基于循证的中医临床路径研制方法研究
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摘要
随着医学的不断进步,医疗水平的不断提高,健康观念的不断改变,人们对医疗卫生服务的需求不断增长,医疗费用和质量的问题日益突出。在医药卫生改革不断深入的社会背景下,医疗机构如何提供更高质量、更合理费用和更高效率的服务,成为各国医药卫生改革的重大目标之一,也是各国临床研究和管理的重大目标之一。临床路径通过综合多学科服务、建立标准化流程的方法来规范临床医疗行为,明确了临床医疗服务的技术路线流程以及实现医疗服务预期目标的途径、方法和基本准则,既是临床诊疗服务的标准和规范,也是一种以病人为中心,优化、简化和增效的有序管理方式,具有技术和管理的双重特性。通过临床路径的实施和应用,可以缩短平均住院时间,减少住院费用,避免医疗资源浪费,并能合理优化医疗方案,使患者享受到最适宜和当下最佳的治疗方案。
我国自上世纪90年代引入临床路径的概念,在部分医院进行了尝试和应用,2009年卫生部、国家中医药管理局在医药卫生改革的相关文件中明确提出要制定实施临床路径规范管理的要求,以促进解决我国“看病难、看病贵”问题。然而临床路径在国际上主要使用在西医医院中规范西医诊疗服务,要在中医或中西医结合医院推行此种管理模式规范中医或中西医结合服务,还是一种新的尝试,与之相应的科学问题研究也亟待进一步深入。
本研究从对临床路径概念、发展状况的综述入手,研究提出了基于循证的中医临床路径的理论基础、制定实施方法、难点及其解决策略、报告规范等,以冀能为中医临床路径的制定机构和人员提供一个较为系统、全面的方法学参考。
[目的]
1从不同角度探讨基于循证的中医临床路径的理论基础,为其推广应用提供科学依据。
2建立基于循证医学原则的、系统全面和科学合理、并符合中医诊疗和管理特点的临床路径研制、实施、评价以及报告规范的方法学框架。
3结合初步的应用实践,分析提出解决基于循证的中医临床路径研制难点及关键问题的思路策略。
[方法]
首先通过文献回顾性研究方法,系统综述了临床路径的概念、制定的基本原则与一般方法；并用比较分析法,分析了临床路径与临床实践指南的异同、临床路径管理模式和传统医疗模式的区别和联系。
在此基础上,应用定性研究中的文献分析法,结合我国中医和中西医结合医疗的实际情况和中医临床路径的初步实践经验,研究分析了基于循证的中医临床路径实施的必要性、适用性和现实意义；并结合突发性耳聋和慢性心力衰竭的中医临床路径示范性研制实施,应用深入访谈、规范分析、个案研究、归纳演绎、小组共识等多种定性定量研究方法,对中医临床路径的理论基础进行了研究,提出了中医临床路径制定与实施的方法学流程,对研制过程中的难点及关键问题提出了解决对策,以及在专家小组讨论共识等方法的基础上形成了中医临床路径报告规范草案。2基于循证的中医临床路径研制方法研究
[发现与结果]
通过文献学研究,对临床路径进行溯源和综述,明确了其内涵和外延,明确了与临床实践指南及传统医疗模式的异同。
通过方法学研究,论证了将临床路径引入中医研究领域的适用性和必要性,提出创建基于循证的中医临床路径的详细步骤,包括：临床路径委员会及小组的成员构成及职责；选择病种、探讨可行性；制定相关管理文件并确定相关人员职责；文献查找与评估；确定完成临床路径标准诊疗流程需要的时间；设计临床路径文本；征询有关人员意见；对相关的一线人员进行培训。
提出基于循证的中医临床路径实施步骤应包括：患者准入评估；执行医疗计划,做好详细记录；实际医疗行为与路径的变异记录、分析、处理；患者退出临床路径的条件；相关指标资料收集与整理。基于循证的中医临床路径的评价应包括路径研发过程科学性、合理性的评价,变异分析,实施过程和效果的评价,以及成果报告的内容。
基于循证的中医临床路径制定的主要难点是要确定中医临床治疗的相对优势、治疗方案的规范化、循证医学证据的选择和取舍。解决难点的方法包括：汇集适用的证据；明确相对优势；取得专家共识。而且基于循证的中医临床路径“基本框架”除了主体内容外,至少应当包括前言、参考文献和相关附件等18个要素。
[结论]
1建立和推行符合循证医学理念的中医临床路径对于进一步发挥中医临床优势,提高中医在服务疾病防治和健康促进中的贡献度具有非常重要的现实意义。
2建立基于循证的中医临床路径,必须基于人本理念、循证医学理念、现代管理学理论和卫生经济学原则,并符合中医临床诊疗特点。
3基于循证的中医临床路径的研制,要在一般方法学的基础上依据上述基本原则进行重构,并着力解决在路径实施过程中个性和共性、证据采集分类使用以及专家共识相结合等关键问题。
4同时应建立可供持续改进的基于循证的中医临床路径报告的统一规范。
Background
Nowadays, the government of different countries and people pay more attention to the increasing consumption of healthcare resources and the requirement of quality of healthcare delivery with the continuant development of medical science and the growing demand about medical services. Accordingly, how to provide and conduct better healthcare services with higher quality, lower expenses and more efficiency have become major challenges, which are big problems to the health officials around the world, especially during the transition period of health system reform in China.
Clinical pathway (CP), with both technology and management characteristics at the same time, means to an optimal, simplified and synergistic management pattern especially for disease management, which works through the collaboration of multi-disciplines, construct standardized operation procedures to guide practitioners'medical behaviors. It clarifies the routine procedure of healthcare technique and provides the approach, methods and basic standard to realize the expected goals for better healthcare. By using the clinical pathway, patients will gain benefit of shortening average hospital stays and lower expenditure so as to decrease waste of limited medical resources and to optimize the effect of medical treatment.
Clinical pathway has been used in only a few hospitals since it was introduced into China in 1990's. However, China's Ministry of Health and the State Administration of Chinese Medicine proposed to establish and carry out clinical pathway to help to relieve the problems of deficiency of medical resources and excessive health care cost.
In this study, the author analyzed and summarized the history, definition, basic theory of clinical pathway, tried to establish the guidelines, to deal with key issues and the measurement, and to propose a structured reporting of evidence-based Chinese clinical pathway, in order to contribute to the development of methodology about Chinese clinical pathway as an example for the relevant institution and officials.
Objectives
1 Try to provide the scientific evidence for the spread and exploitation of evidence-based Chinese medical pathway by analyzing its basic theory from the view of multi-disciplines.
2 Try to establish the evidence-based, systematic and scientific methodology structure of clinical pathway including how to design, measure, appraise and report clinical pathway for a certain disease, which should embody the characteristics of Chinese medicine.
3 Try to propose strategies for resolution of the difficulties and key issues in designing an evidence-based Chinese medicine pathway by analyzing the experience of preliminary application in clinical practice.
Methods
This study defined the clinical pathway, and stated the basic principles and methods for developing a clinical pathway by synthesizing the published literatures systematically, compared the difference between clinical pathway and clinical practice guideline, and compared the differences and analyzed the interaction between the management model based on clinical pathway methodology and the concept and the model based on traditional methodology.
According to the theory of development of clinical pathway, two independent case studies-in application of the clinical pathway for two conditions including sudden deafness and chronic heart failure, were carried out to help to explore the possible basic theory of evidence-based Chinese clinical pathway, and raise the procedures on developing and practicing the evidence-based Chinese clinical pathway, also discuss the difficulties, key issues and the solution during the process of pathway development to format the evidence-based Chinese clinical pathway report guidelines, by different quantitative and qualitative data collecting methods such as in depth-interviewing, analyzing, deep describing, inducing and deducing, group consensus et al.
Findings
In the literature review, we introduced the history and theory of clinical pathway development, and clarified its internal and external implications. Also we compared the difference between the clinical pathway and clinical practice guideline, and analyzed the difference and interaction between the management model based on clinical pathway methodology and concepts and the model based on traditional methodology.
In the methodology study, we analyzed the importance and necessity to apply the clinical pathway into the evidence-based Chinese clinical practice. And we elaborated the details about how to construct the clinical pathway for evidence-based Chinese medicine. The process included:the constitution and responsibility of the team for developing clinical pathway; criteria for selecting diseases for clinical pathway, and analyzing the feasibility; drafting the relevant management documentations and determining relevant stuffs'duty; searching and appraising literatures; making schedules; designing the clinical pathway contents; consulting the experts; training the relevant practitioners and nurses.
And we also elaborated the details about how to implement the clinical pathway of evidence-based Chinese medicine. The process includes:setting up inclusion criteria and exclusion criteria; keeping recording the process of treatment; recording of its implementation, analyzing and solving the possible deviations from pathway; collecting and classifying the patients'outcomes.
Accordingly, the scientific and rationality process of developing clinical pathway, detecting and analyzing deviations, appraising the implementation and efficiency as well as performance reports should be listed on the appraisal program of the evidence-based Chinese clinical pathway.
The difficulties of developing the clinical pathway of evidence-based Chinese medicine included:classifying the TCM treatment strategy, the outcomes of Chinese medicine treatment, choosing and making decisions based on available evidence. And the key issues included:collecting the evidence, identifying the advantages, and reaching experts consensus. Furthermore, the main structure for writing evidence-based Chinese clinical pathway should include introduction, contents, references, attachments, and other in total of 18 items.
Conclusions
This finding from this study suggests:
1 It would be very meaningful to construct and practice the evidence-based Chinese clinical pathway in order to improve healthcare quality and strength the position of Chinese medicine treatment for the patients'healthcare services.
2 It would be very important to construct and form the evidence-based Chinese clinical pathway based on the perspectives of humanity, the theory and methodology of evidence-based medicine, the theory of modern management, health economic principle, and embodying characteristics of Chinese medicine.
3 It would be a crucial technique to construct evidence-based Chinese clinical pathway according to the common methodology and the principles as above-mentioned, and we must pay attention to some key issues such as keeping the balance between the specialty and generalizability, using and classifying the evidence available.
4 It would be necessary to propose a guide for reporting the evidence-based Chinese clinical pathway which could be modified on usage in practice.
我国自上世纪90年代引入临床路径的概念,在部分医院进行了尝试和应用,2009年卫生部、国家中医药管理局在医药卫生改革的相关文件中明确提出要制定实施临床路径规范管理的要求,以促进解决我国“看病难、看病贵”问题。然而临床路径在国际上主要使用在西医医院中规范西医诊疗服务,要在中医或中西医结合医院推行此种管理模式规范中医或中西医结合服务,还是一种新的尝试,与之相应的科学问题研究也亟待进一步深入。
本研究从对临床路径概念、发展状况的综述入手,研究提出了基于循证的中医临床路径的理论基础、制定实施方法、难点及其解决策略、报告规范等,以冀能为中医临床路径的制定机构和人员提供一个较为系统、全面的方法学参考。
[目的]
1从不同角度探讨基于循证的中医临床路径的理论基础,为其推广应用提供科学依据。
2建立基于循证医学原则的、系统全面和科学合理、并符合中医诊疗和管理特点的临床路径研制、实施、评价以及报告规范的方法学框架。
3结合初步的应用实践,分析提出解决基于循证的中医临床路径研制难点及关键问题的思路策略。
[方法]
首先通过文献回顾性研究方法,系统综述了临床路径的概念、制定的基本原则与一般方法；并用比较分析法,分析了临床路径与临床实践指南的异同、临床路径管理模式和传统医疗模式的区别和联系。
在此基础上,应用定性研究中的文献分析法,结合我国中医和中西医结合医疗的实际情况和中医临床路径的初步实践经验,研究分析了基于循证的中医临床路径实施的必要性、适用性和现实意义；并结合突发性耳聋和慢性心力衰竭的中医临床路径示范性研制实施,应用深入访谈、规范分析、个案研究、归纳演绎、小组共识等多种定性定量研究方法,对中医临床路径的理论基础进行了研究,提出了中医临床路径制定与实施的方法学流程,对研制过程中的难点及关键问题提出了解决对策,以及在专家小组讨论共识等方法的基础上形成了中医临床路径报告规范草案。2基于循证的中医临床路径研制方法研究
[发现与结果]
通过文献学研究,对临床路径进行溯源和综述,明确了其内涵和外延,明确了与临床实践指南及传统医疗模式的异同。
通过方法学研究,论证了将临床路径引入中医研究领域的适用性和必要性,提出创建基于循证的中医临床路径的详细步骤,包括：临床路径委员会及小组的成员构成及职责；选择病种、探讨可行性；制定相关管理文件并确定相关人员职责；文献查找与评估；确定完成临床路径标准诊疗流程需要的时间；设计临床路径文本；征询有关人员意见；对相关的一线人员进行培训。
提出基于循证的中医临床路径实施步骤应包括：患者准入评估；执行医疗计划,做好详细记录；实际医疗行为与路径的变异记录、分析、处理；患者退出临床路径的条件；相关指标资料收集与整理。基于循证的中医临床路径的评价应包括路径研发过程科学性、合理性的评价,变异分析,实施过程和效果的评价,以及成果报告的内容。
基于循证的中医临床路径制定的主要难点是要确定中医临床治疗的相对优势、治疗方案的规范化、循证医学证据的选择和取舍。解决难点的方法包括：汇集适用的证据；明确相对优势；取得专家共识。而且基于循证的中医临床路径“基本框架”除了主体内容外,至少应当包括前言、参考文献和相关附件等18个要素。
[结论]
1建立和推行符合循证医学理念的中医临床路径对于进一步发挥中医临床优势,提高中医在服务疾病防治和健康促进中的贡献度具有非常重要的现实意义。
2建立基于循证的中医临床路径,必须基于人本理念、循证医学理念、现代管理学理论和卫生经济学原则,并符合中医临床诊疗特点。
3基于循证的中医临床路径的研制,要在一般方法学的基础上依据上述基本原则进行重构,并着力解决在路径实施过程中个性和共性、证据采集分类使用以及专家共识相结合等关键问题。
4同时应建立可供持续改进的基于循证的中医临床路径报告的统一规范。
Background
Nowadays, the government of different countries and people pay more attention to the increasing consumption of healthcare resources and the requirement of quality of healthcare delivery with the continuant development of medical science and the growing demand about medical services. Accordingly, how to provide and conduct better healthcare services with higher quality, lower expenses and more efficiency have become major challenges, which are big problems to the health officials around the world, especially during the transition period of health system reform in China.
Clinical pathway (CP), with both technology and management characteristics at the same time, means to an optimal, simplified and synergistic management pattern especially for disease management, which works through the collaboration of multi-disciplines, construct standardized operation procedures to guide practitioners'medical behaviors. It clarifies the routine procedure of healthcare technique and provides the approach, methods and basic standard to realize the expected goals for better healthcare. By using the clinical pathway, patients will gain benefit of shortening average hospital stays and lower expenditure so as to decrease waste of limited medical resources and to optimize the effect of medical treatment.
Clinical pathway has been used in only a few hospitals since it was introduced into China in 1990's. However, China's Ministry of Health and the State Administration of Chinese Medicine proposed to establish and carry out clinical pathway to help to relieve the problems of deficiency of medical resources and excessive health care cost.
In this study, the author analyzed and summarized the history, definition, basic theory of clinical pathway, tried to establish the guidelines, to deal with key issues and the measurement, and to propose a structured reporting of evidence-based Chinese clinical pathway, in order to contribute to the development of methodology about Chinese clinical pathway as an example for the relevant institution and officials.
Objectives
1 Try to provide the scientific evidence for the spread and exploitation of evidence-based Chinese medical pathway by analyzing its basic theory from the view of multi-disciplines.
2 Try to establish the evidence-based, systematic and scientific methodology structure of clinical pathway including how to design, measure, appraise and report clinical pathway for a certain disease, which should embody the characteristics of Chinese medicine.
3 Try to propose strategies for resolution of the difficulties and key issues in designing an evidence-based Chinese medicine pathway by analyzing the experience of preliminary application in clinical practice.
Methods
This study defined the clinical pathway, and stated the basic principles and methods for developing a clinical pathway by synthesizing the published literatures systematically, compared the difference between clinical pathway and clinical practice guideline, and compared the differences and analyzed the interaction between the management model based on clinical pathway methodology and the concept and the model based on traditional methodology.
According to the theory of development of clinical pathway, two independent case studies-in application of the clinical pathway for two conditions including sudden deafness and chronic heart failure, were carried out to help to explore the possible basic theory of evidence-based Chinese clinical pathway, and raise the procedures on developing and practicing the evidence-based Chinese clinical pathway, also discuss the difficulties, key issues and the solution during the process of pathway development to format the evidence-based Chinese clinical pathway report guidelines, by different quantitative and qualitative data collecting methods such as in depth-interviewing, analyzing, deep describing, inducing and deducing, group consensus et al.
Findings
In the literature review, we introduced the history and theory of clinical pathway development, and clarified its internal and external implications. Also we compared the difference between the clinical pathway and clinical practice guideline, and analyzed the difference and interaction between the management model based on clinical pathway methodology and concepts and the model based on traditional methodology.
In the methodology study, we analyzed the importance and necessity to apply the clinical pathway into the evidence-based Chinese clinical practice. And we elaborated the details about how to construct the clinical pathway for evidence-based Chinese medicine. The process included:the constitution and responsibility of the team for developing clinical pathway; criteria for selecting diseases for clinical pathway, and analyzing the feasibility; drafting the relevant management documentations and determining relevant stuffs'duty; searching and appraising literatures; making schedules; designing the clinical pathway contents; consulting the experts; training the relevant practitioners and nurses.
And we also elaborated the details about how to implement the clinical pathway of evidence-based Chinese medicine. The process includes:setting up inclusion criteria and exclusion criteria; keeping recording the process of treatment; recording of its implementation, analyzing and solving the possible deviations from pathway; collecting and classifying the patients'outcomes.
Accordingly, the scientific and rationality process of developing clinical pathway, detecting and analyzing deviations, appraising the implementation and efficiency as well as performance reports should be listed on the appraisal program of the evidence-based Chinese clinical pathway.
The difficulties of developing the clinical pathway of evidence-based Chinese medicine included:classifying the TCM treatment strategy, the outcomes of Chinese medicine treatment, choosing and making decisions based on available evidence. And the key issues included:collecting the evidence, identifying the advantages, and reaching experts consensus. Furthermore, the main structure for writing evidence-based Chinese clinical pathway should include introduction, contents, references, attachments, and other in total of 18 items.
Conclusions
This finding from this study suggests:
1 It would be very meaningful to construct and practice the evidence-based Chinese clinical pathway in order to improve healthcare quality and strength the position of Chinese medicine treatment for the patients'healthcare services.
2 It would be very important to construct and form the evidence-based Chinese clinical pathway based on the perspectives of humanity, the theory and methodology of evidence-based medicine, the theory of modern management, health economic principle, and embodying characteristics of Chinese medicine.
3 It would be a crucial technique to construct evidence-based Chinese clinical pathway according to the common methodology and the principles as above-mentioned, and we must pay attention to some key issues such as keeping the balance between the specialty and generalizability, using and classifying the evidence available.
4 It would be necessary to propose a guide for reporting the evidence-based Chinese clinical pathway which could be modified on usage in practice.
引文
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