Abstract
Background:Randomized controlled trials (RCTs) involving surgical procedures are challenging for recruitment and infrequent in the specialty of bariatrics. The pilot phase of the By-Band-Sleeve study (gastric bypass versus gastric band versus sleeve gastrectomy) provided the opportunity for an investigation of recruitment using a qualitative research integrated in trials (QuinteT) recruitment intervention (QRI).Patients/Methods:The QRI investigated recruitment in two centers in the pilot phase comparing bypass and banding, through the analysis of 12 in-depth staff interviews, 84 audio recordings of patient consultations, 19 non-participant observations of consultations and patient screening data. QRI findings were developed into a plan of action and fed back to centers to improve information provision and recruitment organization.Results:Recruitment proved to be extremely difficult with only two patients recruited during the first 2 months. The pivotal issue in Center A was that an effective and established clinical service could not easily adapt to the needs of the RCT. There was little scope to present RCT details or ensure efficient eligibility assessment, and recruiters struggled to convey equipoise. Following presentation of QRI findings, recruitment in Center A increased from 9% in the first 2 months (2/22) to 40% (26/65) in the 4 months thereafter. Center B, commencing recruitment 3 months after Center A, learnt from the emerging issues in Center A and set up a special clinic for trial recruitment. The trial successfully completed pilot recruitment and progressed to the main phase across 11 centers.Conclusions:The QRI identified key issues that enabled the integration of the trial into the clinical setting. This contributed to successful recruitment in the By-Band-Sleeve trial—currently the largest in bariatric practice—and offers opportunities to optimize recruitment in other trials in bariatrics.
Highlights
Randomized controlled trials (RCTs) including surgical procedures have long been acknowledged to be difficult to mount because of methodological, cultural, historical and technical issues.[1,2,3,4] there are fewer RCTs than in other clinical specialties,[5,6,7,8] meaning that only a small proportion of surgical treatments are based on the highest level of evidence generated from RCTs.[9]
Patients were first given an overview of the RCT and the patient information leaflet during an education session and detailed information was provided in the One-Stop Clinic, where they met five professionals in one afternoon
The QRI reported here demonstrates the importance of early identification and addressing of recruitment challenges, and the need for extending the QRI throughout the recruitment period of surgical RCTs that may be difficult to recruit into to sustain benefits gained
Summary
Randomized controlled trials (RCTs) including surgical procedures have long been acknowledged to be difficult to mount because of methodological, cultural, historical and technical issues.[1,2,3,4] there are fewer RCTs than in other clinical specialties,[5,6,7,8] meaning that only a small proportion of surgical treatments are based on the highest level of evidence generated from RCTs.[9]. The By-Band-Sleeve RCT (ISRCTN: 00786323) was initially established to compare gastric bypass and gastric banding for complex obesity[13] and it adapted to a three group trial to compare sleeve gastrectomy in the main phase.[14] These operations were in common use but lacked robust comparative evidence and longer-term follow-up data, with observational studies suggesting that the different techniques led to similar long-term weight loss but different profiles of weight loss. CONCLUSIONS: The QRI identified key issues that enabled the integration of the trial into the clinical setting This contributed to successful recruitment in the By-Band-Sleeve trial—currently the largest in bariatric practice—and offers opportunities to optimize recruitment in other trials in bariatrics
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