Patient- and trial-specific barriers to participation in cardiovascular randomized clinical trials

Seth S. Martin, Fang-Shu Ou, L. Kristin Newby, Victoria Sutton, Patricia Adams, G. Michael Felker, Tracy Y. Wang

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)762-769
Number of pages8
JournalJournal of the American College of Cardiology
Volume61
Issue number7
DOIs
StatePublished - Feb 19 2013
Externally publishedYes

Fingerprint

Randomized Controlled Trials
Confidence Intervals
Patient Participation
Foster Home Care
Medicine
Health

Keywords

  • trial enrollment
  • trial participation
  • trial representation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Patient- and trial-specific barriers to participation in cardiovascular randomized clinical trials. / Martin, Seth S.; Ou, Fang-Shu; Newby, L. Kristin; Sutton, Victoria; Adams, Patricia; Felker, G. Michael; Wang, Tracy Y.

In: Journal of the American College of Cardiology, Vol. 61, No. 7, 19.02.2013, p. 762-769.

Research output: Contribution to journalArticle

Martin, Seth S. ; Ou, Fang-Shu ; Newby, L. Kristin ; Sutton, Victoria ; Adams, Patricia ; Felker, G. Michael ; Wang, Tracy Y. / Patient- and trial-specific barriers to participation in cardiovascular randomized clinical trials. In: Journal of the American College of Cardiology. 2013 ; Vol. 61, No. 7. pp. 762-769.
@article{572da5b164bd42a39b8e440dfa60afea,
title = "Patient- and trial-specific barriers to participation in cardiovascular randomized clinical trials",
abstract = "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.",
keywords = "trial enrollment, trial participation, trial representation",
author = "Martin, {Seth S.} and Fang-Shu Ou and Newby, {L. Kristin} and Victoria Sutton and Patricia Adams and Felker, {G. Michael} and Wang, {Tracy Y.}",
year = "2013",
month = "2",
day = "19",
doi = "10.1016/j.jacc.2012.10.046",
language = "English (US)",
volume = "61",
pages = "762--769",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "7",

}

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.

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

UR - http://www.scopus.com/inward/record.url?scp=84873695399&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84873695399&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2012.10.046

DO - 10.1016/j.jacc.2012.10.046

M3 - Article

C2 - 23410547

AN - SCOPUS:84873695399

VL - 61

SP - 762

EP - 769

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 7

ER -