Table 1

Simulation-based research extensions for the CONSORT statement

ItemItem noCONSORT description (randomised controlled trials)Extension for simulation-based research
Title and abstract1a, 1b1a: Identification as a randomised trial in the title
1b: Structured summary of trial design, methods, results and conclusions
In abstract or key terms, the MeSH or searchable keyword term must have the word ‘simulation’ or ‘simulated’.
Introduction
 Background2a, 2b2a: Scientific background and explanation of rationale
2b: Specific objectives or hypotheses
Clarify whether simulation is subject of research or investigational method for research.
Methods
 Trial design3a, 3b3a: Description of trial design (such as parallel, factorial) including allocation ratio
3b: Important changes to methods after trial commencement (such as eligibility criteria), with reasons
 Participants4a, 4b4a: Eligibility criteria for participants
4b: Settings and locations where the data were collected
 Interventions5The interventions for each group with sufficient details to allow for replication, including how and when they were actually administeredDescribe the theoretical and/or conceptual rationale for the design of each intervention.
Clearly describe all simulation-specific exposures, potential confounders and effect modifiers.
 Outcomes6a, 6b6a: Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed
6b: Any changes to trial outcomes after the trial started, with reasons
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).
 Sample size/study size7a, 7b7a: How sample size was determined
7b: When applicable, explanation of any interim analyses and stopping guidelines
 Randomisation: sequence generation8a, 8b8a: Method used to generate the random allocation sequence
8b: Type of randomisation; details of any restriction (such as blocking and block size)
 Randomisation: allocation concealment mechanism9Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
 Randomisation: implementation10Who generated the random allocation sequence, who enrolled participants and who assigned participants to interventions
 Blinding (masking)11a, 11b11a: If done, who was blinded after assignments to interventions (eg, participants, care providers, those assessing outcomes) and how
11b: If relevant, description of the similarity of interventions
Describe strategies to decrease risk of bias, when blinding is not possible.
 Statistical methods12a, 12b12a: Statistical methods used to compare groups for primary and secondary outcomes
12b: Methods for additional analyses, such as subgroup analyses and adjusted 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
 Participant flow (a diagram is strongly recommended)13a, 13b13a: For each group, the numbers of participants who were randomly assigned, received intended treatment and were analysed for the primary outcome
13b: For each group, losses and exclusions after randomisation, together with reasons
 Recruitment14a, 14b14a: Dates defining the periods of recruitment and follow-up
14b: Why the trial ended or was stopped
 Baseline data15A table showing baseline demographic and clinical characteristics of each groupIn describing characteristics of study participants, include their prior experience with simulation and other relevant features as related to the intervention(s).
 Numbers analysed16For each group, number of participants (denominator) included in each analysis and whether analysis was by original assigned groups
 Outcomes and estimation17a, 17b17a: For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% CI)
17b: For binary outcomes, presentation of absolute and relative effect sizes is recommended
For assessments involving more than one rater, inter-rater reliability should be reported.
 Ancillary analyses18Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory
 Adverse events19All important harms or unintended effects in each group (for specific guidance, see CONSORT for harms)
Discussion
 Limitations20Trial limitations, addressing sources of potential bias, imprecision and, if relevant, multiplicity of analysesSpecifically discuss the limitations of simulation-based research.
 Generalisability21Generalisability (external validity) of the trial findingsDescribe the generalisability of simulation-based outcomes to patient-based outcomes (if applicable).
 Interpretation22Interpretation consistent with results, balancing benefits and harms and considering other relevant evidence
Other information
 Registration23Registration number and name of trial registry
 Protocol24Where the full trial protocol can be accessed, if available
 Funding25Sources of funding and other support (such as supply of drugs), role of fundersList simulator brand and if conflict of interest for intellectual property exists.
  • CONSORT, Consolidated Standards of Reporting Trials; MeSH, medical subject heading.