Time, money, and weight loss: a qualitative study exploring patients' perspectives on randomization for bariatric surgery vs. an intensive non-surgical weight loss program

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.

TRIAL REGISTRATION: The LightBAR trial (NCT06309238). Registered on ClinicalTrials.gov on May 2, 2024.