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Enrollment in MI trials declines
Enrollment in clinical trials of patients treated for MI has decreased over time, according to findings published in the American Heart Journal.
Patients admitted to hospitals enrolled in MI trials had better outcomes compared with patients with MI admitted to hospitals not participating in such trials while often receiving care based on guidelines, the researchers wrote.
Alexander C. Fanaroff, MD, MHS, and colleagues examined the hospital rates of participation in clinical trials enrolling patients with MI and assessed hospital processes and patient outcomes in hospitals that participate in clinical trials compared with those that do not.
“Much of the literature related to clinical trial participation has focused on the inconveniences faced by participants, including a long and difficult informed consent process, intensive trial-related testing and distance traveled to attend study visits,” Fanaroff, a practicing cardiovascular disease doctor in the division of cardiology and the Duke Clinical Research Institute at Duke University, and colleagues wrote. “Furthermore, the effect of hospital participation in clinical research on quality of care and patient outcomes, whether or not the patient was enrolled into the trial, has not been reported.”
The researchers analyzed data from the National Cardiovascular Data Registry and Chest Pain-MI registry of hospitals enrolling patients with acute MI in clinical trials between 2009 and 2014. Institutional adherence to MI performance measures were compared between hospitals enrolling and not enrolling patients in trials.
Fanaroff and colleagues, through Medicare data, compared 1-year major adverse CV events such as death, MI, HF or stroke among patients aged at least 65 years treated at trial compared with non-trial hospitals.
Of the 766 hospitals analyzed, 56% enrolled one or more patients with MI in clinical trials during the study period, but enrollment decreased from 36.8% in 2009 to 26.6% in 2014, according to the researchers.
Trial hospitals achieved complete adherence to performance measures more often compared with non-trial hospitals (73% vs. 65%; adjusted OR = 1.07; 95% CI, 1.03-1.12), Fanaroff and colleagues wrote. Major adverse CV event rates after 1 year were lower in trial hospitals as well (aHR = 0.96; 95% CI, 0.93-0.99).
The researchers wrote that innovations in trial design and conduct that could enhance the appeal and ease of research participation are needed.
“Fostering a culture of clinical research participation — for trainees by integrating site-based research skills into the training process, and established physicians through financial and/or academic incentives for research participation — may not only help answer critical question related to patient care, it may even help foster a culture of quality care delivery,” Fanaroff and colleagues wrote. – by Earl Holland Jr.
Disclosures: Fanaroff reports he received a career development grant from the American Heart Association. Please see the study for all other authors’ relevant financial disclosures.