Table 2.

Potential Problems, Solutions, Pros and Cons Associated with Research in the ED Setting

Potential Problem	Potential Solutions	Pros	Cons
Estimating Eligible Participants	Pilot Study	Up-to-date estimate of available participants, preview potential study problems	Significant investment for a small number of participants
	Chart Review	Estimate number historically available	Does not identify barriers to recruitment, study interventions, and follow-up
Identifying Eligible Participants in Real-time	Emergency Physician / Staff identify during treatment	Treating staff know the patient	Not all staff aware of all studies, ED staff very busy, numerous providers and staff, motivation
	Manual Screening by Research Associates / Students	Can often find subjects for cohort studies in real-time	Need a critical number of studies/patients to keep staff engaged. For clinical trials needing intervention need more experienced staff to come in. Increase risk of HIPAA violations
	Research Coordinator/Network	Familiar with studies, can access and identify participants in real-time outside of treatment team	Funding for position requires large study or multiple studies to be effective
	Central Paging Alerts	Alerts researchers to potential participants in ED through trauma activations, stroke codes etc.	Only available for a limited number of conditions
	Procedure Related Alerts (procedure hold or checklists)	Treatment team made aware of trial prior to performing a procedure/ordering tests	Could delay treatment for people not eligible. Still requires call to research team.
	Alerts through electronic heath records	Alerts can be triggered on a variety of “trigger pints” including orders or results.	Not available in all EHR’s and requires expensive programming. Alerts usually require treating team to still call research team.
	Alerts through HL-7 feed	Alerts can be triggered on a variety of “trigger pints” including orders or results and be sent directly to research team for further screening	Requires institutional IT costs, foreign software installation and data sharing
Obtaining Timely Consent	Legally Authorized Representative (LAR)	Allows for consent by someone other than patient	May not be available, treating team may not have time to explain trial
	Trauma Teams with Designated Counselor	Time to spend with patient and/or LAR	Cost & availability; may require multiple studies to be cost effective
	In-Field Cell Phone	Limits time to first contact of LAR	No guarantee of contact, could take focus away from treatment time
	EFIC	Allows for treatment when patient or LAR consent in unavailable	Restrictions on use for emergency research
Implement Protocol	Protocol should be simple and easy to follow	Allows for easy execution of research	Limits the number of outcomes and data points that can be studied and collected
	Increased study related personnel / use a Network	Decreases likelihood of errors/violations, guarantees knowledge of protocol specifics	Large start-up cost of new networks, may require a large number of trials to be cost effective
Attrition and Follow Up Retention	Reimburse for Transportation	Alleviates issues related to transportation	May not be allowed under all protocols
	Out of area Patients use local follow up	Obtains follow up information	Local Physician must be included in research plan and IRB approval
	Out of area patients us self-reported follow up	Obtains follow up information	Self-report may be less reliable or not a possible outcome
	Follow for research during routine follow up for condition	Obtains follow up information	Requires cooperation of follow up care if not in ED or with ED physician
	Offer no-cost, long term follow up	Obtains follow up information	Costly to trial
	Shorten Follow Up time	Less likely to lose people	Limits to short term endpoints
	Use hard endpoints like death	Can follow up with Death registries (SSDI, NDI)	Not an appropriate outcome for many conditions
	Increase participant contact between visits with phone calls, emails, letters	Keeps the participant engaged in trail and offers reminders of visits, allows for troubleshooting of potential barriers prior to a missed visit	Cost and time involved can be high depending upon number of participants, must obtain IRB arrival for all participant contact and materials

Abbreviations: HL-7 (Hospital Language -7), EFIC (Exception From Informed Consent), LAR (Legally Authorized Representative), IT (Information Technology), EHR (Electronic Health Record), SSDI (Social Security Death Index), NDI (National Death Index), IRB (Institutional Review Board)