TABLE 3.

Model Components, Their Description, and Their Purpose

Model Components	Description/Purpose
Scenario context description	The scenario context description provides a narrative the care context that subjects must imagine themselves to be a part of as they begin their care of the simulated patient. The description must be relevant to the subjects so they can imagine themselves in this context and how they would proceed with patient care were the scenario to be real.
Caregiver orientation scripts	The orientation scripts must: 1) instruct the subject about the simulation equipment and how it works, 2) orient the subject to the environment and the additional people they will interact with during the study, 3) data collection methods and tools they may interact with (e.g., cameras, physiology sensors), 4) allow them to explore the research environment prior to starting the study. We recommend a day-before and an immediately before (day-of) orientation. The day before orientation orients the subject to all but the scenario context; it allows the subject to explore the equipment and supplies available and to reflect on how he/she might conduct themselves during the scenario. The day-of orientation introduces the subject to the scenario context and allows him/her to organize the medical equipment and supplies to his/her liking prior to starting the scenario.
Hourly patient physiology tracks that correspond to caregiver interventions	These are the hardest scenario artifacts to produce because of the potential variability of subject performance. A subject who completes a procedure immediately in a scenario causes the simulation to proceed much differently than a subject who delays an intervention until much later in the scenario. Balancing complexity for the proctor/simulation technician and realism for medical care are constant challenges. Importantly, for unexpected care/decisions made by subjects, the simulation must respond consistently across subjects and across locations. For each “new” path a subject creates through variance in care, the research team must create a new physiology track or a business rule (see below) for how the research team and simulation will respond. This is the primary reason why a proctor should have medical training beyond the level of anticipated subjects during scenario development.
Physiology tracks specific to an intervention/procedure	Physiology tracks must be more detailed than hourly when subjects perform a procedure. For example, decompression of a tension pneumothorax must produce near immediate physiologic response in the simulated patient otherwise the simulation may cause cognitive dissonance for the subject who understands that physiologic improvement indicates a successful procedure. Similarly, the simulated patient’s physiologic response to an intervention, such as endotracheal intubation, must be well considered by the research team in the context of the research purpose. If an intubation takes too long, should the simulated physiology worsen? If so, how quickly? If the subject has difficulty with the procedure, should this cause the simulated patient to “die?” Again, it will be necessary to create physiology tracks or business rules for each of these alternative pathways to maintain consistency across subjects and study locations.
Anticipated caregiver interventions according to time/patient condition	The anticipated timeline is essentially the “correct” patient management and is used to measure caregiver performance metrics of accuracy, reliability, and efficiency. This timeline is both imagined during the scenario development and pilot tested with expert and novice subjects to ensure the baseline, or control group, is well described.
Intervention checklists, equipment lists, prestudy checklists	Checklists are essential for ensuring the simulation is reproducible. Scenario setup—the room appearance, the manikin setup, the control room monitors, the supplies—must be governed by checklists. Research personnel must practice using the checklists, preferably in a read-confirm team to ensure all necessary steps are identified and carried out. Similarly, within the scenario, caregiver procedures must be scripted by checklist so that a baseline of completeness is established. Because there is a high degree of variability in how caregivers perform procedures, procedural checklists must only account for the key steps of a procedure. Too much detail about steps that do not affect the success of the procedure are irrelevant. An exception to this rule, for research studies involving telemedicine, is the need to develop consistent telementor checklists/scripts such that telementors instruct subjects to complete procedures the same way each time.
Photographs/videos of setups or disease as necessary	Photographs that show how to consistently set up the scenario room, the manikin, the supplies, the control room, etc. are a best practice for consistency. Photographs particularly help to maintain consistency if new research team members perform setup. Photographs or videos of real patients (with consent) may be shown to subjects so they can better imagine the problem(s) they will manage during the study. For example, a video showing progressive respiratory distress helps subjects to understand the impact of hypoxia on the simulated patient. It can also add elements of sound to the scenario that might be difficult to consistently reproduce otherwise.
Role player scripts	Scripts are essential for anyone interacting with the subject during the scenario so that interactions are consistent across subjects and locations. The confederate must have a script defining his/her interactions with the subject. Similarly, the simulation technician who acts in the role of patients, must have a script defining what he/she can say on the patient’sbehalf. Other roles, like a concerned family member or a military commander, must be considered and scripted to ensure scenario realism. Telementors must have each interaction with the subject scripted. In situations when the subject varies from the anticipated flow of the scenario, the team must practice staying on script. If forced to leave script, the new narrative used by the role player must be captured and incorporated into the script or into a business rule such that all similar interactions in the future will remain consistent.
Business rules	Business rule help govern how the research team manages complexity during the scenario. These rules define when the scenario will be realistic and follow a physiology track or be unrealistic but allow the scenario to move forward. Some rules about sedative medication are described in the text. Additional rules may be found in the supplementary material.
Data collection methods	These are study specific but likely include audio/video recordings, surveys, and potentially subject physiology.