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

Cheng, Adam MD; Kessler, David MD, MSc; Mackinnon, Ralph BSc, MBChB, FRCA; Chang, Todd P. MD, MAcM; Nadkarni, Vinay M. MD; Hunt, Elizabeth A. MD, MPH, PhD; Duval-Arnould, Jordan MPH, CPH; Lin, Yiqun MD, MHSc; Cook, David A. MD, MHPE; Pusic, Martin MD, PhD; Hui, Joshua MD, MSc; Moher, David PhD; Egger, Matthias MD, MSc; Auerbach, Marc MD, MSc; for the International Network for Simulation-based Pediatric Innovation, Research, and Education (INSPIRE) Reporting Guidelines Investigators

Simulation in Healthcare: The Journal of the Society for Simulation in Healthcare: August 2016 - Volume 11 - Issue 4 - p 238–248
doi: 10.1097/SIH.0000000000000150
Empirical Investigations

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.

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.

Reprints: Adam Cheng, MD, FRCPC, University of Calgary KidSim-ASPIRE Research Program, Section of Emergency Medicine, Department of Pediatrics, Alberta Children’s Hospital, 2888 Shaganappi Trail NW, Calgary, Alberta, Canada T3B 6A8 (e-mail: chenger@me.com).

Supported by the Laerdal Foundation for Acute Medicine that has previously provided infrastructure support for the INSPIRE network and the Society for Simulation in Healthcare that provided funding to cover the expenses of the consensus meeting.

A.C. (study design, writing, editing, and reviewing of manuscript) is supported by KidSIM-ASPIRE Simulation Infrastructure Grant, Alberta Children’s Hospital Foundation, Alberta Children’s Hospital Research Institute, and the Department of Pediatrics, University of Calgary; V.M.N. (study design, writing, editing, and reviewing of manuscript) is supported by Endowed Chair, Critical Care Medicine, Children’s Hospital of Philadelphia, and the following research grants: AHRQ RO3HS021583; Nihon Kohden America Research Grant; NIH/NHLBI RO1HL114484; NIH U01 HL107681; NIH/NHLBI 1U01HL094345-01; and NIH/NINDS 5R01HL058669-10. D.M. (data interpretation, writing, editing, and reviewing of manuscript) is funded by a University Research Chair. Nick Sevdalis (collaborator) is funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care South London at King’s College Hospital NHS Foundation Trust.

The views expressed are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research, or the Department of Health. Sevdalis delivers safety and team skills training on a consultancy basis to hospitals in the United Kingdom and internationally via the London Safety and Training Solutions Ltd. The remaining authors declare no conflict of interest.

The principal investigator, A.C., had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. A.C., D.K., R.M., T.P.C., V.M.N., E.A.H., J.D.-A., D.C., M.P., J.H., and M.A. participated in study design, the consensus-building process, drafting and revising the manuscript, and approving the final version of the manuscript for publication. Y.L., D.M., and M.E. contributed to interpretation of data, critically revising the manuscript for intellectual content, and approving the final version of the manuscript. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy of the work are appropriately resolved.

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© 2016 Society for Simulation in Healthcare