中医临床诊疗指南制修订现状调研、分析与工作建议

Investigation,Analysis and Suggestions on the Preparation and Revision of Clinical Diagnosis and Treatment Guidelines of Traditional Chinese Medicine

背景2014年底,国家中医药管理局政策法规与监督司开展中医临床诊疗指南制修订工作,对中医13个专科领域的240项中医临床诊疗指南项目进行制修订,中华中医药学会承担本部分工作。目的为了解中医领域临床诊疗指南制修订现状,从方法学角度对项目组工作中存在的问题进行分析并给出建议,本项目组对中华中医药学会中医临床诊疗指南制修订项目组进行调研。方法2020年6—12月,以中华中医药学会中医临床诊疗指南制修订项目组为调研对象,每个项目组人员填写一份问卷,汇集项目组整体意见。采用问卷星电子问卷,通过中华中医药学会工作文件的方式下发通知至各项目组进行调查,网络端收取调查结果。围绕调研主题,问卷内容包括5大方面:对中医临床诊疗指南的认识、指南制修订程序和方法学应用、指南制修订工作重点问题和关键环节、指南实施推广和应用情况、指南制修订工作情况整体调研。问卷为半结构化设计,共30个结构化问题、4个开放性问题。调研完成后对结果进行数据汇总与描述性分析。结果本调研最终收回有效问卷198份,调研结果提示,在对中医临床诊疗指南的认识上,大多数项目组(94.45%,187/198)认为本领域内依然需要更多的中医临床诊疗指南,中医临床诊疗指南依旧存在覆盖面不广、临床应用情况不佳等现状;指南制修订程序和方法学应用方面,99.49%(197/198)的项目组在指南制修订过程中遵照学会制修订技术方案,99.49%(197/198)的项目组有方法学专家全程参与;指南制修订工作重点问题和关键环节方面,项目组认为难点主要集中于缺乏高质量临床研究证据支持(89.39%,177/198)、缺乏符合中医药特点的方法学工具(70.20%,139/198)、临床分型标准难以统一(66.16%,131/198)、方药选择与用量无固定标准(60.61%,119/198)方面;指南实施推广和应用情况方面,71.21%(141/198)的项目组认为推广应用情况符合预期,但也存在一些推广应用难点;指南制修订工作情况整体调研方面,绝大多数(96.97%,192/198)项目组表示在指南制修订的过程中投入了大量的人力、物力、精力等资源。结论多数项目组认为中医临床诊疗指南在临床实践中具有重要的指导意义,在指南制修订时注重循证方法学应用,同时,各项目组在制修订工作中也遇到了一些问题和困难。建议应重视指南制修订工作,加大相关资金支持;在中医临床诊疗指南制修订过程中,需要有方法学专家全程参与并把控质量;增加循证医学与临床诊疗指南制订相关培训;严格遵循最新技术方案与方法学流程;在指南制修订过程中注意体现中医药诊疗特色,以临床实用、适用为目标,以期提高中医临床诊疗指南质量,促进中医药更好地服务于人民健康。

Background At the end of 2014,the department of policies,regulations and supervision of the State Administration of traditional Chinese medicine carried out started to the preparation development and revision of clinical diagnosis and treatment guidelines of traditional Chinese medicine at the end of 2014,and made progressdeveloped in 240 clinical diagnosis and treatment guidelines of traditional Chinese medicine in 13 specialized fields.The Chinese society of traditional Chinese medicine undertookakes this part of the work.Objective In order to understand the current situation of the preparation development and revision of clinical diagnosis and treatment guidelines for in the field of traditional Chinese medicine,analyze the problems existing in the work of thethis project team from the perspective of methodology and give suggestions,this project team conducted investigated research on the preparation development and revision project team of clinical diagnosis and treatment guidelines of developed by traditional Chinese medicine of the Chinese Academy of traditional Chinese medicine.Methods The survey will be conducted from June to December 2020.The survey object participants are is the project groups of the preparation development and revision of the clinical diagnosis and treatment guidelines of Chinese medicine of the Chinese Society of Traditional Chinese Medicine.Each project team member of this project team finishedlls in a questionnaire,and finally gathers the overall opinions of the project team were collected.The Chinese Society of Traditional Chinese Medicine issued a notice to invite all project teams to participate in the survey by means ofusing questionnaire star electronic questionnaire,and finally collected the answers on the network.Focusing Based on the research theme,the questionnaire includes five aspects:1.understanding of the clinical diagnosis and treatment guidelines of for traditional Chinese medicine;2.guide preparation development and revision procedures and application of methodology application;3.key issues and key links steps in the preparation development and revision of the guidelines;4.implementation,promotion and application of the guidelines;5.overall investigation on about the guidelines preparation development and revision of the guidelines.The questionnaire is semi-structured,with 30 structured questions and 4 open questions.After the completion of the survey,the researchers conducted data summary and descriptive analysis on the results after survey.Results The survey finally recovered collected 198 valid questionnaires.The survey results suggest that most project teams(94.45%,187/198)think that more clinical diagnosis and treatment guidelines of for traditional Chinese medicine are still needed in this field,and the coverage of clinical diagnosis and treatment guidelines of traditional Chinese medicine is still not wide enough,and the clinical application is poor;In terms of the procedures for the preparation development and revision of the guidelines and the application of methodology application,99.49%(197/198)of the project teams followed the technical plan for the preparation development and revision of the guidelines,and 99.49%(197/198)of the project teams had methodological experts participating in the whole process.In terms of the key issues and key linkssteps in the preparation development and revision of the guidelines,most project teams believed that the main difficulties difficulties mainly focus on theare lack of high-quality clinical research evidence support(89.39%,177/198),the lack of methodological tools consistent with the characteristics of traditional Chinese medicine(70.20%,139/198),the difficulty in unifying clinical classification standards(66.16%,131/198),and the absence of fixed standards for the selection and dosage of prescriptions and drugs(60.61%,119/198).In terms of the implementation,promotion and application of the guidelines,71.21%(141/198)of the project team believed that the promotion and application were in line with expectations,but there were also some difficulties in promotion and application;In terms of overall research investigation on about the preparation development and revision of the guidelines,the vast majority(96.97%,192/198)of the project teams said that they had invested a lot of human,material,energy and other resources in the preparation development and revision of the guidelines.Conclusion Most project teams thought clinical diagnosis and treatment guidelines for traditional Chinese medicine had significant guidance in clinical practice,and each project team face some problems and difficulties in guideline development and revisions.We give proposed the following suggestions:in the future,attention should be paid to the preparation development and revision of the guidelines,and relevant financial support should be increased;during the preparation development and revision of clinical diagnosis and treatment guidelines of traditional Chinese medicine,all working groups need to have methodological experts participate in the whole process and control the quality;increase training on evidence-based medicine and the formulation of clinical diagnosis and treatment guidelines;strictly follow the latest technical solutions and methodological processes;during the preparation development and revision of the guidelines,we should pay attention to the characteristics of traditional Chinese medicine diagnosis and treatment,and aim at clinical practicality and applicability,in order to improve the quality of clinical diagnosis and treatment guidelines of traditional Chinese medicine and promote traditional Chinese medicine to better serve people's health.