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Simul Healthc. 2016 Aug;11(4):238-48. doi: 10.1097/SIH.0000000000000150.

Reporting Guidelines for Health Care Simulation Research: Extensions to the CONSORT and STROBE Statements.

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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.



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.


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.


The following 11 extensions were recommended for


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.


We have developed extensions for the CONSORT and STROBE Statements that can help improve the quality of reporting for SBR.

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