Developing the RIGHT extension statement for practice guideline protocols: the RIGHT-P statement protocol

Xufei Luo; Elie A. Akl; Ying Zhu; Meng Lv; Xiao Liu; Yang Song; Ping Wang; Jianjian Wang; Xuping Song; Yasser S. Amer; Andrey Litvin; Yaolong Chen

doi:10.12688/f1000research.109547.1

Home Browse Developing the RIGHT extension statement for practice guideline protocols:...

ALL Metrics

-

Views

-

Downloads

Get PDF

Get XML

Export

▬

✚

Study Protocol

Developing the RIGHT extension statement for practice guideline protocols: the RIGHT-P statement protocol

[version 1; peer review: 2 approved with reservations]

Xufei Luo^1,2, Elie A. Akl^3,4, Ying Zhu^5-7, [...] Meng Lv^8-10, Xiao Liu^1,2, Yang Song¹¹, Ping Wang², Jianjian Wang^1,2, Xuping Song¹, Yasser S. Amer^12-15, Andrey Litvin¹⁶, Yaolong Chen ^1,2,17-23

Xufei Luo^1,2, Elie A. Akl^3,4, [...] Ying Zhu^5-7, Meng Lv^8-10, Xiao Liu^1,2, Yang Song¹¹, Ping Wang², Jianjian Wang^1,2, Xuping Song¹, Yasser S. Amer^12-15, Andrey Litvin¹⁶, Yaolong Chen ^1,2,17-23

PUBLISHED 04 Mar 2022

Author details Author details

¹ School of Public Health, Lanzhou University, Lanzhou, China
² Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China
³ Clinical Research Institute, American University of Beirut, Beirut, Lebanon
⁴ Department of Internal Medicine, American University of Beirut, Beirut, Lebanon
⁵ The Michael G. DeGroote Cochrane Canada Centre, McMaster University,1280 Main Street West, Hamilton, Canada
⁶ The MacGRADE Centre, McMaster University,1280 Main Street West, Hamilton, Canada
⁷ Health Research Methods, Evidence, and Impact (HEI), McMaster University,1280 Main Street West, Hamilton, Canada
⁸ Chevidence Lab of Child & Adolescent Health, Children’s Hospital of Chongqing Medical University, Chongqing, China
⁹ National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, China
¹⁰ Chongqing Key Laboratory of Pediatrics, Chongqing, China
¹¹ Iberoamerican Cochrane Centre - Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Sant Antonio María Claret 167, 08025, Barcelona, Spain
¹² Pediatrics Department, King Khalid University Hospital, Riyadh, Saudi Arabia
¹³ Clinical Practice Guidelines Unit, Quality Management Department, King Saud University Medical City, Riyadh, Saudi Arabia
¹⁴ Research Chair for Evidence-Based Health Care and Knowledge Translation, King Saud University, Riyadh, Saudi Arabia
¹⁵ Alexandria Center for Evidence-Based Clinical Practice Guidelines, Alexandria University, Alexandria, Egypt
¹⁶ Department of Surgical Disciplines, Immanuel Kant Baltic Federal University, Kaliningrad, Russian Federation
¹⁷ Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences (2021RU017), School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, 730000, China
¹⁸ Institute of Health Data Science, Lanzhou University, Lanzhou, Gansu, 730000, China
¹⁹ WHO Collaborating Centre for Guideline Implementation and Knowledge Translation, Lanzhou, Gansu, 730000, China
²⁰ Guideline International Network Asia, Lanzhou, Gansu, 730000, China
²¹ Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou University, Lanzhou, Gansu, 730000, China
²² Lanzhou University GRADE Center, Lanzhou, Gansu, 730000, China
²³ Lanzhou University, An affiliate of the Cochrane China Network, Lanzhou, Gansu, 730000, China

Xufei Luo
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Writing – Original Draft Preparation

Elie A. Akl
Roles: Methodology, Writing – Review & Editing

Ying Zhu
Roles: Validation, Writing – Review & Editing

Meng Lv
Roles: Formal Analysis, Investigation

Xiao Liu
Roles: Formal Analysis, Investigation

Yang Song
Roles: Writing – Review & Editing

Ping Wang
Roles: Data Curation, Formal Analysis

Jianjian Wang
Roles: Formal Analysis, Investigation

Xuping Song
Roles: Writing – Review & Editing

Yasser S. Amer
Roles: Methodology, Writing – Review & Editing

Andrey Litvin
Roles: Methodology, Writing – Review & Editing

Yaolong Chen
Roles: Conceptualization, Funding Acquisition, Project Administration, Supervision

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Research on Research, Policy & Culture gateway.

Abstract

Background: A protocol for a practice guideline can facilitate the guideline development process, ensure its transparency, and improve the quality of the guidelines. However, there are currently no reporting guideline for guideline protocols.
Methods: We intend to develop an extension of the Reporting Items for Practice Guidelines in HealThcare (RIGHT) statement for guideline protocols (RIGHT-P). We will follow the toolkit for developing a reporting guideline developed by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network. We will form a multidisciplinary international team of experts. The development of RIGHT-P will be conducted in 12 steps grouped in three stages over a two-year period.
Results: The results of RIGHT-P statement will be presented in an article to be published later.
Conclusion: This report describes the process of RIGHT-P statement development. We believe RIGHT-P will help guideline developers improve the reporting of guideline protocols and indirectly improve their quality and the quality of guidelines.
Registration: We registered the protocol on the EQUATOR network.

Keywords

practice guideline; reporting guideline; RIGHT statement; protocol; EQUATOR

Corresponding author: Yaolong Chen

Competing interests: Yaolong Chen, Xufei Luo, Elie A. Ak, and Yasser S. Amer are members of RIGHT Working Group. The authors have no other financial competing interests to declare.

Grant information: The RIGHT-P project is funded by the Fundamental Research Funds for the Central Universities (lzujbky-2021-ey13).
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2022 Luo X et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Luo X, Akl EA, Zhu Y et al. Developing the RIGHT extension statement for practice guideline protocols: the RIGHT-P statement protocol [version 1; peer review: 2 approved with reservations]. F1000Research 2022, 11:275 (https://doi.org/10.12688/f1000research.109547.1) First published: 04 Mar 2022, 11:275 (https://doi.org/10.12688/f1000research.109547.1) Latest published: 04 Mar 2022, 11:275 (https://doi.org/10.12688/f1000research.109547.1)

Abbreviations

AGREE: The Appraisal of Guidelines for Research and Evaluation

E&E: Explanation and Elaboration

EQUATOR: Enhancing the QUAlity and Transparency Of health Research

GIN: Guideline International Network

GRADE: The Grading of Recommendations, Assessment, Development and Evaluation

PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses

PROSPERO: International prospective register of systematic reviews

RIGHT: Reporting Items for practice Guidelines in HealThcare

RIGHT-P: RIGHT for practice guideline protocols

SR: Systematic Review

SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials

WHO: World Health Organization

Introduction

Trustworthy practice guidelines can inform clinical practice and decision-making and improve clinical outcomes.¹ However, high-quality guidelines are currently scarce,²^–⁵ despite many methodological advancements in the field,⁶^–⁸ and the fact that most guideline developers have produced manuals and handbooks to support their processes.⁹^–¹¹ One potential explanation for this could be the lack of a standardized processes to develop and report the guideline protocols in a transparent format.

A research protocol is intended to help researchers to improve the quality of that research by defining a priori the methods to be followed and contributing to its transparent reporting. It is essential to have a standardized way to report these protocols. For example, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for protocols (PRISMA-P) was developed in 2015 to improve the reporting quality of systematic reviews and meta-analysis protocols.¹² One study¹³ showed that the reporting quality of protocols of clinical trials has improved by 8.8% since the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement.¹⁴

To our knowledge, there are no widely agreed on guidelines or standards for how guideline protocols should be reported. The World Health Organization (WHO) guideline development handbook¹¹ proposes that guideline protocols should address 17 topics. A 2019 study found that the contents of existing guideline protocols are diverse and vary.¹⁵ In 2017, a multi-international group of experts developed Reporting Items for practice Guidelines in HealThcare (RIGHT) statement reporting guideline for practice guidelines.⁶ Given the importance of guideline protocols, we will form an international group of stakeholders to develop the reporting guideline for guideline protocols. We intend to develop the RIGHT-Protocol (RIGHT-P), as an extension of the RIGHT statement for practice guideline protocols. The purpose of this paper is to describe the methods to be used for the development of the RIGHT-P.

Methods

In this study, we define a guideline protocol as a document detailing the processes and methods to be followed for developing, adapting or updating guidelines. We will follow the toolkit on how to develop a reporting guideline recommended by Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network to develop the RIGHT extensions for guideline protocols.¹⁶ We will build RIGHT-P as an extension to the RIGHT checklist⁶ while building on the WHO guideline development handbook,¹¹ as well as other guideline manuals collected through a systematic search. The target users of RIGHT-P are guideline developers/adapters, guideline evaluators, and guideline stakeholders. We expect to complete the development of RIGHT-P within two years, from August 2021 to December 2022. The process will consist of three stages: preparation, drafting the RIGHT-P checklist, and testing and dissemination. The detailed development process is illustrated in Figure 1, and the timetable is showed in Table 1.

Figure 1. Flowchart of the development process for RIGHT-P. RIGHT, Reporting Items for practice Guidelines in HealThcare.

Table 1. Timeline for development of RIGHT-P.

STAGE 1 Preparation

Draft the protocol

To enhance the transparency and quality of the RIGHT-P development, we registered it on the EQUATOR network. We have also developed the protocol we are reporting in this paper, and the development of RIGHT-P will be initiated after the publication of this protocol.

Establish RIGHT-P working groups

We will establish three expert groups, a steering committee, a consensus expert group and a secretariat team. The steering committee will consist of 3-5 experts with rich experience in guideline development and reporting standards. The steering committee will form the consensus expert group, manage conflicts of interest of all participants in the project, provide consultation on the RIGHT-P development process, assure the quality of the development process, and approve the final version of the RIGHT-P.

The secretariat team includes three members from the RIGHT Working Group, of which Xufei Luo is the team’s leader and contact person for the RIGHT-P project. The team's responsibilities are to coordinate the consensus expert group and the steering committee, conduct the background research, such as, a systematic review on published guideline protocols, draft the initial RIGHT-P checklist, organize Delphi meetings, manage email communications, and draft the final RIGHT-P article.

The consensus expert group will consist of 20-30 multidisciplinary and international experts whose role is to participate in the Delphi survey and approve the final version of the RIGHT-P checklist. We will invite experts from the Guideline International Network (GIN), the Appraisal of Guidelines for Research and Evaluation (AGREE) Collaboration, the RIGHT Working Group, and the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group. We will also invite representatives of guideline developers/adapters and guideline users to participate in this expert group.

Conduct systematic survey of the guideline protocols

We are conducting a systematic review of published guideline protocols; that review has been registered on the PROSPERO (International prospective register of systematic reviews) website (CRD42021135732). We intend to extract the information reported for the protocols with published guidelines and then try to generate an initial pool of items for consideration in the RIGHT-P.

Cross-sectional survey and review the guideline manuals

We will design questionnaire to investigate the knowledge, attitudes, and behaviors of guideline developers/adapters, guideline users, and other stakeholders regarding the guideline protocols. The questionnaire consists of three parts: (1) the basic information about participants (e.g., gender, age, working time, title, units of employment, profession); (2) the knowledge, attitudes and behaviors with regards to developing and publishing a guideline protocol, and the degree of support for the development of the RIGHT-P; (3) request to propose 3-5 items that the RIGHT-P should address. We plan to use a convenience sample of 20-30 stakeholders outside the consensus expert group. We will use SurveyMonkey for data collection.

In addition, we will review the guideline development manuals and handbooks to collect the potential items. We will systematically search and analyze the guideline development manual, extract the relevant contents about the guideline protocols, and then classify and compile the relevant contents into the initial pool of RIGHT-P items.

STAGE 2 Drafting the RIGHT-P checklist

Generate the initial pool of items for consideration

Based on the findings of the systematic review of the guideline protocols, the results of the cross-sectional survey and the review of handbooks, we will formulate a pool of initial items for consideration in the RIGHT-P. In addition, we will categorize the initial items into basic information, background, development methods, evidence, recommendations, and other information. We will use Microsoft excel 2016 software in the collection and management of all data and items.

Delphi consensus meeting

We will use a modified Delphi method to reach consensus on the RIGHT-P items. We will use a 7-point Likert scale for determining whether an item should be included. Participants will score each initial item on a scale of 1-7 for inclusion, with a score of 1 indicating strong disagreement with the inclusion of the item and a score of 7 indicating strong agreement with the inclusion of the item.¹⁷ We plan to have two rounds of the Delphi survey to collect the opinions, comments, and suggestions of the participants via the SurveyMonkey. If necessary, we will hold online meetings to help reach consensus through the Zoom Cloud Meeting App.

We will send the initial list of items to the consensus expert group members via the SurveyMonkey, and the first round of Delphi survey will allow the experts to score each item of the initial RIGHT-P checklist and give suggestions and modifications. At the same time the participants can add the items they consider important and not included in the initial item pool.

After collating the results of the first round of Delphi survey (median score for each item), we will generate the second round of Delphi questionnaire. If the median score of an item ≥ 6, we will include the item; if the median score of an item is between 3 (exclusive) and 6 (exclusive), we will enter it in the second round of Delphi survey; if the median score of an item is ≤ 3, we will exclude it.¹⁷ We will collate suggestions and comments, and consider them when drafting the list of the second round of Delphi survey. Suggestions and comments from experts will be recorded and responded to one by one.

We will conduct the second round of Delphi survey two months after the first one, using the same scoring scheme as in the first round. We will exclude items with a median score ≤ 3 and include items with a median score ≥ 6. For items with a median between 3 and 6, the steering committee will make the final decision regarding inclusion/exclusion after considering expert suggestions and comments from the second round.

All ideas and comments will be recorded and documented by the secretariat team, and after the second round of the Delphi survey, the steering committee will generate a RIGHT-P checklist draft version 1 and revise for final approval via email.

Use the RIGHT-P to evaluate published guideline protocols

To assess the feasibility and applicability of the RIGHT-P checklist draft version 1, we plan to use it to evaluate published guideline protocols that included in prior systematic survey. We will use the results of that step to copy with any further edits to the draft RIGHT-P checklist version 1.

Quality assurance and final approval

Upon revision of the RIGHT-P checklist based on the results of the evaluation for guideline protocols, we will generate a draft version 2 of the RIGHT-P checklist. We will invite the guideline developers/adapters, guideline users, and other stakeholders to provide feedback and perform external review regarding the draft version 2 checklist. Finally, we will send the revised draft checklist version 2 to the steering committee and the consensus expert group for final approval. To ensure that the RIGHT-P project runs smoothly, we plan to record each step of the process in detail and post it on the RIGHT statement website after the RIGHT-P checklist is published.

STAGE 3 Implementation and transmission

Develop the Explanation and Elaboration (E&E) document

Once the final RIGHT-P checklist is finalized, we intend to develop detailed explanations and elaborations document to explain and provide example(s) for each item to facilitate the understanding and adoption of the reporting checklist by the target users.

Translate RIGHT-P to other languages

To facilitate the understanding and dissemination of the RIGHT-P, we plan to contact those interested to translate the RIGHT-P checklist into non-English languages such as Chinese, French, Japanese, Korean, and Spanish. We will post the different langue version on the RIGHT statement website as soon as they are finalized. In addition, the readers who are interested can contact the RIGHT-P developers to collaborate on its translation into the language of their choice.

Patient and public involvement

Patient and public will not be involved in this study.

Study status

Currently, we are working on reviewing the guideline manuals and generating the initial pool of RIGHT-P items.

Discussion

Despite the fact that few guideline protocols have been published, their importance to guideline development cannot be overstated. This is analogous to the importance of protocols to clinical trials,¹⁴ and systematic reviews.¹² This project will develop an extension of the RIGHT statement for protocols, following the standard methods of international reporting guidelines development.¹⁶ Also, it will engage relevant stakeholders from WHO, AGREE, GIN and other international guideline development organizations.

Since the publication of the RIGHT statement in 2017,⁶ guideline developers have increasingly emphasized reporting on the guidelines and their different procedures, types, fields, and sections. Researchers have developed extensions for patient version guideline (RIGHT-PVG),¹⁸ Traditional Chinese Medicine (RIGHT-TCM).¹⁹ Extensions for acupuncture (RIGHT-Acu)²⁰ and guideline adaptation (RIGHT-Ad@pt)²¹ are currently in development. We aim to enhance and ensure the quality of guideline development by promoting and standardizing the writing and reporting of guideline protocols. The RIGHT Working Group aims to inform guideline developers of the importance of registration²² and protocol drafting, and promote and advocate for protocol drafting in the guideline development process.

We hope that the RIGHT-P will be helpful to guideline developers/adapters in the planning stage of guideline development/adaptation in terms of clarifying the rigorous schedule steps and improving the quality of reporting in the protocol.

Data availability

No data are associated with this article.

Acknowledgements

The RIGHT-P project is funded by “the Fundamental Research Funds for the Central Universities (lzujbky-2021-ey13)”. The funders will have no role in the study design, data collection and analysis, writing of the article or the decision to submit it for publication.

References

1. Institute of Medicine: Clinical practice guidelines we can trust. Washington DC: the National Academies Press; 2011.
2. Chen YL, Wang C, Shang HC, et al.: Clinical practice guidelines in China. BMJ. 2018; 360: j5158. Publisher Full Text
3. Kataoka Y, Anan K, Taito S, et al.: Quality of clinical practice guidelines in Japan remains low: A cross-sectional meta-epidemiological study [published online ahead of print, 2021 Jul 2]. J. Clin. Epidemiol. 2021; 138: 22–31. PubMed Abstract | Publisher Full Text
4. Alonso-Coello P, Irfan A, Solà I, et al.: The quality of clinical practice guidelines over the last two decades: a systematic review of guideline appraisal studies. Qual. Saf. Health Care. 2010; 19(6): e58. PubMed Abstract | Publisher Full Text
5. Venus C, Jamrozik E: Evidence-poor medicine: just how evidence-based are Australian clinical practice guidelines?. Intern. Med. J. 2020; 50(1): 30–37. PubMed Abstract | Publisher Full Text
6. Chen Y, Yang K, Marušic A, et al.: A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement. Ann. Intern. Med. 2017; 166(2): 128–132. PubMed Abstract | Publisher Full Text
7. Brouwers MC, Kho ME, Browman GP, et al.: AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010; 182(18): E839–E842. PubMed Abstract | Publisher Full Text
8. Guyatt GH, Oxman AD, Vist GE, et al.: GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008; 336(7650): 924–926. PubMed Abstract | Publisher Full Text
9. National Institute for Health and Care Excellence (Great Britain): Developing NICE guidelines: the manual [M/OL].[2021-07-21]. Reference Source
10. American Academy of Family Physicians: Clinical Practice Guideline Manual.Reference Source
11. World Health Organization: WHO handbook for guideline development. 2nd ed.World Health Organization; 2014. Reference Source
12. Shamseer L, Moher D, Clarke M, et al.: Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation [published correction appears in BMJ. 2016 Jul 21;354:i4086]. BMJ. 2015; 350: g7647. Published 2015 Jan 2. PubMed Abstract | Publisher Full Text
13. Tan ZW, Tan AC, Li T, et al.: Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study. BMJ Open. 2020; 10(8): e038283. Published 2020 Aug 26. PubMed Abstract | Publisher Full Text
14. Chan AW, Tetzlaff JM, Altman DG, et al.: SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann. Intern. Med. 2013; 158(3): 200–207. PubMed Abstract | Publisher Full Text
15. Luo X, Lv M, Zhang X, et al.: Develop the Reporting Guideline for Clinical Practice Guideline of Proposal: RIGHT for P. Int. J. Evid. Based Healthc. 2019 GIN and JBI Conference.
16. Moher D, Schulz KF, Simera I, et al.: Guidance for developers of health research reporting guidelines. PLoS Med. 2010; 7(2): e1000217. Published 2010 Feb 16. PubMed Abstract | Publisher Full Text
17. Vernooij RWM, Alonso-Coello P, Brouwers M, et al.: Reporting items for updated clinical guidelines: checklist for the reporting of updated guidelines (CheckUp). PLoS Med. 2017; 14: 1002207. Publisher Full Text
18. Wang X, Chen Y, Akl EA, et al.: The reporting checklist for public versions of guidelines: RIGHT-PVG. Implement. Sci. 2021; 16(1): 10. PubMed Abstract | Publisher Full Text
19. Xie R, Xia Y, Chen Y, et al.: The RIGHT Extension Statement for Traditional Chinese Medicine: Development, Recommendations, and Explanation. Pharmacol. Res. 2020; 160: 105178. PubMed Abstract | Publisher Full Text
20. Tang C, Duan Y, Zhang Y, et al.: RIGHT for acupuncture: An extension of the RIGHT statement for clinical practice guidelines on acupuncture [published online ahead of print, 2021 Jun 4]. J. Clin. Epidemiol. 2021. S0895-4356(21)00173-6. Publisher Full Text
21. Song Y, Darzi A, Ballesteros M, et al.: Extending the RIGHT statement for reporting adapted practice guidelines in healthcare: the RIGHT-Ad@pt Checklist protocol. BMJ Open. 2019; 9(9): e031767. Published 2019 Sep 24. PubMed Abstract | Publisher Full Text
22. Chen Y, Guyatt GH, Munn Z, et al.: Clinical Practice Guidelines Registry: Toward Reducing Duplication, Improving Collaboration, and Increasing Transparency. Ann. Intern. Med. 2021; 174(5): 705–707. PubMed Abstract | Publisher Full Text

Comments on this article Comments (0)

Version 1

VERSION 1 PUBLISHED 04 Mar 2022

Author details Author details

¹ School of Public Health, Lanzhou University, Lanzhou, China
² Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China
³ Clinical Research Institute, American University of Beirut, Beirut, Lebanon
⁴ Department of Internal Medicine, American University of Beirut, Beirut, Lebanon
⁵ The Michael G. DeGroote Cochrane Canada Centre, McMaster University,1280 Main Street West, Hamilton, Canada
⁶ The MacGRADE Centre, McMaster University,1280 Main Street West, Hamilton, Canada
⁷ Health Research Methods, Evidence, and Impact (HEI), McMaster University,1280 Main Street West, Hamilton, Canada
⁸ Chevidence Lab of Child & Adolescent Health, Children’s Hospital of Chongqing Medical University, Chongqing, China
⁹ National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, China
¹⁰ Chongqing Key Laboratory of Pediatrics, Chongqing, China
¹¹ Iberoamerican Cochrane Centre - Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Sant Antonio María Claret 167, 08025, Barcelona, Spain
¹² Pediatrics Department, King Khalid University Hospital, Riyadh, Saudi Arabia
¹³ Clinical Practice Guidelines Unit, Quality Management Department, King Saud University Medical City, Riyadh, Saudi Arabia
¹⁴ Research Chair for Evidence-Based Health Care and Knowledge Translation, King Saud University, Riyadh, Saudi Arabia
¹⁵ Alexandria Center for Evidence-Based Clinical Practice Guidelines, Alexandria University, Alexandria, Egypt
¹⁶ Department of Surgical Disciplines, Immanuel Kant Baltic Federal University, Kaliningrad, Russian Federation
¹⁷ Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences (2021RU017), School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, 730000, China
¹⁸ Institute of Health Data Science, Lanzhou University, Lanzhou, Gansu, 730000, China
¹⁹ WHO Collaborating Centre for Guideline Implementation and Knowledge Translation, Lanzhou, Gansu, 730000, China
²⁰ Guideline International Network Asia, Lanzhou, Gansu, 730000, China
²¹ Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou University, Lanzhou, Gansu, 730000, China
²² Lanzhou University GRADE Center, Lanzhou, Gansu, 730000, China
²³ Lanzhou University, An affiliate of the Cochrane China Network, Lanzhou, Gansu, 730000, China

Xufei Luo
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Writing – Original Draft Preparation

Elie A. Akl
Roles: Methodology, Writing – Review & Editing

Ying Zhu
Roles: Validation, Writing – Review & Editing

Meng Lv
Roles: Formal Analysis, Investigation

Xiao Liu
Roles: Formal Analysis, Investigation

Yang Song
Roles: Writing – Review & Editing

Ping Wang
Roles: Data Curation, Formal Analysis

Jianjian Wang
Roles: Formal Analysis, Investigation

Xuping Song
Roles: Writing – Review & Editing

Yasser S. Amer
Roles: Methodology, Writing – Review & Editing

Andrey Litvin
Roles: Methodology, Writing – Review & Editing

Yaolong Chen
Roles: Conceptualization, Funding Acquisition, Project Administration, Supervision

Competing interests

Yaolong Chen, Xufei Luo, Elie A. Ak, and Yasser S. Amer are members of RIGHT Working Group. The authors have no other financial competing interests to declare.

Grant information

The RIGHT-P project is funded by the Fundamental Research Funds for the Central Universities (lzujbky-2021-ey13).
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (1)

version 1

Published: 04 Mar 2022, 11:275

https://doi.org/10.12688/f1000research.109547.1

Copyright

© 2022 Luo X et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Download

Export To

metrics

	Views	Downloads
F1000Research	-	-
PubMed Central Data from PMC are received and updated monthly.	-	-

Citations

0

SEE MORE DETAILS

CITE

how to cite this article

Luo X, Akl EA, Zhu Y et al. Developing the RIGHT extension statement for practice guideline protocols: the RIGHT-P statement protocol [version 1; peer review: 2 approved with reservations]. F1000Research 2022, 11:275 (https://doi.org/10.12688/f1000research.109547.1)

NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.

track

receive updates on this article

Track an article to receive email alerts on any updates to this article.

Open Peer Review

Version 1

VERSION 1

PUBLISHED 04 Mar 2022

Views

4

Reviewer Report 24 Jul 2023

Chris Carmona, University of Sheffield, Sheffield, England, UK; National Institute for Health and Care Excellence, Manchester, England, UK

Approved with Reservations

https://doi.org/10.5256/f1000research.121060.r188611

Thank you for the opportunity to review this interesting protocol.

I think this is a useful project and look forward to seeing how it works out. I hope my comments are helpful in terms of making the ... Continue reading

Thank you for the opportunity to review this interesting protocol.

I think this is a useful project and look forward to seeing how it works out. I hope my comments are helpful in terms of making the proposal a little tighter.

Background:

I think there are a few places where some additional clarity would help. For example, what exactly do you mean by a 'practice guideline'? Are you referring to a guideline produced by an organisation like WHO, NICE or SIGN? Or are you also referring to local practice guidelines in individual hospitals (for example)? There are a lot of different types, informed to different extents by the principles of EBM, some are almost entirely consensus.

Once we're clear what a practice guideline is, then perhaps a little clarity about what a guideline protocol is? Normally a guideline is informed by one or more systematic reviews (or other kinds of evidence synthesis) and each of those SRs should have a review protocol that sets out how the review will be conducted and defines the PICO etc a priori. This is not only to help researchers but primarily to prevent bias through the reviewing process. In terms of the overall guideline, while there is usually some form of document that could be called a 'protocol', it often doesn't detail the parameters of the guideline production process or methods, but usually focusses on delimiting the areas the guideline will cover (or not. For example, at the UK NICE and at WHO they call this a Scope document, but as you know (since you reference it) their methods and process are not contained in that Scope document but instead are part of an overall methods and process manual (your ref 9).

Methods:

The process looks appropriate and sufficient to answer the question at hand. I note there is no 'field testing' of the checklist but perhaps that is beyond the remit of this work. Its more a 'derivation' than a 'validation'. It would be good to note whether there are plans to validate the tool once it is finished.

I'd suggest consistency of language use in headers so perhaps change the header that refers to a 'systematic survey' to a systematic review?

The sentence "We intend to extract the information reported for the protocols with published guidelines " could be clearer about what exactly you're extracting. Is it the fields included in the protocol? This will be easier when we have a clearer idea of what a guideline protocol means (see above).

Cross-sectional survey - perhaps a couple of sentences about how you will derive the questions for part 2. Will this be derived from the SR? Or from somewhere else?

"In addition, we will review the guideline development manuals and handbooks to collect the potential items. We will systematically search and analyze the guideline development manual, extract the relevant contents about the guideline protocols, and then classify and compile the relevant contents into the initial pool of RIGHT-P items." - should this be under the conduct SR of guideline protocols heading? It fits there better than in the cross sectional survey.

Delphi consensus meeting - Heading isnt quite right since youre not actually planning a meeting unless you have to. Suggest rename Delphi consensus process or something like that?

Use the RIGHT-P to evaluate published guideline protocols - selected how? What does 'success' look like? How will you know if the checklist performed adequately? Will you use some kind of reference standard or other checklist as a comparator? Just using it doesn't tell you much about whether its any good, it just tells you whether its useable.

Patient and public involvement - it would be helpful to add a sentence or two to justify this.

With best wishes for the success of your project.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: I am employed by the UK National Institute of Health ad Care Excellence (NICE), which produces health and social care guidelines.

Reviewer Expertise: Guideline development methods, systematic reviewing, evidence-based healthcare, qualitative evidence synthesis.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

Report a concern

Respond or Comment

Views

8

Reviewer Report 07 Apr 2022

Melissa K. Sharp, Health Research Board Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland

Approved with Reservations

https://doi.org/10.5256/f1000research.121060.r126566

Thank you for the opportunity to review this protocol to develop an extension to the RIGHT statement. I do not have major concerns about the content within the article but rather the timeline of the work as, per Table 1, ... Continue reading

Thank you for the opportunity to review this protocol to develop an extension to the RIGHT statement. I do not have major concerns about the content within the article but rather the timeline of the work as, per Table 1, the work is already more than halfway complete. Also, in the text it states what ‘the development of RIGHT-P will be initiated after the publication of this protocol’ which is clearly incorrect if Table 1 is to be believed. Therefore, I question the whether this is in fact a protocol and whether any of my peer review comments could actually meaningfully contribute to the design or conduct of the study. My comments will likely only be used to clarify results manuscripts which I do not believe is the point of peer review for study protocols.

That being said, I will give my comments nonetheless in order in which they appear:

The introduction describes the general impetus for the project but I do think it is a bit too short and cursory.
The description of the three expert groups: steering committee, consensus expert group, and secretariat team is a bit confusing. Assuming that the secretariat team is also involved in the steering committee then there is actually 3 + 3-5 people involved? This is a hierarchical structure, no? The paragraph should be reworded to be clearer about the structure and numbers involved.
Given that it is said you will ‘invite representatives of guideline developers/adapters and guideline users to participate in this expert group’, it is surprising that patient representatives are not involved as they are a key stakeholder in guideline development groups. This is confirmed by the statement near the end of the manuscript ‘Patient and public will not be involved in this study.’
It is also unclear how these representatives will be contacted – by the steering committee? Is all participation online/remote? Are all of these representatives from GIN, AGREE, and GRADE? Are there any geographic or equity concerns to be discussed or addressed?
I find that the information about the cross-sectional survey and guideline manuals review is extremely vague. It’s unclear whether you’re drawing on previous literature, pilot-testing the questionnaire, doing any validation, using any frameworks, or adapting any scales, etc. The synthesis process for the initial pool of RIGHT-P items is a bit unclear. Are there any thresholds that you will establish? Will data be double-screened or extracted? Will the initial pool be agreed upon by the steering committee or a broader group?
The end of the Delphi consensus meeting section seems to get ahead of itself that you will ‘revise for final approval via email’ then continue describing the process to make edits to version 1 and draft version 2. I also think you need more information about what this ‘feasibility/applicability’ assessment entails (who is doing it, how is this feedback being given to other members of the steering committee perhaps?, etc.)

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: epidemiology, public health, reporting guidelines, mental health, meta research, science communication

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

Report a concern

Respond or Comment

Comments on this article Comments (0)

Version 1

VERSION 1 PUBLISHED 04 Mar 2022

Open Peer Review

Reviewer Status

Reviewer Reports

	Invited Reviewers
	1	2
Version 1 04 Mar 22	read	read

Melissa K. Sharp, Royal College of Surgeons in Ireland, Dublin, Ireland
Chris Carmona, University of Sheffield, Sheffield, UK; National Institute for Health and Care Excellence, Manchester, UK

Comments on this article

All Comments(0)

Add a comment

Sign up for content alerts

Browse by related subjects

Back to all reports

Reviewer Report

4 Views

24 Jul 2023 | for Version 1

Chris Carmona, University of Sheffield, Sheffield, England, UK; National Institute for Health and Care Excellence, Manchester, England, UK

4 Views Cite this report Responses(0)

Approved With Reservations

Thank you for the opportunity to review this interesting protocol.

I think this is a useful project and look forward to seeing how it works out. I hope my comments are helpful in terms of making the proposal a little tighter.

Background:

I think there are a few places where some additional clarity would help. For example, what exactly do you mean by a 'practice guideline'? Are you referring to a guideline produced by an organisation like WHO, NICE or SIGN? Or are you also referring to local practice guidelines in individual hospitals (for example)? There are a lot of different types, informed to different extents by the principles of EBM, some are almost entirely consensus.

Once we're clear what a practice guideline is, then perhaps a little clarity about what a guideline protocol is? Normally a guideline is informed by one or more systematic reviews (or other kinds of evidence synthesis) and each of those SRs should have a review protocol that sets out how the review will be conducted and defines the PICO etc a priori. This is not only to help researchers but primarily to prevent bias through the reviewing process. In terms of the overall guideline, while there is usually some form of document that could be called a 'protocol', it often doesn't detail the parameters of the guideline production process or methods, but usually focusses on delimiting the areas the guideline will cover (or not. For example, at the UK NICE and at WHO they call this a Scope document, but as you know (since you reference it) their methods and process are not contained in that Scope document but instead are part of an overall methods and process manual (your ref 9).

Methods:

The process looks appropriate and sufficient to answer the question at hand. I note there is no 'field testing' of the checklist but perhaps that is beyond the remit of this work. Its more a 'derivation' than a 'validation'. It would be good to note whether there are plans to validate the tool once it is finished.

I'd suggest consistency of language use in headers so perhaps change the header that refers to a 'systematic survey' to a systematic review?

The sentence "We intend to extract the information reported for the protocols with published guidelines " could be clearer about what exactly you're extracting. Is it the fields included in the protocol? This will be easier when we have a clearer idea of what a guideline protocol means (see above).

Cross-sectional survey - perhaps a couple of sentences about how you will derive the questions for part 2. Will this be derived from the SR? Or from somewhere else?

"In addition, we will review the guideline development manuals and handbooks to collect the potential items. We will systematically search and analyze the guideline development manual, extract the relevant contents about the guideline protocols, and then classify and compile the relevant contents into the initial pool of RIGHT-P items." - should this be under the conduct SR of guideline protocols heading? It fits there better than in the cross sectional survey.

Delphi consensus meeting - Heading isnt quite right since youre not actually planning a meeting unless you have to. Suggest rename Delphi consensus process or something like that?

Use the RIGHT-P to evaluate published guideline protocols - selected how? What does 'success' look like? How will you know if the checklist performed adequately? Will you use some kind of reference standard or other checklist as a comparator? Just using it doesn't tell you much about whether its any good, it just tells you whether its useable.

Patient and public involvement - it would be helpful to add a sentence or two to justify this.

With best wishes for the success of your project.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

I am employed by the UK National Institute of Health ad Care Excellence (NICE), which produces health and social care guidelines.

Reviewer Expertise

Guideline development methods, systematic reviewing, evidence-based healthcare, qualitative evidence synthesis.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

Back to all reports

Reviewer Report

8 Views

07 Apr 2022 | for Version 1

Melissa K. Sharp, Health Research Board Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland

8 Views Cite this report Responses(0)

Approved With Reservations

Thank you for the opportunity to review this protocol to develop an extension to the RIGHT statement. I do not have major concerns about the content within the article but rather the timeline of the work as, per Table 1, the work is already more than halfway complete. Also, in the text it states what ‘the development of RIGHT-P will be initiated after the publication of this protocol’ which is clearly incorrect if Table 1 is to be believed. Therefore, I question the whether this is in fact a protocol and whether any of my peer review comments could actually meaningfully contribute to the design or conduct of the study. My comments will likely only be used to clarify results manuscripts which I do not believe is the point of peer review for study protocols.

That being said, I will give my comments nonetheless in order in which they appear:

The introduction describes the general impetus for the project but I do think it is a bit too short and cursory.
The description of the three expert groups: steering committee, consensus expert group, and secretariat team is a bit confusing. Assuming that the secretariat team is also involved in the steering committee then there is actually 3 + 3-5 people involved? This is a hierarchical structure, no? The paragraph should be reworded to be clearer about the structure and numbers involved.
Given that it is said you will ‘invite representatives of guideline developers/adapters and guideline users to participate in this expert group’, it is surprising that patient representatives are not involved as they are a key stakeholder in guideline development groups. This is confirmed by the statement near the end of the manuscript ‘Patient and public will not be involved in this study.’
It is also unclear how these representatives will be contacted – by the steering committee? Is all participation online/remote? Are all of these representatives from GIN, AGREE, and GRADE? Are there any geographic or equity concerns to be discussed or addressed?
I find that the information about the cross-sectional survey and guideline manuals review is extremely vague. It’s unclear whether you’re drawing on previous literature, pilot-testing the questionnaire, doing any validation, using any frameworks, or adapting any scales, etc. The synthesis process for the initial pool of RIGHT-P items is a bit unclear. Are there any thresholds that you will establish? Will data be double-screened or extracted? Will the initial pool be agreed upon by the steering committee or a broader group?
The end of the Delphi consensus meeting section seems to get ahead of itself that you will ‘revise for final approval via email’ then continue describing the process to make edits to version 1 and draft version 2. I also think you need more information about what this ‘feasibility/applicability’ assessment entails (who is doing it, how is this feedback being given to other members of the steering committee perhaps?, etc.)

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

epidemiology, public health, reporting guidelines, mental health, meta research, science communication

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

[1] 1. Institute of Medicine: Clinical practice guidelines we can trust. Washington DC: the National Academies Press; 2011.

[2] 2. Chen YL, Wang C, Shang HC, et al.: Clinical practice guidelines in China. BMJ. 2018; 360: j5158. Publisher Full Text

[3] 3. Kataoka Y, Anan K, Taito S, et al.: Quality of clinical practice guidelines in Japan remains low: A cross-sectional meta-epidemiological study [published online ahead of print, 2021 Jul 2]. J. Clin. Epidemiol. 2021; 138: 22–31. PubMed Abstract | Publisher Full Text

[4] 4. Alonso-Coello P, Irfan A, Solà I, et al.: The quality of clinical practice guidelines over the last two decades: a systematic review of guideline appraisal studies. Qual. Saf. Health Care. 2010; 19(6): e58. PubMed Abstract | Publisher Full Text

[5] 5. Venus C, Jamrozik E: Evidence-poor medicine: just how evidence-based are Australian clinical practice guidelines?. Intern. Med. J. 2020; 50(1): 30–37. PubMed Abstract | Publisher Full Text

[6] 6. Chen Y, Yang K, Marušic A, et al.: A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement. Ann. Intern. Med. 2017; 166(2): 128–132. PubMed Abstract | Publisher Full Text

[7] 7. Brouwers MC, Kho ME, Browman GP, et al.: AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010; 182(18): E839–E842. PubMed Abstract | Publisher Full Text

[8] 8. Guyatt GH, Oxman AD, Vist GE, et al.: GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008; 336(7650): 924–926. PubMed Abstract | Publisher Full Text

[9] 9. National Institute for Health and Care Excellence (Great Britain): Developing NICE guidelines: the manual [M/OL].[2021-07-21]. Reference Source

[10] 10. American Academy of Family Physicians: Clinical Practice Guideline Manual.Reference Source

[11] 11. World Health Organization: WHO handbook for guideline development. 2nd ed.World Health Organization; 2014. Reference Source

[12] 12. Shamseer L, Moher D, Clarke M, et al.: Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation [published correction appears in BMJ. 2016 Jul 21;354:i4086]. BMJ. 2015; 350: g7647. Published 2015 Jan 2. PubMed Abstract | Publisher Full Text

[13] 13. Tan ZW, Tan AC, Li T, et al.: Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study. BMJ Open. 2020; 10(8): e038283. Published 2020 Aug 26. PubMed Abstract | Publisher Full Text

[14] 14. Chan AW, Tetzlaff JM, Altman DG, et al.: SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann. Intern. Med. 2013; 158(3): 200–207. PubMed Abstract | Publisher Full Text

[15] 15. Luo X, Lv M, Zhang X, et al.: Develop the Reporting Guideline for Clinical Practice Guideline of Proposal: RIGHT for P. Int. J. Evid. Based Healthc. 2019 GIN and JBI Conference.

[16] 16. Moher D, Schulz KF, Simera I, et al.: Guidance for developers of health research reporting guidelines. PLoS Med. 2010; 7(2): e1000217. Published 2010 Feb 16. PubMed Abstract | Publisher Full Text

[17] 17. Vernooij RWM, Alonso-Coello P, Brouwers M, et al.: Reporting items for updated clinical guidelines: checklist for the reporting of updated guidelines (CheckUp). PLoS Med. 2017; 14: 1002207. Publisher Full Text

[18] 18. Wang X, Chen Y, Akl EA, et al.: The reporting checklist for public versions of guidelines: RIGHT-PVG. Implement. Sci. 2021; 16(1): 10. PubMed Abstract | Publisher Full Text

[19] 19. Xie R, Xia Y, Chen Y, et al.: The RIGHT Extension Statement for Traditional Chinese Medicine: Development, Recommendations, and Explanation. Pharmacol. Res. 2020; 160: 105178. PubMed Abstract | Publisher Full Text

[20] 20. Tang C, Duan Y, Zhang Y, et al.: RIGHT for acupuncture: An extension of the RIGHT statement for clinical practice guidelines on acupuncture [published online ahead of print, 2021 Jun 4]. J. Clin. Epidemiol. 2021. S0895-4356(21)00173-6. Publisher Full Text

[21] 21. Song Y, Darzi A, Ballesteros M, et al.: Extending the RIGHT statement for reporting adapted practice guidelines in healthcare: the RIGHT-Ad@pt Checklist protocol. BMJ Open. 2019; 9(9): e031767. Published 2019 Sep 24. PubMed Abstract | Publisher Full Text

[22] 22. Chen Y, Guyatt GH, Munn Z, et al.: Clinical Practice Guidelines Registry: Toward Reducing Duplication, Improving Collaboration, and Increasing Transparency. Ann. Intern. Med. 2021; 174(5): 705–707. PubMed Abstract | Publisher Full Text

Developing the RIGHT extension statement for practice guideline protocols: the RIGHT-P statement protocol

Abstract

Keywords

Abbreviations

Introduction

Methods

Figure 1. Flowchart of the development process for RIGHT-P. RIGHT, Reporting Items for practice Guidelines in HealThcare.

Table 1. Timeline for development of RIGHT-P.

STAGE 1 Preparation

STAGE 2 Drafting the RIGHT-P checklist

STAGE 3 Implementation and transmission

Discussion

Data availability

Acknowledgements

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Browse by related subjects

Competing Interests Policy

Stay Updated