Papers by ONKAR KSHIRSAGAR
Diabetes
Objective: To assess the association between foot care by podiatric surgeons and outcomes of new ... more Objective: To assess the association between foot care by podiatric surgeons and outcomes of new diabetic foot ulceration (DFU) among patients with end-stage renal disease (ESRD) . Methods: We used the 2015 and 2016 claim data from the United States Renal Data System to identify patients (≥ 40 years and on dialysis for ≥ 12 months) with a new diagnosis of DFU. The patients were stratified into intervention or control cohort based on whether they received any foot care by a podiatric surgeon within 12 months before the diagnosis of a new DFU. Patients were followed from the index DFU date until December 31, 2018. The study outcome was amputation-free survival (composite endpoint of mortality and major amputation) . Adjusted comparisons between preventive foot care and its association with outcomes were performed by Cox-regression analysis after propensity score matching for age, gender, race, hospitalizations, and Charlson Comorbidity Index (CCI) . Results: Among the 51,362 ESRD pati...
Journal of Hepatology, 2018
Results: Twenty-nine patients were excluded from the analysis, 20 (7.6%) since they had F2/F3 OV ... more Results: Twenty-nine patients were excluded from the analysis, 20 (7.6%) since they had F2/F3 OV at baseline and were treated with betablockers (BB), and 9 (3.7%) since they did not achieve SVR. Overall, 234 SVR patients were analysed. At baseline, 83 patients (35.5%) did not have OV and 151 (64.5%) had small OV. None received betablockers. After a median time of 24.5 months EGS showed de novo development of OV in 17/83 (20.5%) patients and progression from F1 to F2/F3 OV in 27/151 patients (17.9%), p = 0.58 by Kaplan Meier. By Cox regression analysis, LSPS as continuum variable (HR:1.05, CI95%:1.01-1.10, p = 0.046) or at a cut off ≥3 (HR:2.87, CI95%:1.44-5.72, p = 0.003) was associated with OV progression. Age (p = 0.15), gender (p = 0.93), BMI (p = 0.84) and SVR did not correlate with progression of OV. Conclusion: Progression of clinically significant portal hypertension, as assessed by the evolution of oesophagogastric varices, is not uncommon among patients with HCV cirrhosis after HCV clearance. Non-invasive evaluation using combined data of LS, spleen diameter, and platelet count can assist in identifying patients in whom portal hypertension is likely to progress notwithstanding SVR.
Gastroenterology, 2018
Background: Current antiviral therapies delay progression to cirrhosis in patients with viral hep... more Background: Current antiviral therapies delay progression to cirrhosis in patients with viral hepatitis. However, among those listed for liver transplantation (LT) there is concern over a growing population who achieve improved MELD scores but not quality of life ('MELD purgatory'). Aim: Evaluate trends and disparities in waitlist (WL) removal due to LT, clinical deterioration, death, and clinical improvement among U.S. adults. Methods: We retrospectively evaluated U.S. adults with chronic hepatitis C virus (HCV), non-alcoholic steatohepatitis (NASH), chronic hepatitis B virus (HBV), alcoholic cirrhosis (EtOH), and EtOH/HCV listed for LT between 1/1/2002-12/31/2016 using the United Network for Organ Sharing registry. Treatment eras were categorized into before and after availability of current direct acting antivirals (DAA) for HCV (
American Journal of Gastroenterology, 2021
INTRODUCTION To evaluate the impact of chronic hepatitis B virus infection (CHB) treatment on ris... more INTRODUCTION To evaluate the impact of chronic hepatitis B virus infection (CHB) treatment on risk of cirrhosis, liver-related outcomes, and death among a diverse CHB cohort with a large proportion of African Americans. METHODS Adults with noncirrhotic CHB without human immunodeficiency virus from 2010 to 2018 were retrospectively evaluated across 4 US safety-net health systems. CHB was identified with International Classification of Diseases, Ninth Revision/Tenth Revision diagnosis coding and confirmatory laboratory data. Propensity-score matching, Kaplan-Meier methods, and adjusted Cox proportional hazards models were used to evaluate impact of CHB treatment on risk of cirrhosis, hepatocellular carcinoma (HCC), death, and composite of cirrhosis, HCC, or death. RESULTS Among 4,064 CHB patients (51.9% female, 42.0% age <45 years, 31.6% African American, 26.6% Asian, 26.7% Hispanic), 23.2% received CHB antiviral therapy and 76.8% did not. Among the propensity score-matched cohort (428 treated and 428 untreated), CHB treatment was associated with lower risk of cirrhosis (hazards ratio 0.65, 95% confidence interval 0.46-0.92, P = 0.015) and composite of cirrhosis, HCC, or death (hazards ratio 0.67, 95% confidence interval 0.49-0.94, P = 0.023). Females vs males and African Americans vs non-Hispanic whites had significantly lower risk of cirrhosis. When treatment effects were stratified by age, sex, and ethnicity, the benefits of antiviral therapies in reducing risk of cirrhosis were seen primarily in CHB patients who were females, age <45 years, and of Asian ethnicity. DISCUSSION Our propensity score-matched cohort of noncirrhotic CHB patients demonstrated significant reductions in risk of cirrhosis due to CHB treatment.
Journal of Clinical Gastroenterology, 2021
Background: Timely initiation of antiviral therapy in chronic hepatitis B virus (CHB) reduces ris... more Background: Timely initiation of antiviral therapy in chronic hepatitis B virus (CHB) reduces risk of disease progression. We evaluate overall treatment rates and predictors of treatment among treatment-eligible safety-net CHB patients. Methods: We retrospectively evaluated adults with CHB from 2010 to 2018 across 4 large safety-net health systems in the United States. CHB was identified with ICD-9/10 diagnosis coding and confirmed with laboratory data. Treatment eligibility was determined using American Association for the Study of Liver Diseases (AASLD) guidelines. Comparison of CHB treatment rates among treatment-eligible patients were performed using χ2 testing, Kaplan Meier methods and log-rank testing. Adjusted multivariate Cox proportional hazards models evaluated independent predictors of receiving treatment among eligible patients. Results: Among 5157 CHB patients (54.7% male, 34.6% African American, 22.3% Asian), 46.8% were treatment-eligible during the study period. CHB treatment rates were 48.4% overall and 37.3% among CHB patients without human immunodeficiency virus. Significantly lower odds of treatment were observed in females versus males (odds ratio: 0.40, 95% confidence interval: 0.33-0.49, P<0.001) and patients age 65 years or above versus age below 45 years (odds ratio: 0.68, 95% confidence interval: 0.51-0.92, P=0.012). Conversely, significantly greater odds of treatment were observed in African American and Asians versus non-Hispanic whites, CHB patients with indigent care versus commercially insured patients, and non-English speaking versus English speaking patients. Conclusion: Among a large multicentered, safety-net cohort of CHB patients, 46.8% of treatment-eligible CHB patients overall and 37.3% of treatment-eligible CHB patients without human immunodeficiency virus received antiviral therapy. Improving CHB treatment rates among treatment-eligible patients represents “low hanging fruit,” given the clear benefits of antiviral therapy in mitigating disease progression.
Journal of Hepatology, 2020
Gastroenterology, 2019
This is a 24-week prospective, cohort study to compare baseline and changes in aortic pulse wave ... more This is a 24-week prospective, cohort study to compare baseline and changes in aortic pulse wave velocity (PWV), glucose homeostasis (HOMA-IR), systemic inflammation [interleukin-6 (IL6), soluble tumor necrosis factor α receptors 1 and 2 (sTNF-R1 and-R2)], monocyte activation (soluble CD14 and CD163), and gut integrity [intestinal fatty acid binding protein (IFAB)] among adults with HIV, HCV, HIV/HCV or neither infection (controls) and after HCV treatment in HCV and HIV/HCV. Adults without CVD or diabetes and on stable antiretroviral therapy (HIV and HIV/HCV) were included. Pairwise comparisons of log-transformed outcome variables were made at baseline and absolute changes over 24 weeks were compared within and between groups that underwent HCV treatment. Analysis of covariance (ANCOVA) was used for adjustment. Results: 126 subjects (25 HIV, 35 HCV, 39 HIV/HCV, 27 controls) were included. 54 (30 HCV, 24 HIV/HCV) received DAAs and attained sustained virologic response (SVR). Groups were similar except HCV subjects were older (56 vs 51 years) and more likely to have HTN (51 vs 23%); controls were more likely Caucasian (85 vs 48%) and non-smokers (81 vs 38%). Of those who underwent HCV treatment, 77% initiated ledipasvir/sofosbuvir. Baseline PWV was not different among groups and 0-24 week changes were not significant within or between groups treated for HCV (p=0.46 for between group test). Baseline HOMA-IR was higher in HIV/HCV than HIV and HCV trended to be higher than controls, but did not change after DAAs (p=0.89 for between group test). Baseline IFAB and sCD163 were greater in HIV/HCV than HCV and HIV, respectively. Most inflammatory markers were higher in HCV and HIV than controls. The figure shows 0-24 week changes in the markers tested. Most markers improved in HCV, while they did not change in HIV/HCV. Changes in sTNF-R1 and sCD14 tended to be different between groups with improvements in HCV group only. Conclusion: After DAA treatment, immune activation and gut markers improved in the HCV group; no change was observed in the HIV/HCV group. Further, PWV did not improve in either group. Cardiac risk may remain elevated in HIV/HCV despite SVR with DAAs.
Gastroenterology, 2020
Background: Early diagnosis and timely antiviral therapy in chronic hepatitis B virus (CHB) patie... more Background: Early diagnosis and timely antiviral therapy in chronic hepatitis B virus (CHB) patients is important to reduce long term morbidity and mortality. Barriers to CHB treatment are multifactorial and insurance-specific differences may highlight socioeconomic disparities in access to hepatitis B virus (HBV) care. We aim to evaluate insurance-specific disparities in HBV treatment rates among a large ethnically diverse HBV cohort. Methods: Adults with chronic HBV across four urban safety-net heath systems from January 1, 2010 to December 31, 2015, with minimum 2-year follow-up, were identified with ICD-9/10 diagnosis coding and confirmed with laboratory data. HBV treatment eligibility was assessed using American Association for the Study of Liver Diseases (AASLD) criteria and included assessment of HBV envelope antigen (HBeAg) status, serum alanine aminotransferase, HBV viral load, and fibrosis stage. Presence of cirrhosis and concurrent HIV co-infection were also incorporated into determination of treatment eligibility, consistent with AASLD guidelines. Insurancespecific comparisons of treatment eligibility and HBV treatment rates among eligible patients were performed using chi-square testing and adjusted multivariate Cox proportional hazards models. Statistical significance was met with p<0.05. Results: Among 5,157 CHB patients (54.7% men, 35.7% white, 34.6% African American, 22.3% Asian, 7.7% Hispanic), 25.8% had cirrhosis and 14.2% HIV co-infection. Overall, 28.4% had commercial insurance, 20.6% Medicaid, 17.7% Medicare, and 16.8% had no insurance/indigent care (indigent care). Among all CHB patients, 46.8% were eligible for HBV treatment, among which 26.4% received treatment. Compared to HBV patients with commercial insurance, patients with Medicare were significantly more likely to be treatment eligible (HR 1.26, 95% CI 1.05-1.52, p<0.02), whereas no differences were seen in Medicaid and indigent care. Among treatment eligible patients, compared to HBV patients with commercial insurance, significantly lower likelihood of receiving treatment was observed in patients with Medicare (23.4% vs. 34.8%; HR 0.57, 95% CI 0.43-0.75, p<0.001), Medicaid (21.1% vs. 34.8%; HR 0.46, 95% CI 0.34-0.63, p<0.001), and indigent care (15.4% vs. 34.8%; HR 0.41, 95% CI 0.32-0.53, p<0.001). Discussion: Among a large ethnically diverse cohort of safety-net HBV patients in the U.S., 46.8% were eligible for HBV treatment, but only 26.4% received treatment. Significant disparities were observed by insurance status, and when compared to patients with commercial insurance, HBV patients with Medicaid and indigent care were nearly 60% less like to receive HBV treatment. This observation is concerning given that Medicaid and indigent care populations are particularly underserved and vulnerable to disparities in timely access to HBV care and treatment.
Journal of Clinical and Experimental Hepatology, 2019
Background & aims: Although serological markers of disease severity improve after hepatitis C vir... more Background & aims: Although serological markers of disease severity improve after hepatitis C virus (HCV) treatment, it is unclear if all patients experience sustained improvement. We aim to evaluate longitudinal changes in aspartate (AST), alanine (ALT) aminotransferase, platelet count (PLT), and fibrosis-4 (FIB-4) after HCV treatment. Methods: All adult chronic HCV patients who received antiviral therapy from January 2011 to February 2017 at four large urban hospital systems were evaluated to assess changes in AST, ALT, PLT, and FIB-4 from pre-treatment to post-treatment annually up to 4 years after HCV therapy. Comparisons used Student's t-test and analysis of variance, and were stratified by sex, race, ethnicity, age, body mass index (BMI), and diabetes mellitus. Results: Among 2691 patients (62.2% men, 76.9% aged 45-65 years, 56.5% white), all markers of disease severity demonstrated sustained improvements from pre-treatment to 4 years post-treatment
Journal of Hepatology, 2019
Hepatology (Baltimore, Md.), Jan 17, 2018
Direct-acting antivirals (DAA) for hepatitis C virus (HCV) became available in 2014, but the role... more Direct-acting antivirals (DAA) for hepatitis C virus (HCV) became available in 2014, but the role of mental health or substance use disorders (MH/SUD) on access to treatment is unknown. To examine extent and predictors of HCV treatment in the pre-DAA and post-DAA periods in 4 large, diverse health care settings in the United States (US). Retrospective analysis of 29,544 adults with chronic HCV who did or did not receive treatment from 1/1/11-2/28/17. Kaplan Meier curve was used to examine cumulative risk for receiving HCV treatment stratified by MH/SUD. Predictors of HCV treatment in the pre-DAA (1/1/11-12/31/13) and post-DAA (1/1/14-2/28/17) cohorts were analyzed using multivariate generalized estimating equations (GEE) and a modified Poisson models. Overall 21.7% (2,879/13,240) of those with chronic HCV post-DAA were treated compared to 3.5% (574/16,304) in the pre-DAA period. Compared to non-Hispanic Whites, Hispanic Whites (AOR 0.36, 95% CI: 0.25, 0.52) were less likely to be tr...
The American journal of gastroenterology, Jan 9, 2018
Despite availability of highly effective direct acting antivirals (DAA), barriers in access to th... more Despite availability of highly effective direct acting antivirals (DAA), barriers in access to these therapies limit our ability to achieve HCV eradication. We aim to evaluate overall rates and predictors of HCV treatment across four community-based health-care systems focusing on race/ethnicity and insurance-specific disparities. We retrospectively evaluated all adults with chronic HCV at four health care systems from 1 January 2011 to 28 February 2017, which included a large proportion of ethnic minorities, two safety-net systems, and a broad payer mix across four states. Overall and stratified HCV treatment rates were calculated using Kaplan-Meier methods. Multivariate logistic regression models evaluated for predictors of receiving treatment. Among 29,544 chronic HCV patients (60.5% male, 38.4% black, 8.8% Hispanic, 18.7% Medicaid, 25.9% Medicare, 22.5% private/commercial), overall annual treatment rates were stable from 2011 (0.5%) to 2013 (2.0%), but increased from 2014 (4.8%)...
Gastroenterology, 2017
codes for cirrhosis and its complications. OBJECTIVE: We sought to examine the accuracy of the IC... more codes for cirrhosis and its complications. OBJECTIVE: We sought to examine the accuracy of the ICD-10 codes for cirrhosis and its related complications (i.e. ascites, varices and hepatocellular carcinoma (HCC)) in identifying patients with these conditions in the medical records. METHODS: We used the national Department of Veterans Affairs (VA) Corporate Data Warehouse administrative and clinical database to identify a random sample of 300 patients with at least one ICD-10 code from an inpatient or outpatient encounter for cirrhosis or any of its complication during FY2016 (Table 1). A trained clinician abstracted the electronic medical record using a standardized, detailed abstraction form to determine the presence or absence of the key conditions, while blinded to the database coding. Clinical diagnoses were identified from progress notes, pathology, endoscopy, radiology, or laboratory reports. We calculated the positive predictive value (PPV i.e. the probability of having the clinical diagnosis of cirrhosis or one of its complications (as identified in medical records) among those with a corresponding ICD-10 code. We also calculated the negative predictive value (NPV), i.e., the probability of not having the clinical diagnosis among those who did not have a corresponding ICD-10 code. RESULTS: The PPV for any cirrhosis ICD-10 code (with or without any complication codes) ranged from 90.1% to 93.4%. A total of 82, 48 and 55 patients had ICD-10 codes of varices, ascites and HCC. The PPV for varices, ascites, HCC were 90.2%, 87.5%, and 98.2% respectively. The corresponding NPVs were 71.7%, 71.7%, and 98.1% respectively. CONCLUSION: The cirrhosis ICD-10 codes demonstrated excellent PPV (>90%) and NPV ranging from 72% to 98%. Our data show that ICD-10 codes can be reliably used to identify patients with cirrhosis in epidemiological, health services and outcomes research. Table 1: List of ICD-10 codes for cirrhosis and its complications Tu1506
Kidney International Reports, 2017
Introduction: The End Stage Renal Disease (ESRD) Prospective Payment System (PPS), implemented by... more Introduction: The End Stage Renal Disease (ESRD) Prospective Payment System (PPS), implemented by the Centers for Medicare and Medicaid Services in January 2011, encouraged use of peritoneal dialysis (PD) through various financial incentives. Our goal was to determine whether PPS effectively increased PD use in incident dialysis patients. Methods: Our study used the United States Renal Data System (USRDS) to identify 430,927 adult patients who initiated dialysis between 2009 and 2012. The interrupted time series method was used to evaluate the association Centers for Medicare and Medicaid Services of PPS with PD use at dialysis initiation. We further stratified by patient demographics, predialysis care, and facility chain and profit status. Results: Interrupted time series analysis indicated PPS was associated with increased PD use in the 2-year period after PPS (change in slope ¼ 0.04, P < 0.0001), although there was no immediate change in the level of PD use at the beginning of PPS (P ¼ 0.512). Stratified analyses indicated PPS led to increased PD use across all age, race, and sex groups (P < 0.05) although marginally among females (P ¼ 0.09). Notably, small dialysis organizations and nonprofit organizations appeared to increase use of PD faster compared to large dialysis organizations and for-profit units, respectively. Discussion: Implementation of the Centers for Medicare and Medicaid Services ESRD payment reform was associated with an increased use of PD in the 2 years after PPS. Our findings highlight the role of financial incentives in changing practice patterns to increase use of a dialysis modality considered to be both more cost-effective and empowering to ESRD patients. However, even after PPS, rates of PD use remain low among the dialysis population in the USA.
American journal of kidney diseases : the official journal of the National Kidney Foundation, 2014
In a landmark study, TREAT (Trial to Reduce Cardiovascular Events With Aranesp Therapy) examined ... more In a landmark study, TREAT (Trial to Reduce Cardiovascular Events With Aranesp Therapy) examined the use of erythropoiesis-stimulating agent (ESA) therapy to treat anemia among patients with chronic kidney disease (CKD) and found no benefit compared to placebo. A retrospective observational design was used to determine the impact of TREAT on clinical practice. A large US health plan database with more than 1.2 million claims for patients with non-dialysis-dependent CKD stages 3 and 4. ESA prescribing 2 years before and after publication of TREAT. Rate of ESA prescribing for ESA-naive and -prevalent cohorts. (1) Monthly ESA prescribing in the 2 years before and after publication of TREAT (ordinary least squares regression), (2) adjusted likelihood of prescribing ESA after TREAT (clustered logistic regression), and (3) probability of receiving ESA therapy based on anemia status (χ(2) test). For patients with CKD stage 3, the proportion prescribed ESA therapy declined from 17% pre-TREA...
American journal of nephrology, 2014
Epoetin therapy used to treat anemia among ESRD patients has cost Medicare ∼$40 billion. Since Ja... more Epoetin therapy used to treat anemia among ESRD patients has cost Medicare ∼$40 billion. Since January 2011, epoetin has been reimbursed via a new bundled prospective payment system (PPS). Our aim was to determine changes in epoetin dosing and hematocrit levels in response to PPS by different types of dialysis providers. Data from the USRDS were used to identify 187,591 and 206,163 Medicare-eligible ESRD patients receiving hemodialysis during January 2010 (pre-PPS) and December 2011 (post-PPS). Standardized weekly mean epoetin dose administered pre- and post-PPS and adjustment in dose (titration) based on previous hematocrit level in each facility was disaggregated by profit status, chain membership and size. Major declines in epoetin use, dosing and achieved hematocrit levels were observed after PPS. Among the three largest dialysis chains, the decline in standardized epoetin dose was 29% at Fresenius, 47% at DaVita, and 52% at DCI. The standardized weekly epoetin dose among profit...
Transplantation, 2014
The proliferation of multi-unit for-profit dialysis chains in the ESRD industry has raised concer... more The proliferation of multi-unit for-profit dialysis chains in the ESRD industry has raised concerns for patient quality of care including access to renal transplantation therapy (RTT). The effect of dialysis facility chain status on RTT is unknown. Data from the United States Renal Data System were used to identify 4,465 dialysis facilities and 56,714 dialysis patients who started hemodialysis in 2006. Patients were followed from initiation of hemodialysis in 2006 to placement on the renal transplant waiting list or to December 31, 2009. The role of dialysis facility chain status (affiliation, size, and ownership) on placement on the renal transplant waiting list was evaluated by multi-level mixed-effect regression models that account for clustering within facilities. Patients from for-profit chain facilities, compared to nonprofit chain facilities, were 13% (95% CI 0.77-0.98) less likely to be waitlisted. In contrast, among nonchains, facility ownership did not influence likelihood of being waitlisted. There was also a marginally significant difference in waiting list placement by chain size: large chains compared with mid or small chains were 8% (95% CI 0.84-1.00) less likely to place patients on the waiting list. After adjustment for patient and facility characteristics, dialysis facility chain affiliation (chain-affiliated or not) was not found to be independently associated with the likelihood of placement on the transplant waitlist. Dialysis chain affiliation expands previously observed ownership-related differences in placement on the waiting list. For-profit ownership of dialysis chain facilities appears to be a significant impediment to access to renal transplants.
Health Services Research, 2012
Objective. Examine the mediating effect of injectable drugs in the relationship between dialysis ... more Objective. Examine the mediating effect of injectable drugs in the relationship between dialysis facility organizational status and patient mortality. Study Setting. Medicare dialysis population. Study Design. Data from the U.S. Renal Data System (USRDS) were used to identify 3,884 freestanding dialysis facilities and 37,942 Medicare patients incident to end-stage renal disease (ESRD) in 2006. The role of injectable medications was evaluated during a 2-year follow-up period by mediational analyses using mixed-effect regression models. Data Collection. USRDS data were matched with Dialysis Facility Report data from Centers for Medicare and Medicaid Services (CMS) and census data. Principal Findings. There was a strong association found between organizational status and use of injectable drugs. Large for-profit chains used significantly higher injectable medications compared with nonprofit chains and independent facilities. However, the relationship between facility organizational status and patient mortality was not found to be mediated through the higher use of injectable drugs. Conclusions. Large for-profit chain facilities administered higher IV epoetin, iron, and vitamin D dosages, but this did not result in improved survival. Given the associated costs and lack of a survival benefit, the overuse of injectable medications among the U.S. dialysis patients will likely end under the recent bundling of injectable medications without jeopardizing patient outcomes.
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Papers by ONKAR KSHIRSAGAR