Danny Mou, MD1, Claire E de Vries, MD2, R N van Veen, MD3, D Makarawung4, Lisa van den Berg1, S W Nienhuijs, MD5, Ronald S Liem, MD6, MJ Wiezer, MD7, Maarten Hoogbergen, MD8, Andrea Pusic, MD1, Anne Klassen, DPhil9, Ali Tavakkoli, MD1. 1Brigham and Women’s Hospital, 2Arts-onderzoeker bariatrische chirurgie, 3Obesitas Centrum Amsterdam, 4Netherlands Obesity Clinic, 5Catharina Hospital, 6Groene Hart Ziekenhuis, 7St. Antonius Hospital Utrecht, 8Catharina Obesity Center, 9McMaster University
Objective of the technology: The effectiveness of novel weight loss interventions should be assessed in a validated, standardized manner. Though % total weight loss (%TWL), morbidity, and mortality have often been the primary outcome measures, patients may suffer symptoms that are best captured with patient-reported outcomes measures (PROMs) such as nausea, satiety, and dissatisfaction with body-image. As more novel weight loss medical devices and surgical interventions come to market, there is an increasing need for a standardized, rigorous tool to assess and monitor patient-reported outcomes.
Most existing bariatric PROMs employ classical test theory principles, which limits their ability to measure clinically meaningful change in individual patients. We have developed PROMs tools using Rasch Measurement Theory (RMT) principle, which optimizes validity and reliability in individual patients. We have created the BODY-Q, a PROMs tool designed to evaluate patients undergoing weight loss and body contouring surgery. We are now validating the BODY-Q Bariatric Module, a new PROMs tool for bariatric surgery patients.
Description of the technology and method of its use or application: The BODY-Q is a PROMs tool that addresses patients’ physical, mental, and social well-being after bariatric surgery. Existing BODY-Q question scales include satisfaction with body, body image, physical functioning, psychological functioning, sexual functioning, social functioning, and physical symptoms. For the BODY-Q Bariatric Module, we are adding new bariatric surgery-specific measurement scales, including eating habits, emotions associated with eating, physical symptoms with eating (e.g. nausea, reflux), and social impact of weight loss (e.g., self-confidence).
These new scales were developed by refining prior qualitative interview data with 15 new patient cognitive interviews. We consulted 16 experts, including bariatric surgeons, nurses, and psychologists to provide feedback. The scales will be field tested and refined with Rasch measurement theory (RMT) analysis.
We are conducting a multicenter, prospective, longitudinal study in the Netherlands, Denmark, and Boston. Patients will complete the BODY-Q Bariatric Module before bariatric surgery, 2 weeks, 6 weeks, 3, 6, 9, 12, 18, and 24 months after bariatric surgery and then yearly up to 5 years after surgery. A total of 2,000 patients will be included.
Preliminary Results: We have tested the BODY-Q in 318 pre-operative bariatric surgery patients (196 Roux-en-Y gastric bypass (RYGB) and 130 Sleeve Gastrectomy (SG)). Of 318, 155 patients (102 RYGB, 53 SG) completed the 4-months postoperative assessment. For all question scales, the mean score did not significantly differ between the RYGB and the SG at the pre-bariatric surgery and at 4 months post-bariatric surgery (p > 0.12).
RYGB patients had higher %TWL than SG patients (mean difference 1.90, p = 0.03). RYGB patients also improved significantly more on the physical functioning (mean difference: -5.54, p = 0.050) and physical symptoms scale (mean difference: -1.85, p = 0.023) compared to SG patients. Further analysis is needed to determine the relationship between %TWL and physical symptoms/functioning.
Conclusions / future directions: We will conduct our large-scale validation of the BODY-Q Bariatric Module tool, which has immense promise in accurately assessing the patient-reported value of novel bariatric surgical procedures and devices.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 98704
Program Number: ETP736
Presentation Session: Emerging Technology Poster Session (Non CME)
Presentation Type: Poster