The advantages and limitations of guideline adaptation frameworks

The advantages and limitations of guideline adaptation frameworks Background: The implementation of evidence-based guidelines can improve clinical and public health outcomes by helping health professionals practice in the most effective manner, as well as assisting policy-makers in designing optimal programs. Adaptation of a guideline to suit the context in which it is intended to be applied can be a key step in the implementation process. Without taking the local context into account, certain interventions recommended in evidence-based guidelines may be infeasible under local conditions. Guideline adaptation frameworks provide a systematic way of approaching adaptation, and their use may increase transparency, methodological rigor, and the quality of the adapted guideline. This paper presents a number of adaptation frameworks that are currently available. We aim to compare the advantages and limitations of their processes, methods, and resource implications. These insights into adaptation frameworks can inform the future development of guidelines and systematic methods to optimize their adaptation. Analysis: Recent adaptation frameworks show an evolution from adapting entire existing guidelines, to adapting specific recommendations extracted from an existing guideline, to constructing evidence tables for each recommendation that needs to be adapted. This is a move towards more recommendation-focused, context- specific processes and considerations. There are still many gaps in knowledge about guideline adaptation. Most of the frameworks reviewed lack any evaluation of the adaptation process and outcomes, including user satisfaction and resources expended. The validity, usability, and health impact of guidelines developed via an adaptation process have not been studied. Lastly, adaptation frameworks have not been evaluated for use in low-income countries. Conclusion: Despite the limitations in frameworks, a more systematic approach to adaptation based on a framework is valuable, as it helps to ensure that the recommendations stay true to the evidence while taking local needs into account. The utilization of frameworks in the guideline implementation process can be optimized by increasing the understanding and upfront estimation of resource and time needed, capacity building in adaptation methods, and increasing the adaptability of the source recommendation document. Keywords: Guidelines, Adaptation, Global health, Adaptation frameworks Background individually or collectively” [1]. Guidelines are developed Guidelines can be defined as “any document containing by a range of organizations including charities endorsed recommendations for clinical practice or public health by local professional societies (e.g., The Heart Foundation policy. A recommendation tells the intended end-user of endorsed by the Royal Australian College of General the guideline what he or she can or should do in specific Practitioners (RACGP)), national health research institutes situations to achieve the best health outcomes possible, (e.g., US National Institutes of Health (NIH), the UK National Institute for Health and Care Excellence (NICE), and Australian National Health and Medical Research * Correspondence: zwan7718@uni.sydney.edu.au 1 Council (NHMRC)), and international health organiza- Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia tions (e.g., the World Health Organization (WHO)). In Charles Perkins Centre, The University of Sydney, D17, The Hub, 6th floor, order to be trustworthy, all guidelines, both clinical and Sydney, New South Wales, Australia public health, should be evidence based and should be Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Wang et al. Implementation Science (2018) 13:72 Page 2 of 13 developed using clear, explicit processes to minimize bias aspects of the local context such as resource capabilities and optimize transparency [2]. (both human and material), disease prevalence, and the values and preferences of community members. Guideline implementation If the local context is not taken into account, interven- The implementation of evidence-based guidelines can tions recommended in existing high-quality guidelines improve clinical and public health outcomes by helping may be impossible to implement. For example, recom- health professionals practice in the most effective man- mending widespread use of information and communi- ner [3, 4], as well as assisting policy-makers in designing cations technologies without adequate knowledge of optimal programs. The development of guidelines with- their use in the local health system may be more of a out adequate consideration of implementation may hin- burden than a boon to the health system [15]. Adapting der the target audiences’ adherence to the guidelines [5]. the guidelines and local capacity building in understand- Without proper implementation, the financial and hu- ing and applying the recommended interventions are man resources expended in the development of guide- vital for their successful uptake. It is not only the recom- lines are wasted. mendations within the guidelines that may need to be The implementation of guidelines in a context that is adapted to suit the local context, but also different im- different from where they were developed is particularly plementation strategies may be required for guidelines challenging. In addition, recommendations in public in different contexts. health guidelines are often more complex to implement Developing guidelines de novo requires substantial than clinical guidelines and usually target health systems time and resources—both methodological expertise and or multi-sector government institutions instead of indi- fiscal capacity. When a high-quality guideline is available vidual clinical decisions. For example, WHO develops which addresses the local need, it may be more practical guidelines for a global audience; each guideline or rec- to adapt this guideline (or selected recommendations ommendation in each guideline then needs to be consid- therein) for local use [16]. For example, until 2012, New ered for implementation at the country or sub-national Zealand had a high-quality internationally respected level (e.g., within a health system). Other examples in- guideline development program through the New clude implementation of national guidelines to the local Zealand Guidelines Group [17]. This group went into (e.g., state or provincial) context [6], international guide- voluntary liquidation in mid-2012 [17]. After this, the lines to a local hospital [7], European guidelines to indi- New Zealand Ministry of Health provided funding to a vidual countries [8], and international guidelines to new guideline organization: The Best Practice Advocacy NZ regions [9]. Centre New Zealand (bpac ) to adapt NICE clinical There are a number of systematic reviews on the guidelines for use in New Zealand based on the effectiveness of various implementation strategies for ADAPTE approach [18]. recommendations in guidelines [10–12]. Most indi- From here on, we will refer to original and established cate that active techniques are the most effective. source materials (e.g., WHO guidelines) as “source However, many guidelines do not include detailed guidelines” or “source materials,” while the new and descriptions of how the guidelines should be imple- modified guidelines/recommendations produced by the mented [13]. adaptation process will be referred to as “adapted guide- lines” or “adapted recommendations.” Guideline adaptation When a clinical practice or public health guideline is Adaptation is a key step in the implementation process needed in a specific context, recommendations can be [13]. Guidelines International Network (G-I-N) defines constructed using one of four possible approaches: guideline adaptation as “the systematic approach to the modification of a guideline(s) produced in one cultural 1) Adopt recommendations from existing evidence- and organisational setting for application in a different based source guidelines without modification; context”. Guideline adaptation is usually initiated by 2) Adapt recommendations from existing guidelines end-users at the local level (e.g., by local governments, to the new context; hospitals, and/or individual clinicians) and not by inter- 3) Develop recommendations de novo based on national (e.g., WHO) or national (e.g., NHMRC) guide- existing reviews of evidence (from source guidelines line developers. Adaptation is an alternative to de novo or systematic reviews) [19]; and guideline development such as customizing an existing 4) Develop recommendations de novo based on new guideline to the local context [14] which could be a spe- evidence syntheses. cific health setting, country, or an emergency situation. In order to achieve effective adaptation, guideline adap- Adapted guidelines can contain recommendations from a tors should take into account a number of important mixture of these approaches. Additional file 1 summarizes Wang et al. Implementation Science (2018) 13:72 Page 3 of 13 factors that may influence a local group to choose one of Table 1 Possible steps in an adaptation framework these approaches over another. 1) Form an organizing committee. 2) Choose a guideline topic. Forms of adaptation 3) Identify resources and skills required for the process. Guideline adaptation occurs via either informal or for- 4) Write an adaptation plan and form a guideline adaptation group. mal processes. 5) Determine the health questions. 6) Search for relevant guidelines and related documents. Informal adaptation Informal guideline adaptation occurs without using an 7) Formally screen and review (i.e., assess currency, content, quality, consistency between sources and acceptability/applicability of the established framework [7]. For example, when a hos- recommendations) selected guidelines. pital in Lebanon considered adapting a guideline on 8) Decide which guideline or recommendations to adapt, taking into low back pain [7], no formal adaptation framework account the quality of the source material, local conditions, and was used. The hospital guideline adapters simply practicality of the guideline/recommendations/intervention. identified international guidelines in the literature, 9) Perform external review of the adapted guideline (by target audience, compared them according to the AGREE instrument endorsement bodies, and source guideline developers). [20], and implemented the “best” one after translating 10) Schedule evidence reviews and updates of the adapted guideline. it into the local language [7]. This framework summary is based on ADAPTE [16] Informal adaptation can also be done on an individual provider or patient level [21]. Doctors in Sudan were the process of guideline adaptation through an ana- noted to adapt international guidelines on an ad hoc lysis of recent adaptation frameworks. This in turn basis, in order to suit the patient and the health care sys- will help to identify optimal characteristics of frame- tem in their country. One of the doctors interviewed in works to inform guideline development, implementa- this study said “I cannot prescribe the new drug (X) tion, and uptake. which is not found in Sudan. We stick to guidelines but with a modified picture” [21]. The high frequency of Analysis testing suggested by international guidelines may also be Description and critique of adaptation frameworks impractical in low-resource settings, as for example, The analysis drew from literature published over the past some patients may have to travel long distances for the 15 years (1 January 2002 to 1 March 2017) as this area of re- tests [21]. search is relatively new. Very few studies on guideline adap- Such ad hoc adaptations, although practical in some tation were published prior to 2002. MEDLINE, Embase, situations, can pose a risk if the intervention that is im- and CINAHL databases were systematically searched for plemented is outside of the scope of the original published accounts of formal adaptation frameworks. The evidence-based recommendation. search strategy can be found in the Additional file 1. The results were limited by language (English) and pub- Formal adaptation lication type (clinical trial, journal article, meta-analysis, This occurs when adaptation of a guideline is performed randomized controlled trial, research, review, systematic using a guideline adaptation group and an established review, multicentre study, or observational study) and framework [22]. Table 1 lists possible steps in an adapta- population (Humans NOT animals). The titles of the re- tion framework. sults were screened for relevance. Formal adaptation frameworks provide a systematic As little work has been done to review this area, the way of approaching adaptation. These frameworks are results were screened in a scoping review style without created to increase methodological rigor and quality limits on types of articles we would include or a priori of the adapted guideline [23]. Due to the complexity protocols of analytical categories of data extraction (spe- of applying formal frameworks, this type of adaptation cific features of adaptation frameworks) [25]. The cat- is always done collectively. Formal frameworks, in egories and the inclusion and exclusion criteria were contrast to informal adaptation methods, can enable refined as the data were collected. We identified eight evaluation of the evidence supporting the recommen- different frameworks, many of which were developed dations in adapted guidelines. A recent review has concurrently or build on each other. identified some of the frameworks for guideline adap- tation [24]. Timeline of frameworks Aim The timeline of framework development is illustrated in We aim to understand advantages and limitations of Fig. 1. The authors overlap in some of the frameworks existing frameworks and identify knowledge gaps in (Harrison, M. B. and Graham, I. D. worked on PGEAC, Wang et al. Implementation Science (2018) 13:72 Page 4 of 13 Fig. 1 Timeline for publication of adaptation frameworks. A brief timeline of the publication dates of the frameworks examined in the paper. Some later frameworks built on the works of previous ones. Note that certain frameworks may have been available before the publication date ADAPTE, and CAN-IMPLEMNT), which may explain The initial steps of the guideline adaptation process some of the similarities among the early frameworks. are similar among the early frameworks (PGEAC, SGR, ADAPTE, AAP, CAN-IMPLEMENT, and Adapted ADAPTE) Similarities and differences in processes of adaptation as they all used a selection of guidelines as their source mater- suggested by the frameworks ial. This process can be summarized as: As shown in Table 2, there are similarities and differ- ences in the adaptation processes suggested by the dif- 1. Define the health questions ferent frameworks. 2. Search and screen the guidelines The frameworks differ in the structure of the commit- 3. Evaluate the guidelines tees that conduct the adaptation, with a number suggest- 4. Select the single or a set of guideline/s to adapt ing two committees (organizers and guideline developers) (e.g., ADAPTE [16]), while later frameworks tend to have These earlier frameworks use versions of the AGREE more complex structures (e.g., AAP [26]). The steps of the tool to evaluate the selected guideline [20, 27]. AGREE adaptation process also differed greatly, particularly with assess the following domains: respect to how adaptation panels were selected and how they evaluated source materials; these differences will be 1. Scope and purpose explored further in the following section. 2. Stakeholder involvement The frameworks also differed in how the adapted rec- 3. Rigor of development ommendations were constructed, although consensus by 4. Clarity of presentation the panel was the most common process. The require- 5. Applicability ments of external review and plans for updating the 6. Editorial independence (conflicts of interest of adapted guideline were almost universal in the eight members of the guideline development group) frameworks. The frameworks usually suggested dissem- inating hardcopies of the adapted guidelines. The SNAP-IT by GRADE framework differs from the others as it does not select and evaluate a range Processes for selecting and evaluating source materials of guidelines. Instead, this framework suggests select- Processes for identifying and evaluating source materials ing a single well-known guideline, then modifying the for adaptation differed significantly across the frame- recommendations for the local context [28]. For ex- works (see Table 3). One point of major divergence is in ample, the guideline “Antithrombotic Therapy and the processes used to search for and evaluate the source Prevention of Thrombosis, 9th ed: American College material used in the adaptation process. Frameworks of Chest Physicians Evidence-Based Clinical Practice have evolved from a focus on identifying source guide- Guidelines (AT9)” was chosen as it was current and the lines for adaptation to identifying specific recommenda- “largest CPG to rigorously apply the GRADE method- tions for adaptation. The frameworks then evolved from ology, providing authoritative assessments of confidence a focus on recommendations to examining the evidence in evidence and explicit rationales for the strength of its underpinning the adapted recommendations. recommendations” [28]. This framework has many Wang et al. Implementation Science (2018) 13:72 Page 5 of 13 � � � � � � � � � � � � � � � Table 2 Processes of adaptation suggested by published frameworks Framework (year published) Committee structure Methods and process Updating of the How adapted External peer Presentation and Author(s) (framework summary adapted recommendations review dissemination of the development group) guideline were constructed adapted guideline (e.g., consultation, consensus, EtD tables) Practice guideline evaluation A single local Identify a clinical area to Yes Consensus in the Yes, by local Unclear, likely hardcopy and adaptation cycle interdisciplinary20 promote best practice, guideline practitioners, documents (2005) [36] guideline evaluation Search and evaluate evaluation group other Graham, I. D. Harrison, M. B. group comprising existing guidelines, stakeholders, and key stakeholders Adopt or adapt the guideline organizational for local use policy-makers for review and comment Systematic guideline review Most steps conducted Use multiple sources to No Consensus by the Yes, a multi- Hardcopy documents (2009) [37] by the 5 authors search for guidelines authors professional, Muth, C. et al. Assess quality of the interdisciplinary (“Kompetenznetz guidelines formal consensus Herzinsuffizienz” and the Collate recommendations process that German Society for General from different guidelines into included a patients’ Practice and Family Medicine “evidence tables of a representative and (DEGAM)) standardized format which apilot testing included recommendation(s), phase evidence level(s), grading, critical appraisal of evidence, and cited sources” ADAPTE (2011) [16] Dual committee Search for source guidelines Yes Consensus by the Yes, by target users, Hardcopy documents ADAPTE Collaboration structure Assess source guidelines panel consulted with (including Graham, I. D. consisting of the Adapt source guideline relevant Harrison, M. B.) organizing committee endorsement and panel of guideline bodies and the developers (usually developers of content experts) source guidelines The Alberta Ambassador Up to 6 committees Formulate the question from Yes “living” guideline Consensus by the Yes, by clinical Targeted to local Program (AAP) adaptation with distinct knowledge gaps in the that will be updated guideline development experts, implementation process (2011) [26] responsibilities in the adaptation context every 2 years group methodologists, facilitators. Including Harstall, C. et al. (The Alberta adaptation process Literature search to identify and potential internet access to the Ambassador Program) relevant source guidelines. guideline users guidelines Assess source guidelines who were not Adapt guideline written via involved in its monthly videoconferences of development the Guideline Development Group CAN-IMPLEMENT (2013) 2 or more committees Similar steps to ADAPT Yes Consensus by the panel Yes, by each Adaptation only the first [30, 38] including a steering Some steps of the adaptation stakeholder group phase of the CAN- Harrison, M. B. Graham, I. D. committee and working process done simultaneously affected by the IMPLEMENT process. et al. (The Canadian panel(s) by different sub-committees recommendations Phase 2 is development Partnership Against Cancer) of theguidelinedevelopment of training programs group. and interventions to implement new Wang et al. Implementation Science (2018) 13:72 Page 6 of 13 � � � � � � � Table 2 Processes of adaptation suggested by published frameworks (Continued) Framework (year published) Committee structure Methods and process Updating of the How adapted External peer Presentation and Author(s) (framework summary adapted recommendations review dissemination of the development group) guideline were constructed adapted guideline (e.g., consultation, consensus, EtD tables) A stronger focus on the guideline. Phase 3 implementation of guidelines involves evaluation of after their adaptation the process and outcomes SNAP-IT by GRADE (2014) [28] Editorial committee, Select one well established Dynamically update One content expert and Yes, by all relevant Published in newly Kristiansen, A. et al. (Canadian individual chapter guideline which was deemed the recommendations one methods expert on medical specialty developed web McMaster University GRADE editors to be current, of high quality, at least every 3 months the editorial committee organizations, authoring and group partnership with and used GRADE (23) reviewed each chapter local publication platform Norwegian Ministry of health) Choose recommendations of the guideline to choose ministry of health (MAGIC), including within this guideline that which recommendations and offline access on they deem relevant in the to adopt and/adapt. The the source smartphones and tablets adaption context to adopt/ panel consulted with guideline adapt editors of the source development guideline on content organization issues and when modifications were made. Adapted ADAPTE (2015) [32] Dual committee Framework based on the work Yes Consensus by the panel Yes, same as Hardcopy documents. Amer, Y. S. Elzalabany, M. M. structure consisting of ADAPTE collaboration and ADAPTE The framework include Omar, T. I. Ibrahim, A. G. of the organizing CAN-IMPLEMENT with some implementation Dowidar, N. L. committee and panel modifications to increase tools which include the timeliness and clarity of professional and the adaptation process organizational interventions, monitoring and evaluation, and an action plan for dissemination GRADE-ADOLOPMENT Methodologist group Local authorities choose N/A This framework stops Evidence to decision N/A This Unclear, in the case (2017) [19] from McMaster the key clinical questions; at the decision to either (EtD) tables framework stops described the adapted Schunemann, H. J et al. university. Guideline Identify specific adopt, adapt the source at the decision to guidelines were made (Canadian McMaster panels made up of local recommendations that recommendation/evidence, adopt, adapt the for the Kingdom of University GRADE group expert members from address those questions. or start de novo source Saudi Arabia and partnership with Saudi multidisciplinary Choose source guidelines development of a new recommendation/ dissemination was the Arabian Ministry of health) backgrounds, including based on the GRADE guideline. evidence or start responsibility of the some patient approach and constructing de novo local government representatives EtD tables development of a Revise and update these new guideline. tables are to match the local context. Abbreviations: EtD evidence-to-decision, GRADE The Grading of Recommendations Assessment, Development and Evaluation, N/A not applicable Wang et al. Implementation Science (2018) 13:72 Page 7 of 13 � � � Table 3 Processes for identification and evaluation of source material by adaptation frameworks Framework Define the health question Search and screen Evaluate guidelines Identify recommendations Evaluate recommendations Identify new evidence Evaluate evidence Practice guidelines Select a clinical question US National Guideline AGREE N/A If more than one guideline N/A N/A evaluation and based on: Clearinghouse and is being considered, a adaptation cycle The prevalence of the guideline repositories, as “content analysis” of the (PGEAC) [36] condition or its associated well as guideline recommendations in each burden developers and PubMed guideline is conducted by Concerns about large [36] clinicians experienced in variations in practice or the content area. A table is care gaps, used to compare the Costs associated with recommendations in each different practices guideline and the level of evidence supporting each recommendation Systematic guideline Not specified by the MEDLINE, The Cochrane AGREE For each clinical question Recommendations within N/A Systematic reviews cited review (SGR) [37] framework. Chronic Heart Library, DARE, and HSTAT extract data into evidence the guidelines are by the source guidelines Disease was the topic [37] tables including: evaluated for whether are re-evaluated, along already chosen for the recommendations, they are supported by with clinical studies of an review. evidence levels, grading, valid study results appropriate design when critical appraisal of secondary publications evidence, and cited did not provide the de sources. sired evidence ADAPTE [16] Topic chosen before the 26 guideline internet sites AGREE, Construct Assess acceptability (i.e., N/A N/A adaptation process. including the Cochrane Assess guideline recommendation matrices whether the Research questions Library, guideline currency, content with a list of recommendations should determined by the repositories, government and consistency recommendations and be put into practice) and guideline committee in the agencies and cancer their respective source applicability (i.e., whether patient population, clinical societies [39] guidelines to allow an organization or group intervention, professional/ comparison of the is able to put the patients (audience of the recommendations recommendation into guideline), outcomes, and practice). healthcare setting (PIPOH) format [16] Assess consistency between the evidence cited by the guidelines and the respective recommendations. The Alberta Knowledge gaps of the Search developed by AGREE modified by Evidence inventory tables Not assessed, evidence N/A N/A Ambassador Program local practitioners were research team in the research team are used by the research cited in the source (AAP) adaptation assessed along with a collaboration with team to extract data from guidelines to support the process [26] systematic review of the experienced medical source guidelines and recommendations is listed. literature on knowledge librarians (28) present all the information gaps among various required for the guideline primary case groups development group in 1 document. Discordant recommendations are highlighted CAN-IMPLEMENT from Topic chosen before the Guideline clearinghouses, AGREE II assess Construct a table or Acceptability and N/A N/A ADAPTE [30, 38] adaptation process. country-specific databases, guideline currency, “matrix” which compares Applicability of Research questions relevant specialty societies content, and similar recommendations recommendations; determined by the and web sites of consistency across multiple guidelines consistency between the guideline committee in the organizations developing between evidence and displays relative levels developers’ selected Patient population, guidelines. MEDLINE, and of evidence evidence, interpretation, Intervention, Professional/ Google, AltaVista, and recommendations and resulting patients (audience of the Yahoo [38] [40] recommendations guideline), Outcomes; and Wang et al. Implementation Science (2018) 13:72 Page 8 of 13 Table 3 Processes for identification and evaluation of source material by adaptation frameworks (Continued) Framework Define the health question Search and screen Evaluate guidelines Identify recommendations Evaluate recommendations Identify new evidence Evaluate evidence Healthcare setting (PIPOH) format [30] SNAP-IT by GRADE [28] Guideline topic requested N/A N/A A designated chapter The chapter editors then N/A If the panel decided to by the local health editor assessed each follow a predefined exclude or modify a authorities chapter and decided taxonomy to decide recommendation, a whether to adopt or adapt whether to adopt, adapt more extensive the recommendation. or develop a new reassessment of the recommendation. underlying evidence is conducted. Adapted ADAPTE [32] Determined by the Seven CPG resources AGREE II Construct a list of Assessment done when N/A N/A guideline committee in the prioritized from the recommendations and tailoring more than one Patient population, original 26-long list in their respective source guideline that includes Intervention, Professional/ ADAPTE and “DynaMed”, guidelines to allow selecting some, not all, patients, Outcomes; and BMJ Best Practice and comparison of the recommendations from Healthcare setting (PIPOH) PubMed [32] recommendations different source guidelines. format [32]) Consistency between the evidence cited by the guidelines and the respective recommendations is assessed. GRADE-ADOLOPMENT Guideline topic selected by N/A N/A Take recommendations Assess each Evidence syntheses related Systematic reviews are [19] the local health authorities from existing guidelines recommendation in EtD to the existing updated if the source that used the GRADE tables. The EtDs included recommendations were systematic reviews are approach and had publicly the summary of evidence searched for; including older than 3 months and available evidence about the benefits and systematic reviews and the results fed into the summaries in the form of harms of the intervention HTAs. EtD tables. The quality of GRADE Summary of option(s) and information the evidence was rated Findings (SoFs) tables or about the importance of using GRADE evidence profiles (EPs) the problem (e.g., baseline risk), patients’ values and preferences, resource use, costs, feasibility, acceptability, and potential impact on health equity of recommending specific intervention options in the context and affected stakeholders Note. AGREE II was published in 2010 Abbreviations: AGREE Appraisal of Guidelines for Research and Evaluation; CPG clinical practice guidelines; EtD evidence-to-decision; GRADE The Grading of Recommendations Assessment, Development and Evaluation; HTA Health Technology Assessment; N/A not applicable Wang et al. Implementation Science (2018) 13:72 Page 9 of 13 similarities to the GRADE-ADOLOPMENT developed To address the lengthy timeframe required for the years later by the same group. ADAPTE framework, the CAN-IMPLEMENT frame- Adaptation frameworks are evolving towards identify- work involves conducting concurrent tasks by multiple, ing and evaluating recommendations within a single collaborative groups to reduce the duplication of effort large guideline. Increasing, the frameworks also started [30]. By delegating tasks according to expertise of guide- to make explicit the multiple paths that the adaptors can line development group members, the workload can be take to construct adapted recommendations. For ex- shared. Additionally to address the need for methodo- ample, in SNAP-IT by GRADE, the panelists were desig- logical expertise, the CAN-IMPLEMENT team suggests nated a chapter in the source guideline to evaluate and outsourcing and consultations with specialists (e.g., li- they “reviewed each recommendation in their designated brary science, evidence appraisal) when required [30]. chapter and formally recorded their views regarding A second limitation is that the frameworks require a whether the recommendation could stand as it was or level of methodological expertise which is not available whether there was a need for modification, exclusion, or to many guideline development groups [29]. Guideline development of new recommendations” [28]. developers may need a specific methods or research GRADE-ADOLOPMENT was the first framework to team separate to the guideline development group that make a distinction between adopting and adapting a guide- can present evidence to the guideline development line. It describes three paths: (1) adopt existing recommen- group for analysis and discussion [26, 29]. To address dations as they are, (2) adapt existing recommendations to this challenge, the Alberta Ambassador Program imple- their own context, and (3) develop recommendations de ments a complex array of committees that oversee dif- novo based on available evidence syntheses [19]. These ferent tasks in the guideline adaptation process [31]: pathways were evident in a less elaborate form in SNAP-IT Steering and Advisory Committees for oversight, a by GRADE. GRADE-ADOLOPMENT goes further in that guideline development group to construct the adapted it not only searches for guidelines or recommendations in guideline, and a research team to select and appraise guidelines, it selects existing “highly credible guidelines and published guidelines, prepare background documents, evidence syntheses, including systematic reviews and and assist with writing the adapted guideline [31]. This [health technology assessments] HTAs” [19]. The evidence structure has proven problematic, however, with high from all these sources is used to construct GRADE rates of attrition of committee members and confusion evidence-to-decision (EtD) tables which include updated among participants about their roles [31]. evidence syntheses on intervention effects, with particular attention to the local health care setting and key context-specific factors [19]. Recommendations were then Gaps in knowledge about the process of guideline formulated based on the EtD tables, via consensus or voting adaptation when necessary. Our analysis of guideline adaptation frameworks has This demonstrates that frameworks have evolved from a identified a few gaps in knowledge about the process of focus on recommendations to examining the related evi- guideline adaptation. Firstly, the guideline adaptation dence (e.g., systematic reviews and HTAs). Few frame- frameworks examined in this study have been applied works described the methods used to assess whether and primarily in high- and upper middle-income countries how a specific recommendation should be adapted. and most were developed by large, experienced collabo- rations such as the GRADE Working Group [19, 28]. Only one framework (i.e., adapted ADAPTE [32]) has been Limitations of adaptation frameworks applied in a lower middle-income setting. Thus, studies of We identified several limitations to using the various guideline adaptation in low- and middle-income countries adaptation frameworks. Firstly, there is minimal guid- are needed, including exploration of the needs for, and bar- ance about the costs or time required for frameworks riers and facilitators of, guideline adaptation. Future studies like ADPATE [29]. Without a clear understanding of can explore what pragmatic and efficient processes can be how much time and resources adaptation frameworks used in resource-limited settings to product valid and im- actually save, guideline developers cannot be sure that a pactful adapted guidelines. Adaptation of a guideline in a framework is worth using [30]. The frameworks are re- high-income country may differ from a low-income coun- ported to be time and resource intensive [16, 28–32], try because low- and middle-income countries may have a despite their original purpose being to increase efficiency more severe lack of human and fiscal resources [32]. The and reduce duplication of effort compared to de novo health systems in many low- and middle-income countries guideline development [16]. Each project can take from may also have practical issues that need to be addressed in 3 years using adapted ADAPTE [32] to 18 months using the guidelines (e.g., medication/staff shortage, hospital over- ADAPTE [29]. crowding, inequity in care delivery) [33]. Wang et al. Implementation Science (2018) 13:72 Page 10 of 13 Secondly, most of the frameworks reviewed lack any effectiveness of the frameworks in improving guideline formal evaluation. In the few instances where evalua- implementation and uptake in different settings. An ex- tions have been performed, they mostly focused on per- ample of an independent test done to evaluate a frame- ceived usability of frameworks through self-administered work can be found in the NHMRC’sadaptationof surveys of the guideline developers [16], reflections from physical activity guidelines using the GRADE ADOLOP- the adaptation process recorded in a “lesson-learned log” MENT framework [34]. Where through their experience [29], and interviews with the participants in the process of adapting a guideline using the framework, the NHMRC [30]. These self-administered evaluations are not ad- provided suggestions to improve the GRADE ADOLOP- equate measures for the quality of the frameworks. MENT approach. With better evaluation, the quality of Thirdly, although the lack of methodological expertise in frameworks could be better modified and continually re- the developers was cited as a major barrier to the frame- fined to take into consideration the current limitations of works’ usability, there were no formal evaluations as to the guideline adaptation process. Evaluation of resources how having a research team with methodological expertise needed and the effect of the guideline adaptation for the could have improved the particular framework [29]. success of the whole guideline implementation and prac- Fourthly, it is unclear whether the shortcuts taken in the tice change process is important for the development of frameworks affect the resulting adapted guidelines. The future frameworks. By increasing the understanding and process of adaptation is meant to expedite the process of upfront estimation of resource (human and material) and constructing context-relevant guidelines compared to de time needed for the adaptation process, guideline imple- novo development. For example, the SNAP-IT framework menters and adaptors will be able to decide which frame- [28] skips the guideline search-and-select process of all works meet their needs. previous frameworks, thus saving time and resources. By go- The massive time and expertise requirements of some ing straight to the evidence (using EtD tables) for the rele- frameworks may make adaptation impractical in some vant recommendations [19], the GRADE-ADOLOPMENT contexts. Increasing the flexibility of adaptation frame- framework integrates the evidence appraisal process into the works can also help adaptors to modify the process to formation of the adapted recommendations. The impact of respond to different challenges that may arise in various these changes in the frameworks on the validity of the result- guideline adaptation contexts. Training of the local ant recommendations and the advantages in terms of re- guideline adaptation team before the adaptation process sources expended are unknown. begins could also potentially minimize some of the diffi- Fifthly, a common missing element in adaptation culties with the expertise required for the utilization of frameworks, even in the most recent ones, is that they the frameworks. As the frameworks are evolving, the im- do not advise developers how to implement the adapted pact of the modifications made to the frameworks to ex- guideline [19]. GRADE-ADOLOPMENT recognizes the pedite the process needs to be further evaluated to importance of involving local stakeholders in the adapta- ascertain the validity of the resultant recommendations tion process [19]; however, this still leaves the local and the advantages in terms of resources expended. health workers and policy-makers on their own to im- Although different implementation strategies may also plement adapted guidelines. be required for different contexts, most frameworks ad- dress only the adaptation process. An exception is the CAN-IMPLEMENT framework, which includes detailed Addressing limitations and gaps in guideline adaptation steps for implementation, evaluation, and sustainability More research in guideline adaptation and the use of assessments for the adapted guidelines. Parts of this frameworks in low- and middle-income countries will in- framework could be included in future frameworks. The crease knowledge and experience in the area. Due to the presentation and dissemination of adapted guidelines is unique challenges of these settings, frameworks could be a vital to their uptake; packaging the recommendations great tool for improving health outcomes or a great bur- with a separate implementation manual and practice/be- den for the local health system. Health care systems of havior change interventions could be explored. low- and lower middle-income countries generally have a The frameworks are all presented from the perspec- shortage of specialized groups and resources for develop- tives of the local level guideline adapters or framework ment or adaptation of guidelines [32]. This calls for developers and focused on their own processes. From greater assistance from international guideline developers the perspective of guideline developers such as WHO or (e.g., WHO) to partner with local institutions and/or gov- NHMRC, publishing a guideline that is adaptable could ernments to adapt evidence-based practice guidelines to be critically important in assisting the local adaptation local settings. process. More independent tests need to be performed to evalu- The source guideline developers could potentially in- ate the usability of the frameworks as well as to assess the clude a system for adaptation based on adaptation Wang et al. Implementation Science (2018) 13:72 Page 11 of 13 frameworks into their “implementation recommenda- Conclusion tions” section of future guidelines. This section could in- We compared adaptation frameworks that are currently clude an estimation of the time and resources (human available in the literature. Advantages and limitations of and fiscal) need for adaptation, as well as the advantages these frameworks were identified. The main advantages and limitations of different adaptation frameworks. It of frameworks include the following: first, the methodo- could also describe which recommendations in the logical rigor of the process that leads to evidence-based guideline are open to some adjustments to suit the local adapted guidelines. With the evolution of the framework context, with evidence tables to explain how far the from adapting from a range of source guidelines, to adaptors can modify them (for example, for type 2 dia- adapting recommendations from within a single guide- betes, the recommended initial treatment maybe metfor- line, to constructing evidence tables for each recommen- min, but the guideline could also include the classes of dation, the frameworks are becoming more evidence drugs for diabetes and drug combination regimens that focused. Second, the clearly laid out steps of adaptation could potentially be substituted for it and specify which frameworks provide structure to the process and in- ones not to use). This will greatly increase the efficiency creases the transparency for future groups to under- of the adaptation process as the end-users of the guide- stand, evaluate, and/or imitate the process. line will have a better idea for how far the adaptations Some limitations of the frameworks were also identi- can go. fied. First, most adaptation frameworks have been devel- The GRADE EtD tables may also be useful for this oped and utilized in high-income settings. Second, many purpose by providing specific contextual information frameworks lack formal evaluation of their impact on that the adaptor can compare and apply to their the ultimate uptake of the adapted guidelines and pa- setting, adding local information for discussion. tient outcomes. Third, many of the frameworks are re- GRADE-ADOLOPMENT hinted at the need for a source and time consuming. Fourth, the frameworks more widespread use of EtD tables to expedite their often do not describe how to implement the adapted framework and facilitate decision making by the adap- guideline. tors (i.e., whether to adopt, adapt, or de novo create We argue that the utilization of frameworks in the recommendations) [19]. Including EtD tables for each guideline implementation process can be optimized by: recommendation in an international or national guideline would mean that the issues and evidence 1. Increasing the understanding and upfront that underpin the global or regional recommendation estimation of resource and time needed and are explicit (e.g., balance of benefits and harms, ac- flexibility of adaptation frameworks to respond to ceptability of the intervention, burden of disease, re- different challenges that arise in various guideline source availability). Local adapters can then update adaptation contexts. the EtD tables with local considerations and data, 2. Capacity building in adaptation methods (i.e., leading to locally relevant and acceptable recommen- collaboration with local stake holders in dations, whether adopted or adapted. It remains to be development and implementation of adaptation determined how flexible such considerations should methods and adapted guidelines). A collaboration be at the local level as recommendations must stay between international guideline developers (e.g., true to the evidence on the balance of benefits and WHO) and local stakeholders could provide harms and other considerations in order to be valid. methodological expertise and take local needs into Currently, no single adaptation framework can be used account. for all guidelines or all contexts. In addition to choosing 3. Increasing the adaptability of the source to follow a framework that suits the setting of guideline recommendation document (e.g., WHO or adaptation, local guideline developers must also focus on NHMRC guidelines). The developers could capacity building in adaptation methods and collabor- potentially include a system for adaptation based on ation with the local stakeholders to implement optimal adaptation frameworks into their implementation guidelines for the local context. Capacity building in recommendations section of future guidelines. adaptation methods could help achieve the full potential 4. Adaptation frameworks should be rigorously tested of the frameworks. This could potentially be done by to assess the usability of the frameworks as well as collaboration between major international guideline de- to evaluate the effectiveness of the frameworks in velopers and local stakeholders, and training of local improving guideline implementation and uptake in guideline developers and policy-makers in the methods different settings. Adaptation is a key step in the of adaptation frameworks. With better knowledge in implementation process of guidelines, especially in adaptation methods, the local adaptors can expedite the the implementation of international guideline in a process of adaptation [32]. variety of contexts. The refinement of the current Wang et al. Implementation Science (2018) 13:72 Page 12 of 13 adaptation frameworks and the process of guideline Received: 18 January 2018 Accepted: 16 May 2018 adaptation would be an important step forward in changing health behaviour (of clinicians and general population alike) and the grand quest of improving References 1. World Health Organization. WHO handbook for guideline development. 2nd global health. The idea of increasing the adaptability ed. Geneva: WHO Press; 2014. of guidelines has been a recent focus of WHO [35]. 2. Institute of Medicine Committee on the Robert Wood Johnson Foundation The effect of integrating adaptation methods such Initiative on the Future of Nursing at the Institute of Medicine. The future of nursing: leading change, advancing health. Washington: National as optimized adaptation frameworks into the Academies Press (US); 2011. implementation sections of source recommendation 3. 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Steps for the implementation of guidelines. (DOCX 31 kb) guidelines. Fam Pract. 2002;19(3):223–30. 7. Maroun CE, Aouad MT, der Sanden MWG N-V, RAB O. International clinical Abbreviations guidelines at the American University of Beirut, Physical Therapy AAP: The Alberta Ambassador Program; AGREE: Appraisal of Guidelines for Department: strategy of implementation and evaluation. Internet Journal of Research and Evaluation; CPG: Clinical practice guidelines; EtD: Evidence to Allied Health Sciences & Practice. 2010;8(4):1–9. decision (mainly referring to EtD tables); GRADE: Grading of 8. Brotons C, Lobos JM, Royo-Bordonada MA, Maiques A, de Santiago A, Recommendations Assessment, Development and Evaluation; Castellanos A, et al. Implementation of Spanish adaptation of the European MAGIC: Making GRADE the irresistible choice; NHMRC: Australian National guidelines on cardiovascular disease prevention in primary care. 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Effective implementation of research into practice: search. an overview of systematic reviews of the health literature. BMC Res Notes. 2011;4:212. 12. Chakkalakal RJ, Cherlin E, Thompson J, Lindfield T, Lawson R, Bradley EH. Availability of data and materials Implementing clinical guidelines in low-income settings: a review of The raw data of this study will be made available to the publisher. literature. Global Public Health: An International Journal for Research, Policy and Practice. 2013;8(7):784–95. Authors’ contributions 13. Wang Z, Norris SL, Bero L. Implementation plans included in World Health ZW abstracted the data, analyzed the findings, prepared the figures/tables, Organisation guidelines. Implement Sci. 2016;11(1):76. and drafted the manuscript. LB and ZW developed the data abstraction and 14. Guideline International Network. Working Groups / Adaptation 2017 analysis process. LB provided the academic support and guidance [Available from: http://www.g-i-n.net/working-groups/adaptation. Accessed throughout the project and assisted in revising the manuscript. SLN 1 Apr 2017. contributed to the design of the study and provided the academic support 15. Kimaro HC. Strategies for developing human resource capacity to support and assisted in revising the manuscript. All authors read and approved the sustainability of ICT based health information systems: a case study from final manuscript. Tanzania. Electron J Inf Syst Dev Ctries. 2006;26(1):1–23. 16. Fervers B, Burgers JS, Voellinger R, Brouwers M, Browman GP, Graham ID, et Ethics approval and consent to participate al. Guideline adaptation: an approach to enhance efficiency in guideline Ethics approval and consent to participate is not applicable to this study. development and improve utilisation. BMJ Qual Saf. 2011;20(3):228–36. 17. New Zealand Ministry of Health. New Zealand Guidelines Group 2015 Competing interests [Available from: https://www.health.govt.nz/about-ministry/ministry-health- SL Norris is an employee of the World Health Organization (WHO) where she websites/new-zealand-guidelines-group. Accessed 20 Apr 2017. oversees the guideline quality assurance process and guideline methods 18. The Best Practice Advocacy Centre New Zealand. Guideline development development. She is also an active member of the GRADE Working Group. process [Available from: https://bpac.org.nz/guidelines/development- Zhicheng Wang and Lisa Bero declare that they have no competing process.html. Accessed 20 Apr 2017. interests. 19. Schunemann HJ, Wiercioch W, Brozek J, Etxeandia-Ikobaltzeta I, Mustafa RA, Manja V, et al. GRADE Evidence to Decision (EtD) frameworks for adoption, adaptation, and de novo development of trustworthy recommendations: Publisher’sNote GRADE-ADOLOPMENT. J Clin Epidemiol. 2017;81:101–10. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. 20. Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al. AGREE II: advancing guideline development, reporting and evaluation in Author details health care. CMAJ. 2010;182(18):E839–42. Faculty of Medicine and Health, The University of Sydney, Sydney, New 21. Elsadig H, Weiss M, Scott J, Laaksonen R. Use of clinical guidelines in South Wales, Australia. World Health Organization, Geneva, Switzerland. cardiology practice in Sudan. J Eval Clin Pract. 2017; Charles Perkins Centre, The University of Sydney, D17, The Hub, 6th floor, 22. Roberge P, Fournier L, Brouillet H, Delorme A, Beaucage C, Cote R, et al. A Sydney, New South Wales, Australia. provincial adaptation of clinical practice guidelines for depression in Wang et al. Implementation Science (2018) 13:72 Page 13 of 13 primary care: a case illustration of the ADAPTE method. 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Qual Saf Health Care. 2003;12(1):18–23. 28. Kristiansen A, Brandt L, Agoritsas T, Akl EA, Berge E, Bondi J, et al. Adaptation of trustworthy guidelines developed using the GRADE methodology: a novel five-step process. Chest. 2014;146(3):727–34. 29. Chakraborty SP, Jones KM, Mazza D. Adapting lung cancer symptom investigation and referral guidelines for general practitioners in Australia: reflections on the utility of the ADAPTE framework. J Eval Clin Pract. 2014; 20(2):129–35. 30. Harrison MB, Graham ID, van den Hoek J, Dogherty EJ, Carley ME, Angus V. Guideline adaptation and implementation planning: a prospective observational study. Implement Sci. 2013;8:49. 31. Harstall C, Taenzer P, Zuck N, Angus DK, Moga C, Scott NA. Adapting low back pain guidelines within a multidisciplinary context: a process evaluation. J Eval Clin Pract. 2013;19(5):773–81. 32. Amer YS, Elzalabany MM, Omar TI, Ibrahim AG, The DNL. ‘Adapted ADAPTE’: an approach to improve utilization of the ADAPTE guideline adaptation resource toolkit in the Alexandria Center for Evidence-Based Clinical Practice Guidelines. J Eval Clin Pract. 2015;21(6):1095–106. 33. Beaglehole R, Epping-Jordan J, Patel V, Chopra M, Ebrahim S, Kidd M, et al. Improving the prevention and management of chronic disease in low- income and middle-income countries: a priority for primary health care. Lancet. 2008;372(9642):940–9. 34. Okely AD, Ghersi D, Hesketh KD, Santos R, Loughran SP, Cliff DP, et al. A collaborative approach to adopting/adapting guidelines—the Australian 24- hour movement guidelines for the early years (birth to 5 years): an integration of physical activity, sedentary behavior, and sleep. BMC Public Health. 2017;17(Suppl 5):869. 35. Dedios MC, Esperato A, De-Regil LM, Peña-Rosas JP, Norris SL. Improving the adaptability of WHO evidence-informed guidelines for nutrition actions: results of a mixed methods evaluation. Implement Sci. 2017;12(1):39. 36. Graham ID, Harrison MB. Evaluation and adaptation of clinical practice guidelines. Evid Based Nurs. 2005;8(3):68–72. 37. Muth C, Gensichen J, Beyer M, Hutchinson A, Gerlach FM. The systematic guideline review: method, rationale, and test on chronic heart failure. BMC Health Serv Res. 2009;9:74. 38. Harrison MB, van den Hoek J, the Canadian Guideline Adaptation Study Group. CAN-IMPLEMENT© guideline adaptation and implementation planning resource. Kingston, Ontario, Canada: Queen’s University School of Nursing and Canadian Partnership Against Cancer; 2012. 39. The ADAPTE Collaboration. The ADAPTE process: resource toolkit for guideline adaptation. Version 2.0.: guideline international. Network. 2009; 40. Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al. AGREE II: advancing guideline development, reporting and evaluation in health care. Cmaj. 2010;182(18):E839–42. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Implementation Science Springer Journals

The advantages and limitations of guideline adaptation frameworks

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Medicine & Public Health; Health Promotion and Disease Prevention; Health Administration; Health Informatics; Public Health
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Abstract

Background: The implementation of evidence-based guidelines can improve clinical and public health outcomes by helping health professionals practice in the most effective manner, as well as assisting policy-makers in designing optimal programs. Adaptation of a guideline to suit the context in which it is intended to be applied can be a key step in the implementation process. Without taking the local context into account, certain interventions recommended in evidence-based guidelines may be infeasible under local conditions. Guideline adaptation frameworks provide a systematic way of approaching adaptation, and their use may increase transparency, methodological rigor, and the quality of the adapted guideline. This paper presents a number of adaptation frameworks that are currently available. We aim to compare the advantages and limitations of their processes, methods, and resource implications. These insights into adaptation frameworks can inform the future development of guidelines and systematic methods to optimize their adaptation. Analysis: Recent adaptation frameworks show an evolution from adapting entire existing guidelines, to adapting specific recommendations extracted from an existing guideline, to constructing evidence tables for each recommendation that needs to be adapted. This is a move towards more recommendation-focused, context- specific processes and considerations. There are still many gaps in knowledge about guideline adaptation. Most of the frameworks reviewed lack any evaluation of the adaptation process and outcomes, including user satisfaction and resources expended. The validity, usability, and health impact of guidelines developed via an adaptation process have not been studied. Lastly, adaptation frameworks have not been evaluated for use in low-income countries. Conclusion: Despite the limitations in frameworks, a more systematic approach to adaptation based on a framework is valuable, as it helps to ensure that the recommendations stay true to the evidence while taking local needs into account. The utilization of frameworks in the guideline implementation process can be optimized by increasing the understanding and upfront estimation of resource and time needed, capacity building in adaptation methods, and increasing the adaptability of the source recommendation document. Keywords: Guidelines, Adaptation, Global health, Adaptation frameworks Background individually or collectively” [1]. Guidelines are developed Guidelines can be defined as “any document containing by a range of organizations including charities endorsed recommendations for clinical practice or public health by local professional societies (e.g., The Heart Foundation policy. A recommendation tells the intended end-user of endorsed by the Royal Australian College of General the guideline what he or she can or should do in specific Practitioners (RACGP)), national health research institutes situations to achieve the best health outcomes possible, (e.g., US National Institutes of Health (NIH), the UK National Institute for Health and Care Excellence (NICE), and Australian National Health and Medical Research * Correspondence: zwan7718@uni.sydney.edu.au 1 Council (NHMRC)), and international health organiza- Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia tions (e.g., the World Health Organization (WHO)). In Charles Perkins Centre, The University of Sydney, D17, The Hub, 6th floor, order to be trustworthy, all guidelines, both clinical and Sydney, New South Wales, Australia public health, should be evidence based and should be Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Wang et al. Implementation Science (2018) 13:72 Page 2 of 13 developed using clear, explicit processes to minimize bias aspects of the local context such as resource capabilities and optimize transparency [2]. (both human and material), disease prevalence, and the values and preferences of community members. Guideline implementation If the local context is not taken into account, interven- The implementation of evidence-based guidelines can tions recommended in existing high-quality guidelines improve clinical and public health outcomes by helping may be impossible to implement. For example, recom- health professionals practice in the most effective man- mending widespread use of information and communi- ner [3, 4], as well as assisting policy-makers in designing cations technologies without adequate knowledge of optimal programs. The development of guidelines with- their use in the local health system may be more of a out adequate consideration of implementation may hin- burden than a boon to the health system [15]. Adapting der the target audiences’ adherence to the guidelines [5]. the guidelines and local capacity building in understand- Without proper implementation, the financial and hu- ing and applying the recommended interventions are man resources expended in the development of guide- vital for their successful uptake. It is not only the recom- lines are wasted. mendations within the guidelines that may need to be The implementation of guidelines in a context that is adapted to suit the local context, but also different im- different from where they were developed is particularly plementation strategies may be required for guidelines challenging. In addition, recommendations in public in different contexts. health guidelines are often more complex to implement Developing guidelines de novo requires substantial than clinical guidelines and usually target health systems time and resources—both methodological expertise and or multi-sector government institutions instead of indi- fiscal capacity. When a high-quality guideline is available vidual clinical decisions. For example, WHO develops which addresses the local need, it may be more practical guidelines for a global audience; each guideline or rec- to adapt this guideline (or selected recommendations ommendation in each guideline then needs to be consid- therein) for local use [16]. For example, until 2012, New ered for implementation at the country or sub-national Zealand had a high-quality internationally respected level (e.g., within a health system). Other examples in- guideline development program through the New clude implementation of national guidelines to the local Zealand Guidelines Group [17]. This group went into (e.g., state or provincial) context [6], international guide- voluntary liquidation in mid-2012 [17]. After this, the lines to a local hospital [7], European guidelines to indi- New Zealand Ministry of Health provided funding to a vidual countries [8], and international guidelines to new guideline organization: The Best Practice Advocacy NZ regions [9]. Centre New Zealand (bpac ) to adapt NICE clinical There are a number of systematic reviews on the guidelines for use in New Zealand based on the effectiveness of various implementation strategies for ADAPTE approach [18]. recommendations in guidelines [10–12]. Most indi- From here on, we will refer to original and established cate that active techniques are the most effective. source materials (e.g., WHO guidelines) as “source However, many guidelines do not include detailed guidelines” or “source materials,” while the new and descriptions of how the guidelines should be imple- modified guidelines/recommendations produced by the mented [13]. adaptation process will be referred to as “adapted guide- lines” or “adapted recommendations.” Guideline adaptation When a clinical practice or public health guideline is Adaptation is a key step in the implementation process needed in a specific context, recommendations can be [13]. Guidelines International Network (G-I-N) defines constructed using one of four possible approaches: guideline adaptation as “the systematic approach to the modification of a guideline(s) produced in one cultural 1) Adopt recommendations from existing evidence- and organisational setting for application in a different based source guidelines without modification; context”. Guideline adaptation is usually initiated by 2) Adapt recommendations from existing guidelines end-users at the local level (e.g., by local governments, to the new context; hospitals, and/or individual clinicians) and not by inter- 3) Develop recommendations de novo based on national (e.g., WHO) or national (e.g., NHMRC) guide- existing reviews of evidence (from source guidelines line developers. Adaptation is an alternative to de novo or systematic reviews) [19]; and guideline development such as customizing an existing 4) Develop recommendations de novo based on new guideline to the local context [14] which could be a spe- evidence syntheses. cific health setting, country, or an emergency situation. In order to achieve effective adaptation, guideline adap- Adapted guidelines can contain recommendations from a tors should take into account a number of important mixture of these approaches. Additional file 1 summarizes Wang et al. Implementation Science (2018) 13:72 Page 3 of 13 factors that may influence a local group to choose one of Table 1 Possible steps in an adaptation framework these approaches over another. 1) Form an organizing committee. 2) Choose a guideline topic. Forms of adaptation 3) Identify resources and skills required for the process. Guideline adaptation occurs via either informal or for- 4) Write an adaptation plan and form a guideline adaptation group. mal processes. 5) Determine the health questions. 6) Search for relevant guidelines and related documents. Informal adaptation Informal guideline adaptation occurs without using an 7) Formally screen and review (i.e., assess currency, content, quality, consistency between sources and acceptability/applicability of the established framework [7]. For example, when a hos- recommendations) selected guidelines. pital in Lebanon considered adapting a guideline on 8) Decide which guideline or recommendations to adapt, taking into low back pain [7], no formal adaptation framework account the quality of the source material, local conditions, and was used. The hospital guideline adapters simply practicality of the guideline/recommendations/intervention. identified international guidelines in the literature, 9) Perform external review of the adapted guideline (by target audience, compared them according to the AGREE instrument endorsement bodies, and source guideline developers). [20], and implemented the “best” one after translating 10) Schedule evidence reviews and updates of the adapted guideline. it into the local language [7]. This framework summary is based on ADAPTE [16] Informal adaptation can also be done on an individual provider or patient level [21]. Doctors in Sudan were the process of guideline adaptation through an ana- noted to adapt international guidelines on an ad hoc lysis of recent adaptation frameworks. This in turn basis, in order to suit the patient and the health care sys- will help to identify optimal characteristics of frame- tem in their country. One of the doctors interviewed in works to inform guideline development, implementa- this study said “I cannot prescribe the new drug (X) tion, and uptake. which is not found in Sudan. We stick to guidelines but with a modified picture” [21]. The high frequency of Analysis testing suggested by international guidelines may also be Description and critique of adaptation frameworks impractical in low-resource settings, as for example, The analysis drew from literature published over the past some patients may have to travel long distances for the 15 years (1 January 2002 to 1 March 2017) as this area of re- tests [21]. search is relatively new. Very few studies on guideline adap- Such ad hoc adaptations, although practical in some tation were published prior to 2002. MEDLINE, Embase, situations, can pose a risk if the intervention that is im- and CINAHL databases were systematically searched for plemented is outside of the scope of the original published accounts of formal adaptation frameworks. The evidence-based recommendation. search strategy can be found in the Additional file 1. The results were limited by language (English) and pub- Formal adaptation lication type (clinical trial, journal article, meta-analysis, This occurs when adaptation of a guideline is performed randomized controlled trial, research, review, systematic using a guideline adaptation group and an established review, multicentre study, or observational study) and framework [22]. Table 1 lists possible steps in an adapta- population (Humans NOT animals). The titles of the re- tion framework. sults were screened for relevance. Formal adaptation frameworks provide a systematic As little work has been done to review this area, the way of approaching adaptation. These frameworks are results were screened in a scoping review style without created to increase methodological rigor and quality limits on types of articles we would include or a priori of the adapted guideline [23]. Due to the complexity protocols of analytical categories of data extraction (spe- of applying formal frameworks, this type of adaptation cific features of adaptation frameworks) [25]. The cat- is always done collectively. Formal frameworks, in egories and the inclusion and exclusion criteria were contrast to informal adaptation methods, can enable refined as the data were collected. We identified eight evaluation of the evidence supporting the recommen- different frameworks, many of which were developed dations in adapted guidelines. A recent review has concurrently or build on each other. identified some of the frameworks for guideline adap- tation [24]. Timeline of frameworks Aim The timeline of framework development is illustrated in We aim to understand advantages and limitations of Fig. 1. The authors overlap in some of the frameworks existing frameworks and identify knowledge gaps in (Harrison, M. B. and Graham, I. D. worked on PGEAC, Wang et al. Implementation Science (2018) 13:72 Page 4 of 13 Fig. 1 Timeline for publication of adaptation frameworks. A brief timeline of the publication dates of the frameworks examined in the paper. Some later frameworks built on the works of previous ones. Note that certain frameworks may have been available before the publication date ADAPTE, and CAN-IMPLEMNT), which may explain The initial steps of the guideline adaptation process some of the similarities among the early frameworks. are similar among the early frameworks (PGEAC, SGR, ADAPTE, AAP, CAN-IMPLEMENT, and Adapted ADAPTE) Similarities and differences in processes of adaptation as they all used a selection of guidelines as their source mater- suggested by the frameworks ial. This process can be summarized as: As shown in Table 2, there are similarities and differ- ences in the adaptation processes suggested by the dif- 1. Define the health questions ferent frameworks. 2. Search and screen the guidelines The frameworks differ in the structure of the commit- 3. Evaluate the guidelines tees that conduct the adaptation, with a number suggest- 4. Select the single or a set of guideline/s to adapt ing two committees (organizers and guideline developers) (e.g., ADAPTE [16]), while later frameworks tend to have These earlier frameworks use versions of the AGREE more complex structures (e.g., AAP [26]). The steps of the tool to evaluate the selected guideline [20, 27]. AGREE adaptation process also differed greatly, particularly with assess the following domains: respect to how adaptation panels were selected and how they evaluated source materials; these differences will be 1. Scope and purpose explored further in the following section. 2. Stakeholder involvement The frameworks also differed in how the adapted rec- 3. Rigor of development ommendations were constructed, although consensus by 4. Clarity of presentation the panel was the most common process. The require- 5. Applicability ments of external review and plans for updating the 6. Editorial independence (conflicts of interest of adapted guideline were almost universal in the eight members of the guideline development group) frameworks. The frameworks usually suggested dissem- inating hardcopies of the adapted guidelines. The SNAP-IT by GRADE framework differs from the others as it does not select and evaluate a range Processes for selecting and evaluating source materials of guidelines. Instead, this framework suggests select- Processes for identifying and evaluating source materials ing a single well-known guideline, then modifying the for adaptation differed significantly across the frame- recommendations for the local context [28]. For ex- works (see Table 3). One point of major divergence is in ample, the guideline “Antithrombotic Therapy and the processes used to search for and evaluate the source Prevention of Thrombosis, 9th ed: American College material used in the adaptation process. Frameworks of Chest Physicians Evidence-Based Clinical Practice have evolved from a focus on identifying source guide- Guidelines (AT9)” was chosen as it was current and the lines for adaptation to identifying specific recommenda- “largest CPG to rigorously apply the GRADE method- tions for adaptation. The frameworks then evolved from ology, providing authoritative assessments of confidence a focus on recommendations to examining the evidence in evidence and explicit rationales for the strength of its underpinning the adapted recommendations. recommendations” [28]. This framework has many Wang et al. Implementation Science (2018) 13:72 Page 5 of 13 � � � � � � � � � � � � � � � Table 2 Processes of adaptation suggested by published frameworks Framework (year published) Committee structure Methods and process Updating of the How adapted External peer Presentation and Author(s) (framework summary adapted recommendations review dissemination of the development group) guideline were constructed adapted guideline (e.g., consultation, consensus, EtD tables) Practice guideline evaluation A single local Identify a clinical area to Yes Consensus in the Yes, by local Unclear, likely hardcopy and adaptation cycle interdisciplinary20 promote best practice, guideline practitioners, documents (2005) [36] guideline evaluation Search and evaluate evaluation group other Graham, I. D. Harrison, M. B. group comprising existing guidelines, stakeholders, and key stakeholders Adopt or adapt the guideline organizational for local use policy-makers for review and comment Systematic guideline review Most steps conducted Use multiple sources to No Consensus by the Yes, a multi- Hardcopy documents (2009) [37] by the 5 authors search for guidelines authors professional, Muth, C. et al. Assess quality of the interdisciplinary (“Kompetenznetz guidelines formal consensus Herzinsuffizienz” and the Collate recommendations process that German Society for General from different guidelines into included a patients’ Practice and Family Medicine “evidence tables of a representative and (DEGAM)) standardized format which apilot testing included recommendation(s), phase evidence level(s), grading, critical appraisal of evidence, and cited sources” ADAPTE (2011) [16] Dual committee Search for source guidelines Yes Consensus by the Yes, by target users, Hardcopy documents ADAPTE Collaboration structure Assess source guidelines panel consulted with (including Graham, I. D. consisting of the Adapt source guideline relevant Harrison, M. B.) organizing committee endorsement and panel of guideline bodies and the developers (usually developers of content experts) source guidelines The Alberta Ambassador Up to 6 committees Formulate the question from Yes “living” guideline Consensus by the Yes, by clinical Targeted to local Program (AAP) adaptation with distinct knowledge gaps in the that will be updated guideline development experts, implementation process (2011) [26] responsibilities in the adaptation context every 2 years group methodologists, facilitators. Including Harstall, C. et al. (The Alberta adaptation process Literature search to identify and potential internet access to the Ambassador Program) relevant source guidelines. guideline users guidelines Assess source guidelines who were not Adapt guideline written via involved in its monthly videoconferences of development the Guideline Development Group CAN-IMPLEMENT (2013) 2 or more committees Similar steps to ADAPT Yes Consensus by the panel Yes, by each Adaptation only the first [30, 38] including a steering Some steps of the adaptation stakeholder group phase of the CAN- Harrison, M. B. Graham, I. D. committee and working process done simultaneously affected by the IMPLEMENT process. et al. (The Canadian panel(s) by different sub-committees recommendations Phase 2 is development Partnership Against Cancer) of theguidelinedevelopment of training programs group. and interventions to implement new Wang et al. Implementation Science (2018) 13:72 Page 6 of 13 � � � � � � � Table 2 Processes of adaptation suggested by published frameworks (Continued) Framework (year published) Committee structure Methods and process Updating of the How adapted External peer Presentation and Author(s) (framework summary adapted recommendations review dissemination of the development group) guideline were constructed adapted guideline (e.g., consultation, consensus, EtD tables) A stronger focus on the guideline. Phase 3 implementation of guidelines involves evaluation of after their adaptation the process and outcomes SNAP-IT by GRADE (2014) [28] Editorial committee, Select one well established Dynamically update One content expert and Yes, by all relevant Published in newly Kristiansen, A. et al. (Canadian individual chapter guideline which was deemed the recommendations one methods expert on medical specialty developed web McMaster University GRADE editors to be current, of high quality, at least every 3 months the editorial committee organizations, authoring and group partnership with and used GRADE (23) reviewed each chapter local publication platform Norwegian Ministry of health) Choose recommendations of the guideline to choose ministry of health (MAGIC), including within this guideline that which recommendations and offline access on they deem relevant in the to adopt and/adapt. The the source smartphones and tablets adaption context to adopt/ panel consulted with guideline adapt editors of the source development guideline on content organization issues and when modifications were made. Adapted ADAPTE (2015) [32] Dual committee Framework based on the work Yes Consensus by the panel Yes, same as Hardcopy documents. Amer, Y. S. Elzalabany, M. M. structure consisting of ADAPTE collaboration and ADAPTE The framework include Omar, T. I. Ibrahim, A. G. of the organizing CAN-IMPLEMENT with some implementation Dowidar, N. L. committee and panel modifications to increase tools which include the timeliness and clarity of professional and the adaptation process organizational interventions, monitoring and evaluation, and an action plan for dissemination GRADE-ADOLOPMENT Methodologist group Local authorities choose N/A This framework stops Evidence to decision N/A This Unclear, in the case (2017) [19] from McMaster the key clinical questions; at the decision to either (EtD) tables framework stops described the adapted Schunemann, H. J et al. university. Guideline Identify specific adopt, adapt the source at the decision to guidelines were made (Canadian McMaster panels made up of local recommendations that recommendation/evidence, adopt, adapt the for the Kingdom of University GRADE group expert members from address those questions. or start de novo source Saudi Arabia and partnership with Saudi multidisciplinary Choose source guidelines development of a new recommendation/ dissemination was the Arabian Ministry of health) backgrounds, including based on the GRADE guideline. evidence or start responsibility of the some patient approach and constructing de novo local government representatives EtD tables development of a Revise and update these new guideline. tables are to match the local context. Abbreviations: EtD evidence-to-decision, GRADE The Grading of Recommendations Assessment, Development and Evaluation, N/A not applicable Wang et al. Implementation Science (2018) 13:72 Page 7 of 13 � � � Table 3 Processes for identification and evaluation of source material by adaptation frameworks Framework Define the health question Search and screen Evaluate guidelines Identify recommendations Evaluate recommendations Identify new evidence Evaluate evidence Practice guidelines Select a clinical question US National Guideline AGREE N/A If more than one guideline N/A N/A evaluation and based on: Clearinghouse and is being considered, a adaptation cycle The prevalence of the guideline repositories, as “content analysis” of the (PGEAC) [36] condition or its associated well as guideline recommendations in each burden developers and PubMed guideline is conducted by Concerns about large [36] clinicians experienced in variations in practice or the content area. A table is care gaps, used to compare the Costs associated with recommendations in each different practices guideline and the level of evidence supporting each recommendation Systematic guideline Not specified by the MEDLINE, The Cochrane AGREE For each clinical question Recommendations within N/A Systematic reviews cited review (SGR) [37] framework. Chronic Heart Library, DARE, and HSTAT extract data into evidence the guidelines are by the source guidelines Disease was the topic [37] tables including: evaluated for whether are re-evaluated, along already chosen for the recommendations, they are supported by with clinical studies of an review. evidence levels, grading, valid study results appropriate design when critical appraisal of secondary publications evidence, and cited did not provide the de sources. sired evidence ADAPTE [16] Topic chosen before the 26 guideline internet sites AGREE, Construct Assess acceptability (i.e., N/A N/A adaptation process. including the Cochrane Assess guideline recommendation matrices whether the Research questions Library, guideline currency, content with a list of recommendations should determined by the repositories, government and consistency recommendations and be put into practice) and guideline committee in the agencies and cancer their respective source applicability (i.e., whether patient population, clinical societies [39] guidelines to allow an organization or group intervention, professional/ comparison of the is able to put the patients (audience of the recommendations recommendation into guideline), outcomes, and practice). healthcare setting (PIPOH) format [16] Assess consistency between the evidence cited by the guidelines and the respective recommendations. The Alberta Knowledge gaps of the Search developed by AGREE modified by Evidence inventory tables Not assessed, evidence N/A N/A Ambassador Program local practitioners were research team in the research team are used by the research cited in the source (AAP) adaptation assessed along with a collaboration with team to extract data from guidelines to support the process [26] systematic review of the experienced medical source guidelines and recommendations is listed. literature on knowledge librarians (28) present all the information gaps among various required for the guideline primary case groups development group in 1 document. Discordant recommendations are highlighted CAN-IMPLEMENT from Topic chosen before the Guideline clearinghouses, AGREE II assess Construct a table or Acceptability and N/A N/A ADAPTE [30, 38] adaptation process. country-specific databases, guideline currency, “matrix” which compares Applicability of Research questions relevant specialty societies content, and similar recommendations recommendations; determined by the and web sites of consistency across multiple guidelines consistency between the guideline committee in the organizations developing between evidence and displays relative levels developers’ selected Patient population, guidelines. MEDLINE, and of evidence evidence, interpretation, Intervention, Professional/ Google, AltaVista, and recommendations and resulting patients (audience of the Yahoo [38] [40] recommendations guideline), Outcomes; and Wang et al. Implementation Science (2018) 13:72 Page 8 of 13 Table 3 Processes for identification and evaluation of source material by adaptation frameworks (Continued) Framework Define the health question Search and screen Evaluate guidelines Identify recommendations Evaluate recommendations Identify new evidence Evaluate evidence Healthcare setting (PIPOH) format [30] SNAP-IT by GRADE [28] Guideline topic requested N/A N/A A designated chapter The chapter editors then N/A If the panel decided to by the local health editor assessed each follow a predefined exclude or modify a authorities chapter and decided taxonomy to decide recommendation, a whether to adopt or adapt whether to adopt, adapt more extensive the recommendation. or develop a new reassessment of the recommendation. underlying evidence is conducted. Adapted ADAPTE [32] Determined by the Seven CPG resources AGREE II Construct a list of Assessment done when N/A N/A guideline committee in the prioritized from the recommendations and tailoring more than one Patient population, original 26-long list in their respective source guideline that includes Intervention, Professional/ ADAPTE and “DynaMed”, guidelines to allow selecting some, not all, patients, Outcomes; and BMJ Best Practice and comparison of the recommendations from Healthcare setting (PIPOH) PubMed [32] recommendations different source guidelines. format [32]) Consistency between the evidence cited by the guidelines and the respective recommendations is assessed. GRADE-ADOLOPMENT Guideline topic selected by N/A N/A Take recommendations Assess each Evidence syntheses related Systematic reviews are [19] the local health authorities from existing guidelines recommendation in EtD to the existing updated if the source that used the GRADE tables. The EtDs included recommendations were systematic reviews are approach and had publicly the summary of evidence searched for; including older than 3 months and available evidence about the benefits and systematic reviews and the results fed into the summaries in the form of harms of the intervention HTAs. EtD tables. The quality of GRADE Summary of option(s) and information the evidence was rated Findings (SoFs) tables or about the importance of using GRADE evidence profiles (EPs) the problem (e.g., baseline risk), patients’ values and preferences, resource use, costs, feasibility, acceptability, and potential impact on health equity of recommending specific intervention options in the context and affected stakeholders Note. AGREE II was published in 2010 Abbreviations: AGREE Appraisal of Guidelines for Research and Evaluation; CPG clinical practice guidelines; EtD evidence-to-decision; GRADE The Grading of Recommendations Assessment, Development and Evaluation; HTA Health Technology Assessment; N/A not applicable Wang et al. Implementation Science (2018) 13:72 Page 9 of 13 similarities to the GRADE-ADOLOPMENT developed To address the lengthy timeframe required for the years later by the same group. ADAPTE framework, the CAN-IMPLEMENT frame- Adaptation frameworks are evolving towards identify- work involves conducting concurrent tasks by multiple, ing and evaluating recommendations within a single collaborative groups to reduce the duplication of effort large guideline. Increasing, the frameworks also started [30]. By delegating tasks according to expertise of guide- to make explicit the multiple paths that the adaptors can line development group members, the workload can be take to construct adapted recommendations. For ex- shared. Additionally to address the need for methodo- ample, in SNAP-IT by GRADE, the panelists were desig- logical expertise, the CAN-IMPLEMENT team suggests nated a chapter in the source guideline to evaluate and outsourcing and consultations with specialists (e.g., li- they “reviewed each recommendation in their designated brary science, evidence appraisal) when required [30]. chapter and formally recorded their views regarding A second limitation is that the frameworks require a whether the recommendation could stand as it was or level of methodological expertise which is not available whether there was a need for modification, exclusion, or to many guideline development groups [29]. Guideline development of new recommendations” [28]. developers may need a specific methods or research GRADE-ADOLOPMENT was the first framework to team separate to the guideline development group that make a distinction between adopting and adapting a guide- can present evidence to the guideline development line. It describes three paths: (1) adopt existing recommen- group for analysis and discussion [26, 29]. To address dations as they are, (2) adapt existing recommendations to this challenge, the Alberta Ambassador Program imple- their own context, and (3) develop recommendations de ments a complex array of committees that oversee dif- novo based on available evidence syntheses [19]. These ferent tasks in the guideline adaptation process [31]: pathways were evident in a less elaborate form in SNAP-IT Steering and Advisory Committees for oversight, a by GRADE. GRADE-ADOLOPMENT goes further in that guideline development group to construct the adapted it not only searches for guidelines or recommendations in guideline, and a research team to select and appraise guidelines, it selects existing “highly credible guidelines and published guidelines, prepare background documents, evidence syntheses, including systematic reviews and and assist with writing the adapted guideline [31]. This [health technology assessments] HTAs” [19]. The evidence structure has proven problematic, however, with high from all these sources is used to construct GRADE rates of attrition of committee members and confusion evidence-to-decision (EtD) tables which include updated among participants about their roles [31]. evidence syntheses on intervention effects, with particular attention to the local health care setting and key context-specific factors [19]. Recommendations were then Gaps in knowledge about the process of guideline formulated based on the EtD tables, via consensus or voting adaptation when necessary. Our analysis of guideline adaptation frameworks has This demonstrates that frameworks have evolved from a identified a few gaps in knowledge about the process of focus on recommendations to examining the related evi- guideline adaptation. Firstly, the guideline adaptation dence (e.g., systematic reviews and HTAs). Few frame- frameworks examined in this study have been applied works described the methods used to assess whether and primarily in high- and upper middle-income countries how a specific recommendation should be adapted. and most were developed by large, experienced collabo- rations such as the GRADE Working Group [19, 28]. Only one framework (i.e., adapted ADAPTE [32]) has been Limitations of adaptation frameworks applied in a lower middle-income setting. Thus, studies of We identified several limitations to using the various guideline adaptation in low- and middle-income countries adaptation frameworks. Firstly, there is minimal guid- are needed, including exploration of the needs for, and bar- ance about the costs or time required for frameworks riers and facilitators of, guideline adaptation. Future studies like ADPATE [29]. Without a clear understanding of can explore what pragmatic and efficient processes can be how much time and resources adaptation frameworks used in resource-limited settings to product valid and im- actually save, guideline developers cannot be sure that a pactful adapted guidelines. Adaptation of a guideline in a framework is worth using [30]. The frameworks are re- high-income country may differ from a low-income coun- ported to be time and resource intensive [16, 28–32], try because low- and middle-income countries may have a despite their original purpose being to increase efficiency more severe lack of human and fiscal resources [32]. The and reduce duplication of effort compared to de novo health systems in many low- and middle-income countries guideline development [16]. Each project can take from may also have practical issues that need to be addressed in 3 years using adapted ADAPTE [32] to 18 months using the guidelines (e.g., medication/staff shortage, hospital over- ADAPTE [29]. crowding, inequity in care delivery) [33]. Wang et al. Implementation Science (2018) 13:72 Page 10 of 13 Secondly, most of the frameworks reviewed lack any effectiveness of the frameworks in improving guideline formal evaluation. In the few instances where evalua- implementation and uptake in different settings. An ex- tions have been performed, they mostly focused on per- ample of an independent test done to evaluate a frame- ceived usability of frameworks through self-administered work can be found in the NHMRC’sadaptationof surveys of the guideline developers [16], reflections from physical activity guidelines using the GRADE ADOLOP- the adaptation process recorded in a “lesson-learned log” MENT framework [34]. Where through their experience [29], and interviews with the participants in the process of adapting a guideline using the framework, the NHMRC [30]. These self-administered evaluations are not ad- provided suggestions to improve the GRADE ADOLOP- equate measures for the quality of the frameworks. MENT approach. With better evaluation, the quality of Thirdly, although the lack of methodological expertise in frameworks could be better modified and continually re- the developers was cited as a major barrier to the frame- fined to take into consideration the current limitations of works’ usability, there were no formal evaluations as to the guideline adaptation process. Evaluation of resources how having a research team with methodological expertise needed and the effect of the guideline adaptation for the could have improved the particular framework [29]. success of the whole guideline implementation and prac- Fourthly, it is unclear whether the shortcuts taken in the tice change process is important for the development of frameworks affect the resulting adapted guidelines. The future frameworks. By increasing the understanding and process of adaptation is meant to expedite the process of upfront estimation of resource (human and material) and constructing context-relevant guidelines compared to de time needed for the adaptation process, guideline imple- novo development. For example, the SNAP-IT framework menters and adaptors will be able to decide which frame- [28] skips the guideline search-and-select process of all works meet their needs. previous frameworks, thus saving time and resources. By go- The massive time and expertise requirements of some ing straight to the evidence (using EtD tables) for the rele- frameworks may make adaptation impractical in some vant recommendations [19], the GRADE-ADOLOPMENT contexts. Increasing the flexibility of adaptation frame- framework integrates the evidence appraisal process into the works can also help adaptors to modify the process to formation of the adapted recommendations. The impact of respond to different challenges that may arise in various these changes in the frameworks on the validity of the result- guideline adaptation contexts. Training of the local ant recommendations and the advantages in terms of re- guideline adaptation team before the adaptation process sources expended are unknown. begins could also potentially minimize some of the diffi- Fifthly, a common missing element in adaptation culties with the expertise required for the utilization of frameworks, even in the most recent ones, is that they the frameworks. As the frameworks are evolving, the im- do not advise developers how to implement the adapted pact of the modifications made to the frameworks to ex- guideline [19]. GRADE-ADOLOPMENT recognizes the pedite the process needs to be further evaluated to importance of involving local stakeholders in the adapta- ascertain the validity of the resultant recommendations tion process [19]; however, this still leaves the local and the advantages in terms of resources expended. health workers and policy-makers on their own to im- Although different implementation strategies may also plement adapted guidelines. be required for different contexts, most frameworks ad- dress only the adaptation process. An exception is the CAN-IMPLEMENT framework, which includes detailed Addressing limitations and gaps in guideline adaptation steps for implementation, evaluation, and sustainability More research in guideline adaptation and the use of assessments for the adapted guidelines. Parts of this frameworks in low- and middle-income countries will in- framework could be included in future frameworks. The crease knowledge and experience in the area. Due to the presentation and dissemination of adapted guidelines is unique challenges of these settings, frameworks could be a vital to their uptake; packaging the recommendations great tool for improving health outcomes or a great bur- with a separate implementation manual and practice/be- den for the local health system. Health care systems of havior change interventions could be explored. low- and lower middle-income countries generally have a The frameworks are all presented from the perspec- shortage of specialized groups and resources for develop- tives of the local level guideline adapters or framework ment or adaptation of guidelines [32]. This calls for developers and focused on their own processes. From greater assistance from international guideline developers the perspective of guideline developers such as WHO or (e.g., WHO) to partner with local institutions and/or gov- NHMRC, publishing a guideline that is adaptable could ernments to adapt evidence-based practice guidelines to be critically important in assisting the local adaptation local settings. process. More independent tests need to be performed to evalu- The source guideline developers could potentially in- ate the usability of the frameworks as well as to assess the clude a system for adaptation based on adaptation Wang et al. Implementation Science (2018) 13:72 Page 11 of 13 frameworks into their “implementation recommenda- Conclusion tions” section of future guidelines. This section could in- We compared adaptation frameworks that are currently clude an estimation of the time and resources (human available in the literature. Advantages and limitations of and fiscal) need for adaptation, as well as the advantages these frameworks were identified. The main advantages and limitations of different adaptation frameworks. It of frameworks include the following: first, the methodo- could also describe which recommendations in the logical rigor of the process that leads to evidence-based guideline are open to some adjustments to suit the local adapted guidelines. With the evolution of the framework context, with evidence tables to explain how far the from adapting from a range of source guidelines, to adaptors can modify them (for example, for type 2 dia- adapting recommendations from within a single guide- betes, the recommended initial treatment maybe metfor- line, to constructing evidence tables for each recommen- min, but the guideline could also include the classes of dation, the frameworks are becoming more evidence drugs for diabetes and drug combination regimens that focused. Second, the clearly laid out steps of adaptation could potentially be substituted for it and specify which frameworks provide structure to the process and in- ones not to use). This will greatly increase the efficiency creases the transparency for future groups to under- of the adaptation process as the end-users of the guide- stand, evaluate, and/or imitate the process. line will have a better idea for how far the adaptations Some limitations of the frameworks were also identi- can go. fied. First, most adaptation frameworks have been devel- The GRADE EtD tables may also be useful for this oped and utilized in high-income settings. Second, many purpose by providing specific contextual information frameworks lack formal evaluation of their impact on that the adaptor can compare and apply to their the ultimate uptake of the adapted guidelines and pa- setting, adding local information for discussion. tient outcomes. Third, many of the frameworks are re- GRADE-ADOLOPMENT hinted at the need for a source and time consuming. Fourth, the frameworks more widespread use of EtD tables to expedite their often do not describe how to implement the adapted framework and facilitate decision making by the adap- guideline. tors (i.e., whether to adopt, adapt, or de novo create We argue that the utilization of frameworks in the recommendations) [19]. Including EtD tables for each guideline implementation process can be optimized by: recommendation in an international or national guideline would mean that the issues and evidence 1. Increasing the understanding and upfront that underpin the global or regional recommendation estimation of resource and time needed and are explicit (e.g., balance of benefits and harms, ac- flexibility of adaptation frameworks to respond to ceptability of the intervention, burden of disease, re- different challenges that arise in various guideline source availability). Local adapters can then update adaptation contexts. the EtD tables with local considerations and data, 2. Capacity building in adaptation methods (i.e., leading to locally relevant and acceptable recommen- collaboration with local stake holders in dations, whether adopted or adapted. It remains to be development and implementation of adaptation determined how flexible such considerations should methods and adapted guidelines). A collaboration be at the local level as recommendations must stay between international guideline developers (e.g., true to the evidence on the balance of benefits and WHO) and local stakeholders could provide harms and other considerations in order to be valid. methodological expertise and take local needs into Currently, no single adaptation framework can be used account. for all guidelines or all contexts. In addition to choosing 3. Increasing the adaptability of the source to follow a framework that suits the setting of guideline recommendation document (e.g., WHO or adaptation, local guideline developers must also focus on NHMRC guidelines). The developers could capacity building in adaptation methods and collabor- potentially include a system for adaptation based on ation with the local stakeholders to implement optimal adaptation frameworks into their implementation guidelines for the local context. Capacity building in recommendations section of future guidelines. adaptation methods could help achieve the full potential 4. Adaptation frameworks should be rigorously tested of the frameworks. This could potentially be done by to assess the usability of the frameworks as well as collaboration between major international guideline de- to evaluate the effectiveness of the frameworks in velopers and local stakeholders, and training of local improving guideline implementation and uptake in guideline developers and policy-makers in the methods different settings. Adaptation is a key step in the of adaptation frameworks. With better knowledge in implementation process of guidelines, especially in adaptation methods, the local adaptors can expedite the the implementation of international guideline in a process of adaptation [32]. variety of contexts. The refinement of the current Wang et al. 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Effective implementation of research into practice: search. an overview of systematic reviews of the health literature. BMC Res Notes. 2011;4:212. 12. Chakkalakal RJ, Cherlin E, Thompson J, Lindfield T, Lawson R, Bradley EH. Availability of data and materials Implementing clinical guidelines in low-income settings: a review of The raw data of this study will be made available to the publisher. literature. Global Public Health: An International Journal for Research, Policy and Practice. 2013;8(7):784–95. Authors’ contributions 13. Wang Z, Norris SL, Bero L. Implementation plans included in World Health ZW abstracted the data, analyzed the findings, prepared the figures/tables, Organisation guidelines. Implement Sci. 2016;11(1):76. and drafted the manuscript. LB and ZW developed the data abstraction and 14. Guideline International Network. Working Groups / Adaptation 2017 analysis process. LB provided the academic support and guidance [Available from: http://www.g-i-n.net/working-groups/adaptation. Accessed throughout the project and assisted in revising the manuscript. SLN 1 Apr 2017. contributed to the design of the study and provided the academic support 15. Kimaro HC. Strategies for developing human resource capacity to support and assisted in revising the manuscript. All authors read and approved the sustainability of ICT based health information systems: a case study from final manuscript. Tanzania. Electron J Inf Syst Dev Ctries. 2006;26(1):1–23. 16. Fervers B, Burgers JS, Voellinger R, Brouwers M, Browman GP, Graham ID, et Ethics approval and consent to participate al. Guideline adaptation: an approach to enhance efficiency in guideline Ethics approval and consent to participate is not applicable to this study. development and improve utilisation. BMJ Qual Saf. 2011;20(3):228–36. 17. New Zealand Ministry of Health. 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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. 20. Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al. AGREE II: advancing guideline development, reporting and evaluation in Author details health care. CMAJ. 2010;182(18):E839–42. Faculty of Medicine and Health, The University of Sydney, Sydney, New 21. Elsadig H, Weiss M, Scott J, Laaksonen R. Use of clinical guidelines in South Wales, Australia. World Health Organization, Geneva, Switzerland. cardiology practice in Sudan. J Eval Clin Pract. 2017; Charles Perkins Centre, The University of Sydney, D17, The Hub, 6th floor, 22. Roberge P, Fournier L, Brouillet H, Delorme A, Beaucage C, Cote R, et al. A Sydney, New South Wales, Australia. provincial adaptation of clinical practice guidelines for depression in Wang et al. Implementation Science (2018) 13:72 Page 13 of 13 primary care: a case illustration of the ADAPTE method. 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Journal

Implementation ScienceSpringer Journals

Published: May 29, 2018

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