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. | |||
 Dissemination | |||
  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. |