STROKE PROGRAM RESEARCH: A CHALLENGE FOR EVEN THE BIGGEST AND BEST
Comprehensive Stroke Centers (CSCs) certified by The Joint Commission, DNV and ACHC are expected to maintain a program of research generally defined as a study requiring International Review Board (IRB) approval and active enrollment of patients. The intention is clear and admirable; to facilitate scientific inquiry that drives stroke management forward. Who better to accept this responsibility than CSCs with the largest and most acute patient populations? However, the standard poses challenges to non-academic and academic CSCs alike. Programs of research require financial acumen and a team invested in the entire research process. When working with both established and aspiring CSC’s, we find this to be one of the more challenging standards for programs to consistently meet. Therefore, we thought we would offer a few common pitfalls we’ve seen and some suggestions for program leadership who work in organizations trying to maintain an active program of research.
One of the first mistakes we see organizations make is to try to find a single study to meet the research standard. While finding a single study, gaining IRB approval and enrolling a handful of patients will meet the standard for stroke certification, this strategy poses significant risk to the program over time. Studies may abruptly and unexpectedly close due to a variety of reasons, so attempting to meet the standard with a single study places the program at risk of non-compliance through no fault of anyone working within the program. Instead, a program of research should involve a few clinicians who are consistently working to evaluate studies and bring more than one study at a time into the organization
This requires individual and organizational support for research beyond a single study to meet the standard. Individuals who are invested in research must connect regularly with those who are conducting research trials. A study can take months (and even years) to be move from concept to reality, and the clinicians invested in research should connect to those developments and work to determine the best fit for the local program. Therefore, meeting the research standard over time requires a longer-term approach with multiple possible studies in the pipeline.
Another mistake we commonly see is trying to use registry-based research (most often sponsored by industry) to meet certification requirements. Database studies can be very helpful to track patients who receive novel treatments but have not historically qualified as patient-centered research for the purpose of stroke certification.
Finally, many organizations assume that research must be large, multi-site trials focused on a medical intervention. This overlooks areas of potential research within stroke programs including nursing, healthcare systems, rehabilitation and using large databases such as Get With the Guidelines to better understand patient outcomes.
While these pitfalls only skim the surface of the challenges of managing a stroke program of research, they are common in certified stroke programs. Having a pipeline of study possibilities and a program of research (rather than a single study) is critical to establishing a stable certified stroke center. Program leaders should also think broadly about research opportunities. In the next few blogs, we will explore several other aspects of supporting a research program within a certified stroke program.