Guidelines for guidelines: are they up to the task? A comparative assessment of clinical practice guideline development handbooks.
ABSTRACT We conducted a comparative review of clinical practice guideline development handbooks. We aimed to identify the main guideline development tasks, assign weights to the importance of each task using expert opinions and identify the handbooks that provided a comprehensive coverage of the tasks.
We systematically searched and included handbooks published (in English language) by national, international or professional bodies responsible for evidenced-based guideline development. We reviewed the handbooks to identify the main guideline development tasks and scored each handbook for each task from 0 (the handbook did not mention the task) to 2 (the task suitably addressed and explained), and calculated a weighted score for each handbook. The tasks included in over 75% of the handbooks were considered as 'necessary' tasks.
Nineteen guideline development handbooks and twenty seven main tasks were identified. The guideline handbooks' weighted scores ranged from 100 to 220. Four handbooks scored over 80% of the maximum possible score, developed by the National Institute for Health and Clinical Excellence, Swiss Centre for International Health, Scottish Intercollegiate Guidelines Network and World Health Organization. Necessary tasks were: selecting the guideline topic, determining the guideline scope, identifying relevant existing guidelines, involving the consumers, forming guideline development group,, developing clinical questions, systematic search for evidence, selecting relevant evidence, appraising identifies research evidence, making group decision, grading available evidence, creating recommendations, final stakeholder consultation, guideline implementation strategies, updating recommendations and correcting potential errors.
Adequate details for evidence based development of guidelines were still lacking from many handbooks. The tasks relevant to ethical issues and piloting were missing in most handbooks. The findings help decision makers in identifying the necessary tasks for guideline development, provide an updated comparative list of guideline development handbooks, and provide a checklist to assess the comprehensiveness of guideline development processes.
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ABSTRACT: This survey explores the role of big data and health analytics developed by IBM in supporting the transformation of healthcare by augmenting evidence-based decision-making.Yearbook of medical informatics 01/2014; 9(1):154-62.
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ABSTRACT: Due to lack of time, a detailed appraisal of guideline quality with complex assessment instruments such as AGREE and DELBI is not always feasible. Therefore, our aim was to develop an assessment tool in the form of a 'mini checklist' that would make it possible to quickly gauge guideline quality.Zeitschrift für Evidenz Fortbildung und Qualität im Gesundheitswesen 01/2014; 108(5-6):299-312.
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ABSTRACT: Clinical guidelines should be updated to maintain their validity. Our aim was to estimate the length of time before recommendations become outdated.Canadian Medical Association Journal 09/2014; 186(16). · 5.81 Impact Factor
Guidelines for Guidelines: Are They Up to the Task? A
Comparative Assessment of Clinical Practice Guideline
Shabnam Ansari1, Arash Rashidian2,3*
1Students’ Scientific Research Center, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran, 2Department of Health Management and Economics,
School of Public Health, Tehran University of Medical Sciences, Tehran, Iran, 3Deputy Directors for Research, Knowledge Utilization Research Center, Tehran University of
Medical Sciences, Tehran, Iran
Objectives: We conducted a comparative review of clinical practice guideline development handbooks. We aimed to
identify the main guideline development tasks, assign weights to the importance of each task using expert opinions and
identify the handbooks that provided a comprehensive coverage of the tasks.
Methods: We systematically searched and included handbooks published (in English language) by national, international or
professional bodies responsible for evidenced-based guideline development. We reviewed the handbooks to identify the
main guideline development tasks and scored each handbook for each task from 0 (the handbook did not mention the task)
to 2 (the task suitably addressed and explained), and calculated a weighted score for each handbook. The tasks included in
over 75% of the handbooks were considered as ‘necessary’ tasks.
Result: Nineteen guideline development handbooks and twenty seven main tasks were identified. The guideline
handbooks’ weighted scores ranged from 100 to 220. Four handbooks scored over 80% of the maximum possible score,
developed by the National Institute for Health and Clinical Excellence, Swiss Centre for International Health, Scottish
Intercollegiate Guidelines Network and World Health Organization. Necessary tasks were: selecting the guideline topic,
determining the guideline scope, identifying relevant existing guidelines, involving the consumers, forming guideline
development group,, developing clinical questions, systematic search for evidence, selecting relevant evidence, appraising
identifies research evidence, making group decision, grading available evidence, creating recommendations, final
stakeholder consultation, guideline implementation strategies, updating recommendations and correcting potential errors.
Discussion: Adequate details for evidence based development of guidelines were still lacking from many handbooks. The
tasks relevant to ethical issues and piloting were missing in most handbooks. The findings help decision makers in
identifying the necessary tasks for guideline development, provide an updated comparative list of guideline development
handbooks, and provide a checklist to assess the comprehensiveness of guideline development processes.
Citation: Ansari S, Rashidian A (2012) Guidelines for Guidelines: Are They Up to the Task? A Comparative Assessment of Clinical Practice Guideline Development
Handbooks. PLoS ONE 7(11): e49864. doi:10.1371/journal.pone.0049864
Editor: Harry Zhang, Old Dominion University, United States of America
Received February 15, 2012; Accepted October 17, 2012; Published November 26, 2012
Copyright: ? 2012 Ansari, Rashidian. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This study was partially funded by the Tehran University of Medical Sciences (www.tums.ac.ir). The funder had no role in study design, data collection
and analysis, decision to publish, or preparation of the manuscript. No additional external funding was received for this study.
Competing Interests: AR was a guideline methodological advisor for the development of two NICE guidelines from 2003–2006. The authors have no other
conflicts of interest.
* E-mail: email@example.com
The Institute of Medicine, in 1990, defined the clinical practice
guidelines as ‘systematically developed statements to assist
practitioner and patient decisions about appropriate health care
for specific clinical circumstances . Most recently it revised its
definition to reflect the importance developing guidelines that are
‘informed by a systematic review of evidence and an assessment of
the benefits and harms of alternative care options’ . Guidelines
are sought for improving the quality of care provided to the
patients, reducing variability and containing the health care costs
[3,4]. Achieving those goals is difficult, and despite the develop-
ment of clinical guidelines in many countries, solving the problems
of cost and quality as well as variation in care remains a challenge
to health systems.
Several countries have adopted the pro-active policies of
guidelines development at the national level. These national
programs are developed in response to the perceived (and
observed) uncertainties in the quality of the published guidelines
[5,6,7]. Developing valid clinical guidelines involves following a
multi-stage program including several tasks, and each stage and
task may be influenced by different biases [2,8,9]. National
programs are also sought with the expectation that it will be easier
and more fruitful to implement national guidelines than local or
society developed clinical guidelines. Especially as the abundance
of the guidelines developed by pharmaceutical companies, medical
PLOS ONE | www.plosone.org1November 2012 | Volume 7 | Issue 11 | e49864
societies, local health authorities and interested groups of clinicians
and academics has made it difficult for the practitioners to select
and follow credible guidelines that are relevant to their practices
The first national programs of guideline development started in
the USA in the 1980s and in several other high income countries
in the 1990s . Most of the guideline development programs are
established in high-income countries, where there are more
(human and financial) resources available to the health systems.
The progress in developing such national programs in low and
middle income countries is still lagging behind. The WHO and
other international organizations have also developed ad-hoc
guidelines, as well as systematic guideline development programs
The methodologies followed in guideline development pro-
grams varies. Burgers et al. (2003) conducted a survey on 18
clinical guideline programs produced in the USA, Canada,
Australia and 9 European countries. They observed that the more
recent programs were benefitting from the methodology created
by the older ones. They also recommended that the programs
should put further emphasis on the dissemination and implemen-
tation of the guidelines . Van der Wees et al. compared six
guideline programs against the Appraisal of Guidelines for
Research and Evaluation (AGREE) criteria to update the Dutch
program for guidelines in physical therapy [11,14]. Similarly,
Turner et al. assessed a limited number of six guideline
development handbooks against the AGREE criteria for guideline
development . Turner et al. covered handbooks developed by
the Council of Europe, the National Health and Medical Research
Council of Australia, the National Institute for Health and Clinical
Excellence in the UK, the New Zealand Guidelines Group, the
Scottish Intercollegiate Guideline Network, and the World Health
As part of a wider initiative to design a program for the
development of clinical guidelines at a national level in Iran we
assessed the methods and approaches adopted by established
guideline development programs around the world . This
study in a way is an update and expansion of the Turner et al.
study. Two reasons convinced us to conduct the study. First,
they had focused on a limited number of ‘tasks’ and not all the
relevant tasks were included. Also only few handbooks were
assessed in their study. Second, their study might not account
for the recent advancements in guideline development tech-
niques. In this study we both expanded the number of programs
covered and the methods used for the assessment. Our aims
were to identify the main guideline development tasks, assign
weights to the importance of each task using expert opinions,
and identify the handbooks that provided a comprehensive
coverage of the tasks.
Selecting Guideline Development Handbooks
We systematically searched Pubmed and TRIP databases using
general sensitive terms representing ‘clinical guideline develop-
ment handbooks’. We also searched the Google using similar
terms, aiming for the most popular handbooks (i.e. appearing on
the first ten pages of Google search outputs) and literature
published in English language and available on the net. We also
contacted the experts and searched the reference lists of the
identified literature and handbooks.
We included documents (‘handbooks’) produced by national or
international organizations responsible for clinical guideline
development and also professional and academic bodies working
on guideline development. These handbooks may have been
produced for the purpose of developing clinical guidelines in
general, or targeting guidelines for specific clinical conditions. We
only included those handbooks that were focused on the
development of evidence-based guidelines.
Identifying the Main Tasks for Guideline Development
Initially, we had planned to extract the main tasks of guideline
development from NICE handbook , and then compare other
handbooks to assess whether those guideline development tasks
were covered. However, an initial screen of a few handbooks
demonstrated that NICE handbook did not specify all the tasks of
evidence-based guideline development (e.g. adapting existing
guidelines was not included).
To determine other tasks not specified in NICE handbook, we
first screened fifteen identified guideline development handbooks
and designed an inclusive list of the tasks. The list was discussed
and revised in a few meetings to ensure consensus was achieved.
Other relevant ‘tasks’ were added as a result of elaborating on the
task list (e.g. ethical issues). Finally, the tasks were re-ordered to
ensure a logical flow existed, and in cases, re-phrased to reduce
Weighing the Importance of Guideline Development
Tasks using Expert Opinions
We prepared a web-based questionnaire (using Google Docu-
ment), and invited nineteen experts in the field (external to the
research team) from seven different countries to respond to the
questionnaire. We asked the participants to weigh each guideline
development task on a 6-point scale from 0 (not important) to 5
(very high importance). We then used the median of the scores
given to each task as the task ‘weight score’.
Scoring Guideline Development Handbooks
Then two authors independently reviewed each handbook and
compared its elements against the task list. Each handbook was
scored for each task from 0 to 2 based on the following criteria:
N 2, if the handbooks addressed the task and provided enough
information to suggest the task was given serious attention
N 1, if the handbook briefly (or just) mentioned the task
N 0, if the handbook did not appropriately mention the task
All disagreements about the scores were resolved through
discussion between the authors. We considered, a priori, any task
that was at least mentioned (i.e. scoring 1 or 2) in 75% of the
handbooks was a ‘necessary’ task for evidence-based guideline
development. We also considered the tasks as ‘relevant’ if they
were mentioned in a minimum of three handbooks.
Then the scores given to each task for each guideline was
multiplied with the task weight scores, and summed up to calculate
the guideline’s total score. For each guideline we also calculated
the percentage of the maximum score that was achieved by the
In total twenty seven main guideline development ‘tasks’ were
noted and considered in this review (Table 1). Nineteen experts
were approached using a web-based questionnaire to ‘weight’ the
tasks, and twelve (63%) completed the questionnaire. They
weighted each task using a 1 to 5 scoring system. The median of
the scores given to the tasks ranged from 3 to 5. ‘Conducting
Assessment of Guideline Development Handbooks
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Table 1. Guideline development tasks, their weight scores, and their coverage in the guideline development handbooks.
mentioning the task
Selecting the guideline topic The process and criteria for selecting and prioritizing topics4.5 19 (100%)
Determining the guideline scopeA framework that describes the epidemiology of the disease or condition and the
aspects of care and the settings is covered by the guideline
5 17 (89.4%)
Preparing the work plan Specifying the guideline development project plan including timelines
and project costs
4 12 (63.1%)
Identifying relevant existing guidelines An objective search of important and relevant databases and search engines
for existing guidelines
4 15 (78.9%)
Appraising relevant existing guidelines Objective appraisal of existing guidelines e.g. by
4 13 (68.4%)
Adapting existing guidelinesDescribing guideline adaption methods4 14 (73.6%)
Involving consumersContribution of the target population (patients, public, etc.) in
4 17 (89.4%)
Forming guideline development groupDescribing the composition of guideline development group, including
all relevant stakeholders
5 19 (100%)
Managing conflict of interests Declaration of guideline development group members
Running guideline development groupDescribing how to run a GDG (meetings, agenda items, chairing,
responsibilities and roles)
5 14 (73.6%)
Developing clinical questionsDeveloping clinical question according to an objective approach,
e.g. PICO framework
5 17 (89.4%)
Systematic search for evidence Systematic searches of important bibliographic
databases using sensitive key words
5 15 (78.9%)
Selecting relevant evidenceInclusion and exclusion criteria for selecting the
Appraising identified research evidence Appraising identified evidences using objective instruments
(for example CASP tools)
5 18 (94.7%)
Evidence synthesis and analysisDescribing synthesis approaches of primary studies,
including meta-analysis etc.
5 13 (68.4%)
Conducting economic evaluationDescribing the process of identifying, selecting and
synthesizing economic evaluation data
Making group decisionsUsing clear and objective consensus development
techniques (e.g. voting, Delphi,…)
Grading available evidence Appraising and summarizing the quality and strength
4 18 (94.7%)
Considering ethical issuesDiscussing the approaches used for considering
ethical issues in the guideline development process
4 7 (36.8%)
Creating recommendations Interpreting the evidence to make recommendations
and the wording and format of recommendations
Final stakeholder consultationFinal consultation with stakeholders before
publishing the guideline
4 18 (94.7%)
Publishing formatsDescribing different publication formats (full
guideline, quick reference guides, information for patient, wed-based publication, …)
4 14 (73.6%)
Guideline implementation strategiesDescribing how the recommendations can be put into
4.5 19 (100%)
PilotingDescribing a process of pre-testing a guideline in the
field before its final release
Assessment the potential impacts of
The cost and resource implications of implementing
the guideline in practice
Developing clinical audit and
Describing monitoring and auditing criteria and
indicators to assess guideline implementation
4 14 (73.6%)
Updating recommendations and
correcting potential errors
Describes the process, timeline, frequency and
criteria for updating recommendations or correcting errors
5 18 (94.7%)
Assessment of Guideline Development Handbooks
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economic evaluation’ scored the lowest weight score of 3. One the
third of the tasks scored the highest score of 5 (Table 1).
We asked the experts about any other tasks that should have
been included in the list. Four experts offered additional
suggestions. Some of the suggestions had been adequately
addressed in the task list (Table 2).
We identified nineteen guideline development handbooks
published in English language (Table 3). Twelve handbooks were
developed by national guideline development programs or national
associations. Others had international or regional mandates. We
also identified four other potentially relevant handbooks that we did
not include in the study for different reasons. Two handbooks
almosttotallytallied otherhandbooksalreadyincludedinthe review
[18,19] and two others provided too little info to make a meaningful
assessment of the handbooks [20,21].
The handbooks were published within the period from 1994 to
2012. The guideline development handbooks’ raw scores ranged
from 22 to 50 (out of a maximum of 54) and the weighted scores
ranged from 100 to 220 (out of a maximum of 236). Four
handbooks achieved over 80% of the maximum possible score
NICE , SCIH , SIGN , WHO . These were
followed by the handbooks developed by CMA , NZGG ,
NHMRC , ASCO , CSP  and IDF , in order of
their weighted scores (Table 4). Weighing the scores resulted in
some changes in the ranking order of the handbooks, but the order
of the handbooks ranked 1 to 4 remained unchanged.
All the tasks were mentioned in at least three handbooks
(Table 1). We defined the tasks mentioned by 75% of the
handbooks, as ‘necessary’ tasks. Based on this definition,
‘selecting the guideline topic’, ‘determining the guideline scope’,
Table 2. Potential additional tasks for guideline development.
‘‘Making recommendations sufficiently specific that they are useable in practice.’’
‘‘For involving consumers, I think it may be better to say ‘involving stakeholders’, as consumers are one of a range of stakeholder groups; (2) Would add
‘identifying and appraising evidence on the feasibility and acceptability of the interventions’; (3) Would add ‘using a systematic and transparent approach to
move from evidence to recommendations’; (4) Would add ‘appropriate organization and facilitation of the guideline panel meeting/s’.’’
‘‘I think you need a question about how far do you look for evidence - for examples is it important to look for all levels of evidence? Or within limited resources is
it acceptable to limit the search to certain levels of evidence.’’
‘‘Writing the guideline in different formats.’’
Additional tasks noted in the handbooks:
Requisition and use of local data in guideline development (in NZGG handbook )
Using qualitative evidence as source of evidence for generating recommendations (in NZGG handbook )
Considering equity issues in guideline development (in ACHR handbook )
Table 3. General description of the guideline development handbooks.
specific diseases Website
National Institute for Health and Clinical Excellence (NICE)2009UK Generalwww.nice.org.uk
Swiss Centre for International Health (SCIH)2011 SwissGeneral http://www.swisstph.ch/
Scottish Intercollegiate Guidelines Network (SIGN)2008 ScotlandGeneral www.sign.ac.uk
World Health Organization (WHO)2012 InternationalGeneral www.who.int
Canadian Medical Association (CMA)2007 Canada Generalwww.accesscopyright.ca
New Zealand Guidelines Group (NZGG) 2001New Zealand Generalwww.nzgg.org.nz
National Health and Medical Research Council (NHMRC) 1998 AustraliaGeneral www.health.gov.au/nhmrc
American Society of Clinical Oncology (ASCO)2011USA Specific www.asco.org
The Chartered Society of Physiotherapy (CSP)2006 UKSpecific www.csp.org.uk
International Diabetes Federation (IDF)2003 International Specificwww.idf.org
Advisory Committee on Health Research (ACHR)2006International General www.who.int/rpc/advisory_committee
World Stroke Organization (WSO)2009 International Specificwww.world-stroke.org
Cancer Care Ontario (CCO)2011 CanadaSpecific www.cancercare.on.ca
Council of Europe (CE)2001 International Generalwww.social.coe.int
U.S. Preventive Services Task Force (UPSTF)2008USA Generalwww.preventiveservices.ahrq.gov
Australian Health Policy Institute (AHPI) 2008Australia Specifichealthpolicystudies.org.au/
Regional Centre for Quality of Health Care (RCQHC)2003RegionalSpecificwww.RCQHC.org
Royal College of Psychiatrists (RCP)1994UKSpecific www.rcpsych.ac.uk
World Confederation for Physical Therapy (WCPT) 2006InternationalSpecificwww.wcpt.org
Assessment of Guideline Development Handbooks
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‘identifying relevant existing guidelines’, ‘involving the consum-
ers’, ‘forming a guideline development group’, ‘developing
clinical questions’, ‘systematic search for evidence’, ‘selecting
relevant evidence from the searches’, ‘appraising identified
consensus’, ‘grading available evidence’, ‘creating recommenda-
tions’, ‘final stakeholder consultation’, ‘guidelines implementa-
tion strategies’, ‘updating recommendations and correcting
potential errors’ are the necessary tasks for guideline develop-
ment. We used the handbooks to produce brief narrative
description of all the tasks, and provided a suggested reading list
to note the handbooks that had provided practical and detailed
explanations for certain tasks (Table 5). Also three further tasks
were identified, each noted in one handbook only (Table 2).
Guideline Development Tasks
Selecting the guideline topic was addressed in all of the handbooks.
For example the CE handbook stated: ‘‘prioritization of guideline
topics may be based on the epidemiology of health problems,
health inequalities, variations in the provision and quality of care,
emergence of new technologies, or other factors that create a need
for high quality, updated information’’ . Previous versions of
the NICE handbook did not mention this task, because selecting
the topic was out of NICE’s mandate and the ‘‘topics were selected
by the Department of Health’’ . In its latest version, it now
covers ‘selecting the topic’ as a guideline development task.
Seventeen of the nineteen handbooks mentioned determining the
guideline scope, and thirteen handbooks provided enough informa-
tion for a clinical guideline developer to understand how to
complete that task. The NICE handbook asserted that ‘‘the scope
provides a framework within which to conduct the development
work. Its content briefly describes the background epidemiology
relevant to the disease or condition and defines the aspects of care
that the guideline will cover in terms of: population to be included
or excluded, healthcare setting, interventions and treatments to be
included and excluded.’’ .
Eight handbooks provided clear guidance on the way in which
the work plan should be prepared. Four handbooks just mentioned
the task; the rest did not address it. ‘‘A key step in the conduct of
ASCO guidelines is completion of the clinical practice guideline
development protocol worksheet. The worksheet specifies the
purpose of the guideline, the target patient population and clinical
outcomes of interest, key features of the systematic literature
review, and a proposed timeline for guideline completion.’’ .
Identifying relevant existing guidelines was mentioned in fifteen
handbooks, appraising relevant existing guidelines in thirteen handbooks,
and adapting relevant existing guidelines in fourteen handbooks. ACHR
states ‘‘in addition to supporting appropriate adaptation of its own
guidelines, WHO should consider adapting guidelines developed
by other organizations, given the potential value of WHO
endorsement and savings, if high quality guidelines already exist
… given WHO’s mandate; limited resources that are available to
develop high quality guidelines that are informed by the best
available evidence, particularly in low and middle income
countries; and the potential to reduce unnecessary duplication,
WHO should continue to develop international guidelines.
However, these guidelines will often require adaptation and
tailoring to local contexts:’’ .
All except two handbooks addressed involving consumers in some
way, and ten handbooks provided clear guidance. To clarify the
objectives and benefits of involving consumers, NZGG handbook
stated: ‘‘the following objectives are needed to achieve the guiding
principles: partnership and collaboration, democratic participa-
tion, equity and fairness, accountability, acceptability, to ensure
the rights of consumers are upheld, to ensure consumer input is
Table 4. Guideline development handbooks raw and weighted scores.
Handbook Raw scoreWeighted score
Percentage of maximum
National Institute for Health and Clinical Excellence (NICE)  50 22093.2
Swiss Centre for International Health (SCIH)  47 20888.1
Scottish Intercollegiate Guidelines Network (SIGN)  4519984.3
World Health Organization (WHO)  44195 82.6
Canadian Medical Association (CMA)  42188 79.6
New Zealand Guidelines Group (NZGG)  42187 79.2
National Health and Medical Research Council (NHMRC)  42182.5 77.3
American Society of Clinical Oncology (ASCO)  41 182.577.3
The Chartered Society of Physiotherapy (CSP)  39175.5 74.3
International Diabetes Federation (IDF)  40 17373.3
Advisory Committee on Health Research (ACHR)  3816770.7
World Stroke Organization (WSO)  36 160.5 68
Cancer Care Ontario (CCO)  35 157.566.7
Council of Europe (CE)  3615465.2
U.S. Preventive Services Task Force (UPSTF)  33149.5 63.3
Australian Health Policy Institute (AHPI)  28128 54.2
Regional Centre for Quality of Health Care (RCQHC)  29124.552.7
Royal College of Psychiatrists (RCP)  28123.5 52.3
World Confederation for Physical Therapy (WCPT)  22100.542.5
Assessment of Guideline Development Handbooks
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Forming a guideline development group was mentioned in all of the
handbooks and most had clear guidance, but they varied in their
proposed methods for selecting the members, size of the group etc.
As SCIH handbook focused on the development of health system
guidance, it recommended the following composition for the
guidance development groups: ‘‘expert(s) in health systems,
expert(s) in the topic of the guidance, expert(s) in research
synthesis and in knowledge translation, representatives of stake-
holders, representative of potential users’’ .
Fourteen handbooks addressed managing conflict of interests and
all fourteen handbooks explained it clearly except one. For
example: ‘‘all experts participating in WHO meetings must declare
any interest relevant to the meeting before their participation. In
the case of guideline development this means that all members of
the guideline development group and the expert review panel, as
well as any other experts or advisers invited to guideline
development meetings, should fill in a declaration of interests
Running guideline development group is mentioned by fourteen
handbooks and twelve handbooks offered clear guidance. The
NICE handbook stated: ‘‘running the guideline development
group is the responsibility of the national collaborating center, in
consultation with the Chair. Core responsibilities for all meetings
include: setting meeting dates, planning agenda items, sending out
papers, keeping records of all meetings and ensuring that all GDG
members have a copy of the current guidelines manual’’ .
Five handbooks just mentioned developing questions and twelve
handbooks described it in detail. NICE, SCIH, SIGN and WHO
provided clear guidance on how to format questions in a patient,
intervention, comparison and outcome (known as ‘PICO’)
Fifteen handbooks addressed systematic search for evidence to gather
the required information. Thirteen of them clearly mentioned
developing search strategies based on questions, sources, and
filters, and using stakeholder’s recommendations, although they
varied in the provided detail.
Selecting relevant evidence from the search results was addressed by
seventeen handbooks and ten handbooks explained it in detail.
NICE handbook suggested: ‘‘first, the titles of the retrieved
citations should be scanned and those that fall outside the topic of
the guideline should be excluded. Next, the remaining abstracts
should be scrutinized against the inclusion criteria agreed by the
Appraising identified research evidence was addressed by eighteen
handbooks and only one handbook did not even mention it. NICE
and SIGN recommend the checklists developed originally by the
Method for Evaluating Research and Guideline Evidence group in
Australia and modified by SIGN. NZGG and IDF recommended
using the GATE Notes (Generic Appraisal Tool for Epidemiology)
developed by the Effective Practice Institute, University of
Auckland to appraise the evidence. Word Confederation for
Physical Therapy handbook suggested: ‘‘the Cochrane Collabo-
ration produces robust systematic reviews and meta-analyses that
can save a lot of work in assessing the literature’’ .
Thirteen handbooks mentioned evidence synthesis and analysis, and
eight handbooks had clear guidance. ASCO handbook stated: ‘‘in
putting together a practice guideline for a specific intervention or
set of interventions, an ASCO expert panel may be faced with
either interpreting existing meta-analyses or initiating a meta-
analysis of its own. It is important to emphasize that not all
systematic reviews will justify or require a formal meta-analysis. …
The decision of whether or not to combine different studies in a
meta-analysis is initially a clinical one, not a statistical one. The
panel should determine, before deciding on the statistical
approach, whether or not it makes sense to include within the
same analysis patients who are different … or treatments that are
Fourteen of nineteen handbooks mentioned conducting economic
evaluation in guideline development, but only seven handbooks
provided clear guidance on how to conduct it. According to NICE
handbook: ‘‘economic evaluation will usually be conducted in the
form of a cost-effectiveness analysis, with the health effects being
Table 5. Suggested readings for detailed explanation of selected guideline development tasks.*
Selecting the guideline topicSIGN, NZGG, CSP, ACHR, UPSTF
Determining the guideline scopeWHO
Adapting relevant existing guidelinesACHR
Involving consumers (patients, …)SIGN, NZGG
Forming guideline development group WHO
Managing conflict of interests WHO, ACHR
Running guideline development groupSIGN
Developing clinical questions NZGG, UPSTF
Systematic search for evidenceNZGG
Selecting relevant evidence from the search results UPSTF
Appraising identified research evidenceWHO, NZGG, UPSTF
Evidence synthesis and analysisASCO
Consider ethical issuesACHR
Creating recommendationSIGN, NZGG, ASCO, UPSTF
Guideline implementation strategiesSIGN, NHMRC, ASCO
Piloting the developed guideline RCQHC
*The handbooks developed by NICE and SCIH provide a generally comprehensive guidance for guideline development. In this table we only note additional
suggestions for further reading.
Assessment of Guideline Development Handbooks
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measured using an appropriate non-monetary outcome indicator.
In circumstances for which cost-effectiveness analysis is not
appropriate, other validated methods may be used’’ . The
NZGG advised for developing a balance sheet to cover the costs
and benefits of the recommendations: ‘‘a balance sheet is a formal
itemization of the major costs and health benefits of a healthcare.
The balance sheet could be considered as a first step in a full
economic evaluation’’ .
Making group decisions and reaching consensus was mentioned by
seventeen handbooks and thirteen handbooks provided clear
explanations about it. The NICE handbook described the use of
focus groups and formal consensus methods (i.e. the Delphi
technique, the nominal-group technique, the consensus-develop-
ment conference) for making group decisions .
Eighteen handbooks addressed grading available evidence and
thirteen described it clearly. SCIH handbook stated: ‘‘grading
recommendations reflects ‘the extent to which we can be confident
that the desirable effects of an intervention outweigh the
undesirable effects’. Strong recommendations imply that they
can be adopted in most circumstances while weak recommenda-
tions will need additional considerations (e.g. decision aids)’’ .
Seven handbooks mentioned considering ethical issues in guideline
development. Only two handbooks provided reasonable discus-
sions of the issue, in additional documents. The NICE handbook
provided guidance on ethical issue in documents besides the
guidelines manual . The Council of Europe stated: ‘‘guidelines
are produced and used in the complex environment of a health
care system with its ethical, economic, legal and other aspects;
these aspects need to be taken into consideration in each country’’
. Royal College of Psychiatrists handbook encouraged that
guidelines might be applied more effectively by considering ethical
Creating recommendation was mentioned by all handbooks and
sixteen handbooks offered well-defined guidance. SIGN used the
concept of ‘considered judgment’ besides the evidence table for
each key question: ‘‘under this heading, guideline development
groups summaries their view of the total body of evidence covered
by each evidence table’’ .
All handbooks addressed final stakeholder consultation on recom-
mendation drafts except one handbook. Word Confederation for
Physical Therapy handbook defined a validation phase, in which
‘‘the draft guidelines can be sent to potential users to test
practicality and clarity, and how acceptable the recommendations
are. Patients and stakeholders can also review the draft guideline.
The comments should be used by the GDG to adjust the
Publishing formats was mentioned in eighteen handbooks and
fourteen explained this phase in detail. According to the NICE
handbook: ‘‘four separate documents are published: the full
guideline, the NICE guideline, a quick reference guide and
‘understanding NICE guidance’ (information for patients and
careers)’’ . Similarly every SIGN guideline was published as a
quick reference guide, in electronic format, and as information for
patient and career.
All of the handbooks tackled guideline implementation strategies.
Thirteen handbooks provided relatively detailed strategies to
implement guidelines. SCIH handbook defines: ‘‘guidance imple-
mentation includes all those activities or strategies that lead to
guidance actually being used in real life situations (measured, for
example, by endorsers adherence to guidance recommendations)’’
Nine handbooks mentioned piloting, but only RCQHC hand-
book provided explanation on how to conduct the pilot phase and
offered practical options . SIGN handbook summarized the
mood of many guideline development programs by asserting that:
‘‘the AGREE instrument suggested that guidelines should be pilot-
tested prior to publication. SIGN considers that the pilot-testing
phase is more appropriately carried out at local level’’ .
Thirteen handbooks considered assessment of the potential impacts of
guideline implementation in guideline development process. According
to NHMRC ‘‘it is important that the impact of guidelines is
assessed. These assessments require complex study designs and will
need to be carried out by researchers in collaboration with
clinicians, rather than by clinicians alone’’ . It suggested two
potential methods for evaluation of guideline impact.
Developing clinical audit and evaluation criteria was mentioned in
fourteen handbooks and eleven provided clear guidance on it.
All the handbooks except one addressed updating and correcting
potential errors after guideline publication. Most of them offered
defined updating processes. The IDF handbook stated: ‘‘there
needs to be a statement of intention as to updating the guideline. If
there is an umbrella organization to provide continuity, then it
may be possible to specify a date, and plans should be made
accordingly. Within the guideline it may be helpful to caution over
some recommendations if major new evidence is expected in the
near future.’’ .
We identified twenty seven tasks that should be considered for
guideline development. These twenty seven tasks include the
major elements of an evidence-based development process for
clinical guidelines and can be used as a checklist for comparison of
guideline development handbooks. We also noted a wide range of
differences among guideline development handbooks. While some
handbooks covered and referred to the majority of the tasks, no
handbook on its own covered all the tasks. Fifteen tasks were
included in at least 75% of the handbooks and we identified them
as the ‘necessary tasks’ that should be covered in all guideline
development programs. Furthermore, there was considerable
variation in quality and depth of attention devoted to these tasks
depending on the handbooks. Closer links and joint works on
guideline development handbooks (e.g. via using Guidelines
International Network forums) can be beneficial.
Compared to previous reviews [11,13,15], our study covers a
wider collection of handbooks and provides an update on the
current state of guideline development handbooks. Our study also
benefits from a more comprehensive coverage of guideline
development ‘tasks’. We also used the views of experts from
several countries to weigh the tasks. Although the weighting
process did not substantially change the results of the study, it
acted as an external validation process for the task list. We
organized the tasks in a logical order. However, the tasks do not
exactly follow a step by step process. Involving consumers, for
example, may exist in all stages of the guideline development
process, and not as a specific stage in the process.
Among the tasks, the least amount of attention was devoted to
considering ethical issues and piloting. There may be different reasons
for such omissions. The piloting task may have been left out due to
the technical difficulties of conducting a pilot on a guideline before
its release. Already, the development of a clinical guideline is a
time-consuming and laborious endeavor that usually takes around
a year . A proper pilot of a guideline can easily double this
period. Given that many handbooks recommend an update of a
guideline every two to three years , it is easily understandable
why a pilot may not be feasible. There are, on the other hand,
indispensible benefits for testing a guideline in the field before its
release, and it may promote the guideline’s implementation which
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PLOS ONE | www.plosone.org7November 2012 | Volume 7 | Issue 11 | e49864
is the ultimate goal of developing guidelines . Further work is
required for the development of rapid pilot or field test
approaches, and for assessing the efficiency of systematic field
testing of newly developed guidelines.
Incorporating ethical concerns into guidelines remains a
challenge. Unlike piloting (and to some extent, use of economic
evaluation), where feasibility and capacity issues are the main
barriers to their inclusion in guideline development, methodolog-
ical and conceptual limitations seems to be the main barriers to
formal consideration of ethical concerns in guideline development
A further task that requires attention is incorporation of
economic evaluation in guidelines. Five handbooks did not
mention it at all and a further eight handbooks just briefly tapped
on the issue, and only seven handbooks gave economic evaluation
a decent attention. Also the experts gave the lowest weight score of
3 out of 5 to this task, implying the limited applications of the task
in many guideline development programs. Guideline development
programs should enhance their capacity for use of economic
evaluation evidence and modeling in developing guidelines’
recommendations. It should be noted that even the guideline
development entities that formally cherish use of economic
evaluation evidence may find it difficult honoring their intention
and ending up in patchy use of such evidence .
In addition to the twenty seven tasks noted above, we faced
three further tasks suggested and explained in two handbooks
(Table 2). Such tasks (e.g. using local data, obtaining qualitative
evidence, considering equity issues) should be considered further as
guideline development methods progress in future.
Obviously, the handbooks were not developed independently of
each other but the links were not clear. SIGN, CSP and IDF
handbooks referred to NICE handbook. On the other hand
NICE, NHMRC, NZGG and CE handbooks mentioned the
SIGN handbook. Closer links and joint works on guideline
development handbooks can be beneficial.
Our study has some limitations. We only included documents
that were published in English. There are other national guideline
development programs (especially in Europe, also in Asia and
Latin America) that may have not published the handbooks in
English language. We included handbooks produced by national
or international organizations as well as professional bodies
working on clinical guideline development. As such the handbooks
had different audiences. On the other hand the wider inclusion
criteria helped us to include more guideline development
We aimed to develop a comprehensive list of the tasks.
However, depending on how detailed a task list might be, the
list might include more or less number of tasks. The study was
focused on ‘what’ written in the handbooks, and not what
happened in reality, which might be better or worse than the
handbooks. Despite these limitations, we reviewed a larger
selection of handbooks using a more comprehensive list of tasks
than Turner et al. and Van der Wees et al (who reviewed six
handbooks each) [11,15].
Turner et al. (2008) described fourteen key elements and
compared the guidelines by these key elements. They concluded
‘‘the key elements of an evidence-based guideline development
process are addressed with strong concordance by existing
guideline development handbooks’’ . Our findings challenge
that conclusion. Burgers et al. (2003) sent questionnaires to
eighteen guideline development programs. They noted that more
recent programs were benefitting from methodology created by
older programs and recommended that further emphasis should
be devoted to guideline dissemination and implementation. Our
findings suggest that despite the improvements, further work is
required to ensure guideline development processes are up to the
task of developing evidence based clinical guidelines.
This study helps health policy maker to compare guideline
development handbooks and choose more suitable ones to use. It
complements previous publications that focused on developing
standard approaches for reporting clinical practice guidelines .
Also the tasks list can be used as a checklist to assess process of
guideline development in any country. Further research is
required to determine that clinical practice guideline development
organizations are committed to follow the guideline development
A summary of the study was presented at the Guideline International
Network conference in Seoul in 2011, and its abstract was published in the
conference’s abstract book. We thank Dr Reza Yousefi-Nooraie for his
help in conducting earlier searches of the literature, and Prof Reza
Majdzadeh and Dr Akbar Soltani for their comments on the study process,
and the anonymous reviewer for making helpful suggestions on the study
methods and the manuscript.
We specially thank the following guideline development experts for their
participation in the survey (in alphabetic order): Hamid Baradaran (Iran),
Xavier Bosch-Capblanch (Switzerland), Melissa Brouwers (Canada), Gene
Feder (UK), Paul Glasziou (Australia), Claire Glenton (Norway), Metin
Gulmezuglu (Switzerland), Ali-Akbar Haghdoost (Iran), Simon Lewin
(Norway, South Africa), Maziar Moradi-Lakeh (Iran), Susan Murray (UK),
Reza Yousefi-Nooraie (Canada).
Conceived and designed the experiments: AR. Performed the experiments:
SA AR. Analyzed the data: AR SA. Contributed reagents/materials/
analysis tools: AR SA. Wrote the paper: SA AR.
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