Cheng Adam, Kessler David, Mackinnon Ralph, Chang Todd P, Nadkarni Vinay M, Hunt Elizabeth A, Duval-Arnould Jordan, Lin Yiqun, Pusic Martin, Auerbach Marc
1Department of Pediatrics, Alberta Children's Hospital, KidSim-ASPIRE Research Program, Section of Emergency Medicine, University of Calgary, 2888 Shaganappi Trail NW, Calgary, AB Canada T3B 6A8.
2Division of Pediatric Emergency Medicine, Columbia University Medical School, 3959 Broadway, CHN-1-116, New York, NY 10032 USA.
Adv Simul (Lond). 2017 Feb 28;2:6. doi: 10.1186/s41077-017-0039-0. eCollection 2017.
Simulation-based research has grown substantially over the past two decades; however, relatively few published simulation studies are multicenter in nature. Multicenter research confers many distinct advantages over single-center studies, including larger sample sizes for more generalizable findings, sharing resources amongst collaborative sites, and promoting networking. Well-executed multicenter studies are more likely to improve provider performance and/or have a positive impact on patient outcomes. In this manuscript, we offer a step-by-step guide to conducting multicenter, simulation-based research based upon our collective experience with the International Network for Simulation-based Pediatric Innovation, Research and Education (INSPIRE). Like multicenter clinical research, simulation-based multicenter research can be divided into four distinct phases. Each phase has specific differences when applied to simulation research: (1) , to define the research question, systematically review the literature, identify outcome measures, and conduct pilot studies to ensure feasibility and estimate power; (2) , when the primary investigator identifies collaborators, develops the protocol and research operations manual, prepares grant applications, obtains ethical approval and executes subsite contracts, registers the study in a clinical trial registry, forms a manuscript oversight committee, and conducts feasibility testing and data validation at each site; (3) , involving recruitment and enrollment of subjects, clear communication and decision-making, quality assurance measures and data abstraction, validation, and analysis; and (4) , where the research team shares results via conference presentations, publications, traditional media, social media, and implements strategies for translating results to practice. With this manuscript, we provide a guide to conducting quantitative multicenter research with a focus on simulation-specific issues.
在过去二十年中,基于模拟的研究有了显著增长;然而,本质上多中心的已发表模拟研究相对较少。与单中心研究相比,多中心研究具有许多明显优势,包括更大的样本量以获得更具普遍性的结果、在协作站点之间共享资源以及促进网络建设。执行良好的多中心研究更有可能提高医疗服务提供者的绩效和/或对患者结局产生积极影响。在本手稿中,我们根据我们在国际儿科模拟创新、研究与教育网络(INSPIRE)的集体经验,提供了一份开展基于模拟的多中心研究的分步指南。与多中心临床研究一样,基于模拟的多中心研究可分为四个不同阶段。每个阶段应用于模拟研究时都有特定差异:(1)定义研究问题、系统回顾文献、确定结局指标并进行试点研究以确保可行性和估计效能;(2)主要研究者确定合作者、制定方案和研究操作手册、准备资助申请、获得伦理批准并执行分中心合同、在临床试验注册中心注册研究、组建手稿监督委员会,并在每个站点进行可行性测试和数据验证;(3)涉及受试者的招募和入组、清晰的沟通和决策、质量保证措施以及数据提取、验证和分析;(4)研究团队通过会议报告、出版物、传统媒体、社交媒体分享结果,并实施将结果转化为实践的策略。通过本手稿,我们提供了一份开展定量多中心研究的指南,重点关注模拟特有的问题。