Extending the Reporting Items of Practice Guidelines in Healthcare (RIGHT) statement for reporting Chinese patent medicine guidelines: a protocol

Xuanlin Li; Lin Huang; Qi Zhou; Zhijun Xie; Xuanming Hu; Yaolong Chen; Chengping Wen

doi:10.12688/f1000research.140288.1

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Study Protocol

Extending the Reporting Items of Practice Guidelines in Healthcare (RIGHT) statement for reporting Chinese patent medicine guidelines: a protocol

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

Xuanlin Li^1,2, Lin Huang^1,2, Qi Zhou^3-5, [...] Zhijun Xie^1,2, Xuanming Hu^1,2, Yaolong Chen ^3-5, Chengping Wen^1,2

Xuanlin Li^1,2, Lin Huang^1,2, [...] Qi Zhou^3-5, Zhijun Xie^1,2, Xuanming Hu^1,2, Yaolong Chen ^3-5, Chengping Wen^1,2

PUBLISHED 11 Jan 2024

Author details Author details

¹ Key Laboratory of Chinese Medicine Rheumatology of Zhejiang Province, Zhejiang Chinese Medical University, Hangzhou, China
² College of Basic Medical Science, Zhejiang Chinese Medical University, Hangzhou, China
³ Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, China
⁴ Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China
⁵ WHO Collaborating Centre for Guideline Implementation and Knowledge Translation, Lanzhou University, Lanzhou, Gansu, China

Xuanlin Li
Roles: Conceptualization, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

Lin Huang
Roles: Conceptualization, Formal Analysis, Writing – Original Draft Preparation, Writing – Review & Editing

Qi Zhou
Roles: Methodology, Project Administration, Writing – Review & Editing

Zhijun Xie
Roles: Data Curation, Formal Analysis, Writing – Original Draft Preparation, Writing – Review & Editing

Xuanming Hu
Roles: Data Curation, Formal Analysis, Writing – Original Draft Preparation

Yaolong Chen
Roles: Funding Acquisition, Methodology, Project Administration

Chengping Wen
Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background: Based on the main document of the Reporting Items of Practice Guidelines in Healthcare (RIGHT) statement, this study will aim to develop the reporting checklist applicable to the guidelines of Chinese patent medicine (CPM).
Methods: According to the methodology recommended by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network, three well-defined working groups were established, namely the coordination team, the advisory group, and the Delphi panel. The coordination team conducted a literature analysis of the already published CPM guidelines, the extensions of the RIGHT statement, and CPM related reporting specifications to initially form an initial item pool. The Delphi panel of multidisciplinary backgrounds will conduct two rounds of Delphi questionnaires to identify an extension item for RIGHT for CPM. These questionnaires will be sent to each Delphi panel member via email, and each member will independently fill out and provide comments within 10 working days of receiving the questionnaire. Finally, feedback will be provided to the coordination team and the post efficacy assessment of the already published clinical practice guidelines for CPM to determine the final items for RIGHT for CPM checklist.
Dissemination: The extended version of the RIGHT for CPM checklist will be published in a peer reviewed journal.
Conclusion: We hope that the upcoming RIGHT for CPM checklist provides detailed guidance for developers and users of CPM guidelines, further improving the quality of reports, and promoting the effective dissemination and implementation of CPM guidelines.

Keywords

RIGHT statement; Chinese patent medicine; reporting guideline

Corresponding authors: Yaolong Chen, Chengping Wen

Competing interests: Qi Zhou and Yaolong Chen are members of the RIGHT Working Group. The authors have no other financial competing interests to declare.

Grant information: This work was supported by the National Natural Science Foundation of China (No: 82004501). The funders had no role in design, data collection and analysis, or preparation of this study.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2024 Li 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: Li X, Huang L, Zhou Q et al. Extending the Reporting Items of Practice Guidelines in Healthcare (RIGHT) statement for reporting Chinese patent medicine guidelines: a protocol [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2024, 13:56 (https://doi.org/10.12688/f1000research.140288.1) First published: 11 Jan 2024, 13:56 (https://doi.org/10.12688/f1000research.140288.1) Latest published: 11 Jan 2024, 13:56 (https://doi.org/10.12688/f1000research.140288.1)

Introduction

Standardizing reporting of clinical practice guidelines (CPGs) can help promote guideline integrity, transparency and reliability, assist clinicians in reading, evaluating, and applying the guidelines efficiently, and is an important safeguard in promoting the scientific implementation of guidelines. Currently, the Reporting Items for practice guidelines in healthcare (RIGHT) statement lays an important foundation for the scientifical and standardized reporting of CPGs.¹ In recent years, the RIGHT workgroup has developed multiple extensions around different guideline types, designs, domains, and so on, containing guideline adaptations (RIGHT - Ad@pt),² guideline interpretations (RIGHT - INT),³ and public and patient guidelines (RIGHT-PVG),⁴ among others. An extension of acupuncture (RIGHT for acupuncture)⁵ and extension of traditional Chinese medicine (RIGHT for TCM)⁶ were developed in the field of traditional and complementary alternative medicine. In particular, the development of RIGHT for TCM⁶ has provided an important basis for the scientific, normative and clear reporting of clinical practice guidelines for TCM compound formulas.

CPM are an important component in the drug supply security system in China and even worldwide. At present, more than 10,000 CPMs have been approved by the Chinese drug regulatory authority (China), and 1,617 CPMs are included in the Pharmacopoeia of the people's Republic of China (2020 Edition), and 4,052 CPMs are included in the pharmaceutical standard of the Ministry of health of the people's Republic of China - Chinese patent formulation. CPMs play important therapeutic, preventive, and health care roles in many disease phyla, but there are also promiscuity and even abuse phenomena.⁷ To standardize the rational application of CPMs, TCM policymakers approved the establishment of a standardized research project on the clinical application of CPMs for the treatment of dominant disease species and to develop CPGs for multiple types of CPMs,^8,⁹so that the number of CPGs for CPMs is growing rapidly. However, there are currently no reporting specifications for CPM guidelines. There are no items for the RIGHT for TCM that relates to CPMs,⁶ and there is insufficient consideration for CPM guidelines to report scientifically and transparently. At the same time, there is a lack of consideration of CPM guidelines in the selection and inclusion criteria of CPMs, policy access, indications/symptoms, instructions for CO-medications, medication for special populations, precautions for use, and medication recommendations for Western physicians. Therefore, to ensure rigor, transparency, clarity, and reproducibility of reporting the process of CPM guidelines, we will develop an extension of the RIGHT statement for the reporting of CPM guidelines (RIGHT for CPM).

Methods

The protocol of RIGHT for CPM checklist draws on the steps and merits of published work-up protocols for an extension of RIGHT statement⁹^–¹¹ and is developed with reference to the methods for reporting guideline development recommended by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network. The target users of RIGHT for CPM are the drafting/adapters, reviewers, and guideline stakeholders of the CPM guidance. In order to enhance the transparency and quality during the development of the RIGHT for CPM checklist, the present protocol intends to complete registration in the EQUATOR network (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-other-study-designs/#CPM). The development process of RIGHT for CPM is shown in Figure 1.

Figure 1. The development process of RIGHT for CPM.

Preparation phase

Establishment of the working group

The RIGHT for CPM working group will include: a coordination group; a advisory group, and a Delphi panel.

The advisory group will consist of 18 experts, including Prof. Yaolong Chen, the initiator of the RIGHT statement, and Prof. Chengping Wen, the co-initiator of the RIGHT for CPM extension. Experts with outstanding achievements in the reporting guidelines or TCM research are invited to form the advisory group. The recruitment criteria were experts with certain influence in the field of traditional Chinese medicine research, who have participated in or are familiar with the development of clinical practice guidelines or reporting standards. They will be contacted by email or direct phone. Their main responsibility is to provide methodological guidance and consultation for the development of RIGHT for CPM, ensure the quality of RIGHT for CPM development, and approve the final version of RIGHT for CPM items.

The coordination group will consist of seven to nine members who will lead and coordinate the development process of the RIGHT for CPM and ensure that it is completed according to the planned schedule. The members of the coordination group are mainly composed of graduate students and research-oriented teachers from universities, who work under the guidance of experienced members. They communicate and coordinate with each other through We-chat groups. Specifically, this group will be responsible for (1) the establishment of a pool of RIGHT for CPM items; (2) draft a preliminary RIGHT for CPM checklist; (3) issuing, collecting and sorting out Delphi questionnaires; (4) manage E-mail communications; and (5) drafting the final extension and explanatory document for RIGHT for CPM checklist.

A total of 17 experts will be invited to form a Delphi panel by e-mail or We-chat mobile application. To ensure clarity and transparency in the development process, all members are required to declare any potential conflicts of interest that may be related to the development of RIGHT for CPM. Recruitment criteria are as follows: (1) TCM clinical experts; (2) Clinical experts of TCM and Western medicine who have participated in or drafted the application guidelines of CPM in the past; and (3) Guideline methodology, evidence-based medicine, and clinical epidemiology experts. The primary responsibility of this panel is to conduct the delphi consultation and approve the final version items of the RIGHT for CPM checklist.

Creating an initial pool of items for RIGHT for CPM

We will systematically search PubMed, Embase, Cochrane Library, Web of science, China National Knowledge Infrastructure (CNKI), Chinese biomedical literature service system (CBM), Wanfang Database, and VIP databases to collect published CPM guidelines. The time range is in the database until April 2023. The full search strategy for PubMed database is shown in Table 1.

Table 1. Full search strategies for PubMed.

Step	Retrieval detail
#1	“Medicine, Chinese Traditional”[Mesh]
#2	((“Chinese Traditional Medicine”[Title/Abstract]) OR (“Traditional Chinese Medicine”[Title/Abstract])) OR (“Chinese patent medicine”[Title/Abstract])
#3	#1 OR #2
#4	“Guidelines as Topic”[Mesh]
#5	((((Guideline [Publication Type]) OR (“Practice Guideline”[Publication Type])) OR (Guideline* [Title/Abstract] OR guidance[Title/Abstract])) OR (recommendation[Title/Abstract])) OR (consensus [Title/Abstract])
#6	#4 OR #5
#7	#3 AND #6

The reporting quality of the CPM guidelines was assessed by four members of the coordination team with reference to the RIGHT for TCM checklist,⁶ and the initial items of the RIGHT for CPM will be initially extracted and condensed. All assessment processes are carried out independently, and if there is disagreement, consensus is reached through group discussion.

In addition, we will access extensions that have been completed or are in development via the RIGHT Statement website (http://www.right-statement.org/). At the same time, we will collect the reporting checklist for CPM research, which was sorted out by another four members of the coordination team, condensed, de-duplicated, summarized and integrated, and formed an items pool of RIGHT for CPM checklist.

Drafting the RIGHT for CPM checklist

Delphi questionnaire survey

The coordinating team will design the initial items as a questionnaire and send them independently to the Delphi penal as an online questionnaire using the Questionnaire Star (https://www.wjx.cn/). On the basis of evaluating the importance of the initial items, the members of the consensus expert group give the judgment of ‘agree’, ‘uncertain’, and ‘disagree’ for each item, and give the corresponding suggestions for modification. The coordination team will collect, sort out, and analysis the feedback results from the experts, count the consensus degree of each item (consensus degree = [number of people who agree/total number of people] *100%), and summarize the feedback opinions put forward by experts.

The eligibility criteria of items for RIGHT for CPM will be judged according to the following principles: (1) Those with a consensus degree <75% are directly excluded; (2) When the consensus degree is ≥75% and there is no substantive opinion, it is regarded as direct inclusion; and (3) When the consensus degree is ≥75% and there are substantive opinions, the second round of the Delphi survey will be conducted after the coordination team discussion determines the exclusion or modification, and the expert opinions will be replied one by one. (4) After the second round of the Delphi survey, items with consensus degree <75% and ≥75% and no substantive modification opinions should be treated in the same way as those in the first round. Items with consensus degree ≥75% and substantive opinions should be included or excluded after discussion between the coordination team. Based on the results of two rounds of the Delphi survey and expert feedback, the coordination team will form the RIGHT for CPM checklist (Version 1) after consensus discussion on the items initially included by advisory group. This version may be further adjusted and improved in later versions after publication to subsequent versions.

Implementation and dissemination

Drafting of interpretation and elaboration documents

The coordination team plans to develop the RIGHT for CPM explanation and elaboration document to explain and provide examples in each item in order to facilitate target users to understand and better apply the RIGHT for CPM checklist (Version 1).

Publicity and interpretation

The coordination group will upload the checklist of RIGHT for CPM and the documents of explanation and explanation to the RIGHT statement website for readers to download and read. At the same time, the publicity of RIGHT for CPM will be carried out through We-chat public accounts and academic conferences. In addition, the coordination group will continue to dynamically apply the RIGHT for CPM checklist to assess the emerging guidelines for CPMs and prepare sufficient information for the update version.

Discussion

Rational use of CPMs, improving the therapeutic level, and reducing abuse and waste are the core starting points for formulating guidelines for the application of CPM. The RIGHT for CPM checklist based on the RIGHT statement will provide detailed guidance for the developers and users of the guidelines for CPMs, with the hope to further improve the quality of the guidelines for CPMs and promote the effective dissemination and implementation of the guidelines for CPMs.

Data availability

No data are associated with this article.

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