|Item||Item no||STROBE description (observational studies)||Extension for simulation-based research|
|Title and abstract||1a, 1b||
||In abstract or key terms, the MeSH or searchable keyword term must have the word ‘simulation’ or ‘simulated’.|
|Background/rationale||2||Explain the scientific background and rationale for the investigation being reported.||Clarify whether simulation is subject of research or investigational method for research.|
|Objectives||3||State specific objectives, including any prespecified hypotheses.|
|Study design||4||Present key elements of study design early in the paper.|
|Setting||5||Describe the setting, locations and relevant dates, including periods of recruitment, exposure, follow-up and data collection.|
|Participants||6a, 6b, 6c||
|Variables||7||Clearly define all outcomes, exposures, predictors, potential confounders and effect modifiers. Give diagnostic criteria, if applicable.||Describe the theoretical and/or conceptual rationale for the design of the intervention/exposure.|
Describe the intervention/exposure with sufficient detail to permit replication.
Clearly describe all simulation-specific exposures, potential confounders and effect modifiers.
|Data sources/measurement||8||For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group.||In describing the details of methods of assessment, include (when applicable) the setting, instrument, simulator type, timing in relation to the intervention, along with any methods used to enhance the quality of measurements.|
Provide evidence to support the validity and reliability of assessment tools in this context (if available).
|Bias||9||Describe any efforts to address potential sources of bias.|
|Study size||10||Explain how the study size was arrived at.|
|Quantitative variables||11||Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen, and why.|
|Statistical methods||12a, 12b, 12c, 12d, 12e||
||Clearly indicate the unit of analysis (eg, individual, team, system) and identify repeated measures on subjects, and describe how these issues were addressed.|
|Participants||13a, 13b, 13c||
|Descriptive data||14a, 14b, 14c||
||In describing characteristics of study participants, include their prior experience with simulation and other relevant features as related to the intervention(s).|
|Outcome data||15||Cohort study: report numbers of outcome events or summary measures over time.|
Case-control study: report numbers in each exposure category or summary measures of exposure.
Cross-sectional study: report numbers of outcome events or summary measures.
|Main results||16a, 16b, 16c||
||For assessments involving more than one rater, inter-rater reliability should be reported.|
|Other analyses||17||Report other analyses done—eg, analyses of subgroups and interactions and sensitivity analyses.|
|Key results||18||Summarise key results with reference to study objectives.|
|Limitations||19||Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss direction and magnitude of any potential bias.||Specifically discuss the limitations of simulation-based research.|
|Interpretation||20||Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies and other relevant evidence.|
|Generalisability||21||Discuss the generalisability (external validity) of the study results.||Describe the generalisability of simulation-based outcomes to patient-based outcomes (if applicable).|
|Funding||22||Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based.||List simulator brand and if conflict of interest for intellectual property exists.|
MeSH, medical subject heading; STROBE, STrengthening the Reporting of OBservational studies in Epidemiology.