Health Affairs, 31, no.9 (2012):2094-2104 doi: 10.1377/hlthaff.2011.0686 The online version of this article, along with updated information and services, is available at
Aims/hypothesis Mounting evidence indicates that Roux-en-Y gastric bypass (RYGB) ameliorates type 2 diabetes, but randomised trials comparing surgical vs nonsurgical care are needed. With a parallel-group randomised controlled trial (RCT), we compared RYGB vs an intensive lifestyle and medical intervention (ILMI) for type 2 diabetes, including among patients with a BMI <35 kg/m2. Methods By use of a shared decision-making recruitment strategy targeting the entire at-risk population within an integrated community healthcare system, we screened 1,808 adults meeting inclusion criteria (age 25–64, with type 2 diabetes and a BMI 30–45 kg/m2). Of these, 43 were allocated via concealed, computer-generated random assignment in a 1:1 ratio to RYGB or ILMI. The latter involved ≥45 min of aerobic exercise 5 days per week, a dietitian-directed weight- and glucose-lowering diet, and optimal diabetes medical treatment for 1 year. Although treatment allocation could not be blinded, outcomes were determined by a blinded adjudicator. The primary outcome was diabetes remission at 1 year (HbA1c <6.0% [<42.1 mmol/mol], off all diabetes medicines). Results Twenty-three volunteers were assigned to RYGB and 20 to ILMI. Of these, 11 withdrew before receiving any intervention. Hence 15 in the RYGB group and 17 in the IMLI group were analysed throughout 1 year. The groups were equivalent regarding all baseline characteristics, except that the RYGB cohort had a longer diabetes duration (11.4±4.8 vs 6.8±5.2 years, p=0.009). Weight loss at 1 year was 25.8±14.5% vs 6.4±5.8% after RYGB vs ILMI, respectively (p<0.001). The ILMI exercise programme yielded a 22±11% increase in V̇O2max (p <0.0001), whereas V̇O2max after RYGB was unchanged. Diabetes remission at 1 year was 60.0% with RYGB vs 5.9% with ILMI (p=0.002). The HbA1c decline over 1 year was only modestly more after RYGB than ILMI: from 7.7±1.0% (60.7 mmol/mol) to 6.4 ±1.6% (46.4 mmol/mol) vs 7.3±0.9% (56.3 mmol/mol) to 6.9±1.3% (51.9 mmol/mol), respectively (p=0.04); however, this drop occurred with significantly fewer or no diabetes medications after RYGB. No life-threatening complications occurred. Conclusions/interpretation Compared with the most rigorous ILMI yet tested against surgery in a randomised trial, RYGB yielded greater type 2 diabetes remission in mild-to-moderately obese patients recruited from a well-informed, population-based sample. Trial registration ClinicalTrials.gov NCT01295229
To reduce late-stage breast cancer occurrence, reaching unscreened women, including elderly, unmarried, low-income, and less educated women, should be made a top priority for screening implementation.
The decision to have bariatric surgery should be based on accurate information on possible risks and benefits of all treatment options. The goal of this study was to determine whether a video‐based bariatric decision aid intervention results in superior decision quality compared to an educational booklet. We conducted a prospective, randomized controlled trial among adult patients in a single health plan who met standard criteria for bariatric surgery. Patients were randomly assigned to review either a video‐based decision aid (intervention) or an educational booklet on bariatric surgery (control). Changes in patient decision quality were assessed using bariatric‐specific measures of knowledge, values, and treatment preference after 3 months. Of 152 eligible participants, 75 were randomly assigned to the intervention and 77 to the control. The 3‐month follow‐up rate was 95%. Among all participants, significant improvements were observed in knowledge (P < 0.001), values concordance (P = 0.009), decisional conflict (P < 0.001), decisional self‐efficacy (P < 0.001), and in the proportion who were “unsure” of their treatment choice (P < 0.001). The intervention group had larger improvements in knowledge (P = 0.03), decisional conflict (P = 0.03), and outcome expectancies (P = 0.001). The proportion of participants choosing bariatric surgery did not differ significantly between groups, although there was a trend toward decreased surgical choice in the intervention group (59% booklet vs. 42% video at 3 months; P = 0.16). The use of bariatric surgery decision aids was followed by improved decision quality and reduced uncertainty about treatment at 3 months. The video‐based decision aid appeared to have a greater impact than the educational booklet on patient knowledge, decisional conflict, and outcome expectancies.
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