TY - JOUR
T1 - What Factors Predict Willingness to Join Low-Risk Pragmatic Clinical Trials?
AU - Morain, Stephanie R.
AU - Kass, Nancy E.
AU - Faden, Ruth R.
N1 - Funding Information:
We are grateful to Kristina Hallez, Rebecca Stametz, Amanda Milo, and Deserae Clarke for their assistance in measure development and data collection. This research was supported by contract #ME-1310-07763 from the Patient-Centered Outcomes Research Institute (PCORI), awarded to Johns Hopkins University, with Faden and Kass as coprincipal investigators.
Publisher Copyright:
© 2021 by The Hastings Center. All rights reserved
PY - 2021/1/1
Y1 - 2021/1/1
N2 - Pragmatic clinical trials (PCTs) may improve the efficiency, relevance, and representativeness of research. While prior research has indicated that willingness to join a PCT is high, it is not universal among those asked in surveys exploring attitudes toward hypothetical PCTs. The objective of this study was to examine what factors predict willingness to join a hypothetical low-risk PCT comparing two blood pressure medicines. In our study, 2,618 respondents, recruited from three populations (adult patients from an academic health system, adult patients from an integrated delivery system, and adults from an online nationally representative panel), completed an online survey. Most respondents (90%) expressed willingness to participate in the hypothetical PCT. The two key predictors of expressed willingness to join low-risk PCTs were respondents' understanding of key features of PCTs, including how they differ from traditional research, and the degree of importance respondents perceived comparative research to have. Increasing awareness of the rationale for PCTs and understanding of these trials, including how they differ from explanatory trials, may increase prospective participants' willingness to contribute to this effort.
AB - Pragmatic clinical trials (PCTs) may improve the efficiency, relevance, and representativeness of research. While prior research has indicated that willingness to join a PCT is high, it is not universal among those asked in surveys exploring attitudes toward hypothetical PCTs. The objective of this study was to examine what factors predict willingness to join a hypothetical low-risk PCT comparing two blood pressure medicines. In our study, 2,618 respondents, recruited from three populations (adult patients from an academic health system, adult patients from an integrated delivery system, and adults from an online nationally representative panel), completed an online survey. Most respondents (90%) expressed willingness to participate in the hypothetical PCT. The two key predictors of expressed willingness to join low-risk PCTs were respondents' understanding of key features of PCTs, including how they differ from traditional research, and the degree of importance respondents perceived comparative research to have. Increasing awareness of the rationale for PCTs and understanding of these trials, including how they differ from explanatory trials, may increase prospective participants' willingness to contribute to this effort.
KW - comparative effectiveness research
KW - human research ethics
KW - informed consent
KW - learning health systems
KW - pragmatic clinical trials
KW - research participation
UR - http://www.scopus.com/inward/record.url?scp=85099648496&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85099648496&partnerID=8YFLogxK
U2 - 10.1002/eahr.500075
DO - 10.1002/eahr.500075
M3 - Article
C2 - 33463074
AN - SCOPUS:85099648496
SN - 2578-2363
VL - 43
SP - 17
EP - 24
JO - Ethics and Human Research
JF - Ethics and Human Research
IS - 1
ER -