TY - JOUR
T1 - Patient- and trial-specific barriers to participation in cardiovascular randomized clinical trials
AU - Martin, Seth S.
AU - Ou, Fang Shu
AU - Newby, L. Kristin
AU - Sutton, Victoria
AU - Adams, Patricia
AU - Felker, G. Michael
AU - Wang, Tracy Y.
N1 - Funding Information:
This study was an investigator-initiated, internally-supported project. Dr. Newby has received research funding from Amylin, AstraZeneca, Bristol-Myers Squibb, diaDexus, Eli Lily & Company, GlaxoSmithKline, Merck, MURDOCK Study, National Heart, Lung, and Blood Institute, Regado Biosciences, and F. Hoffmann-La Roche, Ltd.; and compensation for consultancy from Amgen, AstraZeneca, Daiichi Sankyo, Eli Lily & Company, Genentech, Johnson & Johnson, and Novartis. Dr. Felker has received research funding from Amgen, BG Medicine, Cytokinetics, Johnson & Johnson, Roche, and Otsuka; and compensation for consultancy and lectures from Amgen, Cytokinetics, Novartis, Roche, Otsuka, and Medpace. Dr. Wang has received research funding from AstraZeneca, Bristol-Myers Squibb, Heartscape Technologies, Lilly, Sanofi-Aventis, Schering-Plough, and The Medicines Company; and compensation for consultancy and lectures from the American College of Cardiology, AstraZeneca, and Medco. All other authors have reported they have no relationships relevant to the contents of this paper to disclose.
PY - 2013/2/19
Y1 - 2013/2/19
N2 - Objectives: The purpose of this study was to quantitatively examine the association of patient- and trial-specific factors with participation in cardiovascular randomized clinical trials. Background: Randomized clinical trials are central to evidenced-based medicine, but low patient participation rates and potentially modifiable barriers are not well understood. Methods: At a large U.S. academic health system, we examined screening logs from December 1, 2005, to February 28, 2011, from 15 cardiovascular randomized clinical trials. We identified 655 patients who were screened and potentially eligible for participation in at least 1 trial. We used multivariable Poisson regression to quantify the risk of not participating in a trial associated with patient- and trial-specific factors. Results: The median age was 63 years (interquartile range: 54 to 72), 35% were women, and the median Charlson Index was 2 (interquartile range: 1 to 5). Forty-two percent of patients did not participate in a trial. In multivariable regression (C-Index 0.85), trial-specific factors strongly associated with not participating included intensive trial-related testing (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.63 to 2.20) and anticipated trial participation >6 months (RR: 4.10; 95% CI: 2.30 to 7.29). Patient-specific factors associated with not participating included older age (RR: 1.23; 95% CI: 1.11 to 1.36, per 10-year increase if age ≥65 years), out-of-state residence (RR: 1.26; 95% CI: 1.04 to 1.54), and female sex (RR: 1.17; 95% CI: 1.01 to 1.35). Race was not associated with participation. Conclusions: While patient-specific factors were associated with not participating in cardiovascular trials, longer trial duration and intensive trial-related testing were most strongly associated with risk for patients not participating. Innovative trial designs fostering convenience may most enhance trial participation.
AB - Objectives: The purpose of this study was to quantitatively examine the association of patient- and trial-specific factors with participation in cardiovascular randomized clinical trials. Background: Randomized clinical trials are central to evidenced-based medicine, but low patient participation rates and potentially modifiable barriers are not well understood. Methods: At a large U.S. academic health system, we examined screening logs from December 1, 2005, to February 28, 2011, from 15 cardiovascular randomized clinical trials. We identified 655 patients who were screened and potentially eligible for participation in at least 1 trial. We used multivariable Poisson regression to quantify the risk of not participating in a trial associated with patient- and trial-specific factors. Results: The median age was 63 years (interquartile range: 54 to 72), 35% were women, and the median Charlson Index was 2 (interquartile range: 1 to 5). Forty-two percent of patients did not participate in a trial. In multivariable regression (C-Index 0.85), trial-specific factors strongly associated with not participating included intensive trial-related testing (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.63 to 2.20) and anticipated trial participation >6 months (RR: 4.10; 95% CI: 2.30 to 7.29). Patient-specific factors associated with not participating included older age (RR: 1.23; 95% CI: 1.11 to 1.36, per 10-year increase if age ≥65 years), out-of-state residence (RR: 1.26; 95% CI: 1.04 to 1.54), and female sex (RR: 1.17; 95% CI: 1.01 to 1.35). Race was not associated with participation. Conclusions: While patient-specific factors were associated with not participating in cardiovascular trials, longer trial duration and intensive trial-related testing were most strongly associated with risk for patients not participating. Innovative trial designs fostering convenience may most enhance trial participation.
KW - trial enrollment
KW - trial participation
KW - trial representation
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U2 - 10.1016/j.jacc.2012.10.046
DO - 10.1016/j.jacc.2012.10.046
M3 - Article
C2 - 23410547
AN - SCOPUS:84873695399
SN - 0735-1097
VL - 61
SP - 762
EP - 769
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 7
ER -