Recalibrating the Child-Turcotte-Pugh Score to Improve Prediction of Transplant-Free Survival in Patients with Cirrhosis.

BACKGROUND: The Child-Turcotte-Pugh (CTP) score is a widely used and validated predictor of long-term survival in cirrhosis. However, the cutpoints for stratifying laboratory variables in CTP have never been validated. OBJECTIVE: The objective of this study was to identify evidence-based cutpoints for the CTP laboratory subscores to improve its predictive capacity for transplant-free survival. DESIGN: Retrospective observational study. DATA SOURCE: Using a cohort of 30,897 cirrhotic US Veteran patients with at least 5 years of follow-up, we performed Cox proportional hazard survival model iterations varying the upper and lower cutpoints for INR, total bilirubin and albumin CTP subscores. Cutpoints yielding the highest Harrell's C-statistics for concordance with transplant-free survival were incorporated into a modified CTP (mCTP) score. Validation of the mCTP was performed at multiple time frames within the follow-up period of the cohort and within subsets defined by disease etiology. RESULTS: Modification of CTP cutpoints increased the Harrell's C-statistic for age- and gender-adjusted Cox proportional hazard models from 0.701 ± 0.002 to 0.709 ± 0.002 and the risk ratio per unit change from 1.49 (1.48-1.50) to 1.53 (1.52-1.54). The modified cutpoints showed superiority in predicting 5-year transplant-free survival in various disease etiology subgroups. A mCTP substituting serum creatinine for INR performed superiorly for predicting 5-year transplant-free survival. CONCLUSION: We propose an evidence-based recalibration of CTP score cutpoints that optimizes this model's capacity to predict transplant-free survival in patients with cirrhosis. The CTP score remains the best predictor of 5-year overall and transplant-free survival in patients with cirrhosis.

Development and Performance of an Algorithm to Estimate the Child-Turcotte-Pugh Score From a National Electronic Healthcare Database.

BACKGROUND & METHODS: The Child-Turcotte-Pugh (CTP) score is a widely used and validated predictor of long-term survival in cirrhosis. The CTP score is a composite of 5 subscores, 3 based on objective clinical laboratory values and 2 subjective variables quantifying the severity of ascites and hepatic encephalopathy. To date, no system to quantify CTP score from administrative databases has been validated. The Veterans Outcomes and Costs Associated with Liver Disease study is a multicenter collaborative study to evaluate the outcomes and costs of hepatocellular carcinoma in the U.S. Veterans Health Administration. We developed and validated an algorithm to calculate electronic CTP (eCTP) scores by using data from the Veterans Health Administration Corporate Data Warehouse. METHODS: Multiple algorithms for determining each CTP subscore from International Classification of Diseases version 9, Common Procedural Terminology, pharmacy, and laboratory data were devised and tested in 2 patient cohorts. For each cohort, 6 site investigators (Boston, Bronx, Brooklyn, Philadelphia, Minneapolis, and West Haven VA Medical Centers) were provided cases from which to determine validity of diagnosis, laboratory data, and clinical assessment of ascites and encephalopathy. The optimal algorithm (designated eCTP) was then applied to 30,840 cirrhotic patients alive in the first quarter of 2008 for whom 5-year overall and transplant-free survival data were available. The ability of the eCTP score and other disease severity scores (Charlson-Deyo index, Veterans Aging Cohort Study index, Model for End-Stage Liver Disease score, and Cirrhosis Comorbidity) to predict survival was then assessed by Cox proportional hazards regression. RESULTS: Spearman correlations for administrative and investigator validated laboratory data in the HCC and cirrhotic cohorts, respectively, were 0.85 and 0.92 for bilirubin, 0.92 and 0.87 for albumin, and 0.84 and 0.86 for international normalized ratio. In the HCC cohort, the overall eCTP score matched 96% of patients to within 1 point of the chart-validated CTP score (Spearman correlation, 0.81). In the cirrhosis cohort, 98% were matched to within 1 point of their actual CTP score (Spearman, 0.85). When applied to a cohort of 30,840 patients with cirrhosis, each unit change in eCTP was associated with 39% increase in the relative risk of death or transplantation. The Harrell C statistic for the eCTP (0.678) was numerically higher than those for other disease severity indices for predicting 5-year transplant-free survival. Adding other predictive models to the eCTP resulted in minimal differences in its predictive performance. CONCLUSION: We developed and validated an algorithm to extrapolate an eCTP score from data in a large administrative database with excellent correlation to actual CTP score on chart review. When applied to an administrative database, this algorithm is a highly useful predictor of survival when compared with multiple other published liver disease severity indices.

Are selective serotonin reuptake inhibitors associated with hepatocellular carcinoma in patients with hepatitis C?

BACKGROUND AND AIMS: Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed for patients with chronic hepatitis C virus (HCV) infection. Research suggests that serotonin promotes the development and growth of hepatocellular carcinoma (HCC). We tested the hypothesis whether exposure to SSRIs is associated with an increased risk of HCC in HCV patients. METHOD: Patients who entered the United States Veterans Affairs (VA) Hepatitis C Clinical Case Registry in 2000 to 2009 were analyzed. During the 8 years of follow-up, 36,192 patients filled at least 1 SSRI prescription. Cases of HCC were identified by diagnosis codes (ICD-9 155.0). Multivariable Cox regression analyses estimated adjusted HCC hazard ratios (HRs) for SSRI-exposed versus SSRI-unexposed subjects and categories of average SSRI doses. RESULTS: The annual incidence of HCC in the VA registry cohort of 109,736 patients was 0.5% and significantly greater in the 8% with cirrhosis at baseline (HR = 5.2; 95% CI, 4.7-5.7). There was no evidence for significant interactions between the effect of SSRI-exposure and cirrhosis. Baseline characteristics of the exposed (n = 36,192) and unexposed (n = 73,544) subjects were similar. The median (interquartile range [IQR]) follow-up period after SSRI-exposure began was 44 (20-74) months with 18 (3-49) months between the first and last prescription. The median average SSRI dose during follow-up expressed as a fraction of initial recommended doses for depression was 0.94 (IQR, 0.5 to 1.3). The risk of HCC was not significantly increased after SSRI exposure (HR = 0.96; 95% CI, 0.87-1.05) or with increasing SSRI doses. CONCLUSIONS: Analysis of a large cohort of HCV patients did not support the hypothesis that SSRIs increase the risk of developing HCC.

All-cause mortality and liver-related outcomes following successful antiviral treatment for chronic hepatitis C.

BACKGROUND: Antiviral therapy for the hepatitis C virus (HCV) reduces all-cause and liver-related morbidity and mortality. Few studies are available from populations with multiple medical and psychiatric comorbidities where the impact of successful antiviral therapy might be limited. AIM: The purpose of this study was to determine the effect of sustained virologic response (SVR) on all-cause and liver-related mortality in a cohort of HCV patients treated in an integrated hepatitis/mental health clinic. METHODS: This was a retrospective review of all patients who initiated antiviral treatment for chronic HCV between January 1, 1997 and December 31, 2009. Cox regression analysis was used to determine factors involved in all-cause mortality, liver-related events and hepatocellular carcinoma. RESULTS: A total of 536 patients were included in the analysis. Median follow-up was 7.5 years. Liver and non-liver-related mortality occurred in 2.7 and 5.0 % of patients with SVR and in 17.8 and 6.4 % of patients without SVR. In a multivariate analysis, SVR was the only factor associated with reduced all-cause mortality (HR 0.47; 95 % CI 0.26-0.85; p = 0.012) and reduced liver-related events (HR 0.23; 95 % CI 0.08-0.66, p = 0.007). Having stage 4 liver fibrosis increased all-cause mortality (HR 2.50; 95 % CI 1.23-5.08; p = 0.011). Thrombocytopenia at baseline (HR 2.66; 95 % CI 1.22-5.79; p = 0.014) and stage 4 liver fibrosis (HR 4.87; 95 % CI 1.62-14.53; p = 0.005) increased liver-related events. CONCLUSIONS: Despite significant medical and psychiatric comorbidities, SVR markedly reduced liver-related outcomes without a significant change in non-liver-related mortality after a median follow-up of 7.5 years.

The effect of stimulant use on antiviral treatment in an integrated hepatitis clinic.

OBJECTIVE: The objective was to determine the impact of stimulant use on antiviral treatment for chronic hepatitis C patients in an integrated hepatitis clinic. METHODS: A retrospective chart review of 449 consecutive patients seen in an integrated hepatitis clinic that included co-located mental health clinicians was performed. Psychiatric measures included drug use questionnaire, Beck Depression Inventory (BDI), Alcohol Use Disorders Identification Test-Consumption questions (AUDIT-C), urine drug screen and antiviral treatment outcomes. Patients with stimulant use were compared to patients with no drug use, other drug users and an unknown drug use group using χ(2) and analysis of variance tests. RESULTS: Over 15% of hepatitis C patients presenting to the clinic were using stimulants. Stimulant users had higher BDI and AUDIT-C scores. They were more likely to be followed by a co-located mental health clinician than other groups and were just as likely to initiate and finish antiviral therapy. CONCLUSIONS: Recent stimulant use is common in hepatitis C patients presenting to a hepatitis clinic. Stimulant users were more depressed and used alcohol to a greater degree than nonusers but were as likely to start antiviral therapy. An integrated mental health/medical care approach appears to be effective in addressing this difficult-to-treat population.

Integrated psychiatric/medical care in a chronic hepatitis C clinic: effect on antiviral treatment evaluation and outcomes.

OBJECTIVES: Psychiatric and substance use disorders are common in hepatitis C patients and represent barriers to antiviral treatment. We evaluated the effect of integrating psychiatric and medical care on evaluation for and initiation of antiviral treatment in a cohort of 184 patients with chronic hepatitis C. METHODS: Integrated care consisted of screening for psychiatric problems with Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), Beck Depression Inventory (BDI), Urine Drug Screen (UDS), and Primary Care Posttraumatic Stress Disorder (PC-PTSD) screens, referral based on specified cutoff scores to an established mental health (MH) provider, to a colocated psychiatric clinical nurse specialist (PCNS), or both. Data were collected retrospectively by chart review. RESULTS: Most patients (149/184, 81.0%) had at least one positive screen, 25.5% had a positive UDS. Among patients with positive screens, 38.3% had established MH providers, 47.0% had no MH provider and were referred to the PCNS, and 15.0% refused any psychiatric referral. Patients receiving integrated care with a colocated PCNS were significantly more likely to complete evaluation for and start antiviral treatment than other patients with positive screens, and at a rate similar to that of patients with negative screens. Patients with positive screens followed by any MH provider had significantly greater adherence to antiviral therapy than patients without positive screens. CONCLUSION: An integrated MH and medical approach was associated with rates of antiviral therapy recommendation and initiation similar to patients without risks for psychiatric or substance use problems. MH care was associated with improved adherence to antiviral therapy. Integrated care offers promise as an approach for addressing psychiatric comorbidity in this traditionally difficult to treat population.

Measuring rural hospital quality.

CONTEXT: Increased interest in the measurement of hospital quality has been stimulated by accrediting bodies, purchaser coalitions, government agencies, and other entities. PURPOSE: This paper examines quality measurement for hospitals in rural settings. We seek to identify rural hospital quality measures that reflect quality in all hospitals and that are sensitive to the rural hospital context. METHODS: We develop a conceptual model for measuring rural hospital quality, with a focus on the special issues posed by the rural hospital context for quality measurement. With the assistance of a panel of rural hospital and hospital quality measurement experts, we review hospital quality measures from national and rural organizations for their fit to rural hospitals. FINDINGS: Based on this analysis, we recommend an initial core set of quality measures relevant for rural hospitals with less than 50 beds. This core set of 20 measures includes 11 core measures from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) related to community acquired pneumonia, heart failure, and acute myocardial infarction; 1 measure related to infection control; 3 measures related to medication dispensing and teaching; 2 procedure-related measures; 1 financial measure; and 2 other measures related to the use of advance directives and emergency department monitoring of trauma vital signs. CONCLUSION: Based on the special measurement needs posed by the rural hospital context, we suggest avenues for future quality measure development for core rural hospital functions (eg, triage, stabilization, and transfer, and emergency care) not considered in existing quality measurement sets.

Emergency medical services in rural areas: the supporting role of state EMS agencies.

CONTEXT: EMS is an integral part of health care and is especially important in less densely populated areas. What is known about EMS in rural areas is limited because of fragmentation in the system and rudimentary data collection efforts. PURPOSE: The goal of this study is to identify important issues faced by rural EMS systems and describe the support of rural EMS providers by state EMS agencies. METHODS: A telephone survey of state EMS directors (response rate 95.7%) asked questions regarding issues in medical direction, programs, and initiatives by state EMS agencies that target rural and volunteer EMS providers, integration initiatives, and anticipated effects of the new Medicare fee schedule. FINDINGS: Medical direction in rural EMS was identified as a major issue for a majority of states. Integration in EMS is seen as a possible solution but does not occur very commonly. The survey found substantial variation in the state approach to EMS issues. Less than a third of the states in the study have a statewide EMS plan. State EMS agencies address rural EMS provider needs in a limited manner. EMS state agencies focus on regulation and funding of EMS providers, with only approximately a third providing technical assistance to EMS providers. CONCLUSIONS: The range in approaches to EMS issues at the state level will need to be taken into account in formulating national EMS policy. The limited provision of technical assistance leaves a void that may be addressed by other agencies and organizations in some states. In the absence of major federal funding initiatives, the development of EMS has become a state and local issue. A new national initiative may help address EMS issues and stimulate the development of EMS as a system beyond its current fragmented state.

Medicare minus choice: the impact of HMO withdrawals on rural Medicare beneficiaries.

A disproportionate share of the Medicare beneficiaries who lost coverage as a result of recent health maintenance organization (HMO) withdrawals have been from rural areas. Rural beneficiaries are less likely than urban beneficiaries are to have another Medicare+Choice (M+C) option. We surveyed a nationwide random sample of 1,093 rural beneficiaries to assess the impact of HMO withdrawals. A high proportion of beneficiaries ended up without any coverage beyond traditional Medicare; on average, beneficiaries experienced significant increases in premiums; and the proportion of beneficiaries with prescription drug coverage decreased significantly. These results raise questions about whether the federal government should encourage plans to enter rural markets where they will be the only M+C plan and where their withdrawal could have negative consequences for enrollees who lose coverage.