Background Clinical trials of patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN) can be confounded by difficulties in engaging patients. Identifying factors of non-engagement informs strategies to increase involvement and compliance.
Objectives We generated qualitative data on the engagement and experience of patients in clinical trials, which can be used to improve the design and conduct of future trials.
Methods A unique approach was used simulating key study visits for an upcoming study involving patients with active SLE/LN and clinical staff from an indigent care hospital in Atlanta, GA. Patients underwent a consent procedure (30–45 minutes), simulated SLE/LN screening visit (2.5 hours), and simulated SLE/LN first dosing visit (4.5–5 hours). Patients and site staff were interviewed to obtain sentiments and perceptions relating to the simulated visits.
Results Demographics: Six African-American patients (1 male, 5 female) aged 27–60 years with moderate to severe SLE/LN were recruited. Although the sample size was small, it provided value owing to its targeted clinical context. Patients differed in cognitive ability and health literacy. Communication: Patients expressed a preference for obtaining general disease and specific trial information from the Internet and stated that both strong online and community support were important. Patients valued help and support to discuss their conditions and options with family and friends. For support groups, the use of lupus community leaders was suggested for communicating the importance and relevance of clinical trial participation. Study sponsors were also advised to engage the lupus community through lupus community leaders. Despite completing full informed consent procedures, not all patients understood the degree of commitment at the time of study enrollment; in addition, a few patients thought the study might cure their disease. Patients suggested developing condensed and/or electronic versions of the informed consent form in text or audio format. Staff mentioned using electronic patient-reported outcome tools, which the patients found acceptable to complete. Patient needs: The extent of disruption to patients' lives due to study participation was cited as a major factor for potential study withdrawal. Limited flexibility in work schedules and inflexible commitments such as child care, leading to financial burden were raised as significant concerns. Although patients were generally happy with their current disease management, they were willing to consider changing their medications for a better outcome. Some patients were motivated by being part of developing a possible cure. The simulation also considered infusion visits, which required coordination between relevant parties, with post-infusion observation times potentially shortened. The duration of study visits (2+ hours) was a concern for patients and made them particularly sensitive to wait times between procedures.
Conclusions Insights and techniques from this study at an urban indigent care lupus clinic with large numbers of African-Americans can be applied to the design of future clinical trials for patients with SLE/LN in high-risk populations to potentially improve recruitment, retention, compliance and advocacy.
Disclosure of Interest S. S. Lim Consultant for: AstraZeneca, D. McKinnell Consultant for: AstraZeneca, M. E. Pierson Employee of: AstraZeneca, F. O'Brien Employee of: AstraZeneca