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.
Keywords
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Article info
Publication history
Published online: June 06, 2013
Accepted:
May 21,
2013
Received:
November 21,
2012
Footnotes
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.
Identification
Copyright
© 2013 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
