Cost of Bleeding in Trauma and Complex Cardiac Surgery.

Purpose: Trauma and complex cardiac surgery are associated with a high risk of bleeding complications. The difference in costs between patients who require bleeding control measures and those who do not is poorly understood. Our goal was to assess the cost of care and outcomes for patients in these settings.

Fiscal implications of newborn screening in the diagnosis of severe combined immunodeficiency.

In the United States, newborn screening (NBS) is currently recommended for identification of 31 debilitating and potentially fatal conditions. However, individual states determine which of the recommended conditions are screened. The addition of severe combined immunodeficiency (SCID) screening to the recommended NBS panel has been fully instituted by 18 states, with another 11 states piloting programs or planning to begin screening in 2014.

Comparing antipsychotic treatments for schizophrenia: a health state approach.

The overall impact of first and second generation antipsychotics on quality of life and symptoms of people with schizophrenia remains controversial. We applied health state modeling to data from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Schizophrenia study, a randomized trial of antipsychotic medications, and evaluated the likelihood of patients moving to more favorable health states over time. We applied K-means clustering to the data to create discrete groupings of patients with symptom and side effect characteristics that were then validated using quality of life measures.

Use of blood products in patients with anticoagulant-related major bleeding: an analysis of inhospital outcomes.

Purpose: The impact of correcting elevated International Normalized Ratio (INR) values on inhospital mortality in patients with warfarin-associated major bleeding is presented.

Methods: Using patient information from the database of a large U.S.

Economic impact of infections among patients with primary immunodeficiency disease receiving IVIG therapy.

Purpose: There are limited data on the cost of infections among patients with primary immunodeficiency disease (PIDD) in clinical practice. The purpose of this study was to assess the economic impact, from the US commercial payer perspective, of infections in a cohort of patients with PIDD who were administered intravenous immunoglobulin (IVIG) therapy.

Methods: This study used administrative claims from the MarketScan(®) Database.

Implications to payers of switch from hospital-based intravenous immunoglobulin to home-based subcutaneous immunoglobulin therapy in patients with primary and secondary immunodeficiencies in Canada.

Background: Switching primary/secondary immunodeficiency (PID/SID) patients from intravenous immunoglobulin (IVIg) to home-based subcutaneous immunoglobulin (SCIg) therapy reduces nurse time. A nurse shortage in Canada provides an important context to estimate the net economic benefit, the number of patients needed to switch to SCIg to recoup one full-time equivalent (FTE), and potential population-wide savings of reduced nurse time to a payer.

Methods: The net economic benefit was estimated by multiplying the hourly compensation for nurses in Canada by the hours required for each administration route.

Validation of electronic systems to collect patient-reported outcome (PRO) data-recommendations for clinical trial teams: report of the ISPOR ePRO systems validation good research practices task force.

Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based end points. Regulatory review dictates the rules to follow with ePRO data collection for medical label claims.

The effect of a large regional health plan's value-based insurance design program on statin use.

Background: Cost-sharing requirements employed by health insurers to discourage the unnecessary use of medications may lead to underutilization of recommended treatment regimens and suboptimal quality of care. Value-based insurance design (VBID) programs seek to address these problems by lowering copayments to promote adherence to "high-value" medications that have been proven to be clinically beneficial. VBID evaluations to date have focused on programs implemented by self-insured employers.

The economic burden of Medicare-eligible patients by multiple sclerosis type.

Objective: Although the global rate of multiple sclerosis (MS) is low, a few studies have documented high costs. Costs are highly variable depending on MS stage. This study was designed to assess the economic burden of Medicare-eligible patients by MS type in the United States using a claims-based classification algorithm to examine cost variation by disease stage.

Estimation and validation of a multiattribute model of Alzheimer disease progression.

Objectives: To estimate and validate a multiattribute model of the clinical course of Alzheimer disease (AD) from mild AD to death in a high-quality prospective cohort study, and to estimate the impact of hypothetical modifications to AD progression rates on costs associated with Medicare and Medicaid services.

Data And Methods: The authors estimated sex-specific longitudinal Grade of Membership (GoM) models for AD patients (103 men, 149 women) in the initial cohort of the Predictors Study (1989-2001) based on 80 individual measures obtained every 6 mo for 10 y. These models were replicated for AD patients (106 men, 148 women) in the 2nd Predictors Study cohort (1997-2007).

Q-TWiST analysis of patients receiving temsirolimus or interferon alpha for treatment of advanced renal cell carcinoma.

Background And Objectives: For patients with advanced cancers, it is important that treatment improves the quality as well as the quantity of survival. This quality-adjusted time without symptoms of progression or toxicity (Q-TWiST) analysis provides a combined measure of both the overall survival interval and the quality of survival for patients with advanced renal cell carcinoma (RCC) receiving temsirolimus, interferon (IFN)-alpha or the combination of these agents, using data from a phase III clinical trial.

Methods: Overall survival was partitioned into three distinct health states: time with serious toxicity (TOX), time after progression (REL) and time without symptoms of progression or toxicity (TWiST).

Baseline differences and trajectories of change for deceased, placed, and community residing Alzheimer disease patients.

This study identifies predictors of placement or death in a large ethnically/racially diverse sample of moderately impaired Alzheimer disease patients residing in the community. Patients and caregivers were followed for 18 months with 4 assessments at 6-month intervals. Multinomial regression was used to identify caregiver and patient baseline characteristics and changes over time as predictors of patient placement in a long-term care facility (n=180), patient death (not preceded by placement, n=187), or remaining in the community at home (n=583).

Willingness-to-pay for reductions in care need: estimating the value of informal care in Alzheimer's disease.

Objective: To estimate the value of informal care in Alzheimer's disease using contingent valuation.

Methods: A questionnaire was administered to 517 primary carers in four countries (UK, Spain, Sweden, and US). Dichotomous choice and bidding game methods were used to elicit their willingness to pay for a reduction in care burden by 1 h per day, or a total elimination of care needs.

Patient dependence and longitudinal changes in costs of care in Alzheimer's disease.

Background/aims: To examine the incremental effect of patients' dependence on others, on cost of medical and nonmedical care, and on informal caregiving hours over time.

Methods: Data are obtained from 172 patients from the Predictors Study, a large, multicenter cohort of patients with probable Alzheimer disease (AD) followed annually for 4 years in 3 University-based AD centers in the USA. Enrollment required a modified Mini-Mental State Examination score >or=30.

Sociodemographic and clinical correlates of utility scores in Alzheimer's disease.

Objectives: To examine the relationship between psychiatric symptoms, cognitive performance, functional capacity and quality of life in Alzheimer's disease (AD), and change in the Health Utilities Index (HUI)-Mark III, a widely used generic, multiattribute preference-based health-status classification system.

Methods: Follow-up data were obtained from caregiver proxy raters at 3, to 6, and 9-months postrandom assignment concerning 421 patients with AD, living with at least one caregiver in a noninstitutional setting, who participated in the Clinical Antipsychotic Trial of Intervention Effectiveness-AD of antipsychotic medication. Spearman rank correlations, multivariate linear regression, and mixed modeling were used to examine the correlates of change in the HUI.

Development and testing of a new outcome measure of relationship between patients with Alzheimer's disease and their partners.

In mild Alzheimer's disease (AD), loss of relationship with the patient is a significant consequence for the partner (relative) and may be amenable to improvement with effective intervention. To evaluate relationship dynamics, the authors developed and tested content and discriminative validity of the self-administered Partner-Patient Questionnaire for Shared Activities among 100 partners of patients with mild to moderate Alzheimer's disease. Principal component analysis confirmed that interference in 17 activities derived from the literature and partner-specified activities comprised a relationship factor; internal consistency was very high.