Patient attitudes toward granting consent to participate in perioperative randomized clinical trials

Abstract

Study objective To determine the factors that affect patients' decisions to provide informed consent to participate in perioperative clinical trials. Design Survey instrument (questionnaire). Setting Urban, tertiary-care, university-affiliated hospital. Measurements and main results Of 52 patients who had been asked to participate in a randomized control trial (RCT), 43 agreed to be participate in our survey. Almost all consenters (97%), but only 62% of nonconsenters agreed to answer the survey questions ( p = 0.002). No significant difference in gender, ethnic background, marital status, or education level was found between groups who were or were not willing to participate. Univariate correlates of agreement to participate in RCTs included older age (>60 yrs; p = 0.02), a reassuring attitude conveyed by study personnel ( p = 0.02), and trust in study personnel ( p = 0.02). Those who declined participation in clinical trials more frequently indicated that the study made them feel like a “guinea pig” ( p = 0.02). Conclusion Patient age and personal attitudes predict the likelihood of participation in perioperative clinical trials. Neither gender nor race affected willingness to participate. Further work in larger groups is needed to identify predictors of consent and techniques to increase willing participation.