Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2019-031767 on 24 September 2019. Downloaded from http://bmjopen.bmj.com/ on December 19, 2023 at Univesity Autonomous of Extending the RIGHT statement for reporting adapted practice guidelines in healthcare: the RIGHT-Ad@pt Checklist protocol Yang Song,1 Andrea Darzi,2 Monica Ballesteros,3 Laura Martínez García,‍ ‍ 1,4 Pablo Alonso-Coello,1,4,5 Thurayya Arayssi,6 Soumyadeep Bhaumik,7 Yaolong Chen,8,9 Francoise Cluzeau,10 Davina Ghersi,11 Paulina F Padilla,12 Etienne V Langlois,13 Holger J Schünemann,5 Robin W M Vernooij,14 Elie A Akl2,5,15 To cite: Song Y, Darzi A, Abstract Ballesteros M, et al. Extending Strengths and limitations of this study Introduction The adaptation of guidelines is an the RIGHT statement for increasingly used methodology for the efficient reporting adapted practice ►► There is no current tool for reporting adapted development of contextualised recommendations. guidelines in healthcare: guidelines. The extension of the RIGHT statement Nevertheless, there is no specific reporting guidance. the RIGHT-Ad@pt Checklist for adapted practice guidelines (RIGHT-Ad@pt protocol. BMJ Open The essential Reporting Items of Practice Guidelines in Checklist) will fill this gap and provide a clear guid- Healthcare (RIGHT) statement could be useful for reporting Barcelona. Protected by copyright. 2019;9:e031767. doi:10.1136/ ance for the reporting of guideline adaptation. bmjopen-2019-031767 adapted guidelines, but it does not address all the ►► To develop the checklist, we will use the best avail- important aspects of the adaptation process. The objective ►► Prepublication history and able methodological research evidence, adopt a sys- of our project is to develop an extension of the RIGHT additional material for this tematic and rigorous multistep process and collect statement for the reporting of adapted guidelines (RIGHT- paper are available online. To and build on the views and experiences of interna- view these files, please visit Ad@pt Checklist). tional stakeholders including guideline methodolo- the journal online (http://​dx.​doi.​ Methods and analysis To develop the RIGHT-Ad@pt gists, policymakers, journal editors and guideline org/​10.​1136/​bmjopen-​2019-​ Checklist, we will use a multistep process that includes: users. 031767). (1) establishment of a Working Group; (2) generation of ►► The RIGHT-Ad@pt Checklist can be used within an initial checklist based on the RIGHT statement; (3) Received 17 May 2019 guideline adaptation to guide reporting, to improve optimisation of the checklist (an initial assessment of Revised 30 July 2019 the completeness of reporting, to evaluate publi- adapted guidelines, semistructured interviews, a Delphi Accepted 19 August 2019 cations and to inform implementation decisions of consensus survey, an external review by guideline healthcare. developers and users and a final assessment of adapted ►► We will not conduct a complete formal validation guidelines); and (4) approval of the final checklist. At each of the checklist since our current process will not step of the process, we will calculate absolute frequencies include an assessment of neither construction nor and proportions, use content analysis to summarise and criterion validity. draw conclusions, discuss the results, draft a report and refine the checklist. Ethics and dissemination We have obtained a waiver of approval from the Clinical Research Ethics Committee provide guidance for policies or public health at the Hospital de la Santa Creu i Sant Pau (Barcelona, interventions, changes in resource availability Spain). We will disseminate the RIGHT-Ad@pt Checklist or access to services based on evidence.1 by publishing into a peer-reviewed journal, presenting to relevant stakeholders and translating into different There is evidence that the methodological © Author(s) (or their quality of guidelines has slowly improved over employer(s)) 2019. Re-use languages. We will continuously seek feedback from permitted under CC BY-NC. No stakeholders, surveil new relevant evidence and, if the last decades.2–4 However, most guideline commercial re-use. See rights necessary, update the checklist. developers do not have enough resources and permissions. Published by for developing high-quality de novo guide- BMJ. lines.5 Most low/middle-income countries For numbered affiliations see Introduction still do not have formal organisations, tech- end of article. The WHO defines guidelines as ‘systemati- nical capacity or collaborations to develop Correspondence to cally developed evidence-based statements evidence-based guidelines.6 When guidelines Dr Laura Martínez García; which assist providers, recipients and other are developed in those settings, their quality ​laura.​martinez.​garcia@​ stakeholders to make informed decisions is typically poor.7–13 Adapting published cochrane.​es about appropriate health interventions.’ high-quality evidence-informed guidelines Dr Elie A Akl; ​ea32@​aub.​edu.​lb Guidelines have been increasingly used to becomes a more efficient option.14–16 Song Y, et al. BMJ Open 2019;9:e031767. doi:10.1136/bmjopen-2019-031767 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-031767 on 24 September 2019. Downloaded from http://bmjopen.bmj.com/ on December 19, 2023 at Univesity Autonomous of Adaption of guidelines means the use of existing the design, conduct, analysis and interpretation of a study, trustworthy guidelines, with (adapt) or without (adopt) and to assess the validity of results.26 27 A transparent modifications, to provide local, regional or national guid- reporting approach could help guideline developers frame ance.15–17 Schünemann et al defined adapted recommen- the decision-making during the development process, and dations as recommendations with: (1) potential change guideline users about the suitability for adapting, and conse- in the specific population, intervention, or comparator quently the adaptation process. with respect to the original recommendations; (2) poten- Currently, the main tools available for the reporting of tial change in the certainty of the evidence; and (3) infor- guidelines development are: (1) the Appraisal of Guide- mation on ‘conditions’, monitoring, implementation and lines for Research and Evaluation II (AGREE II) instru- implications for research.16 Adopted recommendations ment, including the AGREE Reporting Checklist28; and were defined as recommendations with: (1) the same (2) the Reporting Items of Practice Guidelines in Health- specific population, intervention and comparators as care (RIGHT) statement to improve the reporting of the original recommendations; (2) the same certainty guidelines.29 The RIGHT statement was formally devel- of the evidence; and (3) information on implementa- oped as a reporting checklist for de novo guidelines.29 tion.16 Adaptation of guidelines is an increasingly used Although it could be useful for the reporting of adapted methodology for the efficient development of contex- guidelines,30 it does not cover some of the steps that tualised recommendations that are relevant for diverse are specific to guidelines adaptation (eg, description of health systems.16–18 Guideline adaptation takes into methods used to search and identify guidelines).29 There- consideration local contextual factors such as language, fore, to ensure rigour, transparency, clarity and reproduc- availability and accessibility of services and resources, the ibility of reporting the adaptation process, we will develop healthcare setting and the relevant stakeholders’ cultural an extension of the RIGHT statement for the reporting of and ethical values.19 At the same time, it should be based adapted guidelines. on similar systematic and transparent approaches as the source guideline in order to benefit from its quality and Objective Barcelona. Protected by copyright. validity.20 However, adaptation is not always possible. For To develop the RIGHT-Ad@pt Checklist as an extension example, when a trustworthy guideline is not available, of the RIGHT statement tailored to adapted guidelines. a de novo guideline development process needs to be considered.16 21 Despite the increasing need, there is no standard adap- tation method implemented internationally.21 22 A system- Methods and analysis atic review of the literature identified eight published To develop the checklist, we will build on the RIGHT frameworks for adaptation of clinical, public health or statement,29 review methodology research evidence on health system guidelines, concluding that the ‘adapta- guidelines adaptation23–25 and adopt a multistep process tion’ phases of the processes were notably different.23 we have successfully implemented in the development of Moreover, the process for adapting guidelines was usually similar tools.31 32 Table 1 describes the multistep devel- poorly reported, including WHO guidelines.24 For opment process of the RIGHT-Ad@pt Checklist, which example, Godah et al systematically assessed the processes includes: (1) establishment of a Working Group; (2) employed in the adaptation of WHO guidelines for HIV generation of an initial checklist; (3) optimisation of the and tuberculosis. Out of 170 eligible adapted guidelines, checklist (an initial assessment of adapted guidelines, only 32 (32/170, 19%) reported the methods used in semistructured interviews, a Delphi consensus survey, an the adaptation process.24 Similarly, Abdul-Khalek et al external review by guideline developers and users and a assessed the methods used for adapting health-related final assessment of adapted guidelines); and (4) approval guidelines published in peer-reviewed journals.25 Out of of the final checklist. Figure 1 illustrates the development the 72 included adapted guidelines, 57 reported some process, and figure 2 presents the timeline. degree of detail about the adaptation method used, and only 23 (23/57, 40%) reported using a specific adaptation Establishment of the RIGHT-Ad@pt Working Group method. These findings call for a need to optimise the The RIGHT-Ad@pt Working Group will include: (1) a methods used in guideline adaptation, and to improve Coordination Team; (2) an Advisory Group; and (3) a the reporting of the adaptation process in adapted Delphi Panel.26 31 32 guidelines.24 Guidelines for reporting health research have been devel- Coordination Team oped to enhance the accurate, complete and transparent The Coordination Team (YS, MB, LMG, PAC, EAA) will lead reporting of health research publications (http://www.​ and coordinate the RIGHT-Ad@pt development process equator-​network.​org/). Moher et al defined a reporting and ensure its completion according to the established time- guideline as ‘a checklist, flow diagram, or explicit text to line. Specifically, the Coordination Team will be responsible guide authors in reporting a specific type of research, devel- for (1) generating the initial version of the checklist; (2) oped using explicit methodology.’26 Its aim is to indicate the implementing each step of the process; and (3) reporting minimum reporting standards, for readers to comprehend the findings of each step of the processes. We have collected 2 Song Y, et al. BMJ Open 2019;9:e031767. doi:10.1136/bmjopen-2019-031767 Table 1 Description of the multistep development process Approval of the Optimisation of the checklist final checklist Establishment Generation Initial assessment External review External review Final assessment of the Working of the initial of adapted Semistructured Delphi consensus by guideline by guideline of adapted Group checklist guidelines interviews survey developers users guidelines Main To identify To develop the To assess the To explore To define the list of To assess the To assess the To assess the To approve the objective individuals who initial version of adequacy of each current practices items to be included usefulness of each usefulness of adequacy of each final version of are relevant to the checklist item of the checklist in adaptation of in the checklist item of the checklist each item of the item of the checklist the checklist participate in the guidelines checklist project Study design – – Methodological Semistructured Delphi consensus Survey Semistructured Methodological – survey of adapted interviews survey interviews survey of adapted guidelines guidelines Song Y, et al. BMJ Open 2019;9:e031767. doi:10.1136/bmjopen-2019-031767 Participants ►► Coordination ►► Coordination Coordination Team Guideline Delphi Panel Guideline Guideline users Coordination Team ►► Coordination Team Team (two reviewers) developers Members developers (two reviewers) Team ►► Advisory ►► Advisory ►► Advisory Group Group Group ►► Delphi Panel   Members Main – – Applicability rating Participants’ Items considered Usefulness rating Participants’ Applicability rating – outcome of each item of the views and relevant to report of each item of the views and of each item of the checklist experiences the adaptation of checklist experiences with checklist with process guidelines the checklist for adapting guidelines Study size Convenience – Convenience sample Sampling 20–30 participants GIN community Sampling Convenience – sample of 10 adapted saturation from GIN saturation sample of 10 guidelines Adaptation adapted guidelines Guidelines Working Group, WHO and authors of adapted guidelines GIN, Guidelines International Network. Open access 3 Barcelona. Protected by copyright. BMJ Open: first published as 10.1136/bmjopen-2019-031767 on 24 September 2019. Downloaded from http://bmjopen.bmj.com/ on December 19, 2023 at Univesity Autonomous of Open access BMJ Open: first published as 10.1136/bmjopen-2019-031767 on 24 September 2019. Downloaded from http://bmjopen.bmj.com/ on December 19, 2023 at Univesity Autonomous of participated in guideline development groups and/ or guideline adaptation groups at least once in the past year); (3) guideline users (defined as healthcare profes- sionals that use guidelines on a regular basis); and (4) journal editors of guideline-related journals.26 Members of the Advisory Group will review and provide expert advice during the different steps of the RIGHT-Ad@pt development process. The Advisory Group will approve the final checklist and accompanying guidance. We have collected the CoIs of all members of the Advisory Group (online supplementary file 1). Delphi Panel The Delphi Panel will be comprising 20–30 members, with profiles similar to those of the members of the Advisory Group (guideline methodological experts, guideline developers, guideline users and journal editors of guideline-related journals).33 34 We will aim for country income, gender and profile representative- ness of participants. We will identify participants from the Guidelines International Network (GIN) Adapta- tion Guidelines Working Group (http://www.​g-​i-​n.​net/​ working-​groups/​adaptation), WHO, authors of adapted Barcelona. Protected by copyright. guidelines25 and expert colleagues. The panel’s CoIs will be collected. Figure 1 Multistep development process of RIGHT-Ad@pt. RIGHT, Reporting Items of Practice Guidelines in Healthcare. Generation of the initial checklist The Coordination Team will generate the initial version the conflicts of interests (CoI) of all members of the Coordi- of the checklist building on the RIGHT statement.29 We nation Team (online supplementary file 1). will conduct this step via monthly face-to-face and online Advisory Group meetings within the Coordination Team. The Coordi- The Advisory Group is a multidisciplinary group (8–10 nation Team will review the results, draft a report with a people) including (1) guideline methodological experts proposal of the initial version for the Advisory Group to (defined as having experience and expertise in guideline review and produce a final version taken into consider- methods); (2) guideline developers (defined as having ation their feedback. Figure 2 Timeline of RIGHT-Ad@pt. RIGHT, Reporting Items of Practice Guidelines in Healthcare. 4 Song Y, et al. BMJ Open 2019;9:e031767. doi:10.1136/bmjopen-2019-031767 Open access BMJ Open: first published as 10.1136/bmjopen-2019-031767 on 24 September 2019. Downloaded from http://bmjopen.bmj.com/ on December 19, 2023 at Univesity Autonomous of Table 2 Research design steps relevant to the optimisation of the checklist and corresponding variables Initial External review Final assessment Delphi assessment of adapted Semistructured consensus Guideline of adapted guidelines interviews survey developers Guideline users guidelines Response rate X X Characteristics of X X X X participants and workplaces Characteristics X X of adapted guidelines Completeness of X X reporting Participants’ XX XX views and experiences Assessment of XX X XX XX X XX each item (adequacy and (understanding and (inclusion, (usefulness, (understanding (adequacy and suggestions) suggestions) understanding understanding and suggestions) suggestions) and suggestions) and suggestions) Overall X X X X assessment of the Barcelona. Protected by copyright. checklist XX: main outcome; X: other outcomes. Optimisation of the checklist Semistructured interviews Initial assessment of adapted guidelines We will survey guideline developers who were involved We will survey published adapted guidelines using initial in guideline adaptation over the past 3 years. We will checklist. We will explore the adequacy of each item explore participants’ views and experiences on guidelines (defined as overall completeness of reporting as well adaptation, and refine the checklist. We will also record as the quantity of example supporting the item35), and the characteristics of participants and their workplaces, refine the checklist. We will also record the main char- participants’ understanding of each item, suggestions to acteristics of the adapted guidelines (eg, title, year or improve the checklist and participants’ overall assessment adaptation process), completeness of reporting process of the checklist (table 2). Each interview will last approx- for adapting guidelines and suggestions to improve the imately 1 hour and will be recorded and transcribed with checklist (table 2). participant’s permission. The interview transcripts will be We will assess a convenience sample of 10 adapted sent to interviewees for approval. guidelines available in English and published in the last We will identify the participants with the support of the 5 years.36 We will also take into account country income Advisory Group. We will contact via email and conduct level, type of organisation and region. Two reviewers online interviews. We will continue recruitment and from the Coordination Team will independently apply collect data until information becomes repetitive and no the initial version of the checklist to adapted guidelines. new information emerges (sampling saturation).37 38 The two reviewers will resolve potential disagreements by For quantitative variables (characteristics of participants discussion, and if necessary, by consulting a third reviewer. and workplaces, participants’ understanding of each item For quantitative variables (characteristics of adapted and participants’ overall assessment of the checklist), we guidelines, completeness of reporting and adequacy), we will calculate absolute frequencies and proportions. For will calculate absolute frequencies and proportions. For qualitative variables (participants’ views and experiences, qualitative variables (suggestions to improve the check- and suggestions to improve the checklist), we will use list), we will use content analysis to summarise and draw content analysis to summarise and draw conclusions.39 conclusions.36 The Coordination Team will review the The Coordination Team will review the results, draft a results, draft a report, review and agree on the relevant report, review and agree on the relevant checklist modi- checklist modifications. If members of the Coordination fications. If members of the Coordination Team do not Team do not reach consensus on specific items, they will reach consensus on specific items, they will consult the consult the Advisory Group. Advisory Group. Song Y, et al. BMJ Open 2019;9:e031767. doi:10.1136/bmjopen-2019-031767 5 Open access BMJ Open: first published as 10.1136/bmjopen-2019-031767 on 24 September 2019. Downloaded from http://bmjopen.bmj.com/ on December 19, 2023 at Univesity Autonomous of Delphi consensus survey We will identify participants by contacting professionals We will conduct a Delphi consensus survey to reach a associated with the GIN community (http://www.​g-​i-​n.​ consensus with the Delphi Panel about the included items net) and WHO. We will use online software to design in the checklist. We will also record response rate, char- the survey and collect responses (http://www.​clinapsis.​ acteristics of participants and workplaces, participants’ com/). understanding of each item, suggestions to improve For quantitative variables (response rate, characteristics the checklist and participants’ overall assessment of the of participants and workplaces, usefulness score, partic- checklist (table 2). ipants’ understanding of each item and participants’ Before the first Delphi round, we will provide the overall assessment of the checklist), we will calculate Delphi Panel Members with a brief background material absolute frequencies and proportions. For qualitative on the topic. In the first Delphi round, we will ask partici- data (suggestions to improve the checklist), we will use pants to rate whether each item should be included in the content analysis to summarise and draw conclusions.39 checklist using a 7-point Likert scale (1=strongly disagree We will not consider questionnaires with no response for and 7=strongly agree).31 32 40 We will calculate the median more than 20% of the items. score for inclusion of each item and will classify them as External review by guideline users (1) excluded (median score of 1–3 points); (2) review, We will conduct external review semistructured inter- modify and retest (median score of 4–5 points or with views with guideline users who have used adapted guide- substantial comments); and (3) included (median score lines over the past 3 years. We will explore participants’ of 6–7 points and without substantial comments).31 32 After views and experiences using the checklist, and refine each Delphi round, we will provide feedback to Delphi the checklist. We will also record the characteristics of Panel Members (data reported will be anonymised). We participants and workplaces, participants’ understanding will conduct additional Delphi rounds until consensus of each item, suggestions to improve the checklist and regarding items inclusion is reached (median score of participants’ overall assessment of the checklist (table 2). 6–7) and no more relevant comments on the items are Barcelona. Protected by copyright. Each interview will last approximately 1 hour and will be provided (two or three rounds, as needed). We will use recorded and transcribed with participant’s permission. online software to design the survey and collect responses The interview transcripts will be sent to interviewees for (http://www.​clinapsis.​com/). We will not invite non-re- approval. sponders or partial responders (questionnaires with no We will identify the participants with the support of the response for more than 20% of the items) to subsequent Advisory Group. We will contact via email and conduct Delphi rounds. online interviews. We will continue recruitment and For quantitative variables (response rate, characteristics collect data until information becomes repetitive and no of participants and workplaces, inclusion score, partici- new information emerges (sampling saturation).37 38 pants’ understanding of each item and participants’ For quantitative variables (characteristics of partic- overall assessment of the checklist), we will calculate abso- ipants and workplaces, usefulness score, participants’ lute frequencies and proportions. For qualitative data understanding of each item and participants’ overall (suggestions to improve the checklist), we will use content assessment of the checklist), we will calculate absolute analysis to summarise and draw conclusions.39 We will not frequencies and proportions. For qualitative data (partici- consider questionnaires with no response for more than pants’ views and experiences, and suggestions to improve 20% of the items. The Coordination Team will review the the checklist), we will use content analysis to summarise results of the Delphi consensus survey, draft a report with and draw conclusions.39 The Coordination Team will a proposal for the Advisory Group to review and produce review the results of the external review (guideline devel- a final version taken into consideration their feedback. opers and users), draft a report with a proposal for the Advisory Group to review and produce a final version External review taken into consideration their feedback. External review by guideline developers We will survey guideline developers who were involved in Final assessment of adapted guidelines guideline adaptation over the past 3 years. We will explore We will conduct a final assessment of the validity of each usefulness of each item (defined as provision of enough item in a set of adapted guidelines. We will also record the and clear information in order to be used with effective- main characteristics of the adapted guidelines (eg, title, ness, efficiency and satisfaction to check the reporting year or adaptation process), completeness of reporting of adapted guidelines41) using a 7-point Likert scale process for adapting guidelines and suggestions to (1=strongly disagree and 7=strongly agree),40 and refine improve the checklist (table 2). the checklist. We will also record response rate, charac- We will assess a convenience sample of 10 adapted teristics of participants and workplaces, participants’ guidelines available in English and published in the last understanding of each item, suggestions to improve 5 years.36 We will also take into account country income the checklist and participants’ overall assessment of the level, type of organisation and region. Two reviewers from checklist (table 2). the Coordination Team will independently apply the final 6 Song Y, et al. BMJ Open 2019;9:e031767. doi:10.1136/bmjopen-2019-031767 Open access BMJ Open: first published as 10.1136/bmjopen-2019-031767 on 24 September 2019. Downloaded from http://bmjopen.bmj.com/ on December 19, 2023 at Univesity Autonomous of version of the checklist to adapted guidelines. The two development, which will be done through an extension of reviewers will resolve potential disagreements by discus- the GIN-McMaster Guideline Development Checklist.43 sion, and if necessary, by consulting a third reviewer. For quantitative variables (characteristics of adapted Strengths and limitations guidelines, completeness of reporting and adequacy), we Our proposal has some limitations. For example, we will will calculate absolute frequencies and proportions. For only include guidelines published in English in the assess- qualitative variables (suggestions to improve the check- ment of adapted guidelines. The checklist will inform list), we will use content analysis to summarise and draw about the completeness of the reporting but not neces- conclusions.39 The Coordination Team will review the sarily about the quality of the adaptation process. We will results, draft a report, review and agree on the relevant not conduct a complete formal validation of the checklist checklist modifications. If members of the Coordination since our current process will not include an assessment Team do not reach consensus on specific items, they will of neither construction nor criterion validity44; however, consult the Advisory Group. our proposed approach will ensure both face and content validity. Approval of the final checklist Our proposal has several strengths. The development The Coordination Team will generate the final version of of the checklist will be comprehensive, including the the checklist. The final checklist will highlight the changes use of previous methodological evidence23–25 29 31 32 and from the RIGHT statement,29 including (1) the items that the engagement of the multidisciplinary international remained unchanged, (2) the items that were modified, guideline community. We will collect views and experi- (3) the items that were added as part of the extension, ences from different stakeholders, including methodol- and (4) the items that were omitted. All members of the ogists, guideline developers, guideline users and journal Coordination Team and the Advisory Group will need editors. We will also ensure the diversity of participants to review and approve the final version of the checklist in terms of country level of income, gender and field of through consensus discussion. expertise. This will allow us to incorporate the different Barcelona. Protected by copyright. stakeholders’ perspective about the adaptation of guide- Patient and public involvement lines. We will address the risk of bias in each step of the Patient and public will not be involved in the study. development process. To minimise interviewer bias, semi- structured interviews will be conducted using an inter- view guide. To minimise selection bias, we will invite all GIN Adaptation Guidelines Working Group members as Discussion well as other stakeholders to join the Delphi Panel and Executive summary to participate in the external review survey. To minimise The aim of this project is to develop the RIGHT-Ad@ non-response bias, we will make the survey available pt Checklist, as an extension of the RIGHT statement online for 4 weeks and we will send two reminders prior tailored for guideline adaptation, to improve the rigour to the round closing date. and transparency of guideline adaptation reporting. To develop the checklist, we will build on the RIGHT state- ment, use the best available evidence from published Implications for practice and research methodological research on this topic and use a rigorous RIGHT-Ad@pt will help improve the completeness when multistep process involving multiple stakeholders. reporting adapted guidelines, therefore contribute to improve their quality, and facilitate their implementation. Our study in the context of previous research The checklist will allow the guideline developers to guide Adaptation of high-quality guidelines is an alternative to their reporting, journal editors to improve the reporting developing de novo guidelines that saves both time and of published adapted guidelines, policymakers to inform resources, and avoids duplication of effort. The ADAPTE on implementation decisions and guideline users to eval- framework is one of the earliest systematic approaches to uate the completeness of the reporting within adapted adapt guidelines to local context.15 42 Building on work guidelines. Future research should focus on the perfor- done for WHO in 2006, the ‘GRADE-ADOLOPMENT’ mance of a complete formal validation of the checklist framework proposed using the Grading of Recommenda- and its assessment in a representative sample of contem- tions Assessment, Development and Evaluation (GRADE) porary adapted guidelines. Surveillance on the use of Evidence to Decision frameworks for the adaptation, the checklist and assessment of its impact could also be a adoption and de novo development of guidelines.16 topic of research. Despite these advances, there is variability in the quality of reporting of adapted practice guidelines and no guid- Ethics and dissemination ance for their reporting is available.23 25 The proposed The protocol obtained a waiver of approval (did not checklist might help with reducing the variability of adap- involve patients, biological samples or clinical data) from tation process and improving the quality of reporting. the Clinical Research Ethics Committee at the Hospital de The checklist is not intended to support guideline la Santa Creu i Sant Pau (Barcelona, Spain). Nevertheless, Song Y, et al. BMJ Open 2019;9:e031767. doi:10.1136/bmjopen-2019-031767 7 Open access BMJ Open: first published as 10.1136/bmjopen-2019-031767 on 24 September 2019. Downloaded from http://bmjopen.bmj.com/ on December 19, 2023 at Univesity Autonomous of we will request written informed consent from all partici- Provenance and peer review Not commissioned; externally peer reviewed. pants and anonymise all data. Open access This is an open access article distributed in accordance with the The dissemination activities will include: (1) publica- Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, tion of the RIGHT-Ad@pt Checklist in a peer-reviewed and license their derivative works on different terms, provided the original work is journal; (2) presentation of the project to relevant stake- properly cited, appropriate credit is given, any changes made indicated, and the use holders (eg, via international conferences, electronic is non-commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/. bulletins, related websites (http://www.​ right-​ statement.​ org/, http://www.​equator-​network.​org/) and social media (eg, Twitter); and (3) translation of the check- list into different languages. The implementation activ- References 1. World Health Organization. WHO handbook for guideline ities will include: (1) engaging with journal editors to development. WHO handbook for guideline development, 2014. encourage the use of the checklist; and (2) evaluation of 2. Alonso-Coello P, Irfan A, Sola I, et al. The quality of clinical practice guidelines over the last two decades: a systematic review of the impact of the checklist on the reporting of adapted guideline appraisal studies. BMJ Qual Saf 2010;19:e58. guidelines. Finally, we will continuously seek feedback 3. Armstrong JJ, Goldfarb AM, Instrum RS, et al. 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Next generation clinical Chile guidance for primary care in South Africa - credible, consistent and 13 Alliance for Health Policy and Systems Research, World Health Organization, pragmatic. PLoS One 2018;13:e0195025. 12. Molino CG, Romano-Lieber NS, Ribeiro E, et al. Non-Communicable Geneve, Switzerland disease clinical practice guidelines in Brazil: a systematic 14 Department of Research, Netherlands Comprehensive Cancer Organisation (IKNL), assessment of methodological quality and transparency. PLoS One Utrecht, The Netherlands 2016;11:e0166367. 15 13. Talagala IA, Samarakoon Y, Senanayake S, et al. Sri Lankan clinical Department of Internal Medicine, American University of Beirut, Beirut, Lebanon practice guidelines: a methodological quality assessment utilizing the agree II instrument. J Eval Clin Pract 2018. Acknowledgements Yang Song is a doctoral candidate at the Paediatrics, 14. Fervers B, Burgers JS, Haugh MC, et al. Adaptation of clinical Obstetrics and Gynaecology and Preventive Medicine Department, Universitat guidelines: literature review and proposition for a framework and Autònoma de Barcelona, Barcelona, Spain. The authors thank Victoria Leo for her procedure. Int J Qual Health Care 2006;18:167–76. help in editing the final version of the manuscript. 15. Fervers B, Burgers JS, Voellinger R, et al. Guideline adaptation: an approach to enhance efficiency in guideline development and Contributors YS, AD, LMG, PAC and EAA wrote the first draft of the manuscript. improve utilisation. BMJ Qual Saf 2011;20:228–36. YS, MB, LMG, PAC and EAA form the coordination team and have day-to-day 16. Schünemann HJ, Wiercioch W, Brozek J, et al. GRADE Evidence responsibility for the project. TA, SB, YC, FC, DG, PFP, EVL, HJS and RWMV are to Decision (EtD) frameworks for adoption, adaptation, and de independent advisors of the project and provide methodological contributions for novo development of trustworthy recommendations: GRADE- the manuscript. All authors critically reviewed the manuscript and approved its final ADOLOPMENT. J Clin Epidemiol 2017;81:101–10. 17. Darzi A, Harfouche M, Arayssi T, et al. Adaptation of the 2015 version. American College of Rheumatology treatment guideline for Funding YS is funded by China Scholarship Council (No 201707040103). LMG rheumatoid arthritis for the Eastern Mediterranean Region: an is funded by a Miguel Servet contract from the Instituto de Salud Carlos III exemplar of the GRADE Adolopment. Health Qual Life Outcomes (CP18/00007). 2017;15:183. 18. Okely AD, Ghersi D, Hesketh KD, et al. A collaborative approach to Disclaimer The funders had no role in the study design, data collection and adopting/adapting guidelines - The Australian 24-Hour Movement analysis, interpretation of data and writing the manuscript. Guidelines for the early years (Birth to 5 years): an integration of physical activity, sedentary behavior, and sleep. BMC Public Health Competing interests EAA and HJS have intellectual CoIs related to his 2017;17(S5):869. contribution to the development of methods of guideline adaptation, the RIGHT 19. Burgers JS, Anzueto A, Black PN, et al. Adaptation, evaluation, and statement and methodological studies in the field. SB is the Analyses Advisor for updating of guidelines: article 14 in integrating and coordinating BMJ and Associate Editor at BMJ Global Health and BMC Systematic Reviews. All efforts in COPD Guideline development. An official ATS/ERS other members have nothing to declare. workshop report. Proc Am Thorac Soc 2012;9:304–10. 20. 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