Lethality of Alzheimer disease and its impact on nursing home placement.

This analysis evaluates the progression of Alzheimer disease (AD) severity and compares the life expectancy and nursing home placement rates for AD patients with the same measures in the general population. Data from the Consortium to Establish a Registry for Alzheimer Disease were analyzed to estimate expected survival, time spent in each Clinical Dementia Rating stage, and nursing home admission rate for a hypothetical cohort of patients aged 70 years with new-onset AD. Corresponding estimates for the US general population were calculated from the 2004 National Nursing Home Survey and the 2003 life table estimates from the US Census Bureau. Deaths from all causes by age 80 years are expected in 61% of AD patients and in 30% of the general population. From the age of 70 to 80 years, a typical AD patient spends 4 years at Clinical Dementia Rating stage 3 (severe), 3 years at stage 2 (moderate), and 3 years at stage 1 (mild). Nursing home admission by the age of 80 years is expected for approximately 75% of surviving AD patients, but for only 4% of the general population. Among persons aged > or =65 years, reported age-adjusted and sex-adjusted mortality rates for AD increased to 33% from 1999 to 2004.

Older Americans' risk-benefit preferences for modifying the course of Alzheimer disease.

Alzheimer disease (AD) is a progressive, ultimately fatal neurodegenerative illness affecting millions of patients, families, and caregivers. Effective disease-modifying therapies for AD are desperately needed, but none currently exist on the market. Thus, accelerating the discovery, development, and approval of new disease-modifying drugs for AD is a high priority for individuals, physicians, and medical decision makers. Potentially disease-modifying drugs likely will have significant therapeutic benefits but also may have treatment-related risks. We quantified older Americans' treatment-related risk tolerance by eliciting their willingness to accept the risk of treatment-related death or permanent severe disability in exchange for modifying the course of AD. A stated-choice survey instrument was administered to 2146 American residents 60 years of age and older. On average, subjects were willing to accept a 1-year risk of treatment-related death or permanent severe disability from stroke of over 30% for a treatment that prevents AD from progressing beyond the mild stage. Thus, most people in this age cohort are willing to accept considerable risks in return for disease-modifying benefits of new AD drugs. These results are consistent with other studies indicating that individuals view AD as a serious, life threatening illness that imposes heavy burdens on both patients and caregivers.

Health economics and the value of therapy in Alzheimer's disease.

In increasingly aging societies throughout the developed and developing world, Alzheimer's disease and related dementias are fast becoming a critical public health issue, exacting an enormous toll on individuals and healthcare systems. Over the past 10 years, five drugs have been developed and approved for the symptomatic treatment of Alzheimer's dementia, and several disease-modifying drugs are in various stages of clinical development. While symptomatic medications were consistently shown to have clinical benefit in numerous efficacy studies, the cost effectiveness of antidementia therapies and their value to healthcare systems remain unclear. The pharmacoeconomics of antidementia therapies is an evolving field, with several unanswered questions. This poses many challenges for biopharmaceutical companies developing these therapies, regulatory agencies responsible for their approval, and payers responsible for ensuring their availability to patients. The challenge partly relates to the unique nature of dementia as a disease of impaired cognition, behavior, and function. Thus, the selection of appropriate outcome measures that directly relate to healthcare utilization, quality of life, caregiver burden, and pharmacoeconomic analysis has been difficult. The development of meaningful and widely acceptable outcome measures, as well as novel clinical-study designs, is needed to better evaluate cost effectiveness and to demonstrate the value of therapeutics for Alzheimer's disease. Providing the decision-makers in healthcare systems with a body of evidence that demonstrates a positive relationship between clinical outcomes and the economic and humanistic benefits of antidementia therapeutics will improve patient access to novel drugs as they become available.

Mapping from disease-specific measures to utility: an analysis of the relationships between the Inflammatory Bowel Disease Questionnaire and Crohn's Disease Activity Index in Crohn's disease and measures of utility.

OBJECTIVES: To examine the relationship between the Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn's Disease Activity Index (CDAI) and measures of utility (EQ-5D and the SF-6D indexes), and to estimate algorithms to map the two utility values from IBDQ and CDAI scores. METHODS: A large data set from clinical trials in Crohn's disease provided contemporaneous patient responses to all four questionnaires. Paired observations from multiple time-points were analyzed. We calculated mean utility scores by IBDQ and CDAI score deciles; Spearman correlation coefficients for paired observations between IBDQ and EQ-5D (n = 3320) and IBDQ and SF-6D (n = 3230), and explored regression models using maximum likelihood estimation. The IBDQ/SF-6D model was validated against paired observations from an independent data set. RESULTS: The IBDQ decile analysis demonstrated a consistent positive relationship with both utility indexes. Correlations between the IBDQ and both the EQ-5D and SF-6D were statistically significant (P < 0.0001), with correlation coefficients of 0.76 and 0.85, respectively. A simple linear model between EQ-5D and IBDQ explained 45% of the variance. The residuals plot for the IBDQ/SF-6D model suggested some nonlinearity and a nonlinear model explained 69% of the variance. In the validation analysis, no statistically significant difference was observed between the mean observed SF-6D and the SF-6D scores estimated using the IBDQ/SF-6D regression model. CONCLUSIONS: Given the strength, consistency, and predictable characteristics of the relationships, the algorithms appear to provide valuable and valid methods to estimate utilities from IBDQ scores (but not CDAI) in trials of Crohn's disease patients that have collected IBDQ scores but not utilities.

Health outcomes assessment in community pharmacy practices: a feasibility project.

OBJECTIVES: To evaluate the feasibility and benefit of capturing outcomes data in community pharmacy settings, and to characterize the health status, resource use, and medication use of patients with musculoskeletal disorders. METHODS: Patients (n = 460) with musculoskeletal disorders including osteoarthritis (OA), rheumatoid arthritis (RA), and low back pain from 12 community pharmacy sites responded to disease-specific questions, the Medical Outcomes Study Short Form-36 (SF-36) health survey, demographics, and resource use using touch screen computer technology. Patients provided information and met with a community pharmacist for scheduled visits at baseline, 3, 6, 9, and 12 months. Pharmacists, with the aid of the patient-reported information, documented medication use and identified and addressed drug therapy problems of the patients at each visit. Baseline results, based on descriptive statistics are reported. RESULTS: OA was reported by 71% of the patients, 55% reported low back pain, and 19% reported RA. Despite receiving a variety of analgesic medications, a majority of the patients reported experiencing moderate to severe pain. SF-36 scores of the study population were significantly lower than age-adjusted population norms, with arthritis patients reporting worse physical health than patients with low back pain. Drug therapy problems were identified in 58% of the population, with need for additional drug therapy (31%) and adverse drug reactions (18%) being the most common problems identified. CONCLUSIONS: Results indicate that routine capture of patient-reported health outcomes data is feasible in community pharmacy settings using touch screen technology.