The objective of this randomized trial was to compare breastfeeding among women who received a levonorgestrel-releasing intrauterine system within 6–48 h (early) or 4–6 weeks (standard) after an ...uncomplicated vaginal birth. Analysis groups of 86 women in each arm were needed to demonstrate a 20% difference in any breastfeeding. Thirty-five women were randomized to the early (N=17) and standard (N=18) arms. The combination of unsuccessful placement (2/17; 12%), expulsions (7/17; 41%) and removals (3/17; 18%) reached 71% (12/17) in the early arm, so the study was stopped. In our small study cohort, levonorgestrel-releasing intrauterine system insertion between 6 and 48h after vaginal birth was associated with a high rate of expulsion or removal soon after insertion.
Antiretroviral therapy (ART) reduces mortality and prevents secondary transmission of HIV. Treatment guidelines now recommend initiating ART immediately following HIV diagnosis. The impact of this ...test-and-treat strategy on survival among HIV-infected persons in the United States (US) is unknown. First, published estimates of the effect of ART have been based on cohorts that are not representative of this target population. Second, evidence as to whether racial/ethnic/sex disparities in survival persist following ART initiation is mixed. In this dissertation, I estimated 5-year mortality risks for ART initiators versus non-initiators among 12,547 patients in the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) using the complement of weighted Kaplan-Meier survival functions. I subsequently standardized estimates to persons diagnosed with HIV in the US between 2009 and 2011, enumerated using national surveillance data from the Centers for Disease Control and Prevention. Furthermore, I calculated the 10-year all-cause mortality risk among 10,017 ART initiators, stratified by race/ethnicity and sex, from weighted Kaplan-Meier survival functions. The 5-year mortality among ART initiators in the CNICS was 10.6% (95% CI: 9.3%, 11.9%) compared to 28.3% (95% CI: 19.1%, 37.5%) among non-initiators. ART initiation lowered 5-year mortality by -19.1% (95% CI: -30.5%, -7.8%) among recently HIV-diagnosed persons in the US. This effect was similar to the effect of ART estimated in the CNICS (risk difference: -17.7%, 95% CI: -27.0%, -8.4%). The overall 10-year mortality risk among ART initiators was 20.2% (95% confidence interval (CI): 19.2%, 21.3%). Black men and women experienced standardized 10-year all-cause mortality risks that were 7.2% (95% CI: 4.3%, 10.1%) and 7.9% (95% CI: 3.9%, 12.0%) larger than white men. White women, Hispanic men, and Hispanic women all had lower 10-year mortality than white men. ART initiation substantially lowers mortality among persons in the CNICS and this benefit is expected to be similar among persons recently diagnosed with HIV in the US. However, survival following ART initiation differs by race/ethnicity. Effective interventions are needed to ensure that the goal of the National HIV/AIDS Strategy to overcome health disparities becomes a reality.
To provide an updated review and examine any trends among congenital malaria cases that might help guide diagnosis, treatment, and public health recommendations.
Retrospective case series.
United ...States.
We reviewed all cases of congenital malaria reported to the US National Malaria Surveillance System between January 1, 1966, and December 31, 2004, including 1 unpublished case from 2005, encompassing all years for which data were collected and available.
Maternal characteristics, including travel history, and malaria treatment. Main Outcome Measure Characteristics of congenitally acquired cases of malaria.
For the 81 cases of congenital malaria reported in the United States in the past 40 years, the predominant infecting species was Plasmodium vivax (81%). Most mothers (96%) were foreign born, and 55 of 65 women (85%), for whom time of most recent exposure was known, were exposed 1 year or less before delivery. A common error in the treatment of infants with congenital malaria was the unnecessary administration of primaquine phosphate for P vivax infection.
Health care professionals should have heightened vigilance for malaria in pregnant women who have emigrated from or traveled to malaria-endemic areas within the past year, as well as in their offspring. Such women with episodes of fever during pregnancy should have a blood film to test for malaria performed promptly and should be treated appropriately. Treatment of a mother does not negate the need for heightened vigilance in her newborn. Health care professionals should be aware that congenital P vivax malaria does not need to be treated with primaquine.
Randomized trials are considered the gold standard for estimating causal effects. Trial findings are often used to inform policy and programming efforts, yet their results may not generalize well to ...a relevant target population due to potential differences in effect moderators between the trial and population. Statistical methods have been developed to improve generalizability by combining trials and population data, and weighting the trial to resemble the population on baseline covariates.Large-scale surveys in fields such as health and education with complex survey designs are a logical source for population data; however, there is currently no best practice for incorporating survey weights when generalizing trial findings to a complex survey. We propose and investigate ways to incorporate survey weights in this context. We examine the performance of our proposed estimator in simulations by comparing its performance to estimators that ignore the complex survey design.We then apply the methods to generalize findings from two trials - a lifestyle intervention for blood pressure reduction and a web-based intervention to treat substance use disorders - to their respective target populations using population data from complex surveys. The work highlights the importance in properly accounting for the complex survey design when generalizing trial findings to a population represented by a complex survey sample.
PURPOSEThe impact of pharmacist-assisted management (PAM) of pharmacotherapy for patients with human immunodeficiency virus (HIV) infection was investigated.
METHODSA retrospective cohort analysis ...was conducted to evaluate antiretroviral therapy (ART) outcomes in treatment-naive patients initiated on ART at an HIV clinic. Eligible patients enrolled in the clinic during the period 1999–2013 were classified into two groupsthose referred to a clinic-based HIV pharmacist for initiation of ART (the PAM group) and those managed by a primary care provider (the control group). The primary study objective was the median time to viral suppression; secondary objectives included the durability of response to the first ART regimen. Relative hazards for the events of interest were estimated using a marginal structural Cox proportional hazards model and Kaplan–Meier curves, with inverse probability weights used to control for selection and confounding bias.
RESULTSPatients referred for PAM services (n = 819) typically had higher baseline viral loads and lower CD4+ cell counts than those in the control group (n = 436). The likelihood of viral suppression during the first two years after ART initiation was significantly higher in the PAM group versus the control group (hazard ratio, 1.37; 95% confidence interval, 1.18–1.59; p < 0.0001). The median durability of the first ART regimen was 100 months in the PAM group versus 44 months in the control group (p > 0.05).
CONCLUSIONIn treatment-naive patients, suppression of HIV viral load occurred earlier when pharmacists assisted with initiating ART than when ART was initiated without that assistance.
Heterogeneity in the underlying mechanisms of disease processes and inter-patient variability in drug responses are major challenges in drug development. To address these challenges, biomarker ...strategies based on a range of platforms, such as microarray gene-expression technologies, are increasingly being applied to elucidate these sources of variability and thereby potentially increase drug development success rates. With the aim of enhancing understanding of the regulatory significance of such biomarker data by regulators and sponsors, the US Food and Drug Administration initiated a programme in 2004 to allow sponsors to submit exploratory genomic data voluntarily, without immediate regulatory impact. In this article, a selection of case studies from the first 5 years of this programme - which is now known as the voluntary exploratory data submission programme, and also involves collaboration with the European Medicines Agency - are discussed, and general lessons are highlighted.
"Sick quitting," a phenomenon describing reductions in alcohol consumption following poor health, may explain observations that alcohol appears protective for frailty risk. We examined associations ...between frailty and reductions in drinking frequency among people with HIV (PWH). At six Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) sites between January 2012 and August 2021, we assessed whether frailty, measured through validated modified frailty phenotype, precedes reductions in drinking frequency. We associated time-updated frailty with quitting and reducing frequency of any drinking and heavy episodic drinking (HED), adjusted for demographic and clinical characteristics in Cox models. Among 5,654 PWH reporting drinking, 60% reported >monthly drinking and 18% reported ≥monthly HED. Over an average of 5.4 years, frail PWH had greater probabilities of quitting (HR: 1.56, 95% confidence interval 95% CI 1.13-2.15) and reducing (HR: 1.35, 95% CI 1.13-1.62) drinking frequency, as well as reducing HED frequency (HR: 1.58, 95% CI 1.20-2.09) versus robust PWH. Sick quitting likely confounds the association between alcohol use and frailty risk, requiring investigation for control.
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