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To address the global burden of sickle cell disease and the need for novel therapies, the American Society of Hematology partnered with the US Food and Drug Administration to engage the work of 7 panels of clinicians, investigators, and patients to develop consensus recommendations for clinical trial end points. The panels conducted their work through literature reviews, assessment of available evidence, and expert judgment focusing on end points related to patient-reported outcome, pain (non-patient-reported outcomes), the brain, end-organ considerations, biomarkers, measurement of cure, and low-resource settings. This article presents the findings and recommendations of the end-organ considerations, measurement of cure, and low-resource settings panels as well as relevant findings and recommendations from the biomarkers panel.

Abstract Background Lower physical and social functioning in pregnancy has been linked to an increased risk of preterm delivery and low birth weight infants, butt few studies have examined racial differences in pregnant women’s perception of their functioning. Even fewer studies have elucidated the demographic and clinical factors contributing to racial differences in functioning. Our objective was to determine whether there are racial differences in health-related quality of life (HRQoL) in early pregnancy; and if so, to identify the contributions of socio-demographic characteristics, depression symptoms, social support and clinical factors to these differences. Methods Cross-sectional study of 175 women in early pregnancy attending prenatal clinics in urban setting. In multivariate analysis, we assessed the independent relation of black race (compared to white) to HRQoL scores from the eight domains of the Medical Outcomes (SF-36) Survey: Physical Functioning, Role-Physical, Bodily Pain, Vitality, General Health, Social Functioning, Role-Emotional, and Mental Health. We compared socio-demographic and clinical factors and depression symptoms between black and white women and assessed the relative importance of these factors in explaining racial differences in physical and social functioning. Results Black women comprised 59% of the sample; white women comprised 41%. Before adjustment, black women had scores that were 14 points lower in Physical Function and Bodily Pain, 8 points lower in General Health, 4 points lower in Vitality and 7 points lower in Social Functioning. After adjustment for depression symptoms, social support and clinical factors, black women still had HRQoL scores that were 4 to 10 points lower than white women, but the differences were no longer statistically significant. Level of social support and payment source accounted for most of the variation in Physical Functioning, Bodily Pain and General Health. Social support accounted for most of the differences in Vitality and Social Functioning. Conclusions Payment source and social support accounted for much of the racial differences in physical and social function scores. Efforts to reduce racial differences might focus on improving social support networks and Socio-economic barriers.

Background: Lower physical and social functioning in pregnancy has been linked to an increased risk of preterm delivery and low birth weight infants, butt few studies have examined racial differences in pregnant women's perception of their functioning. Even fewer studies have elucidated the demographic and clinical factors contributing to racial differences in functioning. Our objective was to determine whether there are racial differences in health-related quality of life (HRQoL) in early pregnancy; and if so, to identify the contributions of socio-demographic characteristics, depression symptoms, social support and clinical factors to these differences. Methods: Cross-sectional study of 175 women in early pregnancy attending prenatal clinics in urban setting. In multivariate analysis, we assessed the independent relation of black race (compared to white) to HRQoL scores from the eight domains of the Medical Outcomes (SF-36) Survey: Physical Functioning, Role-Physical, Bodily Pain, Vitality, General Health, Social Functioning, Role-Emotional, and Mental Health. We compared socio-demographic and clinical factors and depression symptoms between black and white women and assessed the relative importance of these factors in explaining racial differences in physical and social functioning. Results: Black women comprised 59% of the sample; white women comprised 41%. Before adjustment, black women had scores that were 14 points lower in Physical Function and Bodily Pain, 8 points lower in General Health, 4 points lower in Vitality and 7 points lower in Social Functioning. After adjustment for depression symptoms, social support and clinical factors, black women still had HRQoL scores that were 4 to 10 points lower than white women, but the differences were no longer statistically significant. Level of social support and payment source accounted for most of the variation in Physical Functioning, Bodily Pain and General Health. Social support accounted for most of the differences in Vitality and Social Functioning. Conclusions: Payment source and social support accounted for much of the racial differences in physical and social function scores. Efforts to reduce racial differences might focus on improving social support networks and Socio-economic barriers. [ABSTRACT FROM AUTHOR]

The article discusses aspects of the racial disparities in the influenza vaccination coverage among children in the U.S. according to the analysis of U.S. Centers for Disease Control and Prevention (CDC). Topics include the estimation of the proportion of the combined seasonal and seasonal only vaccination, the comparison of the proportion of the coverage between Hispanic white and blacks, and the persistence of the disparities in the coverage among adults.

Concerns about possible allergic reactions to immunizations are raised frequently by both patients/parents and primary care providers. Estimates of true allergic, or immediate hypersensitivity, reactions to routine vaccines range from 1 per 50000 doses for diphtheria-tetanus-pertussis to approximately 1 per 500000 to 1000000 doses for most other vaccines. In a large study from New Zealand, data were collected during a 5-year period on 15 marketed vaccines and revealed an estimated rate of 1 immediate hypersensitivity reaction per 450000 doses of vaccine administered. Another large study, conducted within the Vaccine Safety Datalink, described a range of reaction rates to >7.5 million doses. Depending on the study design and the time after the immunization event, reaction rates varied from 0.65 cases per million doses to 1.53 cases per million doses when additional allergy codes were included. For some vaccines, particularly when allergens such as gelatin are part of the formulation (eg, Japanese encephalitis), higher rates of serious allergic reactions may occur. Although these per-dose estimates suggest that true hypersensitivity reactions are quite rare, the large number of doses that are administered, especially for the commonly used vaccines, makes this a relatively common clinical problem. In this review, we present background information on vaccine hypersensitivity, followed by a detailed algorithm that provides a rational and organized approach for the evaluation and treatment of patients with suspected hypersensitivity. We then include 3 cases of suspected allergic reactions to vaccines that have been referred to the Clinical Immunization Safety Assessment network to demonstrate the practical application of the algorithm.