Open access Original research Current practices and challenges in adaptation of clinical guidelines: a qualitative study based on semistructured interviews Yang Song ‍ ‍,1 Monica Ballesteros,2 Jing Li,3 Laura Martínez García ‍ ‍,1,2 Ena Niño de Guzmán,1 Robin W M Vernooij ‍ ‍,4,5 Elie A Akl ‍ ‍,6,7 Francoise Cluzeau,8 Pablo Alonso-­Coello ‍ ‍1,2 To cite: Song Y, Ballesteros M, Abstract Li J, et al. Current practices Strengths and limitations of this study Objective This study aims to better understand the and challenges in adaptation of current practice of clinical guideline adaptation and ►► To ensure participants’ representativeness, we invit- clinical guidelines: a qualitative study based on semistructured identify challenges raised in this process, given that ed clinical guideline (CG) adaptation experts through interviews. BMJ Open published adapted clinical guidelines are generally of different ways, including adapted CGs, attendees 2021;11:e053587. doi:10.1136/ low quality, poorly reported and not based on published from the Guideline International Network conference bmjopen-2021-053587 frameworks. and additional strategies or sources. Design A qualitative study based on semistructured ►► To reduce participant’s bias, we complemented par- ►► Prepublication history and additional supplemental material interviews. We conducted a framework analysis for the ticipants’ views and experiences with their adapta- for this paper are available adaptation process, and thematic analysis for participants’ tion methodology publications. online. To view these files, views and experiences about adaptation process. ►► The interview format allowed us to explore the chal- please visit the journal online Setting Nine guideline development organisations from lenges of CG adaptation in depth and how the par- (http://​dx.​doi.​org/​10.​1136/​ seven countries. ticipants address specific issues. bmjopen-​2021-​053587). Participants Guideline developers who have adapted ►► The challenges highlighted by our study are likely to Received 23 May 2021 clinical guidelines within the last 3 years. We identified be universal to experienced CG adaptation develop- Accepted 27 October 2021 potential participants through published adapted clinical ers, since our participants’ selection process limits guidelines, recommendations from experts, and a review the study samples to experts with sufficiently large of the Guideline International Network Conference experience in the CG adaptation or development attendees’ list. field. Results We conducted ten interviews and identified ►► Some specific challenges, such as particular con- nine adaptation methodologies. The reasons for adapting textualisation issues, might be under-­reported in our clinical guidelines include developing de novo clinical study due to the small sample size and fewer partic- guidelines, implementing source clinical guidelines, and ipants from low-­income/middle-­income countries. harmonising and updating existing clinical guidelines. We identified the following core steps of the adaptation process (1) selection of scope and source guideline(s), Introduction (2) assessment of source materials (guidelines, Clinical guidelines (CGs) adaptation is an recommendations and evidence level), (3) decision-­ efficient methodology to develop contex- making process and (4) external review and follow-­up tualised recommendations.1 2 CG adapta- process. Challenges on the adaptation of clinical guidelines tion tailors existing trustworthy CGs for include limitations from source clinical guidelines (poor local, regional or national guidance, by quality or reporting), limitations from adaptation settings considering local contextual factors, such (lacking resources or skills), adaptation process intensity as language, availability and accessibility © Author(s) (or their and complexity, and implementation barriers. We also of services and resources, the healthcare employer(s)) 2021. Re-­use described how participants address the complexities and setting and the relevant stakeholders’ permitted under CC BY-­NC. No implementation issues of the adaptation process. cultural and ethical values.3 CG adap- commercial re-­use. See rights and permissions. Published by Conclusions Adaptation processes have been tation may lead to changes compared BMJ. increasingly used to develop clinical guidelines, with the with the original recommendations in For numbered affiliations see emergence of different purposes. The identification of (1) the specific population, intervention end of article. core steps and assessment levels could help guideline or comparator, (2) the certainty of the adaptation developers streamline their processes. More Correspondence to evidence or (3) the strength of recom- methodological research is needed to develop rigorous Ms Yang Song; mendations by including additional infor- international standards for adapting clinical guidelines. ​yangsongcochrane@​gmail.​com mation regarding the health conditions, Song Y, et al. BMJ Open 2021;11:e053587. doi:10.1136/bmjopen-2021-053587 1 Open access monitoring, implementation and implications for In addition, fundamental gaps between international research.4 Besides, CG adaptation could also be used recommendations and realistic best practice are being as an alternative method to develop de novo CGs, with reported due to poorly CG adaptation, which leaves the expectation of reducing waste of resources and health providers with non-­useful guidance.21 There is an avoiding duplication of efforts. However, this process urgent need to explore the proper adaptation process should follow a similar and systematic approach as that and share the global adaptation experience. This study of the source CGs to benefit from their quality.3 5 6 aims to better understand the current practice of CG Currently, there is no single standard adaptation adaptation and identify the challenges raised in this methodology.7 8 One systematic review identified eight process, thus providing accordance for the improvement frameworks for CG adaptation1: Resource Toolkit for of the adaptation process. Guideline Adaptation—ADAPTE instrument,9 Adapted ADAPTE,10 Alberta Ambassador programme adapta- tion phase,11 Grades of Recommendations, Assessment, Methods Development and Evaluation (GRADE) Evidence to We applied a qualitative design using semi-­ structured Decision frameworks for adoption, adaptation and de interviews. This study is part of the RIGHT-­Ad@pt project, novo development of trustworthy recommendations which aims to develop a reporting checklist for CG adap- (GRADE-­ADOLOPMENT),4 Making GRADE the irresist- tation.22 We reported findings using the Consolidated ible choice,12 RAPADAPTE for rapid guideline develop- criteria for Reporting Qualitative research checklist.23 ment,13 Royal College of Nursing (RCN)14 and Systematic From now on, we will refer to the CGs selected for Guideline Review.15 Most of these frameworks are based adaptation as ‘source CGs’, and to the evidence from the on the ADAPTE instrument,9 while some use the GRADE source CGs as ‘source evidence’. Evidence to Decision frameworks.1 4 The comparison between frameworks showed similarities in the initial and Participants final phases of the process, and notable differences in the We sampled a group of CG developers, who had been ‘adaptation’ phase of the process.1 Another recent review involved in CG adaptation over the past 3 years using categorised the frameworks into formal and informal.7 a snowball sampling method.24 We identified poten- However, new methods and experiences of CG adapta- tial participants from (1) authors lists of 16 published tion periodically emerge.16–18 adapted CGs retrieved from a search for adapted CGs via Despite this, published adapted CGs seldom used a PubMed (from 1992 to December 2019) (online supple- published adaptation methodology and their quality mental appendix 01);25 (2) suggestions from the advisory is still suboptimal.19 A systematic survey that assessed group of the RIGHT-­Ad@pt project and (3) attendees 72 published adapted CGs found that only 57 reported of the 2019 Guideline International Network (G-­ I-­ N) any details on adaptation methods, and only 23 used a conference. published adaptation methodology. The proportion of We contacted potential participants by email with an published adapted CGs satisfying the steps of ADAPTE invitation letter including (1) an introduction to the ranges from 4% to 100%. In addition, the mean score of RIGHT-­ Ad@pt project, (2) the eligibility criteria, (3) adapted CGs assessed using Appraisal of Guidelines for the purpose of the semistructured interview, (4) the Research & Evaluation II (AGREE II) was 57% for the topics to be discussed and (5) the expected contribution ‘rigour of development’ domain, and 50% for the ‘appli- from participants. We sent two email reminders within cability’ domain. Similarly, another systematic assessment 1 month. After receiving consent for participation and found that only 30% of adapted WHO CGs reported before starting the semi-­structured interviews, we circu- adaptation process methods.20 lated a more detailed description of the RIGHT-­Ad@pt Challenges faced by adaptation groups are not well project, the interview guide, and collected the Conflicts of known and are likely to vary across CG organisations. A interest (CoI) form from each participant. We continued recent review described several limitations of published to recruit participants and collect data until we reached adaptation frameworks and showed that the time to adapt saturation. CGs using the same framework varies between 18 months and 3 years.7 Besides, most adaptation frameworks require Data collection methodology expertise; this might be a barrier for many We designed an interview guide based on checklists CG adaptation groups, especially those from low-­income/ previously developed by our group, and the experience middle-­ income countries (LMICs). Although interna- obtained from the development of the RIGHT-­ Ad@ tional collaboration and providing staff training could pt checklist.22 26 27 The interview guide included four help, this should be based on a standardised adaptation sections (online supplemental appendix 02): (1) charac- process. Furthermore, most published adaptation frame- teristics of participants (country, experience in the field works were developed from adaptation experiences and of health-­related CGs and CG adaptation), (2) charac- lacked validation.7 No formal evaluation instrument or teristics of participants’ CGs developing organisation, guidance could help expertise methodologists improve (3) participants’ experiences about current practice in adaptation frameworks.7 the adaptation process and (4) participants’ views and 2 Song Y, et al. BMJ Open 2021;11:e053587. doi:10.1136/bmjopen-2021-053587 Open access experiences about challenges in the adaptation process. Participants completed the first two sections before the interview. We also asked participants to provide the published methodology that supported their adaptation processes if applicable. Interviews were conducted face to face or via teleconference and lasted approximately 40 min. We audiorecorded each interview with the partici- pant’s permission. One researcher (YS, PhD(c), female, with guideline development and adaptation experience) conducted the semistructured interviews and transcribed them verbatim. Data analysis For quantitative variables (characteristics of participants and organisations), we calculated absolute frequencies and proportions. For qualitative data regarding adaptation processes, Figure 1 Participant recruitment flow diagram. Relevant we followed a framework deductive analysis.28 First, we conference attendees were identified by screening the list of generated a priori thematic framework for the main steps conference attendees and oral presentation regarding CG of adaptation processes, based on relevant systematic adaptation. CGs, clinical guidelines; CoI, conflict of interest; reviews.1 7 Second, we sought additional concepts from the GIN, Guideline International Network. methodological evidence provided by participants. Third, we coded semistructured interviews findings against the resulting thematic framework, revised and merged codes organisations were included in framework analysis to into themes as new aspects emerged. Finally, we proposed avoid individual bias. In addition, data from individ- subthemes under the drafted thematic framework. For uals were included in the thematic analysis to reflect participants’ views and experiences about challenges, participants’ views and experiences. we applied an inductive thematic analysis; we coded the Participants interview transcripts ‘line by line’, proposed descriptive The main characteristics of participants, as well as their themes following the coding process; and generated organisations, are summarised in table 1. Participants analytical themes by analysing, organising and creating worked in nine different organisations from seven coun- descriptive subthemes.29 30 One author (YS) coded and tries, the majority being from high-­ income countries extracted qualitative data, drafted the framework and (60%; 6/10). Most participants had over 5 years of experi- proposed themes independently. Two authors (MB ence in CG adaptation (70%; 7/10). Most of the included and JL) double-­checked selected codes and the corre- organisations were research/knowledge-­ producing sponding quotations. A second senior author (PA-­ C) centres (67%; 6/9), had over 5 years of experience in reviewed the framework and themes. A final structure was CG adaptation (78%; 7/9), had a working group size that confirmed by discussion and approved by consensus. We ranged from 6 to 20 members (78%; 7/9) and spent less used NVivo (V.12 for Mac, QSR International) for quali- than 2 years to complete their adaptation process (78%; tative analysis.31 7/9). Most of these organisations had funding sources from government, medical association operation fees, Patient and public involvement national/international foundations, or the combination The patient and public were not involved in the study. of those above (78%; 7/9). Three participants declared a CoI as a coauthor of published adaptation methodology. Other participants have nothing to declare. Results We invited 39 CG adaptation developers to participate. Reasons for adapting CGs Participants were identified from published adapted We identified four main reasons for CG adaptation CGs (49%; 19/39), suggestions from the Advisory (table 2, online supplemental appendix 03): (1) to Group of the RIGHT-­ Ad@pt project (28%; 11/39), develop their own CGs; (2) to implement or endorse attendees of G-­I-­N conference (2019) (15%; 6/39) and source CGs; (3) to update an existing CG and (4) to eligible participants’ recommendations (7%; 3/39) analyse conflicting recommendations from different (See figure 1). Finally, we conducted ten semistruc- source CGs. The most common reason to adapt was to tured interviews between November 2019 and January develop CGs for their intended setting based on other 2020 until data saturation on the reason for CG adap- existing CGs, by first retrieving and adapting existing tation and methodology was reached. Data from CGs that could potentially answer their questions, saving published methodologies of different participating resources and time and avoiding duplication of efforts. Song Y, et al. BMJ Open 2021;11:e053587. doi:10.1136/bmjopen-2021-053587 3 Open access Table 1 Characteristics of study sample Table 1 Continued Characteristics of interviewees (n=10) n (%) Characteristics of interviewees (n=10) n (%) Continents (n=10)  Multiple funding without industry 3 (33)  Africa 1 (10)  Multiple funding including industry 1 (11)  Asia‡ 3 (30) *Participation in a CG development/adaptation group at  Europe 2 (20) least once in the past year.  North America 4 (40) †Participation in a CG technical team at least once in the past year or participation in methodological research. Experience in the CG field (n=10) ‡One expert is from Australia but develops CG adaptation  Experience in developing CGs* 8 (80) in Philippines, we classified the country as Philippines.  Experience in adapting CGs* 8 (80) CG, clinical guideline; NR, not reported.  Methodological experience in developing 7 (70) CGs†  Methodological experience in adapting 9 (90) Some organisations focused on implementing source CGs† CGs in the target setting through CG adaptation. Three  CG user 4 (40) organisations also updated their own CGs by adapting newly published CGs, while another conducted adapta- Years of CG adaptation experience (n=10) tion processes only when there were discrepancies among  0–5 years 3 (30) different recommendations for the same topic.  6–10 years 3 (30)  11–20 years 4 (40) Current practice Six participants reported using their own adaptation Characteristics of organisations (n=9) n (%) methodology.8 32–36 Three of them were based on the Type of organisations (n=9) ADAPTE instrument and/or the GRADE-­ADOLOPMENT  Hospital 1 (11) framework.4 9 One participant used a published adapta-  Research/knowledge producing 6 (67) tion framework9 and supplemented it with GRADE to organisation rate the certainty of the evidence.37 Two used a guideline  Service provider organisation (community) 1 (11) quality assessment tool named German Instrument for Methodological Guideline Appraisal (DELBI) to inform  University 2 (22) the CG adaptation process in their setting.38 Lastly, one  Professional medical association 2 (22) participant reported not using a formal methodology. Years of CG adaptation practice (n=9) See online supplemental appendix 04 for detailed new  0–5 years 2 (22) methodologies.  6–10 years 3 (33) Participants reported using the following nine CG adaptation methodologies (table 3):  11–20 years 3 (33) 1. ADAPTE instrument.9  >20 years 1 (11) 2. Adopt–Contextualise–Adapt framework.36 The average size of CG adaptation working group (n=9) 3. American College of Physicians guidance statement.34  0–5 1 (11) 4. American Society of Clinical Oncology CG endorse-  6–10 2 (22) ment/adaptation methodology.32 5. Cancer Care Ontario’s endorsement protocol.35  11–20 5 (56) 6. DynaMed editorial methodology.33  >20 1 (11) 7. DELBI38 Average time for CG adaptation (n=9) 8. GRADE-­ADOLOPMENT framework.4  0–1 year 3 (33) 9. Piloted adaptation Framework.8  1–2 years 4 (44) Seven of the nine methodologies were not identified in previous publications. Based on the framework analysis,  2–3 years 1 (11) we identified four main steps in the process of adapting  NR 1 (11) CGs (figure 2 and table 3). Funding source (n=9)  Government funding 2 (22) Selection of the scope and source CG(s) CG adaptation groups defined or identified CG topic,  Medical association operational fee 2 (22) scope and key questions before or after the selection of  National/international foundations 4 (44) source CGs. Most organisations reported first predefining  Self-­service fee 1 (11) the topic, scope and key questions, then searching for  Pharmacy company 1 (11) existing relevant or implementable CGs.9 32 33 35 Some also identified key questions from newly released, well-­known Continued 4 Song Y, et al. BMJ Open 2021;11:e053587. doi:10.1136/bmjopen-2021-053587 Open access Table 2 Views and experiences of CG adaptation Table 2 Continued No of No of Themes participants Themes participants Reasons for adapting CGs  At recommendation level 4 Develop their CGs  At evidence level 3  As part of de novo CG development process 3 Not applicable when single CG was included 4  To avoid duplicates and save efforts 1 Updating source evidence  To save resources and time 3 Trigger for supplement/update search of source CG(s) Implementing/endorsing for target settings 5  Source CG(s) do not answer all the questions 3 Updating existing CGs 3 of interest Solving recommendations’ controversy 1  Source CG(s) are outdated 1 Challenges for adapting CGs  Source CG(s) are consensus-­based 2 Poor reporting or the limitations of source CG(s) 2  Experts’ suggestions 2 Limited skills in advanced CG development and 3 Way of including new evidence adaptation  Literature search (eg, pragmatic search or a full 6 The intensity in terms of resources and time for 2 de novo search) adaptation  Update the search from source CG(s) 3 Specific steps of adaptation process:  Experts’ suggestions 3  Addressing context differences between source 4 If the source CG(s) are not evidence-­based or do not answer the CG(s) and adapted CG questions  Addressing inconsistency and integrate 3  Start CG de novo development process 3 recommendations from different source CG(s)  Discard the recommendation 1  Updating or supplementing with research 1 evidence  Conduct the consensus process 1 Implementation barriers 5 Considering implementation barriers Addressing context differences between source CG(s) and the Way of obtaining information adapted CG  Experts’ opinion 4 Through panel discussion 7  Literature search 5 Adapting to the target context (at CG level) Group discussion 5  Prioritising the source CG(s) according to 2 Decision making after consideration of implementation barriers different factors  Modifying the practice instead of change 1  Discarding the source CG(s) 1 recommendations Adapting to the target context (at recommendation level)  Modifying the recommendations 1  Evaluating the reason behind and reconsidering 1 Reporting the differences if needed 4 the strength of the recommendations CGs, clinical guidelines.  Contextualising by considering different factors 3  Formulating new recommendations for a 1 specific population (eg, subgroups) Adapting to the target context (at evidence level) and trustworthy CGs.4 35 The screening criteria of source CGs for a further appraisal at this preliminary stage were:  Supplementing new evidence/other 2 considerations (1) stakeholders’ preferences of CG topic;4 32 35 (2) a Reporting the differences when drafting the 3 good reputation of the CGs developers;32 34 35 (3) meth- recommendation odological quality of the source CGs;8 9 (4) clinical rele- Addressing inconsistencies between recommendations from vance to the target context33 and (5) CoIs management different source CG(s) and funding independence of the source CGs.32 Through panel discussion 2 Assessment of source materials Selecting source CG(s) with different criteria (at CG level) CG adaptation groups reviewed and assessed source CGs.  Good quality/rigorous development of source 5 We stratified this step into three levels based on partici- CG(s) pants’ reported practice:  Content relevance/suitability to the target 2 ►► Guideline level: The guideline quality, trustworthi- context ness, transparency of the process, value and relevance  Most up to date 2 to clinical practice, resource availability and inclusion  Trustworthy source CG(s) 1 of latest evidence (up to date) were assessed.9 32–36 Assessing the reason for inconsistency To rate the CG quality, most participants applied the Continued AGREE II instrument. To ensure source CGs were up Song Y, et al. BMJ Open 2021;11:e053587. doi:10.1136/bmjopen-2021-053587 5 6 Table 3 Main steps of the adaptation process Selection of the scope and source Adaptation methodology/year CG(s) Assessment of source materials Decision-­making process External review and follow-­up 9 Open access ADAPTE 2010 ►► Determining the health question ►► Source CG quality assessment ►► Review assessment ►► External review and ►► Search for existing CGs/other ►► Source CG currency assessment ►► Choosing between source acknowledgement of source relevant documents ►► Source CG content assessment CGs and recommendations CG(s) ►► Source CG(s) screening and ►► Source CG consistency ►► Consulting source CG(s) selection assessment ►► Acceptability and applicability of recommendations assessment Adopt–Contextualise–Adapt ►► Predefining CG topics 1 ►► Evaluation of methodological ►► Developing composite ►► Plan Implementation Framework 201636 ►► Search for international existing CGs quality of the source CG(s) a recommendations α ►► Focused public consultation ►► Source CG(s) selection by evaluating ►► Content review and ►► Decision making as adoption, ►► Planning and evaluation of the the implementability of the question recommendations and evidence contextualisation/adaptation CG adaptation roll out to the target setting summary according to the local context ►► Establishing partnerships ►► Identifying recommendations relevant to steps along the patient journey ►► Dealing with two or more relevant recommendations ►► Supplementing with local evidence a ACP guidance statement ►► Choosing topics with ►► Assessing quality and process ►► Presenting evidence ►► Public panel review 201934 recommendation conflictions transparency of source CG(s) summary and proposing ►► Peer review process ►► Search and selection of national-­ ►► Assessing the interpretation of recommendations ►► Publication level source CG(s) within 5 years 2 the evidence (benefits, harms, ►► Reaching consensus by ►► Financial support costs, and patient values and discussion or voting ►► Reporting preferences) ►► Updating ►► Source evidence review b ASCO CG endorsement/ ►► Based on the ASCO’s priority topics ►► Quality of source CGs appraisal ►► Evidence synthesis ►► Review by applicant adaptation methodology 201932 ►► Selection of source CGs matched by using AGREE II c with a matrix containing organisations of source CG(s) criteria 3 ►► Content review with expert’s recommendations and ►► Peer review by journal agreement on recommendations supporting evidence ►► Publication ►► SRs appraisal using AMSTAR ►► Independent evidence review ►► Derivative clinical tools/ and search for new evidence by the expert panel resources (eg, when the evidence base is ►► Modification decision ►► Updating outdated.) (eg, contextualisation, clarification, or new evidence addressing) made by the expert panel ►► Full committee approval or voting for consensus Continued Song Y, et al. BMJ Open 2021;11:e053587. doi:10.1136/bmjopen-2021-053587 Table 3 Continued Selection of the scope and source Adaptation methodology/year CG(s) Assessment of source materials Decision-­making process External review and follow-­up CCO endorsement protocol ►► Defining key topics based on the ►► Initial assessment and selection of ►► Review of the draft ►► Professional Consultation 201935 release of well-­known CGs that meet source CG(s) d endorsement document by ►► Final Publication the interest of CCO or ►► Source recommendations an expert panel ►► Maintenance/Updating ►► Defining key topics based on CG-­ assessment e ►► Consensus and approval related project and identify existing ►► Likelihood of new evidence CG addressing CCO’s topic assessment (if so, a de novo development will start) DynaMed editorial methodology ►► Based on the current existing topics ►► Critically appraisal of source ►► Evidence reporting and ►► Review by the editorial team, 201933 of Dynamed CGs regarding trustworthiness, review by clinicians topic/section editors, and EBM ►► Screening and selection of the relevance, and clinical value ►► Synthesis of multiple experts best available evidence based on ►► Rating of the strength of the evidence reports β ►► Updating daily relevance and potential impact on recommendations (eg, net benefit, ►► Based on conclusions of the clinical decision-­making and patient cost and burdens, and patients’ overviewed evidence with care value) f direct links provided ►► Rating of potential source of bias and certainty of the evidence Song Y, et al. BMJ Open 2021;11:e053587. doi:10.1136/bmjopen-2021-053587 DELBI 201938 ►► Defining key questions before ►► Quality review of source CG(s) g ►► Describing the modifications ►► External review CG adaptation 4 source CG selection ►► Source recommendation review g of recommendations process* ►► Systematic search for existing CGs ►► Systematic update of searches for ►► Criteria description for source CG primary evidence selection GRADE-­ADOLOPMENT 20174 ►► CG topic and source CG selection5 ►► Checking Evidence to Decision ►► Preparing GRADE Evidence ►► NA ►► Questions prioritisation by the panel frameworks availability of source to Decisions frameworks and from selected source CGs CGs review by an expert panel ►► Completing the GRADE Evidence ►► Formulating to Decision frameworks recommendations through ►► Updating systematic reviews of consensus or voting health effects and identifying local data h Piloted adaptation framework ►► CG topic prioritisation and Ministry ►► Source CG quality assessment i ►► Adopted/adapted/ ►► External review 20178 of Health approval ►► Identifying relevant new recommendations ►► Online access for public ►► CG search from National guideline recommendations from source compilation consultation Clearinghouse CG(s) based on panel expertise ►► Expert review ►► Updating and clinical practice settings Adaptation experience 2019 ►► Predefining health questions 6 ►► Source CG quality assessment ►► Evidence review from source ►► National external review ƚ ►► Searching for existing CG 6 using AGREE II j CG(s) ►► Identifying evidence from the ►► Decision-­making by national-­ most up-­to-­date CGs j level experts with no further ►► Underlying evidence review j details provided µ Continued Open access 7 8 Table 3 Continued Selection of the scope and source Adaptation methodology/year CG(s) Assessment of source materials Decision-­making process External review and follow-­up The criteria or clarification for topic/scope/questions selection and source CG screening: Open access 1: Quote: ‘At that time we have identified the top of the conditions for stroke and low back pain. We look at the literature, even at that time, there were so many CGs published already for those two topics.’ (Participant 10) 2: Sources were from PubMed and GIN library in the last five years or current practice, and Web of science. 3: Criteria are: high-­quality CG developers, detailed CoI management, and financially independence; or applicant organisations’ preferable. 4: Quote: ‘If the CG adaptation groups plan to develop a new CG, they will search for the existing evidence from published CGs first.’ (Participant 06) 5: Assessed the relevance to stakeholders, proposed by a professional group or prioritised by stakeholders; In addition, GRADE approach and Evidence to Decision frameworks availability are required. 6: Quote: ‘A lot of kind of process will be in a national process, and there will be specific health questions and PICOs. Then we will be asked to conduct SRs. We do have in that particular process is that the SR would include first to look at what CGs are out there, and then we will look at what SRs are out there before we conduct our systematic review.’ (Participant 09) The considerations or clarifications for the assessment of source materials: a: Quote: ‘We quickly appraise source CGs using AGREE II to ensure the source CG you are basing on are good quality; … To adapt, we update the search and include new evidence. …It means you take evidence surrounded for instance in the local context settings, there might be a new paper has been published locally, not internationally, but it answers the questions the local context actually asked. Then the recommendation could change.’ (Participant 10) b: Quote: ‘We will look at the evidence and do the assessment ourselves. If we do the quality assessment, we look at the systematic review, and if the systematic review doesn’t make sense, we will look at the primary studies.’ (Participant 07) c: Quote: ‘We do not have a numeric cut-­off for AGREE II.’ (Participant 02) d: Criteria: Scope, relevance, and timing, quality and methods, resource availability; acceptability; e: Interpretation and justification, applicability/relevance, qualifications & clarifications. f: Quote: ‘If we see many CGs agree, and we know the evidence is high quality, we don’t need to go into a lot of greater depth because everything is pointing into the right direction. If we see the CGs are disagreeing, then we may have to evaluate and see why they are disagreeing and that where we checked the currency of the content to help us to understand the disagreement.’ (Participant 01) g: Quote: ‘We don’t have a critical cut off to choose which CG to use, we do prioritise by the quality of the CG. The CG adaptation group will create CG synopses, prefer methodologically sound recommendations. …The adaptation group should be transparent if they have appropriate changes in the recommendations when the adaptation process and provide the scientific rationale behind the change.’ (Participant 03) h: We conducted rapid SRs of patient’s value, cost-­effectiveness; We considered local data suggested by panel members (patients’ value and preference, cost, resource use, population prevalence and incidence). i: Quote: ‘We request the adaptation group to assess the quality of the CGs using the AGREE II instrument. We do not have a cut-­off of the AGREE score, because sometimes there are few source CGs for the consideration of adaptation. … If there are no clear answers for several questions in the source CG(s), they looked at existing Cochrane SRs but do not conduct a new one. No cost-­effectiveness evidence was searched, but patients’ values and preferences, yes.’ (Participant 08) j: Quote: ‘If there is a CG of good quality, those are the recommendations. So, if I see a CG from NICE, or from European, our society will have both or do an AGREE appraisal. If there are good quality, I transparently put in my review about what the quality it was, and I pooled out the recommendations that could be relevant for that health question. And then I also look at the underlying evidence from those CGs, also the SRs, that independent of pooling out the if possible, a GRADE evidence table, or something that explains the magnitude of the effect and the certainty of evidence.’ (Participant 09) The considerations or clarifications for the decision-­making process: α: Quote: ‘In the most recent CG we published, we extracted the source recommendations from the source CGs, we have developed composite recommendations, which is the new recommendation based on the other CG have said…’ (Participant 10) β: ‘Current evidence, current CGs, and clinical expertise’s recommendations to support clinical decision making’. µ: Quote: ‘For people who work in the CG adaptation group they have any Evidence to Decision framework, so they will look at the quality of evidence from source CGs or other SRs.’ (Participant 09) Continued Song Y, et al. BMJ Open 2021;11:e053587. doi:10.1136/bmjopen-2021-053587 Open access to date, some participants conducted a comprehen- External review and follow-­up sive search and chose the most recent CG among Clinical Oncology; CCO, Cancer Care Ontario; CGs, clinical guidelines; CoI, conflict of interest; DELBI, German Instrument for Methodological Guideline Appraisal; GRADE, Grading of ACP, American College of Physicians; ADAPTE, Resource Toolkit for Guideline Adaptation; AGREE II, Appraisal of Guidelines for Research & Evaluation II; ASCO, American Society of ƚ Quote: ‘The national group I am referring to send the adapted CG out for comment, feedback, and input as external review. We don’t have a specific small external review team those with similar quality. ►► Recommendation level: The recommendation content, the formulation process of source recom- mendations (eg, how the net benefit, resources, patients’ values and other criteria were consid- ered), as well as the strength of recommendation Recommendations, Assessment, Development and Evaluations; NA, not applicable; NICE, National Institute for Health and Care Excellence; SR, systematic review. were reviewed.8 9 32–35 Some participants used a CG summary format to display recommendations and facilitate panel discussion.8 32 38 Recommendations were modified as needed based on the discussion of the evidence.4 33 34 ►► Evidence level: The certainty of the evidence of the Decision-­making process * Quote: ‘Our organisation doesn’t do for the CG adaptation group, but they do the external review process by themselves’. (Participant 03) source recommendations was reviewed.4 6 9 33–35 Some participants assessed the risk of bias of included primary studies and systematic reviews, and the certainty of the source evidence.32 33 Besides, updating the orig- inal search or supplementing with new evidence was also conducted at this level, if necessary.4 6 8 32 33 38 The reasons to update source evidence were: (1) it did not clearly answer all the key questions; (2) it was not adequately searched or appraised; (3) it was consid- ered outdated (eg, more than 3 years since the last Assessment of source materials search) or (4) when panel experts recommended it (table 2, online supplemental appendix 03). Decision-making process CG adaptation groups review the summarised evidence and decide whether to adapt (with modifications) or adopt (without modifications) the source recommen- dations. To support the decision, some participants DELBI is a CG assessment tool used by adaptation group to inform CG adaptation. presented the summarised evidence using a matrix or direct links containing both recommendations and evidence. Where CG developers of source CGs used The considerations or clarifications for the external review process: GRADE-­ ADOLOPMENT, the GRADE Evidence to Selection of the scope and source Decision frameworks of source CGs were reviewed or completed by the CG adaptation groups.4 Decisions were made mostly through panel discussion or voting. External review and follow-up Following the decision-­ making process, an external review or a peer review process was conducted. More- over, a follow-­ up process was scheduled, including the plan for dissemination, monitoring and updating. Those processes were similar to de novo CG development Adaptation methodology/year CG(s) processes. However, some organisations also consulted source CG developers on the changes made to source recommendations.9 32 broadly.’ (Participant 10) Challenges for adapting CGS Continued Most participants reported challenges to the adaptation and development of CGs in general (table 2, online supplemental appendix 03). Challenges of the adaptation process were: (1) limitations from source CGs, including Table 3 poor reporting and quality; (2) limited advanced CG development and adaptation skills of the CG adapta- tion group; (3) resource and time intensity required for Song Y, et al. BMJ Open 2021;11:e053587. doi:10.1136/bmjopen-2021-053587 9 Open access Selection of the scope and source guideline(s) Assessment of source materials Guideline level Recommendation level Evidence level • Quality assessment • Recommendation content • Re-rating Certainty of • Checking publication date • Recommendation consistency evidence • Trustworthiness • Evidence interpretation • Updating search of source • Applicability • Evidence to decision process guideline(s) •Supplementing with new evidence Decision making process • Reviewing the summarised evidence / assessment results • Making decisions on whether to adapt or adopt source recommendations External review & Follow up • External review or a peer review process • Dissemination • Monitoring • Updating Figure 2 Main steps of the adaptation process. CGs, clinical guidelines. adaptation; (4) challenges arising from specific adapta- to differences after considering the balance of the bene- tion process, including how to address and report context fits and harms, other factors (eg, acceptability or feasi- differences between source CGs and adapted CGs; how bility) or formulating new recommendations (eg, new to address inconsistency and integrate recommendations recommendations for subgroup population) and (3) at from different source CGs, and how to update source evidence level, by supplementing with new evidence (eg, evidence, including update search and supplement with local data). Finally, participants stated that differences additional evidence and (5) implementation barriers of and modifications were reported or documented along CG adaptation. with the adapted CG. We identified participants’ strategies for dealing with the specific challenges within the adaptation process and Addressing inconsistencies between recommendations from implementation issues (table 2, online supplemental different source CG(s) appendix 03). The inconsistency between recommendations was Addressing context differences between source CG(s) and adapted addressed by prioritising those source CGs that (1) had CG good quality or rigorous development process, (2) were According to participants’ views and experiences, the relevant to the target context, (3) were most up to date differences in setting or population between source and (4) were considered trustworthy. The reasons behind CGs and target context were addressed mainly through the inconsistency were also assessed on the recommen- panel discussion and experts’ opinions. CG adaptation dation and evidence level. At the recommendation level, groups could address these differences at multiple levels: whether (1) the inconsistency was due to a different (1) at CG level, by prioritising source CGs according to target population, (2) the evidence was sufficient or up to different criteria or discarding the entire source CGs if date and (3) the evidence was appropriately interpreted. the difference was large enough; (2) at recommendation At the evidence level, whether the source evidence was level, by modifying the strength of recommendations due appropriately assessed. 10 Song Y, et al. BMJ Open 2021;11:e053587. doi:10.1136/bmjopen-2021-053587 Open access Updating source evidence been described by previous reviews, while seven had CG adaptation groups sometimes used evidence that not.1 7 Unlike previous reviews, our study—in addition is more recent or relevant in addition to the source to summarising and comparing published frameworks— evidence. To identify new evidence, participants relied on describes the used adaptation processes in a novel struc- literature searches, including full de novo search or prag- tured way, including the stratified assessment of source matic search (eg, PubMed, local databases or Cochrane materials. This stratification fits the conceptual progres- database), updating the source search or experts’ sugges- sion of CG adaptation; Fervers et al considered two levels tions. However, half of the participants expressed their in this process, the guideline level (quality of source unwillingness to supplement with new evidence since CGs) and recommendation level (coherence between they generally based on the source CGs, maintaining the evidence and recommendations, and the applicability of merits of adaptation to save resources and time. If the specific recommendations).39 More recently, Wang et al evidence base of the source CGs was unclear or did not described a shift towards an evidence level (evidence of answer their questions, participants conducted a de novo recommendations).7 CG development process, discarded the recommendation To this day, very few studies have explored the chal- or formulated recommendations based on the discussion. lenges arising from the adaptation process. Only one review has described the limitations of using adaptation Considering implementation barriers frameworks and gaps for adaptation knowledge.7 Our CG adaptation groups considered different implemen- study identified that adaptation challenges arise from tation barriers, including medical policy, cost of the limitations of source CGs (poor quality or reporting), intervention or management, equity, applicability or limitations of adaptation settings (lacking resources or feasibility. The implementation barriers were identified skills), and the complexity of the adaptation process. In through experts’ opinions (eg, policymakers, primary addition, we described the strategies used by the partici- carers or CG adaptation panel) or literature search (eg, pants to address specific steps of the adaptation process, local data). Most of the CG adaptation groups held a thereby providing new knowledge to inform more stream- discussion to address implementation barriers by consid- lined adaptation processes: for contextualisation and ering the applicability of their settings. As a result, either reconciliation, adaptation groups could address different the recommendations or the implementation plan were issues at three levels of source materials assessment; for modified to facilitate the CG adaptation. Finally, the updating source evidence, they could add new evidence differences in implementation considerations with the through a literature search or experts’ suggestions; for source CGs and the modifications were reported in the implementation, adaptation groups could hold a panel adapted CGs. discussion, and consider modifying recommendations or the implementation plan if necessary. Discussion Limitations and strengths Our study summarises the current practice of CG adap- Our study has some limitations. We only conducted ten tation derived from different methodologies used by interviews and hence could have missed additional adap- nine organisations worldwide. We structured adaptation tation methods from other countries. In addition, we processes into four steps, including three-­ level source recruited participants from published adapted guidelines materials assessment (guideline, recommendation and and G-­I-­N attendees, limiting the study samples to experts evidence level). We identified the reasons of CG adapta- with sufficiently large experience in CG adaptation or tion groups for adaptation, the challenges faced during development field. Besides, we did not interview non-­ the process, and their strategies to overcome these. Most English-­speakers, which may bias the study results. Finally, of the identified methodologies were not discussed in we did not conduct data analysis based on country income previous systematic reviews. due to the small sample size and fewer participants from LMICs that lack resources and technical/methodolog- Our findings in the context of previous research ical experts.21 The challenges highlighted by our study We described reasons for conducting adaptation are likely to be universal within experienced guideline processes, which has not been previously highlighted in adaptation developers (eg, intensity and complexity of the literature.1 7 Fervers et al defined CG adaptation as adaptation process, limitations of source CGs, and imple- an alternative methodology to developing de novo CGs mentation barriers). However, some specific challenges, or as a systematic method to improve implementation.39 such as specific contextualisation issues, would be under-­ Our findings reflect this definition and suggest that most reported in our study. adaptation groups are conducting adaptation processes Our study also has some strengths. We invited CG adap- as part of their CG de novo development. Besides, we iden- tation experts from identified adapted CGs, attendees tified that adaptation processes could also play a role in from the G-­I-­N conference, and other additional strate- updating and harmonising source recommendations. gies or sources to ensure representativeness. To reduce We identified nine adaptation methodologies that CG participant’s bias, we complemented participants’ views adaptation groups have been using, two of which had and experiences with their adaptation methodology Song Y, et al. BMJ Open 2021;11:e053587. doi:10.1136/bmjopen-2021-053587 11 Open access publications. The interview format allowed us to explore Decisions frameworks from source CGs. A standardised the challenges of CG adaptation in depth and how and pragmatic adaptation methodology, including guid- the participants address specific issues. Moreover, we ance on how to make judgements, should be developed. conducted a framework analysis based on published Furthermore, there is still a need of a validated quality adaptation frameworks, ensuring our findings’ compre- assessment tool and comprehensive reporting guidance hensiveness. Finally, we presented the results in a user-­ to improve the rigorous CG adaptation. The structured friendly format, including tables and figures. adaptation process could be considered as a critical aspect of the quality assessment. Implication for practice CG adaptation has been increasingly used in the guideline Author affiliations arena with diverse initiatives emerging and can be used as 1 Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant a pragmatic methodology to develop recommendations. Pau), Barcelona, Spain 2 In 2020, an international WHO collaboration project Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain developed a living map of the latest evidence-­ based 3 Research Institute (VHIR), Universitat Autònoma de Barcelona, Vall d’Hebron recommendations for the prevention and treatment of Hospital Universitari, Barcelona, Spain COVID-­19.40 This project makes the source materials 4 Department of Nephrology and Hypertension, University Medical Centre Utrecht, available online and allows CG developers to adopt or Utrecht, The Netherlands 5 adapt relevant recommendations for their questions of Julius Center for Health Sciences and Primary Care, University Medical Centre interest. CG developers could therefore avoid duplication Utrecht, Utrecht, The Netherlands 6 Department of Health Research Methods, Evidence, and Impact (HEI), McMaster of efforts and focus on how to implement scientific guid- University, Hamilton, Ontario, Canada ance to tackle this public health crisis. 7 Department of Internal Medicine, American University of Beirut, Beirut, Lebanon Adaptation processes should be conducted rigorously. 8 Consultant, London, UK The identified core steps of the adaptation process and assessment levels could help CG adaptation groups stream- Acknowledgements YS is a doctoral candidate for the PhD in Methodology of line their future initiatives. CG adaptation groups could Biomedical Research and Public Health (Department of Paediatrics, Obstetrics and Gynaecology and Preventive Medicine), Universitat Autònoma de Barcelona, predefine the level of source materials to evaluate, simpli- Barcelona, Spain. fying the adaptation process while remaining rigorous. The Contributors YS, PA-­C, LMG, MB, EAA, FC and RWMV participated in protocol adaptation process overlaps with the CG de novo process drafting. YS collected and analysed data. MB and JL reviewed the data for when assessing source materials at the recommendation accuracy. ENdG provided methodological contributions for the data analysis. YS level and the evidence level. At the recommendation level, and PA-­C interpreted the results and wrote the first draft of the manuscript. All CG adaptation groups need to review the factors consid- authors critically reviewed the manuscript and approved its final version. YS took responsibility for guaranteeing the overall content and ensuring integrity and ered to formulate source recommendations. This process accuracy. uses an approach similar to that applied by the source Funding YS is funded by China Scholarship Council (No 201707040103). panels and requires explicit and transparent reporting on Competing interests EAA has intellectual CoIs related to his contribution to the formulation of source recommendations to achieve the development of methods of guideline adaptation, the RIGHT statement and feasibility. For example, if source CGs followed the GRADE methodological studies in the field. Evidence to Decision frameworks, the adaptation groups Patient consent for publication Not applicable. need to review the interpretation of evidence regarding Ethics approval The protocol obtained a waiver approval (did not involve patients, each factor considered under the Evidence to Decision biological samples or clinical data) from the Clinical Research Ethics Committee at frameworks. Not all robust source CGs use the GRADE the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain). Evidence to Decision frameworks, but yet, describe in detail Provenance and peer review Not commissioned; externally peer reviewed. how they make recommendations. Similarly, at the evidence Data availability statement All data relevant to the study are included in the level, the boundary between the CG adaptation process and article or uploaded as online supplemental information. the de novo process blurs. The notable difference could be Supplemental material This content has been supplied by the author(s). It has that a de novo process conducts a full de novo search while not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been the adaptation process updates the source search or supple- peer-­reviewed. Any opinions or recommendations discussed are solely those ments it with local evidence. Although the structured adap- of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content tation process could be used as a framework, its usability includes any translated material, BMJ does not warrant the accuracy and reliability should be further formally assessed and validated. of the translations (including but not limited to local regulations, clinical guidelines, Implication for future research terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise. There is still room for improving adaptation method- Open access This is an open access article distributed in accordance with the ology, especially the efficiency of adaptation processes Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which and the quality as well as credibility of CG adaptation. permits others to distribute, remix, adapt, build upon this work non-­commercially, Besides, there is no framework to guide CG adaptation and license their derivative works on different terms, provided the original work is groups to make judgements on whether to adapt, adopt properly cited, appropriate credit is given, any changes made indicated, and the use or develop de novo recommendations based on the is non-­commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/. assessment of source materials. Although the GRADE-­ ORCID iDs ADOLOPMENT is available, it requires the Evidence to Yang Song http://​orcid.​org/​0000-​0002-​4094-​1388 12 Song Y, et al. 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