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? |