Lupus patient decisions about clinical trial participation: a qualitative evaluation of perceptions, facilitators and barriers

Abstract

ObjectiveAlthough SLE disproportionately affects minority racial groups, they are significantly under-represented in clinical trials in the USA. This may lead to misleading conclusions in race-based subgroup analyses. We conducted focus groups to evaluate the perceptions of diverse patients with lupus about clinical trial participation.MethodsA qualitative research design employed three 90 min focus groups led by a trained moderator and guided by the Theory of Planned Behaviour. Open-ended questions about trial participation included advantages and disadvantages (behavioural beliefs), approving and disapproving significant others (normative beliefs), and participation enhancers and barriers (control beliefs). Discussions were recorded, transcribed and analysed to identify emerging themes.ResultsPatients with SLE (n=23) aged 21–72, with increased proportion of minority groups (65%), participated. Reported advantages of trial participation included altruism and personal benefit. Disadvantages included uncertainties, disappointment, information burden, and life–health balance. Although some patients had discussed research participation with approving or disapproving family or friends, self-approval superseded external approval. Barriers included logistics and time, and facilitators included flexibility in scheduling, advance notice of studies, streamlined forms, and hope for SLE improvement.ConclusionsKnowledge about potential benefits of clinical trial participation was high. Minority patients demonstrated confidence in making their own informed decisions, but major barriers for all participants included burdensome forms, travel, childcare, and work. These suggest a major impact on minority and all recruitment from behavioural and control aspects, which should be considered in the logistics of trial design. This does not minimise the potential importance of improved access and education about clinical research.

Extent of and Reasons for Discontinuation and Nonpublication of Interventional Trials on Connective Tissue Diseases: An Observational Study

“…Advocated reasons are various and complex to investigate, among which the use of too strict inclusion criteria, or the lack of international collaborations as well as patient's related features (22) as the leading ones. The need for a network approach in conducting CTDs trials, where multiple sites -including private practice -and patients themselves are actively involved, is being discussed by experts in the field (23).…”

Using Critical Race Theory to Understand Trial Participation Among Black Individuals With Systemic Lupus Erythematosus: A Qualitative Study of Patients and Caregivers

“…Strengths of the present study include deliberately devoted attention to the role of racism exposure in willingness to participate in clinical research using a theoretical framework specifically designed to detect and evaluate racism as a contributor to racial health disparities. While prior studies have investigated the role of race in underenrollment (30–32), we aimed to explicitly address the role of racism as a key factor. The degree to which issues related to racism would have been raised as a prominent concern without our explicitly asking is unknown; however, the degree and depth of discussions suggest that by explicitly addressing racism, we provided a forum that made it acceptable for racism to be discussed.…”

Behavioural approaches to recruitment and retention in clinical trials: a systematic mapping review

“…Vandenburgh 47 queried participants about their decision to enrol in a glaucoma trial through a self-report survey along with assessing attitudes to see how those measures may inform decisions. Manton et al 34 and Arriens et al 29 both queried participants about their decisions to participate through interview or focus groups. Manton et al 34 focused on healthy volunteers within phase 1 trials, while Arriens et al 29 conducted focus groups with lupus patients.…”

“…Manton et al 34 and Arriens et al 29 both queried participants about their decisions to participate through interview or focus groups. Manton et al 34 focused on healthy volunteers within phase 1 trials, while Arriens et al 29 conducted focus groups with lupus patients.…”