Pivoting from in-person to phone survey assessment of alcohol and substance use: effects on representativeness in a United States prospective cohort of women living with and without HIV.

Background: Many clinical and population-based research studies pivoted from in-person assessments to phone-based surveys due to the COVID-19 pandemic. The impact of these transitions on survey response remains understudied, especially for people living with HIV. Given that there are gender-specific trends in alcohol and substance use, it is particularly important to capture these data for women.Objective: Identify factors associated with responding to an alcohol and substance use phone survey administered during the COVID-19 pandemic in the Women's Interagency HIV Study, a multicenter US prospective cohort of women living with and without HIV.Methods: We used multivariable logistic regression to assess for associations of pre-pandemic (April-September 2019) sociodemographic factors, HIV status, housing status, depressive symptoms, alcohol use, and substance use with response to an early-pandemic (August-September 2020) phone survey.Results: Of 1,847 women who attended an in-person visit in 2019, 78% responded to a phone survey during the pandemic. The odds of responding were lower for women of Hispanic ethnicity (aOR 0.47 95% CI 0.33-0.66, ref=Black/African American) and those who reported substance use (aOR 0.63 95% CI 0.41-0.98). By contrast, the odds were higher for White women (aOR 1.64 95% CI 1.02-2.70, ref=Black/African American) and those with stable housing (aOR 1.74 95% CI 1.24-2.43).Conclusions: Pivoting from an in-person to phone-administered alcohol and substance use survey may lead to underrepresentation of key subpopulations of women who are often neglected in substance use and HIV research. As remote survey methods become more common, investigators need to ensure that the study population is representative of the target population.

Longitudinal Assessment of the Enhanced Liver Fibrosis Score in the Era of Contemporary HIV and Hepatitis C Virus Treatment.

BACKGROUND: The trajectory of liver fibrosis is not well understood in the contemporary era of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) therapy. METHODS: We assessed the Enhanced Liver Fibrosis (ELF) score, aspartate transaminase-to-platelet ratio index (APRI) and Fibrosis-4 (FIB-4) in 116 women with HIV/HCV coinfection over a 4-year period. Random-effects linear regression models examined the rate of fibrosis change 1-2 years before starting HCV treatment, within 1 year before starting (peri-HCV treatment), within 1 year after and 1-2 years post-HCV treatment in unadjusted and adjusted models including age, race, and changes from pretreatment of factors that might affect fibrosis (eg, alcohol, integrase strand inhibitor [INSTI] use, waist circumference, CD4 count). RESULTS: INSTI use nearly doubled from pre- to peri-HCV treatment. In unadjusted analysis, there was a 3.3% rate of rise in ELF pre-HCV treatment, 2.2% and 3.6% rate of decline during the peri- and 1-year post-HCV treatment period, respectively, followed by a 0.3% rise. Similar findings were observed for APRI and FIB-4. There was little effect on the estimated fibrosis trajectories after adjustment. CONCLUSIONS: The apparent lack of decline in biomarkers of liver fibrosis beyond 1 year after HCV cure suggests that continued monitoring of liver fibrosis and interventions to mitigate progression in people with HIV after HCV cure remains essential.

The association of patient preferences and attitudes with trial of labor after cesarean.

OBJECTIVE: To evaluate the association of patient preferences and attitudes with TOLAC. STUDY DESIGN: Prospective observational study of TOLAC-eligible women at 26-34 weeks gestation. Preferences (utilities) were elicited using the time trade-off and standard gamble metrics. Logistic regression was used to identify preference- and attitude-based factors associated with TOLAC. RESULTS: Of the 231 participants, most (n = 197, 85%) preferred vaginal delivery, but only 40% (n = 93) underwent TOLAC. Utilities for uterine rupture outcomes did not differ based on delivery approach. In multivariable analysis, strength of preference for vaginal delivery, value for the experience of labor, and the opinion of the person whom the participant thought of as most important to this decision were associated with TOLAC. CONCLUSIONS: Future decision support interventions incorporating individualized information regarding the likelihood of vaginal birth and empowering patients to express their preferences and engage their families in the decision-making process may improve decision quality and increase TOLAC rates.

Assessing intra-lab precision and inter-lab repeatability of outgrowth assays of HIV-1 latent reservoir size.

Quantitative viral outgrowth assays (QVOA) use limiting dilutions of CD4+ T cells to measure the size of the latent HIV-1 reservoir, a major obstacle to curing HIV-1. Efforts to reduce the reservoir require assays that can reliably quantify its size in blood and tissues. Although QVOA is regarded as a "gold standard" for reservoir measurement, little is known about its accuracy and precision or about how cell storage conditions or laboratory-specific practices affect results. Owing to this lack of knowledge, confidence intervals around reservoir size estimates-as well as judgments of the ability of therapeutic interventions to alter the size of the replication-competent but transcriptionally inactive latent reservoir-rely on theoretical statistical assumptions about dilution assays. To address this gap, we have carried out a Bayesian statistical analysis of QVOA reliability on 75 split samples of peripheral blood mononuclear cells (PBMC) from 5 antiretroviral therapy (ART)-suppressed participants, measured using four different QVOAs at separate labs, estimating assay precision and the effect of frozen cell storage on estimated reservoir size. We found that typical assay results are expected to differ from the true value by a factor of 1.6 to 1.9 up or down. Systematic assay differences comprised a 24-fold range between the assays with highest and lowest scales, likely reflecting differences in viral outgrowth readout and input cell stimulation protocols. We also found that controlled-rate freezing and storage of samples did not cause substantial differences in QVOA compared to use of fresh cells (95% probability of < 2-fold change), supporting continued use of frozen storage to allow transport and batched analysis of samples. Finally, we simulated an early-phase clinical trial to demonstrate that batched analysis of pre- and post-therapy samples may increase power to detect a three-fold reservoir reduction by 15 to 24 percentage points.

Use of Nonantiretroviral Medications That May Impact Neurocognition: Patterns and Predictors in a Large, Long-Term HIV Cohort Study.

BACKGROUND: Neurocognitive impairment is a frequent and often disabling comorbidity of HIV infection. In addition to antiretroviral therapies, individuals with HIV infection may commonly use nonantiretroviral medications that are known to cause neurocognitive adverse effects (NC-AE). The contribution of NC-AE to neurocognitive impairment is rarely considered in the context of HIV and could explain part of the variability in neurocognitive performance among individuals with HIV. SETTING: Women's Interagency HIV Study, a prospective, multisite, observational study of US women with and without HIV. METHODS: After a literature review, 79 medications (excluding statins) with NC-AE were identified and reported by Women's Interagency HIV Study participants. We examined factors associated with self-reported use of these medications over a 10-year period. Generalized estimating equations for binary outcomes were used to assess sociodemographic, behavioral, and clinical characteristics associated with NC-AE medication use. RESULTS: Three thousand three hundred women (71% with HIV) and data from ∼42,000 visits were studied. HIV infection was associated with NC-AE medication use (odds ratio = 1.52; 95% confidence interval: 1.35 to 1.71). After adjustment for HIV infection status, other predictors of NC-AE medication use included having health insurance, elevated depressive symptoms, prior clinical AIDS, noninjection recreational drug use, and an annual household income of <$12,000 (Ps < 0.004). NC-AE medication use was less likely among women who drank 1-7 or 8-12 alcoholic drinks/week (vs. abstaining) (P < 0.04). CONCLUSIONS: HIV infection was associated with NC-AE medication use, which may influence determinations of HIV-associated neurocognitive impairment. Providers should consider the impact of NC-AE medications when evaluating patients with HIV and concurrent neurocognitive symptoms.

Development and validation of an assay to analyze atazanavir in human hair via liquid chromatography/tandem mass spectrometry.

RATIONALE: Assays to quantify antiretrovirals in hair samples are increasingly used to monitor adherence and exposure in both HIV prevention and treatment studies. Atazanavir (ATV) is a protease inhibitor used in combination antiretroviral therapy (ART). We developed and validated a liquid chromatography/tandem mass spectrometry (LC/MS/MS)-based method to quantify ATV in human hair, per the NIH Division of AIDS Clinical Pharmacology Quality Assurance (CPQA) program and the FDA bioanalytical method validation guidelines. METHODS: ATV was extracted from hair using optimized methods and the extracts were injected onto a BDS C-18 column (5 µm, 4.6 × 100 mm), followed by isocratic elution via a mobile phase composed of 55% acetonitrile, 45% water, 0.15% acetic acid, and 4 mM ammonium acetate, at a flow rate of 0.8 mL/min prior to analysis by MS/MS. Levels were quantified using positive electrospray ionization by multiple reaction monitoring (MRM) for the transitions MH+ m/z 705.3 to m/z 168.0 and MH+ m/z 710.2 to m/z 168.0 for ATV and ATV-d5 (internal standard), respectively. RESULTS: Our assay demonstrated a linear standard curve (r = 0.99) over the concentration range of 0.0500 ng ATV/mg hair to 20.0 ng/mg hair. The inter- and intraday accuracy of ATV quality control (QC) samples was -1.33 to 4.00% and precision (% coefficient of variation (%CV)) was 1.75 to 6.31%. The %CV for ATV levels in hair samples from highly adherent patients (incurred samples) was less than 10%. No significant endogenous peaks or crosstalk were observed in the specificity test with other HIV drugs. The overall extraction efficiency of ATV from incurred hair samples was greater than 95%. CONCLUSIONS: This highly sensitive, highly specific and validated assay can be considered for therapeutic drug monitoring for HIV-infected patients on ATV-based ART.

Life-Space Assessment Predicts Hospital Readmission in Home-Limited Adults.

OBJECTIVES: To describe the association between restricted life-space and characteristics of community-dwelling adults hospitalized for congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD), to estimate the effect of hospitalization on postdischarge mobility, and to determine whether baseline restricted life-space predicts hospital readmission. DESIGN: Observational. SETTING: Urban academic hospital that serves as a safety net for urban and rural populations with low resources and serves central and northern Alabama. PARTICIPANTS: Individuals with CHF or COPD hospitalized from home (N = 478). MEASUREMENTS: The Life-Space Assessment (LSA) measures mobility by asking about movement in situations ranging from within one's dwelling to beyond one's town. LSA scores below 60 correspond to "restricted life-space." Baseline LSA scores before admission were measured during an index hospitalization; follow-up LSA scores were determined over the telephone at 90 days. Participant characteristics were examined according to baseline restricted life-space using the chi-square test and Student's t-test. Each characteristic's association with restricted life-space was estimated uisng logistic regression. RESULTS: Of the participants, 372 (77.8%) were classified as having baseline restricted life-space. Baseline restricted life-space was associated with older age (odds ratio (OR) = 1.29 per decade, 95% confidence interval (CI) = 1.17-1.42, P = .001), female sex (OR = 2.69, 95% CI = 1.69-4.29, P < .001), African-American race (OR = 1.55, 95% CI = 1.00-2.41, P = .05), and having inadequate financial resources (OR = 2.03, 95% CI = 1.22-3.38, P = .006). In the baseline unrestricted life-space group, 49.5% (n = 49) had restricted life-space at 90-day follow-up. Baseline restricted life-space was associated with greater odds of 90-day hospital readmission (unadjusted OR = 1.64, 95% CI = 1.00-2.70, P = .05; adjusted OR = 1.72, 95% CI = 1.04-2.85, P = .03). CONCLUSION: Baseline restricted life-space was associated with greater risk of hospital readmission within 90 days after hospital discharge. These findings suggest a need to customize the management of individuals hospitalized with CHF or COPD based on baseline life-space level.

Effect of Present-on-Admission (POA) Reporting Accuracy on Hospital Performance Assessments Using Risk-Adjusted Mortality.

OBJECTIVE: To evaluate how the accuracy of present-on-admission (POA) reporting affects hospital 30-day acute myocardial infarction (AMI) mortality assessments. DATA SOURCES: A total of 2005 California patient discharge data (PDD) and vital statistics death files. STUDY DESIGN: We compared hospital performance rankings using an established model assessing hospital performance for AMI with (1) a model incorporating POA indicators of whether a secondary condition was a comorbidity or a complication of care, and (2) a simulation analysis that factored POA indicator accuracy into the hospital performance assessment. For each simulation, we changed POA indicators for six major acute risk factors of AMI mortality. The probability of POA being changed depended on patient and hospital characteristics. PRINCIPAL FINDINGS: Comparing the performance rankings of 268 hospitals using the established model with that using the POA indicator, 67 hospitals' (25 percent) rank differed by ≥10 percent. POA reporting inaccuracy due to overreporting and underreporting had little additional impact; POA overreporting contributed to 4 percent of hospitals' difference in rank compared to the POA model and POA underreporting contributed to <1 percent difference. CONCLUSION: Incorporating POA indicators into risk-adjusted models of AMI care has a substantial impact on hospital rankings of performance that is not primarily attributable to inaccuracy in POA hospital reporting.

Assessment of HIV antiretroviral therapy adherence by measuring drug concentrations in hair among children in rural Uganda.

Current tools for measuring medication adherence have significant limitations, especially among pediatric populations. We conducted a prospective observational study to assess the use of antiretroviral (ARV) drug levels in hair for evaluating antiretroviral therapy (ART) adherence among HIV-infected children in rural Uganda. Three-day caregiver recall, 30-day visual analog scale (VAS), Medication Event Monitoring System (MEMS), and unannounced pill counts and liquid formulation weights (UPC) were collected monthly over a one-year period. Hair samples were collected quarterly and analyzed for nevirapine (NVP) levels, and plasma HIV RNA levels were collected every six months. Among children with at least one hair sample collected, we used univariable random intercept linear regression models to compare log transformed NVP concentrations with each adherence measure, and the child's age, sex, and CD4 count percentage (CD4%). One hundred and twenty-one children aged 2-10 years were enrolled in the study; 74 (61%) provided at least one hair sample, and the mean number of hair samples collected per child was 1.9 (standard deviation [SD] 1.0). Three-day caregiver recall, VAS, and MEMS were found to be positively associated with increasing NVP concentration in hair, although associations were not statistically significant. UPC was found to have a nonsignificant negative association with increasing hair NVP concentration. In conclusion, NVP drug concentrations in hair were found to have nonsignificant, although generally positive, associations with other adherence measures in a cohort of HIV-infected children in Uganda. Hair collection in this population proved challenging, suggesting the need for community education and buy-in with the introduction of novel methodologies.

Short communication: A low-cost method for analyzing nevirapine levels in hair as a marker of adherence in resource-limited settings.

The measurement of antiretroviral concentrations in hair is emerging as an important technology to objectively quantify adherence to combination antiretroviral therapy. Hair levels of antiretrovirals are the strongest independent predictor of virologic success in large prospective cohorts of HIV-infected patients and surpass self-report in predicting outcomes. Hair is easy to collect and store, but validated methods to analyze antiretroviral levels in hair using liquid chromatography tandem mass spectrometry (LC-MS/MS) are expensive. We report here on the development of a thin-layer chromatography (TLC) assay for the semiquantitative analysis of nevirapine in hair. TLC assay results from 11 samples were consistent with results using LC-MS/MS [Spearman correlation coefficient 0.99 (95% CI 0.95-0.996)]. This simple, low-cost method of analyzing nevirapine concentrations in hair may provide a novel monitoring tool for antiretroviral adherence in resource-limited settings and merits further study in clinical settings.

Progression of biopsy-measured liver fibrosis in untreated patients with hepatitis C infection: non-Markov multistate model analysis.

BACKGROUND: Fibrosis stages from liver biopsies reflect liver damage from hepatitis C infection, but analysis is challenging due to their ordered but non-numeric nature, infrequent measurement, misclassification, and unknown infection times. METHODS: We used a non-Markov multistate model, accounting for misclassification, with multiple imputation of unknown infection times, applied to 1062 participants of whom 159 had multiple biopsies. Odds ratios (OR) quantified the estimated effects of covariates on progression risk at any given time. RESULTS: Models estimated that progression risk decreased the more time participants had already spent in the current stage, African American race was protective (OR 0.75, 95% confidence interval 0.60 to 0.95, p = 0.018), and older current age increased risk (OR 1.33 per decade, 95% confidence interval 1.15 to 1.54, p = 0.0002). When controlled for current age, older age at infection did not appear to increase risk (OR 0.92 per decade, 95% confidence interval 0.47 to 1.79, p = 0.80). There was a suggestion that co-infection with human immunodeficiency virus increased risk of progression in the era of highly active antiretroviral treatment beginning in 1996 (OR 2.1, 95% confidence interval 0.97 to 4.4, p = 0.059). Other examined risk factors may influence progression risk, but evidence for or against this was weak due to wide confidence intervals. The main results were essentially unchanged using different assumed misclassification rates or imputation of age of infection. DISCUSSION: The analysis avoided problems inherent in simpler methods, supported the previously suspected protective effect of African American race, and suggested that current age rather than age of infection increases risk. Decreasing risk of progression with longer time already spent in a stage was also previously found for post-transplant progression. This could reflect varying disease activity, with recent progression indicating active disease and high risk, while longer time already spent in a stage indicates quiescent disease and low risk.

Non-Markov multistate modeling using time-varying covariates, with application to progression of liver fibrosis due to hepatitis C following liver transplant.

Multistate modeling methods are well-suited for analysis of some chronic diseases that move through distinct stages. The memoryless or Markov assumptions typically made, however, may be suspect for some diseases, such as hepatitis C, where there is interest in whether prognosis depends on history. This paper describes methods for multistate modeling where transition risk can depend on any property of past progression history, including time spent in the current stage and the time taken to reach the current stage. Analysis of 901 measurements of fibrosis in 401 patients following liver transplantation found decreasing risk of progression as time in the current stage increased, even when controlled for several fixed covariates. Longer time to reach the current stage did not appear associated with lower progression risk. Analysis of simulation scenarios based on the transplant study showed that greater misclassification of fibrosis produced more technical difficulties in fitting the models and poorer estimation of covariate effects than did less misclassification or error-free fibrosis measurement. The higher risk of progression when less time has been spent in the current stage could be due to varying disease activity over time, with recent progression indicating an "active" period and consequent higher risk of further progression.

Simple, defensible sample sizes based on cost efficiency.

The conventional approach of choosing sample size to provide 80% or greater power ignores the cost implications of different sample size choices. Costs, however, are often impossible for investigators and funders to ignore in actual practice. Here, we propose and justify a new approach for choosing sample size based on cost efficiency, the ratio of a study's projected scientific and/or practical value to its total cost. By showing that a study's projected value exhibits diminishing marginal returns as a function of increasing sample size for a wide variety of definitions of study value, we are able to develop two simple choices that can be defended as more cost efficient than any larger sample size. The first is to choose the sample size that minimizes the average cost per subject. The second is to choose sample size to minimize total cost divided by the square root of sample size. This latter method is theoretically more justifiable for innovative studies, but also performs reasonably well and has some justification in other cases. For example, if projected study value is assumed to be proportional to power at a specific alternative and total cost is a linear function of sample size, then this approach is guaranteed either to produce more than 90% power or to be more cost efficient than any sample size that does. These methods are easy to implement, based on reliable inputs, and well justified, so they should be regarded as acceptable alternatives to current conventional approaches.

Are the uninsured responsible for the increase in emergency department visits in the United States?

STUDY OBJECTIVE: The rise in emergency department (ED) use in the United States is frequently attributed to increased visits by the uninsured. We determine whether insurance status is associated with the increase in ED visits. METHODS: Using the national Community Tracking Study Household Surveys from 1996 to 1997, 1998 to 1999, 2000 to 2001, and 2003 to 2004, we determined for each period the proportion of reported adult ED visits according to insurance status, family income, usual source of care, health status, and outpatient (non-ED) visits. Trends over time were tested for statistical significance. RESULTS: The proportion of adult ED visits by persons without insurance was stable across the decade. Uninsured individuals accounted for 15.5% of ED visits in 1996 to 1997, 16.1% in 1998 to 1999, 15.2% in 2000 to 2001, and 14.5% of visits in 2003 to 2004 (P for trend=.43). The proportion of visits by persons whose family income was greater than 400% of the federal poverty level increased from 21.9% to 29.0% (P=.002). The proportion of visits by those whose usual source of care was a physician's office increased from 52.4% in 1996 to 1997 to 59.0% in 2003 to 2004 (P=.002), whereas the proportion of visits by those without a usual source of care was essentially unchanged (9.7% of visits in 1996 to 1997 and 9.6% in 2003 to 2004; P=.74). CONCLUSION: The rise in ED visits between 1996 and 2003 cannot be primarily attributed to the uninsured. Major contributors to increasing ED utilization appear to be disproportionate increases in use by nonpoor persons and by persons whose usual source of care is a physician's office.

Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others.

BACKGROUND: Published pharmaceutical industry-sponsored trials are more likely than non-industry-sponsored trials to report results and conclusions that favor drug over placebo. Little is known about potential biases in drug-drug comparisons. This study examined associations between research funding source, study design characteristics aimed at reducing bias, and other factors that potentially influence results and conclusions in randomized controlled trials (RCTs) of statin-drug comparisons. METHODS AND FINDINGS: This is a cross-sectional study of 192 published RCTs comparing a statin drug to another statin drug or non-statin drug. Data on concealment of allocation, selection bias, blinding, sample size, disclosed funding source, financial ties of authors, results for primary outcomes, and author conclusions were extracted by two coders (weighted kappa 0.80 to 0.97). Univariate and multivariate logistic regression identified associations between independent variables and favorable results and conclusions. Of the RCTs, 50% (95/192) were funded by industry, and 37% (70/192) did not disclose any funding source. Looking at the totality of available evidence, we found that almost all studies (98%, 189/192) used only surrogate outcome measures. Moreover, study design weaknesses common to published statin-drug comparisons included inadequate blinding, lack of concealment of allocation, poor follow-up, and lack of intention-to-treat analyses. In multivariate analysis of the full sample, trials with adequate blinding were less likely to report results favoring the test drug, and sample size was associated with favorable conclusions when controlling for other factors. In multivariate analysis of industry-funded RCTs, funding from the test drug company was associated with results (odds ratio = 20.16 [95% confidence interval 4.37-92.98], p < 0.001) and conclusions (odds ratio = 34.55 [95% confidence interval 7.09-168.4], p < 0.001) that favor the test drug when controlling for other factors. Studies with adequate blinding were less likely to report statistically significant results favoring the test drug. CONCLUSIONS: RCTs of head-to-head comparisons of statins with other drugs are more likely to report results and conclusions favoring the sponsor's product compared to the comparator drug. This bias in drug-drug comparison trials should be considered when making decisions regarding drug choice.

Predictors of publication: characteristics of submitted manuscripts associated with acceptance at major biomedical journals.

OBJECTIVE: To identify characteristics of submitted manuscripts that are associated with acceptance for publication by major biomedical journals. DESIGN, SETTING AND PARTICIPANTS: A prospective cohort study of manuscripts reporting original research submitted to three major biomedical journals (BMJ and the Lancet [UK] and Annals of Internal Medicine [USA]) between January and April 2003 and between November 2003 and February 2004. Case reports on single patients were excluded. MAIN OUTCOME MEASURES: Publication outcome, methodological quality, predictors of publication. RESULTS: Of 1107 manuscripts enrolled in the study, 68 (6%) were accepted, 777 (70%) were rejected outright, and 262 (24%) were rejected after peer review. Higher methodological quality scores were associated with an increased chance of acceptance (odds ratio [OR], 1.39 per 0.1 point increase in quality score; 95% CI, 1.16-1.67; P < 0.001), after controlling for study design and journal. In a multivariate logistic regression model, manuscripts were more likely to be published if they reported a randomised controlled trial (RCT) (OR, 2.40; 95% CI, 1.21-4.80); used descriptive or qualitative analytical methods (OR, 2.85; 95% CI, 1.51-5.37); disclosed any funding source (OR, 1.90; 95% CI, 1.01-3.60); or had a corresponding author living in the same country as that of the publishing journal (OR, 1.99; 95% CI, 1.14-3.46). There was a non-significant trend towards manuscripts with larger sample size (>/= 73) being published (OR, 2.01; 95% CI, 0.94-4.32). After adjustment for other study characteristics, having statistically significant results did not improve the chance of a study being published (OR, 0.83; 95% CI, 0.34-1.96). CONCLUSIONS: Submitted manuscripts are more likely to be published if they have high methodological quality, RCT study design, descriptive or qualitative analytical methods and disclosure of any funding source, and if the corresponding author lives in the same country as that of the publishing journal. Larger sample size may also increase the chance of acceptance for publication.

Serum sodium predicts mortality in patients listed for liver transplantation.

With the implementation of the model for end-stage liver disease (MELD), refractory ascites, a known predictor of mortality in cirrhosis, was removed as a criterion for liver allocation. Because ascites is associated with low serum sodium, we evaluated serum sodium as an independent predictor of mortality in patients with cirrhosis who were listed for liver transplantation and whether the addition of serum sodium to MELD was superior to MELD alone. This is a single-center retrospective cohort of all adult patients with cirrhosis listed for transplantation from February 27, 2002, to December 26, 2003. Listing laboratories were those nearest the listing date +/-2 months. Of the 513 patients meeting inclusion criteria, 341 were still listed, while 172 were removed from the list (105 for transplantation, 56 for death, 11 for other reasons). The median serum sodium and MELD scores were 137 mEq/L (range, 110-155) and 15 (range, 6-51), respectively, at listing. Median follow-up was 201 (range, 1-662) days. The risk of death with serum sodium <126 mEq/L at listing or while listed was increased, with hazard ratios of 7.8 (P < .001) and 6.3 (P < .001), respectively, and the association was independent of MELD. The c-statistics of receiver operating characteristic curves for predicting mortality at 3 months based upon listing MELD with and without listing serum sodium were 0.883 and 0.897, respectively, and at 6 months were 0.871 and 0.905, respectively. In conclusion, serum sodium <126 mEq/L at listing or while listed for transplantation is a strong independent predictor of mortality. Addition of serum sodium to MELD increases the ability to predict 3- and 6-month mortality in patients with cirrhosis.

The impact of Medicaid managed care on hospitalizations for ambulatory care sensitive conditions.

OBJECTIVE: To determine whether Medicaid managed care is associated with lower hospitalization rates for ambulatory care sensitive conditions than Medicaid fee-for-service. We also explored whether there was a differential effect of Medicaid managed care by patient's race or ethnicity on the hospitalization rates for ambulatory care sensitive conditions. DATA SOURCES/STUDY SETTING: Electronic hospital discharge abstracts for all California temporary assistance to needy families (TANF)-eligible Medicaid beneficiaries less than age 65 who were admitted to acute care hospitals in California between 1994 and 1999. STUDY DESIGN: We performed a cross-sectional comparison of average monthly rates of admission for ambulatory care-sensitive conditions among TANF-eligible Medicaid beneficiaries in fee-for-service, voluntary managed care, and mandatory managed care. DATA COLLECTION/EXTRACTION METHODS: We calculated monthly rates of ambulatory care-sensitive condition admission rates by counting admissions for specified conditions in hospital discharge files and dividing the monthly count of admissions by the size of the at-risk population derived from a separate monthly Medicaid eligibility file. We used multivariate Poisson regression to model monthly hospital admission rates for ambulatory care-sensitive conditions as a function of the Medicaid delivery model controlling for admission month, admission year, patient age, sex, race/ethnicity, and county of residence. PRINCIPAL FINDINGS: The adjusted average monthly hospitalization rate for ambulatory care-sensitive conditions per 10,000 was 9.36 in fee-for-service, 6.40 in mandatory managed care, and 5.25 in voluntary managed care (p<.0001 for all pairwise comparisons). The difference in hospitalization rates for ambulatory care sensitive conditions in Medicaid fee-for-service versus managed care was significantly larger for patients from minority groups than for whites. CONCLUSIONS: Selection bias in voluntary Medicaid managed care programs exaggerates the differences between managed care and fee-for-service, but the 33 percent lower rate of hospitalizations for ambulatory care sensitive conditions found in mandatory managed care compared with fee-for-service suggests that Medicaid managed care is associated with a large reduction in hospital utilization, which likely reflects health benefits. The greater effect of Medicaid managed care for minority compared with white beneficiaries is consistent with other findings that suggest that managed care is associated with improvements in access to ambulatory care for those patients who have traditionally faced the greatest barriers to health care.

Variation in care for nonmelanoma skin cancer in a private practice and a veterans affairs clinic.

BACKGROUND: Nonmelanoma skin cancer is the most common malignancy. Multiple therapies prevent recurrence but vary widely in cost. The most common therapies are local destruction, excision, and Mohs surgery (histologically guided tumor removal). Clinical variables that may affect treatment choices can be identified, but little is known about how clinicians choose among therapies. OBJECTIVE: The objective of this study was to learn if variations exist in the treatment of nonmelanoma skin cancer in different practice settings. RESEARCH DESIGN: Prospective cohort study. SUBJECTS: Subjects consisted of consecutive patients with nonmelanoma skin cancer at a university-affiliated private dermatology practice and the dermatology clinic at the nearby affiliated Veterans Affairs (VA) medical center. DATA: We studied data from medical records and patient surveys. RESULTS: Overall, 1777 nonrecurrent nonmelanoma skin cancers were diagnosed in 1375 patients. Compared with the VA site, patients at the private site were younger, more likely to be female, and less likely to be poor, and their tumors were smaller and less likely to be on visible areas of the body. Treatments varied between the 2 sites (P <0.001). The proportions of tumors treated at the private and VA sites, respectively, were 23% and 19% for destruction, 25% and 48% for excision, and 37% and 25% for Mohs surgery. In multiple clinical subgroups, Mohs surgery was more likely to be performed at the private site than at the VA. Moreover, in multivariable models controlling for clinical features that may have affected treatment choice, tumors at the private site were more likely than tumors at the VA to be treated with Mohs surgery (odds ratio, 2.39; 95% confidence interval, 1.54-3.70). CONCLUSIONS: Care for nonmelanoma skin cancer varied at 2 academic practice sites that are near each other and that share some clinician staff. These findings raise questions not only about overuse or underuse of procedures at the 2 sites, but also about systematic differences in patient preferences and/or physician incentives in prepaid and fee-for-service settings.