Stan N. Finkelstein

Workplace performance effects from chronic depression and its treatment

Utilizing data from a clinical trial and an econometric model incorporating the impact of a medical intervention and regression to the mean, we present evidence supporting the hypotheses that for chronically depressed individuals: (i) the level of perceived at-work performance is negatively related to the severity of depressive status; and (ii) a reduction in depressive severity improves the patients perceived work performance. Improvement in work performance is rapid, with about two-thirds of the change occurring already by week 4. Those patients having the greatest work improvement are those with both relatively low baseline work performance and the least severity of baseline depression.

Trends in the Use and Role of Biomarkers in Phase I Oncology Trials

Purpose: There has been interest in using biomarkers that aid the evaluation of new anticancer agents. We evaluated trends in the use of biomarkers and their contribution to the main goals of phase I trials. Experimental Design: We did a systematic review of abstracts submitted to the American Society of Clinical Oncology annual meeting from 1991 to 2002 and the publications related to these abstracts. We analyzed the use of biomarkers and their contribution to published phase I trials. Results: Twenty percent of American Society of Clinical Oncology phase I abstracts (503 of 2458) from 1991 to 2002 included biomarkers. This proportion increased over time (14% in 1991 compared with 26% in 2002; P < 0.02). Independent predictors of the use of biomarkers included National Cancer Institute sponsorship, submission in the time period of 1999 to 2002, adult population, and drug family (biological agents). Biomarkers supported dose selection for phase II studies in 11 of 87 of the trials (13%) emanating from these abstracts. However, the primary determinants of phase II dose and schedule were toxicity and/or efficacy in all but one of these 87 trials (1%). Biomarker studies provided evidence supporting the proposed mechanism of action in 34 of 87 of the published trials (39%). Conclusions: The use of biomarkers in phase I trials has increased over the period from 1991 to 2002. To date, biomarker utilization has made a limited and primarily supportive contribution to dose selection, the primary end point of phase I studies. Additional studies are needed to determine what type of biomarker information is most valuable to evaluate in phase I trials.

Cost Effectiveness, Quality-Adjusted Life-Years and Supportive Care: Recombinant Human Erythropoietin as a Treatment of Cancer-Associated Anaemia

AbstractObjective: To measure the cost effectiveness of a supportive care intervention when the no-treatment option is unrealistic in an analysis of recombinant human erythropoietin (epoetin) treatment for anaemic patients with cancer undergoing chemotherapy. Further, to assess whether quality-adjusted life-years (QALYs) can provide the basis for an appropriate measure of the value of supportive care interventions. Design: A modelling study drawing cost and effectiveness assumptions from a literature review and from 3 US clinical trials involving more than 4500 patients with cancerwhowere treatedwith chemotherapy, radiotherapy, epoetin and blood transfusions as needed under standard care for patients with cancer. Main outcome measures and results: When compared with transfusions, epoetin is cost effective under varying assumptions, whether effectiveness is measured by haemoglobin level or quality of life. Specifically, under a base-case scenario, the effectiveness resulting from

A statistical analysis of the magnitude and composition of drug promotion in the United States in 1998.

US1 spent on standard care can be achieved with only

Data mining using clinical physiology at discharge to predict ICU readmissions

US0.81 of epoetin care. Due in part to the health-state dependence of the significance patients attach to incremental changes in their responses on the linear analogue scale, cost per QALY results are ambiguous in this supportive care context. Conclusions: Under a broad range of plausible assumptions, epoetin can be used cost effectively in the treatment of anaemic patients with cancer. Further, QALYs have limited applicability here because, as a short term supportive treatment, epoetin enhances the quality but not the length of life. Future research would benefit from the establishment of consistent values for quality-of-life changes across patients and health status, and the extension of the QALY framework to supportive care.

Missing data in medical databases: Impute, delete or classify?

BACKGROUND Although pharmaceutical industry marketing and other factors may influence physician decisions regarding medication prescribing in the United States, little information is available about the composition of promotional efforts by promotional mode and medication class. OBJECTIVES The aims of this study were to determine the magnitude of expenditures for common modes of promotion and to delineate patterns of promotional strategies for particular classes of medications. METHODS Nationally representative data on expenditures (in US

Predicting Outcomes of Septic Shock Patients Using Feature Selection Based on Soft Computing Techniques

) for the 250 most promoted medications in the United States in 1998 were available from an independent pharmaceutical market research company for the 5 most commonly used modes of promotion. Key patterns of drug promotion were identified by descriptive statistics, a cluster analysis of expenditures by class, and an analysis of expenditure concentration. RESULTS In 1998, the pharmaceutical industry spent

Reducing unnecessary lab testing in the ICU with artificial intelligence

12,724 million promoting its products in the United States, of which 85.9% was accounted for by the top 250 drugs and 51.6% by the top 50 drugs. Direct-to-consumer (DTC) advertising was more concentrated on a small subset of medications than was promotion to professionals. Overall, 1998 expenditures were dominated by free drug samples provided to physicians (equivalent retail cost of

Cost Effectiveness of Imatinib Mesylate in the Treatment of Advanced Gastrointestinal Stromal Tumours

6602 million) and office promotion (

Objective and self‐report work performance measures: a comparative analysis

3537 million), followed by DTC advertising (