Growth of community-based immunotherapy treatment in the Veterans Health Administration.

BACKGROUND: The MISSION and CHOICE Acts expanded the Veterans Health Administration's (VA) capacity to purchase immunotherapy services for VA patients from community-based providers. Our objective was to identify predictors of community-based immunotherapy treatment, and assess differences in cost and utilization across community treatment settings METHODS: We examined claims for 21,257 patients who started immunotherapy treatment between 2015 and 2020. We assessed growth in VA community-based immunotherapy care, predictors of community-based immunotherapy treatment using multivariable logistic regression based on patients' sociodemographic and clinical characteristics. We compared utilization and costs among those who received community-based immunotherapy services in hospital outpatient departments (HOPDs) versus physician office settings (POs). RESULTS: The proportion of community-based immunotherapy in the VA increased from 5.3% in 2015 to 32.1% in 2020, with total annual costs of immunotherapy growing from $6.1 million to $187 million. Older, married, and rural patients and those with more comorbidities were more likely than younger, single, or urban patients to be treated in the community. Black patients were more likely to be treated in the VA. Respiratory Cancer was the most common cancer type in both settings. Among community immunotherapy patients, we observed no meaningful differences in the number of units administered, the unit drug costs, or the cost per immunotherapy visit between POs and HOPDs. CONCLUSION: Drug costs did not differ widely across HOPDs and POs among VA patients who receive community-based immunotherapy.

What is the role of selection bias in quality comparisons between the Veterans Health Administration and community care? Example of elective hernia surgery.

OBJECTIVE: To investigate the relationship between community care (CC) treatment and a postoperative surgical complication in elective hernia surgery among Veterans using multiple approaches to control for potential selection bias. DATA SOURCES AND STUDY SETTING: Veterans Health Administration (VHA) data sources included Corporate Data Warehouse (VHA encounters and patient data), the Program Integrity Tool and Fee tables (CC encounters), the Planning Systems Support Group (geographic information), and the Paid file (VHA primary care providers). STUDY DESIGN: Prior works suggest patient outcomes are better in VHA than in CC settings; however, these studies may not have appropriately accounted for the selection of higher-risk cases into CC. We estimated (1) a naïve logistic regression model to calculate the effect of CC setting on the probability of a complication, controlling for facility fixed effects and patient and procedure characteristics, and (2) a 2-stage model using the hernia patient's primary care provider's 1-year prior CC referral rate as the instrument. DATA COLLECTION: We identified patients residing ≤40 miles from a VHA surgical facility with elective VHA or CC hernia surgery from 2018 to 2019. PRINCIPAL FINDINGS: Of 7991 hernia surgeries, 772 (9.7%) were in CC. The overall complication rate was 4.2%; 286/7219 (4.0%) among VHA surgeries versus 51/5772 (6.6%, p < 0.05) in CC. We observed a 2.8 percentage point increase in the probability of postoperative complication given CC surgery (95% confidence interval: 0.7, 4.8) in the naïve model. After accounting for the VHA provider's historical rate of CC referral, we no longer observed a relationship between surgery setting and risk of postoperative complication. CONCLUSIONS: After accounting for the selection of higher-risk patients to CC settings, we found no difference in hernia surgery postoperative complications between CC and VHA. Future VHA and non-VHA comparisons should account for unobserved as well as observed differences in patients seen in each setting.

Effectiveness of a ketogenic diet and virtual coaching intervention for patients with diabetes: A difference-in-differences analysis.

AIM: To test the effectiveness of a ketogenic diet and virtual coaching intervention in controlling markers of diabetes care and healthcare utilization. MATERIALS AND METHODS: Using a difference-in-differences analysis with a waiting list control group-a quasi-experimental methodology-we estimated the 5-month change in HbA1c, body mass index, blood pressure, prescription medication use and costs, as well as healthcare utilization. The analysis included 590 patients with diabetes who were also overweight or obese, and who regularly utilize the Veterans Health Administration (VA) for healthcare. We used data from VA electronic health records from 2018 to 2020. RESULTS: The ketogenic diet and virtual coaching intervention was associated with significant reductions in HbA1c (-0.69 [95% CI -1.02, -0.36]), diabetes medication fills (-0.38, [-0.49, -0.26]), body mass index (-1.07, [-1.95, -0.19]), diastolic blood pressure levels (-1.43, [-2.72, -0.14]), outpatient visits (-0.36, [-0.70, -0.02]) and prescription drug costs (-34.54 [-48.56, -20.53]). We found no significant change in emergency department visits (-0.02 [-0.05, 0.01]) or inpatient admissions (-0.01 [-0.02, 0.01]). CONCLUSIONS: This real-world assessment of a virtual coaching and diet programme shows that such an intervention offers short-term benefits on markers of diabetes care and healthcare utilization in patients with diabetes.

Colder Weather and Fewer Sunlight Hours Increase Alcohol Consumption and Alcoholic Cirrhosis Worldwide.

Risk of alcoholic cirrhosis is determined by genetic and environmental factors. We aimed to investigate if climate has a causal effect on alcohol consumption and its weight on alcoholic cirrhosis. We collected extensive data from 193 sovereign countries as well as 50 states and 3,144 counties in the United States. Data sources included World Health Organization, World Meteorological Organization, and the Institute on Health Metrics and Evaluation. Climate parameters comprised Koppen-Geiger classification, average annual sunshine hours, and average annual temperature. Alcohol consumption data, pattern of drinking, health indicators, and alcohol-attributable fraction (AAF) of cirrhosis were obtained. The global cohort revealed an inverse correlation between mean average temperature and average annual sunshine hours with liters of annual alcohol consumption per capita (Spearman's rho -0.5 and -0.57, respectively). Moreover, the percentage of heavy episodic drinking and total drinkers among population inversely correlated with temperature -0.45 and -0.49 (P < 0.001) and sunshine hours -0.39 and -0.57 (P < 0.001). Importantly, AAF was inversely correlated with temperature -0.45 (P < 0.001) and sunshine hours -0.6 (P < 0.001). At a global level, all included parameters in the univariable and multivariable analysis showed an association with liters of alcohol consumption and drinkers among population once adjusted by potential confounders. In the multivariate analysis, liters of alcohol consumption associated with AAF. In the United States, colder climates showed a positive correlation with the age-standardized prevalence of heavy and binge drinkers. Conclusion: These results suggest that colder climates may play a causal role on AAF mediated by alcohol consumption.

Disparities between research attention and burden in liver diseases: implications on uneven advances in pharmacological therapies in Europe and the USA.

OBJECTIVES: Effective oral therapies for hepatitis B and C have recently been developed, while there are no approved pharmacological therapies for alcoholic and non-alcoholic fatty liver diseases (ALD and NAFLD). We hypothesise that fewer advances in fatty liver diseases could be related to disparities in research attention. METHODS: We developed the Attention-to-Burden Index (ABI) that compares the research activities during 2010-2014, and an estimate of disease burden of these 4 major liver diseases. The resulting ratio reflects either overattention (positive value) or inadequate attention (negative value) compared with disease burden. The mean research attention and disease burden were calculated from 5 and 6 different parameters, respectively. The efficacy rate of current pharmacological therapies was assessed from published clinical trials. FINDINGS: The mean research attention for hepatitis B and C was 31% and 47%, respectively, while NAFLD and ALD received 17% and 5%. The overall burden was 5% and 28% for hepatitis B and C, and 17% and 50% for NAFLD and ALD. The calculated ABI for hepatitis B and C revealed a +6.7-fold and +1.7-fold overattention, respectively. NAFLD received an appropriate attention compared with its burden, while ALD received marked inadequate attention of -9.7-fold. The efficacy rate of current pharmacological agents was 72% for hepatitis B, 89% for hepatitis C, 25% for non-alcoholic steatohepatitis and 13% for alcoholic hepatitis. Importantly, we found a positive correlation between the mean attention and the efficacy rate of current therapies in these 4 major liver diseases. INTERPRETATION: There are important disparities between research attention and disease burden among the major liver diseases. While viral hepatitis has received considerable attention, there is a marked inadequate attention to ALD. There is a critical need to increase awareness of ALD in the liver research community.

Reduced impact of renal failure on the outcome of patients with alcoholic liver disease undergoing liver transplantation.

BACKGROUND & AIMS: Pretransplant renal failure is commonly reported to be a poor prognostic indicator affecting survival after liver transplantation (LT). However, whether the impact of renal failure on patient outcome varies according to the aetiology of the underlying liver disease is largely unknown. METHODS: We investigated the association between renal failure at the time of LT and patient outcome in patients with alcoholic liver disease (ALD) (n = 6920), non-alcoholic steatohepatitis (NASH) (n = 2956) and hepatitis C (HCV) (n = 14 922) using the United Network for Organ Sharing (UNOS) database between February 2002 and December 2013. A total of 24 798 transplant recipients were included. RESULTS: The presence of renal failure was more frequently seen in patients with ALD (23.95%) and NASH (23.27%) compared to patients with HCV (19.38%) (P < 0.001). In multivariate analysis, renal failure was an independent predictor of poor survival. Renal failure showed detrimental effect on patient survival in the overall series (HR = 1.466, P < 0.0001). Importantly, the impact of renal failure was less marked in patients with ALD (HR = 1.31, P < 0.0001) than in patients with NASH (HR = 1.73, P < 0.0001) or HCV (HR = 1.52, P < 0.0001). Despite a higher model for end-stage liver disease (MELD) score at the time of LT, ALD patients with renal failure had better long-term prognosis than non-ALD patients. CONCLUSIONS: Renal failure at the time of LT conferred a lower patient and graft survival post-LT. However, renal failure has less impact on the outcome of patients with ALD than that of patients with non-alcoholic liver disease after LT.

Heavy daily alcohol intake at the population level predicts the weight of alcohol in cirrhosis burden worldwide.

BACKGROUND & AIMS: Studies assessing alcohol as a population level risk factor for cirrhosis typically focus on per capita consumption. However, clinical studies indicate that daily intake is a strong predictor of alcoholic cirrhosis. We aimed to identify the determinants of alcohol's contribution to the global cirrhosis burden and to evaluate the influence of daily drinking on a population level. METHODS: We performed a comprehensive analysis of the WHO 2014 Global Status Report on Alcohol and Health. We categorized countries by heavy or moderate drinking based on daily consumption, using U.S. Department of Agriculture definitions of heavy drinking. Additional data on cirrhosis cofactors were also obtained. Uni- and multivariate models were fitted to identify independent predictors of the alcohol-attributable fraction of cirrhosis. RESULTS: The WHO 2014 Report found that half of cirrhosis mortality worldwide is attributable to alcohol, approximating 60% in North America and Europe. In an integrative multivariate model, the designation of countries by moderate or heavy daily drinking had the strongest influence on the weight of alcohol in the cirrhosis burden. The relative contribution from alcohol increased by 11% with a transition from the moderate to heavy classification (p<0.001). Importantly, drinking patterns such as heavy episodic drinking and the type of alcohol did not independently predict the alcohol-attributable fraction of cirrhosis. CONCLUSIONS: Heavy daily drinking on a population level significantly influences the weight of alcohol in the cirrhosis burden. Reducing heavy drinking should be considered as an important target for public health monitoring and policies. LAY SUMMARY: We carried out an analysis of the WHO 2014 Global Status Report on Alcohol and Health, and categorized countries by their level of drinking (heavy or moderate). We found that half of the global cirrhosis cases, and 60% in both North America and Europe are associated with alcohol intake. We concluded that on a population level heavy daily drinking significantly influences the impact of alcohol on the cirrhosis burden.