中西医临床医患交互式共同决策模式的构建方法

The current clinical decision-making practice is increasingly facing ethical criticism because of its “paternalistic” and “empirical” nature, which has left patient autonomy neglected and scientific findings under-utilized. In this study, drawing on traditional Chinese medicine theories and principles from Evidence-based Medicine (EBM) and Narrative Medicine (NM), we aim to develop a set of methods for implementing interactive patient and physician shared decision-making (SDM) in integrated traditional and western medical practice. Firstly, taking “drug therapy for secondary prevention of myocardial infarction” as a model study, we construct and combine the three key elements of SDM as including the use of a disease-specific patient decision aid, nurse-led decision-support consultation and physician-led shared decision-making meeting, and investigate the way to make SDM part of clinical routine. In the meantime, key techniques and methods to construct SDM elements will be developed, including primarily techniques and methods to generate, evaluate, translate and disseminate research findings, and those to devise specially-designed SDM training programs for participating nurses and physicians. In the next step, 100 patients with decision needs will be randomized to receive either the three interventional elements of SDM (the SDM group) or the traditional decision-making consultation (the TDM group). The process of all meetings will be video-taped, and both the decision-making process and outcome measurements will be evaluated from multifocal perspectives (i.e. nurse/patient/physician/observer). By investigating the possible superiority of SDM over TDM in terms of coming up with improved decision-making process and outcome, this research will help inform heath policy-makers of the promise of practicing interactive patient and physician SDM in integrated traditional and western medical practice, in terms of easing patient-physician tensions, optimizing medical care, and reducing medical costs.

中西医临床中“家长式”与“不循证”决策模式根深蒂固，自主权利不得彰显，科研结果未尽其用，医学实践遭遇人文拷问。本课题拟基于中医传统理论，采用循证、叙事医学方法，探索构建医患交互式共同决策模式的方法。以中西医干预心梗二级预防为例，构建交互式共同决策的三个关键模块，即决策手册、护患决策支持会面及医患共同决策会面，形成一般操作流程；同时针对模块构建，建立关键技术与方法，包括生成、评价，转化与传播研究证据，以及对医护人员进行共同决策能力教育的技术与方法。开展临床验证试验，招募100例受试者，随机分配至共同决策组或传统决策组，开具“信息处方”联合“决策处方”对比传统决策实践，通过第三方观察会面录像与相关指标的测量，评价决策过程与效果，验证交互式医患共同决策可能的优越性。通过探索中西医结合诊疗中医患交互式共同决策的实践模式，为践行共同决策、缓解医患矛盾、优化医疗服务，减少医疗开支提供思路。

医学是自然科学和人文科学的结合体，循证实践的未来是遵循证据的医患共同选择，应当建立切实有效的实施模块和易于嵌入临床常规的具体流程。. 本课题首次从叙事循证医学理论与实践出发，以中西医结合防治冠心病稳定型心绞痛（气滞血瘀证）为例，探索交互式医患共同决策的实践模式与临床路径。组建三个具体的实践模块，包括决策手册使用、护患决策支持会面及医患共同决策会面。明确了每个模块的主题与目的，同时形成关键技术与方法，包括使用meta分析或网状meta分析生成定量证据、采用质性研究或质性研究整合方法生成定性证据，采用GRADEpro评价证据，采用统计与数理转换方法转化证据，研制成冠心病稳定型心绞痛（气虚血淤证）防治的患者决策辅助工具；以及使用工作坊等教育手段培养叙事医学能力、传播证据技术和共同决策能力。采用实施科学的研究方法调研实践共同决策的可行性与阻碍因素，包括决策参与者的主观能动性和认知能力、医学伦理考量、具体临床决策情境、实施困难，医疗制度与医事政策法规的认可与保护等层面。招募100例目标患者，在随机平行对照试验中验证共同决策的过程与效果。该探索性试验的统计结果显示，实施患者决策工具辅助的共同决策有利于提升共同决策程度、提升患者疾病相关知识水平以及降低决策冲突。. 本研究在中西医结合慢病管理门诊情境下构建的决策工具辅助的共同决策实践模式可推广应用于类似临床情境中。形成的关键技术与方法可应用于各种类型的基于证据的决策支持工具的研制。发表的患者决策辅助工具可在临床进行推广使用。转译并验证了两个共同决策领域的重要评价量表。课题组共计发表SCI文章4篇及中文文章4篇，参加10余次国际国内学术大会和论坛，宣传本项目科研成果的同时进行共同决策理念的传播，为在临床中采用多元化决策证据与决策实践模式探索道路。