Tomova-Olsen Sofie Amalie, Kousgaard Marius Brostrøm, Jensen Katrine Tranberg, Reventlow Susanne, Christiansen Ann-Kathrin Lindahl, Bojsen-Møller Kirstine Nyvold, Dirksen Carsten, Overbeck Gritt
Centre for General Practice, the Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Department of Respiratory Diseases and Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.
Trials. 2025 Apr 4;26(1):121. doi: 10.1186/s13063-025-08816-8.
Randomized controlled trials (RCTs) are foundational in advancing medical knowledge and patient care, offering high-quality evidence on the comparative effectiveness of healthcare interventions. However, a common challenge for RCTs is the recruitment of trial participants. To understand and overcome potential obstacles in recruitment for a clinical trial (the LightBAR trial, NCT06309238) comparing the effectiveness of bariatric surgery versus an intensive weight loss program, a qualitative study was conducted.
Nine patients from the public bariatric surgery waiting list participated in focus groups at a hospital in the Capital Region of Denmark. Vignette scenarios were utilized to prompt participants to reflect on barriers and facilitators for participation. Three patients participated in a follow-up interview. Data was analyzed using thematic analysis.
Analysis revealed four main themes: (1) having waited long for surgery reduced participants' willingness to be randomized; (2) the cost of weight loss medication was a major concern for participants; (3) participants were concerned about the extra work involved in program participation; and (4) participants weighed the efficacy and potential negative side effects of surgery against those of an intensive weight loss program based on personal beliefs and experiences.
Tailoring the recruitment strategy to patients' circumstances and concerns, and providing clear, patient-centered communication about the nature and potential implications of participating in the trial may improve recruitment success.
The LightBAR trial (NCT06309238). Registered on ClinicalTrials.gov on May 2, 2024.
随机对照试验（RCTs）是推进医学知识和患者护理的基础，为医疗保健干预措施的比较有效性提供高质量证据。然而，随机对照试验的一个常见挑战是招募试验参与者。为了了解和克服一项比较减肥手术与强化减肥计划有效性的临床试验（LightBAR试验，NCT06309238）招募过程中的潜在障碍，进行了一项定性研究。
来自公共减肥手术等候名单的9名患者参加了丹麦首都地区一家医院的焦点小组。利用情景描述促使参与者思考参与的障碍和促进因素。3名患者参加了随访访谈。采用主题分析法对数据进行分析。
分析揭示了四个主要主题：（1）等待手术时间过长降低了参与者被随机分组的意愿；（2）减肥药物的费用是参与者的主要担忧；（3）参与者担心参与计划所涉及的额外工作；（4）参与者根据个人信念和经验权衡手术与强化减肥计划的疗效和潜在负面副作用。
根据患者的情况和担忧调整招募策略，并就参与试验的性质和潜在影响提供清晰、以患者为中心的沟通，可能会提高招募成功率。
LightBAR试验（NCT06309238）。于2024年5月2日在ClinicalTrials.gov上注册。
