Patient comprehension and reaction to participating in a double-blind randomized clinical trial (ISIS-4) in acute myocardial infarction.

BACKGROUND: Although randomized clinical trials are currently the standard for the evaluation of new therapeutic strategies, little attention has been paid to the viewpoint of the patients recruited to these trials. OBJECTIVES: To examine the perspective of the Israeli patient cohort who participated in the Fourth International Study of Infarct Survival, a randomized trial in acute myocardial infarction. METHODS: A patient questionnaire was mailed to 360 Israeli patients who participated in the Fourth International Study of Infarct Survival and was returned by 150 of them. Main outcome measures included patient perception of consent procedures, comprehension of the study, subjective reaction to participating in the trial, and interest in present and future trials. RESULTS: Forty (31%) of 129 patients perceived that they had full comprehension of the trial, while 64 (50%) claimed partial understanding and 25 (19%), no understanding at all. Comprehension was related to a recollected explanation of 5 minutes or more (P<.001) and to an opportunity for discussion at the time of consent (P<.001). Most patients recollected the oral explanation; fewer, the written material. Patient consent was given by 64 (43%) of 150 patients in the hope of better treatment. In 36 cases (25%), the patients felt they received better treatment because of participation in the trial. CONCLUSIONS: Despite proper attention to accepted ethical and legal standards, perceived patient comprehension in this trial in acute myocardial infarction was incomplete or lacking in a considerable number of subjects. Much progress must be made toward the goal of true informed consent in clinical trials.

Perceived benefit after participating in positive or negative/neutral heart failure trials: the patients' perspective.

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.