Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA.
Internal Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Lupus Sci Med. 2020 Mar 15;7(1):e000360. doi: 10.1136/lupus-2019-000360. eCollection 2020.
Although 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.
A 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.
Patients 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some patients had discussed research participation with approving or disapproving family or friends, self-approval superseded external approval.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.
Knowledge 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.
尽管系统性红斑狼疮（SLE）在少数族裔群体中发病率不成比例，但在美国的临床试验中，他们的代表性严重不足。这可能导致基于种族的亚组分析得出误导性结论。我们进行了焦点小组讨论，以评估不同狼疮患者对临床试验参与的看法。
采用定性研究设计，由一名经过培训的主持人领导了三个 90 分钟的焦点小组，以计划行为理论为指导。关于参与试验的开放性问题包括参与的优缺点（行为信念）、赞成和不赞成的重要他人（规范信念）以及参与促进因素和障碍（控制信念）。记录、转录并分析讨论内容以识别出现的主题。
21-72 岁的 SLE 患者（n=23），其中少数民族比例增加（65%），参与了研究。报告的参与试验的优势包括利他主义和个人受益。缺点包括不确定性、失望、信息负担和生活健康平衡。尽管一些患者已经与赞成或不赞成的家人或朋友讨论过研究参与，但自我认可超过了外部认可。障碍包括后勤和时间，促进因素包括灵活的日程安排、提前通知研究、简化表格以及对 SLE 改善的希望。
对临床试验参与的潜在好处的了解程度很高。少数族裔患者表现出对自己做出知情决策的信心，但所有参与者的主要障碍包括繁琐的表格、旅行、儿童保育和工作。这表明，从行为和控制方面来看，对少数民族和所有参与者的招募都有重大影响，这在试验设计的后勤方面应予以考虑。这并没有最小化改善获得机会和教育的潜在重要性，以提高对临床研究的认识。
