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

Abstract

Objective. 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. Methods. 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. Results. 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. Conclusion. 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.

Assessing the interest to participate in a dengue vaccine efficacy trial among residents of Puerto Rico

“…While clinical trials, including vaccine trials, have been conducted in Puerto Rico with children, only one was double blinded and placebo controlled. [18][19][20][21][22][23][24] The difficulty in recruiting and retaining participants in clinical trials is well documented, [25][26][27][28] particularly among children. This has resulted in cost increases, implementation delays, failure to complete trials, and biased results.…”

“…This has resulted in cost increases, implementation delays, failure to complete trials, and biased results. [25][26][27][28] Contributing factors to recruitment and retention include lack of trust, inadequate knowledge, fear of side effects and risks, and clinical trial procedures. 25,26,[29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] Although studies have been conducted to understand cultural barriers to participation and retention in clinical trials, none have been conducted in Puerto Rico.…”

“…25,26,[29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] Although studies have been conducted to understand cultural barriers to participation and retention in clinical trials, none have been conducted in Puerto Rico. [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] In addition, formative research regarding factors related to participation in placebo controlled, vaccine trials is lacking. Therefore, we conducted two studies among adults and children in Puerto Rican municipalities with highest dengue incidence from 2000 to 2009 to assess factors influencing participation in dengue vaccine clinical trials in this population.…”

Continued Participation in a Ten‐Year Tight Control Treat‐to‐Target Study in Rheumatoid Arthritis: Why Keep Patients Doing their Best?

“…Altruistic motives are also known motivators to enter a clinical study (18)(19)(20), although a study from Romania revealed payment and free complete blood tests as motivators to participate (15). We aimed to increase the sense of contribution to science by presenting the study results through newsletters, booklets, and meetings for trial participants.…”

Musings on participation in health research and the recruitment process: It is not always about the numbers

“…In this issue of Arthritis Care & Research, Costenbader and colleagues present a number of interesting findings regarding individuals' decisions whether to participate in clinical prevention trials (1). The rationale for the study arose when recruitment for a randomized controlled trial aimed at prevention strategies for atherosclerosis in systemic lupus erythematosus (SLE) proved to be so difficult the trial was suspended.…”