Objective: To assess satisfaction of patients who participate in clinical trials requiring informed consent and to analyse factors determining 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 questionnaire were used consecutively (n= 135; 135 out of 172=78.5% response rate) to measure patient's expectancies before starting the trial during the informed consent procedure and to evaluate aspects of trial participation. An additional control group of 34 patients was interviewed only by telephone (100% response).
Measures: Satisfaction was assessed in two distinct ways: first, by measuring the patient's subjective evaluation of several aspects of trial participation; secondly, by comparing prior expectations and subsequent evaluations. Patient satisfaction 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.
Results: Although patient satisfaction was quite high, dissatisfaction with aspects of trial participation became apparent when both prior expectations and subsequent evaluations were compared with each other.
Conclusion: 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 linear relationship was found between perceived improvements in health and illness conditions and patient satisfaction with trial participation.