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BACKGROUND: HIV-infected persons have less robust antibody responses to influenza vaccines. OBJECTIVE: To compare the immunogenicity of high-dose influenza vaccine with that of standard dosing in HIV-positive participants. DESIGN: Randomized, double-blind, controlled trial. (ClinicalTrials.gov: NCT01262846) SETTING: The MacGregor Clinic of the Hospital of the University of Pennsylvania, Philadelphia, from 27 October 2010 to 27 March 2011. PARTICIPANTS: HIV-infected persons older than 18 years. INTERVENTION: Participants were randomly assigned to receive either a standard dose (15 mcg of antigen per strain) or a high dose (60 mcg/strain) of the influenza trivalent vaccine. MEASUREMENTS: The primary end point was the rate of seroprotection, defined as antibody titers of 1:40 or greater on the hemagglutination inhibition assay 21 to 28 days after vaccination. The primary safety end point was frequency and intensity of adverse events. Secondary end points were seroconversion rate (defined as a greater than 4-fold increase in antibody titers) and the geometric mean antibody titer. RESULTS: 195 participants enrolled, and 190 completed the study (93 in the standard-dose group and 97 in the high-dose group). The seroprotection rates after vaccination were higher in the high-dose group for the H1N1 (96% vs. 87%; treatment difference, 9 percentage points [95% CI, 1 to 17 percentage points]; P = 0.029), H3N2 (96% vs. 92%; treatment difference, 3 percentage points [CI, -3 to 10 percentage points]; P = 0.32), and influenza B (91% vs. 80%; treatment difference, 11 percentage points [CI, 1 to 21 percentage points]; P = 0.030) strains. Both vaccines were well-tolerated, with myalgia (19%), malaise (14%), and local pain (10%) the most frequent adverse events. LIMITATIONS: The effectiveness of the vaccine in preventing clinical influenza was not evaluated. The number of participants with CD4 counts less than 0.200 x 109 cells/L was limited. CONCLUSION: HIV-infected persons reach higher levels of influenza seroprotection if vaccinated with the high-dose trivalent vaccine than with the standard-dose. PRIMARY FUNDING SOURCE: National Institute of Allergy and Infectious Diseases and Center for AIDS Research of the University of Pennsylvania. [ABSTRACT FROM AUTHOR]

Background. The ability to control human immunodeficiency virus (HIV) replication in vivo in the absence of antiretroviral therapy (ART) is a measure of the efficiency of antiviral immunity. In a study of patients with chronic, ART-suppressed HIV infection, AIDS Clinical Trials Group 5068 investigated the effects of immunization with an exogenous HIV vaccine and pulse exposure to the subject's unique viral epitopes, by means of structured treatment interruptions (STIs), on the dynamics of viral rebound during a subsequent analytical treatment interruption (ATI). Methods. Ninety-seven subjects receiving stable ART with an HIV-1 RNA load <50 copies/mL and CD4(+) T lymphocyte count >400 cells/mm(3) were randomized to undergo continued ART, STIs, ALVAC-HIV vCP1452 immunization, or STIs and ALVAC-HIV vCP1452 immunization. Results. Subjects in the 2 STI arms had a significantly longer median doubling time in the period of the initial rise of viral load, a significantly lower median peak viral load, a significantly lower median end-of-ATI viral load set point, and a greater proportion of subjects with an end-of-ATI viral load set point <1000 copies/mL, compared with the subjects in the 2 arms without STIs. With an immunization schedule of 3 sets of 3 weekly injections, ALVAC-HIV vCP1452 did not affect viral load measures. Conclusions. In this randomized, controlled study of intermittent STI as a therapeutic autoimmunization strategy, evidence of enhanced immunologic control of HIV replication was demonstrated. Copyright © 2006 Infectious Diseases Society of America [ABSTRACT FROM AUTHOR]

The first article in this 2-part series discussed the challenge of quality health care, the need for sophisticated problem solving methods, the roles of process thinking and project prioritization, and some of the problem-solving methods utilized with Lean. This article describes Six Sigma and Lean Six Sigma. [ABSTRACT FROM AUTHOR]

The Secondary Traumatic Stress Scale (STSS; Bride, Robinson, Yegidis, & Figley, 2004) is an easy to administer 17-item self-report measure of secondary trauma. Bride et al. (2004) reported a measure of three domains of traumatic stress specifically associated with secondary exposure to trauma: intrusion, avoidance, and arousal. The STSS was reported to have high levels of internal consistency reliability and indicated evidence of convergent, discriminant, and factorial validity. The purpose of this paper is to examine the reliability and validity of the STSS with a national, random sample of mental health social workers. To assess the fit of the data to the three-factor structure proposed by Bride et al., a confirmatory factor analysis was performed on data from 275 social workers who indicated exposure to client trauma. The model fit the data adequately although high factor intercorrelations strongly suggest a unidimensional scale. Subsequent confirmatory factor analysis of a unidimensional scale and a second order factor analysis yielded similar results. Findings indicate the need for further scale validation. Challenges remain for measuring and distinctly differentiating between secondary trauma symptoms of arousal, avoidance, and intrusion. Implications and suggestions for future research are discussed. [ABSTRACT FROM AUTHOR]

A stratified random sample of midlife Baby Boom women, ages 35-42, was compared with a group of older midlife women, ages 43-55. The sample consisted of 992 women who had graduated between the years of 1955 and 1975 from a large university in southern California. Measures of anxiety and life satisfaction were administered to each year group. This served to control for the effect of age and was helpful in explaining whether the differences between the groups were age related or the result of socialization. The Baby Boom cohort of women, born after January 1, 1946, have only recently entered the ranks of midlife. They have been recognized as unique and less traditional than their older counterparts with regard to sexual freedom, career choices, and educational opportunities. Similarities and differences were found between the two groups of women. However, the results clearly revealed that the effects of socialization, rather than age, yielded the major significant variables influencing a feeling of well-being in both cohorts of midlife women. [ABSTRACT FROM AUTHOR]