Terlipressin vs Midodrine Plus Octreotide for Hepatorenal Syndrome-Acute Kidney Injury: A Propensity Score-Matched Comparison.

INTRODUCTION: Evidence on the comparison of treatments for hepatorenal syndrome-acute kidney injury (HRS-AKI) in a US population is limited. An indirect comparison of terlipressin plus albumin vs midodrine and octreotide plus albumin (MO) may provide further insight into treatment efficacy. METHODS: Cohorts of patients treated for HRS-AKI characterized by inclusion of patients with serum creatinine (SCr) <5 mg/dL and baseline acute-on-chronic liver failure grades 0-2 and exclusion of patients listed for transplant if model for end-stage liver disease scores ≥35 were pooled from (i) the CONFIRM and REVERSE randomized controlled trials (N = 159 meeting eligibility criteria from N = 216 overall, treated with terlipressin) and (ii) a retrospective review of medical records from 10 US tertiary hospitals (2016-2019; N = 55 treated with MO meeting eligibility criteria from N = 200 overall). The primary end point comparing the 2 cohorts was HRS reversal defined as achieving SCr ≤1.5 mg/dL at least once during the treatment. Covariate balancing propensity scoring was used to adjust for differences in baseline characteristics. RESULTS: HRS-AKI reversal was achieved in 52.35% of terlipressin-treated patients compared with 20% of MO-treated patients (adjusted mean difference 32.35%, 95% confidence interval [CI] 17.40-47.30, P < 0.0001). Terlipressin-treated patients had increased overall survival (adjusted hazard ratio 0.57, 95% CI 0.35-0.93, P = 0.02) but similar transplant-free survival (adjusted hazard ratio 0.79, 95% CI 0.53-1.17, P = 0.24). Achievement of HRS-AKI reversal was associated with increased OS and TFS regardless of treatment ( P < 0.001). DISCUSSION: Consistent with prior reports, terlipressin plus albumin is more effective in improving kidney function and achieving HRS-AKI reversal than MO plus albumin based on indirect comparison in a US population.

Clinical and Economic Burden of Out-of-Hospital Cardiac Arrest in US Commercial Insurance Population (2014 to 2019).

Little is known about the economic burden incurred by out-of-hospital cardiac arrest (OHCA) in the US commercial insurance setting. We used IBM MarketScan Commercial Claims and Encounters Database (January 2014 to March 2019) to identify patients hospitalized with OHCA based on the International Classification of Diseases codes. Patients who survived the initial OHCA episode were stratified by prognosis based on discharge setting and classified into mild (discharged home), moderate (skilled nursing facility), severe (inpatient rehabilitation or long-term hospital), and very severe (hospice) prognosis groups, respectively. Patients were followed up for 12 months after discharge for health care resource utilization and medical costs, which were inflated to year 2020. Overall, 23,512 patients with OHCA hospitalization were identified, of whom 14,667 were <65 years and 60.5% were men. The incidence of OHCA per 100,000 was steady in patients <65 years over the years (17.9 in 2014; 17.5 in 2018) but among those ≥65 years, decreased from 139.7 in 2014 to 111.1 in 2018. Total medical costs 12 months after discharge generally increased with severity of prognosis, with an average for the mild, moderate, and severe prognosis group, respectively, estimated to be $52,746, $100,394, and $130,530 among patients <65 years, and $63,194, $65,794, and $70,973 among those ≥65 years. Costs were lower for those with very severe prognosis ($7,102 for <65 years; $2,553 for ≥65 years), possibly due to high mortality. In conclusion, OHCA continues to pose a substantial clinical and economic burden on patients and the US health care system, which increases with the severity of disease prognosis.

Evaluating the Cost-Effectiveness of Celecoxib versus Ibuprofen and Naproxen in Patients with Osteoarthritis in United Arab Emirates Based on the PRECISION Trial.

OBJECTIVE: Data on osteoarthritis patients from the PRECISION trial were used to evaluate the cost-effectiveness of celecoxib (100 mg twice daily) versus ibuprofen (600-800 mg three times daily) and naproxen (375-500 mg twice daily). The perspective was that of the United Arab Emirates (UAE) healthcare system. METHODS: Discrete-state Markov model with monthly cycles, 30-month horizon, and 3% discount rate was constructed to assess incremental costs per quality adjusted life year (QALYs) gained from reduced incidence of three safety domains examined in PRECISION: renal, serious gastrointestinal (GI), and major adverse cardiovascular events (MACE). Costs for managing these toxicities were derived from Dubai Administrative Billing Claims (2018). Median monthly drug costs were derived from UAE Ministry of Health and Prevention's published prices ($26.98 celecoxib; $20.25 ibuprofen; $20.50 naproxen). Health utility and excess mortality associated with toxicities were sourced from the literature. The willingness-to-pay thresholds used were 1 and 3 GDP per capita ($40,000-$120,000). RESULTS: The total average cost per patient was $812.88 for celecoxib, $775.26 for ibuprofen, and $731.17 for naproxen while cost components attributed to toxicities were lowest with celecoxib ($360.26, $438.31, and $388.60, respectively). Patients on celecoxib had more QALYs (1.339), compared with ibuprofen (1.335) and naproxen (1.337), resulting in an incremental cost-effectiveness ratio of $11,502/QALY gained for celecoxib versus ibuprofen and $39,779 for celecoxib versus naproxen. Probabilistic sensitivity analyses demonstrated celecoxib to be 81% cost-effective versus ibuprofen and 50% versus naproxen at $40,000/QALY. The most influential model parameters were MACE relative safety and drug costs. CONCLUSION: From UAE third payer perspective, celecoxib is a long-term cost-effective treatment for osteoarthritis patients when compared with ibuprofen, and equally likely as naproxen to be cost-effective. With the expected increasing burden of chronic diseases in the Gulf region, study findings can inform decisions regarding the cost-effective pain management of osteoarthritis in UAE. CLINICALTRIALSGOV REGISTRATION NUMBER: NCT00346216.

Machine Learning for Precision Health Economics and Outcomes Research (P-HEOR): Conceptual Review of Applications and Next Steps.

Precision health economics and outcomes research (P-HEOR) integrates economic and clinical value assessment by explicitly discovering distinct clinical and health care utilization phenotypes among patients. Through a conceptualized example, the objective of this review is to highlight the capabilities and limitations of machine learning (ML) applications to P-HEOR and to contextualize the potential opportunities and challenges for the wide adoption of ML for health economics. We outline a P-HEOR conceptual framework extending the ML methodology to comparatively assess the economic value of treatment regimens. Latest methodology developments on bias and confounding control in ML applications to precision medicine are also summarized.

Economic-Burden Trajectories in Commercially Insured US Infants With Respiratory Syncytial Virus Infection.

BACKGROUND: This study evaluates the long-term respiratory syncytial virus (RSV) burden among preterm and full-term infants in the United States. METHODS: Infants with birth hospitalization claims and ≥24 months of continuous enrollment were retrospectively identified in the Truven MarketScan Commercial Claims and Encounters database for the period 1 January 2004-30 September 2015. Infants with RSV infection in the first year of life (n = 38 473) were matched to controls (n = 76 825), and remaining imbalances in the number of individuals in each group were adjusted using propensity score methods. All-cause, respiratory-related, and asthma/wheezing-related 5-year average cumulative costs were measured. RESULTS: Early premature (n = 213), premature (n = 397), late premature (n = 4446), and full-term (n = 33 417) RSV-infected infants were matched to 424, 791, 8875, and 66 735 controls, respectively. After 2 years since RSV diagnosis, all-cause cumulative costs for RSV-infected infants as compared to those for controls increased by $22 081 (95% confidence interval [CI], -$5800-$42 543) for early premature infants, by $14 034 (95% CI, $5095- $22 973) for premature infants, by $10 164 (95% CI, $8835-$11 493) for late premature infants, and by $5404 (95% CI, $5110-$5698) for full-term infants. The 5-year RSV burden increased to $39 490 (95% CI, $18 217-$60 764), $23 160 (95% CI, $13 002-$33 317),$13 755 (95% CI, $12 097-$15 414), and $6631 (95% CI, $6060-$7202), respectively. The RSV burden was higher when stratified by inpatient and outpatient setting and respiratory-related and asthma/wheezing-related costs. CONCLUSIONS: The RSV burden extends across cost domains and prematurity, with the greatest burden incurred by the second year of follow-up. Findings are useful in determining the cost-effectiveness of RSV therapies in development.

Oral corticosteroid exposure and increased risk of related complications in patients with noninfectious intermediate, posterior, or panuveitis: Real-world data analysis.

PURPOSE: This study causally examined the dose-response relationship between oral corticosteroids (OCS) exposure and long-term complications among noninfectious uveitis adult patients in the United States. METHODS: The study design was longitudinal, retrospective cohort using Truven Health MarketScan claims database years 2000-2015. The index date was the first day after diagnosis on which OCS≥ 5 mg prednisone equivalent was administered. The period following the index date was parsed into quarters for tracking OCS-related complications; follow-up time was censored when patients switched off of OCS monotherapy. Each quarter of follow-up was divided into 4 groups based on the mean cumulative daily OCS dose (< 7.5 mg; 7.5 to < 30 mg; 30 to < 60 mg; and ≥ 60 mg) and covariate balancing propensity scoring was used to balance groups on baseline characteristics in the first quarter post-index. Marginal structural models (MSMs) were employed to account for time-varying endogeneity between temporal changes in mean cumulative OCS dose and the risk of complications. Patients with systemic autoimmune conditions at baseline were excluded. RESULTS: The study sample included 3966 patients with a median follow-up of 2 years. Compared to those receiving < 7.5 mg, patients with higher mean cumulative OCS dose had 10%, 16%, and 28% higher risk, respectively, of any OCS-related complication in any given quarter. CONCLUSIONS: A moderate dose-response relationship was found between the long-term use of OCS monotherapy and the risk of developing complications in noninfectious intermediate, posterior, or panuveitis patients. Future research should examine optimal approaches to achieve inflammation control while minimizing OCS exposure.

Development of a Comprehensive Dataset of Hepatitis C Patients and Examination of Disease Epidemiology in the United States, 2013-2016.

INTRODUCTION: Chronic infection with hepatitis C virus (HCV) is a leading cause of liver disease and infectious disease deaths. While recent and emerging treatment options for HCV patients have enabled higher rates of sustained virologic response (SVR), the demographic, clinical, geographic, and payer characteristics of the estimated 3.4 million chronic HCV patients in the USA are poorly understood. The goal of this study was to create a dataset describing the current HCV patient landscape in the USA. METHODS: Data from two large national laboratory companies representing the majority of US patients screened for HCV antibody and/or tested for HCV RNA from 2013 through 2016 were organized into the present study dataset. Age, gender, payer channel, 3-digit ZIP code and ordering physician specialty, and 3-digit ZIP code information were available for all patients. Among RNA-positive patients, additional clinical characteristics included HCV genotype, fibrosis stage, renal function, and HIV status. Initiating treatment and attaining cure were imputed using data-driven algorithms based on successive RNA viral load measurements. RESULTS: The number of RNA-positive HCV patients increased from 200,066 patients in 2013 to 469,550 in 2016. The availability of clinical data measurements and rates of treatment initiation increased over the study period, indicating improved care engagement for HCV patients. Treatment and cure rates varied by age, disease severity, geographic location, and payer channel. Sensitivity and specificity of the cure prediction algorithms were consistently above 0.90, validating the robustness of the data imputation approach. CONCLUSION: This is the largest, most comprehensive dataset available to describe the current US HCV patient landscape. Our results highlight that the epidemiology of HCV is evolving with an increasing number of patients who are younger and have milder disease than described in previous years. Results of this study should help guide efforts toward the elimination of HCV in this country. Future work will focus on factors associated with varying treatment and cure patterns and describing recent changes in the HCV patient landscape. FUNDING: AbbVie. Plain language summary available for this article.

Tree-based Claims Algorithm for Measuring Pretreatment Quality of Care in Medicare Disabled Hepatitis C Patients.

BACKGROUND: To help broaden the use of machine-learning approaches in health services research, we provide an easy-to-follow framework on the implementation of random forests and apply it to identify quality of care (QC) patterns correlated with treatment receipt among Medicare disabled patients with hepatitis C virus (HCV). METHODS: Using Medicare claims 2006-2009, we identified 1936 patients with 6 months continuous enrollment before HCV diagnosis. We ran a random forest on 14 pretreatment QC indicators, extracted the forest's representative tree, and aggregated its terminal nodes into 4 QC groups predictive of treatment. To explore determinants of differential QC receipt, we compared patient-level and county-level (linked AHRF data) characteristics across QC groups. RESULTS: The strongest predictors of treatment included "liver biopsy," "HCV genotype testing," "specialist visit," "HCV viremia confirmation," and "iron overload testing." High QC [n=360, proportion treated (pt)=33.3%] was defined for patients with at least 2 from the above-mentioned metrics. Good QC patients (n=302, pt=12.3%) had either "HCV genotype testing" or "specialist visit," whereas fair QC (n=282, pt=7.1%) only had "HCV viremia confirmation." Low QC patients (n=992, pt=2.5%) had none of the selected metrics. The algorithm accuracy of predicting treatment was 70% sensitivity and 78% specificity. HIV coinfection, drug abuse, and residence in counties with higher supply of hospitals with immunization and AIDS services correlated with lower QC. CONCLUSIONS: Machine-learning techniques could be useful in exploring patterns of care. Among Medicare disabled HCV patients, the receipt of more QC indicators was associated with higher treatment rates. Future research is needed to assess determinants of differential QC receipt.

Clinical effectiveness and cost savings in diabetes care, supported by pharmacist counselling.

OBJECTIVE: To determine the effectiveness and cost savings of a real-world, continuous, pharmacist-delivered service with an employed patient population with diabetes over a 5-year period. SETTING: The Patients, Pharmacists Partnerships (P3 Program) was offered as an "opt-in" benefit to employees of 6 public and private self-insured employers in Maryland and Virginia. Care was provided in ZIP code-matched locations and at 2 employers' worksites. PRACTICE DESCRIPTION: Six hundred two enrolled patients with type 1 and 2 diabetes were studied between July 2006 and May 2012 with an average follow-up of 2.5 years per patient. Of these patients, 162 had health plan cost and utilization data. A network of 50 trained pharmacists provided chronic disease management to patients with diabetes using a common process of care. Communications were provided to patients and physicians. PRACTICE INNOVATION: Employers provided incentives for patients who opted in, including waived medication copayments and free diabetes self-monitoring supplies. The service was provided at no cost to the patient. A Web-based, electronic medical record that complied with the Health Insurance Portability and Accountability Act helped to standardize care. Quality assurance was conducted to ensure the standard of care. EVALUATION: Glycosylated hemoglobin (A1c), blood pressure, and total health care costs (before and after enrollment). RESULTS: Statistically significant improvements were shown by mean decreases in A1c (-0.41%, P <0.001), low-density lipoprotein levels (-4.7 mg/dL, P = 0.003), systolic blood pressure (-2.3 mm Hg, P = 0.001), and diastolic blood pressure (-2.4 mm Hg, P <0.001). Total annual health care costs to employers declined by $1031 per beneficiary after the cost of the program was deducted. This 66-month real-world study confirms earlier findings. Employers netted savings through improved clinical outcomes and reduced emergency and hospital utilization when comparing costs 12 months before and after enrollment. CONCLUSION: The P3 program had positive clinical outcomes and economic outcomes. Pharmacist-provided comprehensive medication therapy management services should be included as a required element of insurance offered by employers and health insurance exchanges.

Impact of Case Mix Severity on Quality Improvement in a Patient-centered Medical Home (PCMH) in the Maryland Multi-Payor Program.

BACKGROUND: We present data on quality of care (QC) improvement in 35 of 45 National Quality Forum metrics reported annually by 52 primary care practices recognized as patient-centered medical homes (PCMHs) that participated in the Maryland Multi-Payor Program from 2011 to 2013. METHODS: We assigned QC metrics to (1) chronic, (2) preventive, and (3) mental health care domains. The study used a panel data design with no control group. Using longitudinal fixed-effects regressions, we modeled QC and case mix severity in a PCMH. RESULTS: Overall, 35 of 45 quality metrics reported by 52 PCMHs demonstrated improvement over 3 years, and case mix severity did not affect the achievement of quality improvement. From 2011 to 2012, QC increased by 0.14 (P < .01) for chronic, 0.15 (P < .01) for preventive, and 0.34 (P < .01) for mental health care domains; from 2012 to 2013 these domains increased by 0.03 (P = .06), 0.04 (P = .05), and 0.07 (P = .12), respectively. In univariate analyses, lower National Commission on Quality Assurance PCMH level was associated with higher QC for the mental health care domain, whereas case mix severity did not correlate with QC. In multivariate analyses, higher QC correlated with larger practices, greater proportion of older patients, and readmission visits. Rural practices had higher proportions of Medicaid patients, lower QC, and higher QC improvement in interaction analyses with time. CONCLUSIONS: The gains in QC in the chronic disease domain, the preventive care domain, and, most significantly, the mental health care domain were observed over time regardless of patient case mix severity. QC improvement was generally not modified by practice characteristics, except for rurality.

Determinants of quality of care and treatment initiation in Medicare disabled patients with chronic hepatitis C.

BACKGROUND: Aligning with a national priority to bridge health disparities in disadvantaged populations, we explored contextual determinants of pretreatment quality of care and treatment receipt of Medicare disabled patients with hepatitis C virus (HCV) infection. METHODS: We used Medicare claims (2006-2009) linked to the Area Health Resource Files. Ordinal partial proportional odds and weighted modified Poisson regressions were used to model the determinants of quality care receipt and interferon-based treatment, respectively. RESULTS: We identified 1936 Medicare disabled HCV patients, of whom 10.4% were treated with peg-interferon. Despite the high comorbidity burden among HCV disabled patients, greater engagement in care correlated with greater likelihood of quality care and treatment receipt. CONCLUSION: Our study highlights the need for process and linkage to care in Medicare disabled HCV patients, but future research relevant to novel interferon-free agents is needed to assess patterns of quality of care and treatment receipt in this vulnerable population.

Impact of a comprehensive pharmacist medication-therapy management service.

OBJECTIVE: This proof of concept study aimed to determine whether a pharmacist-managed medication therapy management (MTM) program in a private endocrinologist physician's practice reduced healthcare services utilization and related costs 6 months after patients' discharge from an institution with a transition of care service. METHODS: Patients were included in the study if they were English-speaking, ages >18 years, had type 1 or 2 diabetes, and had a recent transition of care experience (inpatient hospital stay or emergency department/urgent care/paramedic or other acute care visit). The study had a non-randomized design where intervention patients, enrolled July 1, 2012-September 30, 2013, were administered MTM at four visits over 6 months and were compared to historical control patients with available electronic medical records from August 8, 2008 to March 15, 2012. The primary study end-point was the rate of 30-day hospital readmissions, as related to the reason for the index admission. Secondary end-points included the cumulative rate of all-cause hospitalizations, emergency department, paramedic and urgent care visits at 30, 60, 90, and 180 days post-discharge as well as imputed total costs, including prescription medication costs, at 180 days. Propensity score weights were constructed to balance covariate characteristics between the intervention and control groups. Weighted multivariate negative binomial and generalized linear regressions were used to model cumulative utilization rates and log-transformed costs, respectively. RESULTS: The intervention (n = 28) and control (n = 73) groups had 0% hospital readmissions at 30 days post-discharge. In propensity score weighted multivariate analyses, cumulative utilization rate was not different between the two groups (IRR = 1.61, p = 0.72 at 180 days) while costs in the intervention group were lower but not statistically different (cost ratio = 0.65, p = 0.13 at 180 days). CONCLUSIONS: Further studies should investigate whether the integration of pharmacists in transition of care models could reduce readmission and healthcare utilization rates post-discharge.

Contextual analysis of determinants of late diagnosis of hepatitis C virus infection in medicare patients.

UNLABELLED: Patient- and county-level characteristics associated with advanced liver disease (ALD) at hepatitis C virus (HCV) diagnosis were examined in three Medicare cohorts: (1) elderly born before 1945; (2) disabled born 1945-1965; and (3) disabled born after 1965. We used Medicare claims (2006-2009) linked to the Area Health Resource Files. ALD was measured over the period of 6 months before to 3 months after diagnosis. Using weighted multivariate modified Poisson regression to address generalizability of findings to all Medicare patients, we modeled the association between contextual characteristics and presence of ALD at HCV diagnosis. We identified 1,746, 3,351, and 592 patients with ALD prevalence of 28.0%, 23.0%, and 15.0% for birth cohorts 1, 2, and 3. Prevalence of drug abuse increased among younger birth cohorts (4.2%, 22.6%, and 35.6%, respectively). Human immunodeficiency virus coinfection (prevalence ratio [PR] = 0.63; 95% confidence interval [CI]: 0.50-0.80; P = 0.001), dual Medicare/Medicaid eligibility (PR = 0.89; 95% CI: 0.80-0.98; P = 0.017), residence in counties with higher median household income (PR = 0.82; 95% CI: 0.71-0.95; P = 0.008), higher density of primary care providers (PR = 0.84; 95% CI: 0.73-0.98; P = 0.022), and more rural health clinics (PR = 0.90; 0.81-1.01; P = 0.081) were associated with lower ALD risk. End-stage renal disease (PR = 1.41; 95% CI: 1.21-1.63; P = 0.001), alcohol abuse (PR = 2.57; 95% CI: 2.33-2.84; P = 0.001), hepatitis B virus (PR = 1.32; 95% CI: 1.09-1.59; P = 0.004), and Midwest residence (PR = 1.22; 95% CI: 1.05-1.41; P = 0.010) were associated with higher ALD risk. Living in rural counties with high screening capacity was protective in the elderly, but associated with higher ALD risk among the disabled born 1945-1965. CONCLUSIONS: ALD prevalence patterns were complex and were modified by race, elderly/disability status, and the extent of health care access and screening capacity in the county of residence. These study results help inform treatment strategies for HCV in the context of coordinated models of care.

Physician specialty cost differences of treating nonmelanoma skin cancer.

Specialty-related cost differences for the treatment of nonmelanoma skin cancer (NMSC) have been previously reported but without taking into account confounding factors. Using a previously validated model for NMSC episode of care, episodes were identified in the Medicare Current Beneficiary Survey claims 2005 to 2007. A γ regression with log link model estimated the effect of physician exposure on total episode costs controlling for sociodemographics, health status and comorbidities, treatment and repair procedures, as well as tumor size and location. Treatment-related NMSC episodes (1285) were identified. In the unadjusted model, episodes managed by generalists were associated with 36% lower costs, those by otolaryngologists/plastic surgeons with 82% higher costs, and those by multiple specialists with 111% higher costs, compared to dermatologists. Cost differences were substantially reduced in the adjusted regression analysis; compared to dermatologists, episodes managed by generalists were associated with 20% lower costs (P < 0.0001), whereas otolaryngologists/plastic surgeons and multiple specialists were associated with 20% (P < 0.01) and 11% (P = 0.02) higher costs, respectively. Overall, comparison between unadjusted and adjusted estimates suggests that controlling for severity and treatment modalities explains most of the specialty cost differences. Our estimates could be subject to residual confounding due to selection bias and the limitations to using claims data to characterize an NMSC episode of care. Adjusting for the severity of the disease and other confounders, our study found much smaller specialty-related cost differences for the management of NMSC than previously reported unadjusted estimates.

Multispecialist Care and Mortality in Hepatocellular Carcinoma.

PURPOSE: Multidisciplinary physician care has increased for many cancers yet little evidence exists for hepatocellular carcinoma (HCC). The purpose of this study was to explore the association between multispecialist care and mortality in HCC. METHODS: Treated patients with an HCC primary diagnosis from 2000 to 2007 were studied using Surveillance, Epidemiology, and End Results-Medicare data. A surrogate variable for multidisciplinary care was defined-multispecialist care-as the number of disciplines among surgeons, radiology oncologist, intervention radiologist, hematologist/medical oncologist, gastroenterologist, and generalist in the pretreatment period. Multivariate survival analysis was conducted and adjusted for selection and survival bias. RESULTS: Of 3588 treated HCC patients, 1434 (40%) saw 1, 1343 (37%) saw 2, and 811 (23%) saw 3 or more specialists. Patients with multispecialist care received treatment that differed from patients who saw a single specialist. In propensity score-adjusted survival analysis, patients who saw 3 or more specialist types were associated with 10% (P=0.04) reduced mortality, compared with those who saw 1 specialist. When stratified by treatment received, patients on chemotherapy who saw 3 or more specialist types were associated with 28% (P=0.002) reduced mortality, compared with those who saw 1 specialist. CONCLUSIONS: Multispecialist care for treated HCC patients was associated with reduced mortality, particularly among chemotherapy recipients. While adjusting for selection and survival bias, our study is limited in capturing a causal relationship between coordinated multidisciplinary care and mortality. Our findings may provide support for the development of coordinated care delivery models but should be confirmed through more rigorous examination in future studies.

Association between interferon use and reduced metabolic and vascular complications among patients with hepatitis C.

We examined whether interferon treatment is associated with reduced metabolic/vascular complications in hepatitis C virus patients. The study had historical prospective cohort design using Maryland Medicaid administrative data (2006-2009). The end point was the incidence rate of mild, severe and combined mild/severe events from the Diabetes Complications Severity Index (DCSI). Interferon-treated and -untreated hepatitis C virus patients were matched on baseline covariates. Using multivariate counting process Cox regressions, we modeled the association between interferon receipt of at least 24 weeks and DCSI events incidence rate. Treated whites had similar rate of mild DCSI events, significantly 64% (p < 0.01) lower rate of severe DCSI events, and overall 29% (p = 0.14) lower rate of mild/severe DCSI events, compared with untreated whites. Compared with untreated blacks, treated blacks had a similar rate of DSCI events. Future studies should confirm our findings and should include important clinical variables such as viral genotype, virologic count and achieving sustained virologic response.

Diabetes control through an educational intervention.

OBJECTIVE: We evaluated the effect of an educational intervention administered to patients or/and physicians on the reduction in HbA(1c) and achieving diabetic control in a high-risk primarily Black inner-city population. METHODS: The study was designed as a four-arm randomized clinical trial where an educational program on diabetes was offered to physicians only, patients only, and both physicians and their patients, while the fourth arm did not receive any instruction. We built regression models at 24 months of follow-up to assess the likelihood of reaching glycemic goal as well as to measure the absolute reduction in HbA(1c) controlling for arm assignment, insulin use, race, age, sex, smoking, insulin use, and having achieved blood pressure control. RESULTS: Between April 2005 and July 2007, there were 823 patients randomized into the study. In multivariate analyses, the intervention group in which only patients received education showed a trend toward achieving a significant mean reduction in HbA(1c) with 49% (P = .06) higher odds of reaching glycemic control and .12 (P = .06) greater absolute percentage point drop in HbA(1c) compared to the no education group. CONCLUSION: Although our study reports positive results, it warrants a special emphasis on the behavior of the patient. Study results bring attention to disease management programs such as peer support networks that empower the patients that shift some of the responsibility to them.

Comparative and cost effectiveness of treatment modalities for hepatocellular carcinoma in SEER-Medicare.

BACKGROUND: The incidence of hepatocellular carcinoma (HCC) is increasing in the USA and worldwide. Several treatments are available for patients diagnosed at any disease stage. It remains unclear how medical expenditures vary across patients who remain untreated or undergo different modes of therapy. We evaluate the comparative and cost effectiveness of treatment modalities for HCC from a Medicare perspective. METHODS: The Surveillance, Epidemiology, and End Results (SEER) registries and linked Medicare database with claims from Parts A/B were used to identify Medicare enrollees with initial diagnosis of HCC between 2000 and 2007 and followed through 2009. Patients were assigned to treatment modalities based on HCC staging systems: transplant, resection, liver directed, radiation, chemotherapy or no treatment. Survival benefits and cumulative Medicare expenditures were estimated in multivariate models, stratified by initial disease stage, to control for confounding. Cost-effectiveness ratios compared costs and benefits of the modalities across initial stages. RESULTS: Cancer stages I, II, III, IV and unstaged represented 24, 9, 14, 17 and 37 % of 11,047 patients, respectively. Fewer than 40 % received any treatment. Relative to no treatment, transplant was most effective in reducing mortality, followed by resection, liver directed, and radiation or chemotherapy. Resection tended to be most cost effective in early staged and unstaged patients; transplant was least cost effective. In stage IV patients, liver directed therapy was more cost effective than chemotherapy or radiation. CONCLUSIONS: Survival benefit was attributable to all treatment modalities. More effective treatments incurred greater Medicare expenditures, but resection patients incurred the least expenditures per year of life gained.

Effect of social networks intervention in type 2 diabetes: a partial randomised study.

BACKGROUND: In this partially randomised intervention study, we assessed the effect of social networks on the improvement of type 2 diabetes management in a largely African-American population in Baltimore. METHODS: Patients in the intervention group (n=68) were asked to recruit peers, form small groups, and attend monthly diabetes education sessions, emphasising peer support. Patients in the control group (n=70) were recruited individually to attend standard diabetes education sessions. The primary outcomes were changes in haemoglobin A1C (HbA1c) and blood glucose. Secondary outcomes included blood pressure, weight, functional status, self-efficacy, perceived cohesion, social network connectedness and diabetes knowledge. General linear mixed models were built to assess mean absolute changes in primary and secondary outcomes at 3 and 6 months. RESULTS: At 6 months from baseline, the social network intervention group achieved a larger reduction in HbA1c of -0.32% (p<0.0001) and blood glucose of -10.6 mg/dL, (p<0.0001) compared to the control group. In analyses of secondary endpoints, the intervention group had more favourable outcomes over time for weight, quality of life, self-efficacy, social network scores and diabetes knowledge, compared to the control group. While blood pressure decreased, and perceived cohesion increased in both groups over the duration of the study, the difference between groups was not statistically significant. CONCLUSIONS: The social networks intervention showed improved integration of patients within their existing networks leading to a greater reduction in HbA1c and blood glucose, as well as improved behaviour mediating outcomes.

Transarterial chemoembolization treatment: association between multiple treatments, cumulative expenditures, and survival.

OBJECTIVES: To examine cumulative survival and Medicaid-paid expenses associated with multiple courses of transarterial chemoembolization (TACE) as primary treatment for hepatocellular carcinoma (HCC). METHODS: Medicare enrollees diagnosed with primary HCC from 2000 to 2007, ever treated with TACE, but not transplant/resection, followed through 2009 by using the Surveillance, Epidemiology and End-Results Program and linked Medicare databases. Cumulative all-cause/HCC-related survival was estimated by using multivariate Cox proportional hazards models stratified by the total number of TACE treatments. Multivariate weighted Cox regressions estimated the average risk of mortality faced with nonproportional hazards. Lin's inverse probability-weighted least squares regression method estimated cumulative Medicare expenditures adjusted for censoring and covariates. RESULTS: Of 1228 patients, 34% were stage 1, 16% stage 2, 19% stage 3, 6% stage 4, and 26% unstaged. About 44% were aged 65 to 75 years, 69% were men, and 72% were Caucasian. Over half (57%) of the patients received one course, 24% two, 11% three, and 8% four courses of TACE. One-course patients incurred an average $74,788 (95% confidence interval [CI] $71,890-$77,686), two-course patients $101,126 (95% CI $94,395-$107,856), three-course patients $111,776 (95% CI $101,931-$121,621), and four-plus-course patients $148,878 (95% CI $136,346-$161,409). One-course patients lived (all-cause) an average 1.86 (95% CI 1.82-1.90), two-course patients 2.09 (95% CI 2.05-2.13), three-course patients 2.81 (95% CI 2.66-2.97), and four-plus-course patients 3.06 (95% CI 2.95-3.18) years after diagnosis. Average risk of all-cause mortality was not significantly different between one/two courses or three/four-plus courses. CONCLUSIONS: Cumulative Medicare expenditures nearly doubled from one-course to four-plus-course patients. On average, four-plus-course patients lived over one more year than did one-course patients. Physician/patient decisions should be balanced with consideration of efficient use of limited resources, but payer's intervention in physician discretion may not be important in this setting.