基于循证的中医临床实践指南研制方法研究

【作者】 周莉；

【导师】 高颖；

【作者基本信息】 北京中医药大学 ， 中医内科学， 2011， 博士

【摘要】 过去20年来,由于临床实践的极大差异、医疗措施的明显不恰当使用及人们对医疗费用的关注等原因,临床实践指南的开发与应用得到了迅猛地发展。临床实践指南可促进临床诊疗质量提高,帮助患者取得更好的治疗效果。在指南指导下结合患者的具体病情做出诊断和治疗的决策,有助于循证医学的原则在临床医疗实践中得到更好的贯彻和实施,规范临床医生的医疗行为,提高医疗服务质量。目前我国卫生保健系统同样面临着以上难题,因此更需要应用经科学系统开发的临床指南来解决具体相关问题、规范临床服务。随着科研水平的提高和成果转化力度的提升,临床试验为中医临床实践指南的制定提供了一定的循证医学证据,指南已经由“基于共识的临床指南”逐渐发展为“循证临床指南”,即在广泛收集临床证据的基础上,按照循证医学的方法开发出一组临床指导意见,并将推荐意见与相关的证据质量明确地联系起来,依据对现有证据进行评价的结果来确定推荐意见,制订指南。本研究从临床实践指南的综述入手,结合脑梗死中医循证临床实践指南的示范性研制和实施,对基于循证的中医临床实践指南的意义、建立、评价、关键问题及其解决、报告规范等方面进行探讨,为下一步开展中医药规范化研究提供方法学依据。[研究目的]1.系统分析、评价现有中医临床实践指南,探讨基于循证的中医临床实践指南指定和实施的必要性、适用性和现实意义。2.建立基于循证医学原则的,系统全面和科学合理,符合中医辨证论治特点的临床实践指南研制、实施、评价以及报告规范的方法学框架。3.结合脑梗死中医循证临床实践指南的应用实践,分析、解决基于循证的中医临床实践指南研制难点和关键问题的思路策略。[研究思路和方法]本研究首先系统检索和分析了国内外临床实践指南的相关文献,明确了临床实践指南的概念、基本原则和制定方法,阐述了临床实践指南实施和评价的必要性、内容、方法及指标体系等,比较了临床实践指南与系统评价及其他类型国际标准文件的异同点,说明了临床实践指南实施的效果。在此基础上,采用定性研究和定量分析相结合的研究方法,结合我国现有中医临床实践指南,采用AGREE等进行评价分析,探讨了中医临床实践指南编制的基本思路,提出了基于循证的中医临床实践指南指定和实施的必要性、适用性和现实意义。结合脑梗死中医循证临床实践指南的开发和应用实践,通过深入访谈、调查问卷、专家共识(头脑风暴法、德尔斐法、共识会议等)、个案研究、临床推广试验效果评价等多种定性定量研究方法,提出了基于循证的中医临床实践指南的制定与实施方法学流程,探讨了其难点及关键问题,提出了相应的解决对策,形成了基于循证的中医临床实践指南报告规范。[发现与结果]本研究通过对文献进行系统梳理和评价,对国内发表的中医临床实践指南进行评价和分析,得出结论：中医循证临床实践指南的研制具有极其重要的意义,有助于循证医学的原则在临床医疗实践中得到贯彻和实施,规范中医药临床诊疗技术,促进医疗服务质量,帮助临床医生和患者选择最佳的治疗方案和决策,取得更好的疗效。区别于西医学,中医临床实践指南制定中应体现辨证论治的特色和优势,建立既符合循证医学方法学要求,又体现中医药诊疗核心内容的方法学框架至关重要。通过系统全面的方法学探索,本研究探讨了研制中医循证临床实践指南的原则,提出基于循证医学的临床实践指南主要分为5个步骤进行制定：成立临床实践指南工作组；确定指南的主题和目的；开发循证指南；临床指南的起草；指南的修改、评审及定稿。结合脑梗死中医循证临床实践指南的开发和应用实践,通过深入访谈、调查问卷、专家共识(头脑风暴法、德尔斐法、共识会议等)、临床推广试验效果评价等多种定性定量研究方法,提出了基于循证的中医临床实践指南的研制、评价与实施方法学流程。在此基础上,探讨了中医循证临床实践指南的难点及关键问题：中医诊疗技术的规范性和一致性的探讨；循证医学证据的选择；指南实施效果的评价等。结合案例分析,提出了相应的解决对策：开展标准化研究为指南提供证据；根据目的选择适宜的共识法和临床试验评价指南的后效评价。更多还原

【Abstract】 During the past 20 years, as a result of the large differents between practical behaviors,the inuse of the medical cure,and the care of the medical expanses,the establish and application of clinical guideline has been improved quickly. The clinical guideline can improve the quality of the clinical standard and help the patients get the most efficient clinical effects.diagnosis and treatment of decision made under the guidance of the guideline with the specific patients can help to implemented the principle of evidence-based medicine better in clinical practice, standardize the clinician’s medical behavior, improve the medical service quality.At present our country health care system also faces the problems, so clinical guidelines development by science are more needed to solve related problems and standard clinical services. With the development of scientific research and achievement transformation, clinical trials provided some evidence,for the formulation of TCM clinical practice guidelines.Thus "the clinical guidelines based on consensus " transformates to "the evidence-based clinical guidelines ",.which means that on the ground of clinical evidence, according to some methods of evidence-based medicine,a set of clinical guidelines has been developed and recommended opinions are linked to existing evidence.So according to the result of evidence evaluation,we can determine the recommendation and formulate guidelines.In this study, accompany by the development and application of the clinical guideline of cerebral infarction as a example, the author analyzed and summarized the definition, basic theory,evaluation of clinical guideline, tried to establish the guidelines,to deal with key issues and the measurement, so that the author can apply the study for the standardized study of TCM.Objectives1 by System analysising and evaluating existing Chinese medicine clinical practice guidelines, Try tou discussthe necessity,pplicability and realistic significance..2.Try to establish the evidence-based systematic and scientific methodology structure of clinical guidelines,including how to design,meature,appraise of a certain disease.3.Try to propose strategies for resolution of the difficulties and key issres in designing an evidence-based Chinese clinical guidelines while analyuzing the experience of preliminary application of of cerebral infarction.MethodsFirstly,the study review and analyse domestic and international clinical practice guidelines, clear the concept, basic principle and establishment method, of the clinical practice guidelines, explained the necessity methods and index system, of Clinical practice guidelines, compared the clinical practice guidelines, system evaluation and clinical pathway, and explains implementation effect of clinical practice guidelines.According to the theory of the clinical guideline,the author value the existing domestic Chinese clinical guideline by the AGREE, discusses the basic thought of TCM clinical practice guidelines,and presented the ecessity, applicability and realistic significance.of clinical practice guidelines based on evidence-based medicine.Combined with the development and application practice of the TCM evidence-based clinical practice guidelines about cerebral infarction, through some qualitative and quantitative research methods, such as in depth-interview, questionnaire, expert consensus (brainstorming method, Delphi, consensus conference, etc), case studies, promotion evaluation of clinical test,the authou put forward to the formulation and implementation methodology flow, about the evidence-based medicine clinical practice guidelines,discuss the difficulties, key issues and the solution.FindingsThrough the systematic review and evaluation of the literature,by evaluating the existing domestic published TCM clinical practice guidelines and analysis, this study drew a conclusion:TCM evidence-based clinical practice guidelines research has very important significance. It can help the principle of evidence-based medicine implemented in clinical practice standardize Chinese medicine clinical medical technologies, promote medical service quality, help clinicians and patients to choose the best treatment plan and decision-making, and thus achieve better curative effect. Compare to western medicine, Chinese medicine clinical practice guidelines should reflect in making its features and advantages of differentiation, establish methodology framework which accords with the methodology of evidence-based medicine and also reflect the core content.Through the systematic methodological exploration, this study explores the principle of the development about theTCM evidence-based guidelines and put forward to the theory that Based on evidence-based medicine clinical practice guidelines are mainly divided into five steps:Establish clinical practice guidelines group; Determine the theme and purpose; Development evidence-based guidelines; Draft clinical guidelines; revise, Review and finalize. The guideline. through some qualitative and quantitative research methods, such as in depth-interview, questionnaire, expert consensus (brainstorming method, Delphi, consensus conference, etc), case studies, promotion evaluation of clinical test,the authou put forward to the formulation and implementation methodology flow, about the evidence-based medicine clinical practice guidelines,discuss the difficulties, key issues and the solution; Discuss the standardization and the consistency of TCM treatment technology; Choose the evidence-based medical evidence; Guide to the methodology of the implementation and evaluation. Combined with case analysis, the corresponding countermeasures are put forward: Carry out standardized study to provide evidence for guideline; Choose appropriate consensus method and clinical test evaluation according to the objective for the aftereffects evaluation.更多还原