摘要
背景:绝大部分小样本的疾病干预措施,如肝移植,都不太可能开展临床研究。当缺少循证医学证据时,专家共识能提供更为精细的治疗指导。例如对肝移植受体心血管风险的处理,截至今日,都没有一部基于循证医学证据的临床指南。然而,即便形成了专家共识,对这些实践指导意见的执行也往往是不充分且滞后的。我们提出了一种新型混合方法,Northwestern Method,用于那些缺少循证医学证据的临床实践指导意见的制定。我们通过针对肝移植受体心血管风险的处理所制定的实践指导意见,来阐述该方法的应用。方法:Northwestern Method由4部分组成,分别是(1)对已有的基于循证医学证据的相关指南进行改编;(2)对实践指南意见形成专家共识;(3)明确妨碍实践指导意见在临床中推行的因素;(4)执行和推广实践指导意见的建议。该方法是以用户为中心的迭代方法,在实践指导意见的设计和形成过程的每个环节,都应充分考虑包括患者在内的终端用户的所需、所想及顾虑。结论:Northwestern Method采用一种混合方法,将临床实践各方代表汇集在一起制定临床实践指导意见,充分考虑了患者、护理人员及医生等直接影响实践指导意见执行效果的人员各自的需求和喜好。我们提出了一个假设,即终端用户尽早参与到指导意见的制定过程,有助于指导意见在临床实践中的有效贯彻。
Background Most interventions for conditions with a small cohort size,such as transplantation,are unlikely to be part of a clinical trial.When condition-specific evidence is lacking,expert consensus can offer more precise guidance to improve care.Management of cardiovascular risk in liver-transplant recipients is one example for which clinicians have,to date,adapted evidence-based guidelines from studies in the general population.However,even when consensus is achieved,implementation of practice guidance is often inadequate and protracted.We report on a novel mixed-methods approach,the Northwestern MethodVC,for the development of clinical-practice guidance when condition-specific evidence is lacking.We illustrate the method through the development of practice guidance for managing cardiovascular risk in liver-transplant recipients.Methods The Northwestern MethodVC consists of(i)adaptation of relevant,existing,evidence-based clinical-practice guidelines for the target population;(ii)consensus by experts of the proposed practice guidance;(iii)identification of barriers to guidance adherence in current practice;and(iv)recommendation for implementation and dissemination of the practice guidance.The method is based on an iterative,user-centered approach in which the needs,wants,and limitations of all end users,including patients,are attended to at each stage of the design and development process.Conclusions The Northwestern MethodVC for clinical-practice-guidance development uses a mixed-methods approach to bring together broad representation from multiple disciplines and practice settings to develop consensus considering the unique needs and preferences of patients,caregivers,and practitioners who are directly impacted by clinical-practice-guidance recommendations.We hypothesize that a priori involvement of end users in the guidance-development process will lead to sustainable implementation of guidance statements into clinical practice.
基金
supported by the National Heart,Lung and Blood Institute at the National Institutes of Health to L.B.V.[grant number,K23 HL136891].
