Development process of an evidence‐based guideline for the

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.
Criteria for evaluating clinical practice guidelines (in German).
Dt Ärztebl 1997; 94: A2154–A2155.
The authors wish to thank the many colleagues who contributed to the development of this guideline through their
invaluable comments and other support. The development
of this guideline was supported by a grant from Knoll
Deutschland GmbH.
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Accepted for publication 30 March 2001