Omalizumab substantially improves dermatology-related quality of life in patients with chronic spontaneous urticaria.

BACKGROUND: Chronic spontaneous/idiopathic urticaria (CSU/CIU) has substantial detrimental effects on health-related quality of life (HRQoL) with an effect comparable to or worse than many other skin diseases. OBJECTIVE: To assess the effect of omalizumab on CSU patients' HRQoL, measured by the Dermatology Life Quality Index (DLQI) in three phase III studies ASTERIA I, ASTERIA II and GLACIAL. METHODS: A post hoc analysis examined changes in DLQI scores, distribution of patients across DLQI bands and the proportion reaching minimal clinically important difference (MCID) following omalizumab vs. placebo. RESULTS: Omalizumab 300 mg significantly improved total DLQI scores vs. placebo, with a mean decrease from baseline to week 12 of -10.3 vs. -6.1 (P < 0.0001) in ASTERIA I, -10.2 vs. -6.1 (P = 0.0004) in ASTERIA II and -9.7 vs. -5.1 (P < 0.0001) in GLACIAL. A significant shift from high disease impact on life at baseline towards less impact at week 12 was seen with omalizumab 300 mg vs. placebo (P < 0.001; all studies). The proportion of patients where change in mean total DLQI score from baseline to week 12 reached an MCID of ≥4 was 74.1%, 76.0% and 77.2% in ASTERIA I, II and GLACIAL, respectively (P < 0.01; all studies). LIMITATIONS: Maximum duration of omalizumab treatment was 24 weeks. CONCLUSION: This additional analysis assessed the impact of CSU and benefit of treatment with omalizumab by exploring different facets of DLQI data by treatment arm at multiple assessment points. The original aspects of analysis included applying the concept of the recently validated score for the MCID of the DLQI, changes in DLQI domain scores and in the distribution of subjects based on validated total DLQI score bands. It showed consistently that omalizumab provides significant and clinically relevant improvements in many aspects of HRQoL that are important to patients with CSU. These results contribute to a better understanding of the impact of CSU and its treatment on patients and can support clinical decision-making in routine medical practice.

Implementing evidence-based medicine: the role of market pressures, compensation incentives, and culture in physician organizations.

OBJECTIVES: To assess the extent to which market pressures, compensation incentives, and physician medical group culture are associated with the use of evidence-based medicine practices in physician organizations. METHODS: Cross-sectional exploratory study of 56 medical groups affiliated with 15 integrated health systems from across the United States, involving 1,797 physician respondents. Larger medical groups and multispecialty groups were overrepresented compared with the United States as a whole. Data are from two sources: (1) surveys of physicians assessing the culture of the medical groups in which they work, and (2) surveys of medical directors and other managerial key informants pertaining to care management practices, compensation methods, and the management and governance of the medical groups. Physician-level data were aggregated to the group level to attain measures of group culture and then merged with the data regarding care management, incentives, and management and governance. Stepwise multiple regression was used to examine the study hypotheses. RESULTS: As hypothesized, the number of different types of compensation incentives used (cost containment, productivity, quality) was positively associated with the comprehensiveness of care management practices. The degree of salary control (ie, market-based salary grades and ranges versus the use of bookings or fees and individual negotiation) was also positively associated with the deployment of care management practices. As hypothesized, market pressures in the form of percentages of health maintenance and preferred provider organization patients seen were generally positively associated with the use of care management practices. Organizational culture had no association except that a patient-centered culture in combination with a greater number of different types of compensation incentives used was positively associated with greater use of care management practices. CONCLUSIONS: Both compensation incentives and managed care market pressures were significantly associated with the use of evidence-based care management practices. The lack of association for culture may be due to the relatively amorphous nature of most physician organizations at this point.

Health status disparities among public and private emergency department patients.

OBJECTIVE: To explore whether patients in a public ED had poorer health than patients in a private ED, the authors compared the physical and mental health statuses of patients seeking emergency care. METHODS: A cross-sectional observational study of all adult patients, regardless of acuity, seen during two 24-hour periods in spring 1997 in an urban county trauma center (68,000 annual visits) and a private community ED (35,000 annual visits). Scores on the Physical Component Summary (PCS) and the Mental Component Summary (MCS) scales of the Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12) were compared between sites, with published national norms, and with hospital admission. RESULTS: Of 571 eligible patients, 392 (69%) completed the SF-12. Patients in the public ED had a mean PCS score of 40.1, compared with 43.7 for patients in the private ED, for a difference of 3.6 points (p < 0.01; 95% CI = 0.9 to 6.1). After controlling for age, sex, ethnicity, triage acuity, ambulance arrival, and insurance status, this difference increased to 3.9 points (p = 0.02; 95% CI = 0.7 to 7.0). The mean MCS score among public ED patients was 44.1, compared with 46.5 in the private ED population, for a difference of 2.4 (p = 0.08; 95% CI = -0.3 to 5.0); after adjustment this difference increased to 2.5 (p = 0.15; 95% CI = -0.9 to 5.8), but remained statistically not significant. While all scores were significantly lower than national norms (mean PCS 50.1, mean MCS 50.0), patients in the public ED scored consistently lowest. PCS score was significantly inversely correlated with admission, with each point decrease in PCS score increasing the odds of admission by 0.05 (95% CI = 0.01 to 0.08), and conferring an odds ratio of 5.1 (95% CI = 1.2 to 21.1) for admission among the 25th percentile for PCS scores. CONCLUSIONS: Patients seeking care in the public ED had lower adjusted physical health status scores than comparable patients obtaining care in a private ED. The SF-12 is sufficiently responsive to detect hypothesized differences between ED populations, and correlates well with admission decisions.

Supply dynamics of the mental health workforce: implications for health policy.

The U.S. mental health workforce is varied and flexible. The strong growth in supply of nonphysician mental health professionals, ranging from psychologists to "midlevel" professionals like social workers and nurse specialists, helps to offset the dwindling numbers of medical graduates entering the field of psychiatry. Primary care physicians often see patients who have some form of mental illness, which they are not always trained to recognize and treat. The data on the supply of several specialists--psychiatrists, clinical psychologists, and clinical social workers--indicate that the distribution of mental health professionals varies widely by state. The composition, supply, and distribution of workers in this field also affect the care of vulnerable populations. Broader policy questions, including the lack of parity between mental and physical health insurance coverage and barriers to entry by nonphysician professions, may limit the cost-effective expansion of this diverse and dynamic workforce.

Assessing the needs of women and clinicians for the management of menopause in an HMO.

OBJECTIVE: To determine the perceived needs of perimenopausal women regarding the management of menopause and the resource needs of the clinicians who treat them. SETTING: A large staff and group network model health maintenance organization (HMO) in New England. PARTICIPANTS: A random sample of 790 perimenopausal women aged 45-60 years who were members of the HMO in 1991, and a random sample of 180 clinicians in internal medicine, family practice, and obstetrics/gynecology practicing in the HMO during 1991. METHOD: Mailed surveys of women and clinicians were designed to assess possible needs and attitudes that could lead to the improvement of care for menopausal women. The chi-square test was used to determine differences in perceived needs and satisfaction levels among women with differences in self-reported menopausal status. The Kruskal-Wallis one-way analysis of variance and the Mann-Whitney U test were used in the clinician survey to test for differences among specialties and between genders. RESULTS: The key findings include that: 1) most (81%) of the women wanted to see a woman clinician, 2) many (50%) were interested in a menopause support group, 3) 30% reported that their care for menopause had been fair to poor, 4) only 55% of the primary care specialists (including internal medicine and family practice) reported high confidence in their abilities to treat menopause, compared with 68% of the obstetric/gynecology clinicians, and 5) 56% of the clinicians surveyed said that support from the HMO to their practices for the treatment of menopause was fair to poor. CONCLUSIONS: There is an opportunity for better care for perimenopausal women as reported by two sources, HMO clinicians and members. To provide this care, clinicians may need explicit guidelines as well as administrative supports such as educational materials and specialty access. Since the capability for menopausal care from clinicians in obstetrics/gynecology is perceived to be higher than that from primary care clinicians, an opportunity for cross-specialty collaboration and training may exist.

Strategic planning applied to quality in asthma management for children.

This strategic plan translates the HCHP vision statement into a working plan for one major clinical condition--asthma in children. It is a working plan for clinicians and managers across specialties and levels. The results of the projects will improve in a measurable way significant clinical practice and outcomes, in keeping with the FY 1993 strategic goals.