Biomedical subjects

Bryan R Luce

Publications and source records attributed to Bryan R Luce.

8 recordsLinked to original sources

PubMed2005

Patient satisfaction with budesonide Turbuhaler versus triamcinolone acetonide administered via pressurized metered-dose inhaler in a managed care setting.

Dissatisfaction with medication may negatively affect compliance and thus the effectiveness of the treatment. However, no prospective well-controlled studies have assessed the relative patient satisfaction with competing inhaled corticosteroids in a real-life setting. The objective of the current study was to compare the relative patient satisfaction with budesonide inhalation powder administered via Turbuhaler (AstraZeneca LP, Wilmington, DE) (200 to 1600 microg/d using one of 3 dosing strengths: 100, 200, or 400 microg per inhalation) and triamcinolone acetonide administered via pressurized metered-dose inhaler (200 to 1600 microg/d) among persons treated in managed care settings. A total of 945 subjects 18 years of age or older diagnosed with asthma and enrolled in 25 managed care organizations participated in this prospective, randomized, open-label, parallel-group, 12-month study. As part of the study, subjects completed a self-administered, 17-item patient satisfaction questionnaire that addressed 4 domains: side effects, knowledge/ease of use, convenience, and overall satisfaction. Questionnaire reliability was assessed using Cronbach's alpha, and validity was examined by correlating subscale scores with symptom-free days and Medical Outcomes Study 36-Item Short-Form questionnaire and Asthma Quality of Life Questionnaire scores. The satisfaction questionnaire also included a previously validated section addressing patient compliance. Patients receiving budesonide had significantly higher scores for all four satisfaction subscales throughout the study period than did those receiving triamcinolone acetonide. Similarly, compliance scores were consistently higher for the budesonide group. The difference between the treatment groups in overall satisfaction scores at the end of the study was clinically meaningful. Patients treated with budesonide were significantly more satisfied and compliant with their inhaled corticosteroid regimen compared with patients treated with triamcinolone acetonide.

Administration, Inhalation↗

PubMed2005

What will it take to make cost-effectiveness analysis acceptable in the United States?

Many believe cost-effectiveness analysis (CEA) to be an underused tool to assist healthcare decision-makers. Reasons given for its underuse have largely focused on unstandardized methods, potential for bias, lack of training particularly among potential consumers of studies, and lack of trust between sponsors and users of analyses. This commentary reflects on these and related issues, including legal and political constraints. It discounts many of the conventional arguments regarding the real obstacles to using CEA and suggests steps needed to make CEA more acceptable to US healthcare decision-makers.

Cost-Benefit Analysis↗

PubMed2004

Effectiveness of budesonide administered via dry-powder inhaler versus triamcinolone acetonide administered via pressurized metered-dose inhaler for adults with persistent asthma in managed care settings.

BACKGROUND: Clinical studies have demonstrated the efficacy and relative safety of inhaled corticosteroids in the treatment of asthma. However, effectiveness and cost-effectiveness comparisons of available inhaled corticosteroids in real-life clinical settings are lacking. OBJECTIVE: This study compared the effectiveness and safety of budesonide administered via dry-powder inhaler versus that of triamcinolone acetonide administered via pressurized metered-dose inhaler in the treatment of adult patients with persistent asthma treated in a managed care setting. METHODS: This was a randomized, open-labe, 52-week study of adult patients (aged >or= 18 years) with persistent asthma enrolled in 25 US health plans. The primary study outcome was mean change from baseline to the end of treatment in symptom-free days. Secondary variables were changes from baseline in number of episode-free days, episode-free days at 52 weeks, forced expiratory volume in 1 second (FEV(1)), forced vital capacity, asthma symptom scores, breakthrough bronchdilator use, patient discontinuations, and health-related quality of life. Patients were issued diaries in which to record use of study medication and concomitant asthma medication use, as well as daytime and nighttime asthma symptom severity. Patients were assessed at weeks 4, 13, 26, 39, and 52. Safety was assessed based on adverse events and changes in laboratory tests, vital signs, and physical examinations. RESULTS: A total of 945 patients (344 men, 601 women; mean [SD] age, 46.8 [14] years) were enrolled; 631 received budesonide and 314 received triacinolane acetonide. Improvements in all effectiveness variables were observed with both treatments. The mean increase from baseline in the number of symptom-free days per month assessed at month 12 was 7.74 (95% CI, 6.81-8.66) for patients receiving budesonide and 3.78 (95% CI, 2.47-5.09) for patients receiving triamcinoline acetonide ( P<0.001). The estimated annual mean (SD) number symptom-free days for patients receiving budesonide was 141.1 (125.0) over the treatment phase, compared with 99.3 (112.1) for those receiving triamcinolone acetonide (P<0.001). Patients receiving budesonide demonstrated significant improvements (compared with those receiving triamcinolone acetonide) in overall quality of life, daytime and nighttime asthma symptom severity, breakthrough bronchodilator use, and FEV(1) (all P<0.001). Safety measures were similar between groups. CONCLUSION: In these managed care settings, budesonide inhalation powder administered via dry-powder inhaler was significantly more effective than triamcinolone acetonide administered via pressurized metered-dose inhaler in the treatment of adults with persistent asthma.

Administration, Inhalation↗

PubMed2002

The effect on social welfare of a switch of second-generation antihistamines from prescription to over-the-counter status: a microeconomic analysis.

BACKGROUND: The US Food and Drug Administration (FDA) recently held a meeting to determine whether the status of second-generation antihistamines (SGAs) should be switched from prescription (Rx) to over-the-counter (OTC) status. OBJECTIVE: This article provides a conceptual microeconomic framework for addressing issues regarding the impact of such a switch on social welfare. METHODS: A review of the economic literature on Rx-to-OTC switches was conducted. Relevant articles published in English between 1990 and 2001 were identified through searches of ABI Info, EconLit, PsychInfo, MEDLINE, CANCERLIT, AIDSLINE, and HealthStar, as well as a general Internet search for statements in the press or on the FDA Web site. The search terms used were Rx, prescription, OTC, over-the-counter, second-generation antihistamines, nonsedating antihistamines, first-generation antihistamines, and sedating antihistamines. Microeconomic models focusing on consumer surplus were employed to determine the potential price response and social-welfare implications of a switch of SGAs to OTC status. RESULTS: Unlike the agents involved in previous Rx-to-OTC switches, SGAs are still under patent protection. Economic theory suggests that a firm that is protected by a patent will price aggressively. The market for OTC SGAs is likely to be more elastic due to a lack of insurance coverage for OTC products; hence, drug manufacturers would be likely to charge a lower price if SGAs were sold OTC. However, a lower price does not necessarily guarantee an improvement in social welfare; the net impact is determined by whether the increase in consumer surplus outweighs the deadweight loss (losses of consumer and producer surplus not transferred to other parties). Additionally, the assumption of a price reduction would be called into question if there were inequalities in marginal costs between the Rx and OTC markets. In this situation, the postswitch price might increase or not be reduced significantly. CONCLUSIONS: It is uncertain whether granting OTC status to SGAs would be cost saving to society, particularly as these drugs are patent protected. The social-welfare implications of such a switch would depend heavily on pricing strategies and consumer behavior. Further analyses are needed to determine how both factors influence social welfare; only then can the costs and benefits of a switch be understood completely.

Drug Industry↗

PubMedDate not supplied

Economic burden of heart failure: a summary of recent literature.

OBJECTIVE: We reviewed literature published from 1995 to 2002 to highlight findings on the economic burden of heart failure (HF). Methods A key-word search of literature indexes for relevant citations identified 54 articles that were then summarized for findings on HF economics. RESULTS: Results were described in terms of burden of illness, cost-effectiveness analysis, and resource utilization and costs. Hospitalization of the elderly is the driving force behind HF costs. Interventions that decrease the frequency of hospital admissions while maintaining clinical and patient reported outcomes are considered a high priority among decision makers and clinicians. Although the cost-effectiveness of therapy with beta-adrenergic blocking agents has been well established in the literature, the cost-effectiveness of hospital- or home-based HF management programs is still under debate. The issues of payer status and physician specialty impact on decreased hospital admission and cost have been inconclusive. CONCLUSIONS: Any intervention capable of decreasing even a small fraction of adverse outcomes, most notably hospital admission and length of stay, could trigger significant cost savings in the management of HF. Public policy makers, together with clinicians identifying cost saving or cost-effective interventions in their practice, are expected to increase their efforts to evaluate the cost-effectiveness and outcomes of medical and pharmacologic interventions in HF.

Angiotensin-Converting Enzyme Inhibitors↗

PubMedDate not supplied

Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices--Modeling Studies.

OBJECTIVES: Mathematical modeling is used widely in economic evaluations of pharmaceuticals and other health-care technologies. Users of models in government and the private sector need to be able to evaluate the quality of models according to scientific criteria of good practice. This report describes the consensus of a task force convened to provide modelers with guidelines for conducting and reporting modeling studies. METHODS: The task force was appointed with the advice and consent of the Board of Directors of ISPOR. Members were experienced developers or users of models, worked in academia and industry, and came from several countries in North America and Europe. The task force met on three occasions, conducted frequent correspondence and exchanges of drafts by electronic mail, and solicited comments on three drafts from a core group of external reviewers and more broadly from the membership of ISPOR. RESULTS: Criteria for assessing the quality of models fell into three areas: model structure, data used as inputs to models, and model validation. Several major themes cut across these areas. Models and their results should be represented as aids to decision making, not as statements of scientific fact; therefore, it is inappropriate to demand that models be validated prospectively before use. However, model assumptions regarding causal structure and parameter estimates should be continually assessed against data, and models should be revised accordingly. Structural assumptions and parameter estimates should be reported clearly and explicitly, and opportunities for users to appreciate the conditional relationship between inputs and outputs should be provided through sensitivity analyses. CONCLUSIONS: Model-based evaluations are a valuable resource for health-care decision makers. It is the responsibility of model developers to conduct modeling studies according to the best practicable standards of quality and to communicate results with adequate disclosure of assumptions and with the caveat that conclusions are conditional upon the assumptions and data on which the model is built.

Benchmarking↗

PubMedDate not supplied

The return on investment in health care: from 1980 to 2000.

OBJECTIVE: To estimate the return on US investment (ROI) in overall health as well as four specific conditions. METHODS: The study utilized three distinct approaches to "triangulate" the evidence as related to ROI in health care: 1) an estimation of the average ROI in additional health-care service expenditures in the United States for the year 2000 compared with the year 1980, based on US summaries of health expenditures and health outcomes; 2) an estimate of the ROI in Medicare services for the period from 1985 to 2000 for treatment of heart attack, stroke, type 2 diabetes, and breast cancer, based on National Long-term Care Survey data and Medicare claims; and 3) an estimate of the ROI for selected major treatment innovations for the same four conditions during the period from 1975 to 2000. RESULTS: We calculated that each additional dollar spent on overall health-care services produced health gains valued at Dollars 1.55 to Dollars 1.94 under our base case assumptions. The return on health gains associated with treatment for heart attack, stroke, type 2 diabetes, and breast cancer were Dollars 1.10, Dollars 1.49, Dollars 1.55, and Dollars 4.80, respectively, for every additional dollar spent by Medicare. The ROI for specific treatment innovations ranged from both savings in treatment costs and gains in health to gains in health valued at Dollars 1.12 to Dollars 38.00 for every additional dollar spent. CONCLUSION: The value of improved health in the US population in 2000 compared with 1980 significantly outweighs the additional health-care expenditures in 2000 compared with 1980.

Centers for Medicare and Medicaid Services, U.S.↗

PubMedDate not supplied

Evidence based? Caveat emptor!

Medical practices, clinical practice guidelines, clinical performance measures and measurements, and a variety of health care-related administrative decisions, such as insurance coverage decisions, are claiming to be "evidence based" with increasing frequency. In this paper we examine the "evidence based" label; discuss how evidence ought to have been assembled, evaluated, and synthesized; and when evidence is sufficient for the "evidence-based" moniker to rightfully apply. We also highlight several considerations other than the strength of evidence that are relevant to several common types of health care-related administrative decisions and that influence the extent to which the resulting decisions are truly evidence based.

Evidence-Based Medicine↗