Article Text
Abstract
Background Developing and updating high-quality guidelines requires substantial time and resources. To reduce duplication of effort and enhance efficiency, we developed a process for guideline adaptation and assessed initial perceptions of its feasibility and usefulness.
Methods Based on preliminary developments and empirical studies, a series of meetings with guideline experts were organised to define a process for guideline adaptation (ADAPTE) and to develop a manual and a toolkit made available on a website (http://www.adapte.org). Potential users, guideline developers and implementers, were invited to register and to complete a questionnaire evaluating their perception about the proposed process.
Results The ADAPTE process consists of three phases (set-up, adaptation, finalisation), 9 modules and 24 steps. The adaptation phase involves identifying specific clinical questions, searching for, retrieving and assessing available guidelines, and preparing the draft adapted guideline. Among 330 registered individuals (46 countries), 144 completed the questionnaire. A majority found the ADAPTE process clear (78%), comprehensive (69%) and feasible (60%), and the manual useful (79%). However, 21% found the ADAPTE process complex. 44% feared that they will not find appropriate and high-quality source guidelines.
Discussion A comprehensive framework for guideline adaptation has been developed to meet the challenges of timely guideline development and implementation. The ADAPTE process generated important interest among guideline developers and implementers. The majority perceived the ADAPTE process to be feasible, useful and leading to improved methodological rigour and guideline quality. However, some de novo development might be needed if no high quality guideline exists for a given topic.
- Practice guideline
- adaptation
- evidence based medicine
- guideline adherence
- quality of healthcare
- clinical practice guidelines
- culture
- guideline
- healthcare quality improvement
Statistics from Altmetric.com
- Practice guideline
- adaptation
- evidence based medicine
- guideline adherence
- quality of healthcare
- clinical practice guidelines
- culture
- guideline
- healthcare quality improvement
Introduction
The development, updating and implementation of high quality clinical practice guidelines require substantial time, expertise and resources. Established guideline organisations are being asked to produce guidelines more quickly and with fewer resources.1 Less formal guideline development groups, such as hospitals or group practices, can be overwhelmed by the requirements for creating these tools and keeping them updated. While different initiatives at the international level have attempted to improve the quality and rigour of guidelines,2 3 less investment has been made towards improving the efficiency of guideline production and updating. The ADAPTE Collaboration is an international group of researchers, guideline developers, implementers and users interested in guideline adaptation4 5 which aimed at facilitating the production of valid and high-quality adapted guidelines, and at promoting improved use of evidence-based guidelines that are relevant to the local context of use. We postulate that using existing high quality guidelines as a resource may be an alternative to de novo development to reduce duplication of effort, enhance efficiency, and promote local uptake of guideline recommendations.4 5 However, customising a guideline to local conditions bears the risk that the adapted guideline departs from its evidence base, putting back into question the quality and validity of the recommendations. With the exception of several Canadian studies,6 7 no validated process for the adaptation of guidelines was found in a previously reported review of the literature.4 8 This article presents a systematic approach to assessing and adapting existing guidelines (ADAPTE) and reports initial perceptions of its feasibility and usefulness.
Methods
Definition of guideline adaptation
We define guideline ‘adaptation’ as a systematic approach for considering the endorsement or modification of guidelines produced in one setting for application and implementation in another as an alternative to de novo guideline development or as a first step in the process of implementation, while preserving evidence-based principles.
Development of the ADAPTE process
Between 2005 and 2007 the ADAPTE Collaboration held a series of working meetings to define the ADAPTE process and to develop a manual and resource toolkit, based on preliminary developments of two similar adaptation processes and empirical studies in various contexts.4 6 7 9–12 The development of the adaptation process and accompanying toolkit were based on the following principles:
Respect of evidence-based principles in guideline development13;
Reliable and consistent methods to ensure the quality of the adapted guideline2;
Participation of stakeholders to foster acceptance and ownership of the adapted guideline, and ultimately promote its use14;
Consideration of context during adaptation to ensure feasibility and relevance for local practice and policy15;
Transparent reporting to promote confidence in the recommendations2 16;
Flexible format to accommodate specific needs and circumstances17 18;
Respect for, and acknowledgement of source guideline materials.
After several refinements, the manual and resource toolkit were made available in July 2007 on a dedicated website (http://www.adapte.org). Potential users, guideline developers and implementers were informed about the ADAPTE process and the evaluation study through mailing to relevant local, national and international organisations and relevant groups, in particular through the Guideline International Network as well as through conferences and workshops.
Evaluation of the ADAPTE process
Evaluation of the ADAPTE process was based on a self-administered questionnaire that contained closed questions and space for comments to identify issues not captured in the closed questions. Study outcomes were participants’ perception of the clarity and usefulness of the ADAPTE process rated on a 6-point Likert scale (regrouped for analysis into three categories: no agreement (1 and 2), moderate agreement (3 and 4), strong agreement (5 and 6)), expected feasibility, benefits and barriers of using the ADAPTE process as well as their intention to use the process. Information on demographic characteristics, experience with guideline development, implementation and adaptation was collected. Between July 2007 and September 2009, self-selected individuals accessing the ADAPTE website were invited to register to obtain the ADAPTE manual. Information on the evaluation study was provided and registrants were asked to sign a consent form. After downloading the ADAPTE manual, registered individuals were asked to complete the evaluation questionnaire. Completing the questionnaire provided access to the resource toolkit from the ADAPTE website. Frequency distributions of the answers were calculated. Open comments were analysed for the corresponding themes (frequency, content). The ADAPTE evaluation study has received approval according to French procedures for this type of research.
Results
Outline of the ADAPTE process
The ADAPTE process consists of three main phases, each with a set of modules (figure 1) including a total of 24 steps (table 1). Steps are designed to be flexible in the sequence in which they can be used, to fit with user or guideline developer resource constraints. Users of the process are encouraged to identify, at the outset of an adaptation process, those modules and steps most relevant to their context. The set-up phase, similar to de novo guideline development, outlines the necessary tasks prior to the adaptation process, for example, identifying necessary skills and resources and designing the panel. The adaptation phase constitutes the core of the adaptation process and assists users in moving from topic selection to identifying specific clinical questions; searching for, retrieving and assessing guidelines; selecting among source guidelines and recommendations; and preparing the draft adapted guideline. Assessment of retrieved guidelines involves evaluating their quality (eg, using the AGREE instrument19), currency (how up-to-date they are), consistency (coherence of recommendations with evidence) and applicability within the targeted context of use. Assessment provides an explicit basis for the selection and modification of source guidelines and creation of an adapted guideline. The options proposed for using source guidelines correspond to different degrees of adaptation, such as adopting a guideline unchanged, selecting recommendations from different guidelines and updating of the evidence of selected source guidelines. The finalisation phase, comparable to de novo guideline development, includes external review, feedback from stakeholders, informing developers of source guidelines, establishing an updating process and writing the final document.
The ADAPTE process is complemented by a toolkit consisting of 19 tools to assist the user with the different steps of the adaptation process. For example, Tool N°2 proposes a comprehensive search strategy to help identify existing guidelines by searching websites and databases of guideline sources (eg, guideline clearinghouses, speciality organisations). Tool N°6 helps the panel to convert the guideline topic into a set of clear and focused key questions prior to the adaptation process. Tool N° 15 proposes a series of structured questions and criteria to guide the assessment and discussion, within the guideline panel, whether a guideline recommendation is applicable and acceptable in the targeted context of use, and to identify the organisational changes needed to apply the recommendation. A practical example illustrates how a guideline panel might use the ADAPTE process for the adaptation of a guideline on cervical cancer screening (table 2).20
Evaluation of the ADAPTE process
Between July 2007 and September 2009, 330 individuals from 46 countries registered on the ADAPTE website (Africa: 13; Asia: 36; Australia: 62; Europe: 69; North America: 86; South America: 64). Registrants learned about the project mainly by colleagues (52%), Internet (23%) and conferences (21%). Their interest in the ADAPTE process was for guideline development (80%), implementation (62%) or both (48%). One hundred and forty-four individuals filled in the perception form (participants). Registrants' and participants' demographics were alike (table 3). Most of them were physicians. There were relatively few pharmacists, nurses and allied health professionals. 79% participants declared planning to use the ADAPTE process and 86% (overall 69%) indicated planning to start within the next 6 months. Table 4 presents frequency distributions of participants' perceptions of the ADAPTE process/manual and expected benefits/barriers to their use. The ADAPTE process and manual were rated as clear and comprehensive by a majority of respondents. Most (89%) respondents were expecting benefit from using the ADAPTE process. 75% of participants indicated expecting the quality of the customised guidelines to be increased; less than 30% expected the timeframe and resource use to be decreased in comparison to their current procedures. These observations did not vary according to the experience in CPG development (number of guidelines developed in the past 5 years by the organisation). Several comments indicated that participants considered ADAPTE to be more rigorous than their current processes. The most often reported anticipated barriers to using the adaptation process were low quality and lack of appropriate source guidelines and difficulties to adapt source guidelines to own context of use (table 4). Additional reported barriers were lack of expertise and time of clinicians as well as limited instructions for guideline implementation in the ADAPTE manual.
Discussion
A comprehensive framework for CPG adaptation has been developed to meet the current challenges of timely guideline development and implementation for a range of stakeholders, such as guideline developers, healthcare providers, consumers and policy makers at the local, national and international level.1 21 The process may be applied to guidelines for health promotion, screening, diagnosis, prognosis, treatment, follow-up or other interventions in any disease area. Users are encouraged to customise the process to their own context, resource constraints and expertise.
This first evaluation of the ADAPTE process demonstrated interest of a wide range of individuals and a favourable perception among study participants. A large majority judged the adaptation process and manual clear, comprehensive and useful. Most respondents expected benefits from using ADAPTE, including use of more rigorous methods and improvement of guideline quality. The latter is consistent with accumulating evidence indicating the need to improve guideline quality.2 12 22–24 Although numerous agencies and other groups produce high quality guidelines worldwide, lack of quality guidelines for certain topics, may require a combination of guideline adaptation and some de novo guideline development.
The expected improvement of the methodological rigour and the perceived complexity of the ADAPTE process probably explain the prevailing perception that using the ADAPTE process may require increased time and resources in comparison to current guidelines development processes. As with other new methods, efforts required may decrease with growing experience in using the ADAPTE process. Training workshops have been organised in several settings.
The ADAPTE process is intended to help guideline users select and appraise high quality guidelines among a heterogeneous, expanding volume of guidelines available in the literature and dedicated websites,25–27 with sometimes differing or even contradictory recommendations,22–24 putting into question their validity.21 While respecting the principles of a rigorous evidence-based approach, guideline adaptation stresses the process of putting evidence into context, and directs developers and adapters to identify potential local barriers in applying research evidence to clinical or policy practice. Guideline adaptation recognises differences in organisational, regional or cultural circumstances that could lead to legitimate variations in recommendations supported by the same evidence.11 28–31 To ensure that an adapted guideline addresses specific health questions relevant to a particular setting, the specific epidemiology, needs, priorities, legislation, policies and resources in the target setting should be considered. Guideline recommendations that fit to local circumstances are more likely to be accepted and to foster a sense of ownership by the intended users.30 32–36 Engaging potential end users in the process of evaluating and adapting existing guidelines may help to improve guideline acceptance and adherence. The stepwise approach of the ADAPTE process should help prevent the risk that the changes made to adapt a guideline ignore its evidence base and decrease the validity of the recommendations produced.37 The ADAPTE framework could also be used as an educational tool by exposing clinicians, managers and others to evidence-based practice skills in defining clinical or policy questions of relevance to them.
The large number of individuals and organisations from all continents having registered on the ADAPTE website shows the worldwide interest in guideline adaptation. Adapting from high quality evidence-based guidelines may be most valuable for countries and organisations with limited budgets and experience. However, well-established organisations have also formally adopted the proposed adaptation process, for example, the French National Authority for Health, dedicated to producing guidance for use within the French healthcare system,38 and the Canadian Medical Association are presenting ADAPTE as a resource for guideline development.39 While participation of allied health professionals was relatively low, several examples demonstrate successful use of guideline adaptation processes in these professional groups.6 7
The opportunity provided by the ADAPTE process to share evidence globally, to avoid duplication of effort and to focus on the translation and contextualisation of the evidence to a specific context of use is also supported by the Guidelines International Network.40 This approach may, however, be challenged by potential barriers indicated by questionnaire's respondents: lack of high quality source guidelines, their limited applicability beyond the setting in which they were developed, acceptance of the process by different targeted user groups, and potential complexity of the adaptation process, including the selection between a large number of guidelines with sometimes differing recommendations to create an adapted guideline.
This first evaluation of ADAPTE focuses on the perception of the ADAPTE process. Further evaluation of the ADAPTE process will determine the actual use and practicability of the ADAPTE framework and supporting tools in practice. It will also be important to assess the efficiency of the ADAPTE process as well as the quality and content of the resulting customised guidelines. Eventually, this evaluation will allow further modification and refinement of the ADAPTE process and framework.
References
Footnotes
The Members of the ADAPTE Collaboration who have contributed to this article include (in alphabetical order):
▸ Melissa Brouwers, Program in Evidence-based Care, Cancer Care Ontario; McMaster University, Hamilton, Canada; Cancer Control Guidelines Action Group, Canadian Partnership against Cancer, Canada
▸ George P. Browman, British Columbia Cancer Agency, Vancouver Island Centre; Cancer Guidelines Action Group, Canadian Partnership against Cancer, Canada
▸ Jako S. Burgers, Dutch Institute for Healthcare Improvement, CBO, Utrecht, The Netherlands; IQ healthcare, Radboud University Nijmegen medical Centre, Nijmegen, The Netherlands
▸ Bernard Burnand, Health Care Evaluation Unit and Clinical Epidemiology Centre, Institute of social and preventive medicine, Centre Hospitalier Universitaire Vaudois and Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland
▸ Béatrice Fervers, Fédération Nationale des Centres de Lutte Contre le Cancer; Centre Léon Bérard, Lyon, France; EA 4129 - Santé, Individu, Société, Lyon, France
▸ Ian D. Graham, PhD School of Nursing, University of Ottawa, Canadian Institutes of Health Research, Ottawa, Canada; Cancer Control Guidelines Action Group, Canadian Partnership against Cancer, Canada
▸ Margaret B. Harrison, PhD School of Nursing, Queen's University, Kingston, Canada; Cancer Control Guidelines Action Group, Canadian Partnership against Cancer, Canada
▸ Jean Latreille, Direction de la lutte contre le cancer, Ministère de la santé et des services sociaux, Québec; Centre intégré de lutte contre le cancer, Hôpital Charles Lemoyne; Université de Sherbrooke; Canadian Partnership against Cancer, Canada
▸ Najoua Mlika-Cabanne, Haute Autorité de Santé, Service des Recommandations Professionnelles, Paris, France
▸ Louise Paquet, Direction de la lutte contre le cancer; Ministère de la santé et des services sociaux, Québec; Canadian Partnership against Cancer, Canada
▸ Magali Remy-Stockinger, Fédération Nationale des Centres de Lutte Contre le Cancer; Centre Léon Bérard, Lyon, France
▸ Anita Simon, Alberta Cancer Board, Calgary, Canada
▸ Joan Vlayen, Catholic University of Leuven, Leuven, Belgium
▸ Louise Zitzelsberger, Cancer Guidelines Action Group, Canadian Partnership against Cancer; Ottawa Health Research Institute, Canada
Funding Other Funders: 59th and 60th ‘Commissions permanentes de coopération franco-québécoise (CPCFQ)’ 2003–2006, 'Direction de la lutte contre le cancer', Ministère de la santé et des services sociaux, Québec, Canada; Ligue Nationale contre le Cancer, France; Région Rhône-Alpes, France; Health Canada and The Canadian Partnership against Cancer; Fédération Nationale des Centres de Lutte Contre le Cancer, France; France-Switzerland collaborative fund (PAI G. de Stael); Haute Autorité de Santé, France.
Competing interests None.
Ethics approval This study was conducted with the approval of the This study has received approval according to French procedures for this type of research.
Provenance and peer review Not commissioned; externally peer reviewed.