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Biomedical subjects

B R Luce

Publications and source records attributed to B R Luce.

At least 19 recordsLinked to original sources
PubMed1998

The limited state of technology assessment for medical devices: facing the issues.

Medical devices are an integral part of clinical practice and account for a substantial proportion of the national health budget. Clinical testing and regulation of medical devices, however, is vastly different from and inferior to the testing and regulation of drugs. As managed care organizations begin to exert controls on device use, providers are being caught between the policies of their organizations and the demands of device manufacturers and patients, who want wider access to devices. We outline several reasons for the poor state of medical device evaluations and the dangers of using devices without adequate information, and include the recently developed device assessment and reporting guidelines created by the Task Force on Technology Assessment of Medical Devices.

Device Approval↗
PubMed1998

Health care CBA and CEA from 1991 to 1996: an updated bibliography.

OBJECTIVES: This article updates, through 1996, a previously published bibliography of health-care cost-benefit and cost-effectiveness analysis, which described the literature from 1979 to 1990. METHODS: A systematic search of MEDLARS databases was conducted for all articles falling under the medical subject headings "cost-benefit analysis" (which includes cost-effectiveness analysis) and "costs and cost analysis," as well as any article with the term "cost" in the title or abstract. All titles and abstracts were scanned to determine whether articles pertained to personal health services and whether both costs and consequences were assessed. If both criteria were met, the article was included in the bibliography. RESULTS: This search resulted in 3,539 eligible cost-benefit/cost-effectiveness analysis publications from 1991 through 1996. Publications were subdivided into two major categories: reports of studies and "other" publications, including reviews, descriptions of methodology, letters, and editorials. Reports of studies and "other" publications were classified into approximately 250 different topic areas. Studies were further classified by parameters such as study type, publication vehicle, and medical function. This article describes the results of this classification and describes trends during 1991 to 1996 as compared with 1979 to 1990. OVERVIEW OF CONTENTS: The entire bibliography is reproduced in Appendix A. The classification of study reports and "other" publications into topic areas is presented in Appendix B, with numbered references to all bibliography entries. Detailed tables of findings are presented in Appendix C, and the results are illustrated graphically in Appendix D.

Bibliographies as Topic↗
PubMed1998

The economic and clinical efficiency of point-of-care testing for critically ill patients: a decision-analysis model.

Our study objective was to assess economic and clinical outcomes of use of a point-of-care (POC) blood analysis device for postoperative coronary artery bypass graft (CABG) patients. A decision analytic model was developed for patients with high expected use of blood analysis, high potential benefit from rapid turn around time of results, a large annual volume of patients, and substantial expense associated with surgery. Published literature and clinical experts provided incidence, outcome, and cost estimates associated with four clinical scenarios potentially influenced by POC testing (ventricular arrhythmias, cardiac arrest, severe postoperative bleeding, and iatrogenic anemia). We found that changes in clinical outcomes were predominantly dependent on comparative turn around time or CABG patient volume. The positive clinical impact of using POC testing was consistently associated with a positive economic impact. POC blood gas analysis may be associated with decreased incidence of adverse clinical events or earlier detection of such events, resulting in significant cost savings. This study also supports previous findings that the costs of STAT blood analysis are more personnel-related than equipment-related.

Blood Gas Analysis↗
PubMed1997

Managed care pharmacy, socioeconomic assessments and drug adoption decisions.

A telephone survey of a representative national sample of 51 large managed care organizations in the U.S. (> 50,000 enrollees) was undertaken (1) to understand the role of socioeconomic assessments on drug adoption decisions; (2) to determine the sources of these assessments and the reliance of managed care pharmacy on each; and (3) to determine the resources for internally versus externally performed drug assessments. Socioeconomic assessments (clinical effectiveness, safety, cost of treatment, cost-effectiveness, and quality of life) are often tied to formulary decisions. Plans differ in their use of externally available socioeconomic assessments and in their ratings of the importance to decision making of drug assessments from the various sources. Those using a specific source of drug assessment information rated them in the following order of importance: PBM assessments, other HMOs, peer reviewed literature, evaluations performed by industry, articles in non-peer reviewed publications and, lastly, government reports. Timeliness and comprehensiveness are important components of the overall utility of information. A high percentage of plans reported using some of the various types of assessments, with clinical effectiveness most common, and cost-effectiveness second. The percentage of new drugs that undergo assessments in each of the plans covers a broad range, with 57% of the plans evaluating at least half of all new drugs. All but one surveyed managed care plan reported having either implemented or plans to implement a disease management program. Eighty percent of those surveyed are more concerned about drug assessments than in the past and 88% anticipate greater future use. Although 38 plans (75%) have a person in the organization responsible for drug assessments, this is the primary job in only 14 plans (37%). With greater reliance on drug assessments in the future, there are substantial opportunities for integrating drug assessments, formularies and disease management programs.

Cost Control↗
PubMed1997

Guidelines for pharmacoeconomic studies. Recommendations from the panel on cost effectiveness in health and medicine. Panel on cost Effectiveness in Health and Medicine.

This article reports the recommendations of the Panel on Cost Effectiveness in Health and Medicine, sponsored by the US Public Health Service, on standardised methods for conducting cost-effectiveness analyses. Although not expressly directed at analyses of pharmaceutical agents, the Panel's recommendations are relevant to pharmacoeconomic studies. The Panel outlines a 'Reference Case' set of methodological practices to improve quality and comparability of analyses. Designed for studies that inform resource-allocation decisions, the Reference Case includes recommendations for study framing and scope, components of the numerator and denominator of cost-effectiveness ratios, discounting, handling uncertainty and reporting. The Reference Case analysis is conducted from the societal perspective, and includes all effects of interventions on resource use and health. Resource use includes 'time' resources, such as for caregiving or undergoing an intervention. The quality-adjusted life-year (QALY) is the common measure of health effect across Reference Case studies. Although the Panel does not endorse a measure for obtaining quality-of-life weights, several recommendations address the QALY. The Panel recommends a 3% discount rate for costs and health effects. Pharmacoeconomic studies have burgeoned in recent years. The Reference Case analysis will improve study quality and usability, and permit comparison of pharmaceuticals with other health interventions.

Cost-Benefit Analysis↗
PubMed1997

When is a cost-effectiveness claim valid? How much should the FDA care?

Federal law requires the Food and Drug Administration (FDA) to regulate the promotional claims of prescription drugs and certain devices. Standards of evidence for claims of safety and therapeutic efficacy are rigorous because inappropriate product use may place human life at risk. However, equally demanding criteria for claims of cost-effectiveness of marketed technologies seem to be unnecessary because the consequence of error is principally a bad buy rather than patient harm. Concern exists about the validity of cost-effectiveness studies, the potential for bias, standards for the conduct of cost-effectiveness research, and the needs of managed care. The FDA should moderate its role in regulating cost-effectiveness claims of drugs and devices. This would foster information flow to healthcare providers and insurers and protect the FDA concern regarding false or misleading claims of effectiveness. Although the issues are applicable to both devices and drugs, we draw mainly from the field of pharmacoeconomics because this is where most of the policy has developed.

Cost-Benefit Analysis↗
PubMed1996

National Asthma Education and Prevention Program working group report on the cost effectiveness of asthma care.

The cost effectiveness of asthma care is the first topic of the National Asthma Education and Prevention Program Task Force Report on the Cost Effectiveness, Quality of Care, and Financing of Asthma Care. This working group characterized the role of health economics in understanding optimal asthma management strategies. The report first reviews methods for economic evaluation of medical technologies, with a particular focus on cost-effectiveness analysis. Next, the report explores the nature and usefulness of several key asthma outcome measures, including clinical and symptom measures, measures of lung function, measures of functional status, and measures of health services utilization and cost. The working group also conducted a review of the literature on cost effectiveness of asthma patient education programs, pharmaceutical therapy, and a variety of alternative and adjunct interventions. The report concludes with recommendations for a standardized approach for economic evaluation study designs (e.g., common asthma outcomes, long-term follow-up, and studies with patients of different ages, socioeconomic statuses, and severity levels) and for an expansion in the number of such standardized asthma studies and cost-effectiveness analyses.

Asthma↗
PubMed1996

The view from managed care pharmacy.

This stratified, national telephone survey of fifty-one managed care organizations concerns the perspectives of managed care pharmacy directors on pharmacoeconomics, disease management, and the roles of the pharmaceutical industry and the Food and Drug Administration (FDA). Respondents rated clinical effectiveness assessments as most useful, cost-effectiveness assessments second, and quality-of-life assessments as least useful. Peer-reviewed and industry literature were rated as equally important for decision making. Most plans would consider establishing a partnership with a drug company for disease management, if they have not already done so. Most plans (76 percent) support some form of FDA regulation of pharmacoeconomic claims. Conversely, 69 percent favor either no regulation (24 percent) or less stringent regulation (45 percent) than exists today.

Cost-Benefit Analysis↗
PubMed1995

The use of technology assessment by hospitals, health maintenance organizations, and third-party payers in the United States.

A case study design was used to determine the reliance on technology assessment of decisionmakers in hospitals, health maintenance organizations (HMOs), and third-party payers. Thirty different organizations were contacted and semistructured interviews conducted. The study found that hospitals, HMOs, and insurers are conducting technology assessments, but the form and sophistication of these analyses range widely. Hospitals are particularly focused on traditional financial analyses ("prudent purchasing") with the exception of pharmacy committees, which generally conduct more sophisticated socio-economic analyses. HMOs and insurers conduct outcome assessments for coverage of expensive or controversial technologies but exclude economics. Technology assessment will become increasingly important in resource allocation decision making and it is in the interest of technology providers to foster better information, a more comprehensive assessment process, and a more efficient assessment system.

Decision Making, Organizational↗
PubMed1995

Working toward a common currency: is standardization of cost-effectiveness analysis possible?

The field of cost-effectiveness has been quietly evolving for several decades. However, concerns and controversies have recently surfaced regarding the lack of standardization with which cost-effectiveness analyses are performed. This attention is due to the increasing use of the technique in rationing health care, setting price and/or reimbursement levels, adopting new technologies, and marketing pharmaceutical products. Is standardization possible while the field is still developing? This article explores possible answers to this question and reviews worldwide efforts aimed at the development of standardized guidelines for cost-effectiveness analysis.

Acquired Immunodeficiency Syndrome↗
PubMed1995

Methods of pharmacoeconomic evaluation of new medical treatments in psychiatry.

There is concern in developed countries about the increasing cost of health care. Developers of new psychopharmacologic agents are asked to demonstrate cost-effectiveness as well as safety and efficacy before widespread use is encouraged. Pharmacoeconomic studies are designed to evaluate the health outcomes and cost-effectiveness of new medical treatments relative to existing treatments. Retrospective and prospective research designs have been used in pharmacoeconomic studies. New approaches such as medical effectiveness studies and modeling studies based on clinical decision analysis are increasingly used to evaluate cost-effectiveness. This article introduces important concepts of pharmacoeconomic evaluation and discusses the methods and their strengths and weaknesses. Safety and efficacy studies and pharmacoeconomic studies provide useful and complementary evidence on how a new treatment affects clinical, health-related quality-of-life, and economic outcomes.

Drug Evaluation↗
PubMed1994

The pharmaceutical industry and health reform: lessons from Europe.

Many countries in Europe, which have significant pharmaceutical industries, recently have embarked on reforms in the organization of their health care systems and methods of regulating the pharmaceutical market. This paper describes the different systems in major European countries and the changes taking place. Although it is too early to make final judgment on the impact of these changes, it is possible to predict some of the more likely outcomes. The organizational models and regulatory approaches in Europe offer a useful store of experience for those assessing the potential impact of reform proposals in the United States.

Cost Control↗
PubMed1994

Recombinant human granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer: an economic analysis of a randomised, double-blind, placebo-controlled trial.

In a blinded retrospective economic evaluation of a double-blind, randomised, placebo-controlled clinical trial, total utilisation and charges for lymphoid cancer patients who received recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) or placebo were compared following autologous bone marrow transplantation. The 40 patients enrolled (22 rhGM-CSF, 18 placebo) could have acute lymphoblastic leukaemia, non-Hodgkins lymphoma or Hodgkin's disease, be of any age, and were undergoing autologous bone marrow transplantation in a metropolitan cancer research centre. Main outcome measures consisted of initial hospital lengths of stay (LOS), total and department charges, rehospitalisation rates and charges, and outpatient charges, all inclusive of the first 100 days following bone marrow infusion. The perspective of the study is that of the third party payer. Initial hospitalisation charges were $US54 100 for patients who received rhGM-CSF and $US68 600 for patients who received placebo (p = 0.05). The difference of $US14 500 was 21% less in patients who received rhGM-CSF, mainly due to lower average LOS with rhGM-CSF (24.2 days) compared with placebo (30.8 days). Outpatient charges were $US9500 (rhGM-CSF) and $US6800 (placebo) {p = 0.18}. Total charges, including readmission (10 per group) were $US12 200 lower in the rhGM-CSF group ($US70 300 vs $US82 500, p = 0.19). The use of rhGM-CSF after autologous bone marrow transplantation was shown to result in substantial cost savings during the initial hospitalisation. When comparing total inpatient and outpatient medical charges within the first 100 days following bone marrow infusion, we found no evidence that these savings were negated.

Adolescent↗
PubMed1993

Health care CBA/CEA: an update on the growth and composition of the literature.

Cost-benefit (CBA) and cost-effectiveness analyses (CEA) are methods that enumerate the costs and consequences associated with health-related technologies, services, and programs. This article examines the trends in published CBA and CEA of personal health services from 1979 through 1990. It is based on a bibliography that was compiled to help address the immense need for information on the variation and effectiveness of medical practices, particularly as researchers expand their analysis to a study of the cost effectiveness of medical and surgical interventions, health care technologies, preventive practices, and other health programs. A systematic search was conducted for all articles under the heading "cost-benefit analysis" (which includes cost-effectiveness analysis) and "costs and cost analysis." Data sources included the MEDLARS (National Library of Medicine) database, other bibliographies in specialized areas, reference lists in key articles, and contacts with researchers in the field. All titles and abstracts were scanned to determine if the articles pertained to personal health services and if both costs and consequences were assessed. If both criteria were met, the article was included in the bibliography. This search resulted in 3,206 eligible CBA/CEA publications from 1979 through 1990. The publications were subdivided into two major categories: reports of studies and "other" publications, including reviews, descriptions of methodology, letters, and editorials. Reports of studies and "other" publications were classified into approximately 250 different topic areas. The studies were further classified by parameters, such as study type, publication vehicle, and medical function. This article describes the results of this classification and describes trends during 1979 to 1990 compared with 1966 to 1978. The classification of study reports and "other" publications into 250 topic areas is presented in Appendix A. The entire bibliography is reproduced in Appendix B. Detailed tables of findings are presented in Appendix C, and the results are illustrated graphically in Appendix D. Appendix E provides the coding scheme used in the bibliography's data base.

Cost-Benefit Analysis↗