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Published on: April 19, 2019
Willingness to participate in cardiac trials
Eric D Peterson1, Barbara L Lytle, Mimi S Biswas
1The Outcomes Research and Assessment Group, The Duke Clinical Research Institute, Durham, NC 27710, USA. peter016@mc.duke.edu
Insights
Patient interest in clinical trials varies by demographic. Elderly and minority patients show willingness to participate in randomized clinical trials (RCTs), but women are less likely to consider them.
Area of Science:
- Clinical research
- Cardiovascular medicine
- Health equity
Background:
- Underrepresentation of elderly, women, and minorities in randomized clinical trials (RCTs) is a persistent issue.
- The reasons for these disparities, particularly patient interest, remain unclear.
Purpose of the Study:
- To investigate whether differential patient interest contributes to the underenrollment of specific demographic groups in cardiac randomized clinical trials (RCTs).
Main Methods:
- A survey was conducted with 660 patients regarding their willingness to participate in two hypothetical cardiac RCTs.
- The RCTs compared medical therapy vs. percutaneous coronary angioplasty and medical therapy vs. coronary artery bypass surgery.
- Patient demographics including age, sex, and race were recorded.
Main Results:
- Patients aged 70 years and older were equally or more likely to consider both RCTs compared to younger patients.
- No significant impact of race on trial consideration was observed.
- Women were significantly less likely than men to consider participation in either RCT.
Conclusions:
- Patient willingness to consider participation does not explain the underenrollment of elderly and minority populations in cardiac RCTs.
- Women's reluctance to consider RCT participation warrants further investigation to address sex-based disparities in clinical research.
Abstract:
The elderly, women, and minorities are all less likely to be enrolled in randomized clinical trials (RCTs). Whether differential patient interest in RCTs contributes to these disparities is unclear. The authors surveyed 660 patients willingness to consider two potential cardiac RCTs of medical therapy vs. percutaneous coronary angioplasty or coronary artery bypass surgery, respectively. The cohorts mean age was 67 years (43% aged >or=70 years; 35% women; and 28% nonwhite). Compared with younger patients, those aged >or=70 years were equal or more likely to consider both the percutaneous coronary angioplasty (46% vs. 41%) and coronary artery bypass surgery RCTs (35% vs. 31%). Race also had no significant impact on trial enrollment, yet women were significantly less likely than men to participate in either RCT. In conclusion, patient willingness to consider RCT participation does not explain underenrollment of elderly and minority patients. Women, however, were more reluctant to consider RCTs, an area requiring further study.
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