PATIENT SATISFACTION WITH CLINICAL-TRIAL PARTICIPATION

Objective. To assess satisfaction of patients who participate in clini cal trials requiring informed consent and to analyse factors determini ng;patient satisfaction. Setting. The survey took place in 26 clinical trials at the University Hospital Maastricht (azM), The Netherlands. Design and study participants. A personal interview and telephone ques tionnaire were used consecutively (n 135; 135 out of 172=78.5% respons e rate) to measure patient's expectancies before starring the trial du ring the informed consent procedure and to evaluate aspects of trial p articipation. An additional control group of 34 patients was interview ed only by telephone (100% response). Measures. Satisfaction was asses sed in two distinct ways: first, by measuring the patient's subjective evaluation of several aspects of trial participation; secondly, by co mparing prior expectations and subsequent evaluations. Patient satisfa ction was subdivided with respect to medical-technical, interpersonal and organizational aspects of trial participation. Changes in patient' s health and illness perceptions were regarded as confounding factors in the relationship between satisfaction and its possible causes. Resu lts. Although patient satisfaction was quite high, dissatisfaction wit h aspects of trial participation became apparent when both prior expec tations and subsequent evaluations were compared with each other. Conc lusion. Prior expectations and general attitudes towards medical care and research before entering the trial have an impact on satisfaction with aspects of trial participation (10-20% explained variance). No li near relationship was found between perceived improvements in health a nd illness conditions and patient satisfaction with trial participatio n.