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.

We compared results of safety climate survey questions from health care respondents with those from naval aviation, a high-reliability organization. Separate surveys containing a subset of 23 similar questions were conducted among employees from 15 hospitals and from naval aviators from 226 squadrons. For each question a "problematic response" was defined that suggested an absence of a safety climate. Overall, the problematic response rate was 5.6% for naval aviators versus 17.5% for hospital personnel (p0.0001). The problematic response was 20.9% in high-hazard domains such as emergency departments and operating room. Problematic response among hospital workers was up to 12 times greater than that among aviators on certain questions.

CONCLUSION: Although further research on safety climate in health care is warranted, hospitals may need to make substantial changes to achieve a safety climate consistent with the status of high-reliability organizations.

Objectives The authors sought to determine the effects of cold-weather periods on budgets and nutritional outcomes among poor American families. Methods The Consumer Expenditure Survey was used to track expenditures on food and home fuels, and the Third National Health and Nutrition Examination Survey was used to track calorie consumption, dietary quality, vitamin deficiencies, and anemia. Results Both poor and richer families increased fuel expenditures in response to unusually cold weather. Poor families reduced food expenditures by roughly the same amount as their increase in fuel expenditures, whereas richer families increased food expenditures. Conclusions Poor parents and their children spend less on and eat less food during cold-weather budgetary shocks. Existing social programs fail to buffer against these shocks.

Studies from the early 1990s have documented greater intensity of treatment for patients with acute myocardial infarction (AMI) in the United States compared with Canada, with little difference in health outcomes. Little is known about whether treatments and outcomes are changing differently over time in the two countries, and whether the differences vary with patient age. Methods We conducted a retrospective cohort study of trends in cardiac procedure use, mortality, and recurrent AMI for patients 65 years or older hospitalized with AMI in the United States and Quebec. We examined Medicare claims and enrollment data from the United States (1.5 million) and provincial claims data from Quebec (35,000) between 1988 and 1994. Results Use of cardiac procedures grew more rapidly between 1988 and 1994 in the United States, particularly for patients 75 years or older; unlike in Quebec, these cardiac procedures were performed soon after AMI. Both countries experienced significant declines in 1-year mortality: the decline averaged 1.27% points per year in the United States and 1.05% points in Quebec (P = ns). For AMI patients 75 years or older, 30-day and 1-year mortality declined approximately twice as rapidly in the United States as in Quebec (P 0.01). The decline in mortality in the United States relative to Canada was significantly greater among patients 75 years or older but not among those age 65 to 74 years. Readmission rates with recurrent AMI were almost unchanged. Conclusions Over time, the use of cardiac procedures in elderly patients with AMI has risen more rapidly in the United States than in Quebec. These differences in procedure trends were associated with reductions in overall long-term AMI mortality in both countries. Key words: Acute myocardial infarction; elderly; mortality; catheterization; angioplasty; coronary artery bypass surgery; population studies; trend analysis

Context Substantial discrepanies exist between clinical diagnoses and findings at autopsy. Autopsy may be used as a tool for quality management to analyze diagnostic discrepanies.

Objective To determine the rate at which autopsies detect important, clinically missed diagnoses, and the extent to which this rate has changed over time.

Data Sources A systematic literature search for English-language articles available on MEDLINE from 1966 to April 2002, using the search terms autopsy, postmortem changes, post-mortem, postmortem, necropsy, and posthumous, identified 45 studies reporting 53 distinct autopsy series meeting prospectively defined criteria. Reference lists were reviewed to identify additional studies, and the final bibliography was distributed to experts in the field to identify missing or unpublished studies.

Study Selection Included studies reported clinically missed diagnoses involving a primary cause of death (major errors), with the most serious being those likely to have affected patient outcome (class I errors).

Data Extraction Logistic regression was performed using data from 53 distinct autopsy series over a 40-year period and adjusting for the effects of changes in autopsy rates, country, case mix (general autopsies; adult medical; adult intensive care; adult or pediatric surgery; general pediatrics or pediatric inpatients; neonatal or pediatric intensive care; and other autopsy), and important methodological features of the primary studies.

Data Synthesis Of 53 autopsy series identified, 42 reported major errors and 37 reported class I errors. Twenty-six autopsy series reported both major and class I error rates. The median error rate was 23.5% (range, 4.1%-49.8%) for major errors and 9.0% (range, 0%-20.7%) for class I errors. Analyses of diagnostic error rates adjusting for the effects of case mix, country, and autopsy rate yielded relative decreases per decade of 19.4% (95% confidence interval [CI], 1.8%-33.8%) for major errors and 33.4% (95% [CI], 8.4%-51.6%) for class I errors. Despite these decreases, we estimated that a contemporary US institution (based on autopsy rates ranging from 100% [the extrapolated extreme at which clinical selection is eliminated] to 5% [roughly the national average]), could observe a major error rate from 8.4% to 24.4% and a class I error rate from 4.1% to 6.7%.

Conclusion The possibility that a given autopsy will reveal important unsuspected diagnoses has decreased over time, but remains sufficiently high that encouraging ongoing use of the autopsy appears warranted.

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.

Context The Internet has attracted considerable attention as a means to improve health and health care delivery, but it is not clear how prevalent Internet use for health care really is or what impact it has on health care utilization. Available estimates of use and impact vary widely. Without accurate estimates of use and effects, it is difficult to focus policy discussions or design appropriate policy activities.

Objectives To measure the extent of Internet use for health care among a representative sample of the US population, to examine the prevalence of e-mail use for health care, and to examine the effects that Internet and e-mail use has on users' knowledge about health care matters and their use of the health care system.

Design, Setting, and Participants Survey conducted in December 2001 and January 2002 among a sample drawn from a research panel of more than 60,000 US households developed and maintained by Knowledge Networks. Responses were analyzed from 4764 individuals aged 21 years or older who were self-reported Internet users.

Main Outcome Measures Self-reported rates in the past year of Internet and e-mail use to obtain information related to health, contact health care professionals, and obtain prescriptions; perceived effects of Internet and e-mail use on health care use.

Results Approximately 40% of respondents with Internet access reported using the Internet to look for advice or information about health or health care in 2001. Six percent reported using e-mail to contact a physician or other health care professional. About one third of those using the Internet for health reported that using the Internet affected a decision about health or their health care, but very few reported impacts on measurable health care utilization; 94% said that Internet use had no effect on the number of physician visits they had and 93% said it had no effect on the number of telephone contacts. Five percent or less reported use of the Internet to obtain prescriptions or purchase pharmaceutical products.

Conclusions Although many people use the Internet for health information, use is not as common as is sometimes reported. Effects on actual health care utilization are also less substantial than some have claimed. Discussions of the role of the Internet in health care and the development of policies that might influence this role should not presume that use of the Internet for health information is universal or that the Internet strongly influences health care utilization.

BACKGROUND: Positron emission tomography (PET) with 18-fluorodeoxyglucose (FDG) is a potentially useful but expensive test to diagnose solitary pulmonary nodules. OBJECTIVE: To evaluate the cost-effectiveness of strategies for pulmonary nodule diagnosis and to specifically compare strategies that did and did not include FDG-PET. DESIGN: Decision model. DATA SOURCES: Accuracy and complications of diagnostic tests were estimated by using meta-analysis and literature review. Modeled survival was based on data from a large tumor registry. Cost estimates were derived from Medicare reimbursement and other sources. TARGET POPULATION: All adult patients with a new, noncalcified pulmonary nodule seen on chest radiograph. TIME HORIZON: Patient lifetime. PERSPECTIVE: Societal. INTERVENTION: 40 clinically plausible combinations of 5 diagnostic interventions, including computed tomography, FDG-PET, transthoracic needle biopsy, surgery, and watchful waiting. OUTCOME MEASURES: Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. RESULTS OF BASE-CASE ANALYSIS: The cost-effectiveness of strategies depended critically on the pretest probability of malignancy. For patients with low pretest probability (26%), strategies that used FDG-PET selectively when computed tomography results were possibly malignant cost as little as 20 000 dollars per QALY gained. For patients with high pretest probability (79%), strategies that used FDG-PET selectively when computed tomography results were benign cost as little as 16 000 dollars per QALY gained. For patients with intermediate pretest probability (55%), FDG-PET strategies cost more than 220 000 dollars per QALY gained because they were more costly but only marginally more effective than computed tomography-based strategies. RESULTS OF SENSITIVITY ANALYSIS: The choice of strategy also depended on the risk for surgical complications, the probability of nondiagnostic needle biopsy, the sensitivity of computed tomography, and patient preferences for time spent in watchful waiting. In probabilistic sensitivity analysis, FDG-PET strategies were cost saving or cost less than 100 000 dollars per QALY gained in 76.7%, 24.4%, and 99.9% of computer simulations for patients with low, intermediate, and high pretest probability, respectively. CONCLUSIONS: FDG-PET should be used selectively when pretest probability and computed tomography findings are discordant or in patients with intermediate pretest probability who are at high risk for surgical complications. In most other circumstances, computed tomography-based strategies result in similar quality-adjusted life-years and lower costs.