Purpose

To compare the cost-effectiveness of surgical and angioplasty-based coronary artery revascularization techniques, in particular, angioplasty with primary stenting.

Methods

We used data from the Study of Economics and Quality of Life, a substudy of the Bypass Angioplasty Revascularization Investigation (BARI), to measure the outcomes and costs of angioplasty and bypass surgery in patients with multivessel coronary artery disease who had not undergone prior coronary artery revascularization. Using a Markov decision model, we updated the outcomes and costs to reflect technology changes since the time of enrollment in BARI, and projected the lifetime costs and quality-adjusted life-years (QALYs) for the two procedures from the time of initial treatment through death. We accounted for the effects of improved procedural safety and efficiency, and prolonged therapeutic effects of both surgery and stenting. This study was conducted from a societal perspective.

Results

Surgical revascularization was less costly and resulted in better outcomes than catheter-based intervention including stenting. It remained the preferred strategy after adjusting the stent outcomes to eliminate the costs and events associated with target lesion restenosis. Among angioplasty-based strategies, primary stent use cost an additional $189,000 per QALY gained compared with a strategy that reserved stent use for treatment of suboptimal balloon angioplasty results.

Conclusion

Bypass surgery results in better outcomes than angioplasty in patients with multivessel disease, and at a lower cost.

OBJECTIVE: Positron emission tomography (PET) is a high-cost imaging tool primarily used in oncology, cardiology, and neuropsychiatry. Accurate estimates of the cost of PET are needed to assess its cost effectiveness and determine the appropriate role for this modality in clinical applications. We performed a survey-based cost analysis of PET with FDG by estimating direct, indirect, and capital costs from eight PET centers. A breakdown of the operational budget of PET centers and FDG-compounding facilities is presented along with the costs per scan. Differences in costs between sites that purchase FDG and those that manufacture FDG are also examined. MATERIALS AND METHODS: We sent surveys to managers of eight Veterans Affairs and two non-Veterans Affairs PET scanning and FDG-compounding facilities. The survey included questions about service volume and the direct costs of equipment, personnel, space, supplies, and repairs needed for FDG compounding and PET scanning and interpretation. We estimated the indirect costs associated with FDG compounding, PET scanning, and PET interpretation. RESULTS: Of the eight sites that responded to our survey, three sites manufacture FDG on-site, three sites purchase FDG, and two sites do both. The total mean cost per scan using manufactured FDG is 1885 US dollars, and it is 1898 US dollars using purchased FDG. CONCLUSION: PET is expensive. The cost is similar when FDG is manufactured or purchased. Because both PET and cyclotron facilities have high fixed costs, increasing the number of scans obtained and the number of FDG doses manufactured may lead to a decrease in unit costs.

Background: In recent years, there has been significant controversy over how institutional review board (IRB) procedures are structured, administered, and balanced against other concerns (for example, the feasibility of multicenter research). Formal economic analysis has been largely absent in these debates. With hospitals and research facilities under budgetary pressures, it is essential that cost-effective IRB systems be developed.

Objective: To estimate the cost of IRB procedures in an eight-site observational substance abuse treatment study.

Methods and Findings: We estimated the cost of each IRB "action" (initial reviews, continuing reviews, amendments, and adverse event reports) at each project site using a method that has been described in detail elsewhere. In brief, a national administrative database on IRBs was consulted to determine the estimated total cost of operating IRBs of various sizes. These total costs comprised personnel, space, supplies, and training. Dividing these total costs by the total number of actions conducted per year by an IRB yielded a cost per action. When these data were used as a reference point, each of the eight IRBs in our study was estimated to have a cost per action equal to that of IRBs of a comparable size in the national database.

All study procedures for the substance abuse treatment study were approved by our local university IRB. Nevertheless, the IRBs at each of the eight participating medical centers elected to conduct an independent, full-board review of the research protocol. The focus of our economic study was the costs of these "supplemental" IRB actions. In other words, how much money was expended on further reviewing the study after the home IRB had approved the project?

Expenditures for the supplemental IRB activities were estimated at $56 191 in 2001 dollars. This consumed 16.8% of the total research grant budget for all activities (recruiting sites, enrolling and interviewing participants, analyzing data) over the same period. Most of these costs ($29 824) reflected the IRBs' expenditures for 70 supplemental actions. Coordinating center personnel, space, and supply costs made up the second largest expense, at $16 951. The additional effort for the investigators at the eight participating sites totaled $9416.

Discussion: The high costs of IRBs were driven by several factors. First, our home IRB and committees at local sites frequently disagreed on the formatting of consent procedures and patient survey forms, and all expected final say on study implementation. This resulted in consent forms and patient survey instruments being reviewed and re-reviewed many times. Second, participating institutions required review both by hospital and affiliated university IRBs. We believe this redundancy was due to fear generated by recent high-profile cases in which research institutions were penalized for human subjects violations. Third, our coordinating center was often not allowed to directly contact IRB staff at the participating sites, nor would the nine IRBs involved (including our home IRB) communicate with each other. Coordinating center staff thus spent long periods translating and retransmitting information to IRB staff and local investigators scattered throughout the country, which slowed and sometimes garbled communication.

Conclusion: These extensive IRB procedures had no discernible impact on human subjects protection. The essential procedures of the study never changed substantially, despite exchanges of over 15 000 pages of material among the nine sites. In addition, as an empirical matter, no adverse incidents occurred among the participants. Researchers and policymakers should weigh the cost and benefits of multisite review for minimal-risk studies, such as observational health services research. The National Cancer Institute's centralized IRB for multisite phase III trials is an intriguing model. Other systems exist, although none has explicitly discussed minimal-risk studies. If costs such as those identified in this project continue to grow without consideration of the benefits of facilitating scientific projects, we worry that future research may be unjustly affected.

Employment-based health insurance is failing. Costs are out of control. Employers have no effective strategy to deal with this. They must think strategically about fundamental change. This analysis explains how employers' purchasing policies contribute to rising costs and block growth of economical care. Single-source managed care is ineffective, and effective managed care cannot be a single source. Employers should create exchanges through which they can offer employees wide, responsible, individual, multiple choices among health care delivery systems and create serious competition based on value for money. Recently introduced technology can assist this process.

The economic importance of innovation brings with it an active debate on the impact public policy has on the innovation process. This annual series, sponsored by the National Bureau of Economic Research, brings the work of leading academic researchers to the broader policy community. This volume considers such topics as the implications of software outsourcing for American technology leadership; the complementary roles of large corporations and entrepreneurs in developing innovative technology; city-level policy and planning that establishes a "jurisdictional advantage" in the value of local resources; the effect of taxes on entrepreneurship; and how to incorporate innovation into the analysis of business mergers. These papers highlight the role economic theory and empirical analysis can play in evaluating policies and programs regarding research, innovation, and the commercialization of new technologies.

Managed care may influence technology diffusion in health care. This article empirically examines the relationship between HMO market share and the diffusion of neonatal intensive care units. Higher HMO market share is associated with slower adoption of mid-level units, but not with adoption of the most advanced high-level units. Opposite the common supposition that slowing technology growth will harm patients, results suggest that health outcomes for seriously ill newborns are better in higher-level units and that reduced availability of mid-level units may increase their chance of receiving care in a high-level center, so that slower mid-level growth could have benefitted patients.

The Institute of Medicine recently issued a landmark report on medical error. In light of this report, every aspect of health care is subject to new scrutiny regarding patient safety. Informatics technology can support patient safety by correcting problems inherent in older technology; however, new information technology can also contribute to new sources of error. We report here a categorization of possible errors that may arise in deploying a system designed to give guideline-based advice on prescribing drugs, an approach to anticipating these errors in an automated guideline system, and design features to minimize errors and thereby maximize patient safety. Our guideline implementation system, based on the EON architecture, provides a framework for a knowledge base that is sufficiently comprehensive to incorporate safety information, and that is easily reviewed and updated by clinician-experts.

Also published in the Proceedings of the American Medical Informatics Association's 2001 Symposium.

Evidence from the United States suggests that technological change is a key factor in understanding both medical expenditure growth and recent dramatic improvements in the health of people with serious illnesses. Yet little international research has examined how the causes and consequences of technological change in health care differ worldwide. Seeking to illuminate these issues, this volume documents how use of high-technology treatments for heart attack changed in fifteen developed countries over the 1980s and 1990s. Drawn from the collaborative effort of seventeen research teams in fifteen countries, it provides a cross-country analysis of microdata that illuminates the relationships between public policies toward health care, technology, costs, and health outcomes.

The comparisons presented here confirm that the use of medical technology in treatment for heart attack is strongly related to incentives, and that technological change is an important cause of medical expenditure growth in all developed countries. Each participating research team reviewed the economic and regulatory incentives provided by their country's health system, and major changes in those incentives over the 1980s and 1990s, according to a commonly used framework. Such incentives include: the magnitude of out-of-pocket costs to patients, the generosity of reimbursement to physicians and hospitals, regulation of the use of new technologies or the supply of physicians, regulation of competition, and the structure of hospital ownership. Each team also reviewed how care for heart attacks has changed in their country over the past decade.

The book will be of enormous importance to health economists, medical researchers and epidemiologists, and policymakers.

Functional status as measured by dependencies in the Activities of Daily Living (ADLs) is an important indicator of overall health for older adults. Methodologies for outcomes-based medical-decision-making for public policy, such as decision modeling and cost-effectiveness analysis, require utilities for outcome health states. Utilities have been reported for many disease states, but have not been indexed by functional status, which is a strong predictor of outcome in geriatrics. We describe here a utility elicitation program developed specifically for use with computer-inexperienced older adults: Functional Limitation And Independence Rating (FLAIR1). FLAIR1 design features address common physical problems of the aged and computer attitudes of inexperienced users that could impede computer acceptance. We interviewed 400 adults ages 65 years and older with FLAIR1. In exit interviews with 154 respondents, 118 (76%) found FLAIR1 easy to use. Design features in FLAIR1 can be applied to other software for older adults.