Thyroid Hormones and Diabetes in Euthyroid Hispanic/Latino Adults of Diverse Backgrounds: HCHS/SOL.

Context: Previous studies have demonstrated associations of endogenous thyroid hormones with diabetes; less is known about stages of diabetes development at which they are operative, mechanisms of associations, and the role of the hypothalamic-pituitary-thyroid axis. Objective: This study examined associations of thyroid hormones with incident prediabetes and diabetes and with changes in glycemic traits in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL), the largest cohort of Hispanic/Latino adults with diverse backgrounds in the United States. Methods: The study includes 592 postmenopausal euthyroid women and 868 euthyroid men aged 45 to 74 years without diabetes at baseline participating in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). Baseline hormones included thyrotropin (TSH), free thyroxine (FT4), total triiodothyronine (T3), and indices calculated from thyroid hormones evaluating pituitary sensitivity to thyroid hormone. Transitions to diabetes and prediabetes, and changes in glycemic traits determined at the 6-year follow-up visit, were examined using multivariable Poisson and linear regressions. Results: Among women, T3 (incident rate ratio [IRR] = 1.65; 95% CI, 1.22-2.24; P = .001) and TSH (IRR = 2.09; 95% CI, 1.01-4.33; P = .047) were positively, while FT4 (IRR = 0.59; 95% CI, 0.39-0.88; P = .011) was inversely, associated with transition from prediabetes to diabetes. Among men, the T3/FT4 ratio was positively associated with transition from normoglycemia to prediabetes but not from prediabetes to diabetes. Indices measuring sensitivity of the pituitary to thyroid hormone suggested increased sensitivity in men who transitioned from prediabetes to diabetes. Conclusion: Positive associations in women of T3 and TSH and inverse associations of FT4, as well as inverse associations of thyroid indices in men with transition from prediabetes to diabetes, but not from normoglycemia to diabetes, suggest decreased pituitary sensitivity to thyroid hormones in women and increased sensitivity in men later in the development of diabetes.

Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program: Bariatric Surgical Risk/Benefit Calculator: 1-year comorbidity remission.

BACKGROUND: Clinical calculators can provide patient-personalized estimates of treatment risks and health outcomes. The American College of Surgeons Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) set out to create a publicly available tool to assess both short-term postoperative risk and long-term benefits for prospective adult patients eligible for 1 of 4 primary bariatric procedures. The calculator is comprised of multiple prediction elements: (1) 30-day postoperative risk, (2) 1-year body mass index projections, and (3) 1-year comorbidity remission. OBJECTIVES: To assess the performance of the 1-year comorbidity remission prediction feature of the calculator. SETTING: Not-for-profit organization clinical data registry. METHODS: MBSAQIP data across 4.5 years from 240,227 total patients indicating at least 1 comorbidity of interest present preoperatively and who had a 1-year follow-up record documenting their comorbidity status were included. Six models were constructed, stratified by the presence of the respective preoperative comorbidity: hypertension, hyperlipidemia, gastroesophageal reflux disease, sleep apnea, non-insulin-dependent diabetes, and insulin-dependent diabetes. A multinomial logistic regression model was used to predict 1-year remission (total, partial, or no remission) of insulin-dependent diabetes. All other outcomes were binary (yes or no at 1 yr), and ordinary logistic regression models were used. RESULTS: All models showed adequate discrimination (C statistics ranging from .58 to .68). Plots of observed versus predicted remission (%) showed excellent calibration across all models. CONCLUSION: All remission models were well calibrated with sufficient discrimination. The MBSAQIP Bariatric Surgical Risk/Benefit Calculator is a publicly available tool intended for integration into clinical practice to enhance patient-clinician discussions and informed consent.

First report of outcomes from the patient-reported outcome measures program in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program.

BACKGROUND: Health-related quality-of-life (HRQoL) is one of the most important outcomes to metabolic and bariatric surgery (MBS) patients but was not measured by the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP). A patient-reported outcome measures (PROMs) program pilot started in 2016 with MBSAQIP implementation in 2019. OBJECTIVES: To measure how MBS impacts patient HRQoL 1 and 2 years after primary laparoscopic Roux-en-Y gastric bypass (bypass) or laparoscopic sleeve gastrectomy (sleeve). SETTING: The 82 centers in the United States participating in the MBSAQIP PROMs program. METHODS: Preoperative HRQoL scores and satisfaction were compared with postoperative scores 1 and 2 years after surgery with univariate comparisons and adjusted regression models. RESULTS: There were 13,901 PROMs responses from 11,146 patients. Patient satisfaction with their MBS decision was 97%. On average, patients had significant improvement in Obesity-related Problem (OP) scores (65.8 preoperatively, 23.0 at 1 yr, and 26.3 at 2 yr; P <.05), Obesity and Weight-Loss Quality-of-Life (OWLQOL) scores (36.7 preoperatively, 77.2 at 1 yr, and 74.6 at 2 yr; P < .05), their physical health (39.2 preoperatively versus 51.7 at 1 yr and 50.0 at 2 yr), and mental health (45.6 preoperatively versus 53.3 at 1 yr and 51.4 at 2 yr). Compared with bypass patients, sleeve patients had significantly lower odds of having low OP scores postoperatively (odds ratio [95% CI) ] .67 [.53, .83]) and lower odds of high OWLQOL (.61 [.48, .77]) at 1 year. CONCLUSION: All patients regardless of procedure on average report significant improvement in their scores for OP, OWLQOL, and physical and mental health after MBS. At 1 and 2 years, bypass patients reported greater improvement in their obesity-related PROMs than sleeve patients.

The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program Bariatric Surgical Risk/Benefit Calculator: 1-year weight.

BACKGROUND: Data-driven tools can be designed to provide patient-personalized estimates of health outcomes. Clinical calculators are commonly built to assess risk, but potential benefits of treatment should be equally considered. The American College of Surgeons Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) sought to create a risk and benefit calculator for adult patients considering primary metabolic and bariatric surgery with multiple prediction features: (1) 30-day risk, (2) 1-year body mass index (BMI) projections, and (3) 1-year co-morbidity remission. OBJECTIVE: To assess the performance of the 1-year BMI projections feature of this tool. SETTING: Not-for-profit organization, clinical data registry. METHODS: MBSAQIP data from 596,024 cases across 4.5 years from 882 centers with ∼2.5 million records through 18 months postoperatively were included. A generalized estimating equation model was used to estimate BMI over time for 4 primary procedures: laparoscopic adjustable gastric band, laparoscopic sleeve gastrectomy, laparoscopic Roux-en-Y gastric bypass, and biliopancreatic diversion with duodenal switch. RESULTS: The mean absolute error (MAE) in BMI predictions through postoperative month 12 was 1.68 units; overall correlation of actual and predicted BMI was .94. MAE of postoperative BMI estimates (1-12 mo) was lowest for laparoscopic sleeve gastrectomy (1.64) and highest for biliopancreatic diversion with duodenal switch (1.99). BMI predictions at 12 months showed MAE = 2.99 units. CONCLUSIONS: Predicted BMI closely aligned with actual BMI values across the 12-month postoperative period. The MBSAQIP Bariatric Surgical Risk/Benefit Calculator is publicly available with the intent to facilitate patient-clinician communication and guide surgical decision making. This tool can aid in evaluating postoperative risk as well as benefits and long-term expectations.

Sex Hormones and Diabetes in 45- to 74-year-old Men and Postmenopausal Women: The Hispanic Community Health Study.

Previous studies demonstrated associations of endogenous sex hormones with diabetes. Less is known about their dynamic relationship with diabetes progression through different stages of the disease, independence of associations, and role of the hypothalamic-pituitary gonadal axis. The purpose of this analysis was to examine relationships of endogenous sex hormones with incident diabetes, prediabetes, and diabetes traits in 693 postmenopausal women and 1015 men aged 45 to 74 years without diabetes at baseline participating in the Hispanic Community Health Study/Study of Latinos and followed for 6 years. Baseline hormones included estradiol, luteinizing hormone (LH), follicle stimulating hormone (FSH), sex hormone-binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), and, in men, testosterone and bioavailable testosterone. Associations were analyzed using multivariable Poisson and linear regressions. In men, testosterone was inversely associated with conversion from prediabetes to diabetes (incidence rate ratio [IRR] for 1 SD increase in testosterone: 0.821; 95% CI, 0.676, 0.997; P = 0.046), but not conversion from normoglycemia to prediabetes. Estradiol was positively associated with increase in fasting insulin and homeostatic model assessment of insulin resistance. In women, SHBG was inversely associated with change in glycosylated hemoglobin, postload glucose, and conversion from prediabetes to diabetes (IRR = 0.62; 95% CI, 0.44, 0.86, P = 0.005) but not from normoglycemia to prediabetes. Relationships with other hormones varied across glycemic measures. Stronger associations of testosterone and SHBG with transition from prediabetes to diabetes than from normoglycemic to prediabetes suggest they are operative at later stages of diabetes development. Biologic pathways by which sex hormones affect glucose homeostasis await future studies.

Evaluating agreement between clinic- and patient-reported outcomes for weight and co-morbidities at 1 year after bariatric surgery.

BACKGROUND: Development of patient-reported outcomes (PROs) to include traditionally clinic-reported data has the potential to decrease the data-collection burden for patients and clinicians and increase follow-up rates. However, replacing clinic report by patient report requires that the data reasonably agree. OBJECTIVE: To assess agreement between PROs and clinical registry data at 1 year after bariatric surgery. SETTING: Not-for-profit organization, bariatric surgery data registry, PROs platform. METHODS: Patient- and clinic-reported 1-year postoperative weight and co-morbidities were compared for matched PROs and registry records. The co-morbidities evaluated were diabetes, sleep apnea, hypertension, gastroesophageal reflux disease, and hyperlipidemia. Weight difference in pounds and nominal groupings (binary, 4-level) for co-morbidities were assessed for agreement between data sources using descriptive statistics, Bland-Altman plots, multiple regression, and kappa coefficients. Sensitivity analyses and follow-up by response method were examined. RESULTS: Among 1130 patients with both 1-year PROs and registry weights, 95% of patient-reported weights were within 13 lb of the registry-recorded weight, and patients underreported their weight by ∼2 lb, on average. Percent agreement and kappa coefficients were highest for diabetes (n = 999; binary: 94%, κ = .72; 4-level: 86%, κ = .71) and lowest for gastroesophageal reflux disease (n = 1032; binary: 75%, κ = .40; 4-level: 57%, κ = .35). Of patients eligible for both PROs and registry 1-year follow-up, 21% had PROs only. CONCLUSIONS: One-year patient- and clinic-reported weights and disease status for patients with diabetes and hypertension showed high agreement. The degree of bias from patient report was low. Patient report is a viable alternative to clinic report for certain objective measurements and may increase follow-up.

Surgical complications after living and deceased donor liver transplant: The NSQIP transplant experience.

This study used the prospective National Surgical Quality Improvement Program (NSQIP) Transplant pilot database to analyze surgical complications after liver transplantation (LT) in LT recipients from 2017to 2019. The primary outcome was surgical complication requiring intervention (Clavien-Dindo grade II or greater) within 90 days of transplant. Of the 1684 deceased donor and 109 living donor LT cases included from 29 centers, 38% of deceased donor liver recipients and 47% of living donor liver recipients experienced a complication. The most common complications included biliary complications (19% DDLT; 31% LDLT), hemorrhage requiring reoperation (14% DDLT; 9% LDLT), and vascular complications (6% DDLT; 9% LDLT). Management of biliary leaks (35.3% ERCP, 38.0% percutaneous drainage, 26.3% reoperation) and vascular complications (36.2% angioplasty/stenting, 31.2% medication, 29.8% reoperation) was variable. Biliary (aHR 5.14, 95% CI 2.69-9.8, P < .001), hemorrhage (aHR 2.54, 95% CI 1.13-5.7, P = .024) and vascular (aHR 2.88, 95% CI .85-9.7, P = .089) complication status at 30-days post-transplant were associated with lower 1-year patient survival. We conclude that biliary, hemorrhagic and vascular complications continue to be significant sources of morbidity and mortality for LT recipients. Understanding the different risk factors for complications between deceased and living donor liver recipients and standardizing complication management represent avenues for continued improvement.

Viral Suppression Levels in Men Who Have Sex With Men and Transgender Women With Newly Diagnosed HIV and Alcohol Use Disorder in Peru: Results From a Randomized, Double-Blind, Placebo-Controlled Trial Using Oral Naltrexone.

BACKGROUND: Alcohol use disorders (AUDs) are common in men who have sex with men (MSM) and transgender women (TGW) in Peru and undermine antiretroviral therapy (ART) adherence. Oral naltrexone (NTX) is an evidence-based treatment for AUD that has not been assessed in cotreating AUD in MSM/TGW with HIV. SETTING AND DESIGN: A multi-site, randomized, double-blind, placebo-controlled trial among MSM/TGW with AUD and newly diagnosed with HIV in Lima, Peru. METHODS: Newly diagnosed MSM/TGW with HIV and AUD were prescribed a single-treatment regimen of EFV/TDF/FTC from 2014 to 2015 and randomized 2:1 to oral NTX (N = 103) or placebo (N = 53) for 24 weeks. The primary and secondary outcomes were proportion achieving viral suppression (VS: HIV-1 RNA < 400 copies/mL) or maximal viral suppression (MVS: HIV-1 RNA < 40 copies/mL) at 24 weeks. RESULTS: There were no significant differences between the arms in VS (81.6% NTX arm vs 75.5% placebo arm; P = 0.37) or MVS (61.2% NTX arm vs 66.0% placebo arm; P = 0.48). Adherence to study medication was low (mean = 34.6%) overall with only 21.4% of participants meeting recommended adherence levels (≥80% daily doses/month). Participants allocated to NTX had significantly lower adherence compared with placebo for both the first and second 12-week study periods, respectively (44.0% vs 35.2%, P = 0.04; 31.4% vs 35.2%, P = 0.03). CONCLUSIONS: Findings are inconclusive regarding the use of NTX for treatment of AUD in MSM/TGW newly diagnosed with HIV. VS and MVS levels were high irrespective of allocation. Adherence to study medication was low, requiring further exploration of strategies to optimize adherence to NTX as AUD treatment.

The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program bariatric surgical risk/benefit calculator: 30-day risk.

BACKGROUND: There is increasing demand for data-driven tools that provide accurate and clearly communicated patient-specific information. These can aid discussions between practitioners and patients, promote shared decision-making, and enhance informed consent. The American College of Surgeons Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) sought to create a risk calculator for adult patients considering primary metabolic and bariatric surgery, with multiple prediction features: (1) 30-day risk; (2) 1-year body mass index projections; and (3) 1-year co-morbidity remission. OBJECTIVES: To evaluate the 30-day risk estimation feature of this tool. SETTING: Not-for-profit organization, international bariatric surgery clinical data registry. METHODS: MBSAQIP data across 5.5 years, 925 hospitals, and 775,291 cases were used to develop the 30-day risk feature. Logistic regression models were employed to estimate postoperative risks for 9 outcomes across 4 procedures: laparoscopic Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, laparoscopic adjustable gastric band, and biliopancreatic diversion with duodenal switch. RESULTS: The tool showed good discrimination for mortality and surgical site infection models (c-statistics, .80 and .70, respectively), and was slightly less accurate for the 7 other complications (.62-.69). Graphical representations showed excellent calibration for all 9 outcomes. CONCLUSIONS: Overall, the 30-day risk models were accurate and well calibrated, with acceptable discrimination. The MBSAQIP bariatric surgical risk/benefit calculator is publicly available, with the intent to be integrated into healthcare practice to guide bariatric surgical decision-making and care planning, and to enhance communication between patients and their surgical care team.

Safety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy.

HIV disproportionately affects men who have sex with men (MSM) and transgender women (TW). These populations use alcohol more heavily than the general population, and alcohol use disorders (AUDs) are more prevalent among them. Naltrexone (NTX) has documented efficacy and safety as a medication-assisted therapy for AUD. Its use has not been well-examined in persons with HIV (PWH) newly initiating antiretroviral therapy (ART) where the possibility of hepatotoxicity may be increased when initating multiple new medications. This study assessed the safety of oral NTX treatment (50 mg daily) initiated concomitantly with antiretroviral therapy (ART) in a double-blind randomized placebo-controlled trial of NTX in MSM/TW in Lima, Peru among MSM and TW with AUD (AUDIT score ≥ 8). We analyzed adverse event data from ART-naïve participants (N = 155) who were randomized (2:1) to initiate ART plus NTX (N = 103) or ART plus placebo (N = 52). Participants were monitored for 24 weeks while taking ART plus NTX/placebo, followed by 24 weeks receiving ART alone. Over 48 weeks, 135 grade 2 or 3 adverse events were reported, resulting in 1.3 clinical adverse events per participant equally represented in both treatment and placebo arms. Two serious adverse events occurred among two participants receiving NTX; neither was attributed to the study medication. No significant differences were found in the proportion of subjects reporting any adverse events between treatment arms across all time-points. These results suggest NTX is safe in MSM/TW PWH with AUD newly initiating ART, as no excess of clinical adverse events or transaminase elevation was associated with NTX use.

Employing Enhanced Recovery Goals in Bariatric Surgery (ENERGY): a national quality improvement project using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.

BACKGROUND: To date, there have been no large-scale enhanced recovery projects in bariatric surgery in the United States. OBJECTIVE: The aim of this project was to implement an enhanced recovery protocol for selected Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program centers and determine its impact on length of stay, bleeding, readmissions, and reoperation rates. SETTING: University and private practice programs, United States. METHODS: Participating sites were identified based on historical extended length of stay (ELOS, ≥4 d). A 6-month run-up period was used to allow implementation of the protocol. Primary bariatric procedures were included in the analysis, which compared ELOS from historic data (2016) with outcomes during the Employing Enhanced Recovery Goals in Bariatric Surgery (ENERGY) project. Relationships between adherence to the 26 process measures and ELOS were analyzed. Specific adverse 30-day outcomes were monitored. RESULTS: Thirty-six centers participated in the project. The final analytic sample consisted of 18,048 cases total over a 24-month period, including 8946 from the 2016 calendar year and 9102 from the ENERGY period. The overall rates of ELOS for pre- and postintervention were 8.1% and 4.5%, respectively, without increasing readmission rates, reoperation rates, or overall morbidity. Bleeding rates increased from .8% preintervention to 1.1% during ENERGY (adjusted P = .06). There was a significant association between increased adherence score and decreased odds of ELOS (P < .01). CONCLUSION: Implementation of a large-scale enhanced recovery project is feasible and results in decreased ELOS without increasing overall adverse events or readmissions. Increased adherence to the protocol was closely associated with decreased ELOS. The ENERGY protocol or similar enhanced recovery pathways should be implemented on a larger scale to further improve the care and outcomes of bariatric surgery patients.

Beyond death and graft survival-Variation in outcomes after kidney transplantation. Results from the NSQIP Transplant beta phase.

The National Surgical Quality Program (NSQIP) Transplant was designed by transplant surgeons from the ground up to track posttransplant outcomes beyond basic recipient and graft survival. After an initial pilot phase, the program has expanded to 29 participating sites and enrolled more than 4300 recipient-donor pairs into the database, including 2876 complete kidney transplant cases. In this analysis, surgical site infection (SSI), urinary tract infection (UTI), and reoperation/intervention were evaluated for kidney transplant recipients. We observed impressive variation in the crude incidence between sites for SSI (0%-17%), UTI (0%-14%), and reoperation/intervention (0%-25%). After adjustment for donor and recipient factors, 2 sites were outliers with respect to their incidence of UTI. For the first time, the field of transplantation has data that demonstrate variation in kidney recipient surgical outcomes between sites. More importantly, NSQIP Transplant provides a powerful platform to improve care beyond basic patient and graft survival.

Beyond death and graft survival-Variation in outcomes after liver transplant. Results from the NSQIP transplant beta phase.

The National Surgical Quality Program (NSQIP) Transplant program was designed by transplant surgeons from the ground up to track posttransplant outcomes beyond basic recipient and graft survival. After an initial pilot phase, the program has expanded to 29 participating sites and enrolled more than 4300 recipient-donor pairs into the database, including 1444 completed liver transplant cases. In this analysis, surgical site infection (SSI), urinary tract infection (UTI), and unplanned reoperation/intervention after liver transplantation were evaluated. We observed impressive variation in the crude incidence between sites for SSI (0%-29%), UTI (0%-10%), and reoperation/intervention (0%-57%). After adjustment for donor and recipient factors, at least 1 site was identified as an outlier for each of the analyzed outcomes. For the first time, the field of transplantation has data that demonstrate variation in liver recipient outcomes beyond death and graft survival between sites. More importantly, NSQIP Transplant provides a powerful platform to improve care beyond basic patient and graft survival.