Table 2

Simulation-based research extensions for the STROBE statement

ItemItem noSTROBE description (observational studies)Extension for simulation-based research
Title and abstract1a, 1b
  • 1a: Indicate the study's design with a commonly used term in the title or the abstract.

  • 1b: Provide in the abstract an informative and balanced summary of what was done and what was found.

In abstract or key terms, the MeSH or searchable keyword term must have the word ‘simulation’ or ‘simulated’.
Introduction
 Background/rationale2Explain the scientific background and rationale for the investigation being reported.Clarify whether simulation is subject of research or investigational method for research.
 Objectives3State specific objectives, including any prespecified hypotheses.
Methods
 Study design4Present key elements of study design early in the paper.
 Setting5Describe the setting, locations and relevant dates, including periods of recruitment, exposure, follow-up and data collection.
 Participants6a, 6b, 6c
  • 6a: Cohort study: give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up.

    Case-control study: give the eligibility criteria, and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controls.

    Cross-sectional study: give the eligibility criteria, and the sources and methods of selection of participants.

  • 6b: Cohort study: for matched studies, give matching criteria and number of exposed and unexposed.

  • 6c: Case-control study: for matched studies, give matching criteria and the number of controls per case.

 Variables7Clearly 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/measurement8For 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).
 Bias9Describe any efforts to address potential sources of bias.
 Study size10Explain how the study size was arrived at.
 Quantitative variables11Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen, and why.
 Statistical methods12a, 12b, 12c, 12d, 12e
  • 12a: Describe all statistical methods, including those used to control for confounding.

  • 12b: Describe any methods used to examine subgroups and interactions.

  • 12c: Explain how missing data were addressed.

  • 12d: Cohort study: if applicable, explain how loss to follow-up was addressed.

    Case-control study: if applicable, explain how matching of cases and controls was addressed.

    Cross-sectional study: if applicable, describe analytical methods taking account of sampling strategy.

  • 12e: Describe any sensitivity analyses.

Clearly indicate the unit of analysis (eg, individual, team, system) and identify repeated measures on subjects, and describe how these issues were addressed.
Results
 Participants13a, 13b, 13c
  • 13a: Report the numbers of individuals at each stage of the study—eg, numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up and analysed.

  • 13b: Give reasons for non-participation at each stage.

  • 13c: Consider use of a flow diagram.

 Descriptive data14a, 14b, 14c
  • 14a: Give characteristics of study participants (eg, demographic, clinical, social) and information on exposures and potential confounders.

  • 14b: Indicate the number of participants with missing data for each variable of interest.

  • 14c: Cohort study: summarise follow-up time—eg, average and total amount.

In describing characteristics of study participants, include their prior experience with simulation and other relevant features as related to the intervention(s).
 Outcome data15Cohort 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 results16a, 16b, 16c
  • 16a: Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% CIs). Make clear which confounders were adjusted for and why they were included.

  • 16b: Report category boundaries when continuous variables were categorised.

  • 16c: If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period.

For assessments involving more than one rater, inter-rater reliability should be reported.
 Other analyses17Report other analyses done—eg, analyses of subgroups and interactions and sensitivity analyses.
Discussion
 Key results18Summarise key results with reference to study objectives.
 Limitations19Discuss 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.
 Interpretation20Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies and other relevant evidence.
 Generalisability21Discuss the generalisability (external validity) of the study results.Describe the generalisability of simulation-based outcomes to patient-based outcomes (if applicable).
Other information
 Funding22Give 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.