Trends in Consent for Clinical Trials in Cardiovascular Disease Article Swipe
Louis A. Kerkhoff
,
Javed Butler
,
Anita A. Kelkar
,
Supriya Shore
,
Candace D. Speight
,
Louisa K. Wall
,
Neal W. Dickert
·
YOU?
·
· 2016
· Open Access
·
· DOI: https://doi.org/10.1161/jaha.116.003582
YOU?
·
· 2016
· Open Access
·
· DOI: https://doi.org/10.1161/jaha.116.003582
Background Cardiovascular clinical trials depend on patient enrollment. Enrollment rates appear inadequate, but little is known about how frequently patients accept or decline offers of enrollment. The objective of this study was to assess trends and predictors of patient acceptance of offers to enroll in clinical trials for cardiovascular disease. Methods and Results We utilized an established database containing all randomized, controlled trials (n=1224) in cardiovascular disease published between 2001 and 2012 in the 8 highest‐impact general medical and cardiology journals. Studies were eligible if the number of patients approached and number of patients declining enrollment could be ascertained from published materials. All studies were screened for eligibility. Each eligible study was reviewed by 3 co‐authors. All discrepancies were resolved by the group. The main outcome was acceptance rate, defined as the number of patients enrolled divided by the number patients who were eligible and approached. Only 21.7% (n=266) of studies provided information sufficient to assess patient enrollment and refusals. The median acceptance rate across trials was 83.2%. Significant predictors of higher enrollment included: enrollment in the acute setting ( P =0.031); geographical region ( P <0.001 for group); and trial sponsorship ( P =0.006 for group). Conclusions Rates of reporting data sufficient to calculate acceptance rates are low. This compromises the ability to identify drivers of low enrollment and assess trial generalizability. However, the high rates of acceptance observed suggest that factors other than patients’ decisions may be the primary drivers of declining rates of trial enrollment.
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Metadata
- Type
- review
- Language
- en
- Landing Page
- https://doi.org/10.1161/jaha.116.003582
- OA Status
- gold
- Cited By
- 9
- References
- 16
- Related Works
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- OpenAlex ID
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All OpenAlex metadata
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https://openalex.org/W2435321660Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1161/jaha.116.003582Digital Object Identifier
- Title
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Trends in Consent for Clinical Trials in Cardiovascular DiseaseWork title
- Type
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reviewOpenAlex work type
- Language
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enPrimary language
- Publication year
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2016Year of publication
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2016-06-13Full publication date if available
- Authors
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Louis A. Kerkhoff, Javed Butler, Anita A. Kelkar, Supriya Shore, Candace D. Speight, Louisa K. Wall, Neal W. DickertList of authors in order
- Landing page
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https://doi.org/10.1161/jaha.116.003582Publisher landing page
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YesWhether a free full text is available
- OA status
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goldOpen access status per OpenAlex
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https://doi.org/10.1161/jaha.116.003582Direct OA link when available
- Concepts
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Medicine, Generalizability theory, Clinical trial, Disease, Randomized controlled trial, Family medicine, Internal medicine, Emergency medicine, Statistics, MathematicsTop concepts (fields/topics) attached by OpenAlex
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9Total citation count in OpenAlex
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2025: 1, 2021: 2, 2019: 2, 2018: 2, 2017: 2Per-year citation counts (last 5 years)
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16Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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