Showing papers by "Barry D. Lebowitz published in 2007"

Cost-Benefit Analysis of Second-Generation Antipsychotics and Placebo in a Randomized Trial of the Treatment of Psychosis and Aggression in Alzheimer Disease

Abstract: Context Second-generation antipsychotics (SGAs) are prescribed for psychosis, aggression, and agitation in Alzheimer disease (AD). Objective To conduct a cost-benefit analysis of SGAs and placebo (taken to represent a “watchful waiting” treatment strategy) for psychosis and aggression in outpatients with AD. Design Randomized placebo-controlled trial of alternative SGA initiation strategies. Setting Forty-two outpatient clinics. Participants Outpatients with AD and psychosis, aggression, or agitation (N = 421). Intervention Participants were randomly assigned to treatment with olanzapine, quetiapine fumarate, risperidone, or placebo with the option of double-blind rerandomization to another antipsychotic or citalopram hydrobromide or open treatment over 9 months. Main Outcome Measures Monthly interviews documented health service use and costs. The economic perspective addressed total health care and medication costs. Costs of study drugs were estimated from wholesale prices with adjustment for discounts and rebates. Quality-adjusted life-years (QALYs) were assessed with the Health Utilities Index Mark 3 and were supplemented with measures of functioning, activities of daily living, and quality of life. Primary analyses were conducted using all available data. Secondary analyses excluded observations after the first medication change (ie, phase 1 only). Cost-benefit analysis was conducted using the net health benefits approach in a sensitivity analysis in which QALYs were valued at $50 000 per year and $100 000 per year. Results Average total health costs, including medications, were significantly lower for placebo than for SGAs, by $50 to $100 per month. There were no differences between treatments in QALYs or other measures of function. Phase 1–only analyses were broadly similar. Net-benefit analysis showed greater net health benefits for placebo as compared with other treatments, with probabilities ranging from 50% to 90%. Conclusions There were no differences in measures of effectiveness between initiation of active treatments or placebo (which represented watchful waiting) but the placebo group had significantly lower health care costs. Trial Registration clinicaltrials.gov Identifier: LOCATOR="http://clinicaltrials.gov/ct/show/NCT00015548?order=1">NCT00015548.

Clinical trials: bridging the gap between efficacy and effectiveness.

Abstract: The need for clinical psychiatry research to provide practical information to clinicians, families, and consumers has led to the development of new approaches to clinical trials. Efficacy trials, the historical backbone of clinical research, have many shortcomings in delivering practical information to stakeholders. The 'effectiveness' or 'public-health' model of intervention research targets a diverse group of patients across multiple settings that are outside of academic medical centres, with study design and outcomes that are selected on the basis of their potential to produce clinically meaningful information. The National Institute of Mental Health has funded three such clinical trials in recent years, respectively targeting schizophrenia and Alzheimer's disease, depression, and bipolar disorder. Each of these studies has made a major impact, and provided new insights into the challenges of public health orientated trials in psychiatry. In this review, we describe the underlying principles and practical considerations in efficacy and effectiveness-orientated trials.

Self-administered cognitive screening for a study of successful aging among community-dwelling seniors: a preliminary study.

Abstract: Background Cognitive functioning is a central component of successful aging. Yet, there are few published instruments for brief and reliable self-administered cognitive assessment that could be used in large population-based studies of community-dwelling elderly people. Objective We examined the utility of a self-administered cognitive screening instrument in a group of community-dwelling older adults, and we evaluated correlations of the performance on this measure with demographic variables and specific indicators of self-rated successful aging. Method We assessed 182 well-educated adults ages 58 to 99 with a modified version of a previously published cognitive screening instrument (Cognitive Assessment Screening Test—Revised; CAST-R), a measure of cognitive complaints (Cognitive Failures Questionnaire; CFQ), and a self-rating of successful aging. We used the SF-36 Physical and Mental Composite Scores as measures of physical and mental health-related functioning. Results As expected, most individuals performed well on the CAST-R; only 7% of participants fell below a previously established cut score for cognitive impairment. CAST–R scores were positively correlated with level of education, income, SF-36 Mental Composite Scores, and a self-rating of successful aging, and negatively correlated with chronological age. Scores on the CAST-R were not correlated with cognitive complaints (CFQ total score) or SF-36 Physical Composite Scores. Conclusions A self-administered cognitive screening tool may be a useful, albeit limited, way of screening for cognitive disabilities among well-educated, community-dwelling older adults. Although preliminary, significant associations with several successful aging-related variables in expected directions represent the first step in establishing the validity of the CAST-R. Copyright © 2006 John Wiley & Sons, Ltd.

Enhancing medication adherence: in older adults with bipolar disorder.

Abstract: Objective: The number of older adults with bipolar disorder is increasing, yet little is known about the optimal clinical management of these patients. Medication adherence is a vital to effective long-term treatment of these patients; thus enhancement of adherence is often an important clinical goal. Design: We reviewed available evidence about the characteristics of later-life bipolar disorder along with behavioral and organizational strategies to enhance adherence in this population. Results: Based on available data, cognitive impairment, medical comorbidity, and functional limitations are frequent and are likely to impact treatment adherence in this population. In terms of treatment, there have been no placebo-controlled randomized clinical trials of medications or psychosocial interventions for this population. Based on extrapolation from inter vention research on younger adults with bipolar disorder and older adults with other chronic illness, psychosocial interventions that reduce effortful cognitive processing in managing medications and reduce organizational barriers to adherence may be beneficial in enhancing adherence in this population. Conclusions: Much more research needs to be done to understand the impact of aging on bipolar disorder , along with optimization of treatment. Interventions to enhance adherence in this population need to be adapted to fit with the unique needs of older adults with bipolar