© 2001 European Society of Cardiology
Perceived benefit after participating in positive or negative / neutral heart failure trials: the patients' perspective
a Cardiovascular Clinical Trials Unit, Department of Cardiology, Lady Davis Carmel Medical Center Haifa, Israel
b Bruce Rappaport School of Medicine, Technion-IIT Haifa, Israel
* Corresponding author. Department of Cardiovascular Medicine, Lady Davis Carmel Medical Center, 7 Michal Street, Haifa 34362, Israel. Tel.: +972-4-825-0457; fax: +972-4-834-3755. E-mail address: lewis{at}tx.technion.ac.il (B.S. Lewis).
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Abstract |
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Background: Clinical trials, the gold standard for the evaluation of new therapeutic strategies, may prove a drug to be beneficial, harmful or neutral according to its effect on the end-point(s) under study.
Aims: To study the reaction and perspective of the patients participating in a clinical heart failure trial, particularly in relation to whether the trial subsequently proved to be positive, negative or neutral.
Methods: Anonymous self-completed questionnaire was sent to 78 and returned by 70 consecutive patients 1–6 months after participating in six clinical heart failure trials. The trial was neutral or negative regarding the primary end-point in four (47 patients) of the six studies (MACH-1 trial of mibefradil, REACH trial of bosentan, CASCO trial of calcium sensitizer, ecadotril trial of neutral endopeptidase inhibitor) and positive in two (23 patients) (ICARUS Israel carvedilol study, exercise study of candesartan cilexetil).
Results: Most patients reported subjective global clinical benefit (78% for positive, 74% for negative or neutral trial, NS) after participating in a clinical trial. After adjustment for age, sex, level of education, previous research, perceived comprehension, and treatment allocation (active drug/placebo) in a stepwise regression model, perceived global improvement was greater in older patients (P = 0.02), after participation in a positive trial (P = 0.05) and in females (P = 0.07). The major reason given by the patient for perceived clinical improvement was better follow-up, some believed it was due to change in medication, particularly those who had participated in a positive trial.
Conclusions: More than 70% of patients participating in clinical trials of new drugs for heart failure reported perceived global improvement. Clinical improvement was greater in, but not limited to, patients who participated in positive trials. These salutary findings support the continued recruitment of patients to clinical heart failure trials.
Key Words: Clinical trials • Placebo effect • Patient perception • Patient benefit
Received May 19, 2000; Revised September 11, 2000; Accepted November 30, 2000
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