VanWagner Lisa B, Aghaulor Blessing, Hussain Tasmeen, Kosirog Megan, Campbell Patrick, Pine Stewart, Daud Amna, Finn Daniel J, Levitsky Josh, Lloyd-Jones Donald M, Holl Jane L
Division of Gastroenterology and Hepatology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Gastroenterol Rep (Oxf). 2020 Dec 10;9(1):22-30. doi: 10.1093/gastro/goaa068. eCollection 2021 Jan.
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 ©, 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.
The © 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.
© 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.
大多数针对小队列规模疾病的干预措施，如移植手术，不太可能成为临床试验的一部分。当缺乏针对特定疾病的证据时，专家共识可为改善医疗提供更精确的指导。肝移植受者心血管风险的管理就是一个例子，迄今为止，临床医生一直采用从普通人群研究中得出的循证指南。然而，即使达成了共识，实践指南的实施往往也不充分且进展缓慢。我们报告了一种新颖的混合方法——©，用于在缺乏特定疾病证据时制定临床实践指南。我们通过制定肝移植受者心血管风险管理的实践指南来说明该方法。
©包括：（i）针对目标人群改编相关的、现有的循证临床实践指南；（ii）专家对拟议的实践指南达成共识；（iii）确定当前实践中遵循指南的障碍；（iv）对实践指南的实施和传播提出建议。该方法基于一种迭代的、以用户为中心的方法，在设计和开发过程的每个阶段都关注所有最终用户（包括患者）的需求、期望和限制。
用于临床实践指南制定的©采用混合方法，汇集多学科和实践环境的广泛代表，以考虑直接受临床实践指南建议影响的患者、护理人员和从业者的独特需求和偏好来达成共识。我们假设最终用户在指南制定过程中的预先参与将导致指南声明在临床实践中的可持续实施。
