Recruitment in Acute Stroke Trials: Challenges and Potential Solutions.

Autor: Broderick JP; University of Cincinnati Gardner Neuroscience Institute, OH (J.P.B., Y.N.A., P.K.)., Aziz YN; University of Cincinnati Gardner Neuroscience Institute, OH (J.P.B., Y.N.A., P.K.)., Adeoye OM; Department of Emergency Medicine, Washington University, St Louis, MO (O.M.A.)., Grotta JC; Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.)., Naidech AM; Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL (A.M.N.)., Barreto AD; Department of Neurology, McGovern Medical School at the University of Texas Health Science Center at Houston (A.D.B.)., Derdeyn CP; Department of Radiology, University of Iowa Hospitals and Clinics (C.P.D.)., Sucharew HJ; Department of Emergency Medicine, University of Cincinnati, OH (H.J.S.)., Elm JJ; Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.)., Khatri P; University of Cincinnati Gardner Neuroscience Institute, OH (J.P.B., Y.N.A., P.K.).
Jazyk: angličtina
Zdroj: Stroke [Stroke] 2023 Feb; Vol. 54 (2), pp. 632-638. Date of Electronic Publication: 2022 Dec 19.
DOI: 10.1161/STROKEAHA.122.040071
Abstrakt: Randomized clinical trials of acute stroke have led to major advances in acute stroke therapy over the past decade. Despite these successes, recruitment in acute trials is often difficult. We outline challenges in recruitment for acute stroke trials and present potential solutions, which can increase the speed and decrease the cost of identifying new treatments for acute stroke. One of the largest opportunities to increase the speed of enrollment and make trials more generalizable is expansion of inclusion criteria whose impact on expected recruitment can be assessed by epidemiologic and registry databases. Another barrier to recruitment besides the number of eligible patients is availability of study investigators limited to business hours, which may be helped by financial support for after-hours call. The wider use of telemedicine has accelerated quicker stroke treatment at many hospitals and has the potential to accelerate research enrollment but requires training of clinical investigators who are often inexperienced with this approach. Other potential solutions to enhance recruitment include rapid prehospital notification of clinical investigators of potential patients, use of mobile stroke units, advances in the process of emergency informed consent, storage of study medication in the emergency department, simplification of study treatments and data collection, education of physicians to improve equipoise and enthusiasm for randomization of patients within a trial, and clear recruitment plans, and even potentially coenrollment, when there are competing trials at sites. Without successful recruitment, scientific advances and clinical benefit for acute stroke patients will lag.
Databáze: MEDLINE