TY - JOUR
T1 - The unspoken benefit of participation in a clinical trial
AU - Schwarz, Konstantin
AU - Parasuraman, Sathish
AU - Singh, Satnam
AU - Horowitz, John D.
AU - Dawson, Dana K.
AU - Frenneaux, Michael P.
N1 - Funding Information:
The study was funded by the Medical Research Council.
PY - 2021/12/3
Y1 - 2021/12/3
N2 - Background Publicly funded trials do not usually offer financial incentives to volunteers. An intensive level of medical care could act as an additional motivator for participation. Our aim was to establish whether patients may draw any clinical benefit from volunteering in a clinical trial. Methods We analysed the recruitment process of a phase II randomised controlled trial, the Inorganic Nitrate in Angina Study. Results Two-hundred and thirteen patients with a history of stable angina and who had been under at least annual primary care review were screened for participation by history taking, examination, 12-lead electrocardiography, treadmill test and echocardiography. Thirty-five (16.4%) patients were found to have significant unstable or new clinical pathology, requiring urgent clinical attention. We identified 17 (7.9%) patients with unstable angina. Furthermore, we found new undiagnosed pathologies: amyloidosis in two (0.9%), hypertrophic cardiomyopathy in two (0.9%), left ventricular systolic dysfunction (ejection fraction <45%) in three (1.4%), left ventricular thrombus in one (0.4%), significant valvular disease in five (2.4%) and arrhythmias in six (2.8%). Conclusion Compared with routine care, patients screened for a clinical trial may come under an increased level of scrutiny that may affect their clinical management. This may act as additional motivator to attract patients to future studies.
AB - Background Publicly funded trials do not usually offer financial incentives to volunteers. An intensive level of medical care could act as an additional motivator for participation. Our aim was to establish whether patients may draw any clinical benefit from volunteering in a clinical trial. Methods We analysed the recruitment process of a phase II randomised controlled trial, the Inorganic Nitrate in Angina Study. Results Two-hundred and thirteen patients with a history of stable angina and who had been under at least annual primary care review were screened for participation by history taking, examination, 12-lead electrocardiography, treadmill test and echocardiography. Thirty-five (16.4%) patients were found to have significant unstable or new clinical pathology, requiring urgent clinical attention. We identified 17 (7.9%) patients with unstable angina. Furthermore, we found new undiagnosed pathologies: amyloidosis in two (0.9%), hypertrophic cardiomyopathy in two (0.9%), left ventricular systolic dysfunction (ejection fraction <45%) in three (1.4%), left ventricular thrombus in one (0.4%), significant valvular disease in five (2.4%) and arrhythmias in six (2.8%). Conclusion Compared with routine care, patients screened for a clinical trial may come under an increased level of scrutiny that may affect their clinical management. This may act as additional motivator to attract patients to future studies.
KW - Clinical research
KW - Recruitment
UR - http://www.scopus.com/inward/record.url?scp=85121664182&partnerID=8YFLogxK
UR - https://europepmc.org/article/pmc/pmc8806308
U2 - 10.7861/clinmed.2021-0292
DO - 10.7861/clinmed.2021-0292
M3 - Article
C2 - 34862226
AN - SCOPUS:85121664182
SN - 1470-2118
VL - 21
SP - E645-E647
JO - Clinical Medicine, Journal of the Royal College of Physicians of London
JF - Clinical Medicine, Journal of the Royal College of Physicians of London
IS - 6
ER -