RESUMO
BACKGROUND: The goal of this study was to compare the performance of several database algorithms designed to identify red blood cell (RBC) Transfusion Related hospital Admissions (TRAs) in Veterans with end stage renal disease (ESRD). METHODS: Hospitalizations in Veterans with ESRD and evidence of dialysis between 01/01/2008 and 12/31/2013 were screened for TRAs using a clinical algorithm (CA) and four variations of claims-based algorithms (CBA 1-4). Criteria were implemented to exclude patients with non-ESRD-related anemia (e.g., injury, surgery, bleeding, medications known to produce anemia). Diagnostic performance of each algorithm was delineated based on two clinical representations of a TRA: RBC transfusion required to treat ESRD-related anemia on admission regardless of the reason for admission (labeled as TRA) and hospitalization for the primary purpose of treating ESRD-related anemia (labeled TRA-Primary). The performance of all algorithms was determined by comparing each to a reference standard established by medical records review. Population-level estimates of classification agreement statistics were calculated for each algorithm using inverse probability weights and bootstrapping procedures. Due to the low prevalence of TRAs, the geometric mean was considered the primary measure of algorithm performance. RESULTS: After application of exclusion criteria, the study consisted of 12,388 Veterans with 26,672 admissions. The CA had a geometric mean of 90.8% (95% Confidence Interval: 81.8, 95.6) and 94.7% (95% CI: 80.5, 98.7) for TRA and TRA-Primary, respectively. The geometric mean for the CBAs ranged from 60.3% (95% CI: 53.2, 66.9) to 91.8% (95% CI: 86.9, 95) for TRA, and from 80.7% (95% CI: 72.9, 86.7) to 96.7% (95% CI: 94.1, 98.2) for TRA-Primary. The adjusted proportions of admissions classified as TRAs was 3.2% (95% CI: 2.8, 3.8) and TRA-Primary was 1.3% (95% CI: 1.1, 1.7). CONCLUSIONS: The CA and select CBAs were able to identify TRAs and TRA-primary with high levels of accuracy and can be used to examine anemia management practices in ESRD patients.
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BACKGROUND: The high cost of new hepatitis C (HCV) treatments has resulted in "watchful waiting" strategies being developed to safely delay treatment, which will in turn delay viral load suppression (VLS). OBJECTIVE: To document if delayed VLS adversely impacted patient risk for adverse events and death. METHODS: 187,860 patients were selected from the Veterans Administration's (VA) clinical registry (CCR), a longitudinal compilation of electronic medical records (EMR) data for 1999-2010. Inclusion criteria required at least 6 months of CCR/EMR data prior to their HCV diagnosis and sufficient data post-diagnosis to calculate one or more FIB-4 scores. Primary outcome measures were time-to-death and time-to-a composite of liver-related clinical events. Cox proportional hazards models were estimated separately using three critical FIB-4 levels to define early and late viral response. RESULTS: Achieving an undetectable viral load before the patient's FIB-4 level exceed pre-specified critical values (1.00, 1.45 and 3.25) effectively reduced the risk of an adverse clinical events by 33-35% and death by 21-26%. However, achieving VLS after FIB-4 exceeds 3.25 significantly reduced the benefit of viral response. CONCLUSIONS: Delaying VLS until FIB-4 >3.25 reduces the benefits of VLS in reducing patient risk.
RESUMO
IMPORTANCE: The impact of viral load suppression, genotype, race, and other factors on the risk of late-stage liver-related events in patients with hepatitis C (HCV) has been assessed previously using data from small observational cohorts or clinical trials. Data from large real-world practice samples are needed to improve risk factor estimates for late-stage liver events and death in HCV. OBJECTIVE: To describe the natural history of HCV in real-world clinical practice. DESIGN, SETTING, AND PARTICIPANTS: Observational cohort study. Patients with a detectable viral load (>25 IU/mL) and a recorded baseline genotype were selected from the Veterans Affairs (VA) HCV clinical registry (CCR), which compiles electronic medical records data from 1999 to present. EXPOSURES: Risk factors included genotype, race, age, sex, and time to achieving an observed undetected viral load. MAIN OUTCOMES AND MEASURES: The primary outcomes were time to death and time to a composite of liver-related clinical events. Secondary outcomes included the components of the composite clinical outcome. Outcomes were measured using a time-to-event format and were analyzed using Cox proportional hazards models. RESULTS A total of 28,769 of 360,857 unique HCV CCR patients met all study criteria. Only 24.3% of patients received treatment, and 16.4% of treated patients (4.0% of all patients) achieved an undetectable viral load. The unadjusted death rates were 6.8 (95% CI, 6.0-7.7) per 1000 person-years for patients who achieved viral load suppression vs 21.8 (95% CI, 21.5-22.2) deaths per 1000 person-years in patients who did not achieve this goal. Cox model results found that achieving viral suppression reduced risk of the composite clinical end point by 27% (hazard ratio [HR], 0.73 [95% CI, 0.66-0.82]) and the risk of death by 45% (HR, 0.55 [95% CI, 0.47-0.64]). Genotype 2 patients were at significantly lower risk, and genotype 3 patients were at higher risk for all study outcomes relative to genotype 1. Black patients were at lower risk for all liver events than white patients. CONCLUSION AND RELEVANCE: Achieving an undetectable viral load was associated with decreased hepatic morbidity and mortality. It remains to be determined whether newer treatment regimens can offer higher response rates with fewer adverse effects in real-world settings.