Success, regret, and the struggle for balance.

The genesis of this article was a conversation between the authors: M.I., a senior faculty member, and J.C., his primary care doctor and a midcareer faculty member. It addresses the challenges facing physicians today as they struggle to strike the proper balance between career and personal life; it also addresses the potential toll to oneself and loved ones when career success is placed above all other concerns.

Single leg separation prevalence among explanted Björk-Shiley prosthetic heart valves.

BACKGROUND AND AIM OF THE STUDY: Björk-Shiley convexo-concave (BSCC) prosthetic heart valves are believed to have been implanted in over 86,000 patients worldwide. Limited data are available on the prevalence of single leg separations (SLS) of the valves' outlet struts, a potential precursor to complete valve fracture. METHODS: Data maintained by the manufacturer, including results of examinations for SLS in explanted valves, were merged with available information on the characteristics of the valve. The prevalence of SLS in the examined valves was calculated according to valve angle, size, position, and study. RESULTS: Among 343 examined valves, the overall prevalence of SLS was 8.2%, but this varied significantly by valve size, being three-fold higher among 29+ mm valves than among smaller valves, with statistically non-significantly higher prevalences among mitral than aortic, and among 70 degrees than 60 degrees valves. By applying the size, position and angle-specific SLS prevalences to the worldwide valve distribution, it is estimated that SLS may be present in 6.8% (95% confidence limits 4.1-9.4%) of all BSCC valves. CONCLUSION: These findings suggest that SLS may affect between 820 and 1,880 of the almost 20,000 BSCC valves among surviving patients worldwide. Such estimates help frame the context for potential patient screenings, should imaging and acoustic techniques to detect SLS become available.

Twenty-five-year experience with the Björk-Shiley convexoconcave heart valve: a continuing clinical concern.

BACKGROUND: The first Björk-Shiley convexoconcave (BSCC) prosthetic heart valves were implanted in 1978. The 25th anniversary provided a stimulus to summarize the research data relevant to BSCC valve fracture, patient management, and current clinical options. METHODS AND RESULTS: Published and unpublished data on the risks of BSCC valve fracture and replacement were compiled, and strategies for identifying candidates for prophylactic valve reoperation were summarized. By December 2003, outlet strut fractures (OSFs), often with fatal outcomes, had been reported in 633 BSCC valves (0.7% of 86,000 valves implanted). Fractures still continue to occur, but average rates of OSFs in 60 degrees valves are now <0.1% per year. OSF risk varies markedly by valve characteristics, especially valve angle and size, with weaker effects associated with other manufacturing variables. OSF risks are mildly lower among women than men but decline sharply with advancing age. The risks of valve replacement typically greatly exceed those of OSF. By comparing individualized estimated risks of OSF versus valve replacement, guidelines have been developed to identify the small percentage of BSCC patients (mostly younger men) who would be expected to have a gain in life expectancy should reoperative surgery be performed. CONCLUSIONS: Twenty-five years after the initial BSCC valve implants, fractures continue to occur. Continued monitoring of BSCC patients is needed to track and quantify risks and enable periodic updating of guidelines for patients and their physicians.

Accessing a new medication in Germany: a novel approach to assess a health insurance-related barrier.

PURPOSE: Knowledge of the existence, position, and magnitude of barriers to equitable healthcare is an important consideration in shaping healthcare policies. METHODS: The authors developed a novel three-dimensional person-time-related hurdle model and followed a cohort of 7358 statutorily (SHI) and 457 privately health insured (PHI) patients with migraine headaches at 377 primary-care practices (MediPlus, IMS Health) in the second to fourth year of the HealthCare Structural Reform Act in Germany. RESULTS: For SHI compared with PHI migraine patients, there was a hurdle to receiving sumatriptan at all (2.4-fold lower hazard, 95% confidence interval, 1.8-3.2). Among patients who received sumatriptan, frequency and intensity of use differed only minimally between SHI and PHI patients. CONCLUSIONS: These findings have implications for healthcare researchers and healthcare policies. The framework extends traditional hurdle models and can serve as a model for quantifying barriers to receipt of services under different funding policies.

Veterans Affairs primary care organizational characteristics associated with better diabetes control.

OBJECTIVE: To examine organizational features of Veterans Affairs (VA) primary care programs hypothesized to be associated with better diabetes control, as indicated by hemoglobin A1C (HbA1C) levels. STUDY DESIGN: Cross-sectional cohort. METHODS: We established a cohort of 224 221 diabetic patients using the VA Diabetes Registry and Dataset and VA corporate databases. The 1999 VHA (Veterans Health Administration) Survey of Primary Care Practices results were combined with individual patient data. A 2-level hierarchical model was used to determine the relationship between organizational characteristics and HbA1C levels in 177 clinics with 82 428 cohort members. RESULTS: The following attributes were associated with lower (better) HbA1C and were statistically significant at P < .05: greater authority to establish or implement clinical policies (lower by 0.21%), greater staffing authority (0.28%), computerized diabetes reminders (0.17%), notifying all patients of their assigned provider (0.21%), hiring needed new staff during fiscal year 1999 (0.18%), having nurses that report only to the program (0.16%), and being a large academic practice (0.27%). Associated with higher (worse) HbA1C were programs reporting that patients almost always see their assigned provider (greater by 0.18%), having a quality improvement program involving all nurses without all physicians (0.38%), having general internal medicine physicians report only to the program (0.20%), and being located at an acute care hospital (0.20%). CONCLUSION: Programs that are associated with better diabetes control simultaneously have teams that actively involve physicians in quality improvement, use electronic health information systems, have authority to respond to staffing and programmatic issues, and engage patients in care.

The Björk-Shiley convexo-concave heart valve experience from the perspective of the supervisory panel.

The 20-year activities of a medical supervisory panel appointed under the terms of a settlement agreement of the Bowling v. Pfizer class action suit involving the Björk-Shiley convexo-concave (BSCC) heart valve are detailed. Of approximately 86,000 valves implanted, catastrophic failure of the valve was reported in 663 patients from 1978 to 2012. In 1994, a 7-member medical panel consisting of cardiologists, cardiovascular surgeons, epidemiologists, and a nontechnical chairman was appointed by the federal court. The panel collected clinical and manufacturing data, supported epidemiologic studies assessing risk factors for valve fracture, and developed guidelines for payment for explanting potentially defective valves in patients. Three sets of guidelines, based on comparisons of estimated risks of valve fracture versus risks of valve replacement surgery, were issued by the panel to help guide patients and their physicians in decisions about explanting valves. In addition, the panel supported research directed at identifying valves at risk for outlet strut fracture. The primary techniques evaluated included analyzing acoustic signals from the valves, imaging valves for potential cracks in the struts, and structural analyses of Björk-Shiley convexo-concave valves, but none proved applicable for large-scale surveillance of the patient population. The panel also became a patient advocate and acted as an intermediary between the manufacturer and the attorneys initiating the legal settlement. The panel's experiences may help inform future strategies for guideline development for other medical devices or procedures involving risk-benefit comparisons.

The disparity in access to new medication by type of health insurance: lessons from Germany.

BACKGROUND: Drug provision within the German statutory health insurance system has undergone several reforms, including the introduction of drug macrobudgets in 1993. OBJECTIVE: The objective of this study was to investigate the extent to which statutorily (SHI) and fully privately (PHI) health-insured patients were provided with new medication recommended by professional bodies in an equitable fashion using the example of migraine patients. RESEARCH DESIGN: We conducted a retrospective cohort study. SETTING: A total of 367 primary-care practices (MediPlus, IMS Health) in Germany in the second year of the HealthCare Structural Reform Act were studied. SUBJECTS: Subjected consisted of 7703 SHI and 470 PHI migraineurs (International Classification of Diseases, 10th edition G43) aged 18 to 65 years at their first migraine prescription visit in 1994. OUTCOME MEASURE: We compared prescription of oral or subcutaneous serotonin 5HT1B/1D receptor agonist sumatriptan with nonserotoninergic migraine therapy. RESULTS: In multiplicative risk regression with variance estimation accounting for clustering of patients within practices, PHI patients were 2.3 times (95% confidence interval [CI], 1.6-3.3) more likely to receive sumatriptan than their SHI counterparts at the mean age of the cohorts (43 years) adjusted for incident versus prevalent migraine treatment, the gender of the patient, the age, gender, and primary care specialist group of the physician, and the type and the community size class of the practice. This disparity widened by 38% (95% CI, 1-88%) every 10 years of patient age. CONCLUSION: Even though virtually everyone in Germany has health insurance and drug coverage, use of new and recommended migraine medicines was less common among those with SHI compared with their privately insured counterparts. Systematic studies of access to health care recommended by professional bodies will be critically important to ensure delivery of high-quality health care for all patients.

Quantifying delay in access to new medical treatment: an application of risk advancement period methodology.

BACKGROUND: We present a novel application of the concept of risk or rate advancement to compute the extent of delay in adoption of an effective new drug in 2 German health insurance systems. METHODS: We identified individuals with migraines, age 18 to 65 years, in 371 primary care practices in Germany in 1994 (MediPlus, IMS Health database). These included 8173 persons covered under the statutory health insurance system and 503 persons covered by private health insurance. We derived risk and population risk advancement periods for sumatriptan compared with nonserotoninergic acute migraine therapy using multiplicative risk regression and generalized estimating equations, adjusted for patient, physician, and practice cofactors. RESULTS: For patients at the mean age of the cohort, 43 years of age, sumatriptan was prescribed 1.2 (95% confidence interval [CI] = 0.3-2.0) years later among those in the statutory health insurance system compared with those who had private insurance. The lag increased by 0.6 (-0.1 to 1.3) years for every 10 years of patient age. In the age-mix of our sample, access to the health benefits of sumatriptan therapy lagged nearly 1.5 years behind in the statutory health insurance system and for Germany as a whole. CONCLUSIONS: Migraine patients' access to sumatriptan therapy lagged substantially in the statutory health insurance system and in the country as a whole. Risk advancement periods provide a useful methodology for communicating major healthcare issues in a meaningful way to society and policymakers.