Patient perception of a long-term clinical trial: experience using a close-out questionnaire in the Studies of Left Ventricular Dysfunction (SOLVD) Trial. SOLVD Close-out Working Group.
A close-out questionnaire was distributed to the participants in a long-term heart failure trial, Studies of Left Ventricular Dysfunction (SOLVD). The respondents' primary motivation for enrollment, positive and negative experiences, and reported changes in habitual behavior was analyzed. Seventy-four percent (N = 3522) of the eligible patients responded to the survey. The most commonly cited reason for enrollment was recommendation by the primary physician. A wish "to contribute to medical science" and "to help others" was also a frequent incentive. A majority of the respondents were satisfied with participation and would be willing to participate in a future clinical trial. Most negative experiences included transportation to and from the clinic and frequent staff changes. A significant number of the patients reported changes in their smoking habits, alcohol intake, and diet despite the absence of behavioral interventions in the study protocol. There were minor differences between attitudes and perceptions of the male and female participants. No differences were found between patients who had previously participated in a clinical trial and those who had not.
Mount Sinai Medical Center, Division of Cardiology, New York, New York 10029.
M J
MJ
Henzlova
G H
GH
Blackburn
E J
EJ
Bradley
W J
WJ
Rogers
D001290:Attitude; D001294:Attitude to Health; D004656:Enalapril / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D015438:Health Behavior; D006333:Heart Failure / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010358:Patient Participation; D017060:Patient Satisfaction; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D012737:Sex Factors; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000187:drug effects*
D010919:Placebos; D004656:Enalapril