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Table 1 Simulation-Based Research Extensions for the CONSORT Statement

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

Item Item number CONSORT description (Randomized Controlled Trials) Extension for SBR
Title and abstract 1 a. Identification as a randomized trial in the title
b. 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
 Background 2 a. Scientific background and explanation of rationale
b. Specific objectives or hypotheses
Clarify whether simulation is subject of research or investigational method for research.
Methods
 Trial design 3 a. Description of trial design (such as parallel, factorial) including allocation ratio
b. Important changes to methods after trial commencement (such as eligibility criteria), with reasons
 
 Participants 4 a. Eligibility criteria for participants
b. Settings and locations where the data were collected
 
 Interventions 5 The interventions for each group with sufficient details to allow for replication, including how and when they were actually administered. Describe the theoretical and/or conceptual rationale for the design of each intervention.
Clearly describe all simulation-specific exposures, potential confounders, and effect modifiers.
 Outcomes 6 a. Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed
b. Any changes to trial outcomes after the trial commenced, 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 size 7 a. How sample size was determined
b. When applicable, explanation of any interim analyses and stopping guidelines
 
 Randomization: sequence generation 8 a. Method used to generate the random allocation sequence
b. Type of randomization and details of any restriction (such as blocking and block size)
 
 Randomization: allocation concealment mechanism 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned  
 Randomization: implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions  
 Blinding (masking) 11 a. If done, who was blinded after assignments to interventions (e.g., participants, care providers, those assessing outcomes) and how
b. If relevant, description of the similarity of interventions
Describe strategies to decrease risk of bias, when blinding is not possible.
 Statistical methods 12 a. Statistical methods used to compare groups for primary and secondary outcomes
b. Methods for additional analyses, such as subgroup analyses and adjusted analyses
Clearly indicate the unit of analysis (e.g., individual, team, system), identify repeated measures on subjects, and describe how these issues were addressed.
Results
 Participant flow (a diagram is strongly recommended) 13 a. For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome
b. For each group, losses and exclusions after randomization, together with reasons
 
 Recruitment 14 a. Dates defining the periods of recruitment and follow-up
b. Why the trial ended or was stopped
 
 Baseline data 15 A table showing baseline demographic and clinical characteristics of each group In describing characteristics of study participants, include their previous experience with simulation and other relevant features as related to the intervention(s).
 Numbers analyzed 16 For each group, number of participants (denominator) included in each analysis and whether analysis was by original assigned groups  
 Outcomes and estimation 17 a. For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95 % confidence interval)
b. For binary outcomes, presentation of both absolute and relative effect sizes is recommended
For assessments involving >1 rater, interrater reliability should be reported.
 Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory  
 Adverse events 19 All important harms or unintended effects in each group (for specific guidance, see CONSORT for harms)  
Discussion
 Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Specifically discuss the limitations of SBR.
 Generalizability 21 Generalizability (external validity, applicability) of the trial findings Describe generalizability of simulation-based outcomes to patient-based outcomes (if applicable).
 Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence  
Other information
 Registration 23 Registration number and name of trial registry  
 Protocol 24 Where the full trial protocol can be accessed, if available  
 Funding 25 Sources of funding and other support (such as supply of drugs), role of funders List simulator brand and if conflict of interest for intellectual property exists.
  1. MESH Medical Subject Headings