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Table 1 Differences between clinical trials and simulation studies: implications for multicenter simulation-based research

From: Conducting multicenter research in healthcare simulation: Lessons learned from the INSPIRE network

Research phase/step Clinical study Simulation study Implications for multicenter simulation-based research
 Planning phase
  Identifying outcome measures Clinical outcomes Education and/or performance outcomes, clinical outcomes or both Investigators should ensure data captured is reliable and accurate. Equipment should be calibrated and tested across sites prior to study implementation.
 Project Development phase
  Research operations manual Clinical environment difficult control/standardize Simulated environment can be standardized to isolate independent variable. The simulation-based research environment and intervention (if applicable) should be carefully standardized across sites to minimize risk of bias.
  Grant preparation Clinical studies typically have clinical outcomes. Simulation studies may have T1 or T2 outcomes. In grants, investigators should outline a chain of causality: describing the potential link between proposed outcomes, often accessible outcomes and the relevant patient outcomes.
  Ethical approval and subsite contracts Clinical studies require full ethical approval. Some simulation studies may be exempt from full ethical review. Investigators should share institutional review board comments with collaborators submit an inquiry for ethics exempt status at all sites (when appropriate).
  Clinical trial registration Clearly required for all clinical trials Unclear if required for simulation studies reporting T1 outcomes. Investigators should prospectively registering simulation-based studies, thereby eliminating the possibility that a manuscript be rejected due to a lack of trial registration.
  Manuscript oversight committee Clinical journals are most likely target. Simulation, education, clinical journals may all be possible targets. Research teams should consider the journal scope, focus, and audience when selecting a journal—and matching this to the study topic, quality, and ideal audience.
  Feasibility testing Clinical environment is variable and controlling variability is difficult. Simulation environment is variable but control is possible. Feasibility testing helps identify and minimize sources of variance/potential confounding variables across sites.
 Study Execution
  Recruitment and enrollment Patients are recruited by study personnel. Participants (healthcare providers or trainees) are recruited by study personnel. Participants may have different expectations of participation in simulation-based research from site to site.
Investigator must ensure that all sites have the appropriate pool of healthcare providers or trainees to recruit as participants.
  Data abstraction and analysis Video review infrequently used as means to collect outcomes Video review and performance assessment often used to collect outcomes (T1 level) Feasibility testing should be conducted to ensure quality of audio and video across sites.
Raters must be trained—allocation videos to raters should be done to avoid bias.
  Publication Educational content typically not part of clinical trials Educational content may be published or shared as enduring materials. Educational interventions developed for simulation-based educational studies can be disseminated through publication to facilitate implementation by educators.
  1. This table describes only the steps in the research process where differences between clinical trials and simulation studies exist. Steps where there are no discernable differences have been left out of the table