Dataset Information

Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study.

ABSTRACT: BACKGROUND:Bariatric surgery has been used for treatment of severe obesity in adolescents but most studies have been small and limited in follow-up. OBJECTIVES:We hypothesized that electronic health record data could be used to compare effectiveness of bariatric procedures in adolescents. SETTING:Data were obtained from clinical research networks using a common data model to extract data from each site. METHODS:Adolescents who underwent a primary bariatric procedure from 2005 through 2015 were identified. The percent change in body mass index (BMI) at 1, 3, and 5 years was estimated using random effects linear regression for patients undergoing all operations. Propensity score adjusted estimates and 95% confidence intervals were estimated for procedures with >25 patients at each time period. RESULTS:This cohort of 544 adolescents was predominantly female (79%) and White (66%), with mean (±standard deviation) age of 17.3 (±1.6) years and mean BMI of 49.8 (± 7.8) kg/m2. Procedures included Roux-en-Y gastric bypass (RYGB; n?=?177), sleeve gastrectomy (SG; n?=?306), and laparoscopic adjustable gastric banding (n?=?61). For those undergoing RYGB, SG, and laparoscopic adjustable gastric banding, mean (95% confidence interval) BMI changes of -31% (-30% to -33%), -28% (-27% to -29%), and -10% (-8% to -12%), were estimated at 1 year. For RYGB and SG, BMI changes of -29% (-26% to -33%) and -25% (-22% to -28%) were estimated at 3 years. CONCLUSIONS:Adolescents undergoing SG and RYGB experienced greater declines in BMI at 1- and 3-year follow-up time points, while laparoscopic adjustable gastric banding was significantly less effective for BMI reduction.

SUBMITTER: Inge TH

PROVIDER: S-EPMC6165694 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study.

Inge Thomas H TH Coley R Yates RY Bazzano Lydia A LA Xanthakos Stavra A SA McTigue Kathleen K Arterburn David D Williams Neely N Wellman Rob R Coleman Karen J KJ Courcoulas Anita A Desai Nirav K NK Anau Jane J Pardee Roy R Toh Sengwee S Janning Cheri C Cook Andrea A Sturtevant Jessica J Horgan Casie C Zebrick Ava J AJ Michalsky Marc M

Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery 20180417 9

<h4>Background</h4>Bariatric surgery has been used for treatment of severe obesity in adolescents but most studies have been small and limited in follow-up.<h4>Objectives</h4>We hypothesized that electronic health record data could be used to compare effectiveness of bariatric procedures in adolescents.<h4>Setting</h4>Data were obtained from clinical research networks using a common data model to extract data from each site.<h4>Methods</h4>Adolescents who underwent a primary bariatric procedure ...[more]

PMID: 29793877

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Project description:BackgroundThere has been a dramatic shift in use of bariatric procedures, but little is known about their long-term comparative effectiveness.ObjectiveTo compare weight loss and safety among bariatric procedures.DesignRetrospective observational cohort study, January 2005 to September 2015. (ClinicalTrials.gov: NCT02741674).Setting41 health systems in the National Patient-Centered Clinical Research Network.Participants65 093 patients aged 20 to 79 years with body mass index (BMI) of 35 kg/m2 or greater who had bariatric procedures.Intervention32 208 Roux-en-Y gastric bypass (RYGB), 29 693 sleeve gastrectomy (SG), and 3192 adjustable gastric banding (AGB) procedures.MeasurementsEstimated percent total weight loss (TWL) at 1, 3, and 5 years; 30-day rates of major adverse events.ResultsTotal numbers of eligible patients with weight measures at 1, 3, and 5 years were 44 978 (84%), 20 783 (68%), and 7159 (69%), respectively. Thirty-day rates of major adverse events were 5.0% for RYGB, 2.6% for SG, and 2.9% for AGB. One-year mean TWLs were 31.2% (95% CI, 31.1% to 31.3%) for RYGB, 25.2% (CI, 25.1% to 25.4%) for SG, and 13.7% (CI, 13.3% to 14.0%) for AGB. At 1 year, RYGB patients lost 5.9 (CI, 5.8 to 6.1) percentage points more weight than SG patients and 17.7 (CI, 17.3 to 18.1) percentage points more than AGB patients, and SG patients lost 12.0 (CI, 11.6 to 12.5) percentage points more than AGB patients. Five-year mean TWLs were 25.5% (CI, 25.1% to 25.9%) for RYGB, 18.8% (CI, 18.0% to 19.6%) for SG, and 11.7% (CI, 10.2% to 13.1%) for AGB. Patients with diabetes, those with BMI less than 50 kg/m2, those aged 65 years or older, African American patients, and Hispanic patients lost less weight than patients without those characteristics.LimitationPotential unobserved confounding due to nonrandomized design; electronic health record databases had missing outcome data.ConclusionAdults lost more weight with RYGB than with SG or AGB at 1, 3, and 5 years; however, RYGB had the highest 30-day rate of major adverse events. Small subgroup differences in weight loss outcomes were observed.Primary funding sourcePatient-Centered Outcomes Research Institute.

Project description:ImportanceBariatric surgery is the most effective treatment for severe obesity; yet it is unclear whether the long-term safety and comparative effectiveness of these operations differ across racial and ethnic groups.ObjectiveTo compare outcomes of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) across racial and ethnic groups in the National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study.Design, setting, and participantsThis was a retrospective, observational, comparative effectiveness cohort study that comprised 25 health care systems in the PCORnet Bariatric Study. Patients were adults and adolescents aged 12 to 79 years who underwent a primary (first nonrevisional) RYGB or SG operation between January 1, 2005, and September 30, 2015, at participating health systems. Patient race and ethnicity included Black, Hispanic, White, other, and unrecorded. Data were analyzed from July 1, 2021, to January 17, 2022.ExposureRYGB or SG.OutcomesPercentage total weight loss (%TWL); type 2 diabetes remission, relapse, and change in hemoglobin A1c (HbA1c) level; and postsurgical safety and utilization outcomes (operations, interventions, revisions/conversions, endoscopy, hospitalizations, mortality, 30-day major adverse events) at 1, 3, and 5 years after surgery.ResultsA total of 36 871 patients (mean [SE] age, 45.0 [11.7] years; 29 746 female patients [81%]) were included in the weight analysis. Patients identified with the following race and ethnic categories: 6891 Black (19%), 8756 Hispanic (24%), 19 645 White (53%), 826 other (2%), and 783 unrecorded (2%). Weight loss and mean reductions in HbA1c level were larger for RYGB than SG in all years for Black, Hispanic, and White patients (difference in 5-year weight loss: Black, -7.6%; 95% CI, -8.0 to -7.1; P < .001; Hispanic, -6.2%; 95% CI, -6.6 to -5.9; P < .001; White, -5.9%; 95% CI, -6.3 to -5.7; P < .001; difference in change in year 5 HbA1c level: Black, -0.29; 95% CI, -0.51 to -0.08; P = .009; Hispanic, -0.45; 95% CI, -0.61 to -0.29; P < .001; and White, -0.25; 95% CI, -0.40 to -0.11; P = .001.) The magnitude of these differences was small among racial and ethnic groups (1%-3% of %TWL). Black and Hispanic patients had higher risk of hospitalization when they had RYGB compared with SG (hazard ratio [HR], 1.45; 95% CI, 1.17-1.79; P = .001 and 1.48; 95% CI, 1.22-1.79; P < .001, respectively). Hispanic patients had greater risk of all-cause mortality (HR, 2.41; 95% CI, 1.24-4.70; P = .01) and higher odds of a 30-day major adverse event (odds ratio, 1.92; 95% CI, 1.38-2.68; P < .001) for RYGB compared with SG. There was no interaction between race and ethnicity and operation type for diabetes remission and relapse.Conclusions and relevanceVariability of the comparative effectiveness of operations for %TWL and HbA1c level across race and ethnicity was clinically small; however, differences in safety and utilization outcomes were clinically and statistically significant for Black and Hispanic patients who had RYGB compared with SG. These findings can inform shared decision-making regarding bariatric operation choice for different racial and ethnic groups of patients.

Project description:AimTo compare the frequencies of neurosurgical procedures to treat comorbid conditions of myelomeningocele in patients who underwent fetal surgery versus postnatal surgery for closure of the placode.MethodBy utilizing the National Spina Bifida Patient Registry in a comparative effectiveness study, 298 fetal surgery patients were matched by birthdate (±3mo) and spina bifida clinic site with one to three postnatal surgery patients (n=648). Histories were obtained by record review on enrollment and yearly subsequently. Multivariable Poisson regression was used to compare frequencies of procedures between cohorts, with adjustments for sex, ethnicity, insurance status, spinal segmental level of motor function, age at last visit recorded in the Registry, and, for shunt revision in shunted patients, age at cerebrospinal fluid (CSF) diversion.ResultsThe median age at last visit was 4 years. In fully adjusted analyses in patients aged at least 12 months old, fetal surgery was associated with decreased frequency of CSF diversion for hydrocephalus by ventriculoperitoneal shunt insertion or endoscopic third ventriculostomy compared with postnatal surgery (46% vs 79%; incidence rate ratio=0.61; 95% confidence interval [CI] 0.53-0.71; p<0.01). Over all ages, fetal surgery was associated with decreased frequency of Chiari decompression for brainstem dysfunction (3% vs 7%; incidence rate ratio=0.41; 95% CI 0.19-0.88; p=0.02). Also over all ages, differences were not significant in frequencies of shunt revision in shunted patients (53% vs 55%; incidence rate ratio=0.87; 95% CI 0.69-1.11; p=0.27), nor tethered cord release for acquired spinal cord dysfunction (18% vs 16%; incidence rate ratio=1.11; 95% CI 0.84-1.47; p=0.46).InterpretationEven with the variations inherent in clinical practice, fetal surgery was associated with lower frequencies of CSF diversion and of Chiari decompression, independent of covariates. What this paper adds Fetal surgery was associated with lower frequencies of cerebrospinal fluid diversion and decompression of Chiari II malformation than postnatal surgery. Frequencies of ventriculoperitoneal shunt revision and tethered cord release were not significantly different between cohorts.

Project description:OBJECTIVE:To compare risk of reintervention, long-term clinical outcomes, and health care utilization among women who have bulk symptoms from leiomyoma and who underwent the following procedures: hysterectomy, myomectomy, uterine artery embolization, and magnetic resonance-guided, focused ultrasound surgery. METHODS:This was a retrospective analysis of administrative claims from a large U.S. commercial insurance database. Women aged 18-54 years undergoing any of the previously mentioned leiomyoma procedures between 2000 and 2013 were included. We assessed the following outcome measures: risk of reintervention between uterine-sparing procedures, risk of other surgical procedures or complications of the index procedure, 5-year health care utilization, pregnancy rates, and reproductive outcomes. Propensity score matching along with Cox proportional hazard models were used to adjust for differences in baseline characteristics between study cohorts. RESULTS:Among the 135,522 study-eligible women with mean follow-up of 3.4 years, hysterectomy was the most common first-line procedural therapy (111,324 [82.2%]) followed by myomectomy (19,965 [14.7%]), uterine artery embolization (4,186 [3.1%]) and magnetic resonance-guided focused ultrasound surgery (47 [0.0003%]). Small but statistically significant differences were noted for uterine artery embolization and myomectomy in reintervention rate (17.1% compared with 15.0%, P=.02), subsequent hysterectomy rates (13.2% compared with 11.1%, P<.01) and subsequent complications from index procedures (18.1% compared with 24.6%, P<.001). During follow-up, women undergoing myomectomy had lower leiomyoma-related health care utilization, but had higher all-cause outpatient services. Pregnancy rates were 7.5% and 2.2% among myomectomy and uterine artery embolization cohorts, respectively (P<.001) with both cohorts having similar rates of adverse reproductive outcome (69.4%). CONCLUSIONS:Although the overwhelming majority of women having leiomyoma with bulk symptoms underwent hysterectomy as their first treatment procedure, among those undergoing uterine-sparing index procedures, approximately one seventh had a reintervention, and one tenth ended up undergoing hysterectomy during follow-up. Compared with women undergoing myomectomy, women undergoing uterine artery embolization had a higher risk of reintervention, lower risk of subsequent complications, but similar rate of adverse reproductive outcomes.

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.

Dataset Information

Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study.

Publications

Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study.

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