Who will participate in acute stroke trials?
BACKGROUND
Despite the high incidence of acute stroke, only a minority of patients are enrolled in acute stroke treatment trials. We aimed to identify factors associated with participation in clinical trials of novel therapeutic agents for acute stroke.


METHODS
Prospective survey of patients with acute stroke <72 hours from onset. A structured interview was administered to the patient or primary decision-maker. If offered participation in an actual acute treatment trial, questions focused on decisions about that trial; otherwise a similar mock trial was proposed. The primary outcome was whether the subject agreed to participate in the proposed trial.


RESULTS
A total of 200 subjects (47% patients, 53% proxies) completed the survey: mean age 63 +/- 14 years, 47% women, 44% white, 50% black. A real acute trial was offered to 22%; others were offered a mock trial. Overall, 57% (95% confidence interval: 50%-64%) of respondents stated they would participate in the proposed acute treatment trial. There were no differences with respect to age, sex, race, educational level, self-assessed stroke severity or stroke type, vascular risk factors, or comorbidities. Misconceptions about key research concepts were found in 50% but did not impact participation. Participation was associated with the perceived risk of the proposed trial intervention (p < 0.001), prior general attitudes about research (p < 0.001), and influences attributed to family, religion, and other personal beliefs (p < 0.001). Patients were more likely to participate than proxy decision-makers (p = 0.04).


CONCLUSIONS
Demographic factors, clinical factors, and prior knowledge about research have little impact on the decision to participate in acute stroke clinical trials. Preexisting negative attitudes and external influences about research strongly inhibit participation. Patients are more inclined to participate than their proxy decision-makers.
Department of Neurology, University of Pennsylvania Medical Center, 3 West Gates Building, 3400 Spruce Street, Philadelphia, PA 19104, USA. kasner@mail.med.upenn.edu
S E
SE
Kasner
A
A
Del Giudice
S
S
Rosenberg
M
M
Sheen
J M
JM
Luciano
B L
BL
Cucchiara
S R
SR
Messé
L H
LH
Sansing
J M
JM
Baren
D000208:Acute Disease / Q000628:therapy; D000368:Aged; D001294:Attitude to Health; D035843:Biomedical Research / Q000941:ethics; D017028:Caregivers / Q000523:psychology / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic / Q000523:psychology* / Q000706:statistics & numerical data; D003469:Culture; D003625:Data Collection / Q000379:methods*; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000523:psychology* / Q000706:statistics & numerical data; D008297:Male; D016743:Mental Competency / Q000523:psychology*; D008875:Middle Aged; D010349:Patient Compliance / Q000523:psychology* / Q000706:statistics & numerical data; D010353:Patient Education as Topic / Q000706:statistics & numerical data; D010817:Physician-Patient Relations; D011446:Prospective Studies; D018570:Risk Assessment / Q000706:statistics & numerical data; D012309:Risk-Taking; D020521:Stroke / Q000188:drug therapy*