Factors determining participation in prevention trials among systemic lupus erythematosus patients: a qualitative study

Abstract

A feasibility study for a trial of strategies for the prevention of atherosclerosis in patients with systemic lupus erythematosus (SLE) was stopped because of inadequate recruitment. There is little understanding of the factors influencing patients' decisions about participation in prevention trials. Our goal was to determine factors that patients with SLE consider in deciding about participating in prevention trials, to uncover concerns about SLE trials, and to investigate how study design and purpose affect participation decisions. We conducted focus groups with trial participants (n = 13), trial nonparticipants (n = 8), and a group of patients with diabetes (n = 9). We conducted telephone interviews with SLE patients who refused participation in the trial and the focus groups (n = 10). A trained facilitator elicited factors influencing participation decisions. Transcripts were coded and grouped into themes using grounded theory. Demographic characteristics of the groups were similar. Seven factors emerged as important in decision making: current health status, study design, physician involvement, personal benefit, altruism, time, and incentives. These factors were considered by individuals who elected to participate and those who did not, but weighed differently. Among the trial participants, good health status, encouragement from one's physician, and desires to learn and to contribute stimulated participation. Reasons for nonparticipation included current health status, medication and randomization concerns, and personal factors. We observed that similar factors were weighed differently by participants and nonparticipants. Our results suggest that strategies such as health education, enlistment of personal physicians, and limitation of time requirements may enhance recruitment of patients with SLE into clinical prevention trials.