Cohort profile: The Bariatric Experience Long Term (BELONG): a long-term prospective study to understand the psychosocial, environmental, health and behavioural predictors of weight loss and regain in patients who have bariatric surgery.

PURPOSE: The Bariatric Experience Long Term (BELONG) prospective study cohort was created to address limitations in the literature regarding the relationship between surgical weight loss and psychosocial, health, behaviour and environmental factors. The BELONG cohort is unique because it contains 70% gastric sleeve and 64% patients with non-white race/ethnicity and was developed with strong stakeholder engagement including patients and providers. PARTICIPANTS: The BELONG cohort study included 1975 patients preparing to have bariatric surgery who completed a baseline survey in a large integrated health system in Southern California. Patients were primarily women (84%), either black or Hispanic (59%), with a body mass index (BMI) of 45.1±7.4 kg/m2, age 43.3±11.5 years old, and 32% had at least one comorbidity. FINDINGS TO DATE: A total of 5552 patients were approached before surgery between February 2016 and May 2017, and 1975 (42%) completed a baseline survey. A total of 1203 (73%) patients completed the year 1 and 1033 (74%) patients completed the year 3 postoperative survey. Of these survey respondents, 1341 at baseline, 999 at year 1, and 951 at year 3 were included in the analyses of all survey and weight outcome data. A total of 803 (60% of eligible patients) had survey data for all time points. Data collected were self-reported constructs to support the proposed theoretical model. Height, weight and BMI were abstracted from the electronic medical record to obtain the main outcomes of the study: weight loss and regain. FUTURE PLANS: We will collect self-reported constructs and obtain height, weight and BMI from the electronic medical record 5 years after bariatric surgery between April 2022 and January 2023. We will also collect patient experiences using focus groups of 8-12 patients each throughout 2022.

Minimum Threshold of Bariatric Surgical Weight Loss for Initial Diabetes Remission.

OBJECTIVE: There are few studies testing the amount of weight loss necessary to achieve initial remission of type 2 diabetes mellitus (T2DM) following bariatric surgery and no published studies with use of weight loss to predict initial T2DM remission in sleeve gastrectomy (SG) patients. RESEARCH DESIGN AND METHODS: With Cox proportional hazards models we examined the relationship between initial T2DM remission and percent total weight loss (%TWL) after bariatric surgery. Categories of %TWL were included in the model as time-varying covariates. RESULTS: Of patients (N = 5,928), 73% were female; mean age was 49.8 ± 10.3 years and BMI 43.8 ± 6.92 kg/m2, and 57% had Roux-en-Y gastric bypass (RYGB). Over an average follow-up of 5.9 years, 71% of patients experienced initial remission of T2DM (mean time to remission 1.0 year). With 0-5% TWL used as the reference group in Cox proportional hazards models, patients were more likely to remit with each 5% increase in TWL until 20% TWL (hazard ratio range 1.97-2.92). When categories >25% TWL were examined, all patients had a likelihood of initial remission similar to that of 20-25% TWL. Patients who achieved >20% TWL were more likely to achieve initial T2DM remission than patients with 0-5% TWL, even if they were using insulin at the time of surgery. CONCLUSIONS: Weight loss after bariatric surgery is strongly associated with initial T2DM remission; however, above a threshold of 20% TWL, rates of initial T2DM remission did not increase substantially. Achieving this threshold is also associated with initial remission even in patients who traditionally experience lower rates of remission, such as patients taking insulin.

Bariatric Surgery and Risk of Death in Persons With Chronic Kidney Disease.

OBJECTIVE: A retrospective cohort study investigated the association between having surgery and risk of mortality for up to 5 years and if this association was modified by incident ESRD during the follow-up period. Summary of Background Data: Mortality risk in individuals with pre-dialysis CKD is high and few effective treatment options are available. Whether bariatric surgery can improve survival in people with CKD is unclear. METHODS: Patients with class II and III obesity and pre-dialysis CKD stages 3-5 who underwent bariatric surgery between January 1, 2006 and September 30, 2015 (n = 802) were matched to patients who did not have surgery (n = 4933). Mortality was obtained from state death records and ESRD was identified through state-based or healthcare system-based registries. Cox regression models were used to investigate the association between bariatric surgery and risk of mortality and if this was moderated by incident ESRD during the follow-up period. RESULTS: Patients were primarily women (79%), non-Hispanic White (72%), under 65 years old (64%), who had a body mass index > 40kg/m 2 (59%), diabetes (67%), and hypertension (89%). After adjusting for incident ESRD, bariatric surgery was associated with a 79% lower 5-year risk of mortality compared to matched controls (hazard ratio = 0.21; 95% confidence interval: 0.14-0.32; P < 0.001). Incident ESRD did not moderate the observed association between surgery and mortality (hazard ratio = 1.59; 95% confidence interval: 0.31-8.23; P =0.58). CONCLUSIONS: Bariatric surgery is associated with a reduction in mortality in pre-dialysis patients regardless of developing ESRD. These findings are significant because patients with CKD are at relatively high risk for death with few efficacious interventions available to improve survival.

Bariatric Surgical Alterations in Tolerability, Enjoyment and Cravings in the Diet (BSATED) instrument: A new scale to measure food preferences following bariatric surgery.

Bariatric surgery is associated with changing food preferences, but it is not known whether these changes differ by type of operation or are associated with weight loss. The current study presents validation results for a new 27-item scale, Bariatric Surgical Alterations in Tolerability, Enjoyment and Cravings in the Diet (BSATED). This scale measured enjoyment, craving, and intolerance changes for nine food and beverage categories common to dietary habits in the Southern California region of the U.S. one year following bariatric surgery in the Bariatric Experience Long Term (BELONG) study. Validation of BSATED was done using exploratory factor analyses, construct validity with other conceptually related survey instruments, and criterion validity using hypothesized differences for operation type and percent total weight loss (%TWL) at 12-18 months after surgery. Participants (n = 999) were 86% female, 41% non-Hispanic White, with a mean age of 43.1 ± 11.3 years and a body mass index (BMI) of 43.4 ± 6.8 kg/m2 at the time of surgery. Participants reported less enjoyment and craving for high-fat meats (62%), grains (54%), candy and other desserts (e.g. candy bars, chocolate, ice cream) (52%), and sweet baked goods (48%) 12 months after surgery. These changes were more common among participants undergoing Roux-en-Y gastric bypass (RYGB) compared to those receiving sleeve gastrectomy (SG). Participants who reported decreased enjoyment and craving for foods and beverages that post-bariatric patients are counseled to reduce or avoid had greater %TWL at 12-18 months following surgery (p < .001 and p = .003 respectively). The foods and beverages in BSATED that post-bariatric patients are counseled to reduce or avoid could be used to understand how changes in enjoyment, craving and tolerability of these foods/beverages contribute to weight loss following surgery.

Five-year Longitudinal Cohort Study of Reinterventions After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass.

OBJECTIVE: To compare the long-term risks of reintervention following sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) in a large surgical cohort. BACKGROUND: The use of SG has increased dramatically relative to RYGB for the treatment of obesity. However, long-term risks following SG compared with RYGB have not been adequately defined in a large population-based study. METHODS: A retrospective longitudinal cohort study of all adult health-plan members undergoing SG or RYGB for obesity in a multistate integrated health care system from January 2005 through September 2015. The risks of nutritional, endoscopic, radiologic, and surgical reintervention as well as the overall risk of any reinterventions at 1, 3, and 5 years were identified using diagnosis and procedure codes from comprehensive electronic medical records. RESULTS: The study included 15,319 patients who underwent SG and 19,954 patients who underwent RYGB with a follow-up of 79.2%. The overall risk of any reintervention at 5 years was 21.3% for SG and 28.3% for RYGB (P < 0.0001). After adjustment, SG was associated with fewer reinterventions through 5 years than RYGB (hazard ratio, 0.78; 95% confidence interval, 0.74-0.84). When comparing subcategories, SG also had a lower risk of nutritional, endoscopic, radiologic, and surgical reinterventions when examined versus RYGB. The findings for risks of reinterventions were consistent across clinical subgroups. CONCLUSION: SG has significantly lower risk of reintervention in all categories studied when compared with RYGB at 5-year follow-up. The long-term safety profile of LSG compared with RYGB should be an essential part of the discussion in patient-centered decision making when choosing between bariatric procedure options.

The Bariatric Experience Long Term (BELONG): Factors Related to Having Bariatric Surgery in a Large Integrated Healthcare System.

PURPOSE: Bariatric surgery is the most effective treatment for severe obesity, but currently, only 1-2% of all eligible patients undergo surgery each year. This study examined which factors were associated with a patient receiving bariatric surgery after referral in a real-world healthcare setting. MATERIALS AND METHODS: The current study used the baseline survey and electronic medical record (EMR) data from the Bariatric Experience Long Term (BELONG) study (n = 1975). Predictors of who did (n = 1680) and who did not (n = 295) have surgery were analyzed using multivariate logistic regression. RESULTS: Participants (n = 1975; 42.4% response rate) were primarily women (84%) and either non-Hispanic Black or Hispanic (60%). In the fully adjusted multivariate model, the strongest predictors of having surgery were being a woman (OR = 3.17; 95% CI = 2.15, 4.68; p < .001) and losing at least 5% of their body weight in the year before surgery (OR = 3.16; 95% CI = 2.28, 4.38; p < .001). The strongest predictors of not having surgery were a ≥ BMI 50 kg/m2 (OR = .39; 95% CI = .27, .56; p < .001) and having a higher physical comorbidity burden (OR = .84; 95% CI = .75, .94; p = .004). CONCLUSIONS: Practices such as 5-10% total weight loss before surgery and selection of patients with safer operative risk profiles (younger with lower comorbidity burden) may inadvertently contribute to under-utilization of bariatric surgery among some demographic subpopulations who could most benefit from this intervention.

Effectiveness of Gastric Bypass Versus Gastric Sleeve for Cardiovascular Disease: Protocol and Baseline Results for a Comparative Effectiveness Study.

BACKGROUND: When compared with conventional weight loss strategies, bariatric surgery results in substantially greater durable weight loss and rates of disease remission. OBJECTIVE: The ENGAGE CVD (Effectiveness of Gastric Bypass versus Gastric Sleeve for Cardiovascular Disease) cohort study aimed to provide population-based, comprehensive, rigorous evidence for clinical and policy decision making regarding the choice between gastric bypass and gastric sleeve for overall cardiovascular disease (CVD) risk reduction, risk factor remission, and safety. METHODS: The cohort had 22,095 weight loss surgery patients from a large integrated health care system in Southern California assembled from 2009 to 2016 who were followed up through 2018. Bariatric surgery patients were followed up for the length of their membership in the health care system. Of the patients who had at least five years of follow-up (surgery between 2009 and 2013), 85.86% (13,774/16,043) could contribute to the outcome analyses for the ENGAGE CVD cohort. RESULTS: Patients in the ENGAGE CVD cohort were 44.6 (SD 11.4) years old, mostly women (17,718/22,095; 80.19%), with 18.94% (4185/22,095) non-Hispanic black and 41.80% (9235/22,095) Hispanic, and had an average BMI of 44.3 (SD 6.9) kg/m2 at the time of surgery. When compared with patients who did not contribute data to the 5-year outcome analysis for the ENGAGE CVD cohort (2269/16,043; 14.14%), patients who contributed data (13,774/16,043; 85.86%) were older (P=.002), more likely to be women (P=.02), more likely to be non-Hispanic white (P<.001), more likely to have had an emergency department visit in the year before surgery (P=.006), less likely to have a mental illness before surgery (P<.001), and more likely to have had a CVD event at any time before surgery (P<.001). CONCLUSIONS: This study had one of the largest populations of gastric sleeve patients (n=13,459). The 5-year follow-up for those patients who had surgery between 2009 and 2013 was excellent for a retrospective cohort study at 85.86% (13,774/16,043). Unlike almost any study in the literature, the majority of the ENGAGE CVD cohort was racial and ethnic minority, providing a rare opportunity to study the effects of bariatric surgery for different racial and ethnic groups, some of whom have the highest rates of severe obesity in the United States. Finally, it also used state-of-the-art statistical and econometric comparative effectiveness methods to mimic the effect of random assignment and control for sources of confounding inherent in large observational studies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/14936.

Impact of ICD-10-CM Transition on Mental Health Diagnoses Recording.

OBJECTIVE: This study examines the impact of the transition from ICD-9-CM to ICD-10-CM diagnosis coding on the recording of mental health disorders in electronic health records (EHRs) and claims data in ten large health systems. We present rates of these diagnoses across two years spanning the October 2015 transition. METHODS: Mental health diagnoses were identified from claims and EHR data at ten health care systems in the Mental Health Research Network (MHRN). Corresponding ICD-9-CM and ICD-10-CM codes were compiled and monthly rates of people receiving these diagnoses were calculated for one year before and after the coding transition. RESULTS: For seven of eight diagnostic categories, monthly rates were comparable during the year before and the year after the ICD-10-CM transition. In the remaining category, psychosis excluding schizophrenia spectrum disorders, aggregate monthly rates of decreased markedly with the ICD-10-CM transition, from 48 to 33 per 100,000. We propose that the change is due to features of General Equivalence Mappings (GEMS) embedded in the EHR. CONCLUSIONS: For most mental health conditions, the transition to ICD-10-CM appears to have had minimal impact. The decrease seen for psychosis diagnoses in these health systems is likely due to changes associated with EHR implementation of ICD-10-CM coding rather than an actual change in disease prevalence. It is important to consider the impact of the ICD-10-CM transition for all diagnostic criteria used in research studies, quality measurement, and financial analysis during this interval.

Strategies in the transfer of varying grades of vitrified-warmed blastocysts in women aged over 35 years: A propensity-matched analysis.

AIM: For in vitro fertilization, the optimal number of blastocysts to transfer according to blastocyst grade has not been well established, especially with respect to vitrified-warmed blastocyst transfer (VBT) in women aged over 35 years. This study aimed to compare the pregnancy and neonatal outcomes for three different VBT methods with variable numbers and qualities of blastocysts in women aged over 35 years. METHODS: All VBT cycles were categorized into three groups according to blastocyst grade: GG (two good-quality blastocysts transferred), GP (one good-quality blastocyst transferred with one of poor quality) and GS (one good-quality blastocyst transferred). Blastocysts graded greater than or equal to 3BB were considered good quality. We conducted three 1:1 propensity score-matched analyses (GG vs GS, GP vs GS and GG vs GP) to compare the clinical pregnancy rate (CPR), live birth rate (LBR), multiple pregnancy rate (MPR), preterm birth rate and low birthweight rate. RESULTS: Compared to GS, GG had higher CPR and LBR; however, MPR was also higher with GG. There were no significant differences, except implantation rate and MPR between GP and GS. Although implantation rate and CPR with GG were higher than those with GP, there were no significant differences in LBR and MPR. CONCLUSION: To reduce high MPR after double blastocyst transfer methods, single good-quality blastocyst transfers are recommended in the VBT of women aged over 35 years. Transferring a good blastocyst with a poor one should be avoided because it confers no advantage.

The impact of race and ethnicity on rates of return to psychotherapy for depression.

BACKGROUND: There are many limitations with the evidence base for the role of race and ethnicity in continuation of psychotherapy for depression. METHODS: The study sample consisted of 242,765 patients ≥ 18 years old from six healthcare systems in the Mental Health Research Network (MHRN) who had a new episode of psychotherapy treatment for depression between 1/1/2010 and 12/31/2013. Data were from electronic medical records and organized in a Virtual Data Warehouse (VDW). The odds of racial and ethnic minority patients returning for a second psychotherapy visit within 45 days of the initial session were examined using multilevel regression. RESULTS: The sample was primarily middle aged (68%, 30-64 years old), female (68.5%), and non-Hispanic white (50.7%), had commercial insurance (81.4%), and a low comorbidity burden (68.8% had no major comorbidities). Return rates within 45 days of the first psychotherapy visit were 47.6%. Compared to their non-Hispanic white counterparts, racial and ethnic minority patients were somewhat less likely to return to psychotherapy for a second visit (adjusted odds ratios [aORs] ranged from 0.80 to 0.90). Healthcare system was a much stronger predictor of return rates (aORs ranged from 0.89 to 5.53), while providers accounted for 21.1% of the variance in return rates. CONCLUSIONS: Provider and healthcare system variation were stronger predictors of patient return to psychotherapy than race and ethnicity. More research is needed to understand why providers and healthcare systems determine psychotherapy return rates for patients of all racial and ethnic groups.

Insulin resistance does not affect early embryo development but lowers implantation rate in in vitro maturation-in vitro fertilization-embryo transfer cycle.

OBJECTIVE: Although extensive evidence indicates the hyperinsulinemia directly contributes to reproductive dysfunction in polycystic ovarian syndrome (PCOS), influence of insulin resistance (IR) on assisted reproductive technology outcomes is poorly understood. In this study we aimed to evaluate the effects of IR on in vitro maturation-in vitro fertilization-embryo transfer (IVM-IVF-ET) in patients with PCOS. DESIGN: Prospective observational study. PATIENTS: Women with PCOS (n = 115) commencing IVM. MEASURMENTS: IR (n = 51) and non-IR (n = 64) women with PCOS ready to commence an IVM cycle were recruited. IR was diagnosed using the glucose tolerance test (GTT) and homeostasis model assessment (HOMA) index. Patients with an abnormal GTT and/or HOMA index >2·4 were considered IR. Patients underwent 115 cycles of unstimulated hCG-primed IVM. RESULTS: Maturation, fertilization, cleavage rates, the number of good-quality embryo, and blastocyst formation rates were not significantly different between groups. However, implantation (11·6% vs 28·7%, P = 0·001, respectively), clinical pregnancy (23·5% vs 53·1%, P = 0·002, respectively), and ongoing pregnancy rates (21·6% vs 46·9%. P = 0·006, respectively) were significantly decreased in the IR group. The negative effect of IR on pregnancy outcomes remained after controlling for age, body mass index (BMI) and lipid profiles (OR 4·928, 95% CI 1·735-13·991, P = 0·003). CONCLUSIONS: Pregnancy rate after IVM is impaired in IR patients with PCOS. Oocyte development and embryo quality are not affected, suggesting that the effects of hyperinsulinemia on endometrial function and implantation process underlie the decreased pregnancy rate.