The development of clinical guidelines in China: insights from a national survey

Yang Song,Yaolong Chen,Pablo Alonso-Coello,Yuan Zhang,Ruixia Guo,Jing Li

doi:10.1186/s12961-021-00799-7

Abstract

BackgroundPrevious research suggests that the quality of clinical guidelines (CGs) in China is suboptimal. However, little is known about the methodology that CGs follow. We conducted a national survey of methods used by Chinese CG developers for CG development, adaptation, and updating.MethodsWe used a previously piloted questionnaire based on methodologies of CG development, adaptation, and updating, which was distributed during September–November 2020 to 114 organizations identified from published Chinese CGs (searched 2017–2020), recommended by Chinese CG developers, and recommended by clinical discipline experts.ResultsWe collected 48 completed questionnaires (42.1% response). Most organizations developed CGs based on scientific evidence (89.6%), existing CGs (75%), or expert experience and opinion (64.6%). Only a few organizations had a specific CG development division (6.3%), a CG monitoring plan (on clinicians 33.3%; on patients 18.8%), funding (33.3%), or a conflict-of-interest (COI) management policy (23.4%). Thirty (62.5%) organizations reported using a CG development methodology handbook, from international organizations (14/30, 46.7%), methodology or evaluation resources (3/30, 10.0%), expert experience and opinion (3/30, 10.0%), or in-house handbooks (3/30, 10.0%). One organization followed a published adaptation methodology. Thirty-eight organizations (88.4%) reported de novo CG development: 21 (55.3%) formed a CG working group, and 29 (76.3%) evaluated the quality of evidence (21 [72.4%] using a methodological tool). Nineteen organizations (52.8%) reported CG adaptation: three (31.6%) had an adaptation working group, and 12 (63.2%) evaluated the quality of source CGs (2 (16.7%) using the AGREE II instrument). Thirty-three organizations (68.8%) updated their CGs, seven (17.5%) using a formal updating process.ConclusionsOur study describes how CGs are developed in a middle-income country like China. To ensure better healthcare, there is still an important need for improvement in the development, adaptation, and updating of CG in China.

Highlights

Previous research suggests that the quality of clinical guidelines (CGs) in China is suboptimal
While previous evidence shows that many international CGs have been used to develop Chinese CGs [12]—for example, the National Comprehensive Cancer Network (NCCN) guidelines or National Institute for Health and Care Excellence (NICE) guidelines—how those source CGs were evaluated and adapted is poorly reported [21]
Questionnaire We developed a self-administered questionnaire based on several methodological and evaluation resources, including AGREE II [17], Grading of Recommendations Assessment, Development and Evaluation (GRADE) [23], GRADE Evidence to Decision (EtD) frameworks [24], Resource Toolkit for Guideline Adaptation (ADAPTE) [6], and the Checklist for the Reporting of Updated Guidelines (CheckUp) [25]

Summary

Introduction

Previous research suggests that the quality of clinical guidelines (CGs) in China is suboptimal. The evidence shows that Chinese CG quality, as assessed by the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument [17], is scored at under 30% in most domains [16]. Empirical evidence shows that China lacks high-quality clinical and epidemiological studies or other types of studies as evidence-based resources [18], which may hinder the adequate updating of Chinese CGs or adaptation for local use. While previous evidence shows that many international CGs have been used to develop Chinese CGs [12]—for example, the National Comprehensive Cancer Network (NCCN) guidelines or National Institute for Health and Care Excellence (NICE) guidelines—how those source CGs were evaluated and adapted is poorly reported [21]

Results

Discussion

Conclusion