Context:

Women with inherited BRCA1/2 mutations are at high risk for breast cancer, which mammography often misses. Screening with contrast-enhanced breast magnetic resonance imaging (MRI) detects cancer earlier but increases costs and results in more false-positive scans.

Objective:

To evaluate the cost-effectiveness of screening BRCA1/2 mutation carriers with mammography plus breast MRI compared with mammography alone.

Design, Setting, and Patients:

A computer model that simulates the life histories of individual BRCA1/2 mutation carriers, incorporating the effects of mammographic and MRI screening was used. The accuracy of mammography and breast MRI was estimated from published data in high-risk women. Breast cancer survival in the absence of screening was based on the Surveillance, Epidemiology and End Results database of breast cancer patients diagnosed in the prescreening period (1975-1981), adjusted for the current use of adjuvant therapy. Utilization rates and costs of diagnostic and treatment interventions were based on a combination of published literature and Medicare payments for 2005.

Main Outcome Measures:

The survival benefit, incremental costs, and cost-effectiveness of MRI screening strategies, which varied by ages of starting and stopping MRI screening, were computed separately for BRCA1 and BRCA2 mutation carriers.

Results:

Screening strategies that incorporate annual MRI as well as annual mammography have a cost per quality-adjusted life-year (QALY) gained ranging from less than $45 000 to more than $700 000, depending on the ages selected for MRI screening and the specific BRCA mutation. Relative to screening with mammography alone, the cost per QALY gained by adding MRI from ages 35 to 54 years is $55 420 for BRCA1 mutation carriers, $130 695 for BRCA2 mutation carriers, and $98 454 for BRCA2 mutation carriers who have mammographically dense breasts.

Conclusions:

Breast MRI screening is more cost-effective for BRCA1 than BRCA2 mutation carriers. The cost-effectiveness of adding MRI to mammography varies greatly by age.

Background:

Unlike medicines prescribed for Food and Drug Administration-approved indications, off-label uses may lack rigorous scientific scrutiny. Despite concerns about patient safety and costs to the health care system, little is known about the frequency of off-label drug use or the degree of scientific evidence supporting this practice.

Methods:

We used nationally representative data from the 2001 IMS Health National Disease and Therapeutic Index (NDTI) to define prescribing patterns by diagnosis for 160 commonly prescribed drugs. Each reported drug-diagnosis combination was identified as Food and Drug Administration-approved, off-label with strong scientific support, or off-label with limited or no scientific support. Outcome measures included (1) the proportion of uses that were off-label and (2) the proportion of off-label uses supported by strong scientific evidence. Multivariate analyses were used to identify drug-specific characteristics predictive of increased off-label use.

Results:

In 2001, there were an estimated 150 million (95% confidence interval, 127-173 million) off-label mentions (21% of overall use) among the sampled medications. Off-label use was most common among cardiac medications (46%, excluding antihyperlipidemic and antihypertensive agents) and anticonvulsants (46%), whereas gabapentin (83%) and amitriptyline hydrochloride (81%) had the greatest proportion of off-label use among specific medications. Most off-label drug mentions (73%; 95% confidence interval, 61%-84%) had little or no scientific support. Although several functional classes were associated with increased off-label use (P.05), few other drug characteristics predicted off-label prescription.

Conclusions:

Off-label medication use is common in outpatient care, and most occurs without scientific support. Efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use.

Does quality of care systematically differ among government-owned, private not-for-profit, and for-profit hospitals? A large empirical literature provides conflicting evidence. Through quantitative review of 46 studies since 1990, we find that several study features that can explain divergent results: analytic methods, disease studied, and data sources. For unprofitable care, how studies handle market competition and regional differences account for substantial variation. Policymakers should be aware that differences in results appear to arise predominantly from differences between studies' analytic methods. Moreover, conventional methods of meta-analytic synthesis should be applied with great caution given the considerable overlap among studied hospitals.

Although the quality of health care would logically seem to be a universal concept, this study hypothesized that physicians and their patients could differ in their perceptions of high-quality care and that those beliefs might vary by country. Such a mismatch in beliefs may be especially important as clinical practice guidelines developed in the United States are globalized.

A survey of 20 statements describing various components of health care delivery and quality was sent to pediatric cardiologists in 33 countries, who ranked the statements in order of priority for ideal health care. Each participating physician administered the questionnaire to the parents of children with congenital heart disease; 554 questionnaires were received and analyzed. A subanalysis of 9 countries with the largest number of responses was done (Canada, the Czech Republic, France, Germany, Italy, The Netherlands, Sweden, the United Kingdom, and the United States). Doctors and parents rated the same 4 statements among the top 5: the doctor is skillful and knowledgeable; the doctor explains health problems, tests, and treatments in a way the patient can understand; a basic level of healthcare is available to all citizens regardless of their ability to pay; and treatment causes the patient to feel physically well.

Overall, parents' responses differed more among countries than those of physicians; the magnitude of the difference between parents and physicians varied by country. This discrepancy highlights a potential mismatch between patients' and physicians' views about the desired components of health care delivery, in particular the application of American quality standards for health care to systems in other countries.

This issue of CHP/PCOR's quarterly newsletter, which covers news from the winter 2006 quarter, includes articles about:

• a comprehensive review of worldwide anthrax cases from 1900 to 2005, conducted by CHP/PCOR researchers, which found that timely diagnosis and antibiotic treatment, along with pleural fluid drainage, are key to anthrax patients' survival;
• an early-stage research project in which CHP/PCOR core faculty member Grant Miller is collaborating with an NGO in Bangladesh to study whether villagers' traditional cooking practices are contributing to life-threatening respiratory infections;
• assertions by two CHP/PCOR health policy experts that health-savings accounts -- the cornerstone of President Bush's healthcare agenda -- won't save much money and won't address the fundamental problems of the U.S. healthcare system;
• the Agency for Healthcare Research and Quality's release of the Pediatric Quality Indicators, developed by CHP/PCOR researchers and collaborators. This is the first set of data-analysis tools specifically designed to help hospitals monitor their quality of care for hospitalized children; and
• a roundup of CHP/PCOR's 7th annual retreat, which featured panel discussions on improving healthcare quality, conducting health services research in developing countries, and health systems comparisons across industrialized nations.