医疗模拟研究报告指南：对CONSORT和STROBE声明的扩展
Reporting Guidelines for Health Care Simulation Research: Extensions to the CONSORT and STROBE Statements.
作者信息
Cheng Adam, Kessler David, Mackinnon Ralph, Chang Todd P, Nadkarni Vinay M, Hunt Elizabeth A, Duval-Arnould Jordan, Lin Yiqun, Cook David A, Pusic Martin, Hui Joshua, Moher David, Egger Matthias, Auerbach Marc
机构信息
From the University of Calgary KidSim-ASPIRE Research Program (A.C.), Section of Emergency Medicine, Department of Pediatrics, Alberta Children's Hospital, Calgary, Alberta, Canada; Columbia University College of Physicians and Surgeons (D.K.), New York, NY; Royal Manchester Children's Hospital (R.M.), Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK; and Department of Learning, Informatics, Management and Ethics, Karolinska Institute, Stockholm, Sweden; Children's Hospital Los Angeles (T.P.C.), University of Southern California, Los Angeles, CA; The Children's Hospital of Philadelphia (V.M.N.), University of Pennsylvania Perelman School of Medicine, Philadelphia, PA; Johns Hopkins University School of Medicine (E.A.H., J.D.-A.), Baltimore, MD; Alberta Children's Hospital (Y.L.), Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Multidisciplinary Simulation Center (D.A.C.), Mayo Clinic Online Learning, and Division of General Internal Medicine, Mayo Clinic College of Medicine; Institute for Innovations in Medical Education (M.P.), Division of Education Quality and Analytics, NYU School of Medicine, New York, NY; Department of Emergency Medicine (J.H.), David Geffen School of Medicine at UCLA, Los Angeles, CA; Ottawa Methods Centre (D.M.), Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Institute of Social and Preventive Medicine, University of Bern (M.E.), Bern, Switzerland; and Department of Pediatrics (M.A.), Section of Emergency Medicine, Yale University School of Medicine, New Haven, CT.
出版信息
Simul Healthc. 2016 Aug;11(4):238-48. doi: 10.1097/SIH.0000000000000150.
INTRODUCTION
Simulation-based research (SBR) is rapidly expanding but the quality of reporting needs improvement. For a reader to critically assess a study, the elements of the study need to be clearly reported. Our objective was to develop reporting guidelines for SBR by creating extensions to the Consolidated Standards of Reporting Trials (CONSORT) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statements.
METHODS
An iterative multistep consensus-building process was used on the basis of the recommended steps for developing reporting guidelines. The consensus process involved the following: (1) developing a steering committee, (2) defining the scope of the reporting guidelines, (3) identifying a consensus panel, (4) generating a list of items for discussion via online premeeting survey, (5) conducting a consensus meeting, and (6) drafting reporting guidelines with an explanation and elaboration document.
RESULTS
The following 11 extensions were recommended for
CONSORT
item 1 (title/abstract), item 2 (background), item 5 (interventions), item 6 (outcomes), item 11 (blinding), item 12 (statistical methods), item 15 (baseline data), item 17 (outcomes/estimation), item 20 (limitations), item 21 (generalizability), and item 25 (funding). The following 10 extensions were recommended for STROBE: item 1 (title/abstract), item 2 (background/rationale), item 7 (variables), item 8 (data sources/measurement), item 12 (statistical methods), item 14 (descriptive data), item 16 (main results), item 19 (limitations), item 21 (generalizability), and item 22 (funding). An elaboration document was created to provide examples and explanation for each extension.
CONCLUSIONS
We have developed extensions for the CONSORT and STROBE Statements that can help improve the quality of reporting for SBR.
引言
基于模拟的研究（SBR）正在迅速发展，但报告质量有待提高。为使读者能够严格评估一项研究，需要清晰报告研究的各个要素。我们的目标是通过对《试验报告统一标准》（CONSORT）和《加强流行病学观察性研究报告规范》（STROBE）声明进行扩展，制定SBR的报告指南。
方法
基于制定报告指南的推荐步骤，采用了迭代多步骤的共识构建过程。共识过程包括：（1）组建指导委员会；（2）界定报告指南的范围；（3）确定共识小组；（4）通过在线会前调查生成讨论项目列表；（5）召开共识会议；（6）起草带有解释和阐述文件的报告指南。
结果
建议对CONSORT进行以下11项扩展：项目1（标题/摘要）、项目2（背景）、项目5（干预措施）、项目6（结局）、项目11（盲法）、项目12（统计方法）、项目15（基线数据）、项目17（结局/估计）、项目20（局限性）、项目21（可推广性）和项目25（资金资助）。建议对STROBE进行以下10项扩展：项目1（标题/摘要）、项目2（背景/基本原理）、项目7（变量）、项目8（数据来源/测量）、项目12（统计方法）、项目14（描述性数据）、项目16（主要结果）、项目19（局限性）、项目21（可推广性）和项目22（资金资助）。创建了一份阐述文件，为每个扩展提供示例和解释。
结论
我们已对CONSORT和STROBE声明进行了扩展，有助于提高SBR的报告质量。
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