Elsevier

Surgery for Obesity and Related Diseases

Volume 9, Issue 6, November–December 2013, Pages 837-844
Surgery for Obesity and Related Diseases

Original article
A population-based, shared decision-making approach to recruit for a randomized trial of bariatric surgery versus lifestyle for type 2 diabetes

https://doi.org/10.1016/j.soard.2013.05.006Get rights and content

Abstract

Background

Randomized trials of bariatric surgery versus lifestyle treatment likely enroll highly motivated patients, which may limit the interpretation and generalizability of study findings. The objective of this study was to assess the feasibility of a population-based shared decision-making (SDM) approach to recruitment for a trial comparing laparoscopic Roux-en-Y gastric bypass surgery with intensive lifestyle intervention among adults with mild to moderate obesity and type 2 diabetes.

Methods

Adult members with a body mass index (BMI) between 30 and 45 kg/m2 taking diabetes medications were identified in electronic databases and underwent a multiphase screening process. Candidates were given a telephone survey, education about treatment options for obesity and diabetes using decision aids, and an SDM phone call with a nurse practitioner, in addition to standard office-based consent.

Results

We identified 1808 members, and 828 (45.7%) had a BMI of 30–34.9 kg/m2. Among these, 1063 (59%) agreed to the telephone survey, 416 (23%) expressed interest in education about treatment options, and 277 (15%) completed the SDM process. The preferred treatment options were surgery (21 [8%]), diet and exercise (149 [53.8%]), pharmacotherapy (5 [2%]), none of the above (8 [3%]), and unsure (94 [34%]). Ultimately, 43 participants were randomly assigned to the trial. Significant differences, mainly related to sex, disease severity, and hypoglycemic medication use, were observed among people who did and did not agree to participate in our trial.

Conclusion

This population-based, SDM-based recruitment strategy successfully identified, enrolled, and randomly assigned patients who had balanced views of surgery and lifestyle management. Even with this approach, selection biases may remain, highlighting the need for careful characterization of nonparticipants in all future studies.

Section snippets

Study setting

Recruitment for this prospective, randomized trial was conducted between July 2011 and June 2012 at Group Health Cooperative (GHC), a large, mixed-model, nonprofit healthcare system that coordinates healthcare and insurance coverage. The GHC system includes>600,000 enrolled members. GHC contracts with the Group Health Physicians medical group to provide care within an integrated group practice (IGP) for approximately 70% of the plan’s enrollees. The remaining 30% receive care from non-GHC

Results

Fig. 1 shows the flow of participant recruitment. We identified 1808 (Box A) members from GHC’s electronic databases who appeared eligible and mailed these individuals an invitation to participate in a telephone survey about their weight and experience with weight loss programs (828 [45.7%] of these had a BMI 30–34.9 kg/m2). Among these, 745 (41%) could not be contacted or, when contacted, refused to participate (Box B). The remaining 1063 (59%) began our telephone survey (Box C). Appendix 1

Discussion

There are many important barriers to conducting randomized trials of bariatric surgery versus nonsurgical treatment. Herein, we tested a pragmatic, SDM recruitment strategy for a randomized trial of RYGB versus an intensive lifestyle intervention for diabetes and obesity in a defined health plan population. Based on our prior study of SDM in bariatric surgery we hypothesized that we would need to contact approximately 100 people to identify one who was willing to be randomly assigned to a

Conclusion

Randomized trials of bariatric surgery are expensive endeavors and challenging to conduct. However, our study provides further evidence that a pragmatic SDM-based recruitment strategy is feasible for randomized trials of bariatric surgery versus intensive lifestyle intervention. Our study also clearly describes the selection biases inherent in recruitment for trials of bariatric surgery, which brings into question the validity of all published trials that fail to report detailed characteristics

Disclosures

David Arterburn receives research funding, has received salary support, and received free access to the DVD decision aids used in this study as a medical editor for the not-for profit (501[3]c) Informed Medical Decisions Foundation (http://www.informedmedicaldecisions.org), which develops content for patient education programs, including the bariatric surgery program that was used the subject of this study. The Foundation has an arrangement with a for-profit company, Health Dialog, to

Acknowledgments

The authors would like to acknowledge the contributions of the following individuals in the conduct of this study: The CROSSROADS Study Team: Chun P. Chan, Allison Devlin, Karen E. Foster-Schubert, Julie Grimm, Mario Kratz, Jessica Kuzma, Skye Stewart, Overlake Hospital Medical Center; Matrix Anesthesia; DSMB members: David McCulloch, Ann Melvin, and Andrew Wright; GHC leadership and staff: Paul Sherman, Michael Evans, and Athina Psomos; Mark Rylander; David Glazer; and the Group Health

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This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (grant #R01-DK089528) and grants from the Group Health Research Institute and the Group Health Foundation. The video-based decision aid used in this study was provided by the Informed Medical Decisions Foundation.

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