to a better understanding of the phenomenon of MR. 10.2 General Conclusions The overall objective of this thesis was to generate knowledge of non-medical MR-prevention. This thesis and the four included studies complement each other by using different means to investigate specific preventive factors with the potential to minimise the number of MR episodes. This thesis began with a systematic review of the literature to identify the most evident and effective preventive MR factors. The practices in other countries were then examined, and Norway was identified to be included in the later studies (Studies 3 and 4). Finally, specific MR-preventive factors that could reduce the number of MR episodes in practice were investigated. 55 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE These results have increased our understanding of the ability of specific MR-preventive factors to reduce the number of MR episodes in Denmark and Norway, thereby generating knowledge in the field of MR-prevention. These findings have not been identified via randomised controlled trials (RCTs), and although some biases could be present, the questionnaire was thoroughly developed to include several potential confounders. Furthermore, similar results have been demonstrated in previous international studies. These factors are not likely to have adverse effects on the patients or staff. Rather, the potential positive effects of these factors on the prevention of MR episodes may reflect a general strengthening of the care and treatment environments. Therefore, further investigation into the effects of implementing the following within Danish and Norwegian practices is recommended: mandatory review, patient involvement, less crowding, higher staff education, less substitute staff use, better work environment, increased number of staff per patient, and the identification of the patient’s crisis triggers. 11 Perspectives 11.1 Clinical Implications In Denmark the need to implement MR-preventive strategies is more urgent than ever; the number of persons experiencing MR has never been higher, and the number of MR episodes is among the highest over the 24 years of registration. Although, Norway uses less MR than Denmark, the numbers has not decreased over the last decade; perhaps it even has a tendency to increase, making the need for implementing MR-preventives strategies equally important. First, though these studies addressed MR of inpatients in “closed” units, it would have been preferred, that the patients had never become ill enough to require forceful/involuntary admission. Thus, outpatient prevention, e.g., as joint crisis planning (177) or the use of the early recognition method (166), should also be addressed in cooperation with the primary and secondary mental health sectors. Another means of decreasing forced admission rates into “closed” units might be to make it easier for patients to be voluntarily admitted. Second, as shown in this thesis and as supported by other researchers (38;39;178;179), the phenomenon of MR is multifaceted, and the reduction in the number of MR episodes thus requires interventions in many different areas. Accordingly, many MR-preventive initiatives such as several individual initiatives or programs encompassing several initiatives must be implemented in practise. 56 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Third, the selection process of MR-preventive factors to implement in practise should address both those supported by the most obvious research and those most transferrable to Danish or Norwegian conditions. Fourth, any implementation of MR-preventive initiatives in practise must be followed by an investigation of eventual adverse effects, e.g. injuries to patients or staff, rises in other coercive measures, or the decreased psychological wellbeing of patients or staff. The results from this thesis arise from a Danish and a Norwegian cohort; thus, although the generalisability is acceptable, the grade of the evidence is not high, indicating that causality has not been established. Thus, the clinical implications of the results of this thesis might include investigating the effects and adverse effects of implementing a program containing the identified MR-preventive factors in such a way that the effects of individual elements (organisational factors, MR-preventive methods and tools), on the number of MR episodes can be addressed. 11.2 Future Research Recommendations Although some RCTs have been conducted, they are biased due to the complex nature of the MR phenomenon. Furthermore, three of these studies are cluster RCTs, and one of them involves optional randomisation, because involuntary admitted patients in most countries cannot be included in trials. This limitation suggests that a very well-designed and conducted RCT cannot by itself reach the highest grade of recommendation; instead, this level of evidence requires several studies be conducted before a meta-synthesis can be performed to reach the highest evidence grade. 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Cognitive milieu therapy and restraint within dual diagnosis populations. Ugeskr Laeger 2008 Jan 28;170(5):339-43. Thyrsting K, Hall EOC. Prevention of coercion in psychiatric units: a secondary analysis of a practitioner research project. Klinisk sygepleje 2008;22(2):78-86. Combined intervention Fisher WA. Elements of successful restraint programmes are effective in and seclusion reduction programs and their avoiding mechanical restraints e.g. application in a large, urban, state patient participation, patient psychiatric hospital. Journal of psychiatric education, staff education, practice 2003;9(1):7. programmatic changes, high-level Hellerstein DJ, Staub AB, Lequesne E. administrative endorsement, Decreasing the use of restraint and seclusion cultural changes, data analysis, among psychiatric inpatients. Journal of etc. psychiatric practice 2007;(5):308-17. Khadivi AN, Patel RC, Atkinson AR, Levine JM. Association between seclusion and restraint and patient-related violence. Psychiatric Services 2004;55(11):1311-2. Sullivan AM, Bezmen J, Barron CT, Rivera J, Curley-Casey L, Marino D. Reducing restraints: alternatives to restraints on an inpatient psychiatric service--utilizing safe and effective methods to evaluate and treat the violent patient. Psychiatr Q 2005;76(1):51-65. Taxis JC. Ethics and praxis: alternative strategies to physical restraint and seclusion in a psychiatric setting. Issues in Mental Health Nursing 2002;23(2):157-70. Implementation of patient-centred Fletcher E, Stevenson C. Launching the care with a higher degree of Tidal Model in an adult mental health patients´ positive involvement in programme. Nurs Stand 2001 Aug their own care reduces the number 22;15(49):33-6. Qualitative recommendation grade Implementation of cognitive milieu therapy reduces the number of mechanical restraint episodes, among other things through patient involvement and empowerment. Quantitative recommendation grade 1 Reference Qualitative evidence level MR-preventive factor Quantitative evidence level (effect) No Appraisal, Grading, and Combining the Recommendations of the MR-preventive Factors 4 3 3 1 3 N.a. 3 2 4 3 3 2 2 -2 (67%) +2 (91%) 4 (52%) -2 (72%) 4 (94%) -2 (67%) MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE of mechanical restraint episodes. 4 5 6 The identification of the patients’ crisis triggers unique calming techniques and decisions on specific crisis interventions early in the admission procedure, thereby reducing the number of mechanical restraints. Introduction of validated risk assessment systems including suggestions of care interventions reduce the number of mechanical restraints. Effective treatment of substance abuse and psychosis reduces the number of mechanical restraint episodes; the treatment of mental illnesses is also described elsewhere in the review. Sullivan D, Wallis M, Lloyd C. Effects of patient-focused care on seclusion in a psychiatric intensive care unit. Int J Ther Rehabil 2004 Nov;11 2004;503-8. Thyrsting K, Hall EOC. Prevention of coercion in psychiatric units: a secondary analysis of a practitioner research project. Klinisk sygepleje 2008;22(2):78-86. Jonikas JA, Cook JA, Rosen C, Laris A, Kim JB. A program to reduce use of physical restraint in psychiatric inpatient facilities. Psychiatr Serv 2004 Jul;55(7):818-20. McCain M, Kornegay K. Behavioral Health Restraint: The Experience and Beliefs of Seasoned Psychiatric Nurses. Journal for Nurses in Staff Development 2005;21(5):236. Meehan T, McIntosh W, Bergen H. Aggressive behaviour in the high secure forensic setting: the perceptions of patients. Journal of Psychiatric and Mental Health Nursing 2006;13(1):19-25. Wynn R, Mykleburst LH. Patients´ Satisfaction and Self-Rated Improvement Following Coercive Interventions. Psychiatry, Psychology and Law 2006;13(2):199-202. Abderhalden C, Dassen T, Fisher JE, Halfens RJG, Haug HJ, Needham I. Structured risk assessment and violence in acute psychiatric wards: randomised controlled trial. The British Journal of Psychiatry 2008;193(1):44. Cochrane-Brink KA, Lofchy JS, Sakinofsky I. Clinical rating scales in suicide risk assessment. General Hospital Psychiatry 2000;22(6):445-51. Dernevik M, Grann M, Johansson S. Violent behaviour in forensic psychiatric patients: Risk assessment and different riskmanagement levels using the HCR-20. Psychology, Crime & Law 2002;8(1):93111. Fletcher E, Stevenson C. Launching the Tidal Model in an adult mental health programme. Nurs Stand 2001 Aug 22;15(49):33-6. Palmstierna T, Olsson D. Violence from young women involuntarily admitted for severe drug abuse. Acta Psychiatrica Scandinavica 2007;115(1):66-72. Sullivan D, Wallis M, Lloyd C. Effects of patient-focused care on seclusion in a psychiatric intensive care unit. Int J Ther Rehabil 2004 Nov;11 2004;503-8. Thyrsting K, Hall EOC. Prevention of coercion in psychiatric units: a secondary analysis of a practitioner research project. Klinisk sygepleje 2008;22(2):78-86. (this paper ads very little to the synthesis) -2 (36%) 2 +2 (50%) 4 3 3 3 2 N.a. 2 4 2 N.a. 4 3 3 4 -2 (–%) -1 (27%) -2 (–%) 3 (–%) -2 (67%) 3 (–%) -2 (36%) – 69 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE 7 8 70 Mandatory review from qualified clinical experts, e.g. as postincident review minimizes the number of mechanical restraint episodes. Better staff training reduces the number of mechanical restraints (longer duration of the training, more staff participating, use of different and involving education methods, higher quality of the content and greater diversity of the topics, e.g. legislation, crisis management, physical intervention strategies, antecedents, warning signs, deescalation techniques etc.). Donat DC. Impact of a mandatory behavioral consultation on seclusion/restraint utilization in a psychiatric hospital. Journal of Behavior Therapy and Experimental Psychiatry 1998 Mar;29(1):13-9. Prescott DL, Madden LM, Dennis M, Tisher P, Wingate C. Reducing mechanical restraints in acute psychiatric care settings using rapid response teams. Journal of Behavioral Health Services & Research 2007 Jan;34(1):96-105. Bonner G, Lowe T, Rawcliffe D, Wellman N. Trauma for all: a pilot study of the subjective experience of physical restraint for mental health inpatients and staff in the UK. Journal of Psychiatric and Mental Health Nursing 2002;9(4):465-73. Bowers L, Nijman H, Allan T, Simpson A, Warren J, Turner L. Prevention and Management of Aggression Training and Violent Incidents on UK Acute Psychiatric Wards. Psychiatric Services 2006;57(7):1022. Delaney KR, Johnson ME. Keeping the Unit Safe: Mapping Psychiatric Nursing Skills. Journal of the American Psychiatric Nurses Association 2006 Aug 1;12(4):198-207. Hahn S, Abderhalden C, Duxbury J, Halfens RJG, Needham I. The effect of a training course on mental health nurses' attitudes on the reasons of patient aggression and its management. Journal of Psychiatric & Mental Health Nursing 2006;13(2):197-204. Jonikas JA, Cook JA, Rosen C, Laris A, Kim JB. A program to reduce use of physical restraint in psychiatric inpatient facilities. Psychiatr Serv 2004 Jul;55(7):818-20. Lee S, Wright S, Sayer J, Parr A, Gray R, Gournay K. Physical restraint training for nurses in English and Welsh psychiatric intensive care and regional secure units. Journal of Mental Health 2001 Apr;10(2):151-62. Mackay I, Paterson B, Cassells C. Constant or special observations of inpatients presenting a risk of aggression or violence: nurses' perceptions of the rules of engagement. Journal of Psychiatric & Mental Health Nursing 2005;12(4):464-71. Needham I, Dassen T, Halfens RJG, Haug HJ, Fisher JE. The effect of a training course in aggression management on mental health nurses perceptions of aggression: a cluster randomised controlled trial. International Journal of Nursing Studies 2005;42(6):649-55. Spokes K, Bond K, Lowe T, Jones J, Illingworth P. HOVIS Hertfordshire/Oxfordshire violent incident study. Journal of Psychiatric and Mental Health Nursing 2002;9(2):199-209. -2 (62%) 4 N.a. 4 3 4 3 3 4 -2 (36%) 4 3 (–%) 2 -2 (–%) +2 (34%) -2 (–%) 4 -1 (–%) 4 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE 9 Staff attitudes such as positive care for the patients, respect, collaboration, communication, humanism, empathy and less control and involuntary procedures, reduce the number of mechanical restraints. 10 Higher staff-patient ratio reduces the number of mechanical restraints. Wright S, Sayer J, Parr AM, Gray R, Southern D, Gournay K. Breakaway and physical restraint techniques in acute psychiatric nursing: Results from a national survey of training and practice. Journal of Forensic Psychiatry & Psychology 2005;16(2):380-98. Allen MH, Carpenter D, Sheets JL, Miccio S, Ross R. What do consumers say they want and need during a psychiatric emergency? J Psychiatr Pract 2003 Jan;9(1):39-58. Bowers L, Brennan G, Flood C, Lipang M, Oladapo P. Preliminary outcomes of a trial to reduce conflict and containment on acute psychiatric wards: City Nurses. Journal of Psychiatric & Mental Health Nursing 2006;13(2):165-72. Bowers L, Alexander J, Simpson A, Ryan C, Carr-Walker P. Student psychiatric nurses' approval of containment measures: relationship to perception of aggression and attitudes to personality disorder. International Journal of Nursing Studies 2007;44(3):349-56. Cardell R, Pitula CR. Suicidal Inpatients' Perceptions of Therapeutic and Nontherapeutic Aspects of Constant Observation. Psychiatric Services 1999;50(8):1066. Duxbury J. An evaluation of staff and patient views of and strategies employed to manage inpatient aggression and violence on one mental health unit: a pluralistic design. Journal of Psychiatric and Mental Health Nursing 2002;9(3):325-37. Gillig PM, Markert R, Barron J, Coleman F. A Comparison of Staff and Patient Perceptions of the Causes and Cures of Physical Aggression on a Psychiatric Unit. Psychiatric Quarterly 1998;69(1):45-60. Meehan T, McIntosh W, Bergen H. Aggressive behaviour in the high secure forensic setting: the perceptions of patients. Journal of Psychiatric and Mental Health Nursing 2006;13(1):19-25. Robins CS, Sauvageot JA, Cusack KJ, Suffoletta-Maierle S, Frueh BC. Special Section on Seclusion and Restraint: Consumers' Perceptions of Negative Experiences and" Sanctuary Harm" in Psychiatric Settings. Psychiatric Services 2005;56(9):1134. Spokes K, Bond K, Lowe T, Jones J, Illingworth P. HOVIS Hertfordshire/Oxfordshire violent incident study. Journal of Psychiatric and Mental Health Nursing 2002;9(2):199-209 Smith GM, Davis RH, Bixler EO, Lin HM, Altenor A, Altenor RJ, et al. Special section on seclusion and restraint: Pennsylvania State Hospital System's seclusion and restraint reduction program. Psychiatric Services 2005;56(9):1115. -2 (–%) 4 (–%) 4 4 4 4 4 N.a. 4 4 -2 (27%) 3 (–%) 4 3 (–%) 3 (–%) 4 4 4 3 (22%) 71 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE 11 The higher educated staff, the fewer episodes of mechanical restraints. 12 The more experienced staff the fewer episodes of mechanical restraints. 72 Wynn R. Staff's attitudes to the use of restraint and seclusion in a Norwegian university psychiatric hospital. Nordic Journal of Psychiatry 2003;57(6):453-9. Delaney KR, Johnson ME. Keeping the Unit Safe: Mapping Psychiatric Nursing Skills. Journal of the American Psychiatric Nurses Association 2006 Aug 1;12(4):198-207. Flannery Jr RB, Stone P, Rego S, Walker AP, Farley E. Characteristics of Staff Victims of Patient Assault: 15-year Analysis of the Assaulted Staff Action Program (ASAP). Psychiatric Quarterly 2006. Gim YS, Cheng SOB, Hong TL, Chin MWB, Hen WH, Lee YJ. Nurses experiences in identifying and managing violence precipitants in a psychiatric inpatient setting. Singapore Nursing Journal 1999;26(1):21-4. Mackay I, Paterson B, Cassells C. Constant or special observations of inpatients presenting a risk of aggression or violence: nurses' perceptions of the rules of engagement. Journal of Psychiatric & Mental Health Nursing 2005;12(4):464-71. Spokes K, Bond K, Lowe T, Jones J, Illingworth P. HOVIS Hertfordshire/Oxfordshire violent incident study. Journal of Psychiatric and Mental Health Nursing 2002;9(2):199-209. Bowers L, Jeffery D, Simpson A, Daly C, Warren J, Nijman H. Junior staffing changes and the temporal ecology of adverse incidents in acute psychiatric wards. Journal of Advanced Nursing 2007;57(2):153-60. Delaney KR, Johnson ME. Keeping the Unit Safe: Mapping Psychiatric Nursing Skills. Journal of the American Psychiatric Nurses Association 2006 Aug 1;12(4):198-207. Flannery Jr RB, Stone P, Rego S, Walker AP, Farley E. Characteristics of Staff Victims of Patient Assault: 15-year Analysis of the Assaulted Staff Action Program (ASAP). Psychiatric Quarterly 2006. Gim YS, Cheng SOB, Hong TL, Chin MWB, Hen WH, Lee YJ. Nurses experiences in identifying and managing violence precipitants in a psychiatric inpatient setting. Singapore Nursing Journal 1999;26(1):21-4. Mackay I, Paterson B, Cassells C. Constant or special observations of inpatients presenting a risk of aggression or violence: nurses' perceptions of the rules of engagement. Journal of Psychiatric & Mental Health Nursing 2005;12(4):464-71. Spokes K, Bond K, Lowe T, Jones J, Illingworth P. HOVIS Hertfordshire/Oxfordshire violent incident study. Journal of Psychiatric and Mental Health Nursing 2002;9(2):199-209. 3 (–%) 2 4 3 3 5 4 3 3 5 -2 (–%) 3 (–%) 4 4 3 (–%) 2 -2 (–%) 3 (–%) 4 4 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE 13 Limit-setting. If nurses change their focus from considering the patient as deviant to being a resource in their own treatment it would decrease the number of mechanical restraint. 14 Early and adequate administration of oral p.n. medication guided by the individual patients´ problems, medication experiences, and preferences leads to fewer mechanical restraint episodes. Vatne S, Fagermoen MS. To correct and to acknowledge: two simultaneous and conflicting perspectives of limit-setting in mental health nursing. J Psychiatr Ment Health Nurs 2007 Feb;14(1):41-8. Allen MH, Carpenter D, Sheets JL, Miccio S, Ross R. What do consumers say they want and need during a psychiatric emergency? J Psychiatr Pract 2003 Jan;9(1):39-58. Goedhard LE, Stolker JJ, Nijman HLI, Egberts ACG, Heerdink ER. Aggression of Psychiatric Patients Associated with the Use of As-needed Medication. Pharmacopsykiatry 2007;40(1):25. McCain M, Kornegay K. Behavioral Health Restraint: The Experience and Beliefs of Seasoned Psychiatric Nurses. Journal for Nurses in Staff Development 2005;21(5):236. Meehan T, McIntosh W, Bergen H. Aggressive behaviour in the high secure forensic setting: the perceptions of patients. Journal of Psychiatric and Mental Health Nursing 2006;13(1):19-25. Thapa PB, Palmer SL, Owen RR, Huntley AL, Clardy JA, Miller LH. P.R.N. (Asneeded) orders and exposure of psychiatric inpatients to unnecessary psychotropic medications. Psychiatr Serv 2003 Sep;54(9):1282-6. 15 Debriefing, defusing and crisis Bonner G, Lowe T, Rawcliffe D, Wellman intervention minimize the number N. Trauma for all: a pilot study of the of mechanical restraint episodes. subjective experience of physical restraint for mental health inpatients and staff in the UK. Journal of Psychiatric and Mental Health Nursing 2002;9(4):465-73. Bowers L, Simpson A, Eyres S, Nijman H, Hall C, Grange A, et al. Serious untoward incidents and their aftermath in acute inpatient psychiatry: the Tompkins Acute Ward study. Int J Ment Health Nurs 2006 Dec;15(4):226-34. Flannery Jr RB, Stone P, Rego S, Walker AP, Farley E. Characteristics of Staff Victims of Patient Assault: 15-year Analysis of the Assaulted Staff Action Program (ASAP). Psychiatric Quarterly 2006. Jonikas JA, Cook JA, Rosen C, Laris A, Kim JB. A program to reduce use of physical restraint in psychiatric inpatient facilities. Psychiatr Serv 2004 Jul;55(7):818-20. 16 Patients´ response to rules can be Alexander J. Patients' feelings about ward positive and lead to fewer cases of nursing regimes and involvement in rule mechanical restraint. For instance, construction. J Psychiatr Ment Health Nurs if staff helps patients to 2006 Oct;13(5):543-53. 4 4 (–%) N.a. 3 3 5 4 4 4 5 4 5 4 5 4 5 4 5 -2 (–%) 3 4 3 (–50%) 4 4 -2 (–%) +2 (15%) 3 (–%) 73 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE understand not only the rules, but also the rationale for the presence of such rules. If the staff manages to make patients understand that the rules are imposed out of concern for their welfare, then patients may be less reluctant to following these rules. Duxbury J. An evaluation of staff and patient views of and strategies employed to manage inpatient aggression and violence on one mental health unit: a pluralistic design. Journal of Psychiatric and Mental Health Nursing 2002;9(3):325-37 (this paper ads only a little to the synthesis). Gillig PM, Markert R, Barron J, Coleman F. A Comparison of Staff and Patient Perceptions of the Causes and Cures of Physical Aggression on a Psychiatric Unit. Psychiatric Quarterly 1998;69(1):45-60. Meehan T, McIntosh W, Bergen H. Aggressive behaviour in the high secure forensic setting: the perceptions of patients. Journal of Psychiatric and Mental Health Nursing 2006;13(1):19-25. Robins CS, Sauvageot JA, Cusack KJ, Suffoletta-Maierle S, Frueh BC. Special Section on Seclusion and Restraint: Consumers' Perceptions of Negative Experiences and" Sanctuary Harm" in Psychiatric Settings. Psychiatric Services 2005;56(9):1134. 17 Activity-based nursing Meehan T, McIntosh W, Bergen H. interventions e.g. physical Aggressive behaviour in the high secure activities are effective in avoiding forensic setting: the perceptions of patients. mechanical restraints. Journal of Psychiatric and Mental Health Nursing 2006;13(1):19-25. Thomas B, Jones M, Johns P, Trauer T. Prn medication use in a psychiatric highdependency unit following the introduction of a nurse-led activity programme. International Journal of Mental Health Nursing 2006;15(4):266. 18 Several mental and physical Bonner G, Lowe T, Rawcliffe D, Wellman working environmental factors N. Trauma for all: a pilot study of the influence positively the number of subjective experience of physical restraint mechanical restraints e.g.: Good for mental health inpatients and staff in the management as a high degree of UK. Journal of Psychiatric and Mental order, organisation or support, Health Nursing 2002;9(4):465-73. Adequate staffing, Psychiatric Bowers L, Allan T, Simpson A, Jones J, training, Rotation, Education, No Whittington R. Morale is high in acute crowding, Emergency backup, etc. inpatient psychiatry. Soc Psychiatry Several of these factors are Psychiatr Epidemiol 2008 Jul 5. described elsewhere in the review. Daffern M, Mayer M, Martin T. Staff gender ratio and aggression in a forensic psychiatric hospital. International Journal of Mental Health Nursing 2006;15(2):93-9. Owen C, Tarantello C, Jones M, Tennant C. Violence and Aggression in Psychiatric Units. Psychiatric Services 1998;49(11):1452. Whittington D, McLaughlin C. Finding time for patients: an exploration of nurses' time allocation in an acute psychiatric setting. Journal of Psychiatric & Mental Health Nursing 2000;7(3):259-68. 19 Less crowding e.g. less stimuli, Meehan T, McIntosh W, Bergen H. less environmental stress and Aggressive behaviour in the high secure more personal space decrease the forensic setting: the perceptions of patients. number of mechanical restraints. Journal of Psychiatric and Mental Health Nursing 2006;13(1):19-25. 74 3 (–%) 3 (–%) 4 4 4 4 5 4 5 4 4 5 4 5 4 4 5 4 5 +2 (–%) -2 (–%) 3 (–%) 4 (–%) 3 (–%) MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Vaaler AE, Morken G, Fløvig JC, Iversen VC, Linaker OM. Effects of a psychiatric intensive care unit in an acute psychiatric department. Nordic Journal of Psychiatry 2006;60(2):144-9. 20 Higher regular staff and lower Bonner G, Lowe T, Rawcliffe D, Wellman substitute ratio reduce the number N. Trauma for all: a pilot study of the of mechanical restraints. subjective experience of physical restraint for mental health inpatients and staff in the UK. Journal of Psychiatric and Mental Health Nursing 2002;9(4):465-73. Bowers L, Allan T, Simpson A, Nijman H, Warren J. Adverse Incidents, Patient Flow and Nursing Workforce Variables on Acute Psychiatric Wards: The Tompkins Acute Ward Study. International Journal of Social Psychiatry 2007;53(1):75. Spokes K, Bond K, Lowe T, Jones J, Illingworth P. HOVIS Hertfordshire/Oxfordshire violent incident study. Journal of Psychiatric and Mental Health Nursing 2002;9(2):199-209. (this paper ads only a little to the synthesis). 21 Staffs´ opposition towards Lind M, Kaltiala-Heino R, Suominen T, mechanical restraint, due to the Leino-Kilpi H, Valimaki M. Nurses'ethical perception that mechanical perceptions about coercion. Journal of restraint is ethically problematic, Psychiatric & Mental Health Nursing decrease the number of 2004;11(4):379-85. mechanical restraints. Van Doeselaar M., Sleegers P, Hutschemaekers G. Professionals' attitudes toward reducing restraint: the case of seclusion in the Netherlands. Psychiatr Q 2008 Jun;79(2):97-109. 22 Alarm systems e.g. video D'Orio BM, Purselle D, Stevens D, Garlow surveillance and radio systems and SJ. Reduction of episodes of seclusion and well trained response teams, restraint in a psychiatric emergency service. reduce the number of mechanical Psychiatric Services 2004;55(5):581-3. restraints. 23 Better care-alliance between Wynn R. Staff's attitudes to the use of patients and the nursing staff restraint and seclusion in a Norwegian reduces the number of mechanical university psychiatric hospital. Nordic restraints. Journal of Psychiatry 2003;57(6):453-9. 24 Communication especially Duxbury J, Whittington R. Causes and communicative de-escalation management of patient aggression and reduces the number of mechanical violence: staff and patient perspectives. restraint episodes. Journal of Advanced Nursing 2005 Jun;50(5):469-78. 25 Well-maintained and familiar Vaaler AE, Morken G, Linaker OM. Effects surroundings reduce the number of different interior decorations in the of mechanical restraints. seclusion area of a psychiatric acute ward. Nordic Journal of Psychiatry 2005;59(1):1924. 26 Music as diversion and relaxation Janelli LM, Kanski G. Music for untying before and after mechanical restrained patients. Journal of the New York restraint reduces the number of State Nurses Association 1998;29(1):13-5. mechanical restraint episodes. 27 Separation of acutely disturbed Meehan T, McIntosh W, Bergen H. patients reduces the number of Aggressive behaviour in the high secure mechanical restraint episodes. forensic setting: the perceptions of patients. Journal of Psychiatric and Mental Health Nursing 2006;13(1):19-25. (This factor is graded, in the review as 5, it should have been 4). No refers to the number in the hierarchy for which 1 is highest/best. -2 (–%) 4 4 5 4 5 4 N.a. 4 5 +2 (16%) 4 N.a. 4 5 -2 (–%) 4 N.a. 4 5 -3 (–%) 4 N.a. 4 5 +2 (–%) 4 N.a. 4 5 4 (–%) 4 N.a. 4 5 N.a. 5 5 5 3 (–%) 4 -2 (–%) -2 (–%) 4 75 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE Factor refers to synthesized description of the MR-preventive factor. The final synthesis was guided by the following three questions: Which interventions match patients’ views and experiences? Which interventions have yet to be evaluated in clinical settings? Does the effect of the intervention seem plausible from a clinical point of view? Reference refers to the literature reference in Vancouver style. Quantitative evidence level describes the appraisal of individual quantitative papers. Appraising the quantitative research papers was conducted as outlined by the Danish Reference Programme Secretariat (Sekretariatet for Referenceprogrammer, 2004), Method for Evaluating Research and Guideline Evidence (MERGE; Liddle et al., 1996), and SIGN (Harbour, 2008); 1++, 1+, 1-, 2++, 2+, 2-, 3, 4, where 1++ is the best level. Checklists for evaluating the methodological quality of the papers can be acquired from the authors. In brackets, the reduction in the number of mechanical restraints (in a few cases combined MR and seclusion rates) is displayed as a percentage, if the reduction was caused by more than one intervention, it was downgraded accordingly. – describes no available figures. Qualitative evidence level describes the appraisal of individual qualitative papers. Appraising the qualitative research papers was conducted as outlined by Sandelowski and Barroso (2007). The papers were rated according to the complexity levels by Kearney in which 1 = dense explanatory description, 2 = depiction of experimental variation, 3 = shared pathway or meaning, 4 = descriptive categories, 5 = findings restricted by a priori frameworks (level 5 papers were excluded), 1 is the “best” level. The checklist for evaluating the methodological quality of the papers can be required from the author. Quantitative recommendation grade from 1 to 5, in which 1 is the highest/best. N.a. refers to no available paper. The hierarchy of the quantitative grading was developed from the DRPS (2004, NERGE (1996), and SIGN (2008). Qualitative recommendation grade from 1 to 5, for which 1 is the highest/best. N.a. referred to no available paper. The hierarchy of the qualitative grading can be found below. Combined recommendation grade describes the whole body of evidence regarding the level of scientific “truth” or its potential for clinical application of a specific intervention ranked from 1 to 5, for which 1 is the highest/best. Combining the quantitative and qualitative recommendations was conducted by taking the better of the two. Combined effect refers to the reduction in the number of MRs, from 1 to 5, with 1 being the best (80% to 100% reduction), 2 representing a reduction of 60% to 80% and so on. These were combined as follows: no paper, the level was set to 5 (0–20% reduction); one paper, the level was directly transferred; two or more papers, the level was influenced by: (1) the paper with the best recommendation grade, (2) the paper best describing the intervention, and (3) a simple average. Assessment system for quantitative research Evaluation criteria for the study (paper) (MERGE-1996) Evaluation criteria are coded according to the extent to which the criteria in the specific checklist are fulfilled: Criterion entirely fulfilled. Criterion mostly fulfilled. Criterion mostly not fulfilled. Criterion not at all fulfilled. Criterion not described adequately to classify as a, b1, b2 or c. Criterion not applicable. Overall assessment of the study (paper) (DRPS-2004) This table is used to assess the general methodological quality of the study, in three grades: All or the most criterion are fulfilled. Criterion witch are not fulfilled, will very rarely change the conclusions of the study. Some criterions are fulfilled. Criterion witch are not fulfilled or thorough described, will rarely change the conclusions of the study. Few or none criterions are fulfilled. The conclusions of the study can easily change. 1++ 1+ 12++ 76 Code a b1 b2 c ? n/a Code ++ + - Levels of evidence for quantitative studies (Insp. from SIGN-2008, MERGE-1996 and DRPS-2004) High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias or Controlled trials without randomisation. High-quality systematic reviews of case–control or cohort studies High-quality case–control or cohort studies with a very low risk of confounding, bias or chance and a MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE 2+ 2- 3 4 1 2 3 4 5 high probability that the relationship is causal. Well-conducted case–control or cohort studies or multiple time series or before and after studies (Preferably from more than one centre or research group) with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal. Diagnostic tests (diagnostic method). Case–control or cohort studies or multiple time series or before and after studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal. High quality descriptive studies. Diagnostic tests (Nosographic method). Moderate quality descriptive studies. Case reports, case series, decision analyses. Expert opinion. Formal consensus. Low quality descriptive studies. Grades of recommendation for quantitative research (Insp. from SIGN-2008, MERGE-1996 and DRPS-2004) At least one meta-analysis, systematic review or RCT rated as 1++, and directly applicable to the target population, or a systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population and demonstrating overall consistency of results. A body of evidence including studies rated as 1- and 2++, directly applicable to the target population and demonstrating overall consistency of results, or extrapolated evidence from studies rated as 1++ or 1+. A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results, or extrapolated evidence from studies rated as 2++. A body of evidence including studies rated as 2- or 3, directly applicable to the target population and demonstrating overall consistency of results, or extrapolated evidence from studies rated as 2+. Opinions of respected authorities, based on clinical experience, or reports of expert committees rated as 4. Assessment system for qualitative research Evaluation criteria for the study (paper) (Sandelowski and Barroso – 2007) Evaluation criteria are coded according to the extent to which the criteria in the specific checklist are fulfilled: Presence Relevance Overall assessment of the study (paper) (Sandelowski and Barroso – 2007) This table is used to evaluate the quality of the study: Acceptable (Signal > noise) Questionable (Noise > signal) Code +/+/- Code + - Levels of evidence for qualitative studies (Kearny – 2004) No 1 Description Notes Dense explanatory The highest level of complexity and discovery might be termed the qualitative gold description standard. These findings may be seen as representing the characteristics of the “experiential variation” category, when achieved to the highest degree, but in doing so, these findings appear qualitatively different. Clifford Geertz (1973) exemplified this level of findings in his definition of “thick description,” but this level of explanatory detail can be seen outside ethnography as well. These findings are a rich evocation of a situated understanding of a multifaceted and varied human phenomenon in a unique situation. With dense factual and descriptive detail, they portray the full depth and range of complex influences that propel 77 MECHANICAL RESTRAINT – PREVENTIVE FACTORS IN THEORY AND PRACTICE 2 3 4 5 persons to make one choice over another, to speak one way versus another, and to view life one way rather than another. Physical and social context is colorfully conveyed, and the experience of time is captured at the levels of social, cultural, and political history as well as at the level of personal progress. The role of the researcher in this particular context and interaction also is clearly apparent. Dense explanatory description may be achieved using a number of qualitative methods including ethnography, phenomenology, and grounded theory. Depiction of An even greater degree of qualitative complexity is achieved in findings that not only experiential describe the main pathway or essence of an experience but also portray how that variation experience or pathway varies depending on individuality and context. Portraying or explaining variation in a human experience requires considerable breadth and depth of sampling and data collection and a high level of analytic expertise, which can produce a high degree of discovery of new insights or perspectives on human phenomena. Although grounded theories are the type of findings most commonly thought of as portraying variation, this level of complexity can be seen in other approaches as well. The rich detail in a fully realized phenomenology or ethnography can capture a variety of viewpoints and realizations of a human experience and the contextual sources of that variety, whether political, cultural, familial, or intrapersonal. Shared pathway or The third category shows an increase in complexity. Here, the investigator's interpretation meaning produces a synthesis of a shared experience or process. It is distinguished from the previous grouping by the investigator's integration of concepts or themes into a linked and logical portrayal. The commonality, core, or essence of the experience is captured by the analyst. This synthesis has the potential to reveal something previously undescribed about the phenomenon that would not be readily apparent in a series of unlinked categories. The increased complexity enables greater discovery. Shared pathways or meanings can be seen in findings achieved with a variety of qualitative approaches. For example, in a qualitative description, data clusters are linked in a holistic picture of the experience. In a grounded-theory study, concepts are connected in a model of influences and strategies or actions, with each relationship substantiated by data. In a phenomenological study, themes are experiential components integrated into a narrative depiction of a multifaceted phenomenon. The analyst has moved from describing parts of a data set to explaining how these are components of a larger social or experiential whole. Descriptive The simplest level of complexity of qualitative evidence, but one that nonetheless may categories portray discovery is a series of labelled data categories. Clusters of data are labelled with brief headings that indicate the topic or type of data contained therein, as in a book's table of contents. Content analysis techniques often produce findings in this format. Findings restricted Findings that are produced by applying an existing set of ideas to qualitative data without by a priori identifying new insights or enriching, extending, or revising existing theory may offer a frameworks certain degree of complexity but little discovery, and consequently they provide little or no evidence for practice. Grades of recommendation for qualitative research (Insp. by Sandelowski and Barroso – 2007, Kearney – 2004, MERGE – 1996, DRPS – 2004, and SIGN – 2008) At least one high quality meta-synthesis, systematic review or meta-summary rated as 1 and directly applicable 1 to the target population and context, or a body of evidence consisting principally of papers rated as 1, directly applicable to the target population and context and demonstrating overall consistency of findings. A body of evidence including papers rated as 2 or one paper rated as 1, directly applicable to the target 2 population and context and demonstrating overall consistency of findings, or extrapolated evidence from papers rated as 1. A body of evidence including papers rated as 3 or one paper rated as 2, directly applicable to the target 3 population and context and demonstrating overall consistency of findings, or extrapolated evidence from papers rated as 2. A body of evidence including papers rated as 4 or one paper rated as 3, directly applicable to the target 4 population and context and demonstrating overall consistency of findings. One or two papers rated as 4. 5 78 Paper 1 Mechanical Restraint Which Interventions Prevent Episodes of Mechanical Restraint? A Systematic Review. Perspectives in Psychiatric Care ISSN 0031-5990 Mechanical Restraint—Which Interventions Prevent Episodes of Mechanical Restraint?—A Systematic Review ppc_307 83..94 Jesper Bak, RN, SD, MPH, Stud. PhD, Mette Brandt-Christensen, MD, PhD, Dorte Maria Sestoft, MD, PhD, and Vibeke Zoffmann, RN, MPH, PhD Jesper Bak, RN, SD, MPH, Stud. PhD, is a Head Nurse, Mental Health Centre Sct. Hans, Roskilde, Denmark; Mette Brandt-Christensen, MD, PhD, is Employed Senior Consultant, Forensic Psychiatric Centre Glostrup, Copenhagen, Denmark; Dorte Maria Sestoft, MD, PhD, is Head of Department, Ministry of Justice, Clinic of Forensic Psychiatry, Copenhagen, Denmark; and Vibeke Zoffmann, RN, MPH, PhD, is a Senior Researcher, Steno Diabetes Center, Gentofte, Denmark. Search terms: Mechanical restraint, mental disorder, nursing, psychiatry, systematic review Author contact: [email protected], with a copy to the Editor: [email protected] Conflict of Interest Statement The authors report no actual or potential conflicts of interest. No external or intramural funding was received. PURPOSE: To identify interventions preventing mechanical restraints. DESIGN AND METHODS: Systematic review of international research papers dealing with mechanical restraint. The review combines qualitative and quantitative research in a new way,describing the quality of evidence and the effect of intervention. FINDINGS: Implementation of cognitive milieu therapy, combined interventions, and patient-centered care were the three interventions most likely to reduce the number of mechanical restraints. PRACTICE IMPLICATIONS: There is a lack of high-quality and effective intervention studies. This leaves patients and metal health professionals with uncertainty when choosing interventions in an attempt to prevent mechanical restraints. First Received August 11, 2010; Final Revision received February 10, 2011; Accepted for publication February 18, 2011. doi: 10.1111/j.1744-6163.2011.00307.x In some countries, mechanical restraint is performed according to the law when psychiatric inpatients pose a risk to themselves or to others (Indenrigs- og Sundhedsministeriet, 2006). Other countries do not allow the use of mechanical restraint; for example, in the United Kingdom, only the use of seclusion and holding (physical restraint) is allowed (except in exceptional circumstances in special hospital environments). Therefore, what constitutes the use of mechanical restraint differs a lot across Europe and the rest of the world. Nursing staff has the primary role in carrying out the practical procedure. Leather or fiber belts are used to fixate the patient to the bed, occasionally together with straps around the hands and feet. In this paper, mechanical restraint is defined: The use of restraining straps, belts, or other equipment to restrict movement, as suggested by Bowers, van der Werf, et al. (2007). Even though mechanical restraint is used within the law, thorough ethical considerations regarding patients’ right of selfdetermination and human rights, in general, should be made on how much this intervention should be used. The European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment has, after visits to Denmark, even stated that applying instruments of physical restraint to psychiatric patients for days cannot have any medical justification and amounts to ill treatment (The EuroPerspectives in Psychiatric Care 48 (2012) 83–94 © 2011 Wiley Periodicals, Inc. pean Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment, 2002; Hauksson, 2008). Physically, applying mechanical restraints is a risky intervention where patients can develop deep vein thromboses, pulmonary embolisms, and lactic acidosis, which could contribute to cardiovascular collapse, broken bones, etc. (Chan, Neuman, Clausen, Eisele, & Vilke, 2004; Hem, Steen, Opjordsmoen, & Moussaoui, 2001; Hick, Smith, & Lynch, 1999; Laursen, Jensen, Bolwig, & Olsen, 2005; Morrison & Sadler, 2001; Nielsen, 2005). Against this are also the negative psychological impact of mechanical restraint on patients feeling helpless, angry, trapped, sad, fearsome, unpleasant, or offended, and patients often regard it as an injustice or see it as punishment, in the worst case developing lifetime trauma and possibly post-traumatic stress disorder (Bower, McCullough, & Timmons, 2003; Cusack, Frueh, Hiers, Suffoletta-Maierle, & Bennett, 2003; Frueh et al., 2005; Steinert, Bergbauer, Psych, Schmid, & Gebhardt, 2007). These negative consequences are inconsistent with healthcare providers’ basic attitudes regarding“doing good”for the patients. Weighty arguments for using mechanical restraint are, however, that staff members have to allow for the patient’s own health and life, as well as the health, lives, and rights of others, for example, violence toward fellow patients, relatives, 83 Mechanical Restraint—Which Interventions Prevent Episodes of Mechanical Restraint?—A Systematic Review and staff. Altogether, the dilemma is not easily solved, but it is widely agreed that the number of mechanical restraints should be reduced as much as possible (Sundhedsstyrelsen, 2009). Scientists and clinicians agree that many factors influence the complex phenomenon of mechanical restraint. The factors, which influence the aggressive or self-destructive behavior of the patient and, secondarily, the frequency of restraints inside a psychiatric ward, could be relative to the patient, ward, and staff, or to“situational/interactional condition” (Nijman, Campo, Ravelli, & Merckelbach, 1999). Many of these factors are related to daily activities when socializing with other persons in the psychiatric ward. Daily living is the area where nurses and other nursing staff members have a crucial role in reducing the use of mechanical restraint. Also, the rate of coercive interventions is, in many countries, considered an indicator of the quality of psychiatric inpatient treatment (Institut for Kvalitet og Akkreditering i Sundhedsvæsenet, 2009). However, research into the type of nursing interventions required, to prevent episodes of mechanical restraint, is scarce (Leitner, Barr, Jones, McGuire, & Whittington, 2006; National Institute for Health and Clinical Excellence [NICE], 2004, 2005). Numerous actions are recommended in order to reduce the use of mechanical and physical restraint: risk management; physical environment and alarm systems; staff attitudes and care alliance; prediction: antecedents, warning signs, and risk assessment; training, education, skills, and competencies; working with psychiatric patients; de-escalation methods and techniques; post-incident review; and staff environmental factors, both mental and physical working environment; medication; effective treatment of illness and abuse; effective observation; and physical training (Department of Health, 2007; NICE, 2005). Though, locally, some of these actions have been shown to reduce the numbers of restraint (Fisher, 2003; Hellerstein, Staub, & Lequesne, 2007), the nationwide figures still fail to decrease in some countries (Bremmes, Hatling, & Bjørngaard, 2008; Sundhedsstyrelsen, 2008). Purpose In order to provide a basis for choosing and developing nursing interventions, under which the number of mechanical restraint episodes are decreased, the following will be reviewed: Which conditions in nursing and which nursing interventions have been shown to reduce the frequency of mechanical restraint episodes? Table 1. Stages of the Review Process Developing scope of the review. Developing review questions with clinical focus, and inclusion and exclusion criteria. Developing search strategy and search phrases. Identifying sources of evidence. Carrying out the searches. Sifting the evidence. Extracting relevant data from studies meeting methodological and clinical criteria. Evaluating methodological quality using relevant checklists. Compiling papers in relevant evidence tables. Interpreting and grading each paper. Abstracting interventions and summarizing intervention levels. Grading the recommendations for the quantitative and qualitative evidence separately. Summarizing the whole body of evidence. Drawing up presentation of the result. Formulating conclusions and implications for further research. Drawing up the review article. were found (Muralidharan & Fenton, 2006). Therefore, searches were not limited to these study designs. Also, many of the areas under investigation could not be covered from quantitative papers solely. Therefore, we developed a way to combine quantitative and qualitative papers into ranked recommendations in order to deduce maximum information from the available papers. Theory The method was based on principles outlined by the Danish Reference Programme Secretariat (Sekretariatet for Referenceprogrammer, 2004) and NICE (2007) involving evaluation of the quantitative research; by Sandelowski and Barroso (2007) and Kearney (2001) involving evaluation of the qualitative research; and by Scottish Intercollegiate Guidelines Network (SIGN; Harbour, 2008) inspiring the process of the combined evaluation of both qualitative and quantitative research. The combination of principles from the mentioned sources has been necessary because no one in itself covered both quantitative and qualitative research quantification. The stages of the review process can be found in Table 1. Inclusion Criteria Original peer-reviewed papers, covering the care of adult psychiatric inpatients who have been physically restrained, were included in the review. The interventions and conditions covered in the review can be found in Table 2. Design and Methods Exclusion Criteria It was recognized very early during the process that only very few randomized clinical trials existed, and no meta-analyses Reviews were excluded to avoid some papers to be included twice or more, spoiling the calculations of effect and recom- 84 Perspectives in Psychiatric Care 48 (2012) 83–94 © 2011 Wiley Periodicals, Inc. Mechanical Restraint—Which Interventions Prevent Episodes of Mechanical Restraint?—A Systematic Review Table 2. Interventions and Conditions Covered Care Pathways (MR Sequence) Fundamental causes (psychosis, conflicts, abuse) Negative aggressive feelings. Toward the patient himself/herself or toward others. Negative aggressive actions. Toward the patient himself/herself or toward others. The mechanical restraint. Framework and aftercare/prevention. Interventions and Conditions Fundamental causes: • Degree of illness and substance abuse • Working with psychiatric patients, for example, in environment therapy or using nursing theory • Background variables such as diagnosis, gender distribution, ethnicity, types of staff being injured, reasons for being mechanically restrained, etc. Negative aggressive feelings: • Patients’ and relatives’ knowledge, feelings, and attitudes • Staff attitudes and care alliance • Prescription and use of p.n. medication, administered by nurses Negative aggressive actions: • Prediction such as antecedents, warning signs, and risk assessment • De-escalation methods and techniques • Observation • Limit setting The mechanical restraint: • Alarm systems • Physical environment • Physical staff training • Debriefing, defusing, or post-incident reviews (patients and staff) • Potential health risk because of MR • Staff training, education, skills, and competencies • Staff environmental factors, both mental and physical working environment MR, mechanical restraint; p.n., pro necessitate (as needed). mendation. Papers describing interventions and conditions to prevent physical restraint in nonpsychiatric inpatient settings, learning disability settings, nursing homes, and prisons were excluded. Time Frame The study included papers published after 1998. The papers were obtained between August and November 2008, with an update in April 2009. Search Strategies The searches included English, Danish, Norwegian, and Swedish language citations, all with English abstracts. Key words used in different combinations and inflections in the search were active, admitted, adolescence, affect, aged, aggression, alarm, and alliance, and the antecedents were anxiety, appreciative, atmosphere, attitude, bipolar, care plan, check, child, committed, communication, coping, debriefing, de-escalation, delusion, depression, detained, diffusion, developmental disability, disorder, diversion, dual diagnosis, education, elder, environmental therapy, forensic, hospitalised, house rule, hypo, hysterical, impulse, inpatient, intervention, learning disability, manage, manic, medication, mental health, milieu, mood, music, nonaversive, nonconfrontational, nursing, nursing home, nursing theory, observation, old, one on one, one to one, outpatient, panic, paranoid, personality disorder, pharmacology, physical, prediction, prevention, prison, p.r.n./p.n. (pro re nata/ pro necessitate—as needed or as the situation arises) medication, psychiatry, rapid tranquillisation, rehabilitation, reorganizing, restraint, review, risk assessment, schizophrenia, seclusion, strategy, surveillance, talk down, therapy, time out, training, treatment, violence, warning signs, and young. The structure of the search strategy is: • An overarching strategy for conditions and interventions across selected databases • A search to identify guidance and reports, for example, governmental reports, not indexed in the major databases • A topic-specific search strategy on PubMed • For each condition or intervention, evidence of effectiveness or harm was sought • Manual searching was performed in key areas not electronically indexed (e.g., PhD thesis) • Reference lists of the most relevant papers were checked for articles not otherwise found. One example from the searches is provided below in Table 3; the whole search strategy, from the 32 databases, can be required from the authors. Table 3. Example of a Search String CINAHL and AMED/EBSCOhost: (Restrained OR Restraint OR Restraints OR Secluded OR Seclusion OR (“restraint”)) or (MH “Psychiatry”) not (Nursing-home OR Prison OR Learning-disability OR Learning-disabilities OR Rehabilitation OR Outpatient OR developmental-disability OR developmental-disabilities), Limiters Applied, Publication Year from: 1998-; Inpatients; Age Groups: Adult, 19–44 years, Middle Age, 45–64 years. Perspectives in Psychiatric Care 48 (2012) 83–94 © 2011 Wiley Periodicals, Inc. 85 Mechanical Restraint—Which Interventions Prevent Episodes of Mechanical Restraint?—A Systematic Review Table 4. Grades of Recommendation for Qualitative Research 1 At least one high-quality meta-synthesis, systematic review, or meta-summary rated as 1 and directly applicable to the target population and context, or a body of evidence consisting principally of papers rated as 1, directly applicable to the target population and context, and demonstrating overall consistency of findings. 2 A body of evidence including papers rated as 2 or one paper rated as 1, directly applicable to the target population and context, and demonstrating overall consistency of findings, or extrapolated evidence from papers rated as 1. 3 A body of evidence including papers rated as 3 or one paper rated as 2, directly applicable to the target population and context, and demonstrating overall consistency of findings, or extrapolated evidence from papers rated as 2. 4 A body of evidence including papers rated as 4 or one paper rated as 3, directly applicable to the target population and context, and demonstrating overall consistency of findings. 5 One or two papers rated as 4. The papers were rated according to the complexity levels by Kearney where 1 = dense explanatory description, 2 = depiction of experimental variation, 3 = shared pathway or meaning, 4 = descriptive categories, 5 = findings restricted by a priori frameworks (level 5 papers were excluded). The basic assumption for the recommendation model was that the greater complexity and discovery, the more trustworthy the evidence was, and the more researchers that found independently the same finding (here intervention), the more reason there was to believe that it would work in the clinical setting. If the evidence was not directly applicable to the target population and context, it was downgraded. Checklists and Evidence Tables Checklists for evaluating the methodological quality of the papers and evidence tables for compiling studies can be required from the authors (Critical Appraisal Skills Programme, 2006; Health Care Practice Research and Development Unit, 2005; Kearney, 2001; Liddle, Williamsom, & Irwing, 1996; NICE, 2007; Sandelowski & Barroso, 2007; Sekretariatet for Referenceprogrammer, 2004). Evidence Grading Quantitative Research Grading. Once individual papers had been assessed for methodological quality and relevance in terms of the clinical questions, they were graded according to the levels of evidence. The available evidence for each intervention/condition was then compiled into tables. Grading of quantitative research papers was conducted as outlined by the Danish Reference Programme Secretariat (Sekretariatet for Referenceprogrammer, 2004). Because of the small number of eligible quantitative studies, it was not possible to perform meta-analyses. The levels of evidence and grades of recommendation (the grade of recommendation describes the whole body of evidence regarding a specific quantitative or qualitative topic [here interventions] and its ability to influence the phenomenon, “mechanical restraint,” in the clinical setting) were developed from the Danish Reference Programme Secretariat (Sekretariatet for Referenceprogrammer, 2004), Method for Evaluating Research and Guideline Evidence (MERGE; Liddle et al., 1996), and SIGN (Harbour, 2008); the developed descriptions can be required from the authors. Qualitative Research Grading. Once individual papers had been assessed for methodological quality and relevance in terms of the clinical questions, they were graded according to 86 the levels of complexity in the evidence described by Kearney (2001) (Kearney argues that: “The greater the complexity and discovery within qualitative findings, the stronger may be the potential for clinical application”). The available evidence was then compiled into tables. Appraising the qualitative research papers was conducted as outlined by Sandelowski and Barroso (2007). The new hierarchy of the recommendation grades for the qualitative evidence was developed for this review by the first author, Jesper Bak, in order to provide a united and structured evidence base. The development was inspired by Kearney, Sandelowski, and Barroso, the Danish Reference Programme Secretariat (Sekretariatet for Referenceprogrammer, 2004), MERGE (Liddle et al., 1996), and SIGN (Harbour, 2008); the developed hierarchy can be seen in Table 4. Synthesizing the Papers The final synthesis was based on consensus decisions by the four authors and was guided by the following three questions: Which interventions match patients’ views and experiences?, which interventions have yet to be evaluated in clinical settings?, and does the effect of the intervention seem plausible from a clinical point of view? Sample The search yielded a total of 2,885 papers. This number was reduced to 358 after sifting the material that potentially met eligibility criteria on the basis of the title/abstract. After the full papers were reviewed for relevance/eligibility or for vague relevance/eligibility, the number of papers was further reduced to 268. Lastly, the papers were critically appraised and quality checked, leading to a final number of 59 papers. Out of these, 48 were quantitative papers and 11 were qualitative papers. Perspectives in Psychiatric Care 48 (2012) 83–94 © 2011 Wiley Periodicals, Inc. Mechanical Restraint—Which Interventions Prevent Episodes of Mechanical Restraint?—A Systematic Review Displaying the Findings The development of the combined recommendation grading made it possible to display the registered interventions hierarchically (see Table 5). The Hierarchy. In Table 5, the first column shows the number in the hierarchy. The second column shows the description of the synthesized intervention, and the third column shows the combined quantitative and qualitative recommendation grade. The recommendation grade describes the intervention’s ability to exert an effect on reducing the number of mechanical restraints in the clinical setting, not the degree of how much it would reduce the number of mechanical restraints, but if it would. This is described in five levels from 1 to 5, with 1 being the best. 1 indicates an intervention that most certainly would have an effect on the phenomenon (mechanical restraint), and 5 indicates a high degree of uncertainty whether or not the intervention would have an impact on, or have any relation at all to, the phenomenon. Combining the quantitative and qualitative recommendations was done by taking the better of the two, to show what kind of evidence had influence on the combined recommendation; the individual recommendations are shown in brackets, first, the qualitative recommendation grade and, second, the quantitative recommendation grade. This is followed by the fourth column showing the effect of the intervention, where the reduction in the number of mechanical restraints was divided into five levels from 1 to 5, with 1 being the best, from 80% to 100% reduction, 2 from 60% to 80%, etc. The effect of the intervention was extrapolated from the quantitative papers and was combined in the following way: • No paper: The level was set to 5 (0–20% reduction) • One paper: The level was transferred directly • Two or more papers: The level was influenced by: 1. The paper with the best recommendation grade. 2. The paper best describing the intervention. 3. A simple average. The Matrix. To illustrate which interventions were the most likely to reduce the use of mechanical restraints, every intervention was placed in a matrix of effect and recommendation grade (represented as numbers in Figure 1). The closer the intervention was placed to the upper right corner, the more likely it could reduce the occurrence of mechanical restraints (the “better” the intervention was). Approval and Ethics Literature reviews do not need approval from the scientific– ethical committee system (Indenrigs- og SundhedsminisPerspectives in Psychiatric Care 48 (2012) 83–94 © 2011 Wiley Periodicals, Inc. teriet, 2004). The study followed the Ethical Guidelines for Nursing Research in the Nordic Countries (Northern Nurse Federation, 2003) and the White Paper Regarding a Draft Recommendation on Legal Protection of Persons Suffering From Mental Disorder Especially Those Placed as Involuntary Patients (Council of Europe, 2000). Findings No interventions reached the highest degree of recommendation combined with the highest effect. One intervention reached the highest effect, with a decrease in mechanical restraints of 87%, but only with a recommendation grade of 3 (Table 5, no. 1), and another with a recommendation grade of 2, but only with decrease in mechanical restraints of 27% (Table 5, no. 5). The Three Highest Ranked Interventions The highest ranked intervention found was implementation of cognitive milieu therapy (CMT) (Lykke, Austin, & Morch, 2008), where the reduction in mechanical restraints was 87%. CMT was an active, structured, problemorientated, psycho-educational, and dynamic treatment form. The cognitive treatment model in the environment gave the patient opportunity to find new alternatives to inappropriate patterns of reactions and develop new skills (Oestrich, Lykke, & Holm, 2001). One of the core issues in the CMT was a schema-focused dialog between the patient and the nursing staff, in the situation just before a potential mechanical restraint. Here, the patient had the opportunity to try out new actions. This sort of patient involvement is also found elsewhere (Robins, Sauvageot, Cusack, SuffolettaMaierle, & Frueh, 2005; Thyrsting & Hall, 2008) to have positive influence on the occurrence of mechanical restraint. Especially one of these papers (Robins et al., 2005) had a high evidence quality, and for that reason, the combination of CMT and patient involvement is regarded as the “best” intervention in this review (Table 5, no. 1). The second highest ranked intervention is not one particular intervention but programs including several interventions, for instance, patient education, staff education, patient participation, programmatic changes, high-level administrative endorsement, cultural changes, data analyses, etc. There are several papers describing different programs (Fisher, 2003; Hellerstein et al., 2007; Khadivi, Patel, Atkinson, & Levine, 2004; Sullivan et al., 2005; Taxis, 2002). An average of these gives a 76% decrease of mechanical restraints (Table 5, no. 2). The evidence consisted mostly of “before- and after” papers, and because some of these are well founded, the recommendation grade is the same as in no. 1. The third highest ranked intervention is implementation of patient-centered care (Fletcher & Stevenson, 2001; Robins 87 Mechanical Restraint—Which Interventions Prevent Episodes of Mechanical Restraint?—A Systematic Review Table 5. Intervention Hierarchy No. Intervention Recommendation Effect Literature Reference Implementation of cognitive milieu therapy reduces the number of mechanical restraint episodes, among other things, through patient involvement and empowerment. Combined intervention programs are effective in avoiding mechanical restraints, for example, patient participation, patient education, staff education, programmatic changes, high-level administrative endorsement, cultural changes, data analysis, etc. Implementation of patient-centered care with a higher degree of patients’ positive involvement in their own care reduces the number of mechanical restraint episodes. The identification of the patients’ crisis triggers unique calming techniques and decisions on specific crisis interventions early in the admission procedure, thereby reducing the number of mechanical restraints. Introduction of validated risk assessment systems including suggestions of care interventions reduces the number of mechanical restraints. Effective treatment of substance abuse and psychosis reduce the number of mechanical restraint episodes; the treatment of mental illnesses is also described elsewhere in the review. Mandatory review from qualified clinical experts, for example, as post-incident review, minimizes the number of mechanical restraint episodes. Better staff training reduces the number of mechanical restraints (longer duration of the training, more staff participating, use of different and involving education methods, higher quality of the content, and greater diversity of the topics, for example, legislation, crisis management, physical intervention strategies, antecedents, warning signs, de-escalation techniques, etc.). Staff attitudes such as positive care for the patients, respect, collaboration, communication, humanism, empathy, and less control and involuntary procedures reduce the number of mechanical restraints. 3 (3–4) 1 Lykke et al., 2008; Robins et al., 2005; Thyrsting and Hall, 2008 3 (n.a.–3) 2 Fisher, 2003; Hellerstein et al., 2007; Khadivi et al., 2004; Sullivan et al., 2005; Taxis, 2002 3 (3–4) 2 Fletcher and Stevenson, 2001; Robins et al., 2005; Sullivan et al., 2004; Thyrsting and Hall, 2008 3 (4–3) 3 Jonikas, Cook, Rosen, Laris, and Kim, 2004; McCain and Kornegay, 2005; Meehan, Mcintosh, and Bergen, 2006; Wynn and Mykleburst, 2006 2 (n.a.–2) 4 Abderhalden et al., 2008; Cochrane-Brink, Lofchy, and Sakinofsky, 2000; Dernevik, Grann, and Johansson, 2002 4 (n.a.–4) 3 Fletcher and Stevenson, 2001; Palmstierna and Olsson, 2007; Sullivan et al., 2004; Thyrsting and Hall, 2008 4 (n.a.–4) 3 Donat, 1998; Prescott, Madden, Dennis, Tisher, and Wingate, 2007 3 (3–4) 4 4 (4–4) 4 10 Higher patient–staff ratio reduces the number of mechanical restraints. 4 (n.a.–4) 4 Bonner, Lowe, Rawcliffe, and Wellman, 2002; Bowers, Nijman, et al., 2006; Cardell and Pitula, 1999; Delaney and Johnson, 2006; Hahn, Abderhalden, Duxbury, Halfens, and Needham, 2006; Jonikas et al., 2004; Lee et al., 2001; Mackay, Paterson, and Cassells, 2005; Needham, Dassen, Halfens, Haug, and Fisher, 2005; Spokes et al., 2002; Wright et al., 2005 Allen, Carpenter, Sheets, Miccio, and Ross, 2003; Bowers, Alexander, Simpson, Ryan, and Carr-Walker, 2007; Bowers, Brennan, Flood, Lipang, and Oladapo, 2006; Duxbury, 2002; Gillig, Markert, Barron, and Coleman, 1998; Meehan et al., 2006; Robins et al., 2005; Spokes et al., 2002 Smith et al., 2005; Wynn, 2003 11 The higher educated the staff, the fewer episodes of mechanical restraints. 3 (3–4) 5 12 The more experienced the staff, the fewer episodes of mechanical restraints. 3 (3–4) 5 13 If nurses change their focus from considering the patient as deviant to being a resource in his/her own treatment, it would decrease the number of mechanical restraint. Early and adequate administration of oral p.n. medication guided by the individual patients’ problems, medication experiences, and preferences leads to fewer mechanical restraint episodes. Debriefing, defusing, and crisis intervention minimize the number of mechanical restraint episodes. Patients’ response to rules can be positive and lead to fewer cases of mechanical restraint, for instance, if staff helps patients to understand not only the rules, but also the rationale for the presence of such rules. If the staff manages to make patients understand that the rules are imposed out of concern for their welfare, then patients may be less reluctant to following these rules. Activity-based nursing interventions, for example, physical activities, are effective in avoiding mechanical restraints. 3 (3–n.a.) 5 4 (4–4) 5 4 (5–4) 5 4 (5–4) 5 4 (5–4) 5 1 2 3 4 5 6 7 8 9 14 15 16 17 88 Bonner et al., 2002; Cardell and Pitula, 1999; Delaney and Johnson, 2006; Flannery, Stone, Rego, Walker, and Farley, 2006; Gim et al., 1999; Mackay et al., 2005; Spokes et al., 2002 Bonner et al., 2002; Bowers, Jeffery, et al., 2007; Cardell and Pitula, 1999; Delaney and Johnson, 2006; Flannery et al., 2006; Janssen, Noorthoorn, Linge, and Lendemeijer, 2007; Mackay et al., 2005; Spokes et al., 2002 Vatne and Fagermoen, 2007 Allen et al., 2003; Goedhard, Stolker, Nijman, Egberts, and Heerdink, 2007; McCain and Kornegay, 2005; Meehan et al., 2006; Thapa et al., 2003 Bonner et al., 2002; Bowers, Simpson, et al., 2006; Flannery et al., 2006; Jonikas et al., 2004 Alexander, 2006; Duxbury, 2002; Gillig et al., 1998; Meehan et al., 2006; Robins et al., 2005 Meehan et al., 2006; Thomas, Jones, Johns, and Trauer, 2006 Perspectives in Psychiatric Care 48 (2012) 83–94 © 2011 Wiley Periodicals, Inc. Mechanical Restraint—Which Interventions Prevent Episodes of Mechanical Restraint?—A Systematic Review Table 5. Continued No. Intervention Recommendation Effect Literature Reference 18 Several mental and physical working environmental factors influence positively the number of mechanical restraints, for example, good management as a high degree of order, organization, or support; adequate staffing; psychiatric training; rotation; education; no crowding; emergency backup, etc. Several of these factors are described elsewhere in the review. Less crowding, for example, less stimuli and less environmental stress, and more personal space decrease the number of mechanical restraints. Higher regular staff and lower substitute ratio reduce the number of mechanical restraints. 4 (5–4) 5 Bonner et al., 2002; Bowers, Allan, Simpson, Jones, and Whittington, 2008; Daffern, Mayer, and Martin, 2006; Owen, Tarantello, Jones, and Tennant, 1998; Whittington and McLaughlin, 2000 4 (5–4) 5 Meehan et al., 2006; Vaaler, Morken, Fløvig, Iversen, and Linaker, 2006 4 (5–4) 5 4 (n.a.–4) 5 Bonner et al., 2002; Bowers, Allan, Simpson, Nijman, and Warren, 2007; Spokes et al., 2002 Lind, Kaltiala-Heino, Suominen, Leino-Kilpi, and Valimaki, 2004; Van Doeselaar, Sleegers, and Hutschemaekers, 2008 4 (n.a.–4) 5 D’Orio, Purselle, Stevens, and Garlow, 2004 4 (n.a.–4) 5 Wynn, 2003 4 (n.a.–4) 5 Duxbury and Whittington, 2005 4 (n.a.–4) 5 Vaaler, Morken, and Linaker, 2005 4 (n.a.–4) 5 Janelli and Kanski, 1998 5 (5–n.a.) 5 Meehan et al., 2006 19 20 21 22 23 24 25 26 27 Staffs’ opposition toward mechanical restraint because of the perception that mechanical restraint is ethically problematic decreases the number of mechanical restraints. Alarm systems, for example, video surveillance and radio systems, and well-trained response teams reduce the number of mechanical restraints. Better care alliance between patients and the nursing staff reduces the number of mechanical restraints. Communication especially communicative de-escalation reduces the number of mechanical restraint episodes. Well-maintained and familiar surroundings reduce the number of mechanical restraints. Music as diversion and relaxation before and after mechanical restraint reduces the number of mechanical restraint episodes. Separation of acutely disturbed patients reduces the number of mechanical restraint episodes. No. refers to the number in the hierarchy where 1 is highest/best. Recommendation describes the whole body of evidence regarding a specific intervention level of scientific “truth” or its potential for clinical application. To show what kind of evidence that mostly influenced the combined recommendation, the individual recommendations are shown in brackets, first, the qualitative recommendation grade and, second, the quantitative recommendation grade. All from 1 to 5, where 1 is the highest/best. n.a. referred to no available paper. Effect refers to the reduction in the number of mechanical restraints, from 1 to 5, with 1 being the best, from 80% to 100% reduction, 2 from 60% to 80%, etc. p.n., pro necessitate (as needed). et al., 2005; Sullivan, Wallis, & Lloyd, 2004; Thyrsting & Hall, 2008) (Table 4, no. 3). Here, implementation of the Tidal Model (TM) reduces the number of mechanical restraints by 68%. TM is a philosophical approach to the discovery of mental health. TM focuses on helping people who have experienced some metaphorical “breakdown” to recover their lives as fully as possible, by reclaiming the personal story of their distress and difficulty (Barker & Buchanan-Barker, 2010). One of the core elements in TM is empowerment of the patient. Empowerment is only possible if the patients are involved in their own care. Patient involvement is also found elsewhere (Robins et al., 2005; Thyrsting & Hall, 2008) to have a positive influence on the occurrence of mechanical restraint. Therefore, the recommendation grade is the same as in the first intervention described. Discussion The highest ranked intervention was CMT combined with patient involvement. To our knowledge, this result has not Perspectives in Psychiatric Care 48 (2012) 83–94 © 2011 Wiley Periodicals, Inc. Figure 1. Effect and Recommendation Grade Matrix The numbers in the matrix refer to a specific intervention (the first number in the intervention hierarchy [Table 5]). 89 Mechanical Restraint—Which Interventions Prevent Episodes of Mechanical Restraint?—A Systematic Review been identified in prior reviews, one probable cause being that the CMT paper was not published in English, and in the abstract, the effect was only described as a significant effect, not the exact figure of a staggering 87% reduction. Also, the fact that this paper is rather new (from 2008) might explain its limited impact. The second highest ranked intervention was combined interventions (many interventions in a program or a package). This finding is supported by an earlier review (Gaskin, Elsom, & Happell, 2007) where the authors’ conclusion recommended a combination of several interventions to reduce the number of mechanical restraints. The third highest ranked intervention was implementation of patient-centered care, which means that the patient is placed in the center of his/her own care. Despite being in closed units where restrictions to individual liberty often must be exerted, the patient should be given as much influence over his/her situation as possible. The positive influence on mechanical restraint by patient-centered or patientinvolving care is also supported in other reviews (Gaskin et al., 2007; Sailas & Wahlbeck, 2005). No interventions reached the highest degree of recommendation combined with the highest effect, and to create strong evidence-based practice in this area, substantially further research is needed. This is necessary because implementing not effective interventions could be both expensive and unethical. Many apparently different interventions centered on the patient could be more efficacious on reducing the number of mechanical restraints. This point could lead us to speculate that therapeutic interventions could allow us to reduce coercive measures in psychiatry. Limitations First, only one person was involved in the initial review process, until the drawing up of evidence statements; it might be argued that two or more persons reading all the material followed by consensus evaluations would produce more reliable results. However, all the evidence was rated in exactly the same way (no inter-rater differences). Second, the quantification combining qualitative and quantitative evidence is new and possibly controversial. A simple argument in favor is that the more mechanical restraint and a specific intervention are interrelated (no matter if this relation in nature is quantitative or qualitative), the greater the evidence for this relation becomes. So, in the authors’ opinion, as mechanical restraint is a multifaceted phenomenon and the evidence is limited, it is reasonable to combine well-established quantitative review procedures with well-established quantified qualitative review procedures in order to deduce maximum information from the available papers. 90 Implication for Research There is an obvious lack of high-quality intervention studies, which may be because of the vast difficulties in performing such studies because of the complexity of the phenomenon and because of the fact that the interventions must be performed in clinical settings. The findings of this review point to the need for randomized clinical trials on specific interventions. The likelihood of implementing interventions in several units as a cluster-randomized trial would constitute a suitable study design for this purpose. Before choosing the intervention for the clinical trial, it could be interesting to investigate the “effect and recommendation grade matrix” through a cross-sectional study evaluating the potency of the individual interventions in relation to mechanical restraints in terms of hypotheses testing and falsification. This would strengthen the choice of intervention. Implications for Nursing Practice The papers included in this review do not imply that the interventions easily can be transferred to practice because in many cases, they describe specific settings and narrow populations. Neither did any of the interventions reach the highest degree of recommendation, as far as influencing the number of mechanical restraints in the clinical setting is concerned. However, no intervention seemed to have any negative or harmful side effects. Considering that mechanical restraint is one of the most intrusive care interventions, every effort to avoid it must be used until convincing evidence is provided. Acknowledgments For funding this project, we thank: the Mental Health Centre Sct. Hans, Copenhagen University Hospital, the mental health services in the capital region of Denmark, and the Research Foundation in the capital region of Denmark. The authors wish to thank Margit Asser (Deputy Head of Centre, Mental Health Centre Sct. Hans, Roskilde, Denmark), Jeanett Bauer (Employed Senior Physician, Psychiatric Centre Copenhagen, Bispebjerg Hospital, Denmark), and Thomas Werge (Head of Research, Mental Health Centre Sct. Hans, Roskilde, Denmark) for valuable comments and careful reading during the writing process. References Abderhalden, C., Dassen, T., Fisher, J. E., Halfens, R. J. G., Haug, H. J., & Needham, I. (2008). Structured risk assessment and violence in acute psychiatric wards: Randomised controlled trial. 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Perspectives in Psychiatric Care Corrigendum ppc_337 ISSN 0031-5990 183..184 Bak, J., Brandt-Christensen, M., Sestoft, D. M., & Zoffmann, V. (2011). Mechanical restraint—Which interventions prevent episodes of mechanical restraint?—A systematic review. Perspectives in Psychiatric Care, 48(2), 83–94. Under “Findings” and sub-heading “The Three Highest Ranked Interventions”: 1. The citations for “Robins, Sauvageot, Cusack, Suffoletta-Maierle, & Frueh, 2005” and “(Robins et al., 2005)” should be removed. 2. The following two sentences have been changed. “The study included papers published after 1998.” The correct statement is: “The study included papers published from 1998.” And, “Especially one of these papers (Robins et al., 2005) had a high evidence quality, and for that reason, the combination of CMT and patient involvement is regarded as the ‘best’ intervention in this review (Table 5, no. 1).” The correct statement is: “Especially this paper had a high evidence quality and for that reason, the combination of CMT and patient involvement is regarded as the ‘best’ intervention in this review (Table 5, no. 1).” 3. Several references have been amended in Table 5. The corrected Table 5 is below: Table 5. Intervention Hierarchy No. 1 2 3 4 5 6 7 8 Intervention Recommendation Effect Literature Reference Implementation of cognitive milieu therapy reduces the number of mechanical restraint episodes, among other things, through patient involvement and empowerment. Combined intervention programs are effective in avoiding mechanical restraints, for example, patient participation, patient education, staff education, programmatic changes, high-level administrative endorsement, cultural changes, data analysis, etc. Implementation of patient-centered care with a higher degree of patients’ positive involvement in their own care reduces the number of mechanical restraint episodes. The identification of the patients’ crisis triggers unique calming techniques and decisions on specific crisis interventions early in the admission procedure, thereby reducing the number of mechanical restraints. Introduction of validated risk assessment systems including suggestions of care interventions reduces the number of mechanical restraints. Effective treatment of substance abuse and psychosis reduce the number of mechanical restraint episodes; the treatment of mental illnesses is also described elsewhere in the review. Mandatory review from qualified clinical experts, for example, as post-incident review, minimizes the number of mechanical restraint episodes. Better staff training reduces the number of mechanical restraints (longer duration of the training, more staff participating, use of different and involving education methods, higher quality of the content, and greater diversity of the topics, for example, legislation, crisis management, physical intervention strategies, antecedents, warning signs, de-escalation techniques, etc.). 3 (3–4) 1 Lykke et al., 2008; Thyrsting and Hall, 2008 3 (n.a.–3) 2 Fisher, 2003; Hellerstein et al., 2007; Khadivi et al., 2004; Sullivan et al., 2005; Taxis, 2002 3 (3–4) 2 Fletcher and Stevenson, 2001; Sullivan et al., 2004; Thyrsting and Hall, 2008 3 (4–3) 3 Jonikas, Cook, Rosen, Laris, and Kim, 2004; McCain and Kornegay, 2005; Meehan, Mcintosh, and Bergen, 2006; Wynn and Mykleburst, 2006 2 (n.a.–2) 4 Abderhalden et al., 2008; Cochrane-Brink, Lofchy, and Sakinofsky, 2000; Dernevik, Grann, and Johansson, 2002 4 (n.a.–4) 3 Fletcher and Stevenson, 2001; Palmstierna and Olsson, 2007; Sullivan et al., 2004; Thyrsting and Hall, 2008 4 (n.a.–4) 3 Donat, 1998; Prescott, Madden, Dennis, Tisher, and Wingate, 2007 3 (3–4) 4 Bonner, Lowe, Rawcliffe, and Wellman, 2002; Bowers, Nijman, et al., 2006; Delaney and Johnson, 2006; Hahn, Abderhalden, Duxbury, Halfens, and Needham, 2006; Jonikas et al., 2004; Lee et al., 2001; Mackay, Paterson, and Cassells, 2005; Needham, Dassen, Halfens, Haug, and Fisher, 2005; Spokes et al., 2002; Wright et al., 2005 doi:10.1111/j.1744-6163.2012.00337.x Perspectives in Psychiatric Care 48 (2012) 183–184 © 2012 Wiley Periodicals, Inc. 183 Corrigendum Table 5. Continued No. Intervention Recommendation Effect Literature Reference Staff attitudes such as positive care for the patients, respect, collaboration, communication, humanism, empathy, and less control and involuntary procedures reduce the number of mechanical restraints. 4 (4–4) 4 Allen, Carpenter, Sheets, Miccio, and Ross, 2003; Bowers, Alexander, Simpson, Ryan, and Carr-Walker, 2007; Bowers, Brennan, Flood, Lipang, and Oladapo, 2006; Cardell and Pitula, 1999; Duxbury, 2002; Gillig, Markert, Barron, and Coleman, 1998; Meehan et al., 2006; Robins et al., 2005; Spokes et al., 2002 10 Higher patient–staff ratio reduces the number of mechanical restraints. 4 (n.a.–4) 4 Smith et al., 2005; Wynn, 2003 11 The higher educated the staff, the fewer episodes of mechanical restraints. 3 (3–4) 5 Delaney and Johnson, 2006; Flannery, Stone, Rego, Walker, and Farley, 2006; Gim et al., 1999; Mackay et al., 2005; Spokes et al., 2002 12 The more experienced the staff, the fewer episodes of mechanical restraints. 3 (3–4) 5 13 If nurses change their focus from considering the patient as deviant to being a resource in his/her own treatment, it would decrease the number of mechanical restraint. 3 (3–n.a.) 5 Bowers, Jeffery, et al., 2007; Delaney and Johnson, 2006; Flannery et al., 2006; Janssen, Noorthoorn, Linge, and Lendemeijer, 2007; Mackay et al., 2005; Spokes et al., 2002 Vatne and Fagermoen, 2007 14 Early and adequate administration of oral p.n. medication guided by the individual patients’ problems, medication experiences, and preferences leads to fewer mechanical restraint episodes. 4 (4–4) 5 Allen et al., 2003; Goedhard, Stolker, Nijman, Egberts, and Heerdink, 2007; McCain and Kornegay, 2005; Meehan et al., 2006; Thapa et al., 2003 15 Debriefing, defusing, and crisis intervention minimize the number of mechanical restraint episodes. Patients’ response to rules can be positive and lead to fewer cases of mechanical restraint, for instance, if staff helps patients to understand not only the rules, but also the rationale for the presence of such rules. If the staff manages to make patients understand that the rules are imposed out of concern for their welfare, then patients may be less reluctant to following these rules. Activity-based nursing interventions, for example, physical activities, are effective in avoiding mechanical restraints. Several mental and physical working environmental factors influence positively the number of mechanical restraints, for example, good management as a high degree of order, organization, or support; adequate staffing; psychiatric training; rotation; education; no crowding; emergency backup, etc. Several of these factors are described elsewhere in the review. Less crowding, for example, less stimuli and less environmental stress, and more personal space decrease the number of mechanical restraints. Higher regular staff and lower substitute ratio reduce the number of mechanical restraints. Staffs’ opposition toward mechanical restraint because of the perception that mechanical restraint is ethically problematic decreases the number of mechanical restraints. Alarm systems, for example, video surveillance and radio systems, and well-trained response teams reduce the number of mechanical restraints. Better care alliance between patients and the nursing staff reduces the number of mechanical restraints. Communication especially communicative de-escalation reduces the number of mechanical restraint episodes. Well-maintained and familiar surroundings reduce the number of mechanical restraints. Music as diversion and relaxation before and after mechanical restraint reduces the number of mechanical restraint episodes. Separation of acutely disturbed patients reduces the number of mechanical restraint episodes. 4 (5–4) 5 4 (5–4) 5 Bonner et al., 2002; Bowers, Simpson, et al., 2006; Flannery et al., 2006; Jonikas et al., 2004 Alexander, 2006; Duxbury, 2002; Gillig et al., 1998; Meehan et al., 2006; Robins et al., 2005 4 (5–4) 5 Meehan et al., 2006; Thomas, Jones, Johns, and Trauer, 2006 4 (5–4) 5 Bonner et al., 2002; Bowers, Allan, Simpson, Jones, and Whittington, 2008; Daffern, Mayer, and Martin, 2006; Owen, Tarantello, Jones, and Tennant, 1998; Whittington and McLaughlin, 2000 4 (5–4) 5 Meehan et al., 2006; Vaaler, Morken, Fløvig, Iversen, and Linaker, 2006 4 (5–4) 5 4 (n.a.–4) 5 Bonner et al., 2002; Bowers, Allan, Simpson, Nijman, and Warren, 2007; Spokes et al., 2002 Lind, Kaltiala-Heino, Suominen, Leino-Kilpi, and Valimaki, 2004; Van Doeselaar, Sleegers, and Hutschemaekers, 2008 4 (n.a.–4) 5 D’Orio, Purselle, Stevens, and Garlow, 2004 4 (n.a.–4) 5 Wynn, 2003 4 (n.a.–4) 5 Duxbury and Whittington, 2005 4 (n.a.–4) 5 Vaaler, Morken, and Linaker, 2005 4 (n.a.–4) 5 Janelli and Kanski, 1998 5 (5–n.a.) 5 Meehan et al., 2006 9 16 17 18 19 20 21 22 23 24 25 26 27 No. refers to the number in the hierarchy where 1 is highest/best. Recommendation describes the whole body of evidence regarding a specific intervention level of scientific “truth” or its potential for clinical application. To show what kind of evidence that mostly influenced the combined recommendation, the individual recommendations are shown in brackets, first, the qualitative recommendation grade and, second, the quantitative recommendation grade. All from 1 to 5, where 1 is the highest/best. n.a. referred to no available paper. Effect refers to the reduction in the number of mechanical restraints, from 1 to 5, with 1 being the best, from 80% to 100% reduction, 2 from 60% to 80%, etc. p.n., pro necessitate (as needed). 184 Perspectives in Psychiatric Care 48 (2012) 183–184 © 2012 Wiley Periodicals, Inc. Paper 2 Coercion within Danish psychiatry compared with 10 other European countries. Coercion within Danish psychiatry compared with 10 other European countries Nord J Psychiatry Downloaded from informahealthcare.com by Danmarks Veterinaer & Jordbrugsbibliotek on 10/22/12 For personal use only. JESPER BAK, HELLE AGGERNÆS Bak J, Aggernæs H. Coercion within Danish psychiatry compared with 10 other European countries. Nord J Psychiatry 2012;66:297–302. Background: In 2008, the European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment (CPT) criticized the use of mechanical restraint in Denmark and referred to it as ill-treatment. What do other European countries do better? To answer this question, we compared the use of coercive measures regarding psychiatric inpatients in Denmark and comparable European countries. Aims: Comparing coercive measures from Denmark, Sweden, Norway, Finland, Iceland, Belgium, The Netherlands, United Kingdom, Ireland, France and Italy. Methods: Review of international literature and a cross-sectional study performed as a questionnaire survey. Results: Denmark used more mechanical restraint and holding than Finland and Norway; however Sweden used twice as much as Denmark. Finland used more seclusion than did the other countries. Norway was the country that used the smallest amount of physical coercion. Only Norway, Finland, Sweden and Denmark had comparable representative data on coercion. Conclusions: Norway used less physical restraint than Denmark. We could not find any obvious reasons for the differences in the use of physical restraint. Clinical implications: Comparing the factors surrounding coercion between countries may serve as a basis for minimizing coercion and carrying it out in the most acceptable manner for the patients, thereby providing better psychiatric treatment in Europe. • Coercion, Mental health, Psychiatric code, Restraint. Jesper Bak, Head Nurse, R.N., S.D., M.P.H., Ph.D. student, Mental Health Centre Sct. Hans, Boserupvej 2, 4000 Roskilde, Denmark, E-mail: [email protected]; Accepted 12 October 2011. I n the autumn of 2008, public interest on coercion was rekindled following the European Committee for the Prevention of Torture and Inhumane or Degrading Treatment or Punishment’s visit to Denmark. The Committee criticized the use of mechanical restraint in terms of duration and frequency and labelled it ill-treatment. Before changing the psychiatric legislation in Denmark, the Minister of Health requested that a comparison between Denmark and comparable European countries were made on the use of coercive measures targeted at psychiatric inpatients together with a professional expert evaluation on the coercive measures already used in Denmark. The National Board of Health appointed the authors to help prepare a clearing report (1). The report was modified according to discussions in an appointed group of non-governmental organizations, academics and professionals prior to publication. Aim To compare the use of coercive measures on psychiatric inpatients between Denmark (DK) and Sweden (SE), © 2012 Informa Healthcare Norway (NO), Finland (FI), Iceland (IC), Belgium (BE), The Netherlands (NL), United Kingdom (UK), Ireland (IE), France (FR) and Italy (IT), in order to share knowledge and learn about what other countries do to minimize coercion. Material and methods Data were collected by: 1) Reviewing international reports, research literature and national registers; 2) Performing a survey, asking government officials and medical specialists to complete a questionnaire. Literature review The review covered legislation and coercive measures used in psychiatry across Europe comprising: forced medication/long period, forced medication/short period (in some papers defined acute medication), mechanical restraint, seclusion/isolation, physical restraint/holding, time out and constant observation. DOI: 10.3109/08039488.2011.632645 J BAK & H AGGERNÆS Nord J Psychiatry Downloaded from informahealthcare.com by Danmarks Veterinaer & Jordbrugsbibliotek on 10/22/12 For personal use only. The coercive measures were mostly defined as suggested by Bowers et al. (2). The review was conducted between April and June 2009, with an update in March 2010, and covered the years from 1999 to 2010. The searches included literature in the languages: English, Danish, Norwegian, Dutch, Finnish and Swedish. The search strategy was structured: 1) An overall search for legislation and coercion across selected databases; 2) A search to identify registers and reports, e.g. governmental reports not indexed in the major databases; 3) A topic-specific search on PubMed; 4) Reference lists of the most relevant papers were checked for articles not otherwise found. Major differences between countries were found in almost every area under investigation: • • • • • • • Number of psychiatric beds per 100,000 inhabitants: from 8 in IT to 152 in BE. Number of forced admissions per 100,000 inhabitants: from 31 in IT to 218 in FI. Mean length of stay in days: from 14 days in IT to 52 days in UK. Number of forensic psychiatric beds per 100,000 inhabitants: from 0 in NO to 10.3 in BE. Number of psychiatric beds in jails per 100,000 inhabitants: from 0 in several countries to 4.6 in NL. Year of last revision of the psychiatric code; from 1990 in FR to 2009 in NL. National register for coercion: four countries had national registers and seven countries had none. Number of psychiatrists per 100,000 inhabitants: from 7 in IE to 26 in FI. Number of nurses working in Mental Health Care: from 33 in IT to 163 in FI. All references were placed in an electronic referencemanaging program (Ref. Man 11). Once the references were retrieved, the following sifting process was initiated: • • First sift—sift for material that potentially met eligibility criteria based on title/abstract. • Second sift—full reference that appeared relevant and eligible or where relevance/eligibility was not clear from the abstract where scrutinized. • Third sift—lastly, the references were critically assessed. No formal statistics were performed because of the low number of respondents. • The different use of coercive measures A questionnaire was developed and covered the same areas as mentioned earlier in the literature review. The questionnaires were sent to governmental health authorities (European Platform of Supervisory Organisations, EPSO) and the Psychiatric Section of the European Union of Medical Specialists (Union Européenne des médicins Spécialistes, UEMS). An example from the questionnaire appears in Supplementary Appendix 2 to be found online at http://informahealthcare.com/doi/abs/ 10.3109/08039488.2011.632645. The questionnaire survey was conducted between May and July 2009. Table 2 shows the different types of coercive measures that can be applied in the countries, as reported in the questionnaire survey (2009) where specialists from EPSO and UEMS have described the legislation and clinical use of the coercive measures in their countries. As shown in Table 2, all countries allowed the use of forced medication in some form in 2009. In NL and FR, only acute medication was allowed. UK was the only country where mechanical restraint was not allowed and DK was the only country where seclusion was not allowed. Physical restraint/holding was used in two different ways: for a short period e.g. while the patient was restrained either during forced medication or for longer periods to calm the patient. Some countries argue that holding a patient for a longer period, especially very a psychotic patient, was more intrusive to the patient than mechanical restraint and seclusion. Time out and constant observation were evaluated differently between countries. Some saw it as coercion, others as “best practice”. Results The number of physically coercive measures per 100,000 inhabitants The focused search strategy is shown in Supplementary Appendix 1 to be found online at http://informahealthcare. com/doi/abs/10.3109/08039488.2011.632645. Questionnaire survey Background data The background data in Table 1 were collected from several sources: national registers, governmental and specialist reports, research papers and the questionnaire survey (3–11). 298 Table 3 shows the numbers of the three most frequent physical coercive measures: mechanical restraint, seclusion and holding. The numbers were obtained from national registers (DK, NO, FI, NL), national reports (SE) and scientific papers (UK, IT) (12–19). NORD J PSYCHIATRY·VOL 66 NO 5·2012 COERCION IN EUROPE Table 1. Background data. DK SE NO FI IS BE NL UK IE FR IT Nord J Psychiatry Downloaded from informahealthcare.com by Danmarks Veterinaer & Jordbrugsbibliotek on 10/22/12 For personal use only. Psychiatric beds per 100,000 inhabitants (3) (2007) 61 54 119 72 n.a. 152 114 23 94 95 8 Number of forced admissions per 100,000 inhabitants (4–7) (1999–2001) 70 114 135 218 n.a. 47 44 93 74 103 31 Mean length of stay in days (3, 8) (1998 and 2007) 30 25 29 38 n.a. 25 n.a. 52 16 36 14 Forensic psychiatric beds per 100,000 inhabitants (9, 10) (2002–2007) 6.6 8.0 0 6.9 2.3 10.3 9.8 6.1 2.2 0.8 2.2 Psychiatric beds in jails per 100,000 inhabitants (9, 10) (2002–2007) 0 1.6 0 1.2 0 2.1 4.6 0 0 1.2 n.a. Year of last revision of the psychiatric code (Survey, 2009) 2006 2008 2006 2001 n.a. 2007 2009 2007 2001 1990 n.a. National register for coercion (Survey, 2009) X (X) X X X Psychiatrists per 100,000 inhabitants (3) (2007) 11 24 16 26 n.a. 23 15 13 7 22 10 Nurses working in Mental Health Care per 100,000 inhabitants (3, 11) (2007) 64 73 n.a. 163 n.a. n.a. 122 52 126 n.a. 33 n.a.: No available information. Year: The available data were recorded from 1998 to 2008. The numbers of forced admissions: DK: 2000, SE: 1998, NO: 2001, FI: 2000, BE: 1998, NL: 1999, UK: 1998, IE: 1999, FR: 1999, IT: 2001. Mean length of stay was from 2007 only NO.UK and FR were from 1998. Mean length of stay: The median number of days in mental hospitals and community-based psychiatric inpatient units. DK: The number of forced admissions includes forced compulsory retention of voluntarily admitted patients; the number on forced admissions alone would be 34. “Nurses working in Mental Health Care” refers to all nurses in the number of specialized nurses that was 9 (3, 11). The length of stay is only from community-based psychiatric inpatient units. SE: National register for coercion should start in 2009. The length of stay was only from community-based psychiatric inpatient units. NO: The number of forced admissions is from 2001. FI: The length of stay is only from mental hospitals. IS: IS did not have a Psychiatric code, but a § in the law regarding guardianship “Lögræðislögin” from 1997. BE: The number of beds included some ambulatory inpatients. UK: The number of psychiatric beds does not include Scotland. The number of forced admissions includes forced compulsory retention of voluntarily admitted patients; the number of forced admissions alone would be 48. The mean length of stay includes forensic patients. The last version of the approved mental health legislation in Scotland was before 2005. FR: The number of forced admissions was adjusted according to Barbato’s comments. IT: The number of beds only represented Sardinia. The number of forced admissions only represented the Lombardia region, but numbers from whole IT in 1997 was 26 and quite similar. IT had psychiatric beds in jails; however, the number of beds was uncertain. The length of stay was only from community-based psychiatric inpatient units. Year of last revision of the psychiatric code was uncertain, we only know that it was after 2005 (3). Table 2. Applied methods of coercion. Forced medication/long period Forced medication/short period Mechanical restraint Seclusion/isolation Physical restraint/holding Time out Constant observation Are other types of coercion used DK SE NO FI IS X X X X X X X X X X X X X X X X X X X X X X X X X X X X X BE NL X X X X X X X X X X X X UK IE X X X X X X X X X X X X FR IT X X X X X X X X X X X X X X X DK: If patients complained about the use of forced medication, it would give 2–3 weeks delayed effect before medication could be initiated. During mechanical restraint, constant observation was required. Seclusion had only been allowed since 2005 and only in a particularly high security department for extraordinarily dangerous psychiatric patients. Physical restraint was only used few minutes in connection with other coercive measures. Constant observation as a coercive measure was first reported if it was prolonged more than 24 h. SE: Seclusion was only used if the patient was quite dangerous for other patients. Time out was regarded as isolation (Time out was defined as being placed in a room with the door unlocked). NO: Seclusion was only allowed in acute situations and was not to be used if patients were under 16 years. Time out was not regarded as coercion. Constant observation was first regarded as a coercive measure after 12–24 h. FI: During mechanical restraint, constant observation was required if patients were under 18 years. During seclusion, constant observation was required if patients were under 18 years. Physical restraint was rarely used in adult psychiatry and could only be used in child psychiatry if parents agreed. IS: Mechanical restraint has not been used as a routine measure for decades. Physical restraint was only used a few minutes in connection with forced medication and to calm patients. Constant observation was not regarded as coercion. BE: Beside three-point restraint (waist, hand and foot), chest belts and straitjackets were allowed. During mechanical restraint and seclusion, the staff could use camera surveillance and should always be able to hear the patient. Time out was only allowed max 48 h. NL: Today, mechanical restraint is rarely used in acute psychiatric wards. The use in chronic wards was unknown. UK: The forced medication was only allowed if it was part of the total treatment plan. Seclusion was only allowed in acute situations. FR: Seclusion was described in a clinical guideline. If seclusion was prolonged more than 24 h, the patient was transferred to a special unit (Unites pour maladies difficiles). Physical restraint was used in relation to forced medication and acute situations to calm patients and to prevent seclusion. NORD J PSYCHIATRY·VOL 66 NO 5·2012 299 J BAK & H AGGERNÆS Table 3. Physical coercion/100,000 inhabitants. DK SE NO FI IS BE NL UK IE FR IT Table 4. Ranking of coercive measures with respect to perceived intrusion. DK SE NO FI IS BE NL UK IE FR IT Nord J Psychiatry Downloaded from informahealthcare.com by Danmarks Veterinaer & Jordbrugsbibliotek on 10/22/12 For personal use only. Mechanical restraint 34 70 21 20 n.a. n.a. 14 0 n.a. n.a. 7 Seclusion/isolation 0 31 2 43 n.a. n.a. 34 4 n.a. n.a. n.a. Physical restraint/ 18 0 6 8 n.a. n.a. n.a. 13 n.a. n.a. 7 holding n.a.: Not available. DK: 2007. The numbers included geronto-, child/adolescence and forensic psychiatry (12). In DK, it was possible for the patients to be subjected to voluntary mechanical restraint, which happened in 10% of all incidents. NO: 2007. The numbers included geronto-, adolescence and forensic psychiatry (13). FI: 2007. The numbers included geronto-, adolescence and forensic psychiatry (14). SE: 2007. The numbers came from control visits in the southern hospital region made by the National Board of Health and Welfare. The numbers were then extrapolated to the whole of SE. The numbers included geronto-, adolescence and forensic psychiatry (15, 16). NL: 2006. The numbers came from the Dutch hospital database (IGZ) (17). Mechanical restraint was only used for protection in geronto-psychiatry. UK: 2002. The numbers came from three hospitals in London. The numbers were then extrapolated to the whole of the UK. The numbers did not include geronto-, adolescence and forensic psychiatry (18). Steinert et al. described a total of seclusion and restraint in 2005–2007 between 52 and 77 (Wales 40) (19). IT: 2002. The numbers came from two hospitals in the Modena region. The numbers were then extrapolated to the whole of IT (18). NL, NO, FI and DK had national registers. The numbers from NL were reported as very uncertain and could easily be twice as high (20). The numbers from SE covered around 20% of the population (not including the capital region); data were deemed reasonably representative. The data from UK and IT came from small samples, so the data were deemed not representative. From the remaining countries, it was not possible to find any data. Comparing the data from the three countries with national registers that is DK, NO, FI and the numbers from SE, which covered a reasonable part of the country, we could see that DK more often used mechanical restraint and holding than FI and NO. SE more often used mechanical restraint than the other countries. FI more often used seclusion than the other countries. DK more often used physical restraint/holding than the other countries. NO was the country that used the smallest amount of physical coercion. It was reasonable to compare these four countries since they were somewhat similar with respect to legislation, culture and clinical use. The countries that were most alike probably were NO and DK, whereas the culture and legislation were different in FI and SE. Most intrusive coercive measures Table 4 describes the most intrusive coercive measures obtained from the questionnaire survey (2009). The respondents were asked to rank the coercive measures, from 1 to 8, 1 indicating the measure perceived as the least intrusive and 8 the most intrusive. 300 Forced medication/long period Forced medication/short period Mechanical restraint Seclusion/isolation Holding/physical restraint Time out Constant observation Mechanically restraint ambulatory 5 6 8 3 5 4 3 4 2 7 2 8 1 2 7 6 3 1 2 8 4 5 3 6 4 3 1 2 5 5 7 6 3 1 2 4 5 3 2 7 6 4 1 5 2 7 3 2 1 4 1 5 1 2 Blank: Coercive measures were not in use or allowed in the country or no reply was given, or it was ranked as “0”. Forced medication/short period: Was defined as medicine given against the patient’s will in an emergency (not medical treatment for a longer time according to treatment plan). Forced medication/long period: Was defined as medicine given against the patient’s will, as treatment (medical treatment for a longer time according to treatment plan). Mechanically restraint ambulatory: Was defined as the use of restraint devices, which allow patients to be out of bed and to walk around. IE: No answer. IT: No answer. The answers from the European countries reflected culture based differences in how coercion was perceived, e.g. forced medication/long period was considered worst in NO; forced medication/short period in BE; mechanical restraint in FI, IS and FR; seclusion in the UK; holding/ physical restraint in NL and mechanical restraint ambulatory in SE, DK and IS. The answers also showed that in the countries using both seclusion and mechanical restraint, mechanical restraint was regarded as the most intrusive. Discussion and conclusions To our knowledge, this is the first comparative study on coercion in psychiatry trying to combine both scientific papers and questionnaire surveys from 11 European countries. Background variables A statistical evaluation of the background data (Table 1) was not possible because of sample size, differences in registration practice, data collection, legislation and framework. Furthermore, some countries allowed the private sector to use coercion, others not. In some countries, this also included the forensic area and data from the private sector was not reported. We found no explanation for the lower number of psychiatric beds, forced admissions and shorter mean length of stay in IT. One explanation might be, as mentioned NORD J PSYCHIATRY·VOL 66 NO 5·2012 COERCION IN EUROPE earlier, not representative data, or the effect of factors not under investigation in this paper, e.g. attitudes towards authorities or the families’ role in caring for the patients. Nord J Psychiatry Downloaded from informahealthcare.com by Danmarks Veterinaer & Jordbrugsbibliotek on 10/22/12 For personal use only. The different types of coercive measures All countries allowed the use of forced medication in some form. Differences in culture and history are probably the main reason for allowing and using different coercive measures. For instance, we do not know whether holding is used for a longer or shorter period and what the patients perceive as more or less intrusive. This discussion could also be influenced by economy, because holding for a long period necessitates competent and expensive staff resources. There were few answers from UEMS and in some cases; they were contrary to the answers from EPSO. The reason could be that in some countries, legislation is implemented in practice after a delay of several months to years. Most intrusive coercive measures Five of the nine countries in Europe answering the question believe that mechanical restraint, in some form, was the most intrusive coercive measure towards the patients. An often-mentioned argument in countries using mechanical restraint, against using seclusion, is the high amount of medication used to calm the patients, preparing them for seclusion. The only study we could find describing this problem was “Comparisons of psychotropic drug prescribing patterns in acute psychiatric wards across Europe (21)”, not describing the actual relationship between coercion and medication but more in general. What could support the above-mentioned idea is that England is the country using the highest dose of anti-psychotic drugs and at the same time the only country not using mechanical restraint. On the other hand, they used the smallest amount of anxiolytic/ bezodiazepine drugs. The study did not incorporate depot-medication, it was a small-scale pilot study and overall not able to confirm or reject the above idea. However, whether mechanical restraint or seclusion is considered more or less intrusive towards patients is in fact unknown. In a small randomized study, Steinert & Bergk (22) describes that “both from ethical and safety aspects the results do not yield evidence to prefer or forbid one of the interventions. Clinical decisions should take into account patients’ preferences.” Of course, considering patients’ preferences requires that clinicians have the option to choose between the two kinds of coercion, which is not the case in the UK and DK. In the questionnaire, the countries were asked to rank all the coercive measures, not all countries did answer as requested. Some countries used the same number twice, some had not used all the numbers and some had not ranked measures they did not use themselves. However, NORD J PSYCHIATRY·VOL 66 NO 5·2012 these discrepancies did not affect the conclusions made above. The number of physically coercive measures per 100,000 inhabitants As mentioned in the results section, the only countries, of the 11 under investigation, that provided national public representative data were NO, FI, SE and DK. We believe that NL after 2006 has qualified their data and SE yet has not started, as planned, collection of nationwide data. Why other countries in Europe, beside the Nordic countries, are not able to provide data on physical coercive measures are unknown. One reason could be lack of public openness; another could be that they have a minor tradition for measuring and working with continuous quality improvement, or that some countries have both private and public psychiatric hospitals, complicating the collection of data, but we do not know. What we can see is that NO used physical coercion less than FI, SE and DK; the reason for this is unknown. However, between 1998 and 2006, NO allocated an extra US$576 million in running costs and US$789 million in investments (in buildings and so on), a total of US$1.4 billion to the psychiatric area (23). During approximately the same period, the economic growth in the psychiatric area in DK was US$189 million (24). In addition, NO has a long tradition of specialized education in environmental therapy of nursing staff and the number of psychiatrists in NO is 31% higher than in DK but 50% lower than SE and 63% lower than FI. Also, legal treatment practice in NO does not have the delaying effect of patient’s complaints on forced medication. During this 2–3-week period, where the Danish patients are not medicated, they are probably exposed to more physical coercion. How the legal treatment practices are in SE and FI we do not know exactly. Lastly, NO used twice as much forced admission as DK, and maybe some patients, because of earlier treatment were exposed to less physical coercion; on the other hand FI uses even more forced admissions. Yet the figures on forced admissions was somewhat insecure because DK had, in 2010, 2638 forensic psychiatric patients (25), whereas NO had mostly around 500 (we do not know the exact number) and the forensic psychiatric patients were not a part of the figure in Table 1. How many forensic psychiatric patients FI and SE had we do not know but the number of forensic psychiatric beds where quite similar to DK. Finally, caution must be shown when trying to compare coercive measures between the different countries. The differences in legislation, nursing and treatment culture, framework and economics make it important that the European countries on a national level produce public data on coercion. If not, the basis for research, benchmarking and the possibility to learn from each other is made much more difficult. 301 Nord J Psychiatry Downloaded from informahealthcare.com by Danmarks Veterinaer & Jordbrugsbibliotek on 10/22/12 For personal use only. J BAK & H AGGERNÆS Regarding research in the area, it is evident that there is a lack of high-quality intervention studies. One of the reasons is probably the lack of instruments that can measure the degree of patients’ intrusive experiences of coercion. Only one validated instrument, the Coercion Experience Scale (26), was found. It is very important to have scales that measure the degree of intrusive experience, because not all mechanical restraint episodes are intrusive. From a public point of view, it is worth noting that some people voluntarily accept mechanical restraint, given that 10% of the psychiatric patients that were mechanically restrained in DK were restrained voluntarily. Despite their psychotic condition, some patients seem to have such a high sense of reality that they prefer coercion to the risk of hurting themselves and/or others. One could hope that in future psychiatry, we will know when it is inevitable to choose the kind of coercion that not only is the most acceptable to the individual patient, but also convincingly is the means of least restriction. It is obvious from the reported diversity of the coercive measures in the present data that no country holds the optimal solution for dealing with coercion in psychiatry. Acknowledgements—The authors wish to thank Mette Dons (Head of Department, the National Board of Health, Copenhagen), Torben Hærslev (Senior Specialist, the National Board of Health, Copenhagen) and Louise Gjørup (Administrative Assistant, the National Board of Health, Copenhagen) for discussions and participation, and Thomas Werge (Head of Research, Mental Health Centre Sct. Hans, Roskilde) for valuable comments and careful reading during the writing process. Disclosure of interest: The project was partly funded by the National Board of Health. There are no known conflicts of interest, financial, personal, political and academic or others. The authors are responsible for the contents and writing the paper. References 1. Sundhedsstyrelsen. Tvangsforanstaltninger i psykiatrien—en udredning. København: Sundhedsstyrelsen; 2009. 2. Bowers L, van der Werf B, Vokkolainen A, Muir-Cochrane E, Allan T, Alexander J. International variation in containment measures for disturbed psychiatric inpatients: A comparative questionnaire survey. Int J Nurs Stud 2007;44:357–64. 3. World Health Organization. Policies and practices for mental health in Europe—Meeting the challenges. Copenhagen: WHO Regional Office for Europe; 2008. 4. Barbato A, D’Avanzo B. Involuntary placement in Italy. Br J Psychiatry 2005;186:542. 5. Bremnes R, Hatling T., Bjørngaard JH. Tvungent psykisk helsevern med døgnophold i perioden 2001–2006. Trondheim: SINTEF Helse; 2008. Report No. SINTEF A4319. 6. Salize HJ, Dressing H, Peitz M. Compulsory admission and involuntary treatment of mentally ill patients—Legislation and practice in EU-member states (Final Report). Mannheim, Germany: Central Institute of Mental Health; 2002. 7. Salize HJ, Dressing H. Epidemiology of involuntary placement of mentally ill people across the European Union. Br J Psychiatry 2004;184:163–8. 8. Aggernæs H, Cubli-Bauer A, Zarotti G, Schudel W, Saliba J, Pietrowski A, Martin V. Psychiatric legislation in Europe 1998. Report of the UEMS Section for Psychiatry. Prague: European Board of Psychiatry; 2001. 9. Salize HJ, Dressing H, Kief C. Placement and treatment of mentally ill offenders—Legislation and practice in EU member states. Mannheim: Central Institute of Mental Health; 2005. 10. Salize HJ, Dressing H, Kief C. Mentally disordered persons in European Prison Systems—Needs, Programmes and Outcome (EUPRIS). Mannheim, Germany: Central Institute of Mental Health; 2007. 11. Dansk Sygeplejeråd. Medlemsstatistik—Januar 2009. København: Dansk Sygeplejeråd; 2009. 12. Sundhedsstyrelsen. Nye tal fra sundhedsstyrelsen. Anvendelse af tvang i psykiatrien 2007. København: Sundhedsstyrelsen; 2008. 13. Bremnes R, Hatling T, Bjørngaard JH. Bruk av tvangsmidler i psykisk helsevern i 2001, 2003, 2005 og 2007. Trondheim: SINTEF Helse; 2008. Report No. SINTEF A8231. 14. Psykiatrian erikoisalan laitoshoito 2007. National Research and Develope Centre for Welfare and Health; 2008. Report No. 36/2008. 15. Beskrivning av vårdutnyttjande i psykiatrin—En rapport baserad på hälsodataregistren vid Socialstyrelsen. Socialstyrelsen; 2008. Report No. 2008-131-31. 16. Den psykiatriske tvångvården—Verksamhetstillsyn av vården enligt LPT och LVR i södra sjukvårdsregionen. Malmö: Socialstyrelsens regionala tillsynsenhet i Malmö; 2008. Report No. 2006-126-60. 17. Inspectie voor de Gezondheidszorg. Tabellenboek Wet Bopz 2002–2006. Haag: Staatstoezicht op de volksgezondheid; 2007. 18. Bowers L, Douzenis A, Galeazzi G, Forghieri M, Tsopelas C, Simpson A, Allan T. Disruptive and dangerous behaviour by patients on acute psychiatric wards in three European centres. Soc Psychiatry Psychiatr Epidemiol 2005;40:822–8. 19. Steinert T, Lepping P, Bernhardsgrütter R, Conca A, Hatling T, Janssen W, et al. Incidence of seclusion and restraint in psychiatric hospitals: A literature review and survey of international trends. Soc Psychiatry Psychiatr Epidemiol 2010;45:889–97. 20. Janssen WA, Noorthoorn EO, De Vries WJ, Hutschemeakers GJ, Lendemeijer HH, Widdershoven GA. The use of seclusion in the Netherlands compared to countries in and outside Europe. Int J Law Psychiatry 2008;31:463–70. 21. Bowers L, Callaghan P, Clark N, Evers C. Comparisons of psychotropic drug prescribing patterns in acute psychiatric wards across Europe. Eur J Clin Pharmacol 2004;60:29–35. 22. Steinert T, Bergk J. A randomised study comparing seclusion and mechanical restraint in people with serious mental illness. Eur Psychiatry 2007;22:220. 23. Helse- og omsorgsdepartementet. Om optrappingsplan for psykisk helse 1999–2006 Endringer i statsbudsjettet for 1998. 1998. Report No. St. prp. nr. 63. 24. Danske Regioner. Behandlingsgaranti i psykiatrien—Udfordringer og muligheder. København: Danske Regioner; 2006. 25. Danske Regioner. Retspsykiatri. Kvalitet og sikkerhed. København: Danske Regioner; 2011. 26. Jan B, Erich F, Tilman S. Coercion Experience Scale (CES)— Validation of a questionnaire on coercive measures. BMC Psychiatry 2010;10:5. Jesper Bak, Head Nurse, R.N., S.D., M.P.H., Ph.D. student, Research Institute, Mental Health Centre Sct. Hans, Boserupvej 2, 4000 Roskilde, Denmark. Helle Aggernæs, Head of Clinic, M.D., Mental Health Centre Amager, Digevej 10, 2300 Copenhagen, Denmark. Supplementary material available online Supplementary Appendix 1 and 2. 302 NORD J PSYCHIATRY·VOL 66 NO 5·2012 Supplementary material for Bak J, Aggernæs H. Coercion within Danish psychiatry compared with 10 other European countries. Nord J Psychiatry 2012;66:297–302. Supplementary Appendix 1: Focused search strategy No/database/host Search phrase/”-string” Date GOOGLE Scholar Europa lovgivning psykiatri OR psykiatrisk OR psykisk OR psykotisk tvangsfiksering OR bæltefiksering OR fiksering OR tvang OR tvangsmidler. Limiters—Publication Year from: 1999-, Area: Medicin, farmakologi og veterinærvidenskab, Samfundsvidenskab, kunst og humaniora Restrained OR Restraint OR Restraints OR Secluded OR Seclusion OR Coercion OR Coercive OR Containment Legislation OR Legal Comparison OR Differences OR Variations European OR Europe OR Europeans Mental OR Psychiatric OR Psychiatry OR Mental health OR Mentally ill, Limiters—Publication Year from: 1999-, Area: Medicin, farmakologi og veterinærvidenskab, Samfundsvidenskab, kunst og humaniora (Restrained OR Restraint OR Restraints OR Secluded OR Seclusion OR Coercion OR Coercive OR Containment) and (Legislation OR Legal) and (Mental OR Psychiatric OR Psychiatry OR Mental health OR Mentally ill) and (Europe OR European OR Europeans), Limiters— Publication Year from: 1999–, Expanders—Also search within the full text of the articles, Search modes—Boolean/Phrase (Ment* OR Psychiat* OR Psycho*) AND (Restrain* OR Seclu* OR Coerc* OR Containt*) AND (Europe*) AND (Compar* OR Difference* OR Variat*) (Ment* OR Psychiat* OR Psycho*) AND (Restrain* OR Seclu* OR Coerc* OR Containt*) AND (Europe*) AND (Compar* OR Difference* OR Variat*), Date Range: 1999 to 2010 08 April 2009 24 8 4 1 15 April 2009 200 21 6 2 15 April 2009 21 3 1 1 15 April 2009 21 3 0 0 15 April 2009 2 1 1 1 15 April 2009 10 1 1 1 15 April 2009 13 0 0 0 15 April 2009 42 9 3 2 15 April 2009 10 0 0 0 15 April 2009 14 0 0 0 ? ? 63 40 357 46 8 87 3 51 GOOGLE Scholar CINAHL and AMED/ EBSCOhost /PubMed/ Silverplatter Criminal justice abstracts/ CSAILLUMINA British Journal of Criminology Cochrane Library PSYCINFO/ WebSPIRS/ OvidSP ISI web of knowledge SCIRUS http:// www.scirus. com/srsapp/ GOOGLE different Universities, National Health Boards and others Update Sum ((Ment* OR Psychiat* OR Psycho*) AND (Restrain* OR Seclu* OR Coerc* OR Containt*) AND (Europe*) AND (Compar* OR Difference* OR Variat*)) AND PDN (⬎ 1/1/1999) “Restrain* OR Seclu* OR Coerc* OR Containt* and Compar* OR Difference* OR Variat* and Europe* and Ment* OR Psychiat* OR Psycho* and Legislat* OR Legal*, from 1999 to 2009 in Cochrane Database of Systematic Reviews” (Restrain* or Seclusion or Coercion or Contain*) and (Comparison or Difference* or Variation*) and Europe* and (Ment* or Psychiat* or Psycho*) and (Legislation* or Legal*) (Including Related Terms) (english language and abstracts and yr ⫽ “1999–2009”) Topic ⫽ ((Ment* OR Psychiat*) AND (Restrain* OR Seclu* OR Coerc* OR Containt*) AND (Legisla* OR Legal*) AND (Compar* OR Difference* OR Variat*) AND Europ*) (Ment* OR Psychiat*) AND (Restrain* OR Seclu* OR Coerc* OR Containt*) AND (Legisla* OR Legal*) AND (Compar* OR Difference* OR Variat*) AND Europ*, 1999–2009, Law, Medicine, Neuroscience, Pharmacology, Psychology, Social and Behavioral Sciences, Sociology Restrained OR Restraint OR Restraints OR Secluded OR Seclusion OR Coercion OR Coercive OR Containment OR Psychiatric Legislation AND Denmark OR Sweden OR Norway OR Finland OR Iceland OR The Nederlands OR United Kingdom OR Scotland OR Ireland OR France OR Italy (Part of titles from earlier found papers reference lists, ex: Psykiatrian erikoisalan laitoshoito, Anvendelse af tvang i psykiatrien, Den psykiatriske tvångvården, Inspectie voor de Gezondheidszorg, Bruk av tvangsmidler i psykisk helsevern and so on) April–June 2009 Result 1st sift March 2010 2nd sift 3rd sift 1 Supplementary Appendix 2 Example from the questionnaire, the whole questionnaire can be required from the authors 2 Paper 3 Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish-Norwegian Association Study. bs_bs_banner Perspectives in Psychiatric Care ISSN 0031-5990 Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish–Norwegian Association Study Jesper Bak, RN, SD, MPH, Vibeke Zoffmann, RN, MPH, PhD, Dorte Maria Sestoft, MD, PhD, Roger Almvik, RN, RMN, Dr. Philos, and Mette Brandt-Christensen, MD, PhD Jesper Bak, RN, SD, MPH, is PhD student, Head Nurse, Mental Health Centre Sct. Hans, Roskilde, Denmark; Vibeke Zoffmann, RN, MPH, PhD, is Senior Researcher, Steno Diabetes Centre, Gentofte, Denmark; Dorte Maria Sestoft, MD, PhD, is Head of Department, Clinic of Forensic Psychiatry, Ministry of Justice, Copenhagen, Denmark, Roger Almvik, RN, RMN, Dr. Philos, is Research Director, Centre for Research & Education in Forensic Psychiatry, St. Olavs University Hospital, Forensic Department Bröset, Trondheim, Norway; and Mette Brandt-Christensen, MD, PhD, is Head of Research & Education in Forensic Psychiatry, Mental Health Centre Sct. Hans, Roskilde, Denmark. Search terms: Coercion, mental health, nursing, physical restraint, psychiatry Author contact: [email protected], with a copy to the Editor: [email protected] Conflict of Interest Statement There are no known financial, personal, ethical, political, academic, or other conflicts of interest. PURPOSE: To examine how potential mechanical restraint preventive factors in hospitals are associated with the frequency of mechanical restraint episodes. DESIGN AND METHODS: This study employed a retrospective association design, and linear regression was used to assess the associations. FINDINGS: Three mechanical restraint preventive factors were significantly associated with low rates of mechanical restraint use: mandatory review (exp[B] = .36, p < .01), patient involvement (exp[B] = .42, p < .01), and no crowding (exp[B] = .54, p < .01). PRACTICE IMPLICATIONS: None of the three mechanical restraint preventive factors presented any adverse effects; therefore, units should seriously consider implementing these measures. First Received April 5, 2013; Final Revision received June 10, 2013; Accepted for publication June 27, 2013. doi: 10.1111/ppc.12036 In some countries, mechanical restraint (MR) can be performed legally when psychiatric inpatients pose a risk to themselves or to others (Psykiatriloven, LBK nr. 1729, 2010). The procedure is primarily performed by nursing staff and involves the use of leather or fiber belts to secure the patient to a bed. The straps are also occasionally attached around the patient’s wrists and ankles. MR exposes patients to potential physical risks, such as deep vein thrombosis, pulmonary embolism, pressure sores, bone fractures, and even death (Hem, Steen, & Opjordsmoen, 2001; Hick, Smith, & Lynch, 1999; Laursen, Jensen, Bolwig, & Olsen, 2005; Morrison & Sadler, 2001; Nielsen, 2005). For many patients, MR produces negative psychological effects, such as feelings of helplessness, anger, being trapped, sadness, fear, displeasure, or offense. Patients often regard the use of MR as an injustice or even a punishment (Bonner, Lowe, Rawcliffe, & Wellman, 2002; Bower, McCullough, & Timmons, 2003; Cusack, Frueh, Hiers, Suffoletta-Maierle, & Bennett, 2003; Frueh et al., 2005). In the worst cases, MR can cause post-traumatic stress and lifelong trauma (Cusack et al., 2003; Frueh et al., 2005; Steinert, Bergbauer, Schmid, & Gebhardt, 2007). These negaPerspectives in Psychiatric Care 50 (2014) 155–166 © 2013 Wiley Periodicals, Inc. tive consequences are inconsistent with healthcare providers’ basic sense of “doing good” for the patients. Equally important arguments in favor of using MR are that healthcare professionals are obliged to secure and care for not only the individual patient’s health and life, but also the health, lives, and rights of others. This second obligation requires providers to prevent violence toward other patients, relatives, and staff. Previous studies indicate that up to 10% of patients request MR to prevent themselves from acting out (Bak & Aggernæs, 2012). Nevertheless, the use of MR generally poses problems, requiring that greater effort be undertaken to reduce its frequency (Sundhedsstyrelsen, 2009). Many factors or conditions probably influence the events that lead to the use of MR. A lot of these conditions result from daily activities while socializing with others in the psychiatric ward, and they can potentially be changed or prevented by mental-healthcare providers, who thereby have a crucial role in reducing the use of MR. Numerous actions have been recommended to reduce the use of mechanical and physical restraints (National Risk Management Programme, 2007; The National Collaborating Centre for Nursing and 155 Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish–Norwegian Association Study Supportive Care, 2005). More than 30 reviews on the management of agitation, aggression, violence, and coercion (including MR, seclusion, manual restraint, and forced medication, among others) were identified; 10 explicitly included MR, and all described the no high-quality research. Thus, no causal relationship between preventive interventions and the reduction of MR episodes has been established (Johnson, 2010; Scanlan, 2010; Steinert et al., 2010; Stewart, Van der Merve, Bowers, Simpson, & Jones, 2010; Strout, 2010). The most recent review (Bak, Brandt-Christensen, Sestoft, & Zoffmann, 2012) identified numerous MR-preventive factors based on studies specifically targeting MR prevention. No MR-preventive factors found in the review were based on the highest scientific-recommendation grade (see grading levels in the review). Furthermore, several of these MRpreventive factors might be effective only in controlled research environments. Thus, the applicability and impact of these MR-preventive factors in everyday practice remain unknown. In 2008, a critical public debate concerning the use of MR in Denmark led to a comparative study on the use of coercion in 11 European countries, including Denmark (Bak & Aggernæs, 2012). Few of the included countries had national statistics available on the use of MR. Finland, Norway, and Denmark had valid nationwide statistics, as did the Netherlands and Sweden, to some extent (Bak & Aggernæs, 2012). Norway had the lowest rate of physical coercion (MR, seclusion, and physical restraint/holding), with 29 people per 100,000 inhabitants having experienced physical coercion. Compared to Denmark, which had 122 episodes of MR per 100,000 inhabitants, Norway had 87 episodes of MR per 100,000 inhabitants in 2007 (Bremmes, Hatling, & Bjørngaard, 2008; Sundhedsstyrelsen, 2008). Because the lower frequency of MR episodes in Norway might indicate that more effective MR-preventive factors have been implemented there compared to Denmark, we presumed that including both countries in this study might generate new knowledge. In addition, a cross-country study was possible because the national legislations, administrative structures, and cultures of these nations are similar. movement (Bowers et al., 2007). Note that this definition refers only to the restraint of inpatients in psychiatric hospitals. A retrospective association study was conducted to investigate the degree to which the nonmedical MR-preventive factors identified in a previous review (Bak et al., 2012) were implemented in the psychiatric units of Denmark and Norway. Next, we investigated whether the chosen factors were associated with the number of MR episodes. The following conditions must be present to legally initiate MR according to the Danish Mental Health Act (translated by the authors): Mechanical restraint may be used only when necessary to prevent a patient from 1. exposing their body or health or the body or health of others to danger, 2. pursuing or in any other way grossly molesting fellow patients, or 3. committing significant acts of vandalism. (Psykiatriloven, LBK nr. 1729, 2010) These conditions are consistent with Norwegian legislation (translated by the authors): Restraints may be used on a patient only when absolutely necessary to prevent him or her from damaging him or herself or others or to prevent damage to buildings, clothing, inventory or other things. (Lov nr. 62, 1999) The MR-preventive factors identified by the literature review (Bak et al., 2012) were included in an online questionnaire sent to the clinical nurse managers for the purpose of quantifying whether they were implemented in the units. These managers were chosen because they had exclusive access to the requested information. The units were the smallest organizational collection of beds led by a clinical nurse manager. Time Frame The questionnaire was administered between December 23, 2009, and January 27, 2011. The collected data pertained to 2008 in Denmark and 2010 in Norway. Included Participants Purpose The goal of this study was to provide a basis for developing MR-preventive practices by answering the following question: How are presumed MR-preventive factors of nonmedical origin associated with the frequency of MR episodes in Denmark and Norway? Design and Methods This paper uses Bowers et al.’s (2007) definition of MR: The use of restraining straps, belts, or other equipment to restrict 156 All psychiatric hospital units in Denmark (87) and Norway (96) that treated adult inpatients (18–65 years) in which MR had been used for approximately two years prior to the year of investigation were included in the study. The clinical nurse manager of each unit provided the requested information by answering the questionnaire. The units were identified by contacting the clinical heads of the departments. In Denmark, the departments were selected from the national register on coercion; in Norway, they were selected by contacting the administrators of the health regions and the researchers already working in the area. Perspectives in Psychiatric Care 50 (2014) 155–166 © 2013 Wiley Periodicals, Inc. Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish–Norwegian Association Study Table 1. Hierarchy of Preventive Factors That Might Decrease the Use of MR Rank MR-Preventive Factor Rank MR-Preventive Factor 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Cognitive milieu therapy and patient involvement Combined intervention programs Patient-centered care and patient involvement Identification of the patient’s crisis triggers Risk assessment Treatment of substance abuse and psychosis Mandatory review (e.g., post-incident review) Staff training Staff attitudes Patient–staff ratio Staff education Staff experience Patients perceived as a resource in their own treatment p.n. medication guided by individual patients 15 16 17 18 19 20 21 22 23 24 25 26 27 Debriefing, defusing, and crisis intervention Patient’s positive responses to rules Activity-based nursing Working environmental factors No crowding Regular staff–substitute ratio Staff opposition to MR Alarm systems Care alliance Communication (communicative de-escalation) Well-maintained and familiar surroundings Music used as a diversion and for relaxation Separation of acutely disturbed patients Note. Rank refers to the decreasing order in the hierarchy of effect and recommendation grade (Bak et al., 2012). p.n. medication, pro necessitate/asneeded medication; MR, mechanical restraint. Excluded Participants The special high-security department in Denmark was excluded because specific legislation concerning seclusion/ isolation was in effect. MR did occur in Norway in settings other than hospitals; however, because only 1.5% of recorded Norwegian MR episodes in 2007 occurred in these settings (Bremmes et al., 2008) and because the primary focus of this study was hospitals, these units were also excluded. Excluded Outcome Data If MR was used more than 25 times on the same patient during the investigation period, then these data were excluded. Chance determined the units to which these patients were admitted, but their presence significantly affected the unit MR frequency, distorting the results. Data Collection: The Questionnaire A questionnaire was developed based on the results from an earlier systematic literature review that focused on factors that might reduce the use of MR (Bak et al., 2012). The found MR-preventive factors can be found in Table 1. For a more thorough description, see Bak et al. (2012). Every MR-preventive factor was“translated”into questions to identify the degree to which the factor was present in the units. Six factors were not included in the present study. Number 2 (combined intervention programs) was omitted because it was too complex to measure. The following factors were omitted because they were not considered to be measured appropriately by the questionnaire: Number 6 (treatment of substance abuse and psychosis), Number 13 (patients perceived as a resource in their own treatment), Number 14 Perspectives in Psychiatric Care 50 (2014) 155–166 © 2013 Wiley Periodicals, Inc. (pro necessitate/as-needed medication guided by individual patients), Number 23 (care alliance), and Number 26 (music used as a diversion and for relaxation). Numbers 1 (cognitive milieu therapy and patient involvement) and 3 (patientcentered care and patient involvement) were separated into three factors: cognitive milieu therapy, patient-centered care, and patient involvement. Although patient involvement is part of cognitive milieu therapy and patient-centered care, it might also occur by itself. The questionnaire was developed by conceptualizing and operationalizing the MR-preventive factors. To increase validity and reliability, we followed the Question Appraisal System (QAS-99; Willis & Lessler, 1999) that was developed to identify problems in questionnaires, including the cognitive processes inherent to the question-answering process. The construction and pretesting of the questionnaire involved an eight-step appraisal of each item (QAS-99): reading, instructions, clarity, assumption, knowledge/ memory, sensitivity/bias, response categories, and others.1 The pretest was conducted by creating a cognitive-test protocol that included probes for each item. The probes covered the aforementioned eight steps and consisted of seven types: general, specific, understanding/interpretation, safety, 1 Step 1: Reading: Determine if it is difficult for the interviewers to read the question uniformly to all respondents. Step 2: Instructions: Look for problems with any introductions, instructions, or explanations from the respondent’s point of view. Step 3: Clarity: Identify problems related to communicating the intent or meaning of the question to the respondent. Step 4: Assumptions: Determine whether there are problems with assumptions or the underlying logic. Step 5: Knowledge/Memory: Check whether respondents are likely to not know or have trouble remembering information. Step 6: Sensitivity/Bias: Assess questions for sensitive nature or wording, and for bias. Step 7: Response categories: Assess the adequacy of the range of responses to be recorded. Step 8: Other: Look for problems not identified in Steps 1–7 (Willis & Lessler, 1999). 157 Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish–Norwegian Association Study paraphrasing, and memory (e.g., how did you reach this answer, how do you define physical activity, etc.). The pretest consisted of cognitive interviewing (Willis, 2005) four clinical nurse managers individually using concurrent probing (Watt et al., 2008) in which verbal probes were asked immediately after a question. This protocol led to the revision of seven questions that were subsequently pretested in a group interview. Data collection, administration, and processing, as well as error identification and the creation of electronic data files (Olsen, 2006; Schaeffer & Presser, 2003), were administered using the electronic web-based survey system Enalyzer Survey Solution, Version 2010 (Enalyzer A/S, Copenhagen, Denmark). The questionnaire was checked for test–retest reliability by asking three clinical nurse managers to answer the questionnaire a second time after a 3-month interval (the respondents were instructed not to check their previous answers). The estimated mean correlation between all of the first and second answers was reasonable (Kendall’s Taub [τKen,b] = .75). With regard to the Norwegian portion of the study, the questionnaire was translated and retranslated by JB and then checked by two healthcare professionals who were familiar with the subject. A pretest was conducted to test face validity through cognitive interviewing seven clinical nurse managers. This test led to the revision of eight questions, mostly due to imprecise translations. Moreover, one question was added to the questionnaire due to different staff competences: Psychologists in Norway are partially responsible for their patients’ treatment, which is not the case in Denmark. Later, the outcome variable (i.e., the number of MR episodes) was reexamined. This procedure was necessary due to the confusing wording of a heading in the Danish questionnaire and the lack of precise numbers regarding the Norwegian patients who experienced MR more than 25 times (14 answer categories instead of the actual number were provided, which made the exclusion imprecise). The reexamination was accomplished by contacting all of the clinical nurse managers in Denmark and four of the clinical nurse managers in Norway. The respondent rate was 94%, and the results lowered the overall frequency of MR by 3.2%. A high correlation coefficient (τKen,b = .89) was found between the two answers, revealing that the confusing headline and the categorization error did not have an important effect. From Review to Data Analyses The flowchart in Figure 1 shows an example of transforming the findings in the literature review to the final analyses. The Danish and Norwegian questionnaire can be obtained from the authors. All dichotomized MR-preventive factors can be found in Table 2. 158 Literature review The literature review revealed that two studies found that the preventative factor “Mandatory review” was most likely associated with the use of MR. Specifically, MR-reduction rates were between 36% and 62%. Questionnaire The questionnaire was created using a conversion process in which the factor was “translated” into a question (e.g., did you audit, review or conduct a similar systematic follow-up after the MR events to analyze and learn from them?) The question was measured using five levels: 1. Yes, after all MR incidents 2. Yes, after ¾ of all MR incidents 3. Yes, after ½ of all MR incidents 4. Yes, after ¼ of all MR incidents 5. No Combining the questions into a dichotomized factor The dichotomization of the five levels in the question was accomplished by examining the two papers from the literature review. One review was conducted after all MR episodes, and the other was conducted after six events or one long-lasting MR episode. The unit and department staff conducted the review in both papers. The above question does not answer whether this is the case in the actual unit. Therefore, we decided that the dichotomization should be conducted after all MR incidents, rather than after those that are fewer or newer. Data analyses Finally, we analyzed whether associations existed among the outcome variable (the numbers of MR incidents), the background variables, and the preventive factor. Figure 1. Flowchart “From review to Data Analyses” An example of the possible MR-preventive factor “Mandatory review” from the literature review. Qualified clinical experts should conduct mandatory post-incident reviews because they minimize the number of MR episodes. MR, mechanical restraint. The Outcome Variable The outcome variable was the number of MR episodes per unit over 1 year. Potential Confounders Several conditions may be associated with both the frequency of MR use and the presence of the preventive factors in the units; therefore, they must be treated as covariates in the estimation of the associations between the preventive factors and the outcome variable. These conditions were geography (Bremmes et al., 2008; Keski-Valkama et al., 2007), unit size, bed occupancy, type of bed, reason for the MR, forensic provision, ethnicity other Perspectives in Psychiatric Care 50 (2014) 155–166 © 2013 Wiley Periodicals, Inc. Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish–Norwegian Association Study Table 2. A Description of How the MR-Preventive Factors Were Measured MR-Preventive Factors Measurement Description Cognitive milieu therapy vs. no cognitive milieu therapy The clinical nurse manager described the care in his or her unit as “cognitive behaviour therapy” or “cognitive milieu therapy,” and the staff had participated in 40 hr of training or more in this care method—The care method was not described. One of the following factors was present: the patients participated in ward rounds/conferences, influenced the rules imposed by the unit, or influenced what was written in the nurse’s journal—Patients did not participate in these areas. The clinical nurse manger described the care in his or her unit using the words “individual,” and “cooperative,” or “patient-centred,” and the staff had participated in 40 hr of training or more in this care method—These words were not used to describe this care method. The initial nurse evaluation of at-risk patients always contained a written evaluation of aggressive, self-mutilating, or suicidal behaviors (e.g., crisis triggers, unique calming techniques, and coping strategies)—The initial evaluation only sometimes or never contained a written evaluation. The risk of developing aggressive/violent or self-mutilating/suicidal behaviors was always systematically evaluated and documented, and care actions were initiated—These behaviors were only sometimes or never evaluated and documented. An audit, review, or similar systematic follow-up evaluation was conducted after all MR episodes—The evaluation was only conducted after some or none of the MR episodes. An average of 50% or more of the staff had participated in training regarding de-escalation, avoiding physical attacks, careful restraining techniques, legislation, MR predictors/antecedents, and suicide prevention—Less than 50% of the staff had such training. All staff directed their attention toward the patient and possessed communicative skills, optimism, and empathy—Not all of the staff possessed these skills. The staff-to-patient ratio was higher than or equal to three-to-one on average—This ratio was lower than three-to-one on average. The staff had received basic training for at least 3 years—The staff had less than 3 years of training. The experience of the staff in the psychiatric specialty was more than 5 years on average—Staff experience was 5 years or fewer. Follow-up evaluations were initiated after each MR episode for debriefing, defusing, or other crisis interventions—No follow-up was initiated. The patients reacted positively to the rules, and limit-setting was motivational—The opposite occurred. Patient involvement vs. no patient involvement Patient-centered care vs. no patient-centered care Identification of the patient′s crisis triggers vs. no identification Risk assessment vs. no risk assessment Mandatory review vs. no mandatory review Staff training (> 50% vs. less) Positive staff attitudes vs. less positive Patient–staff ratio (≥ 3 staff per patient vs. fewer) Staff education (≥ 3 years vs. fewer) Staff experience (> 5 years vs. fewer) Debriefing, defusing vs. none Positive patient responses to rules vs. negative responses Activity-based nursing vs. no activity-based nursing Acceptable work environment vs. poor work environment No crowding vs. crowding Substitute staff (< 50 vs. more) Staff opposition to MR (many vs. some) Alarm systems (many and well-trained responses vs. less well-trained responses) Communication (all staff have communicative skills vs. less that all) Well-maintained, clean, and tidy surroundings (always vs. seldom) Separation of acutely disturbed patients vs. no separation Individual patient-activity plans were devised, and the patients participated in many or several physical or other-type activities—The patients had no activity plans, and they participated in few or no physical or other activities. Presence of a workplace assessment, no or only insignificant physical or mental work-environment problems existed, and the overall work environment was evaluated as acceptable—The work environment was not evaluated, more work-environment problems existed, and the overall work environment was evaluated as poor. Two of the following three factors were present for no crowding: only one bed in a patient’s room, more than 25 m2 of all-day-accessible space per patient, and the perception of no crowding—Only one or none of these factors was present. Substitute staff was used less than 50 times (8-hr shifts) over the year—These employees were used more than or equal to 50 times. All staff had the attitude that “MR should be initiated rarely to protect the lives of the patient and others”—Not all staff had this attitude. More than three night-shift staff members responded to an alarm call, and they were all trained in this task—Not all such staff were trained, or they were trained but failed to respond. All staff had general communicative skills or special skills with regard to communicative de-escalation—Less than all the staff had these skills. The unit was perceived as well maintained, clean, and tidy—The perceptions were otherwise. The unit was able to separate acutely disturbed patients from other patients—The unit was unable to do so. MR, mechanical restraint. Perspectives in Psychiatric Care 50 (2014) 155–166 © 2013 Wiley Periodicals, Inc. 159 Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish–Norwegian Association Study Table 3. Potential Confounders Number of MRs per Unit Potential Confounders Geography Unit size Bed occupancya Type of bed Reason for the MRa Forensic provision Ethnicity Type of unit Helse Sør-Øst RHF Helse Vest RHF Helse Midt-Norge RHF Helse Nord RHF Region Hovedstaden Region Sjælland Region Syddanmark Region Midtjylland and Nordjylland 0–9 beds 10–19 beds More than 20 beds ≤ 100% occupancy rate > 100% occupancy rate Closed Shielded or integrated Open or other Self-mutilation or suicidal behaviors Aggressive behaviors or “acting out” ≤ 20.65% of patients with a forensic provision > 20.65% of patients with a forensic provision ≤ 10.6% of patients with an ethnic background other than Danish/Norwegian > 10.6% of patients with an ethnic background other than Danish/Norwegian Acute Forensic/secure Special/rehabilitation/long term Missing n Mean Range 0 26 6 10 6 16 6 8 12 16 63 11 78 11 61 16 13 87 87 64 23 51 26 31 9 11 28 39 94 40 17 37 26 34 21 34 42 16 8 25 32 34 32 0–74 4–64 0–22 2–21 0–254 2–105 38–184 0–87 0–50 0–254 0–108 0–254 3–87 0–254 0–184 2–64 0–150 0–170 0–184 2–254 0–184 32 34 1–254 55 23 12 40 26 12 0–254 0–184 0–31 0 1 0 3 3 7 0 Note. aUsed as continuous variable in the further analyses. MR, mechanical restraint. RHF, regionale helseforetak. than Danish/Norwegian (Knutzen, Sandvik, Hauff, Opjordsmoen, & Friis, 2007; Norredam, Garcia Lopez, Keiding, & Krasnik, 2010), and type of unit (De Benedictis et al., 2011). See the distributions in Table 3. Other variables (e.g., the diagnostic distribution among patients, the unit’s population base, patient flow, age, medication and types of therapy, or other treatment activities) could affect the outcome; however, these variables were either not the focus of this study (nonmedical factors, including medication and types of therapy) or “covered” in the earlier mentioned covariates, as unit type and geographic region acted as proxy covariates (e.g., diagnostic distribution, patient flow, and age were included in unit type; country was included in geographic region; and the population base was included both in the unit type and the geographic region). Gender is most likely not associated with MR (Keski-Valkama et al., 2010; Knutzen et al., 2007); thus, we did not use it as a covariate. The number of patients who experienced MR and time spent in MR was closely related to the number of MR episodes; therefore, these factors were not confounders. 160 Data Analyses The data analyses were conducted in four steps. First, we analyzed how the factors were individually associated with the number of MR episodes (Model 1). Second, we analyzed how the factors were associated with the number of MR episodes, using a model with all factors included (Model 2). Third, to eliminate multicollinearity and the chance that important effects may hide each other from Model 2, a third model was constructed by a forward factor-selection procedure, where the most significant factors were included stepwise until the corrected quasi-likelihood under independence model criterion value began to rise, denoting no further improvement for the model (Model 3). All these models were additionally adjusted for the potentially confounding variables. Additionally, we adjusted for nesting of units in departments—17 departments contained two units each, and three departments contained three units each—by a generalized estimating equations technique. Finally, we analyzed the correlation between the factors by Pearson’s correlation coefficient, adjusted for department, to explore multicollinearity and justify a reduction of Model 2. Perspectives in Psychiatric Care 50 (2014) 155–166 © 2013 Wiley Periodicals, Inc. Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish–Norwegian Association Study In Models 1–3, linear regression was used to assess the associations between the number of MR episodes and the chosen factors. To stabilize the variance, the outcome was logarithmically transformed. Hence, the regression coefficients are reported back-transformed (exponentiated; exp(B)) and are to be interpreted multiplicatively. Hence, because the preventive factors were dichotomized, a regression coefficient exp(B) indicates the average number of times MR increased for units where this factor was present compared to units where this factor was absent. Even though the outcome is a count, for which a Poisson regression may often be used, the linear regression fit the data better, for example, the quasilikelihood under independence model criterion value was more than twice as high using Poisson regression. To account for multiple testing, a p value < .01 was chosen to indicate significance. All analyses were performed using IBM SPSS Statistics for Windows, Version 19.0 (Released 2010. IBM Corp, Armonk, NY, USA). Denmark (n = 87) Norway (n = 96) Excluded: special high-security forensic units (n = 3) Norway does not have special highsecurity units (n = 0) Nonresponders/ Refused/Missing data (n = 41) Nonresponders/ Refused/Missing data (n = 49) Included (n = 43) Included (n = 47) Participants from Denmark and Norway (n = 90) Figure 2. Flowchart of the Participating Units Number of MR episodes Approval and Ethics Questionnaires such as the one included in the present study do not require approval from the scientific-ethical committee system in Denmark or Norway when the respondents are able to provide informed consent or when sensitive information is not collected. The Danish Data Protection Agency (Journal number: 2007-2058-0015, PSV-2009-2013) approved this study,and we received permission from the Danish Health and Medicines Authorities and the Danish Psychiatric Central Research Register to use the register data on the frequency of MR in Denmark (Munk-Jørgensen & Mortensen, 1997). This study followed the Ethical Guidelines for Nursing Research in the Nordic Countries (Northern Nurse Federation, 2003) and the Recommendations on Legal Protection of Persons Suffering From Mental Disorders Especially Those Placed as Involuntary Patients (Council of Europe, 2000). Findings Flow of Participating Study Units Figure 2 displays a flowchart of the participating units. Respondents The responding and nonresponding units were equally distributed across the countries (response rate = 49%). Clinical nurse managers did not respond for the following reasons, as provided by managers: “change of clinical nurse manager” (n = 9), “lack of personal resources for accomplishing the task” (n = 7), sick leave (n = 5), inability to remember/identify the number of MR episodes (n = 5), lack of belief that this type of research was beneficial (n = 1). The remaining 63 did not provide a reason. Perspectives in Psychiatric Care 50 (2014) 155–166 © 2013 Wiley Periodicals, Inc. The respondents reported 2,361 MR episodes in Denmark and 1,017 MR episodes in Norway during the examined time periods. Nine units accounted for 451 of the excluded MR episodes (>25 per person), leaving 1,938 episodes in Denmark and 989 in Norway for analysis. Estimating Associations The outcome variable (the number of MR episodes during 1 year per unit) varied between 0 and 254, with a mean value of 32.5. Alternatively, the number of MR episodes per year per bed varied between 0 and 15.9, with a mean value of 2.5. In Table 4, Model 1, one MR-preventive factor was significantly associated with a low frequency of MR episodes: mandatory review (exp(B) = .41, p < .01). In Model 2, seven MR-preventive factors were significantly associated with a low frequency of MR episodes: patient involvement (exp(B) = .14, p < .01), staff education (exp(B) = .14, p < .01), mandatory review (exp(B) = .27, p < .01), positive patient responses to rules (exp(B) = .34, p < .01), staff experience (exp(B) = .40, p < .01), identification of the patient’s crisis triggers (exp(B) = .45, p < .01), and no crowding (exp(B) = .50, p < .01). One MR-preventive factor was significantly associated with a high frequency of MR episodes: staff training (exp(B) = 3.60, p < .01). In Model 3, three MR-preventive factors were significantly associated with a low frequency of MR episodes: mandatory review (exp(B) = .36, p < .01), patient involvement (exp(B) = .42, p < .01), and no crowding (exp(B) = .54, p < .01). The Pearson’s correlation matrix showed one highly (Pearson’s r > .50) intercorrelated pair: communication and positive staff attitudes (Pearson’s r = .77). Furthermore, six pairs showed medium intercorrelation (Pearson’s r .30 ≤ .50): 161 Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish–Norwegian Association Study Table 4. Effects of Potential MR-Preventive Factors on the Annual Number of MR Episodes Model 1 Model 2 Model 3 MR-Preventive Factors exp(B) 95% CIs of exp(B) p exp(B) 95% CIs of exp(B) p exp(B) 95% CIs of exp(B) p Cognitive milieu therapy vs. no cognitive milieu therapy Patient involvement vs. no patient involvement Patient-centered care vs. no patient-centered care Identification of the patient’s crisis triggers vs. no identification Risk assessment vs. no risk assessment Mandatory review vs. no mandatory review Staff training (> 50% vs. less) Positive staff attitudes vs. less positive Patient-staff ratio (≥ 3 staff per patient vs. less) Staff education (≥ 3 years vs. less) Staff experience (> 5 years vs. less) Debriefing, defusing vs. none Positive patient responses to rules vs. negative responses Activity-based nursing vs. no activity-based nursing Acceptable work environment vs. poor work environment No crowding vs. crowding Substitute staff (< 50 vs. more) Staff opposition to MR (many vs. some) Alarm systems (many and well-trained responses vs. less well-trained responses) Communication (all staff have communicative skills vs. less that all) Well-maintained, clean, and tidy surroundings (always vs. seldom) Separation of acutely disturbed patients vs. no separation 0.75 0.51 0.79 0.73 [0.26, [0.29, [0.30, [0.46, 2.07] 0.88] 2.06] 1.15] .57 .02 .62 .17 0.67 0.14* 0.42 0.45* [0.37, [0.07, [0.17, [0.29, 1.18] 0.30] 1.01] 0.72] .17 .00 .05 .00 – 0.42* – – – [0.25, 0.73] – – – .00 – – 2.01 0.41* 1.08 1.15 0.72 1.16 0.76 1.20 0.82 0.93 0.54 0.56 0.82 0.85 1.12 [0.84, [0.23, [0.69, [0.61, [0.42, [0.39, [0.47, [0.81, [0.46, [0.51, [0.33, [0.34, [0.51, [0.54, [0.42, 4.81] 0.73] 1.69] 2.16] 1.24] 3.41] 1.23] 1.70] 1.47] 1.70] 0.90] 0.92] 1.32] 1.34] 3.00] .12 .00 .74 .67 .24 .79 .27 .36 .50 .82 .02 .02 .42 .49 .82 2.91 0.27* 3.60* 1.15 1.36 0.14* 0.40* 0.85 0.34* 1.65 1.09 0.50* 0.57 1.12 2.31 [1.28, [0.18, [2.49, [0.58, [0.83, [0.06, [0.24, [0.59, [0.19, [1.08, [0.76, [0.31, [0.33, [0.77, [1.15, 6.60] 0.39] 5.20] 2.26] 2.21] 0.32] 0.67] 1.22] 0.62] 2.51] 1.58] 0.80] 1.01] 1.62] 4.63] .01 .00 .00 .69 .22 .00 .00 .39 .00 .02 .64 .00 .05 .56 .02 – 0.36* – – – – – – – – – 0.54* – – – – [0.21, 0.63] – – – – – – – – – [0.36, 0.81] – – – – .00 – – – – – – – – – .00 – – – 1.08 [0.66, 1.75] .77 1.53 [0.84, 2.81] .17 – – – 0.69 [0.41, 1.17] .17 1.08 [0.71, 1.66] .72 – – – 1.55 [0.95, 2.52] .08 1.14 [0.73, 1.78] .57 1.65 [1.10, 2.49] .02 Note. The exp(B) parameters were estimated using a linear regression, and all three models were adjusted for the background variables: geography, unit size, bed occupancy, type of bed, reason for the MR, forensic provision, ethnicity, and type of unit. Additionally, the nesting of units in departments was adjusted for by generalized estimating equations techniques. In Model 1, the MR-preventive factors were analyzed alone. In Model 2, all the MR-preventive factors were analyzed together. In Model 3, a forward-selection procedure included the most significant MR-preventive factors until the Corrected quasi-likelihood under independence model criterion value began to rise. In all three models, the outcome variable (i.e., the number of MR episodes) was log-transformed. Hence, the parameters should be interpreted multiplicatively (e.g., in Model 1, cognitive milieu therapy results in 0.75 times the average number of MR incidents without cognitive milieu therapy or 25% fewer MR episodes occur with cognitive milieu therapy than without). *p < .01. MR, mechanical restraint. patient-centered care and cognitive milieu therapy (Pearson’s r = .49); communication and staff opposition to MR (Pearson’s r = .38); substitute staff and activity-based nursing (Pearson’s r = .36); communication and risk assessment (Pearson’s r = .32); positive patient responses to rules and identification of the patient’s crisis triggers (Pearson’s r = .31); and staff education and cognitive milieu therapy (Pearson’s r = .31). All correlations were significant (p < .01). Patient involvement, mandatory review, and crowding were the only potential MR-preventive factors that had a significant effect (p < .01) in Model 3. The parameter estimates (exp(B) = .36, .42, and .54) are interpreted below. Mandatory review: Units in which the staff audited, reviewed, or conducted a similar systematic follow-up evaluation after all MR episodes (to analyze and learn from the 162 episodes) experienced an average of .36 times as many (or 64% fewer) MR episodes than did those where the evaluation was conducted after some or none of the MR episodes. Patient involvement: Units in which the patients participated in ward rounds/conferences, influenced the rules applied to the unit, or influenced what was written in the nurse’s journal experienced an average of .42 times as many (or 58% fewer) MR episodes than those in units in which no such participation existed. Crowding: Units in which two of the following three conditions were present experienced an average of .54 times (or 46% fewer) MR episodes than those in units where only one or none of the conditions was present: only one bed in a patient’s room, more than 25 m2 of all-day-accessible space per patient, and the perception of no crowding. Perspectives in Psychiatric Care 50 (2014) 155–166 © 2013 Wiley Periodicals, Inc. Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish–Norwegian Association Study Discussion Mandatory review was significant in all three models; correspondingly, no significant intercorrelations were found with the other factors. Thus, no other factors greatly influenced the association between mandatory review and the number of MR episodes. Previous research also reported that conducting mandatory reviews of MR episodes was associated with a low number of MR episodes (Donat, 1998, 2003; McCue, Urcuyo, Lilu, Tobias, & Chambers, 2004; Pollard, Yanasak, Rogers, & Tapp, 2007; Prescott, Madden, Dennis, Tisher, & Wingate, 2007). The previous research has suggested that an optimal process should review all MR episodes within a few days and that the review board should consist of an interdisciplinary team that includes a nurse specialist, a physician, a psychologist, and the clinical department heads with the supervisory authority to change nursing and treatment practices. In addition, the review process should require a protocol that includes a description of the episode, the environmental conditions that might have provoked the problem behavior, possible “crisis triggers” and any unique calming techniques identified, the ways in which the patient is involved, their medications, any behavioral treatments and milieu therapies, and other items. Patient involvement was significant in both Model 2 and Model 3; because patient involvement was not significant in Model 1, minor intercorrelations did occur (albeit not strongly or significantly) with, for example, staff training and well-maintained, clean, and tidy surroundings. Potentially, elements of patient involvement are included in some staff training, and patients who are more involved in their own care may have a greater sense of responsibility toward their surroundings. Thus, the nonsignificant and highly complex statistics in the correlation matrix with regard to patient involvement did not precisely explain which factors influenced the association between patient involvement and the number of MR episodes. Previous research also reported that patient involvement might reduce MR episodes (Borckardt et al., 2011; Thyrsting & Hall, 2008). In our study, patient involvement was measured using three items (whether the patients participated in ward rounds/conferences, as well as whether they influenced the rules and what was written in nurses’ journals). Of course, patient involvement is a much more complex phenomenon that includes the concept that the patient is the expert on his or her life, and the staff is expert with regard to their care or treatment; actions are negotiated via dialog. It is, however, reasonable to believe that units with a recovery-orientated or an empowering approach, that integrate patient involvement in the delivery of care and treatment, will include one of the aforementioned items (whether the patients participated in ward rounds/conferences, as well as whether they influenced the rules and what was written in nurses’ journals). Perspectives in Psychiatric Care 50 (2014) 155–166 © 2013 Wiley Periodicals, Inc. No crowding was significant in both Model 2 and Model 3; one minor but significant intercorrelation between no crowding and patient/staff ratio existed (Pearson’s r, .24, p < .05). This intercorrelation is understandable, where more staff creates a perception of more crowding. Previous research also reported that no crowding might influence the number of MR episodes (Meehan, McIntosh, & Bergen, 2006; Vaaler, Morken, Fløvig, Iversen, & Linaker, 2006; van der Schaaf, Dusseldorp, Keuning, Janssen, & Noorthoorn, 2013; Virtanen et al., 2011). Several MR-preventive factors had high parameter estimates that indicated an increase in the number of MR episodes, although none was significant in Model 3. One of the most interesting was risk assessment; strong evidence supported the role of this preventive factor in earlier studies, including at least two cluster randomized controlled trials (RCTs). One study showed a reduction in coercive measures (Abderhalden et al., 2008), and the other showed a reduction in aggressive incidents (van de Sande et al., 2011). The reason we did not find a significant relationship between risk assessment and MR reduction in our study might be that we combined the risk assessments for self-destructive/suicidal behaviors and aggressive/violent behaviors. The difference in the risk assessments of self-destructive behaviors is most likely impossible to measure because both Denmark and Norway have focused on this factor over the past several years; thus, almost all institutions have implemented this system of assessment. Assessment of aggressive/violent behavior has also become more common. Fifty-five percent of the patients were systematically assessed for the risk of developing aggressive or violent behaviors in the units; however, this assessment system appears to have been introduced initially in units with high numbers of MR episodes. Therefore, risk assessment must be investigated by another means (e.g., single riskassessment methods using a cluster-RCT design). The same pattern could be seen with staff training, which was the only significant factor with high parameter estimates, though only in Model 2. Training in de-escalation, avoiding physical attacks, careful restraining techniques, etc., were likely offered first to staff in units with high numbers of MR episodes. Overall, because the quality of the supporting research does not establish a causal relationship between the number of MR episodes and mandatory review, patient involvement, or no crowding, the findings of this study cannot be seen as a rejection of hypotheses in practice; rather, they support and provide a better understanding of the mechanisms involved in MR prevention. Limitations Several limitations must be considered when examining the results. First, some confounding covariates might be missing from the analyses. This basic limitation is embedded in the 163 Mechanical Restraint in Psychiatry: Preventive Factors in Theory and Practice. A Danish–Norwegian Association Study study design, given that there was no controlled laboratory environment and that it was not possible to control all potential covariates (e.g., patient flow, diagnostic distribution, the units’ different population bases, and age of the patients who experienced MR); however, either these covariates are not associated with the number of MR episodes, or their effect disappeared after geographic region and type of unit were added to the analyses of the data from the Danish National Register on coercion, where they acted as proxy covariates. The two datasets (the questionnaire and the Danish National Register on coercion) were obtained from different organizational levels (units/wards) in the same year, which leads us to believe that the same effect might be found in our questionnaire data (the covariates without confounding); however, we did not have access to these data from the Norwegian sample; therefore, we do not know whether these conclusions apply to the entire dataset. Second, recall bias is possible, especially for the Danish data; the clinical nurse manager had to recall all MRpreventive factors and the conditions and number of MR episodes from 2 years prior. The outcome variable (i.e., the number of MR episodes) and the number of patients who experienced MR more than 25 times were validated or reexamined (see the Data Collection section). This analysis did not reveal significant recall bias with regard to the outcome variable. Nurses’ recall is reliable over 4 weeks (Gerolamo, 2008). In this study, the clinical nurse managers were able to support their memories by checking charts, protocols, etc., to answer many of the questions. Additionally, recall bias could affect when the MR-preventive factors were implemented, for example, if patient involvement only had been implemented for the last 3 months and not over the whole year under investigation. Thus, this factor would probably only increase the effect on patient involvement. Nevertheless, we must consider the possibility of recall bias with regard to other variables. Third, three participants answered the questionnaires twice over a 3-month interval to check the test–retest reliability (see the Data Collection section). Although three participants are too few to properly calculate reliability, the results indicate no substantial difference in the measured constructs between the two administrations. Fourth, the nonresponders’ reasons for failure to reply were reviewed, and no systematic differences were found between those who responded and those who did not. Reviewing the Danish National Register on coercion, we found for the same population that 49% of responding units were “responsible” for 52% of the MR episodes, suggesting very small differences in MR episodes between responders and nonresponders; however, no proper dropout analysis was conducted. Consequently, we cannot establish whether the high dropout rate created systematic flaws, but we believe that the most important preventive factors and background variables were included in the study. Thus, the regression coeffi164 cients most likely can be generalized to the populations of both countries. Transferring the results to other countries, however, would require a thorough examination of their cultures, legislations, and other relevant factors. Finally, when the data were reanalyzed including patients who experienced MR more than 25 times, the result differed only marginally. Some of the parameter estimates were slightly higher and some slightly lower, and in Model 1, patient involvement became significant, but the effect in Model 3 was unchanged. Overall, exclusion of the patients who experienced MR more than 25 times did not affect results. Implications for Nursing Practice and Research Because no causal effect was established between the reduction in MR episodes and mandatory review, patient involvement, or no crowding, we cannot claim that implementation of these potential preventive measures would reduce the number of MR episodes. More studies are needed to investigate effective procedures to reduce the number of MR episodes; however, because mandatory review, patient involvement, and no crowding did not have any adverse effects, they are recommended because they might contribute positively to existing MR-preventive management programs. Acknowledgments We thank the Health Science Research Foundation in the Capital Region of Denmark, the Mental Health Services in the Capital Region of Denmark, and the Mental Health Centre Sankt Hans, Copenhagen University Hospital for funding this project. We thank all of the clinical nurse managers of the “closed” psychiatric units in Norway and Denmark for participating in this project. The authors also thank Volkert Dirk Siersma, Statistician, PhD, the Research Unit for General Practice, Centre for Health and Society, Copenhagen University, and the Department of Biostatistics at Copenhagen University for supervising the data analyses. 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N., Bolwig, T., & Olsen, N. V. (2005). Deep venous thrombosis and pulmonary embolism following physical restraint. Acta Psychiatrica Scandinavica, 111(4), 324–327. doi:10.1111/j.1600-0447.2004.00456.x Lov nr. 62-§ 4-8 (1999). Lov om etablering og gjennomføring av psykiak helsevern. McCue, R. E., Urcuyo, L., Lilu, Y., Tobias, T., & Chambers, M. J. (2004). Reducing restraint use in a public psychiatric inpatient service. Journal of Behavioral Health Services and Research, 31(2), 217–224. Meehan, T., McIntosh, W., & Bergen, H. (2006). Aggressive behaviour in the high secure forensic setting: The perceptions of patients. Journal of Psychiatric and Mental Health Nursing, 13(1), 19–25. doi:10.1111/j.1365-2850.2006.00906.x Morrison, A., & Sadler, D. (2001). Death of a psychiatric patient during physical restraint. Excited delirium—A case report. Medicine, Science, and the Law, 41(1), 46–50. Munk-Jørgensen, P., & Mortensen, P. B. (1997). The Danish Psychiatric Central Register. 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Nordic Journal of Psychiatry, 60(2), 144–149. doi:10.1080/08039480600583472 van de Sande, R., Nijman, H. L. I., Noorthoorn, E. O., Wierdsma, A. I., Hellendoorn, E., van der Staak, C., & Mulder, C. L. (2011). Aggression and seclusion on acute psychiatric wards: Effect of short-term risk assessment. British Journal of Psychiatry: The Journal of Mental Science, 199(6), 473–478. doi:10.1192/bjp.bp.111.09514 van der Schaaf, P. S., Dusseldorp, E., Keuning, F. M., Janssen, W. A., & Noorthoorn, E. O. (2013). Impact of the physical environment of psychiatric wards on the use of seclusion. British Journal of Psychiatry: The Journal of Mental Science, 202(2), 142–149. doi:10.1192/bjp.202.2.162 Virtanen, M., Vahtera, J., Batty, G. D., Tuisku, K., Pentti, J., Oksanen, T., . . . Kivimäki, M. (2011). Overcrowding in psychiatric wards and physical assaults on staff: Data-linked longitudinal study. British Journal of Psychiatry: The Journal of Mental Science, 198(2), 149–155. doi:10.1192/bjp.bp.110.08238 Watt, T., Rasmussen, Å., Groenvold, M., Bjorner, J. B., Watt, S. H., Bonnema, S. J., & Feldt-Rasmussen, U. (2008). Improving a newly developed patient-reported outcome for thyroid patients, using cognitive interviewing. Quality of Life Research, 17(7), 1009–1017. doi:10.1007/s11136-008-9364-z Willis, G. B. (2005). Cognitive interviewing. A tool for improving questionnaire design. London: Sage. Willis, G. B., & Lessler, J. T. (1999). Question appraisal system (QAS-99). Atlanta: Research Triangle Institute. Perspectives in Psychiatric Care 50 (2014) 155–166 © 2013 Wiley Periodicals, Inc. Paper 4 Comparing the effect of non-medical mechanical restraint preventive factors between psychiatric units in Denmark and Norway. Comparing the effect of non-medical mechanical restraint preventive factors between psychiatric units in Denmark and Norway Nord J Psychiatry Downloaded from informahealthcare.com by Rigshospitalet on 01/23/15 For personal use only. JESPER BAK, VIBEKE ZOFFMANN, DORTE MARIA SESTOFT, ROGER ALMVIK, VOLKERT DIRK SIERSMA, METTE BRANDT-CHRISTENSEN Bak J, Zoffmann V, Sestoft DM, Almvik R, Siersma VD, Brandt-Christensen M. Comparing the effect of non-medical mechanical restraint preventive factors between psychiatric units in Denmark and Norway. Nord J Psychiatry 2015;68:1–11. Background: The use of mechanical restraint (MR) is controversial, and large differences regarding the use of MR are often found among countries. In an earlier study, we observed that MR was used twice as frequently in Denmark than Norway. Aims: To examine how presumed MR preventive factors of non-medical origin may explain the differing number of MR episodes between Denmark and Norway. Methods: This study is a cross-sectional survey of psychiatric units. Linear regression was used to assess the confounding effects of the MR preventive factors, i.e. whether a difference in the impact of these factors is evident between Denmark and Norway. Results: Six MR preventive factors confounded [Δexp(B)⬎ 10%] the difference in MR use between Denmark and Norway, including staff education (⫺ 51%), substitute staff (⫺ 17%), acceptable work environment (⫺ 15%), separation of acutely disturbed patients (13%), patient–staff ratio (⫺ 11%), and the identification of the patient’s crisis triggers (⫺ 10%). Conclusions: These six MR preventive factors might partially explain the difference in the frequency of MR episodes observed in the two countries, i.e. higher numbers in Denmark than Norway. One MR preventive factor was not supported by earlier research, the identification of the patient’s crisis triggers; therefore, more research on the mechanisms involved is needed. Clinical implications: None of the six MR preventive factors presents any adverse effects; therefore, units in Denmark and Norway may consider investigating the effect of implementing, the identification of the patient’s crisis triggers, an increased number of staff per patient, increased staff education, a better work environment and reduced use of substitute staff in practice. • Coercion, Mechanical restraint, Mental health, Nursing, Psychiatry. Jesper Bak, Research Institute, Mental Health Centre Sct. Hans, Boserupvej 2, 4000 Roskilde, Denmark, E-mail: [email protected]; Accepted 4 December 2014. I n Denmark and Norway, mechanical restraint (MR) can be legally performed when psychiatric inpatients pose a risk to themselves or others (1, 2). The procedure is primarily performed by nursing staff, and involves the use of leather or fibre belts to secure the patient to a bed. MR exposes patients to potential physical risks (3–7) and has negative psychological effects for many patients (8–12). A Danish review (13) identified numerous MR preventive factors based on studies that target MR prevention. No MR preventive factors found in the review received the highest scientific recommendation grade.1 Furthermore, several of these MR preventive factors © 2015 Informa Healthcare might be effective only in controlled research environments. In an earlier retrospective association study (14), we found three MR preventive factors associated with low numbers of MR episodes in Denmark and Norway (mandatory review, patient involvement and no crowding). In that study, we eliminated the differences between the countries by making adjustments to make the findings more universal. However, focusing on the differences between the countries is important when the aim is to develop effective MR reduction programs in Denmark and Norway. In a comparative study on the use of coercion in 11 European countries, including Denmark and Norway DOI: 10.3109/08039488.2014.996600 J BAK ET AL. Nord J Psychiatry Downloaded from informahealthcare.com by Rigshospitalet on 01/23/15 For personal use only. (15), Norway had the lowest rate of physical coercion (MR, seclusion and physical restraint/holding) with 29 inhabitants per 100,000 experiencing physical coercion. In comparison, Denmark had 122 episodes of MR per 100,000 inhabitants, and Norway had 87 episodes of MR per 100,000 inhabitants in 2007 (16, 17). The same tendency was observed in the subpopulation we investigated earlier (14); Denmark had 72 MR episodes per 100,000 inhabitants, and Norway had 42 MR episodes per 100,000 inhabitants. The lower frequency of MR episodes in Norway might indicate that more effective MR preventive factors have been implemented in Norway compared with Denmark or that MR preventive factors exhibit differing effects between the countries. Aim To examine how presumed MR preventive factors of non-medical origin may explain the differing number of MR episodes between Denmark and Norway. access to the requested information. The units were the smallest organizational collection of beds led by a clinical nurse manager. Time frame The Danish questionnaire was administered between 23 December 2009 and 28 May 2010, and the collected data pertained to 2008. The Norwegian questionnaire was administered between 29 October 2010 and 27 January 2011, and the collected data pertained to the previous 12 months, most of which occurred in 2010. Included participants The study included all psychiatric hospital units in Denmark (n ⫽ 87) and Norway (n ⫽ 96) that treated adult inpatients (18–65 years) and used MR for approximately 2 years prior to the year of investigation. MR did occur in Norway in settings other than hospitals; however, given that only 1.5% of recorded MR episodes in 2007 occurred in these settings (16) and that hospitals served as the primary focus of this study, these units were not included. Material and methods A comparative study was conducted to investigate the degree to which the non-medical MR preventive factors identified in a previous review (13) were implemented in the psychiatric units and whether the chosen MR preventive factors association with the number of MR episodes differed between Denmark and Norway. The following conditions must be present legally to initiate MR according to the Danish Mental Health Act (translated by the authors) (1): Mechanical restraint may be used only when necessary to prevent a patient from 1) exposing their body or health or the body or health of others to danger, 2) pursuing or in any other way grossly molesting fellow patients, or 3) committing significant acts of vandalism. These conditions are consistent with Norwegian legislation (translated by the authors) (2): Restraints may be used on a patient only when absolutely necessary to prevent him or her from damaging him or herself or others or to prevent damage to buildings, clothing, inventory or other things. This paper uses Bowers et al.’s (18) definition of MR: The use of restraining straps, belts or other equipment to restrict movement. Note that this definition refers only to the restraint of inpatients in psychiatric hospitals. The MR preventive factors identified by the literature review (13) were included in an online questionnaire and sent to the clinical nurse managers for the purpose of quantifying whether they were implemented in the units. These managers were chosen because they had exclusive 2 Excluded participants The special high-security department in Denmark was excluded due to specific legislation concerning seclusion. Excluded outcome data If MR was used more than 25 times on the same patient during the investigation period, then the episodes of MR ⬎ 25 were excluded. Chance determined the units to which these patients were admitted, but the presence of these patients could significantly affect the units’ MR frequencies, distorting the results. Data collection: the questionnaire A questionnaire was developed based on the results from an earlier systematic literature review that focused on factors that might reduce the use of MR (13). Each MR preventive factor was “translated” into questions to identify the degree to which the factor was present in the units. Six factors were not included in the present study. Combined intervention programmes, were omitted because it were too complex to measure. The following four factors were omitted because they were not considered measured appropriately by the questionnaire: treatment of substance abuse and psychosis, patients perceived as a resource in their own treatment, pro necessitate [p.n.]/as-needed medication guided by individual patients, and care alliance. Lastly, music used as a diversion and for relaxation were omitted, because it were partially covered by another factor, activity-based nursing. Cognitive milieu therapy and patient involvement and patient-centred care and patient involvement, were sepaNORD J PSYCHIATRY·EARLY ONLINE·2015 Nord J Psychiatry Downloaded from informahealthcare.com by Rigshospitalet on 01/23/15 For personal use only. PREVENTING MECHANICAL RESTRAINTS IN PSYCHIATRY rated into three factors: cognitive milieu therapy, patientcentred care, and patient involvement. Although patient involvement is part of cognitive milieu therapy and patient-centred care, it might also occur by itself. Leaving, 22 separate MR preventive factors to be included in the present study. The questionnaire was developed by conceptualizing and operationalizing the MR preventive factors. To increase validity and reliability, we followed the Question Appraisal System [QAS-99 (19)] that was developed to identify problems in questionnaires, including the cognitive processes inherent to the question-answering process. The construction and pre-testing of the questionnaire involved an eight-step appraisal of each item (QAS-99): reading, instructions, clarity, assumption, knowledge/memory, sensitivity/bias, response categories and others.2 The pre-test was conducted by creating a cognitive-test protocol that included probes for each item. The probes covered the aforementioned eight steps and consisted of several types: general (e.g. How did you reach this answer?); specific (e.g. Why do you believe MR is an intrusive and coercive measure?); understanding/interpretation (e.g. How do you define physical activity?); safety (e.g. How sure are you of your answer?); paraphrasing (e.g. Can you repeat the question in your own words?); and memory (e.g. How did you know that you had 56 MR last year?). The pre-test consisted of cognitive interviews (20) of four clinical nurse managers individually using concurrent probing (21), in which verbal probes were asked immediately after a question. This protocol led to the revision of seven questions that were subsequently pretested in a group interview. Data collection, administration, and processing, as well as error identification and the creation of electronic data files (22, 23), were administered using the electronic web-based survey system Enalyzer (2010). The questionnaire was checked for test–retest reliability by asking three clinical nurse managers to answer the questionnaire a second time after a 3-month interval (The respondents were instructed not to check their previous answers). The estimated mean correlation between all of the first and second answers was reasonable (Kendall’s Taub (tKen,b) ⫽ 0.75). With regard to the Norwegian portion of the study, the questionnaire was translated and retranslated by JB and then checked by two healthcare professionals who were familiar with the subject. A pretest was conducted to test face validity through cognitive interviews of seven clinical nurse managers. This test led to the revision of eight questions, mostly due to imprecise translations. Moreover, one question was added to the questionnaire due to different staff competences: psychologists in Norway are partially responsible for their patients’ treatment, which is not the case in Denmark. NORD J PSYCHIATRY·EARLY ONLINE·2015 Later, the outcome variable (i.e. the number of MR episodes) was re-examined. This procedure was necessary due to the confusing wording of a heading in the Danish questionnaire and the lack of precise numbers regarding the Norwegian patients who experienced MR more than 25 times (14 answer categories instead of the actual number were provided, which made the exclusion imprecise). The re-examination was accomplished by contacting all of the clinical nurse managers in Denmark and four of the clinical nurse managers in Norway. The respondent rate was 94%, and the results lowered the overall frequency of MR by 3.2%. A high correlation coefficient (tKen,b ⫽ 0.89) was found between the two answers, revealing that the confusing headline and the categorization error did not have an important effect. A description of how the 22 dichotomized MR preventive factors were measured in the Supplementary Appendix to be found online at http://informa healthcare. com/doi/abs/10.3109/08039488.2014.996600. Background variables Several conditions might have affected the outcome. These conditions included unit size, bed occupancy, type of bed, reason for the MR, forensic provision, ethnicity other than Danish/Norwegian and type of unit. A description of the background variables included in the study is presented in Table 1. Other variables, e.g. the unit’s population base, the country’s inhabitants and patient flow, could also affect the outcome; however, these variables were covered by the previously mentioned covariates. Unit type and unit size acted as proxy covariates [e.g. patient flow and population base were included in unit type; inhabitants were included in unit size, where the number of beds per 100,000 inhabitants in each country was very similar (Denmark ⫽ 23.96 and Norway ⫽ 22.81 beds per 100,000 inhabitants)]. A patient’s gender is most likely not associated with MR (24, 25); thus, we did not use gender as a covariate. Data analyses The data analyses were conducted in five steps. First, we analysed the difference in the frequency of MR episodes between the countries. Second, we analysed how the factors were individually associated with the number of MR episodes in Denmark and Norway separately. Third, we determined whether an interaction between the MR preventive factors and the country (second order interaction, SOI) existed. Fourth, we analysed the difference in the prevalence of the MR predictive factors between the two countries using Pearson’s chi-squared test (χ2). Fifth, we analysed the confounding effects of the MR preventive factors, i.e. the difference in the effect of the country in 3 J BAK ET AL. Table 1. Background variables. Number of MR episodes per unit in Denmark Background variables Nord J Psychiatry Downloaded from informahealthcare.com by Rigshospitalet on 01/23/15 For personal use only. Unit size 0–9 beds 10–19 beds More than 20 beds Bed occupancy* ⱕ 100% occupancy rate ⬎ 100% occupancy rate Type of bed Closed Shielded or integrated Open or other Reason for the MR* Self-mutilation or suicidal behaviours Aggressive behaviours or “acting out” Forensic provision ⱕ 20.65% of patients with a forensic provision ⬎ 20.65% of patients with a forensic provision Ethnicity ⱕ 10.6% of patients with an ethnic background other than Danish/ Norwegian ⬎ 10.6% of patients with an ethnic background other than Danish/ Norwegian Type of unit Acute Forensic/secure Special/rehabilitation/long-term Number of MR episodes per unit in Norway χ2: Difference in the prevalence of the background variable between countries Missing n Mean n Mean P 0 2 33 8 16 51 28 14 30 3 17 23 21 0.00 1 35 8 50 22 43 3 21 20 0.08 0 6 12 25 15 50 50 7 4 36 18 15 22 0.54 2 2 41 41 10 34 47 47 4 18 0.48 0.46 3 25 15 45 47 39 8 23 10 0.03 7 24 48 27 18 0.79 16 42 16 25 6 12 25 15 50 50 7 4 36 18 15 22 0 0.05 MR, mechanical restraint. Missing, number of missing data from units within each background variable; n, number of units in each category. *Used as a continuous variable in further analyses. χ2, P-value of a chi square test for the difference in the prevalence of the background variables in the units between the countries. models with and without the corresponding MR preventive factor expressed as a percentage [Δexp(B)]; a percentage of greater than 10% was chosen to denote a difference. Linear regression was used to estimate the associations among the frequency of MR episodes, the countries, and the MR preventive factors. To stabilize the variance, the outcome was logarithmically transformed. Hence, the regression coefficients are back-transformed [exponentiated; exp(B)] and should be interpreted multiplicatively. Because the preventive factors were dichotomized, a regression coefficient exp(B) indicates the average number of times MR increased for units where a factor was present compared with units where this factor was absent (e.g. if the result was exp(B) ⫽ 0.42, it should be interpreted as 0.42 times the average number of MR incidents without the MR preventive factor or 58% fewer MR episodes occur with the MR preventive factor than without). Except in the first analysis, where the dichotomized variable was “country”, here the regression 4 coefficient exp(B), indicates the difference between the countries in an average number of MR episodes. All models except the fourth set of analyses (χ2-test) were additionally adjusted for background variables. Additionally, we adjusted for nesting of units in departments (17 departments contained two units each and three departments contained three units each), using Generalized Estimating Equations (GEE). To account for multiple testing, a P-value ⬍ 0.01 was chosen to indicate significance. All analyses were performed using IBM SPSS Statistics for Windows, Version 19.0 (Released 2010; IBM Corp., Armonk, NY). Approval and ethics Questionnaires, such as the one included in the present study, do not require approval from the scientific ethical committee system in Denmark or Norway when the respondents are able to provide informed consent or when sensitive information is not collected. The Danish Data Protection Agency (Journal number: 2007-58-0015, PSVNORD J PSYCHIATRY·EARLY ONLINE·2015 PREVENTING MECHANICAL RESTRAINTS IN PSYCHIATRY Denmark (n=87) Norway (n=96) Excluded: special high-security forensic units (n=3) Non-responders/ Refused/Missing data (n=41) Non-responders/ Refused/Missing data (n=49) Included (n=43, response rate 49%) Included (n=47, response rate 49%) Participants from Denmark and Norway (n=90, response rate 49%) Nord J Psychiatry Downloaded from informahealthcare.com by Rigshospitalet on 01/23/15 For personal use only. Fig. 1. Flowchart of the units participating in the survey. 2009-13) approved the data collection, and we received permission from the Danish Health and Medicines Authorities and the Danish Psychiatric Central Research Register to use the register data on the frequency of MR in Denmark (26). This study followed the Ethical Guidelines for Nursing Research in the Nordic Countries (Northern Nurse Federation, 2003) and the Recommendations on Legal Protection of Persons Suffering from Mental Disorders Especially Those Placed as Involuntary Patients (27). Results A flowchart of the participating units can be found in Figure 1, and the annual number of MR episodes can be found in Table 2. A difference in MR episodes was observed between the countries in a model that included the background variables [exp(B) ⫽ 1.92, P ⫽ 0.01] (Fig. 1, Table 2). Table 3 indicates that a single MR preventive factor, staff education [exp(B) ⫽ 0.34, P ⫽ 0.00], was significantly associated with a lower frequency of MR episodes in Denmark. In Norway, three MR preventive factors were significantly associated with a higher frequency of MR episodes: cognitive milieu therapy [exp(B) ⫽ 7.46, P ⫽ 0.00], patient-centred care [exp(B) ⫽ 5.01, P ⫽ 0.00] and alarm systems [exp(B) ⫽ 3.72, P ⫽ 0.00]. Notably, for cognitive milieu therapy and patient-centred care, the confidence intervals were large, which makes the interpretation less precise. We identified three incidents of interaction among the MR preventive factor, the countries and the frequency of MR episodes: cognitive milieu therapy (SOI, P ⫽ 0.00), patient-centred care (SOI, P ⫽ 0.01) and alarm systems (SOI, P ⫽ 0.00). Each of these factors exhibited a positive effect in Denmark [exp(B): 0.36, 0.41, and 0.18] and a negative effect in Norway [exp(B): 7.46, 5.01, and 3.72]. Six MR preventive factors were significantly different between the two countries: the identification of a patient’s crisis triggers (χ2, P ⫽ 0.01), patient–staff ratio (χ2, P ⫽ 0.00), staff education (χ2, P ⫽ 0.00), acceptable work environment (χ2, P ⫽ 0.01), substitute staff (χ2, P ⫽ 0.00) and separation of acutely disturbed patients (χ2, P ⫽ 0.00). Lastly, we identified six MR preventive factors with confounding effects, i.e. the MR preventive factor acted as a confounder [Δexp(B)⬎ 10%]: identification of the patients’ crisis triggers [Δexp(B) ⫽ ⫺ 10%], patient–staff ratio [Δexp(B) ⫽ ⫺ 11%], staff education [Δexp(B) ⫽ ⫺ 51%], acceptable work environment [Δexp(B) ⫽ ⫺ 15%], substitute staff [Δexp(B) ⫽ ⫺ 17%] and separation of acutely disturbed patients [Δexp(B) ⫽ 13%]. In both countries, the following MR preventive factors was associated with lower numbers of MR episodes: identification of patients’ crisis triggers (Denmark, exp(B) ⫽ 0.65; Norway, exp(B) ⫽ 0.75), a higher patient–staff ratio (Denmark, exp(B) ⫽ 0.96; Norway, exp(B) ⫽ 0.62), higher levels of staff education (Denmark, exp(B) ⫽ 0.34; Norway, exp(B) ⫽ 0.76), better work environment (Denmark, exp(B) ⫽ 0.52; Norway, exp(B) ⫽ 0.55), reduced use of substitute staff (Denmark, exp(B) ⫽ 0.59; Table 2. Annual number of mechanical restraint (MR) episodes. Denmark and Norway (n ⫽ 90) Annual number of MR episodes Mean annual number of MR episodes per unit Mean annual number of MR episodes per bed Mean annual number of MR episodes per 100,000 inhabitants Denmark (n ⫽ 43) No. Norway (n ⫽ 47) No. Range Range No. Range 2927 32.5 2.5 58 – 1938 – 0–254 45.1 0–254 0–15.9 3.2 0–15.9 – 72 – 989 21.0 2.0 42 – 0–74 0–7.1 – No., the number of MR episodes. Nine units accounted for 451 of the excluded MR episodes (⬎ 25 per person), thereby leaving 1938 episodes in Denmark and 989 in Norway for analysis. The number of MR episodes per 100,000 inhabitants in this sub-sample is estimated from the number of MR episodes, the response percentages and the number of inhabitants the actual year. NORD J PSYCHIATRY·EARLY ONLINE·2015 5 6 21 19 49 10 5 7 84 72 78 38 14 51 19 27 7 20 55 50 9 8 20 4 2 3 36 28 32 15 6 19 8 11 3 8 23 21 1.05 0.89 1.56 2.85 0.38 1.26 1.30 0.96 0.34 0.81 0.79 0.61 0.78 0.52 0.59 0.59 1.09 0.18 0.36 0.66 0.41 0.65 exp(B) [0.46–2.40] [0.42–1.87] [0.85–2.85] [1.28–6.36] [0.15–0.97] [0.65–2.46] [0.56–2.99] [0.45–2.06] [0.17–0.66] [0.45–1.44] [0.46–1.36] [0.29–1.29] [0.34–1.79] [0.22–1.25] [0.31–1.13] [0.32–1.10] [0.47–2.54] [0.03–1.17] [0.11–1.16] [0.26–1.71] [0.12–1.38] [0.38–1.10] 95% Cis of exp(B) 0.90 0.75 0.15 0.47 0.40 0.20 0.56 0.14 0.11 0.10 0.84 0.07 0.01 0.04 0.49 0.54 0.91 0.00* 0.09 0.40 0.15 0.11 P 38 29 17 17 7 21 13 25 43 44 24 34 22 17 20 33 17 5 1 37 4 40 No. 83 63 36 37 15 48 28 53 93 98 65 85 54 40 59 73 39 11 3 86 10 93 [0.60–3.26] [0.21–1.37] [0.39–2.01] [0.53–3.06] [0.32–1.19] [0.28–2.04] [0.14–2.19] [1.07–3.89] [0.49–7.44] [0.25–1.88] [0.30–1.03] [0.27–1.14] [0.25–1.18] [0.30–1.63] [2.16–6.41] [2.94–18.89] [0.27–1.31] [2.03–12.36] [0.26–2.17] 95% CI of exp(B) 1.94 [0.92–4.09] 1.03 [0.53–2.04] 1.03 [0.51–2.10] 1.39 0.53 0.88 1.28 0.62 0.76 0.56 2.04 1.92 0.69 0.55 0.55 0.54 0.70 3.72 7.46 0.60 5.01 0.75 % exp(B) Norway 0.08 0.92 0.93 0.28 0.63 0.43 0.13 0.97 0.22 0.75 0.56 0.05 0.84 0.02 0.80 0.53 0.93 0.22 0.33 0.65 0.00* 0.00* 0.80 0.00* 0.67 0.00* 0.20 0.00* 0.59 0.45 0.19 0.76 0.59 0.15 0.59 0.41 0.03 0.35 0.47 0.06 0.11 0.12 0.41 0.00* P P 0 13† 0.00* 3 7 ⫺1 0 3 ⫺ 11† ⫺ 51† ⫺1 ⫺3 ⫺1 ⫺6 ⫺ 15† 6 ⫺ 17† ⫺1 4 6 ⫺2 3 ⫺ 10† % 0.43 0.08 0.53 0.00* 0.25 0.50 0.02 0.52 0.42 0.14 0.01* 0.11 0.60 0.92 0.03 0.00* 0.00* 0.09 0.53 0.72 0.01* P Δ exp(B) Difference in the effect of country No., the number of units where the factor was present; %, the percentage of units where the factor was present; exp(B), the parameter estimate. The outcome variable (i.e. the number of MR episodes) was log-transformed. Hence, the exp(B) should be interpreted multiplicatively (e.g. in Denmark, cognitive milieu therapy results in 0.36 times the average number of MR incidents without cognitive milieu therapy (or 64% fewer MR episodes occur with cognitive milieu therapy than without). 95% CI of exp(B), 95% Wald confidence interval for exp(B); P, P-value; SOI, second order interaction, P-value of a test for the interaction between the MR preventive factor and the country, i.e. whether the effect of the MR preventive factor differs between the countries; χ2, P-value of a chi square test for the difference in the prevalence of the MR preventive factor in the units between the countries; Δ exp(B), Differences in the effect of the country in models with and without the corresponding MR factor (confounding effect of the MR preventive factor) expressed as a percentage; negative Δ exp(B) values should be interpreted as a MR preventive factor that minimises the difference between the countries. In the estimation of exp(B), SOI, and Δ exp(B), we used linear regression and adjusted for the following background variables: unit size, bed occupancy, type of bed, reason for the MR, forensic provision, ethnicity and type of unit. Additionally, the nesting of units in departments was adjusted using Generalized Estimating Equations (GEE) techniques. *P ⬍ 0.01. †Δexp(B)⬎⫾ 10%. 13 81 13 69 5 34 5 29 Cognitive milieu therapy vs. no cognitive milieu therapy Patient involvement vs. no patient involvement Patient-centred care vs. no patient-centred care Identification of the patient’s crisis triggers vs. no identification Risk assessment vs. almost none or no risk assessment Mandatory review vs. no mandatory review Staff training (⬎ 50% vs. less) Positive staff attitudes vs. less positive Patient–staff ratio (⬎ 3 staff per patient vs. less) Staff education (ⱕ 3.5 years vs. less) Staff experience (⬎ 5 years vs. less) Debriefing, defusing vs. none Positive patient responses to rules vs. negative responses Activity-based nursing vs. no activity-based nursing Acceptable work environment vs. poor work environment No crowding vs. crowding Substitute staff (⬍ 50 vs. more) Staff opposition to MR (many vs. some) Alarm systems (many and well-trained responses vs. less well-trained responses) Communication (all staff possess communicative skills vs. less than all) Well-maintained, clean and tidy surroundings (always vs. seldom) Separation of acutely disturbed patients vs. no separation % No. MR preventive factors Denmark SOI: Interaction between the MR preventive factor and the country χ2: Difference in the prevalence of the MR predictive f actor between countries Table 3. Differences in the effects of potential mechanical restraint (MR) preventive factors on the annual number of MR episodes in Denmark and Norway. Nord J Psychiatry Downloaded from informahealthcare.com by Rigshospitalet on 01/23/15 For personal use only. J BAK ET AL. NORD J PSYCHIATRY·EARLY ONLINE·2015 PREVENTING MECHANICAL RESTRAINTS IN PSYCHIATRY Norway, exp(B) ⫽ 0.54), except more separation of acutely disturbed patients, which was associated with increased MR episodes (Denmark, exp(B) ⫽ 1.05; Norway, exp(B) ⫽ 1.94). Nord J Psychiatry Downloaded from informahealthcare.com by Rigshospitalet on 01/23/15 For personal use only. Discussion Three potential MR preventive factors displayed very different effects in the two countries, which was demonstrated by significant interactions among the MR preventive factor, the countries and the frequency of MR episodes. These preventative factors included cognitive milieu therapy (SOI, P ⫽ 0.00), patient-centred care (SOI, P ⫽ 0.01) and alarm systems (SOI, P ⫽ 0.00). None of the factors had a significant difference in prevalence (χ2, P ⫽ 0.09, 0.72, and 0.50). Therefore, it was difficult to interpret the differences in the effect based on the country [Δexp(B)] due to the interaction. It was also difficult to determine why these factors exhibited a different effect in the two countries. One explanation of why cognitive milieu therapy and patient-centred care were effective in Denmark could be that these two factors were well described as methods and included a treatment philosophy in Denmark. Therefore, in Denmark, these descriptions of care and treatment actually covered phenomena such as patient involvement and cooperation; this was, to our knowledge, not the case in Norway in 2010. Another potential explanation is that the limited number of units in Norway that had implemented the three MR preventive factors could be special units with fewer MR episodes. Although the three MR preventive factors were significantly associated with an increased number of MR episodes in Norway, we would not recommend that Norway implement less of these three factors given the small number of units that implemented the factors. Further research is needed to explore the different effects of these three MR preventive factors. Six MR preventive factors exhibited a significant difference between the countries with regard to the frequency of MR episodes [Δexp(B)]. First, identification of a patient’s crisis triggers: units wherein the initial nurse evaluation of at-risk patients always contained a written evaluation of aggressive, selfmutilating or suicidal behaviours (e.g. crisis triggers, unique calming techniques, and coping strategies) vs. units where the initial evaluation only occasionally or never contained a written evaluation. This factor explains a large [Δexp(B) ⫽ ⫺ 10%] portion of the difference in MR episodes between the countries. The identification of a patient’s crisis triggers was supported by earlier research. In a well-designed before and after study, Jonikas et al. (28) observed a significant decrease (between 49% and 99%) in physical restraint episodes after patients were interviewed to determine their crisis triggers and personal crisis management strategies. In a reasonably designed cluster randomized controlled trial NORD J PSYCHIATRY·EARLY ONLINE·2015 (RCT), Putkonen et al. (29) reported the same tendency, where seclusion and restraint time decreased by 51% after implementing six core strategies to prevent seclusion and restraint. In both studies, the effect was attributed to variables other than the patients’ crisis triggers. In a one-way case-crossover designed study, Fluttert et al. (30) reported that implementing the early recognition method (ERM) decreased the number of seclusions by 54%. The ERM is a technique for patients and staff to work systematically with the patients’ triggers (early warning signs), crisis intervention and coping strategies; this is the same identification procedure we asked the clinical nurse managers about in the questionnaire. Overall, the earlier research supports the finding that, identification of a patient’s crisis triggers, is part of explaining the difference in MR use between the two countries. The mechanism involved in this process is probably that patients and staff earlier recognize sign of a forthcoming crisis, and together develop counteractions to avoid escalation of the crisis, thereby reducing the risk of a MR episode. Early prevention could constitute one of the most effective strategies to reduce MR episodes. Second, patient–staff ratio: units in which the staffto-patient ratio was higher than or equal to three-to-one on average vs. those units where this ratio was lower than three-to-one. In Denmark, the effect was small, possibly due to the small number of units where the staff-topatient ratio was lower than three-to-one on average. The factor explains a large [Δexp(B) ⫽ ⫺ 11%] portion of the difference in MR episodes between the countries. The effects of the staff-to-patient ratio were partially supported by earlier research. Smith et al. (31) found a 66% decrease in restraint episodes. However, because several factors contributed to the effect, it is unclear what portion of the MR reduction was attributable to the 50% increase in staffing. Janssen et al. (32) found that seclusion was used more commonly when the number of patients per staff was greater in long-term wards. Donat (33) reported a significant association between increased staffing levels and decreased MR and seclusion numbers. However, Owen et al. (34) noted that the relative risk of violence increased with more nursing staff. In addition, Bowers et al. (35) reported that increased levels of aggressive incidents were associated with increased staffing. Nonetheless, both studies with opposite outcomes did not precisely target MR or seclusion but instead targeted violence and aggression; the results could be influenced by staff employment policies, wherein staffing levels are increased in units with more aggressive incidents. Our study most likely eliminated this problem by introducing “type of unit” and “type of bed” as confounders. Overall, the earlier research specific dealing with the same conditions does support the finding that, the staff to patient ratio, is part of explaining the difference in MR use between the two countries. The mechanisms involved in 7 Nord J Psychiatry Downloaded from informahealthcare.com by Rigshospitalet on 01/23/15 For personal use only. J BAK ET AL. higher staffing levels could be that the staff would be more able to observe, interact and corporate with the patients, probably reduce the number of stressed staff, thereby calming the environment, having more personal resources to positive reinforcement, support, and communication, hopefully creating a more empowering and recovery orientated environment for the patients. Third, staff education: units wherein the staff received basic training for at least 31/2 years vs. units where the staff had less than 31/2 years of training. The factor explains a large portion [Δexp(B) ⫽ ⫺ 51%] of the difference in MR episodes between the countries. Staff education was supported by earlier research. Janssen et al. (32) reported that seclusion was used more commonly in units with less educated staff in the long-term wards. Gim et al. (36) found a significant difference between psychiatric trained and non-psychiatric trained staff in identifying and managing precipitants of violence. In a large 20-year analysis of 1,565 mental health workers, Flannery et al. (37) found that staff who were victims of patients’ aggressions were less formally educated and less trained. None of the studies was an RCT, but otherwise well designed, so it is reasonable to deduce, that earlier research supports the finding that, staff education, is part of explaining the difference in MR use between the two countries. Higher basic education among staff is probably leaving the staff with higher analytic and action competences, even in crisis situations, thereby reducing the number of MR episodes. Fourth, acceptable work environment: units where a workplace environment assessment was present, no or only insignificant physical or mental work-environment problems existed, and the overall work environment was evaluated as acceptable vs. units where the workplace environment was not assessed, more workenvironment problems existed, and the overall work environment was evaluated as poor. This factor explains a large [Δexp(B) ⫽ ⫺ 15%] portion of the differences in MR episodes between the countries. An acceptable work environment is somewhat complex because the work environment is a mix of leadership, degree of order, organization, staffing, training, crowding, etc. De Benedictis et al. (38) reported that several organizational factors, e.g. team climate, staff perception of aggression and interaction of team-members, were associated with increased use of seclusion and restraint. Hanrahan et al. (39) observed a relationship between psychiatric nurses’ work environments and inpatients’ environments. van der Schaff et al. (40) reported a number of building design features that had an effect on seclusion and restraint. Virtanen et al. (41) indicated that patient overcrowding was associated with violent assaults towards employees. Huckshorn (42) found that leaders played a critical role in reducing seclusion and restraint. Camerino et al. (43) found a significant 8 association between work-related factors and some types of violence. Some of the other examined factors are also part of the overall work environment, such as staff training, staff/patient ratio, etc. Overall, the research that supports the association between MR and work environment includes many parts of a healthy work environment, and it supports the finding that the work environment partly explains the difference in MR use between the two countries Whatever part of the environment that creates a positive work environment, the wellbeing of the staff is most certainly affecting the wellbeing of the patients, so when staff experiences a more positive work environment the patient probably experience a more positive environment. Fifth, substitute staff: units in which substitute staff was used less than 50 times (8-h shifts) over the year vs. units where these employees were used greater than or equal to 50 times. The factor explains a large [Δexp(B) ⫽ ⫺ 17%] portion of the difference in MR episodes between the countries. The effects of substitute staff were supported by earlier research. Bonner et al. (8) found that both patients and staff discriminated between permanent and regular staff. Bowers et al. (44) reported that adverse incidents were more likely to occur during weeks where regular staff was absent. In another study, Bowers et al. (35) noted that increased levels of aggression were associated with an increased use of bank and agency staff. None of the studies was an RCT, but all the studies indicate similar results, supporting less use of substitute staff. The reason for this finding could be that substitute staff lacks knowledge of the unit structures, processes and patients, thereby creating insecurity and disturbances in the everyday life of the unit among some of the most vulnerable patients. This could be a stressing factor for the patients creating more aggressive or self-destructive behaviour—hence, more MR episodes. Sixth, one factor, separation of acutely disturbed patients, had different results: units that were able to separate acutely disturbed patients from other patients vs. units that were unable to separate patients. The factor explains a large [Δexp(B) ⫽ 13%] portion of the difference in MR episodes between the countries. This negative association was not supported by earlier research; in fact, the opposite result was indicated. In a qualitative content analysis study, Meehan et al. (45) noted that patients proposed that the separation of acutely disturbed patients would reduce the number of aggressive incidents. Overall, this result is not supported by earlier research. Therefore, more research is needed to explore the mechanisms involved in placing one or few patients in a separate and isolated part of the unit. Limitations Several limitations must be considered when examining the results. NORD J PSYCHIATRY·EARLY ONLINE·2015 Nord J Psychiatry Downloaded from informahealthcare.com by Rigshospitalet on 01/23/15 For personal use only. PREVENTING MECHANICAL RESTRAINTS IN PSYCHIATRY First, some confounding covariates might be missing from the analyses. We believe that we included the most important covariates or covered the effects of others by proxy (46), e.g. patients who experience MR could be more aggressive or self-mutilating in one of the countries—hence, acting as a confounder. However, one earlier study that assessed aggressive behaviour (47) did not report large differences between Denmark and Norway. Additionally, some of the covariates (number of forensic patients, type of bed and the reason for the MR) could eliminate portions of the difference. Therefore, it is not likely that the potential differences in aggressive or selfmutilating patients would influence the results. Second, recall bias is possible, especially for the Danish data; the clinical nurse manager had to recall all MR preventive factors as well as the conditions and number of MR episodes from 2 years ago. The outcome variable (i.e. the number of MR episodes) were validated or re-examined, and this did not reveal significant recall bias with regard to the outcome variable. Additionally, recall bias could affect the results if the MR preventive factors had only been implemented for a portion of the year. Thus, this recall bias would most likely only increase the effect on patient involvement. Nevertheless, we must consider the possibility of recall bias with regard to some variables. Third, three participants answered the questionnaires twice during a 3-month interval to check the test–retest reliability. Although three participants are insufficient to calculate reliability properly, the results indicate no substantial difference in the measured constructs between the two administrations. Fourth, selection bias—the non-responders’ reasons for failure to reply were reviewed, and no systematic differences were observed between responders and nonresponders. Reviewing the Danish National Register on coercion, we found that 49% of responding units were “responsible” for 52% of the MR episodes in the same population, suggesting minimal differences in MR episodes between responders and non-responders; however, no proper drop-out analysis was conducted. Thus, the results most likely can be generalized to the population of both countries. Transferring the results to other countries, however, would require a thorough examination of their cultures, legislation and other relevant factors. Finally, when data were reanalysed to include patients who experienced MR more than 25 times, the results changed only marginally. Therefore, the exclusion of the patients who experienced MR more than 25 times did not affect results. MR, but it is important to acknowledge that this type of comparative research does not allow for cause–effect conclusions. Thus, we cannot claim that the implementation of these potential preventive measures in Denmark and Norway would reduce the number of MR episodes. More high-quality studies are needed to investigate the identification of a patient’s crisis triggers, an increased number of staff per patient, increased staff education, better work environment, reduced use of substitute staff, and separation of acutely disturbed patients. Notes 1. The review was a a systematic review combining qualitative and quantitative research, so the highest recommendation grade could be: qualitative; at least one high-quality meta-synthesis, systematic review, or metasummary, or a body of high-quality evidence, or quantitative; at least one meta-analysis, systematic review or one or a body of high-quality RCT. 2. STEP 1: READING: Determine if it is difficult for the interviewers to read the question uniformly to all respondents. STEP 2: INSTRUCTIONS: Look for problems with any introductions, instructions or explanations from the respondent’s point of view. STEP 3: CLARITY: Identify problems related to communicating the intent or meaning of the question to the respondent. STEP 4: ASSUMPTIONS: Determine whether there are problems with assumptions or the underlying logic. STEP 5: KNOWLEDGE/MEMORY: Check whether respondents are likely to not know or have trouble remembering information. STEP 6: SENSITIVITY/BIAS: Assess questions for sensitive nature or wording, and for bias. STEP 7: RESPONSE CATEGORIES: Assess the adequacy of the range of responses to be recorded. STEP 8: OTHER: Look for problems not identified in Steps 1–7 (19). Acknowledgements—We thank the Health Science Research Foundation in the Capital Region of Denmark, the Mental Health Services in the Capital Region of Denmark, and the Mental Health Centre Sct. Hans, Copenhagen University Hospital for funding this project. We thank all of the clinical nurse managers of the “closed” psychiatric units in Norway and Denmark for participating in this project. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper. References Conclusion The comparison of these MR preventive factors may contribute to better understanding of the phenomenon of NORD J PSYCHIATRY·EARLY ONLINE·2015 1. Indenrigs- og Sundhedsministeriet. Bekendtgørelse af lov om anvendelse af tvang i psykiatrien. Psykiatriloven, LBK nr. 1729; 2010. 2. Helse- og omsorgsdepartementet. Lov om etablering og gjennomføring av psykiak helsevern. 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J Psychiatr Ment Health Nurs 2006;13:19–25. 46. Janssen WA, van de Sande R, Noorthoorn EO, Nijman HLI, Bowers L, Mulder CL, et al. Methodological issues in monitoring the use of coercive measures. Int J Law Psychiatry 2011;34:429–38. 47. Nijman HLI, Palmstierna T, Almvik R, Stolker JJ. Fifteen years of research with the Staff Observation Aggression Scale: A review. Acta Psychiatr Scand 2005;111:12–21. NORD J PSYCHIATRY·EARLY ONLINE·2015 PREVENTING MECHANICAL RESTRAINTS IN PSYCHIATRY Jesper Bak, R.N., S.D., M.P.H., Ph.D. student, Head nurse, Mental Health Centre Sct. Hans, Roskilde, Denmark. E-mail: Jesper.Bak@ regionh.dk. Vibeke Zoffmann, R.N., M.P.H., Ph.D., Head of Research, Women and Children’s Health, Juliane Marie Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. E-mail: vibeke. [email protected]. Dorte Maria Sestoft, M.D., Ph.D., Head of Department, Ministry of Justice, Clinic of Forensic Psychiatry, Copenhagen, Denmark, E-mail: [email protected]. Roger Almvik, R.N., R.M.N., D.Phil., Research Director, St. Olavs University Hospital, Forensic Department Bröset, Centre for Research & Education in Forensic Psychiatry, Norway. E-mail: [email protected]. Volkert Dirk Siersma, Ph.D., Statistician, The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark, E-mail: [email protected]. Mette Brandt-Christensen, M.D., Ph.D., Head of Department, Forensic Psychiatry, Mental Health Centre Glostrup, Copenhagen University Hospital, Denmark, E-mail: [email protected]. Supplementary material available online Nord J Psychiatry Downloaded from informahealthcare.com by Rigshospitalet on 01/23/15 For personal use only. Appendix: A description of mechanical restraint (MR) preventive factor measurements NORD J PSYCHIATRY·EARLY ONLINE·2015 11 Corrigendum (private) Correction in the abstract: Conclusions: These six MR preventive factors might partially explain the difference in the frequency of MR episodes observed in the two countries, i.e. higher numbers in Denmark than Norway. One MR preventive factor was not supported by earlier research, the identification of the patient’s crisis triggers; therefore, more research on the mechanisms involved is needed. Should be corrected to: Conclusions: These six MR preventive factors might partially explain the difference in the frequency of MR episodes observed in the two countries, i.e. higher numbers in Denmark than Norway. One MR preventive factor was not supported by earlier research, separation of acutely disturbed patients; therefore, more research on the mechanisms involved is needed. Correction on page seven: Second, patient-staff ratio: units in which the staff-to-patient ratio was higher than or equal to three-to-one on average vs. those units where this ratio was lower than three-to-one. In Denmark, the effect was small, possibly due to the small number of units where the staff-topatient ratio was lower than three-to-one on average. Should be corrected to: Second, patient-staff ratio: units in which the staff-to-patient ratio was higher than or equal to three-to-one on average vs. those units where this ratio was lower than three-to-one. In Denmark, the effect was small, possibly due to the small number of units where the staff-topatient ratio was higher than three-to-one on average. Supplementary material for Bak J, et al., Comparing the effect of non-medical mechanical restraint preventive factors between psychiatric units in Denmark and Norway, Nordic Journal of Psychiatry, 2015; doi: 10.3109/ 08039488.2014.996600. Supplementary Appendix: A description of mechanical restraint (MR) preventive factor measurements. MR preventive factors Cognitive milieu therapy vs. no cognitive milieu therapy Patient involvement vs. no patient involvement Patient-centred care vs. no patient-centred care Identification of the patient´s crisis triggers vs. no identification Risk assessment vs. almost none or no risk assessment Mandatory review vs. no mandatory review Staff training (⬎ 50% vs. less) Positive staff attitudes vs. less positive Patient-staff ratio (⬎ 3 staff per patient vs. fewer) Staff education (ⱖ 3.5 years vs. fewer) Staff experience (⬎ 5 years vs. fewer) Debriefing and defusing vs. none Positive patient responses to rules vs. negative responses Activity-based nursing vs. no activity-based nursing Acceptable work environment vs. poor work environment No crowding vs. crowding Substitute staff (⬍ 50 vs. more) Staff opposition to MR (many vs. some) Alarm systems (numerous well trained responses vs. less well trained responses) Communication (all staff possess communicative skills vs. less than all) Well maintained, clean and tidy surroundings (always vs. seldom) Separation of acutely disturbed patients vs. no separation NORD J PSYCHIATRY·EARLY ONLINE·2015 Measurement description The clinical nurse manager described the care in his or her unit as “cognitive behaviour therapy” or “cognitive milieu therapy”, and the staff had participated in 40 h of training or more in this care method—The care method was not described. One of the following factors was present: the patients participated in ward rounds/ conferences or the patients influenced the rules imposed by the unit or influenced what was written in the nurse’s journal—Patients did not participate in these areas. The clinical nurse manger described the care in his or her unit using the words “individual”, “cooperative” or “patient-centred”, and the staff participated in 40 h of training or more in this care method—These words were not used to describe this care method. The initial nurse evaluation of at-risk patients always contained a written evaluation of aggressive, self-mutilating or suicidal behaviours (e.g. crisis triggers, unique calming techniques and coping strategies)—The initial evaluation only occasionally or never contained a written evaluation. The risk of developing aggressive/violent or self-mutilating/suicidal behaviours was always or almost always systematically evaluated and documented, and care actions were initiated—These behaviours were only occasionally or never evaluated and documented. An audit, review or similar systematic follow-up evaluation was conducted after all MR episodes—The evaluation was only conducted after some or none of the MR episodes. An average of 50% or more of the staff participated in training regarding de-escalation, avoiding physical attacks, careful restraining techniques, legislation, MR predictors/ antecedents and suicide prevention—Less than 50% of the staff experienced such training. All staff directed their attention towards the patient and possessed communicative skills, optimism and empathy—Not all of the staff possessed these skills. The staff-to-patient ratio was higher than or equal to three-to-one on average—This ratio was lower than three-to-one on average. The staff received basic training for at least 3½ years—The staff had less than 3½ years of training. The staff had an average of more than 5 years of experience in the psychiatric speciality was more than 5 years on average—Staff experience was 5 years or fewer. Follow-up evaluations were initiated after each MR episode for debriefing, defusing or other crisis interventions—No follow-up was initiated. The patients reacted positively to the rules, and limit-setting was motivational—The opposite occurred. Individual patient-activity plans were devised, and the patients participated in many or several physical or other types of activities—The patients had no activity plans, and they participated in few or no physical or other activities. The unit had the following features: a workplace environment assessment was present, no or only insignificant physical or mental work-environment problems existed, and the overall work environment was evaluated as acceptable—The workplace environment was not assessed, more work-environment problems existed and the overall work environment was evaluated as poor. Two of the following three factors were evident for no crowding: only one bed in a patient’s room, more than 25 m2 of all day-accessible space per patient and the perception of no crowding—Only one or none of these factors was evident. Substitute staff was used less than 50 times (8-h shifts) over the year—These employees were used greater than or equal to 50 times. All staff had the attitude that “MR should be initiated rarely to protect the lives of the patient and others”—Not all staff had this attitude. More than three night-shift staff members responded to an alarm call, and they were all trained in this task—Not all of the night-shift staff members were trained, or they were trained but failed to respond. All staff had general communicative skills or special skills with regard to communicative de-escalation—Less than all the staff had these skills. The unit was perceived as well maintained, clean and tidy—The perceptions were otherwise. The unit was able to separate acutely disturbed patients from other patients—The unit was unable to do so. 1
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