设计和开展随机实施试验:研究者指南

作     者：Luke Wolfenden Robbie Foy Justin Presseau Jeremy M Grimshaw Noah M Ivers Byron J Powell Monica Taljaard John Wiggers Rachel Sutherland Nicole Nathan Christopher M Williams Melanie Kingsland Andrew Milat Rebecca K Hodder Sze Lin Yoong 玉炫(译) 吴守媛(译) 兰慧(译) 张静怡(译) 李沁原(校) 陈耀龙(校) 

作者机构：School of Medicine and Public HealthFaculty of Health and MedicineUniversity of NewcastleCallaghanNSWAustralia Hunter New England Population HealthLocked Bag 10WallsendNSW 2287Australia Leeds Institute of Health SciencesUniversity of LeedsLeedsUK Clinical Epidemiology ProgramOttawa Hospital Research InstituteOttawaONCanada School of Epidemiology and Public HealthUniversity of OttawaOttawaONCanada Department of MedicineUniversity of OttawaOttawaONCanada Women′s College Research InstituteWomen′s College HospitalTorontoONCanada Institute for Health Systems Solutions and Virtual CareWomen′s College HospitalTorontoONCanada Department of Family Medicine and Community MedicineFaculty of MedicineUniversity of TorontoTorontoONCanada Institute of Health PolicyManagement and EvaluationUniversity of TorontoTorontoONCanada Brown School and School of MedicineWashington University in St LouisSt LouisMIUSA School of Public HealthFaculty of Medicine and HealthUniversity of SydneySydneyNSWAustralia Swinburne University of TechnologySchool of Health SciencesFaculty HealthArts and DesignHawthornVICAustralia 兰州大学循证医学中心世界卫生组织指南实施与知识转化合作中心 

基　　金：Australian National Health and Medical Research Council Canada Research Canada Research chair United States National Institute of Mental Health National Institute of Mental Health, NIMH, (APP1150661, APP1160419, APP1177226, K01MH113806) National Institute of Mental Health, NIMH Canadian Institutes of Health Research, CIHR, (FDN 143269) Canadian Institutes of Health Research, CIHR Australian Research Council, ARC, (DE170100382) Australian Research Council, ARC National Health and Medical Research Council, NHMRC, (APP1128348) National Health and Medical Research Council, NHMRC National Heart Foundation of Australia, (101175) National Heart Foundation of Australia Department of Family and Community Medicine, University of Toronto, DFCM 

出 版 物：《英国医学杂志中文版》 (The BMJ Chinese Edition)

年 卷 期：2021年第24卷第11期

页      码：646-655页

摘      要：实施科学是一门研究方法的学科,旨在实践和政策中促进循证干预措施的系统实施,进而改善健康。尽管实施研究需要高质量的证据,但实施策略的随机试验往往存在较为严重的局限性。这些局限性包括存在偏倚风险、缺乏理论运用、缺乏描述实施策略标准术语、局限于实施结局以及不充分报告。本文旨在对实施策略随机试验的设计、实施和报告提供指导,以提升循证实施科学。由研究人员、卫生政策制订者和实践者组成的国际小组整合了构建随机试验方法的重要文献和实施科学的最新进展。本文为实施策略随机试验的主要内容提供指导,包括试验目的阐明、试验中人员招募和保留策略、随机设计的选择、实施科学理论和框架的使用、测量(结局指标)、样本量计算、伦理审查和试验报告。本文也关注了实施试验中需要特别重视或调整的主题。为了推进实施策略随机试验的严格开展和报告,我们建议将本指南作为研究人员、卫生保健和公共卫生政策制订者或实践者、研究资助者和期刊编辑的参考资料。

主 题 词：实施策略 参考资料 期刊编辑 随机试验 卫生保健 伦理审查 公共卫生 试验报告 

学科分类：0401[教育学-教育学类] 04[教育学] 

核心收录：

D　O　I：10.1136/bmj.m3721

馆 藏 号：203101487...