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Survival and Cost-Effectiveness of Bariatric Surgery Among Patients With Obesity and Cirrhosis
Abstract
Importance
Obesity and steatotic liver disease are associated with excess morbidity and mortality from cardiovascular, pulmonary, metabolic, and hepatic causes. Bariatric surgery has demonstrated long-term benefits in terms of weight loss and mortality rates, but barriers to its utilization persist.
Objective
To evaluate the impact of bariatric surgery on outcomes and cost-effectiveness among patients with obesity, focusing on those with cirrhosis.
Design, Setting, and Participants
This economic evaluation was a retrospective cohort study including US veterans older than 18 years with a body mass index (BMI) higher than 35 or with a BMI higher than 30 and more than 1 major metabolic comorbidity. These veterans were referred to a structured lifestyle modification program (MOVE!), and a subset proceeded to bariatric surgery, including sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) from 2008 to 2020. Risk set matching was used to match bariatric surgery cases 1:5 with nonsurgical controls. Data were analyzed from September 2008 to September 2023.
Exposures
Bariatric surgery (SG or RYGB) or structured lifestyle intervention (MOVE!).
Main Outcomes and Measures
The primary outcomes were the incremental cost-effectiveness ratio (ICER) of SG or RYGB vs MOVE! over 10 years. Secondary outcomes included overall survival, quality-adjusted survival, and weight loss achieved.
Results
The final cohort included 4301 SG, 1906 RYGB, and 31 055 MOVE! participants, among whom 64, 8, and 354, respectively, had cirrhosis. The median (IQR) age of the cohort was 52 (44-59) years; there were 25 581 male patients (68.7%) and 11 681 female (31.3%). Compared with MOVE!, bariatric surgery was associated with longer observed survival (9.67 years vs 9.46 years overall; 9.09 years vs 8.23 years in cirrhosis). The ICER was 159 027 for RYGB in the overall cohort, and 44 704 for RYGB in the cirrhosis cohorts. Bariatric surgery was cost-effective at a willingness-to-pay threshold of $100 000 per quality-adjusted life-year among patients with cirrhosis.
Conclusions and Relevance
Bariatric surgery was associated with improved survival and expected weight loss and was cost-effective. These findings support the expanded use of bariatric surgery in appropriately selected patients, including those with cirrhosis, to improve outcomes and reduce long-term health care costs.
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Background
The SF-6D index can be used to calculate quality-adjusted life years in economic evaluations, which is required by reimbursement agencies and national advisory bodies, including the Swedish ones. However, despite that SF-36 has been largely applied among patients undergoing bariatric surgery, almost no study has accessed the short form six-dimensions (SF-6D) after bariatric surgery.
Aim
To establish normative values for the SF-6D index among patients undergoing bariatric surgery.
Materials and Methods
All patients who received bariatric surgery in Sweden between 2011–01-01 and 2019–03-31 were obtained from the Scandinavian Obesity Surgery Registry (SOReg). Information includes patients’ sociodemographic characteristics, details regarding the procedure, and postsurgical conditions. The SF-36 is applied at baseline and at follow-up years 1, 2, and 5. The multiple sequential imputation method was applied to handle missingness on SF-6D items. Based on the UK tariff, the SF-6D preference scores were calculated. The normative values for the mean (SD) SF-6D index were reported by timepoint and surgical complications for men and women, respectively. Multivariate analyses were applied to investigate how the SF-6D index is associated with timepoint, controlling for age, sex, BMI, and comorbidities in a stepwise manner.
Results
The SF-6D index increased at 1 year relative to baseline and was roughly maintained at the same level at 2 years. The normative value of the SF-6D index can be used in economic evaluations for bariatric surgery.
Aims:
The favourable effects of bariatric surgeries on body weight reduction and glucose control have been demonstrated in several studies. Additionally, the cost-effectiveness of bariatric surgeries has been confirmed in several analyses. The aim of the current analysis was to demonstrate the cost-effectiveness of bariatric surgeries in obese patients with type 2 diabetes in Hungary compared to conventional diabetes treatments based on economic modelling of published clinical trial results.
Materials and methods:
Patients entered the simulation model at the age of 45 with body mass index (BMI) ≥ 30 kg/m2 and type 2 diabetes. The model was performed from the public payer's perspective, comparing sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) procedures to conventional care of diabetes. The results were provided separately for three BMI categories.
Results:
The base-case analysis demonstrated that both surgery types were dominant; i.e., they saved 17 064 to 24 384 Euro public payer expenditures and resulted in improved health outcomes (1.36 to 1.50 quality-adjusted life years gain (QALY)) in the three BMI categories. Bariatric surgeries extended the life expectancy and the disease-free survival times of all the investigated diabetes complications. All the scenario analyses confirmed the robustness of the base-case analysis, such that bariatric surgeries remained dominant compared to conventional diabetes treatments.
Conclusion:
The results of this cost-effectiveness analysis highlight the importance of bariatric surgeries as alternatives to conventional diabetes treatments in the obese population. Therefore, it is strongly recommended that a wider population has access to these surgeries in Hungary.
Major updates to 1991 National Institutes of Health guidelines for bariatric surgery
Metabolic and bariatric surgery (MBS) is recommended for individuals with a body mass index (BMI) > 35 kg/m ² , regardless of presence, absence, or severity of co-morbidities.
MBS should be considered for individuals with metabolic disease and BMI of 30-34.9 kg/m ² .
BMI thresholds should be adjusted in the Asian population such that a BMI > 25 kg/m ² suggests clinical obesity, and individuals with BMI > 27.5 kg/m ² should be offered MBS.
Long-term results of MBS consistently demonstrate safety and efficacy.
Appropriately selected children and adolescents should be considered for MBS.
(Surg Obes Relat Dis 2022; https://doi.org/10.1016/j.soard.2022.08.013 ) © 2022 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Introduction:
Using a large diverse population of incident end-stage kidney disease (ESKD) patients from an integrated health system, we sought to evaluate the concordance of causes of death (CODs) between the underlying COD from the United States Renal Data System (USRDS) registry and CODs obtained from Kaiser Permanente Southern California (KPSC).
Methods:
A retrospective cohort study was performed among incident ESKD patients who had mortality records and CODs reported in both KPSC and USRDS databases between January 1, 2007, and December 31, 2016. Underlying CODs reported by the KPSC were compared to the CODs reported by USRDS. Overall and subcategory-specific COD agreements were assessed using Cohen's weighted kappa statistic (95% CI). Proportions of positive and negative agreement were also determined.
Results:
Among 4,188 ESKD patient deaths, 4,118 patients had CODs recorded in both KPSC and USRDS. The most common KPSC CODs were circulatory system diseases (35.7%), endocrine/nutritional/metabolic diseases (24.2%), genitourinary diseases (12.9%), and neoplasms (9.6%). Most common USRDS CODs were cardiac disease (46.9%), withdrawal from dialysis (12.6%), and infection (10.1%). Of 2,593 records with causes listed NOT as "Other," 453 (17.4%) had no agreement in CODs between the USRDS and the underlying, secondary, tertiary, or quaternary causes recorded by KPSC. In comparing CODs recorded within KPSC to the USRDS, Cohen's weighted kappa (95% CI) was 0.20 (0.18-0.22) with overall agreement of 36.4%.
Conclusion:
Among an incident ESKD population with mortality records, we found that there was only fair or slight agreement between CODs reported between the USRDS registry and KPSC, a large integrated health care system.
Background
Obesity is a worldwide epidemic that has been associated with a plurality of diseases in observational studies. The aim of this study was to summarize the evidence from Mendelian randomization (MR) studies of the association between body mass index (BMI) and chronic diseases.
Methods
PubMed and Embase were searched for MR studies on adult BMI in relation to major chronic diseases, including diabetes mellitus; diseases of the circulatory, respiratory, digestive, musculoskeletal, and nervous systems; and neoplasms. A meta-analysis was performed for each disease by using results from published MR studies and corresponding de novo analyses based on summary-level genetic data from the FinnGen consortium ( n = 218,792 individuals).
Results
In a meta-analysis of results from published MR studies and de novo analyses of the FinnGen consortium, genetically predicted higher BMI was associated with increased risk of type 2 diabetes mellitus, 14 circulatory disease outcomes, asthma, chronic obstructive pulmonary disease, five digestive system diseases, three musculoskeletal system diseases, and multiple sclerosis as well as cancers of the digestive system (six cancer sites), uterus, kidney, and bladder. In contrast, genetically predicted higher adult BMI was associated with a decreased risk of Dupuytren’s disease, osteoporosis, and breast, prostate, and non-melanoma cancer, and not associated with Alzheimer’s disease, amyotrophic lateral sclerosis, or Parkinson’s disease.
Conclusions
The totality of the evidence from MR studies supports a causal role of excess adiposity in a plurality of chronic diseases. Hence, continued efforts to reduce the prevalence of overweight and obesity are a major public health goal.
Background:
Severe obesity is associated with adverse health outcomes and increased risk of death. This study evaluates the real-world cost-utility of therapy for severe obesity, from the publicly funded health care system and societal perspectives.
Methods:
We conducted a cost-utility analysis using primary data from a prospective observational cohort of adults living with severe obesity (BMI ≥ 35 kg/m2 and a major medical comorbidity or BMI ≥ 40 kg/m2) who were enrolled in a regional obesity program over 2 years. We extrapolated 10-year and lifetime Markov models, validated and supplemented with literature sources, to compare medical, surgical and standard care therapies. We performed deterministic and probabilistic sensitivity analyses.
Results:
The cohort included 500 adults living with severe obesity, 150 of whom received laparoscopic surgical therapy. From a publicly funded health system perspective, at 2 years, surgical therapy had an incremental cost-effectiveness ratio (ICER) of 14 056 per QALY. From the societal perspective, at 2 years, surgical therapy had an ICER of $340 per QALY; over a lifetime, it was the dominant option. The results were robust to sensitivity analysis.
Interpretation:
From a public health care perspective, surgery for severe obesity is cost effective, and when approached from a societal perspective, it becomes cost saving. Real-world data support using surgical therapy for severe obesity, and our results contribute to the health economic and clinical literature with regard to a robust analysis from a societal perspective.
This systematic review aimed to comprehensively synthesize cost-effectiveness evidences of bariatric surgery by pooling incremental net monetary benefits (INB). Twenty-eight full economic evaluation studies comparing bariatric surgery with usual care were identified from five databases. In high-income countries (HICs), bariatric surgery was cost-effective among mixed obesity group (i.e., obesity with/without diabetes) over a 10-year time horizon (pooled INB = 42,647.96, 101,897.96; 95% CI 79,390.93, 124,404.99). All studies conducted among obese with diabetes reported that bariatric surgery was cost-effective. Also, the pooled INB for obesity with diabetes group over lifetime horizon in HICs was 32,500.75, $129,151.81). Nevertheless, no evidence is available in low- and middle-income countries.
Graphical abstract
Background
Nonalcoholic fatty liver disease (NAFLD) is highly prevalent in morbidly obese patients, and fibrosis is an independent predictor of mortality. Noninvasive tests (NITs) are being developed for the detection of advanced fibrosis (AF).
Purpose
To assess the performance of three NITs (NAFLD fibrosis score, NFS, fibrosis-4 index, FIB-4, and aspartate aminotransferase-to-platelet ratio, APRI), in the identification of AF among morbidly obese patients.
Materials and Methods
Patients, who underwent bariatric surgery between 2004 and 2009 and had liver biopsy, were included. Fibrosis stages ≥ F2 and ≥ F3 were defined as significant and AF, respectively. Published and optimal thresholds (Youden index) for NFS, FIB-4 and APRI, sensitivity, specificity, positive and negative predictive values (PPV-NPV), and area under the receiver operator curves (AUROC) were evaluated.
Results
Among 584 patients (mean age 43.3 ± 11.3 years, 21.2% male, 75% white, mean BMI 45.5 ± 8.80), 31.7% had NASH. Stages distributions were F1 = 68.1%, F2 = 16.4%, F3 = 8%, and F4 = 3.2%. At published thresholds, all 3 NITs performed poorly for detection of AF, with AUROC < 0.62. Overall performance at optimal thresholds improved to 0.68, 0.72, and 0.74 for NFS, FIB-4, and APRI, respectively. At optimal thresholds, all tests had good NPV (94.4–95.9%) but low PPV (24.2–32.5%). Combinations of the tests did not improve their performance.
Conclusions
NFS, FIB-4, and APRI fall short to detect advanced fibrosis but valuable for excluding advanced fibrosis. More research is needed to develop new NITs with high positive predictive value.
Background
Obesity is commonly observed in patients with cirrhosis, especially with the increasing prevalence of non-alcoholic steatohepatitis (NASH). Bariatric surgery has been avoided in these patients given concerns about increased perioperative risk; therefore, data are lacking regarding long-term outcomes. In this study, we aimed to evaluate the long-term outcomes of patients with cirrhosis who underwent bariatric surgery.
Methods
We reviewed the charts of adult patients with compensated cirrhosis who underwent bariatric surgery after they were prospectively enrolled between February 23, 2009 and November 9, 2011, and followed in a pilot study for evaluation of bariatric surgery outcomes. Only patients with more than 4 years of follow-up were included in the analysis. Data regarding their liver disease, metabolic status, and survival were collected. A descriptive analysis was performed.
Results
The cohort consisted of 10 patients, of whom 7 were females. The median post-surgical follow-up was 8.7 years (± 1.4 years). All patients had biopsy-proven NASH; two patients had concurrent, untreated hepatitis C infection. During the observation period, there was a mean weight loss of 24 kg (19.2% of total body weight pre surgery, P < 0.001) and only one patient regained weight to the baseline pre-surgical measurement. One patient who was not eligible for transplant developed hepatic encephalopathy 3 years after surgery and later died. The remainder of the patients did not have any hepatic decompensation, cardiovascular event, or mortality. Except for one patient with Gilbert syndrome, bilirubin was normal in all patients at last follow-up.
Conclusions
Bariatric surgery in patients with compensated cirrhosis can lead to sustained weight loss and stable hepatic function on long-term follow-up.
Background & aims
Given ongoing challenges in non-invasive non-alcoholic liver disease (NAFLD) diagnosis, we sought to validate an ALT-based NAFLD phenotype using measures readily available in electronic health records (EHRs) and population-based studies by leveraging the clinical and genetic data in the Million Veteran Program (MVP), a multi-ethnic mega-biobank of US Veterans.
Methods
MVP participants with alanine aminotransferases (ALT) >40 units/L for men and >30 units/L for women without other causes of liver disease were compared to controls with normal ALT. Genetic variants spanning eight NAFLD risk or ALT-associated loci (LYPLAL1, GCKR, HSD17B13, TRIB1, PPP1R3B, ERLIN1, TM6SF2, PNPLA3) were tested for NAFLD associations with sensitivity analyses adjusting for metabolic risk factors and alcohol consumption. A manual EHR review assessed performance characteristics of the NAFLD phenotype with imaging and biopsy data as gold standards. Genetic associations with advanced fibrosis were explored using FIB4, NAFLD Fibrosis Score and platelet counts.
Results
Among 322,259 MVP participants, 19% met non-invasive criteria for NAFLD. Trans-ethnic meta-analysis replicated associations with previously reported genetic variants in all but LYPLAL1 and GCKR loci (P<6x10⁻³), without attenuation when adjusted for metabolic risk factors and alcohol consumption. At the previously reported LYPLAL1 locus, the established genetic variant did not appear to be associated with NAFLD, however the regional association plot showed a significant association with NAFLD 279kb downstream. In the EHR validation, the ALT-based NAFLD phenotype yielded a positive predictive value 0.89 and 0.84 for liver biopsy and abdominal imaging, respectively (inter-rater reliability (Cohen’s kappa = 0.98)). HSD17B13 and PNPLA3 loci were associated with advanced fibrosis.
Conclusions
We validate a simple, non-invasive ALT-based NAFLD phenotype using EHR data by leveraging previously established NAFLD risk-associated genetic polymorphisms.
Importance:
Obesity is the most common risk factor for nonalcoholic steatohepatitis (NASH), the progressive form of nonalcoholic fatty liver disease that can lead to cirrhosis and hepatocellular carcinoma. Weight loss can be an effective treatment for obesity and may slow the progression of advanced liver disease.
Objective:
To assess the cost-effectiveness of bariatric surgery in patients with NASH and compensated cirrhosis.
Design, setting, and participants:
This economic evaluation study used a Markov-based state-transition model to simulate the benefits and risks of laparoscopic sleeve gastrectomy (SG), laparoscopic Roux-en-Y gastric bypass (GB), and intensive lifestyle intervention (ILI) compared with usual care in patients with NASH and compensated cirrhosis and varying baseline weight (overweight, mild obesity, moderate obesity, and severe obesity). Patients faced varied risks of perioperative mortality and complications depending on the type of surgery they underwent. Data were collected on March 22, 2017.
Main outcomes and measures:
Life-years, quality-adjusted life-years (QALYs), costs (in 2017 66 119 per QALY; mild obesity, 10 274 per QALY; and severe obesity, 28 734 by 3189 for moderate obesity, and by $2289 for severe obesity. In overweight patients, GB involved fewer QALYs than SG, and thus decreasing the cost of surgery would not result in cost-effectiveness.
Conclusions and relevance:
Bariatric surgery could be highly cost-effective in patients with NASH compensated cirrhosis and obesity or overweight. The findings from this analysis suggest that it can inform clinical trials evaluating the effect of bariatric procedures in patients with NASH cirrhosis, including those with a lower body mass index.
The epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world. Fueled by economic growth, industrialization, mechanized transport, urbanization, an increasingly sedentary lifestyle, and a nutritional transition to processed foods and high-calorie diets over the last 30 years, many countries have witnessed the prevalence of obesity in its citizens double and even quadruple. A rising prevalence of childhood obesity, in particular, forebodes a staggering burden of disease in individuals and healthcare systems in the decades to come. A complex, multifactorial disease, with genetic, behavioral, socioeconomic, and environmental origins, obesity raises the risk of debilitating morbidity and mortality. Relying primarily on epidemiologic evidence published within the last decade, this non-exhaustive review discusses the extent of the obesity epidemic, its risk factors-known and novel-, sequelae, and economic impact across the globe.
The ratio of $50,000 per quality-adjusted life-year (QALY) gained by using a given health care intervention has long served as a benchmark for the value of U.S. health care. But evidence suggests that it is too low and might best be thought of as an implied lower boundary.
Background
Laparoscopic sleeve gastrectomy (SG) is a validated procedure for the surgical treatment of morbid obesity. Cirrhosis is often considered a relative contraindication to elective extrahepatic surgery. The objective of this study was to evaluate the morbidity related to SG performed in cirrhotic patients compared with noncirrhotic patients.
Methods
Between March 2004 and January 2013, we included all patients with cirrhosis undergoing SG (13 patients). These patients (SG-cirrhosis group) were matched in terms of preoperative data (age, gender, body mass index, and co-morbidities) on a 1:2 basis, with 26 noncirrhotic patients (SG group) selected from a population of 750 patients. Cirrhosis was diagnosed postoperatively on histologic exam. The primary endpoint was the overall postoperative complication rate. Secondary endpoints were operating time, revisional surgery rate, gastric fistula and bleeding rates, postoperative mortality, and weight loss over a 24-month period.
Results
The SG-cirrhosis group consisted of 13 patients with a median age of 52 years. All patients in the SG-cirrhosis group were Child A. Etiology of cirrhosis was related to NASH in 93.3%. Median operating time in the SG-cirrhosis group and SG group was 75 minutes versus 80 minutes (P = .59). No postoperative mortality was observed in either group. The overall postoperative complication rate was 7.7% versus 7.7% (P = 1). The major complication rate was 0% versus 7.7% (P = .22), and the postoperative gastric fistula rate was 0% versus 3.8% (P = .47). No complications related to cirrhosis were reported.
Conclusion
SG can be performed in Child A cirrhosis with no increased risk of postoperative complications and no specific complications related to cirrhosis. Weight loss for patients with cirrhosis undergoing SG is similar to that observed in noncirrhotic patients.
Harmon S. Jordan, ScD, Karima A. Kendall, PhD, Linda J. Lux, Roycelynn Mentor-Marcel, PhD, MPH, Laura C. Morgan, MA, Michael G. Trisolini, PhD, MBA, Janusz Wnek, PhD
Jeffrey L. Anderson, MD, FACC, FAHA, Chair , Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect , Nancy M. Albert, PhD, CCNS, CCRN,
Objective:
The Institute of Medicine proposed recently that, while current pay for performance measures should target multiple dimensions of care, including measures of technical quality, they should transition toward longitudinal and health-outcome measures across systems of care. This article describes the development of the Diabetes Epidemiology Cohorts (DEpiC), which facilitates evaluation of intermediate "quality of care" outcomes and surveillance of adverse outcomes for veterans with diabetes served by the Veterans Health Administration (VHA) over multiple years.
Methods:
The Diabetes Epidemiology Cohorts is a longitudinal research database containing records for all diabetes patients in the VHA since 1998. It is constructed using data from a variety of national computerized data files in the VHA (including medical encounters, prescriptions, laboratory tests, and mortality files), Medicare claims data for VHA patients, and large patient surveys conducted by the VHA. Rigorous methodology is applied in linking and processing data into longitudinal patient records to assure data quality.
Results:
Validity is demonstrated in the construction of the DEpiC. Adjusted comparisons of disease prevalence with general population estimates are made. Further analyses of intermediate outcomes of care demonstrate the utility of the database. In the first example, using growth curve models, we demonstrated that hemoglobin A1c trends exhibit marked seasonality and that serial cross-sectional outcomes overestimate the improvement in population A1c levels compared to longitudinal cohort evaluation. In the second example, the use of individual level data enabled the mapping of regional performance in amputation prevention into four quadrants using calculated observed to expected major and minor amputation rates. Simultaneous evaluation of outliers in all categories of amputation may improve the oversight of foot care surveillance programs.
Conclusions:
The use of linked, patient level longitudinal data resolves confounding case mix issues inherent in the use of serial cross-sectional data. Policy makers should be aware of the limitations of cross-sectional data and should make use of longitudinal patient databases to evaluate clinical outcomes.
The propensity score is a subject's probability of treatment, conditional on observed baseline covariates. Conditional on the true propensity score, treated and untreated subjects have similar distributions of observed baseline covariates. Propensity-score matching is a popular method of using the propensity score in the medical literature. Using this approach, matched sets of treated and untreated subjects with similar values of the propensity score are formed. Inferences about treatment effect made using propensity-score matching are valid only if, in the matched sample, treated and untreated subjects have similar distributions of measured baseline covariates. In this paper we discuss the following methods for assessing whether the propensity score model has been correctly specified: comparing means and prevalences of baseline characteristics using standardized differences; ratios comparing the variance of continuous covariates between treated and untreated subjects; comparison of higher order moments and interactions; five-number summaries; and graphical methods such as quantile-quantile plots, side-by-side boxplots, and non-parametric density plots for comparing the distribution of baseline covariates between treatment groups. We describe methods to determine the sampling distribution of the standardized difference when the true standardized difference is equal to zero, thereby allowing one to determine the range of standardized differences that are plausible with the propensity score model having been correctly specified. We highlight the limitations of some previously used methods for assessing the adequacy of the specification of the propensity-score model. In particular, methods based on comparing the distribution of the estimated propensity score between treated and untreated subjects are uninformative.
Who pays the healthcare costs associated with obesity? Among workers, this is largely a question of the incidence of the costs of employer-sponsored coverage. Using data from the National Longitudinal Survey of Youth and the Medical Expenditure Panel Survey, we find that the incremental healthcare costs associated with obesity are passed on to obese workers with employer-sponsored health insurance in the form of lower cash wages. Obese workers without employer-sponsored insurance do not have a wage offset relative to their non-obese counterparts. A substantial part of the lower wages among obese women attributed to labor market discrimination can be explained by their higher health insurance premiums.
The U.S. Department of Veterans Affairs (VA) maintains discharge abstracts, but these do not include cost information. This article describes the methods the authors used to estimate the costs of VA medical-surgical hospitalizations in fiscal years 1998 to 2000. They estimated a cost regression with 1996 Medicare data restricted to veterans receiving VA care in an earlier year. The regression accounted for approximately 74 percent of the variance in cost-adjusted charges, and it proved to be robust to outliers and the year of input data. The beta coefficients from the cost regression were used to impute costs of VA medical-surgical hospital discharges. The estimated aggregate costs were reconciled with VA budget allocations. In addition to the direct medical costs, their cost estimates include indirect costs and physician services; both of these were allocated in proportion to direct costs. They discuss the method's limitations and application in other health care systems.
Background:
Metabolic dysfunction-associated steatohepatitis (MASH), formerly nonalcoholic steatohepatitis, is characterized by fat accumulation and inflammation of the liver and may result in progression to cirrhosis and liver-related events.
Objective:
To characterize the impact of cirrhosis and progression to liver-related events on costs and health care resource use (HCRU) among MASH patients in the United States.
Methods:
The study cohort included patients with diagnosed nonalcoholic steatohepatitis (International Classification of Diseases, Tenth Revision, Clinical Modification code K75.81) in Optum's deidentified Clinformatics Data Mart Database (October 2015 to December 2022) and were stratified by baseline cirrhosis status. Among those without cirrhosis at baseline, patients were further stratified by status of progression to cirrhosis during follow-up. Total HCRU and costs per-person per-year (PPPY) were estimated and compared descriptively between the cohorts. In addition, gamma generalized linear models were used to compare costs PPPY between those with vs without cirrhosis at baseline, as well as with vs without progression during follow-up, while adjusting for baseline patient and disease characteristics. Annual costs per person were also longitudinally modeled using gamma generalized linear mixed models to understand longitudinal changes in costs PPPY while accounting for time correlations within individual patients. Lastly, a series of sensitivity analyses were conducted to assess the impact of study design features and clinical variations of total costs PPPY.
Results:
A total of 28,576 adults were included, and 9,157 (32.0%) had baseline cirrhosis; of the 19,419 without baseline cirrhosis, a total of 4,235 (21.8%) progressed over follow-up. Mean (SD) HCRU and costs PPPY were higher among patients with cirrhosis (226,037]) than without (61,472]; P < 0.01) and among those with progression (102,626]) than without (39,740]; P < 0.01). Costs remained significantly greater when adjusted for covariates, with a risk ratio (95% CI) of 1.99 (1.89-2.09) when comparing with vs without baseline cirrhosis and 2.28 (2.15-2.42) when comparing with vs without progression over follow-up. Costs increased with each subsequent year, to 21% by year 6 among those with cirrhosis at baseline and 49% among those without baseline cirrhosis who progressed.
Conclusions:
The financial burden of MASH is substantial and significantly greater among those with cirrhosis or disease progression. Although patients without cirrhosis incur lower burden, the increase over time is greater and associated with progression. Therapies that slow progression may help alleviate the financial burden, and strategies are needed to identify patients with MASH at risk of progressing to cirrhosis.
Importance
Randomized clinical trials of bariatric surgery have been limited in size, type of surgical procedure, and follow-up duration.
Objective
To determine long-term glycemic control and safety of bariatric surgery compared with medical/lifestyle management of type 2 diabetes.
Design, Setting, and Participants
ARMMS-T2D (Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes) is a pooled analysis from 4 US single-center randomized trials conducted between May 2007 and August 2013, with observational follow-up through July 2022.
Intervention
Participants were originally randomized to undergo either medical/lifestyle management or 1 of the following 3 bariatric surgical procedures: Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding.
Main Outcome and Measures
The primary outcome was change in hemoglobin A 1c (HbA 1c ) from baseline to 7 years for all participants. Data are reported for up to 12 years.
Results
A total of 262 of 305 eligible participants (86%) enrolled in long-term follow-up for this pooled analysis. The mean (SD) age of participants was 49.9 (8.3) years, mean (SD) body mass index was 36.4 (3.5), 68.3% were women, 31% were Black, and 67.2% were White. During follow-up, 25% of participants randomized to undergo medical/lifestyle management underwent bariatric surgery. The median follow-up was 11 years. At 7 years, HbA 1c decreased by 0.2% (95% CI, −0.5% to 0.2%), from a baseline of 8.2%, in the medical/lifestyle group and by 1.6% (95% CI, −1.8% to −1.3%), from a baseline of 8.7%, in the bariatric surgery group. The between-group difference was −1.4% (95% CI, −1.8% to −1.0%; P < .001) at 7 years and −1.1% (95% CI, −1.7% to −0.5%; P = .002) at 12 years. Fewer antidiabetes medications were used in the bariatric surgery group. Diabetes remission was greater after bariatric surgery (6.2% in the medical/lifestyle group vs 18.2% in the bariatric surgery group; P = .02) at 7 years and at 12 years (0.0% in the medical/lifestyle group vs 12.7% in the bariatric surgery group; P < .001). There were 4 deaths (2.2%), 2 in each group, and no differences in major cardiovascular adverse events. Anemia, fractures, and gastrointestinal adverse events were more common after bariatric surgery.
Conclusion and Relevance
After 7 to 12 years of follow-up, individuals originally randomized to undergo bariatric surgery compared with medical/lifestyle intervention had superior glycemic control with less diabetes medication use and higher rates of diabetes remission.
Trial Registration
ClinicalTrials.gov Identifier: NCT02328599
Introduction:
Obesity is a growing public health problem leading to substantial economic impact. This study aimed to summarize the economic impact of obesity and to critically analyze the methods used in the cost-of-illness (COI) studies on obesity.
Methods:
We conducted systematic search in PubMed and Scopus from September 1, 2016, to July 22, 2022. Original COI studies estimating the economic cost of obesity and/or overweight in at least one country, published in English were included. To facilitate the comparison of estimates across countries, we converted the cost estimates of different years to 2022 purchasing power parity (PPP) values using each country’s consumer price index (CPI) and PPP conversion rate.
Results:
Nineteen studies were included. All studies employed a prevalence-based approach using Population Attributable Fraction (PAF) methodology. About half of the included studies (53%) were conducted in high-income countries while the others (47%) were conducted in middle-income countries. The economic burden of obesity ranged between PPP 15 million in Brazil to PPP 126 billion in the USA, in the year 2022. Direct medical costs accounted for 0.7% to 17.8% of the health system expenditure. Furthermore, the total costs of obesity ranged from 0.05% to 2.42% of the country’s gross domestic product (GDP). Of the seven studies that estimated both direct and indirect costs, indirect costs accounted for the largest portion of five studies. Nevertheless, a variety in methodology across studies was identified. The number of co-morbidities included in the analysis varied across studies.
Conclusions:
Although there was a variety of methodologies across studies, consistent evidence indicated that the economic burden of obesity was substantial. Obesity prevention and control should be a public health priority, especially among countries with high prevalence of obesity.
Background:
There are limited longitudinal data on the cost of treating patients with cirrhosis which hampers value-based improvement initatives.
Methods:
We conducted a retrospective cohort study of patients with cirrhosis seen in the Veterans Affairs healthcare system from 2011 to 2015. Patients were followed up through 2019. We identified a sex- and age-matched control cohort without cirrhosis. We estimated incremental annual health care costs attributable to cirrhosis for 4 years overall and in subgroups based on severity (compensated, decompensated), cirrhosis complications (ascites, encephalopathy, varices, hepatocellular cancer, acute kidney injury), and comorbidity (Deyo index).
Results:
We compared 39,361 patients with cirrhosis and 138,964 controls. The incremental adjusted costs for caring of patients with cirrhosis were 32,473-14,216 to 50,080) or ascites (20,488) or hepatocellular cancer (64,413 and $66,653 in the first year, respectively.
Conclusion:
Patients with cirrhosis had substantially higher healthcare costs than matched controls and multimorbid patients had even higher costs. Cirrhosis complications accounted for most of the excess cost, so preventing complications has the largest potential for cost saving and could serve as targets for improvement.
Objective:
Hypertension is the most common risk factor for cardiovascular disease (CVD). Several guidelines have lowered diagnostic blood pressure (BP) thresholds and treatment targets for hypertension. We evaluated the impact of the more stringent guidelines among Veterans, a population at high risk of CVD.
Methods:
We conducted a retrospective analysis of Veterans with at least two office BP measurements between January 2016 and December 2017. Prevalent hypertension was defined as diagnostic codes related to hypertension, prescribed antihypertensive drugs, or office BP values according to the BP cutoffs at least 140/90 mmHg (Joint National Committee 7 [JNC 7]), at least 130/80 mmHg [American College of Cardiology/American Heart Association (ACC/AHA)], or the 2020 Veterans Health Administration (VHA) guideline (BP ≥130/90 mmHg). Uncontrolled BP was defined per the VHA guideline as mean SBP ≥130 mmHg or DBP ≥90 mmHg.
Results:
The prevalence of hypertension increased from 71% for BP at least 140/90 to 81% for BP at least 130/90 mmHg and further to 87% for BP at least 130/80 mmHg. Among Veterans with known hypertension (n = 2 768 826), a majority [n = 1 818 951 (66%)] were considered to have uncontrolled BP per the VHA guideline. Lowering the treatment targets for SBP and DBP significantly increased the number of Veterans who would require initiation of or intensification of pharmacotherapy. The majority of Veterans with uncontrolled BP and at least one CVD risk factor remained uncontrolled after 5 years of follow-up.
Conclusion:
Lowering the BP diagnostic and treatment cutoffs increases the burden on healthcare systems significantly. Targeted interventions are needed to achieve the BP treatment goals.
Importance
Bariatric surgery procedures, in particular Roux-en-Y gastric bypass (RYGB), have been associated with subsequent alcohol-related complications. However, previous studies lack data to account for changes in body mass index (BMI) or alcohol use over time, which are key potential confounders.
Objective
To evaluate the association between RYGB, sleeve gastrectomy, or gastric banding on subsequent alcohol use disorder (AUD)–related hospitalization and all-cause mortality as compared with referral to a weight management program alone.
Design, Setting, and Participants
This cohort study included 127 Veterans Health Administration health centers in the US. Patients who underwent RYGB, sleeve gastrectomy, or gastric banding or who were referred to MOVE!, a weight management program, and had a BMI (calculated as weight in kilograms divided by height in meters squared) of 30 or greater between January 1, 2008, and December 31, 2021, were included in the study.
Exposures
RYGB, sleeve gastrectomy, or gastric banding or referral to the MOVE! program.
Main Outcomes and Measures
The primary outcome was time to AUD-related hospitalization from the time of bariatric surgery or MOVE! referral. The secondary outcome was time to all-cause mortality. Separate propensity scores were created for each pairwise comparison (RYGB vs MOVE! program, RYGB vs sleeve gastrectomy, sleeve gastrectomy vs MOVE!). Sequential Cox regression approaches were used for each pairwise comparison to estimate the relative hazard of the primary outcome in unadjusted, inverse probability treatment weighting (IPTW)–adjusted (generated from the pairwise logistic regression models), and IPTW-adjusted approaches with additional adjustment for time-updating BMI and categorical Alcohol Use Disorders Identification Test-Concise scores.
Results
A total of 1854 patients received RYGB (median [IQR] age, 53 [45-60] years; 1294 men [69.8%]), 4211 received sleeve gastrectomy (median [IQR] age, 52 [44-59] years; 2817 men [66.9%]), 265 received gastric banding (median [IQR] age, 55 [46-61] years; 199 men [75.1%]), and 1364 were referred to MOVE! (median [IQR] age, 59 [49-66] years; 1175 men [86.1%]). In IPTW Cox regression analyses accounting for time-updating alcohol use and BMI, RYGB was associated with an increased hazard of AUD-related hospitalization vs MOVE! (hazard ratio [HR], 1.70; 95% CI, 1.20-2.41; P = .003) and vs sleeve gastrectomy (HR, 1.98; 95% CI, 1.55-2.53; P < .001). There was no significant difference between sleeve gastrectomy and MOVE! (HR, 0.76; 95% CI, 0.56-1.03; P = .08). While RYGB was associated with a reduced mortality risk vs MOVE! (HR, 0.63; 95% CI, 0.49-0.81; P < .001), this association was mitigated by increasing alcohol use over time.
Conclusions and Relevance
This cohort study found that RYGB was associated with an increased risk of AUD-related hospitalizations vs both sleeve gastrectomy and the MOVE! program. The mortality benefit associated with RYGB was diminished by increased alcohol use, highlighting the importance of careful patient selection and alcohol-related counseling for patients undergoing this procedure.
Objective
Elevated body mass index (BMI) is associated with multiple chronic conditions including diabetes and cardiovascular disease. Patients with overweight or obesity may also suffer from comorbidities not directly related to the pathophysiology of elevated BMI. The current study sought to determine the impact of BMI and different types of chronic conditions on health-related quality of life (HRQoL) outcomes.
Design
Six weight categories by BMI were identified: Underweight, Normal weight, Overweight, Class-I obesity, Class-II obesity, and Class-III obesity. Twenty chronic conditions were considered and categorized as elevated BMI-related (concordant) or -unrelated (discordant) conditions. HRQoL outcomes were measured using Short Form-6 Dimensions (SF-6D). Multivariable regression models were performed to examine the impact of type, number of comorbid conditions, and BMI categories on SF-6D scores.
Setting
Medical Expenditure Panel Survey (2013-2015).
Participants
Nationally representative sample of US population; 18 years or older (n=58,960).
Results
Of the sample, 1.7%, 32.9%, 34.0%, and 31.4% were classified as underweight, normal weight, overweight, and obese, respectively. The SF-6D scores were significantly decreased across all obesity classes, with the largest reduction in Class-III obesity (0.033; p < 0.001). Additionally, individuals with obesity having one or more concordant or discordant comorbidities further reduced SF-6D scores between 0.031 and 0.148 (p-values < 0.001) or between 0.080 and 0.212 (p-values < 0.001), respectively.
Conclusions
Individuals with obesity had a significant reduction in HRQoL outcomes compared to those with normal BMI. Importantly, discordant comorbidity resulted in greater reduction in HRQoL outcomes compared to concordant comorbidity in subjects with elevated BMI.
Importance:
Severe obesity and its related diseases, such as type 2 diabetes, hypertension, dyslipidemia, and sleep apnea, are very common in the United States, but currently very few patients with these conditions choose to undergo bariatric surgery. Summaries of the expanding evidence for both the benefits and risks of bariatric surgery are needed to better guide shared decision-making conversations.
Observations:
There are approximately 252 000 bariatric procedures (per 2018 numbers) performed each year in the US, of which an estimated 15% are revisions. The 1991 National Institutes of Health guidelines recommended consideration of bariatric surgery in patients with a body mass index (calculated as weight in kilograms divided by height in meters squared) of 40 or higher or 35 or higher with serious obesity-related comorbidities. These guidelines are still widely used; however, there is increasing evidence that bariatric procedures should also be considered for patients with type 2 diabetes and a body mass index of 30 to 35 if hyperglycemia is inadequately controlled despite optimal medical treatment for type 2 diabetes. Substantial evidence indicates that surgery results in greater improvements in weight loss and type 2 diabetes outcomes, compared with nonsurgical interventions, regardless of the type of procedures used. The 2 most common procedures used currently, the sleeve gastrectomy and gastric bypass, have similar effects on weight loss and diabetes outcomes and similar safety through at least 5-year follow-up. However, emerging evidence suggests that the sleeve procedure is associated with fewer reoperations, and the bypass procedure may lead to more durable weight loss and glycemic control. Although safety is a concern, current data indicate that the perioperative mortality rates range from 0.03% to 0.2%, which has substantially improved since early 2000s. More long-term randomized studies are needed to assess the effect of bariatric procedures on cardiovascular disease, cancer, and other health outcomes and to evaluate emerging newer procedures.
Conclusions and relevance:
Modern bariatric procedures have strong evidence of efficacy and safety. All patients with severe obesity-and especially those with type 2 diabetes-should be engaged in a shared decision-making conversation about the risks and benefits of surgery compared with continuing usual medical and lifestyle treatment, and the decision about surgery should be driven primarily by informed patient preferences.
Study objectives:
We examined the performance of a simple algorithm to accurately distinguish cases of diagnosed obstructive sleep apnea (OSA) and noncases using the electronic health record (EHR) across six health systems in the United States.
Methods:
Retrospective analysis of EHR data was performed. The algorithm defined cases as individuals with ≥ 2 instances of specific International Classification of Diseases (ICD)-9 and/or ICD-10 diagnostic codes (327.20, 327.23, 327.29, 780.51, 780.53, 780.57, G4730, G4733 and G4739) related to sleep apnea on separate dates in their EHR. Noncases were defined by the absence of these codes. Using chart reviews on 120 cases and 100 noncases at each site (n = 1,320 total), positive predictive value (PPV) and negative predictive value (NPV) were calculated.
Results:
The algorithm showed excellent performance across sites, with a PPV (95% confidence interval) of 97.1 (95.6, 98.2) and NPV of 95.5 (93.5, 97.0). Similar performance was seen at each site, with all NPV and PPV estimates ≥ 90% apart from a somewhat lower PPV of 87.5 (80.2, 92.8) at one site. A modified algorithm of ≥ 3 instances improved PPV to 94.9 (88.5, 98.3) at this site, but excluded an additional 18.3% of cases. Thus, performance may be further improved by requiring additional codes, but this reduces the number of determinate cases.
Conclusions:
A simple EHR-based case-identification algorithm for diagnosed OSA showed excellent predictive characteristics in a multisite sample from the United States. Future analyses should be performed to understand the effect of undiagnosed disease in EHR-defined noncases. This algorithm has wide-ranging applications for EHR-based OSA research.
Background:
Although the national obesity epidemic has been well documented, less is known about obesity at the U.S. state level. Current estimates are based on body measures reported by persons themselves that underestimate the prevalence of obesity, especially severe obesity.
Methods:
We developed methods to correct for self-reporting bias and to estimate state-specific and demographic subgroup-specific trends and projections of the prevalence of categories of body-mass index (BMI). BMI data reported by 6,264,226 adults (18 years of age or older) who participated in the Behavioral Risk Factor Surveillance System Survey (1993-1994 and 1999-2016) were obtained and corrected for quantile-specific self-reporting bias with the use of measured data from 57,131 adults who participated in the National Health and Nutrition Examination Survey. We fitted multinomial regressions for each state and subgroup to estimate the prevalence of four BMI categories from 1990 through 2030: underweight or normal weight (BMI [the weight in kilograms divided by the square of the height in meters], <25), overweight (25 to <30), moderate obesity (30 to <35), and severe obesity (≥35). We evaluated the accuracy of our approach using data from 1990 through 2010 to predict 2016 outcomes.
Results:
The findings from our approach suggest with high predictive accuracy that by 2030 nearly 1 in 2 adults will have obesity (48.9%; 95% confidence interval [CI], 47.7 to 50.1), and the prevalence will be higher than 50% in 29 states and not below 35% in any state. Nearly 1 in 4 adults is projected to have severe obesity by 2030 (24.2%; 95% CI, 22.9 to 25.5), and the prevalence will be higher than 25% in 25 states. We predict that, nationally, severe obesity is likely to become the most common BMI category among women (27.6%; 95% CI, 26.1 to 29.2), non-Hispanic black adults (31.7%; 95% CI, 29.9 to 33.4), and low-income adults (31.7%; 95% CI, 30.2 to 33.2).
Conclusions:
Our analysis indicates that the prevalence of adult obesity and severe obesity will continue to increase nationwide, with large disparities across states and demographic subgroups. (Funded by the JPB Foundation.).
To assess safety and outcomes (metabolic and liver) of bariatric surgery in patients with cirrhosis with or without portal hypertension.
This study is a retrospective review of 14 patients with Child's A cirrhosis with or without portal hypertension who were prospectively enrolled from February 23, 2009, through November 9, 2011, with 6- to 24-month follow-up after bariatric surgery (11 patients underwent sleeve gastrectomy [78.6%] and 3 gastric bypass [21.4%]). Four patients had portal hypertension detected by esophagogastroduodenoscopy.
The mean patient age was 55.5 years, and 10 of 14 patients were women. The mean weight decreased from 125±18 to 94±17 at 1 year (P<.001) and 93±17 kg at 2 years (P<.001) postsurgery. The prevalence of diabetes decreased from 10 of 14 patients to 4 of 12 (P=.01) and 1 of 6 (P=.02) at 1 and 2 years postsurgery. The frequency of dyslipidemia and hypertension decreased but was not statistically significant; however, the number of medications required to control them decreased. Hepatic steatosis was detected by perioperative liver biopsy in 13 of 14 patients (5%-30% steatosis in 6 patients, 31%-60% in 6, and >60% in 1). At 1 year postsurgery, only 1 of 8 patients who underwent follow-up ultrasound imaging showed evidence of steatosis. The bilirubin level was above 2 mg/dL in 1 patient at 1 year postsurgery. One patient had encephalopathy at 2 years postsurgery. None of the patients developed peri- or postoperative bleeding or surgical complications.
Bariatric surgery in patients with compensated cirrhosis even with mild portal hypertension is well tolerated and safe with minimal risk of postoperative complications if performed in a large referral center. This population can experience the beneficial effects of weight loss and improved metabolic syndrome, as well as reduced hepatic steatosis.
Copyright © 2015 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.
Objective:
To provide state-level estimates of obesity-attributable costs of absenteeism among working adults in the United States.
Methods:
Nationally representative data from the National Health and Nutrition Examination Survey for 1998 to 2008 and from the Behavioral Risk Factor Surveillance System for 2012 are examined. The outcome is obesity-attributable workdays missed in the previous year because of health and their costs to states.
Results:
Obesity, but not overweight, is associated with a significant increase in workdays absent, from 1.1 to 1.7 extra days missed annually compared with normal-weight employees. Obesity-attributable absenteeism among American workers costs the nation an estimated $8.65 billion per year.
Conclusions:
Obesity imposes a considerable financial burden on states, accounting for 6.5% to 12.6% of total absenteeism costs in the workplace. State legislatures and employers should seek effective ways to reduce these costs.
Background:
Given the rising epidemics of obesity and metabolic syndrome, nonalcoholic steatohepatitis (NASH) is now the most common cause of liver disease in the developed world. Effective treatment for NASH, either to reverse or prevent the progression of hepatic fibrosis, is currently lacking.
Aim:
To define the predictors associated with improved hepatic fibrosis in NASH patients undergoing serial liver biopsies at prolonged biopsy interval.
Methods:
This is a cohort study of 45 NASH patients undergoing serial liver biopsies for clinical monitoring in a tertiary care setting. Biopsies were scored using the NASH Clinical Research Network guidelines. Fibrosis regression was defined as improvement in fibrosis score ≥1 stage. Univariate analysis utilized Fisher's exact or Student's t test. Multivariate regression models determined independent predictors for regression of fibrosis.
Results:
Forty-five NASH patients with biopsies collected at a mean interval of 4.6 years (±1.4) were included. The mean initial fibrosis stage was 1.96, two patients had cirrhosis and 12 patients (26.7 %) underwent bariatric surgery. There was a significantly higher rate of fibrosis regression among patients who lost ≥10 % total body weight (TBW) (63.2 vs. 9.1 %; p = 0.001) and who underwent bariatric surgery (47.4 vs. 4.5 %; p = 0.003). Factors such as age, gender, glucose intolerance, elevated ferritin, and A1AT heterozygosity did not influence fibrosis regression. On multivariate analysis, only weight loss of ≥10 % TBW predicted fibrosis regression [OR 8.14 (CI 1.08-61.17)].
Conclusion:
Results indicate that regression of fibrosis in NASH is possible, even in advanced stages. Weight loss of ≥10 % TBW predicts fibrosis regression.
& Aims: At least 40% of patients with cirrhosis have comorbidities, which increase mortality. We developed a cirrhosis-specific comorbidity scoring system (CirCom) to help determine how these comorbidities affect mortality, and compared it with the generic Charlson Comorbidity Index.
We used data from nationwide healthcare registries to identify Danish citizens diagnosed with cirrhosis in 1999-2008 (n=12,976). They were followed through 2010 and characterized by 34 comorbidities. We used Cox regression to assign severity weights to comorbidities with an adjusted mortality hazard ratio ≥1.20. Each patient's CirCom score was based on at most 2 of these comorbidities. Performance was measured with Harrell's C statistic and the Net Reclassification Index (NRI), and results were compared with those obtained using the Charlson index (based on 17 comorbidities). Findings were validated in 2 separate cohorts of patients with alcohol-related cirrhosis or chronic hepatitis C.
The CirCom score included chronic obstructive pulmonary disease, acute myocardial infarction, peripheral arterial disease, epilepsy, substance abuse, heart failure, non-metastatic cancer, metastatic cancer, and chronic kidney disease; 24.2% of patients had 1 or more of these, and mortality correlated with the CirCom score. Patients' CirCom score correlated with their Charlson Comorbidity Index (Kendall's τ = 0.57, P<.0001). Compared with the Charlson index, the CirCom score increased Harrell's C statistic by 0.6% (95% confidence interval, 0.3%-0.8%). The NRI for the CirCom score was 5.2% (95% confidence interval, 3.7%-6.9%), whereas the NRI for the Charlson index was 3.6% (95% confidence interval, 2.3%-5.0%). Similar results were obtained from the validation cohorts.
We developed a scoring system to predict mortality among patients with cirrhosis, based on 9 comorbidities. This system had higher C statistic and NRI values than the Charlson Comorbidity Index, and is easier to use. It could therefore be a preferred method to predict death or survival of patients and for epidemiologic studies.
Importance:
Weight loss surgery (WLS) has been shown to produce long-term weight loss but is not risk free or universally effective. The weight loss expectations and willingness to undergo perioperative risk among patients seeking WLS remain unknown.
Objectives:
To examine the expectations and motivations of WLS patients and the mortality risks they are willing to undertake and to explore the demographic characteristics, clinical factors, and patient perceptions associated with high weight loss expectations and willingness to assume high surgical risk.
Design:
We interviewed patients seeking WLS and conducted multivariable analyses to examine the characteristics associated with high weight loss expectations and the acceptance of mortality risks of 10% or higher.
Setting:
Two WLS centers in Boston.
Participants:
Six hundred fifty-four patients.
Main outcome measures:
Disappointment with a sustained weight loss of 20% and willingness to accept a mortality risk of 10% or higher with WLS.
Results:
On average, patients expected to lose as much as 38% of their weight after WLS and expressed disappointment if they did not lose at least 26%. Most patients (84.8%) accepted some risk of dying to undergo WLS, but only 57.5% were willing to undergo a hypothetical treatment that produced a 20% weight loss. The mean acceptable mortality risk to undergo WLS was 6.7%, but the median risk was only 0.1%; 19.5% of all patients were willing to accept a risk of at least 10%. Women were more likely than men to be disappointed with a 20% weight loss but were less likely to accept high mortality risk. After initial adjustment, white patients appeared more likely than African American patients to have high weight loss expectations and to be willing to accept high risk. Patients with lower quality-of-life scores and those who perceived needing to lose more than 10% and 20% of weight to achieve "any" health benefits were more likely to have unrealistic weight loss expectations. Low quality-of-life scores were also associated with willingness to accept high risk.
Conclusions and relevance:
Most patients seeking WLS have high weight loss expectations and believe they need to lose substantial weight to derive any health benefits. Educational efforts may be necessary to align expectations with clinical reality.
The prevalence of nonalcoholic fatty liver disease and ensuing cirrhosis is expected to increase as a result of the obesity epidemic. These trends might increase the number of bariatric surgeries among patients with cirrhosis. We sought to assess the impact of cirrhosis on perioperative mortality after bariatric procedures.
Data on patients who underwent bariatric surgery in the United States between 1998 and 2007 were extracted from the Nationwide Inpatient Sample. In-hospital mortality and length of stay were compared for patients with no cirrhosis, compensated cirrhosis, and decompensated cirrhosis.
Patients without cirrhosis had lower mortality rates than those with compensated and decompensated cirrhosis (0.3% vs 0.9% and 16.3%, respectively, P = .0002). After adjusting for covariates, the adjusted odds ratio of mortality among compensated and decompensated cirrhotic patients compared with noncirrhotic patients was 2.17 (95% confidence interval, 1.03-4.55) and 21.2 (95% confidence interval, 5.39-82.9), respectively. Mortality increased with volume of surgery among centers; those with more than 100 surgeries per year had the lowest mortality rates, compared with those with 50 to 100 surgeries per year and fewer than 50 surgeries per year (0.2% vs 0.4% and 0.7%, respectively; P < .0001). The average length of stay was longer for patients with decompensated and compensated cirrhosis, compared with patients without liver disease (6.7 and 4.4 d vs 3.2 d, respectively; P = .0001 and P = .03).
Bariatric surgery in patients with cirrhosis should be performed while liver disease is well compensated. Patients with cirrhosis should undergo surgery at centers that perform large numbers of these procedures.
Over 23 million Americans are afflicted with severe obesity, i.e. their body mass index (in kilograms per square meter) values exceed 35. Of even greater concern is the association of the adiposity with comorbidities such as diabetes, hypertension, cardiopulmonary failure, asthma, pseudotumor cerebri, infertility, and crippling arthritis.
Diets, exercise, behavioral modification, and drugs are not effective in these individuals. This article examines the effect of surgery on the control of the weight and the comorbidities, as well as the safety of these operations.
Although the article focuses on the outcomes of the three most commonly performed operations, i.e. adjustable gastric banding, the gastric bypass, and the biliopancreatic bypass with duodenal switch, it aims for perspective with the inclusion of abandoned and current investigational procedures, a review of the complications, and an emphasis on the appropriate selection of patients. POSITIONS: Ample evidence, including controlled randomized studies, now document that bariatric surgery produces durable weight loss exceeding 100 lb (46 kg), full and long-term remission of type 2 diabetes in over 80% with salutary effects on the other comorbidities as well with significant reductions in all-cause mortality. Although the severely obese present with serious surgical risks, bariatric surgery is performed safely with a 0.35% 90-d mortality in Centers of Excellence throughout the United States-similar to the complication rates after cholecystectomy.
Until better approaches become available, bariatric surgery is the therapy of choice for patients with severe obesity.
Critics charge that Veterans Health Administration (VA) medical centers are inefficient and the cost of veteran health care would be reduced if VA purchased care for its patients directly from private-sector providers. This analysis compares VA medical care expenditures with estimates of total payments under a hypothetical Medicare fee-for-service payment system reimbursing providers for the same counts of each service VA medical centers provided in fiscal 1999. At six study sites, hypothetical payments were more than 20 percent greater than actual budgets. Nationally, this represented more than 3 billion US dollars in 1999 and more than 5 billion US dollars in 2003. Data limitations suggest the estimate is conservative. Less than half of the difference is due to VA's low pharmacy costs. The study demonstrates the potential savings to patients and taxpayers of the VA health care system.
To analyze the socioeconomics of the morbidly obese patient population and the impact on access to bariatric surgery using 2 nationally representative databases. Bariatric surgery is a life-changing and potentially life-saving intervention for morbid obesity. Access to bariatric surgical care among eligible patients might be adversely affected by a variety of socioeconomic factors.
The national bariatric eligible population was identified from the 2005-2006 National Health and Nutrition Examination Survey and compared with the adult noneligible population. The eligible cohort was then compared with patients who had undergone bariatric surgery in the 2006 Nationwide Inpatient Sample, and key socioeconomic disparities were identified and analyzed.
A total of 22,151,116 people were identified as eligible for bariatric surgery using the National Institutes of Health criteria. Compared with the noneligible group, the bariatric eligible group had significantly lower family incomes, lower education levels, less access to healthcare, and a greater proportion of nonwhite race (all P <.001). Bariatric eligibility was associated with significant adverse economic and health-related markers, including days of work lost (5 versus 8 days, P <.001). More than one third (35%) of bariatric eligible patients were either uninsured or underinsured, and 15% had incomes less than the poverty level. A total of 87,749 in-patient bariatric surgical procedures were performed in 2006. Most were performed in white patients (75%) with greater median incomes (80%) and private insurance (82%). Significant disparities associated with a decreased likelihood of undergoing bariatric surgery were noted by race, income, insurance type, and gender.
Socioeconomic factors play a major role in determining who does and does not undergo bariatric surgery, despite medical eligibility. Significant disparities according to race, income, education level, and insurance type continue to exist and should prompt focused public health efforts aimed at equalizing and expanding access.
The objective was to determine the best strategy for identifying outpatients with hypertension-related diagnoses using Veterans Affairs (VA) administrative databases. We reviewed 1176 outpatient charts from 10 VA sites in 1999, taking the presence of 11 diagnoses relevant to hypertension management as the "gold standard" for identifying the comorbidity. We calculated agreement, sensitivity, and specificity for the chart versus several administrative data-based algorithms. Using 1999 data and requiring 1 administrative diagnosis, observed agreement ranged from 0.98 (atrial fibrillation) to 0.85 (hyperlipidemia), and kappas were generally high. Sensitivity varied from 38% (tobacco use) to 97% (diabetes); specificity exceeded 91% for 10 of 11 diagnoses. Requiring 2 years of data and 2 diagnoses improved most measures, with minimal sensitivity decrease. Agreement between the database and charts was good. Administrative data varied in its ability to identify all patients with a given diagnosis but identified accurately those without. The best strategy for case-finding required 2 diagnoses in a 2-year period.
Bariatric surgery has become an increasingly popular treatment option for individuals with extreme obesity (defined as a BMI > or = 40 kg/m2) or those with less severe obesity accompanied by significant comorbidities. Sustained postoperative weight loss and improvements in obesity-related health problems make bariatric surgery the most effective treatment for this population. Nevertheless, most experts agree that psychosocial and behavioral factors contribute to successful postoperative outcomes. This paper reviews the literature on the preoperative psychosocial status, eating behaviors, and quality of life of patients who seek bariatric surgery. In addition, the paper examines studies that investigated changes in these factors postoperatively. The review concludes with an agenda for future research in this area.
Despite widespread use of generic health-related quality-of-life (HRQoL) scores, few have publicly published nationally representative US values.
To create current nationally representative values for 7 of the most common HRQoL scores, stratified by age and sex.
The authors used data from the 2001 Medical Expenditures Panel Survey (MEPS) and the 2001 National Health Interview Survey (NHIS), nationally representative surveys of the US noninstitutionalized civilian population: The MEPS was used to calculate 6 HRQoL scores: categorical self-rated health, EuroQoL-5D with US scoring, EuroQoL-5D with UK scoring, EuroQol Visual Analog Scale, mental and physical component summaries from the SF-12, and the SF-6D. The authors estimated Quality of Well-being scale scores from the NHIS.
They included 22,523 subjects from MEPS 2001 and 32,472 subjects from NHIS 2001. Most age and sex categories had instrument completion rates above 85%. Females reported lower scores than males across all ages and instruments. In general, those in older age groups reported lower scores than younger age groups, with the exception of the mental component summary from the SF-12.
This is one of the first sets of publicly available, nationally representative US values for any standardized HRQoL measure. These values are important for use in both generalized comparisons of health status and in cost-effectiveness analyses.
Currently, no clinically useful scoring system is available to stratify the mortality risk for patients undergoing gastric bypass (GBP). We propose the obesity surgery mortality risk score as a clinically useful score system to predict the mortality risk for patients undergoing GBP.
Prospectively collected data from 2075 consecutive patients undergoing GBP at a single university from 1995 to 2004 were analyzed to determine the preoperative factors correlating with 90-day mortality.
Four independent variables correlated with mortality using multivariate analysis, including body mass index >or =50 kg/m(2) (odds ratio [OR] 3.60, 95% confidence interval [CI] 1.44-8.99), male gender (OR 2.80, 95% CI 1.32-5.92), hypertension (OR 2.78, 95% CI 1.11-7.00), and a novel variable pulmonary embolus risk, that included previous thrombosis, pulmonary embolus, inferior vena cava filter, right heart failure, and obesity hypoventilation (OR 2.62, 95% CI 1.12-6.12). A fifth variable, patient age > or =45 years (OR 1.64, 95% CI 0.78-3.48), significant on univariate analysis, was added to the ultimate scoring system because of its significance in other studies. A scoring system was developed by arbitrarily scoring the presence of each independent variable as equal to 1 point, resulting in an overall score of 0-5 points for each patient. The factors were grouped into 3 risk classes (A, B, or C) to increase the evaluable cases in each class (e.g., <1% of 2075 patients accrued all 5 points). The mortality rate among the 3 risk classes was significantly different: class A, 0.31%; class B, 1.90%; and class C, 7.56%.
The analysis reveals that mortality risk for gastric bypass can be stratified based upon independent variables that can be identified before surgery. The OS-MRS, a simple, clinically relevant scoring system, is proposed, which stratifies mortality risk into low (Class A), intermediate (Class B), and high (Class C) risk groups in the current study population. This risk assessment scoring system may contribute to surgical decision making in bariatric surgery if its ability to stratify risk is validated in subsequent studies.