BACKGROUND: Given the threat of bioterrorism and the increasing availability of electronic data for surveillance, surveillance systems for the early detection of illnesses and syndromes potentially related to bioterrorism have proliferated.

PURPOSE: To critically evaluate the potential utility of existing surveillance systems for illnesses and syndromes related to bioterrorism.

DATA SOURCES: Databases of peer-reviewed articles (for example, MEDLINE for articles published from January 1985 to April 2002) and Web sites of relevant government and nongovernment agencies.

STUDY SELECTION: Reports that described or evaluated systems for collecting, analyzing, or presenting surveillance data for bioterrorism-related illnesses or syndromes.

DATA EXTRACTION: From each included article, the authors abstracted information about the type of surveillance data collected; method of collection, analysis, and presentation of surveillance data; and outcomes of evaluations of the system.

DATA SYNTHESIS: 17 510 article citations and 8088 government and nongovernmental Web sites were reviewed. From these, the authors included 115 systems that collect various surveillance reports, including 9 syndromic surveillance systems, 20 systems collecting bioterrorism detector data, 13 systems collecting influenza-related data, and 23 systems collecting laboratory and antimicrobial resistance data. Only the systems collecting syndromic surveillance data and detection system data were designed, at least in part, for bioterrorism preparedness applications. Syndromic surveillance systems have been deployed for both event-based and continuous bioterrorism surveillance. Few surveillance systems have been comprehensively evaluated. Only 3 systems have had both sensitivity and specificity evaluated.

LIMITATIONS: Data from some existing surveillance systems (particularly those developed by the military) may not be publicly available.

CONCLUSIONS: Few surveillance systems have been specifically designed for collecting and analyzing data for the early detection of a bioterrorist event. Because current evaluations of surveillance systems for detecting bioterrorism and emerging infections are insufficient to characterize the timeliness or sensitivity and specificity, clinical and public health decision making based on these systems may be compromised.

The anthrax attacks of 2001, the outbreak of severe acute respiratory syndrome (SARS), and weapons of mass destruction tabletop exercises have made it clear that no single community can prepare fully, nor respond completely, to a large-scale bioterrorism event. Policymakers recognize the need to forge relationships and coordinate preparedness planning efforts at the local, state, national, and international levels.1 However, there is little consensus about the optimal level of localization or regionalization for each of the resources and services that must be operationalized during a bioterrorism response.

We sought to evaluate the evidence regarding the effectiveness of existing regional systems that facilitate a response to bioterrorism. We sought evidence regarding the tasks that would need to be performed during a bioterrorism response (such as triage, provision of emergency medical care, transportation, and surveillance) and regionalized organizations that would likely contribute personnel, material, and information required to perform these bioterrorism response tasks.

The key questions addressed in this report are:

*What are the key tasks of local responders - such as local public health officials, clinicians, and emergency medical personnel - during a bioterrorism event?

*What resources do local responders require to perform the tasks identified in Key Question 1?

*Which existing regional systems for delivery of goods and services could be relevant to supplying the resources identified in Key Question 2?

*Can regionalization of bioterrorism preparedness planning facilitate supplying needed resources to local responders during a bioterrorism event?

*How do geographic variations in the affected population (e.g., urban as opposed to rural), special populations, and the interplay of private and public sector players affect regionalized systems?

OBJECTIVE: To examine the effects of market-level managed care activity on the treatment, cost, and outcomes of care for Medicare fee-for-service acute myocardial infarction (AMI) patients.

DATA SOURCES/STUDY SETTING: Patients from the Cooperative Cardiovascular Project (CCP), a sample of Medicare beneficiaries discharged from nonfederal acute-care hospitals with a primary discharge diagnosis of AMI from January 1994 to February 1996.

STUDY DESIGN: We estimated models of patient treatment, costs, and outcomes using ordinary least squares and logistic regression. The independent variables of primary interest were market-area managed care penetration and competition. The models included controls for patient, hospital, and other market area characteristics.

DATA COLLECTION/EXTRACTION METHODS: We merged the CCP data with Medicare claims and other data sources. The study sample included CCP patients aged 65 and older who were admitted during 1994 and 1995 with a confirmed AMI to a nonrural hospital.

PRINCIPAL FINDINGS: Rates of revascularization and cardiac catheterization for Medicare fee-for-service patients with AMI are lower in high-HMO penetration markets than in low-penetration ones. Patients admitted in high-HMO-competition markets, in contrast, are more likely to receive cardiac catheterization for treatment of their AMI and had higher treatment costs than those admitted in low-competition markets.

CONCLUSIONS: The level of managed care activity in the health care market affects the process of care for Medicare fee-for-service AMI patients. Spillovers from managed care activity to patients with other types of insurance are more likely when managed care organizations have greater market power.

OBJECTIVE: To investigate the relative impact of physician groups and health plans on quality of care measures. DESIGN: Secondary data analysis of receipt of preventive care services included in the Health Plan Employer Data and Information Set (HEDIS) among 10 758 patients representing 21 health maintenance organizations and 22 large provider groups in the San Francisco and Los Angeles, California, areas in 1997. Each patient was eligible for (at least) one of six HEDIS-measured services. Data identify whether or not the service was provided, the patient's health plan, and the provider group responsible for the care. We used logistic regression to examine variations across plans in HEDIS rates, and whether variations persist after controls for provider groups are included.

SETTING: Patients from 21 health maintenance organizations serving San Francisco and Los Angeles, California, in 1997.

MAIN OUTCOME MEASURES: Breast cancer screening, childhood immunizations, cervical cancer screening, diabetic retinal exam, prenatal care in the first trimester, and check-ups after delivery among patients for whom these services are appropriate.

RESULTS: There are statistically significant differences across health plans in utilization rates for the six services examined. These differences are not substantially affected when we control for the provider group that cared for the patient. That is, controlling for provider group does not explain variations across plans, consistent with the view that health plans have an impact on HEDIS quality measures independent of the providers that they contract with.

CONCLUSIONS: There are activities that plans can undertake which influence their HEDIS scores. On the face of it, these results suggest that plans can independently improve quality, in contrast to hypotheses that plans would be "too far" from patients to have an influence. Continued attention to collecting plan-level data is warranted. Further work should address other possible sources of variations in HEDIS scores, such as variability in the quality of plan administrative databases.

Advances in Health Care Organization Theory is a much-needed volume for faculty and students in health care administration. It highlights and explains key trends in health care organizations and organizational development, specifically, in the 1990s. This book will be essential for doctoral-level students studying health care organizational theory and research, as well as for those studying organizational sociology, organizational psychology, political science, and management.

PURPOSE: To compare the diagnostic accuracy of computed tomography (CT) and positron emission tomography (PET) with 18-fluorodeoxyglucose (FDG) for mediastinal staging in patients with non-small-cell lung cancer and to determine whether test results are conditionally dependent (the sensitivity and specificity of FDG-PET depend on the presence or absence of enlarged mediastinal lymph nodes on CT).

DATA SOURCES: Computerized search of MEDLINE, EMBASE, BIOSIS, and CancerLit through March 2003 and reference lists of retrieved studies and review articles.

STUDY SELECTION: Studies in any language that examined FDG-PET for mediastinal staging in patients with known or suspected non-small-cell lung cancer, enrolled at least 10 participants (including at least 5 participants with mediastinal metastasis), and provided enough data to permit calculation of sensitivity and specificity for identifying lymph node involvement.

DATA EXTRACTION: One reviewer (of non-English-language studies) or 2 reviewers (of English-language studies) independently evaluated studies for inclusion, rated methodologic quality, and abstracted relevant data.

DATA SYNTHESIS: Thirty-nine studies met inclusion criteria. Methodologic quality varied, but few aspects of study quality affected diagnostic accuracy. The authors constructed summary receiver-operating characteristic curves for CT and FDG-PET. Positron emission tomography with 18-fluorodeoxyglucose was more accurate than CT for identifying lymph node involvement (P 0.001). For CT, median sensitivity and specificity were 61% (interquartile range, 50% to 71%) and 79% (interquartile range, 66% to 89%), respectively. For FDG-PET, median sensitivity and specificity were 85% (interquartile range, 67% to 91%) and 90% (interquartile range, 82% to 96%), respectively. Fourteen studies provided information about the conditional test performance of CT and FDG-PET. Positron emission tomography with 18-fluorodeoxyglucose was more sensitive but less specific when CT showed enlarged lymph nodes (median sensitivity, 100% [interquartile range, 90% to 100%]; median specificity, 78% [interquartile range, 68% to 100%]) than when CT showed no lymph node enlargement (median sensitivity, 82% [interquartile range, 65% to 100%]; median specificity, 93% [interquartile range, 92% to 100%]; P = 0.002).

CONCLUSIONS: Positron emission tomography with 18-fluorodeoxyglucose is more accurate than CT for mediastinal staging. Positron emission tomography with 18-fluorodeoxyglucose is more sensitive but less specific when CT shows enlarged mediastinal lymph nodes.

PURPOSE: To evaluate the validity of standard gamble (SG) utilities, by comparing utilities with decision-making behavior in a group of lung transplant candidates facing a risky health decision.

METHODS: The authors elicited SG utilities for current health from 57 transplant candidates. They assessed the concordance between utility scores and patients' self-reported readiness to be placed on the transplant waiting list ("listed"). Because transplantation represents a real-life gamble with a short-term survival probability of 85%, the authors defined their minimum validity criterion as utility for current health < or = 0.85 in transplant-ready patients.

RESULTS: Utilities were significantly higher in patients who were not ready for listing (n = 22, median utility = 0.79, range 0.06-1) than in those who were ready or listed (n = 35, median utility = 0.50, range 0-0.85, P < 0.00005). All transplant-ready patients had utilities < or = 0.85 for current health.

CONCLUSIONS: Low SG utilities were associated with transplant readiness in this population of lung transplant candidates. These results provide one line of evidence supporting the validity of SG utilities as a measure of health-related quality of life, using the criterion of decision-making behavior.

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.