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ABSTRACTThe prevalence of obesity continues to rise around the world, driving up the need for effective and durable treatments. The field of metabolic/bariatric surgery has grown rapidly in the past 25 years, with observational studies and randomized controlled trials investigating a broad range of long term outcomes. Metabolic/bariatric surgery results in durable and significant weight loss and improvements in comorbid conditions, including type 2 diabetes. Observational studies show that metabolic/bariatric surgery is associated with a lower incidence of cardiovascular events, cancer, and death. Weight regain is a risk in a fraction of patients, and an association exists between metabolic/bariatric surgery and an increased risk of developing substance and alcohol use disorders, suicidal ideation/attempts, and accidental death. Patients need lifelong follow-up to help to reduce the risk of these complications and other nutritional deficiencies. Different surgical procedures have important differences in risks and benefits, and a clear need exists for more long term research about less invasive and emerging procedures. Recent guidelines for the treatment of obesity and metabolic conditions have been updated to reflect this growth in knowledge, with an expansion of eligibility criteria, particularly people with type 2 diabetes and a body mass index between 30.0 and 34.9.

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/m 2 . 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/m 2 ). 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 (HbA 1c <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 V ⋅ O 2 max ( p <0.0001), whereas V ⋅ O 2 max after RYGB was unchanged. Diabetes remission at 1 year was 60.0% with RYGB vs 5.9% with ILMI ( p  = 0.002). The HbA 1c 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

Background Gastric bypass has profound effects on glycemic control in adults with type 2 diabetes mellitus. The goal of this study was to examine the long-term rates and clinical predictors of diabetes remission and relapse among patients undergoing gastric bypass. Methods We conducted a retrospective cohort study of adults with uncontrolled or medication-controlled type 2 diabetes who underwent gastric bypass from 1995 to 2008 in three integrated health care delivery systems in the USA. Remission and relapse events were defined by diabetes medication use and clinical laboratory measures of glycemic control. We identified 4,434 adults with uncontrolled or medication-controlled type 2 diabetes who had gastric bypass. Results Overall, 68.2 % (95 % confidence interval [CI], 66 and 70 %) experienced an initial complete diabetes remission within 5 years after surgery. Among these, 35.1 % (95 % CI, 32 and 38 %) redeveloped diabetes within 5 years. The median duration of remission was 8.3 years. Significant predictors of complete remission and relapse were poor preoperative glycemic control, insulin use, and longer diabetes duration. Weight trajectories after surgery were significantly different for never remitters, relapsers, and durable remitters ( p  = 0.03). Conclusions Gastric bypass surgery is associated with durable remission of type 2 diabetes in many but not all severely obese diabetic adults, and about one third experience a relapse within 5 years of initial remission. More research is needed to understand the mechanisms of diabetes relapse, the optimal timing of surgery in effecting a durable remission, and the relationship between remission duration and incident microvascular and macrovascular events.

BackgroundPatient-centered counseling to help women achieve their reproductive goals is an essential yet often absent component of primary care.ObjectiveWe developed and piloted MyPath, a novel web-based decision support tool integrating reproductive goals assessment, information about optimizing health before pregnancy, and contraceptive decision support, for use prior to primary care visits in the Veterans Administration (VA).DesignWe created MyPath using best practices for decision tool development, including a conceptual framework informed by theory and user-centered design with input from patients, providers, and scientific experts. We conducted a non-randomized pilot in two VA Women’s Health primary care clinics. A control group (n = 28) was recruited prior to and intervention group (n = 30) recruited after introduction of MyPath into clinics.ParticipantsWomen Veterans ages 18–44 with an upcoming visit scheduled with one of eight providers.InterventionsAfter recruitment of controls, providers and staff received a brief introduction to MyPath. Patients scheduled to see providers in the intervention phase used MyPath on an iPad in the waiting room prior to their visit.Main MeasuresAcceptability, feasibility, discussions about pregnancy and/or contraceptive needs, and contraceptive decision quality by a survey of participants and providers.Key ResultsNearly all participants who used MyPath reported they learned new information (97%) and would recommend it to other Veterans (93%). No providers reported that MyPath significantly increased workload. A greater proportion of intervention participants reported having discussions about reproductive needs in their visit compared to controls (93% vs 68%; p = 0.02). Intervention participants also experienced greater increases in pre-/post-visit knowledge and communication self-efficacy and a trend towards greater reduction in contraceptive decision conflict compared to controls.ConclusionsMyPath was highly acceptable to women, increased the proportion of primary care visits addressing reproductive needs, and improved decision quality without increasing providers’ perceived workload. A larger randomized evaluation of effectiveness is warranted.

OBJECTIVE:Designing optimal insurance is important to ensure access to care for individuals that are most likely to benefit. We examined the potential impact of lowering patient cost-sharing for bariatric procedures. METHODS:After defining 10 subgroups by body mass index (BMI) and type 2 diabetes mellitus (T2DM), we analyzed the National Health and Nutrition Examination Survey datasets to estimate the prevalence of each subgroup. The MarketScan claims database provided utilization rates and costs of bariatric procedures. Using an existing cost-effectiveness model, we estimated the economic value of bariatric procedures under various cost-sharing levels (0%–25%) with 2 frameworks(1) a traditional cost-effectiveness analysis and (2) a new approach that incorporates utilization effects across subgroups. RESULTS:The utilization rate was higher among individuals with T2DM than those without T2DM (90.4 vs. 59.1 cases per 100,000) for bariatric procedures, which were more cost-effective for those with T2DM and a higher BMI. After accounting for utilization effects, the economic value of bariatric surgery was $177 and $63 per individual from a lifetime and a 5-year time horizon, respectively. Under no patient cost-sharing for individuals with BMI≥40 and T2DM, utilization rates were expected to increase by 21 cases per 100,000, resulting in additional $2 realized value per patient and $7.07 million in returns at the US population level. CONCLUSIONS:Cost-sharing is a barrier to uptake of a clinical and cost-effective treatment for severe obesity. Reducing cost-sharing for patients with severe obesity and T2DM could potentially increase the utilization of bariatric procedures and result in greater economic value to payers.

Lack of body mass index (BMI) measurements limits the utility of claims data for bariatric surgery research, but pre-operative BMI may be imputed due to existence of weight-related diagnosis codes and BMI-related reimbursement requirements. We used a machine learning pipeline to create a claims-based scoring system to predict pre-operative BMI, as documented in the electronic health record (EHR), among patients undergoing a new bariatric surgery. Using the Optum Labs Data Warehouse, containing linked de-identified claims and EHR data for commercial or Medicare Advantage enrollees, we identified adults undergoing a new bariatric surgery between January 2011 and June 2018 with a BMI measurement in linked EHR data ≤30 days before the index surgery (n=3226). We constructed predictors from claims data and applied a machine learning pipeline to create a scoring system for pre-operative BMI, the B3S3. We evaluated the B3S3 and a simple linear regression model (benchmark) in test patients whose index surgery occurred concurrent (2011-2017) or prospective (2018) to the training data. The machine learning pipeline yielded a final scoring system that included weight-related diagnosis codes, age, and number of days hospitalized and distinct drugs dispensed in the past 6 months. In concurrent test data, the B3S3 had excellent performance (R 0.862, 95% confidence interval [CI] 0.815-0.898) and calibration. The benchmark algorithm had good performance (R 0.750, 95% CI 0.686-0.799) and calibration but both aspects were inferior to the B3S3. Findings in prospective test data were similar. The B3S3 is an accessible tool that researchers can use with claims data to obtain granular and accurate predicted values of pre-operative BMI, which may enhance confounding control and investigation of effect modification by baseline obesity levels in bariatric surgery studies utilizing claims data.

Purpose Obesity is a highly prevalent condition with severe clinical burden. Bariatric procedures are an important and expanding treatment option. This study compared short-(30-day composite adverse events) and long-term (intervention/operation, endoscopy, hospitalization, and mortality up to 5 years) safety outcomes associated with three bariatric surgical procedures. Materials and Methods This observational cohort study replicated an electronic health record study comparing short- and long-term problems associated with three bariatric surgical procedures between January 1, 2006, and September 30, 2015, within a Health Plan Research Network. Results Of 95,251 adults, 34,240 (36%) underwent adjustable gastric banding (AGB), 36,206 (38%) Roux-en-Y gastric bypass (RYGB), and 24,805 (26%) sleeve gastrectomy (SG). Median (interquartile range) years of follow-up was 3.3 (1.4–5.0) (AGB), 2.5 (1.0–4.6) (RYGB), and 1.1 (0.5–2.1) (SG). Overall mean (SD) age was 44.2 (11.4) years. The cohort was predominantly female (76%). Thirty-day composite adverse events occurred more frequently following RYGB (3.8%) than AGB (3.1%) and SG (2.8%). Operation/intervention was less likely in SG than in RYGB (adjusted hazard ratio (AHR), 0.87; 95%CI, 0.80–0.96; P =0.003), and more likely in AGB than in RYGB (AHR, 2.10; 95%CI, 2.00–2.21; P <0.001). Hospitalization was less likely after ABG and SG than after RYGB: AGB vs. RYGB, AHR=0.73; 95%CI, 0.71–0.76; P< 0.001; SG vs. RYGB, AHR=0.79; 95%CI, 0.76–0.83; P <0.001. Mortality was most likely for RYGB (SG vs. RYGB: AHR, 0.76; 95%CI, 0.64–0.92; P =0.004; AGB vs. RYGB: AHR, 0.49; 95%CI, 0.43–0.56; P =0.001). Conclusions Interventions, operations, and hospitalizations were more often associated with AGB and RYGB than SG while RYGB had the lowest risk for revision. Graphical abstract

Purpose Bariatric surgery is associated with a greater venous thromboembolism (VTE) risk in the weeks following surgery, but the long-term risk of VTE is incompletely characterized. We evaluated bariatric surgery in relation to long-term VTE risk. Materials and Methods This population-based retrospective matched cohort study within three United States–based integrated health care systems included adults with body mass index (BMI) ≥ 35 kg/m 2 who underwent bariatric surgery between January 2005 and September 2015 ( n  = 30,171), matched to nonsurgical patients on site, age, sex, BMI, diabetes, insulin use, race/ethnicity, comorbidity score, and health care utilization ( n  = 218,961). Follow-up for incident VTE ended September 2015 (median 9.3, max 10.7 years). Results Our population included 30,171 bariatric surgery patients and 218,961 controls; we identified 4068 VTE events. At 30 days post-index date, bariatric surgery was associated with a fivefold greater VTE risk (HR adj  = 5.01; 95% CI = 4.14, 6.05) and a nearly fourfold greater PE risk (HR adj  = 3.93; 95% CI = 2.87, 5.38) than no bariatric surgery. At 1 year post-index date, bariatric surgery was associated with a 48% lower VTE risk and a 70% lower PE risk (HR adj  = 0.52; 95% CI = 0.41, 0.66 and HR adj  = 0.30; 95% CI = 0.21, 0.44, respectively). At 5 years post-index date, lower VTE risks persisted, with bariatric surgery associated with a 41% lower VTE risk and a 55% lower PE risk (HR adj  = 0.59; 95% CI = 0.48, 0.73 and HR adj  = 0.45; 95% CI = 0.32, 0.64, respectively). Conclusion Although in the short-term bariatric surgery is associated with a greater VTE risk, in the long-term, it is associated with a substantially lower risk. Graphical Abstract

BackgroundSleeve gastrectomy is now the most common bariatric operation performed. With lower volumes of Roux-en-Y gastric bypass (RYGB), it is unclear whether decreasing surgeon experience has led to worsening outcomes for this procedure.MethodsWe used State Inpatient Databases from Florida, Iowa, New York, and Washington. Bariatric surgeons were designated as those who performed ten or more bariatric procedures yearly. Patients who had RYGB were included in our analysis. Using multi-level logistic regression, we examined whether surgeon average yearly RYGB volume was associated with RYGB patient 30-day complications, reoperations, and readmissions and 1-year revisions and readmissions.ResultsFrom 2013 to 2017 there were 27,714 patients who underwent laparoscopic RYGB by 311 surgeons. Median surgeon volume was 77 RYGBs per year. The distribution was 10 bypasses yearly at the 5th percentile, 16 bypasses at the 10th percentile, 38 bypasses at the 25th percentile, and 133 bypasses at the 75th percentile.Multi-level regression revealed that patients of surgeons with lower RYGB volumes had small but statistically significant increased risks of 30-day complications and 1-year readmissions. At 30 days, risk for any complication was 6.71%, 6.43%, and 5.55% at 10, 38, and 133 bypasses per year, respectively (p = 0.01). Risk for readmission at 1 year was 13.90%, 13.67%, and 12.90% at 10, 38, and 133 bypasses per year, respectively (p = 0.099). Of note, volume associations with complications and reoperations due to hemorrhage and leak were not statistically significant. There was also no significant association with revisions.ConclusionThis is the first study to examine the association of surgeon RYGB volume with patient outcomes as the national experience with RYGB diminishes. Overall, surgeon RYGB volume does not appear to have a large effect on patient outcomes. Thus, patients can safely pursue RYGB in this early phase of the sleeve gastrectomy era.