International Journal for Quality in Health Care 2001; Volume 13, Number 4: 325–332 Development process of an evidencebased guideline for the treatment of obesity AFSCHIN GANDJOUR1, JOACHIM WESTENHÖFER2, ALFRED WIRTH3, CHRISTIANE FUCHS1 AND KARL WILHELM LAUTERBACH1 1 Institute of Health Economics and Clinical Epidemiology, University of Cologne, Cologne, 2Department of Nutrition and Home Economics, University of Applied Sciences (Fachhochschule), Hamburg and 3Teutoburger Wald Clinic, Bad Rothenfelde, Germany Abstract Objectives. To present the development process, summarize the content and discuss the implications of the German evidence-based guideline for the treatment of obesity. Design. The target audience and the development process were defined by a multidisciplinary team of experts. A systematic search of the literature was performed to identify relevant clinical articles. The validity of published studies was systematically evaluated. After developing the draft, an external peer review process was initiated. Results. Three versions of the guideline were published; an expert version, a short version tailored to primary care physicians and a patient version supporting patient participation in the decision-making process. Total development, printing and distribution costs were estimated to be 300 000 Euro. Conclusions. The guideline raises the awareness of obesity and related comorbidities in Germany and may improve the quality of care for obese patients. The development process could serve as an efficient model for other guideline developers. Keywords: evidence-based, Germany, guideline, obesity, prevention, therapy The prevalence rate of obesity defined as a body mass index (BMI) of 30 kg/m2 or higher has increased rapidly in many industrialised countries [1–3]. In Germany, the prevalence of obesity rose between 1984/85 and 1994/95 as demonstrated by the German Cardiovascular Disease Prevention Study [4] and the MONICA project in the Augsburg area [5]. It is estimated from these data that at present approximately 20% of the adult German population is obese. Therefore, increasing health care expenditures and a bottleneck in the provision of care for the obese population are expected. Currently, the direct and indirect costs of obesity in Germany are estimated to be at least 5.7 billion Euro or 4.3% of total national health care expenditures [6]. In Germany, there is a general agreement that the increasing demand for health care requires a more efficient use of the limited financial resources. On the other hand, there is a lack of agreement about the management of obesity. For similar reasons, other European countries such as the United Kingdom and France have developed clinical practice guidelines [7–9]. Furthermore, in the United States, the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has published an evidence-based clinical guideline on the identification, evaluation and treatment of overweight and obesity in adults [10]. In Germany, a first guideline for the treatment of obesity was published by the German Association for the Study of Obesity in 1995 [11]. This guideline, however, represents consensus recommendations by a self-selected committee of members of the national scientific association. Given the medical and economic burden of obesity as well as a lack of evidence-based recommendations for obesity treatment in Germany, a group of experts for obesity care and methods of evidence-based medicine decided in 1997 to develop the first German evidence-based guideline for the treatment of obesity. This first guideline considered the criteria of the U.S. Agency for Health Care Policy and Research (now Agency for Healthcare Research and Quality) [12] and the German Federal Chamber of Physicians [13]. The goals of this article are to present the development process, summarize the content and discuss the implications Address reprint requests to A. Gandjour, Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universität zu Köln, Gleueler Straße 176–178, 50935 Köln, Germany. Email: [email protected] 2001 International Society for Quality in Health Care and Oxford University Press 325 A. Gandjour et al. of the German evidence-based guideline for the treatment of obesity. Methods A multidisciplinary team was formed, consisting of three clinical experts on obesity care (an endocrinologist, a cardiologist and a behavioural psychologist), an expert on the methods of evidence-based medicine, physicians with and without additional training in public health or business administration, an economist and a statistician. Experts were KWL, AW, JW and H. Hauner, Clinical Department of the Diabetes Research Institute, Heinrich-Heine University, Düsseldorf. The development process of the national guideline involved addressing the following four fundamental questions: (i) What are the goals of the guideline and who is its target audience? (ii) Should a foreign guideline be translated into German or should a guideline with new content be developed? (iii) Should a guideline be developed with or without local adaptation? (iv) What type of implementation strategy should be chosen? Regarding the first question, the three main purposes of the guideline can be summarised as follows: (i) to strengthen the awareness of obesity in Germany; (ii) to give practical guidance to physicians and patients; and (iii) to provide evidence-based information and recommendations regarding the prevention and treatment of obesity. Thus, primary care physicians, the main providers of obesity care in Germany, as well as obese patients themselves were the primary targets of the guideline. Regarding the second question, the only evidence-based guideline on obesity available in 1997, the guideline of the Scottish Intercollegiate Guidelines Network (SIGN) [8], was considered in terms of its applicability to the German setting. In general, requirements for a guideline are validity (measured by the degree to which the health gains and costs predicted occur), low development and induced disease costs, reproducibility, reliability, clinical applicability, clinical flexibility, clarity, meticulous documentation, completeness and acceptance by end users. Simply translating a guideline might not be valid because of country-to-country differences in disease epidemiology, clinical practice and conventions, organization of health care delivery, relative price levels, individual preferences, opportunity costs of resources as well as social, ethical and cultural factors. Because of these differences, a guideline can be valid in one country and invalid in another. For the following reasons, the SIGN guideline was not regarded as suitable for translation: (i) the literature search of the SIGN guideline was confined to articles in the English language. Thus, it could not have been ruled out that relevant studies conducted in Germany were missed (ii) patient preferences as well as the degree of patient participation in decision making might be different (for example, with regard to the decision whether to operate on an obese patient) (iii) the co-operation among German primary care and specialty physicians is inadequate in many areas of health care [14] 326 and (iv) the SIGN guideline based almost 50% of its recommendations on expert opinion (11 out of 24 recommendations). Many of these recommendations referred to specific characteristics of the Scottish health care system (for example, the recommendation to establish regional tertiary referral centres). Regarding the third question, about the necessity of considering the local setting, it was decided to develop a national guideline without local adaptation. On the one hand, local adaptation might have increased the acceptance and thus the effectiveness of a guideline. On the other hand, in Germany co-operation among office-based physicians was thought to be poor. Thus, an agreement upon a local guideline version was assumed to have low probability. Regarding the final question, relating to the implementation strategy, a mixed pull-push approach was chosen. In general, a pull strategy relies on communication to patients. The goal is to encourage patients to contact physicians regarding the prevention and treatment of obesity. In general, a push strategy relies on academic detailers (i.e. therapeutics advisers such as salespersons or clinical pharmacists) or opinion leaders to convince physicians to use the guideline content. Both strategies have been shown to lead to a successful implementation of clinical practice guidelines [15]. Assuming that targeting physicians from two channels would be most effective, patient versions of the guideline were distributed and the guideline was also promoted by opinion leaders. After it was decided to develop a guideline considering the specific structures of the German health care system, a systematic search of the literature was performed on Medline from July 1992 to July 1997 using the keywords ‘obesity’ and ‘overweight’. All animal studies and case reports were excluded, only key articles on the pathophysiology of the disorder and its complications were selected. All articles were screened and abstracted by two independent reviewers. In cases of divergent classification a third reviewer was consulted. Clinical trials were categorised by the level of evidence (EL) according to their scientific evidence or study design (EL I to IV) [8,12]. Three grades of recommendations (RG) were assigned to the levels of evidence (A to C) [8,12] (Table 1). If no trials were available to provide the basis for a recommendation, we relied upon consensus and expert opinions [11] as well as published guidelines [7–10]. To this end, additional sources on obesity, particularly from all available guidelines and expert recommendations were extensively hand-searched. In addition, many national and international experts were addressed to bring clinical trials on various aspects of obesity to our attention, many of which provided additional material. A first draft of the guideline was prepared from the results of the systematic review and categorization of the literature in the summer of 1997. This first draft was sent for external peer review to more than 900 hospital and practice-based physicians, health policymakers, health insurance companies and other leaders in health care organizations (Autumn 1997). All these experts were asked to comment on the guideline draft considering its validity, clarity, completeness and applicability. All experts were also encouraged to provide additional material and were invited to a 1 day symposium in Evidence-based guideline Table 1 Classification of publications by the level of scientific evidence and the grade of recommendation1 Table 2 Number of clinical trials on weight management by the level of evidence and type of treatment Level of recommendation Level of evidence ............................................................................................................ A Ia Evidence obtained from meta-analyses of randomized controlled trials Ib Evidence obtained from at least one randomized controlled trial B IIa Evidence obtained from at least one well-designed controlled study without randomization IIb Evidence obtained from at least one other type of well-designed quasiexperimental study III Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case control studies C IV Evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities 1 Treatment/EL Ib IIa IIb III IV Total ............................................................................................................ Diet 5 2 4 3 11 25 Exercise 1 1 2 1 7 12 Behaviour 1 – 3 1 3 8 Diet and exercise 3 – 2 2 6 13 Diet and behaviour 3 1 7 1 2 14 Best practice 3 1 – 3 19 26 Diet and drugs 13 1 3 1 29 47 Behaviour and 1 – – – – 1 drugs Best practice and 2 – – – – 2 drugs Surgery – 1 6 2 14 23 Others – – – – 17 17 Total 32 7 27 14 108 188 1 Reproduced from SIGN[8] and AHCPR[12]. September 1997 in Cologne. At this symposium the first draft of the guideline was presented and discussed. All comments, suggestions and recommendations were included in the revised draft upon agreement by the expert panel. Moreover, scientific material published on Medline between July 1997 and the date of final editing, August 1998, was systematically reviewed for additional evidence. Between September 1997 and August 1998, additional meetings of the expert panel were arranged during which the experts discussed the contents of the guideline in detail. The revision and finalization also included regular telephone calls and conferences. Further information on the search strategy, the evaluation process and the incorporation of expert recommendations has been published by Steiner and Lauterbach [16]. After repeated revision and supplementation, the guideline was finalized in August 1998 and introduced to the scientific community and medical journalists at the 8th International Congress on Obesity on 1 September 1998. Three versions were presented; a comprehensive expert version, a short version tailored to the needs of office-based primary care physicians and a patient version. The patient version translates the medical content of the guideline into the language of the non-professional to help patients contribute to the decisionmaking process on an informed basis and increase their compliance. The expert version in its German edition is freely accessible via the world wide web [17]. In addition, English editions of the three versions have been published. The guideline has been implemented through the distribution of copies, announcements in appropriate media 1 Level of evidence. channels, presentation at meetings of experts, placement on the world wide web and promotion by opinion leaders. To ensure continuous updating of the guideline, it is planned to revise the three versions of the guideline 2 years after publication. Results Systematic review of the scientific literature A total of 973 publications were screened. Of these, 295 were evaluated as described and 287 were cited. Out of 20 recommendations, 13 were based on expert opinion. Table 2 classifies the 188 clinical trials on weight management by the type of treatment and the EL. Only 32 studies fulfilled the criteria for EL Ib reserved for randomized controlled trials, whereas the bulk of the studies was classified as belonging to EL IV. Guideline development and distribution The format, structure and content of the three versions of the guideline are described in Table 3. The detailed or expert version of the guideline contains abstracts of all 287 articles referred to in the text. The short version contains detailed information on the prevention and therapy of obesity, including all of the recommendations made by the expert version. However, sections of the short version that only contain background information and do not make recommendations are largely condensed (i.e. methods of guideline development, definition and classification, epidemiology, aetiologies, comorbidities, weight loss and consequences). The patient version of the guideline assumes that obese patients and persons at risk are less familiar with background information on obesity; therefore, it has a stronger emphasis 327 A. Gandjour et al. Table 3 Description of the three editions of the evidence-based guideline for the treatment of obesity in Germany Edition for primary care Edition for experts physicians Edition for patients ............................................................................................................................................................................................................................. Size Book size Pocket size Pocket size Format and content Detailed evidence-based information Summary of the expert Explanation of evidence in edition language comprehensible to the patient Summary flow-chart Summary flow-chart Tables Tables Memory phrases References and abstracts (divided References Pictures into three categories: cited, but not evaluated; evaluated, but not cited and cited and evaluated) Structure Methods of guideline development Same as expert edition, Definition Definition and classification except for the chapter Aetiology Epidemiology on economics which was Comorbidities Aetiologies not included Therapy Comorbidities Weight loss and consequences Prevention Therapy Overweight and obesity in adolescents Flow chart Economics References on the definition and aetiology of obesity than the short version for primary care physicians. User-friendliness of the short version for physicians is ensured because users can apply recommendations directly to their patients. The short version lists inclusion and exclusion criteria of the patients to whom the recommendations apply and also indicates when patient preferences should be considered in order to make a decision. In addition, the summary flow-chart of the short version allows a quick assessment of the degree of health risk and the resulting treatment strategy. User-friendliness is ensured in the patient version through the use of lay terms and the provision of a chart for calculating the individual BMI. Thus, the patient version helps the patient to assess his or her present risk and also gives advice on the corresponding initial action steps. Total development, printing and distribution costs of the guideline were estimated to be 300 000 Euro. By 12 December 1999, 8761 patient versions, 5223 short versions and 2928 expert versions had been mailed. The corresponding figures for the English editions were 404, 159 and 110, respectively. Most of the versions were mailed on request. Most of the requests came from physicians, patients and decision-makers. These groups were reached by one of the implementation strategies (announcements in appropriate media channels, presentation at meetings of experts, placement on the world wide web and promotion by opinion leaders). 328 Content of the guideline The flow chart presented in Figure 1 summarises the proposed treatment classes, goals and steps based on the systematic approach described in the Methods section of this study. The general goal of treatment was defined to be long term weight control after a period of weight loss. For long term weight management, moderate weight loss was preferred in contrast to achieving normal body weight (EL IV, RG C). As the first step and cornerstone of every weight management program a best practice program was recommended. It was suggested to include dietary (EL III, RG B) and behaviour therapy (EL Ib, RG A) as well as an increase in physical activity (EL Ib, RG A). In accordance with a statement of the German Association for the Study of Obesity [11] the indication for treatment and, in particular, the best practice program would be given if one of the following conditions were met (EL IV, RG C): (i) BMI [ 30. (ii) BMI is between 25 and 29.9 and obesity-related comorbidities (e.g. hypertension, type 2 diabetes mellitus) and/or an abdominal fat distribution and/or diseases which are aggravated by being overweight are present. (iii) BMI is between 25 and 29.9 and there is evidence of strong psychosocial pressure. Evidence-based guideline Figure 1 Summary flowchart on the prevention and therapy of obesity in Germany. 329 A. Gandjour et al. Additional recommendations for the management of cardiovascular risk factors such as smoking (EL III, RG B), hypertension (EL IIb, RG B), dyslipidemia (EL Ia, RG A) and diabetes (EL III, RG B) were included in the therapeutic management strategy. For smokers, the advantages from smoking cessation clearly exceeded potential disadvantages from weight gain (EL IV, RG C). Additional pharmacotherapy was only recommended as a possible adjunct to the best practice program [7–11] and for the following patients (EL IV, RG C): (i) patients with a BMI [ 30 who had not been successful (weight loss of less than 5 kg) with the best practice program over a period of at least 3 months. (ii) patients with a BMI [ 27 with severe risk factors and/or comorbidities who had been similarly unsuccessful with the best practice program. The guideline clearly stated that, based upon available evidence, surgical treatment should only be offered to severely obese subjects (BMI > 40 kg/m2) or patients with a BMI of 35–39.9 kg/m2 and a significant decrease in quality of life and/or severe comorbidities. Surgical treatment should be restricted to gastroplasty in specialised units under quality control. A comprehensive program for postsurgical care was proposed (EL III, RGB). Institutional organization of care The primary care physician should play the key role in the provision of care for obese patients without severe complications. Obese patients with a BMI > 35 kg/m2 or those with severe comorbidities or therapeutic problems should be referred to specialised institutions if required (e.g. specialists for diabetes or hypertension). For obese patients with severe comorbidities, initial treatment by an obesity specialist or at a specialised clinic could be advantageous (EL IV, RG C). Prevention of weight regain The guideline emphasised that obesity is a chronic disorder which becomes aggravated over time and requires long term medical care. Patients should be informed about the high risk of relapse. They should adopt proven strategies to prevent weight regain such as following a low fat diet, practising regular physical exercise, having regular contact with therapists or treatment teams and participating in self-help activities (EL IIa, RG B). Discussion This paper introduces the first evidence-based guideline for the treatment of obesity in Germany. The guideline incorporates the best available evidence on the prevention and treatment of obesity derived from clinical trials up to August 1998. Given the relatively small amount of resources spent for the guideline (approximately 300 000 Euro for development, printing and distribution) its development process might 330 serve as an efficient model for other developers or countries. Ideally, the impact of our guideline should be assessed by the degree of its validity and the level of usage in clinical practice. Validity testing requires that physicians are randomly allocated to use and not use the guideline and that changes in long term clinical outcomes are evaluated. Such an assessment study, however, requires a large sample size since random variations in clinical outcomes need to be ruled out. Usage in clinical practice should ideally be studied by a crosssectional survey of potential users. As a surrogate parameter for usage we looked at users’ demand for the guideline assuming that a requested guideline is more likely to result in usage than one posted blindly. Given that most of the 17 000 versions posted within Germany up to December 1999 have been mailed by request, we conclude that our mixed pull-push strategy has been successful in creating demand for the guideline and has potentially encouraged its usage. Similar to the SIGN guideline, a large proportion of our recommendations (65%) was based on expert opinion due to a lack of clinical trials. Many critical questions have not been adequately studied in clinical settings, such as when to refer a patient to a specialist, when to prescribe drugs or when to perform surgery. In addition, there is a particular deficit of long term studies on the outcomes of prevention and treatment strategies. In contrast, only about 20% of treatments in general medicine were shown to lack scientific proof of evidence [18,19]. The question remains, therefore, as to the validity of recommendations based on expert opinion. The only way to test validity is to randomly allocate physicians to use and not use the recommendations. However, validity cannot be assessed by comparing an expert recommendation today with the result of a future clinical trial. The problem is that an expert recommendation should combine all the information available at the time it is made (t). But the results of a trial at t+1 are based on the new information generated by the trial which was not available at t. Therefore, the expert recommendation and the result of the trial are based on entirely different sets of information. Since information accumulates over time, all recommendations made at t will be ‘wrong’ (in terms of their predictions) at t+1 and this is known at t. Short of a clinical trial of using or not using the expert recommendations, the validity of the recommendations cannot be assessed [20,21]. Since the validity of our expert recommendations has not been tested they should be used with caution and in view of the clinical status and preferences of the individual. Our expert recommendations might also be considered as part of the content presented in graduate and postgraduate medical training if the importance of integrating clinical status and patient preferences is communicated simultaneously. However, we do not recommend rigid use of our expert recommendations, which is more likely to occur with one or more of the following applications: (i) for allocating health care resources if compliance with recommendations were rewarded, (ii) as criteria for clinical audit and feedback as well as quality assurance and (iii) as criteria for evaluating quality improvement initiatives. Evidence-based guideline Apart from providing treatment recommendations, an important goal of this guideline is to strengthen the awareness of obesity in Germany. It is a true challenge to draw more attention to this threatening health problem, from health professionals as well as from the general population. In a recent analysis of health insurance data it turned out that only 6.2 % of all subjects from a representative sample of a local German health insurance fund carried the diagnosis ‘overweight’ or ‘obesity’ and these subjects were mainly those with significant comorbidities [22]. In view of the high prevalence rate of this disorder the clinical impact of obesity is considerably underestimated. It was our intention to target obese patients and their primary care physicians as well as obesity specialists. Thus, three editions were published, each tailored to the specific interests and requirements of the target group. The rationale was to provide the three groups with essentially the same quality of information, thereby facilitating communication and improving treatment results. The expert edition provided obesity specialists with comprehensive evidence-based information in German. Furthermore, the edition for primary care physicians summarized the evidence for crucial aspects of the management of obesity. Finally, the edition for patients will enable them to follow therapeutic decisions and to express their preferences [23]. The patient edition contains relevant and comprehensibly translated information extracted from the expert edition. Specific information on the therapy of obese children and adolescents was not included in the patient edition due to the special needs of these age groups [24]. How does this guideline compare to other national or international guidelines? The two national guidelines currently available, one released by the German Association for the Study of Obesity [11] and the other published by the German Association of Primary Care Physicians [25], do not have an explicit evidencebased approach. They may not rely on the best available evidence obtained from the systematic review of the scientific literature. In addition, they do not distinguish between evidence-based statements and expert opinions and do not quote the literature for validating the efficacy of the treatment recommendations. Our guideline follows a similar structure to international guidelines such as those recently presented by the NHLBI of the NIH [10] or the SIGN [8] and contains in essence comparable recommendations reflecting the common evidence-based approach. The guideline development process carried out by the expert panel of the NIH was extremely detailed and extensive and involved a much larger groups of experts than ours. In addition, the systematic review of the literature was supported by the San Antonio Cochrane Center. Due to limited financial resources, our systematic literature search was restricted to the period 1992–1997. Despite our efforts to consider older studies it cannot be excluded that important clinical studies might have been missed. A specific feature of our guideline is that it considers the characteristics of the German health care system in great detail in order to be suitable and acceptable as a national standard. It is well known that the German health care system differs in many aspects from other national health care systems [26,27]. One characteristic is that mainly office-based and not hospital-based physicians, e.g. general practitioners in private practice, provide outpatient care and thus, provide most medical services for the obese population. In addition, primary care physicians usually do not refer obese patients with or without related comorbidities to outpatient obesity specialists. Encountering a wide variety of diseases, primary care physicians often do not know when to refer their patients to specialists. Hence, a specific aim of our guideline is to influence referral patterns by defining therapeutic goals and giving guidance about which patients to refer and to which specialist. Furthermore, the high prevalence rate of obesity among adults in Germany is reflected in a separate chapter for treating obesity in childhood. One specific target of this German guideline was to include all significant studies performed in Germany and published in German. Only a few regular medical journals whose publishing language is German are listed on Medline or other international databases, which may lead to a language bias if only articles in English were considered. However, it turned out that many studies found outside Medline did not fulfil the criteria of well designed clinical trials and were excluded. However, a number of reviews and expert comments published in German journals and related to the national health care characteristics were found outside of Medline and were used for the preparation of the guideline. Given the limited evidence for a differential treatment of obesity, the guideline also contains recommendations to conduct randomized controlled trials in those areas that have not been addressed by appropriate studies. Due to the limited observational period of most studies we also strongly recommend more long term studies on the efficacy of treatment strategies including drugs. Based on this analysis, we also encourage a clear assignment of responsibilities for screening and preventing obesity in Germany. Because responsibilities are divided among local health authorities, health insurance funds and primary care physicians, the present programs and facilities are provided and used rather unsystematically. Finally, we recommend further research on the psychosocial consequences of obesity in Germany. The methodological approach used for evidence-based guidelines is not without caveats: randomized controlled trials even if available have some limitations as outlined by the expert panel of the NIH [10]. One has to keep in mind that such trials do not necessarily reflect the real life situation in a primary care setting. On the other hand, treatment modes that have not been tested with a proper design cannot be considered as effective. For these and other reasons guidelines have their limits independent of the methodological approach and cannot replace medical experience and intuition [23]. This article presents the first evidence-based guideline for the treatment of obesity in Germany tailored to the special requirements of the national health care system. The authors hope that this guideline will serve to increase the recognition 331 A. Gandjour et al. that obesity is a serious disorder and help to establish a more evidence-based approach to the medical care of affected persons. 12. US Agency for Health Care Policy and Research. Acute pain management: operative and medical procedures and trauma. Rockville, Maryland: US Agency for Health Care Policy and Research, 1992. Acknowledgements 13. Bundesärztekammer und Kassenärztliche Bundesvereinigung. 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