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Titolo:
Perceived benefit after participating in positive or negative/neutral heart failure trials: the patients' perspective
Autore:
Yuval, R; Uziel, K; Gordon, N; Merdler, A; Khader, N; Karkabi, B; Flugelman, MY; Halon, DA; Lewis, BS;
Indirizzi:
Lady Davis Carmel Med Ctr, Dept Cardiol, Cardiovasc Clin Trials Unit, Haifa, Israel Lady Davis Carmel Med Ctr Haifa Israel Clin Trials Unit, Haifa, Israel Technion Israel Inst Technol, Bruce Rappaport Sch Med, Haifa, Israel Technion Israel Inst Technol Haifa Israel paport Sch Med, Haifa, Israel
Titolo Testata:
EUROPEAN JOURNAL OF HEART FAILURE
fascicolo: 2, volume: 3, anno: 2001,
pagine: 217 - 223
SICI:
1388-9842(200103)3:2<217:PBAPIP>2.0.ZU;2-J
Fonte:
ISI
Lingua:
ENG
Soggetto:
LEFT-VENTRICULAR DYSFUNCTION; ACUTE MYOCARDIAL-INFARCTION; CONVERTING ENZYME-INHIBITORS; CLINICAL-TRIAL; INFORMED CONSENT; MORTALITY; MORBIDITY; PLACEBO; CAPTOPRIL; QUALITY;
Keywords:
clinical trials; placebo effect; patient perception; patient benefit;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
23
Recensione:
Indirizzi per estratti:
Indirizzo: Lewis, BS Lady Davis Carmel Med Ctr, Dept Cardiovasc Med, 7 Michal St, IL-34362 Haifa, Israel Lady Davis Carmel Med Ctr 7 Michal St Haifa Israel IL-34362 ael
Citazione:
R. Yuval et al., "Perceived benefit after participating in positive or negative/neutral heart failure trials: the patients' perspective", EUR J HE FA, 3(2), 2001, pp. 217-223

Abstract

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 uas 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 carvedilolstudy, 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 ofpatients to clinical heart failure trials. (C) 2001 European Society of Cardiology. All rights reserved.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 21/01/20 alle ore 00:58:44