Reporting guidelines for health care simulation research: extensions to the CONSORT and STROBE statements

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Abstract

Background

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 ( Sim Healthcare 00:00-00, 2016).

Electronic supplementary material

The online version of this article (doi:10.1186/s41077-016-0025-y) contains supplementary material, which is available to authorized users.

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Most cited references 59

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Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.

A Tong, P SAINSBURY, J. Craig (2007)

Qualitative research explores complex phenomena encountered by clinicians, health care providers, policy makers and consumers. Although partial checklists are available, no consolidated reporting framework exists for any type of qualitative design. To develop a checklist for explicit and comprehensive reporting of qualitative studies (in depth interviews and focus groups). We performed a comprehensive search in Cochrane and Campbell Protocols, Medline, CINAHL, systematic reviews of qualitative studies, author or reviewer guidelines of major medical journals and reference lists of relevant publications for existing checklists used to assess qualitative studies. Seventy-six items from 22 checklists were compiled into a comprehensive list. All items were grouped into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. Duplicate items and those that were ambiguous, too broadly defined and impractical to assess were removed. Items most frequently included in the checklists related to sampling method, setting for data collection, method of data collection, respondent validation of findings, method of recording data, description of the derivation of themes and inclusion of supporting quotations. We grouped all items into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. The criteria included in COREQ, a 32-item checklist, can help researchers to report important aspects of the research team, study methods, context of the study, findings, analysis and interpretations.

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Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.

David Moher, Alessandro Liberati, Jennifer Tetzlaff … (2009)

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Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement

David Moher, Larissa Shamseer, Mike Clarke … (2017)

Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.

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Author and article information

Contributors

Adam Cheng: chenger@me.com

Journal

Journal ID (nlm-ta): Adv Simul (Lond)

Journal ID (iso-abbrev): Adv Simul (Lond)

Title: Advances in Simulation

Publisher: BioMed Central (London )

ISSN (Electronic): 2059-0628

Publication date (Electronic): 25 July 2016

Publication date PMC-release: 25 July 2016

Publication date Collection: 2016

Volume: 1

Electronic Location Identifier: 25

Affiliations

[1 ]GRID grid.22072.35, ISNI 0000000419367697, Section of Emergency Medicine, Department of Pediatrics, Alberta Children’s Hospital, , University of Calgary KidSim-ASPIRE Research Program, ; 2888 Shaganappi Trail NW, Calgary, Alberta T3B 6A8 Canada

[2 ]GRID grid.21729.3f, ISNI 0000000419368729, Columbia University College of Physicians and Surgeons, ; New York, NY USA

[3 ]GRID grid.411037.0, ISNI 0000000404309101, Royal Manchester Children’s Hospital, , Central Manchester University Hospitals NHS Foundation Trust, ; Manchester, UK

[4 ]GRID grid.4714.6, ISNI 0000000419370626, Department of Learning, Informatics, Management and Ethics, , Karolinska Institute, ; Stockholm, Sweden

[5 ]GRID grid.42505.36, ISNI 0000000121566853, Children’s Hospital Los Angeles, , University of Southern California, ; Los Angeles, CA USA

[6 ]GRID grid.25879.31, ISNI 0000000419368972, The Children’s Hospital of Philadelphia, , University of Pennsylvania Perelman School of Medicine, ; Philadelphia, PA USA

[7 ]GRID grid.21107.35, ISNI 0000000121719311, Johns Hopkins University School of Medicine, ; Baltimore, MD USA

[8 ]GRID grid.22072.35, ISNI 0000000419367697, Alberta Children’s Hospital, Cumming School of Medicine, , University of Calgary, ; Calgary, Alberta Canada

[9 ]GRID grid.66875.3a, ISNI 000000040459167X, Multidisciplinary Simulation Center, Mayo Clinic Online Learning, and Division of General Internal Medicine, , Mayo Clinic College of Medicine, ; Rochester, USA

[10 ]GRID grid.137628.9, ISNI 0000000419368753, Institute for Innovations in Medical Education, Division of Education Quality and Analytics, , NYU School of Medicine, ; New York, NY USA

[11 ]GRID grid.19006.3e, ISNI 0000000096326718, Department of Emergency Medicine, , David Geffen School of Medicine at UCLA, ; Los Angeles, CA USA

[12 ]GRID grid.412687.e, ISNI 0000000096065108, Ottawa Methods Centre, Clinical Epidemiology Program, , Ottawa Hospital Research Institute, ; Ottawa, Ontario Canada

[13 ]GRID grid.5734.5, ISNI 0000000107265157, Institute of Social and Preventive Medicine, , University of Bern, ; Bern, Switzerland

[14 ]GRID grid.47100.32, ISNI 0000000419368710, Department of Pediatrics, Section of Emergency Medicine, , Yale University School of Medicine, ; New Haven, CT USA

Article

Publisher ID: 25

DOI: 10.1186/s41077-016-0025-y

PMC ID: 5806464

PubMed ID: 27465839

SO-VID: c229698b-14f9-4c23-b0c9-3eaeb8dc5a1c

License:

Open AccessAdvances in Simulation is pleased to co-publish this article jointly with Simulation in Healthcare. The article is published here under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License ( http://creativecommons.org/licenses/by-nc-nd/4.0/).

History

Date received : 23 March 2016

Date accepted : 8 July 2016

Custom metadata

Keywords: simulation,research,reporting guidelines,extension,health care

Data availability:

Keywords: simulation, research, reporting guidelines, extension, health care

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Reporting guidelines for health care simulation research: extensions to the CONSORT and STROBE statements

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Abstract

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Methods

Results

Conclusions

Electronic supplementary material

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Most cited references 59

Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.

Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.

Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement

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Cited by 103

Most referenced authors 1,887