康复临床实践指南：专家组构成及利益冲突研究

Clinical Practice Guidelines of Rehabilitation: Composition of Expert Group and Situation of Conflict of Interest

目的评价和分析康复临床实践指南专家组的构成和利益冲突管理情况。方法计算机检索PubMed、EMBASE、中国生物医学文献数据库(CBM)、中国知网(CNKI)和万方数据库,同时补充检索医脉通、英国国家卫生与临床优化研究所(NICE)、美国国立指南文库(NGC)、苏格兰校际指南协作网(SIGN)、世界卫生组织(WHO)、国际指南协作网(GIN),检索时限均为建库至2020年1月11日。由2名研究人员独立筛选文献并交叉核对,提取纳入指南的基本信息,包括指南题目、指南制订机构、指南发表期刊,以及专家组、专家组组数、专家组成员具体分工、学科专业、所属机构极其地理位置的报告情况以及利益冲突声明和管理、利益冲突的类型,是否接受资助、资助的来源等信息,并分析。结果最终纳入84篇指南,其中国内17篇,国外67篇。52篇(61.9%)报告专门的指南制订专家组;22篇(26.2%)报告具体的专家组组数;21篇(25.0%)报告专家组成员具体分工;74篇(88.1%)报告专家组成员具体姓名;47篇(56.0%)报告专家组成员的学科及专业;70篇(83.3%)报告专家组成员机构及其位置。14篇(16.7%)提及利益冲突的管理;25篇(29.8%)报告是否存在利益冲突。16篇(19.0%)报告制订的集体或者专家组成员受到外界的资金资助,但仅有5篇声明所受资助与指南制订无利益冲突。其中,国外指南专家组信息报告率明显高于国内(χ^2=9.542,P<0.01);国外指南专家组成员的姓名报告和具体分工报告率均高于国内(χ^2>4.155,P<0.05);国外指南利益冲突的管理报告率高于国内(χ^2=4.263,P<0.05);是否存在利益冲突、是否受到资助和所受资助类型这三方面,国内外比较无显著性差异(P>0.05)。结论国内外康复指南对专家组的制订与分工、利益冲突的声明与管理的报告程度均有待提高。建议康复临床实践指南制订者应当根据指南制订手册,重视专家组的建立和分组分工,加强对利益冲突内容的管理与报告,加强指南制订过程和报告形式的规范性。

Objective To evaluate and analyze the panel composition and conflict of interest management of clinical practice guidelines of rehabilitation.Methods Clinical practice guidelines of rehabilitation were systematically retrieved from Pub Med,EMBASE,China Biology Medicine disc,CNKI,Wanfang Data and Medlive database,the National Institute for Health and Care Excellence,National Guideline Clearinghouse,The Scottish Intercollegiate Guidelines Network,World Health Organization(WHO)and Guidelines International Network until January 11,2020.Two researchers independently screened and cross-checked the literatures,and extracted the basic information of included guidelines,including the title,formulating institution,published journol,as well as the expert group,the number of expert group,the specific division of labor and their discipline,affiliation and the geographic location,the statement and management of conflict of interest,types of conflicts of interest,and whether to accept fund and the source of the fund.Results A total of 84 guidelines were finally included,17 domestic ones and 67 foreign ones,in which,52(61.9%)reported the expert panel;22(26.2%)reported the number of expert panel groups,21(25.0%)indicated the specific division of work among the members of the expert panel,74(88.1%)reported the names of the members of the expert panel,47(56.0%)reported the subjects and specialties of the panelists,70(83.3%)reported the affiliation and location of panelists,14(16.7%)mentioned the management of conflicts of interest,and 25(29.8%)reported if there were conflicts of interest.Only five of the 16 funded guidelines stated that there was no conflict of interest between the funding and the development of the guidelines.Among them,the reporting rate of expert panel was significantly higher in foreign countries than in China(χ^2=9.542,P<0.01),the reporting rate of name of expert panel members and specific division of labor were higher in foreign countries than in China(χ^2>4.155,P<0.05),and the reporting rate of conflict of interest management was also higher in foreign countries than in China(P<0.05).There was no significant difference in whether there was a conflict of interest,whether it was funded and the type of funding at home and abroad(P>0.05).Conclusion In gerenal,clinical practice guidelines of rehabilitation published at home and abroad are necessary to be improved in the reporting quality of expert group formulation and division of labor,conflict of interest reporting and management.It is proposed that future guideline developers should follow the WHO Handbook for Guideline Development,assign roles of experts,strengthen the management and reporting of conflicts of interest,and standarderize the development process and reporting of the guidelines.