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Table 2 Checklist for Conducting Multicenter Simulation Research

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

Study Phase & Step

Items to Consider

 Planning Phase

  Defining the Research Question

o Have consensus recommendations/guidelines for simulation research been reviewed?

o Has a review of the published literature (within and outside of simulation / healthcare) been conducted?

o Is the question feasible, interesting, novel, ethical and relevant?

  Identifying Outcome Measures

o Is it possible to measure a clinically relevant outcome?

o If simulation outcomes are being collected -- have the measurement tool(s) been previously validated? Can you establish a causal link to clinically relevant outcomes?

o If technology is being used to collect data, is the data known to be reliable and accurate?

  Pilot Study

o Have you conducted/do you plan to conduct a pilot study?

o Is a multicenter study needed to answer the question? If so why - for generalizability, sample size?

o If the pilot study is complete, have you documented lessons learned and iteratively adapted your work for protocol development of multicenter study?

 Project Development Phase

  Identify Collaborators

o Does your research team have expertise in all relevant areas?

o Have you considered inviting trainees or junior faculty as collaborators?

o Have you considered inviting collaborators and/or content experts from outside the simulation community?

o Do you have a clear role for each collaborator?

  Protocol Development

o Have all members of your research team had opportunity to contribute to protocol development?

o Have external experts and/or peers reviewed your protocol and provided feedback?

o Have you reached consensus before finalizing the protocol?

  Research Operations Manual

o Does your research operations manual contain all the key elements: consent and recruitment strategy, study team members, study flow, inclusion and exclusion criteria, study methods and data management procedures?

o Have you described in detail how to standardize the simulation environment (and intervention if applicable) across sties?

o Have you conducted training sessions for other sites (either in person or remotely)?

  Grant Preparation

o Is it possible to complete your multicenter study without grant funding?

o Have you maximized opportunities for matching/in-kind support?

o Have you identified appropriate funding agencies and opportunities that align with your research objectives?

o Have you appropriately prioritized high value items in your budget?

  Ethical Approval and Subsite Contracts

o Has the lead study site obtained ethics approval?

o Has a copy of the approved ethics submission been circulated to collaborators?

o Has feedback from prior ethics board reviews been circulated to collaborators?

o Has work to execute subsite contracts been initiated early to prevent delays in research?

o Have you created a timeline for ethics review for participating sites?

  Clinical Trial Registration

o Has the study been registered in a clinical trial registry?

  Manuscript Oversight Committee

o Has a manuscript oversight committee been established?

o Has the manuscript oversight committee developed a document outlining planned publications with proposed writing teams and target journals?

o Have all collaborators received a copy of this document?

  Feasibility Testing

o Have all sites conducted feasibility testing?

o Have lessons learned from feasibility testing been shared across sites?

 Study Execution Phase

  Recruitment and Enrollment

o Is the consent process standardized across sites?

o For randomized controlled trials, does the randomization process ensure equal allocation of study groups within sites?

  Communication and Decision Making

o Has a plan for frequent, planned communications amongst investigators been established?

o Has a clear organizational structure been established and communicated with all collaborators?

o Has a research steering committee been established?

o Do all sites have a research operations committee?

o Is there a strategy to foster collaborative spirit and to build team cohesion?

o Is there a plan to use motivational strategies (eg. dashboards)?

  Quality Assurance

o Is there a quality assurance plan?

o Will there be centralized monitoring and intermittent review of data?

o Will there be site visits by the principal investigator or core study team members?

  Data Abstraction and Analysis

o When assessment tools are being used, is there a plan to do rater orientation training?

o When assessment tools are being used, is there a plan to do rater booster training?

o When video review is being used, to avoid bias, can raters be assigned participants that are not from their own site?

o Has missing data been analyzed to determine if systematic biases exist?

 Dissemination Phase

  Presentation and Publication

o Have abstracts been submitted for presentation at relevant conferences?

o Has the research team taken advantage of all potential opportunities for publication?

o Has the main study been submitted and published prior to other sub-studies?

  Media

o Does the research team have a media dissemination strategy?

o Has the research team considered opportunities for dissemination through traditional media, social media and online forums?

  Translation to Practice

o Have relevant stakeholders been engaged in efforts to translate results to practice?

o Have the results been shared with colleagues within existing networks and societies?

  Future work

o Has the team discussed next steps for this research group/question?