PATIENT PERCEPTION OF A LONG-TERM CLINICAL-TRIAL - EXPERIENCE USING ACLOSE-OUT QUESTIONNAIRE IN THE STUDIES OF LEFT-VENTRICULAR DYSFUNCTION (SOLVD) TRIAL

A close-out questionnaire was distributed to the participants in a lon g-term heart failure trial, Studies of Left Ventricular Dysfunction (S OLVD). The respondents' primary motivation for enrollment, positive an d negative experiences, and reported changes in habitual behavior was analyzed. Seventy-four percent (N = 3522) of the eligible patients res ponded to the survey. The most commonly cited reason for enrollment wa s recommendation by the primary physician. A wish ''to contribute to m edical science'' and ''to help others'' was also a frequent incentive. A majority of the respondents were satisfied with participation and w ould be willing to participate in a future clinical trial. Most negati ve experiences included transportation to and from the clinic and freq uent staff changes. A significant number of the patients reported chan ges in their smoking habits, alcohol intake, and diet despite the abse nce of behavioral interventions in the study protocol. There were mino r differences between attitudes and perceptions of the male and female participants. No differences were found between patients who had prev iously participated in a clinical trial and those who had not.