Dataset Information

Interventions and Operations after Bariatric Surgery in a Health Plan Research Network Cohort from the PCORnet, the National Patient-Centered Clinical Research Network.

ABSTRACT:

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.

SUBMITTER: Ma Q

PROVIDER: S-EPMC8270856 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceAdditional data comparing longer-term problems associated with various bariatric surgical procedures are needed for shared decision-making.ObjectiveTo compare the risks of intervention, operation, endoscopy, hospitalization, and mortality up to 5 years after 2 bariatric surgical procedures.Design, setting, and participantsAdults who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) between January 1, 2005, and September 30, 2015, within the National Patient-Centered Clinical Research Network. Data from 33 560 adults at 10 centers within 4 clinical data research networks were included in this cohort study. Information was extracted from electronic health records using a common data model and linked to insurance claims and mortality indices. Analyses were conducted from January 2018 through October 2019.ExposuresBariatric surgical procedures.Main outcomes and measuresThe primary outcome was time until operation or intervention. Secondary outcomes included endoscopy, hospitalization, and mortality rates.ResultsOf 33 560 adults, 18 056 (54%) underwent RYGB, and 15 504 (46%) underwent SG. The median (interquartile range) follow-up for operation or intervention was 3.4 (1.6-5.0) years for RYGB and 2.2 (0.9-3.6) years for SG. The overall mean (SD) patient age was 45.0 (11.5) years, and the overall mean (SD) patient body mass index was 49.1 (7.9). The cohort was composed predominantly of women (80%) and white individuals (66%), with 26% of Hispanic ethnicity. Operation or intervention was less likely for SG than for RYGB (hazard ratio, 0.72; 95% CI, 0.65-0.79; P < .001). The estimated, adjusted cumulative incidence rates of operation or intervention at 5 years were 8.94% (95% CI, 8.23%-9.65%) for SG and 12.27% (95% CI, 11.49%-13.05%) for RYGB. Hospitalization was less likely for SG than for RYGB (hazard ratio, 0.82; 95% CI, 0.78-0.87; P < .001), and the 5-year adjusted cumulative incidence rates were 32.79% (95% CI, 31.62%-33.94%) for SG and 38.33% (95% CI, 37.17%-39.46%) for RYGB. Endoscopy was less likely for SG than for RYGB (hazard ratio, 0.47; 95% CI, 0.43-0.52; P < .001), and the adjusted cumulative incidence rates at 5 years were 7.80% (95% CI, 7.15%-8.43%) for SG and 15.83% (95% CI, 14.94%-16.71%) for RYGB. There were no differences in all-cause mortality between SG and RYGB.Conclusions and relevanceInterventions, operations, and hospitalizations were relatively common after bariatric surgical procedures and were more often associated with RYGB than SG.Trial registrationClinicalTrials.gov identifier: NCT02741674.

Project description:ImportanceBariatric surgery can lead to substantial improvements in type 2 diabetes (T2DM), but outcomes vary across procedures and populations. It is unclear which bariatric procedure has the most benefits for patients with T2DM.ObjectiveTo evaluate associations of bariatric surgery with T2DM outcomes.Design, setting, and participantsThis cohort study was conducted in 34 US health system sites in the National Patient-Centered Clinical Research Network Bariatric Study. Adult patients with T2DM who had bariatric surgery between January 1, 2005, and September 30, 2015, were included. Data analysis was conducted from April 2017 to August 2019.InterventionsRoux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).Main outcome and measuresType 2 diabetes remission, T2DM relapse, percentage of total weight lost, and change in glycosylated hemoglobin (hemoglobin A1c).ResultsA total of 9710 patients were included (median [interquartile range] follow-up time, 2.7 [2.9] years; 7051 female patients [72.6%]; mean [SD] age, 49.8 [10.5] years; mean [SD] BMI, 49.0 [8.4]; 6040 white patients [72.2%]). Weight loss was significantly greater with RYGB than SG at 1 year (mean difference, 6.3 [95% CI, 5.8-6.7] percentage points) and 5 years (mean difference, 8.1 [95% CI, 6.6-9.6] percentage points). The T2DM remission rate was approximately 10% higher in patients who had RYGB (hazard ratio, 1.10 [95% CI, 1.04-1.16]) than those who had SG. Estimated adjusted cumulative T2DM remission rates for patients who had RYGB and SG were 59.2% (95% CI, 57.7%-60.7%) and 55.9% (95% CI, 53.9%-57.9%), respectively, at 1 year and 86.1% (95% CI, 84.7%-87.3%) and 83.5% (95% CI, 81.6%-85.1%) at 5 years postsurgery. Among 6141 patients who experienced T2DM remission, the subsequent T2DM relapse rate was lower for those who had RYGB than those who had SG (hazard ratio, 0.75 [95% CI, 0.67-0.84]). Estimated relapse rates for those who had RYGB and SG were 8.4% (95% CI, 7.4%-9.3%) and 11.0% (95% CI, 9.6%-12.4%) at 1 year and 33.1% (95% CI, 29.6%-36.5%) and 41.6% (95% CI, 36.8%-46.1%) at 5 years after surgery. At 5 years, compared with baseline, hemoglobin A1c was reduced 0.45 (95% CI, 0.27-0.63) percentage points more for patients who had RYGB vs patients who had SG.Conclusions and relevanceIn this large multicenter study, patients who had RYGB had greater weight loss, a slightly higher T2DM remission rate, less T2DM relapse, and better long-term glycemic control compared with those who had SG. These findings can help inform patient-centered surgical decision-making.

Project description:BackgroundThe supplementation of electronic health records data with administrative claims data may be used to capture outcome events more comprehensively in longitudinal observational studies. This study investigated the utility of administrative claims data to identify outcomes across health systems using a comparative effectiveness study of different types of bariatric surgery as a model.MethodsThis observational cohort study identified patients who had bariatric surgery between 2007 and 2015 within the HealthCore Anthem Research Network (HCARN) database in the National Patient-Centered Clinical Research Network (PCORnet) common data model. Patients whose procedures were performed in a member facility affiliated with PCORnet Clinical Research Networks (CRNs) were selected. The outcomes included a 30-day composite adverse event (including venous thromboembolism, percutaneous/operative intervention, failure to discharge and death), and all-cause hospitalization, abdominal operation or intervention, and in-hospital death up to 5 years after the procedure. Outcomes were classified as occurring within or outside PCORnet CRN health systems using facility identifiers.ResultsWe identified 4899 patients who had bariatric surgery in one of the PCORnet CRN health systems. For 30-day composite adverse event, the inclusion of HCARN multi-site claims data marginally increased the incidence rate based only on HCARN single-site claims data for PCORnet CRNs from 3.9 to 4.2%. During the 5-year follow-up period, 56.8% of all-cause hospitalizations, 31.2% abdominal operations or interventions, and 32.3% of in-hospital deaths occurred outside PCORnet CRNs. Incidence rates (events per 100 patient-years) were significantly lower when based on claims from a single PCORnet CRN only compared to using claims from all health systems in the HCARN: all-cause hospitalization, 11.0 (95% Confidence Internal [CI]: 10.4, 11.6) to 25.3 (95% CI: 24.4, 26.3); abdominal operations or interventions, 4.2 (95% CI: 3.9, 4.6) to 6.1 (95% CI: 5.7, 6.6); in-hospital death, 0.2 (95% CI: 0.11, 0.27) to 0.3 (95% CI: 0.19, 0.38).ConclusionsShort-term inclusion of multi-site claims data only marginally increased the incidence rate computed from single-site claims data alone. Longer-term follow up captured a notable number of events outside of PCORnet CRNs. The findings suggest that supplementing claims data improves the outcome ascertainment in longitudinal observational comparative effectiveness studies.