Related Experiment Video
Updated: May 17, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Time, money, and weight loss: a qualitative study exploring patients' perspectives on randomization for bariatric
Sofie Amalie Tomova-Olsen1, Marius Brostrøm Kousgaard2, Katrine Tranberg Jensen2
1Centre for General Practice, the Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark. sofie.olsen@sund.ku.dk.
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.
Related Concept Videos
Randomized Experiments
Simple randomization
Simple...
Blind Procedures
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Psychosurgery
Historical Development of Psychosurgery
In the 1930s, Portuguese neurologist Antonio Egas Moniz introduced a surgical procedure designed...
Blinding
Regression Toward the Mean

