Safety and Efficacy of a Typhoid Conjugate Vaccine in Malawian Children.

BACKGROUND: Typhoid fever caused by multidrug-resistant H58 Salmonella Typhi is an increasing public health threat in sub-Saharan Africa. METHODS: We conducted a phase 3, double-blind trial in Blantyre, Malawi, to assess the efficacy of Vi polysaccharide typhoid conjugate vaccine (Vi-TCV). We randomly assigned children who were between 9 months and 12 years of age, in a 1:1 ratio, to receive a single dose of Vi-TCV or meningococcal capsular group A conjugate (MenA) vaccine. The primary outcome was typhoid fever confirmed by blood culture. We report vaccine efficacy and safety outcomes after 18 to 24 months of follow-up. RESULTS: The intention-to-treat analysis included 28,130 children, of whom 14,069 were assigned to receive Vi-TCV and 14,061 were assigned to receive the MenA vaccine. Blood culture-confirmed typhoid fever occurred in 12 children in the Vi-TCV group (46.9 cases per 100,000 person-years) and in 62 children in the MenA group (243.2 cases per 100,000 person-years). Overall, the efficacy of Vi-TCV was 80.7% (95% confidence interval [CI], 64.2 to 89.6) in the intention-to-treat analysis and 83.7% (95% CI, 68.1 to 91.6) in the per-protocol analysis. In total, 130 serious adverse events occurred in the first 6 months after vaccination (52 in the Vi-TCV group and 78 in the MenA group), including 6 deaths (all in the MenA group). No serious adverse events were considered by the investigators to be related to vaccination. CONCLUSIONS: Among Malawian children 9 months to 12 years of age, administration of Vi-TCV resulted in a lower incidence of blood culture-confirmed typhoid fever than the MenA vaccine. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT03299426.).

Cancer-work management: Hourly and salaried wage women's experiences managing the cancer-work interface following new breast cancer diagnosis.

OBJECTIVE: The purpose of this paper is to report the baseline characteristics of EMPOWER participants-a group of newly diagnosed breast cancer survivors-and describe differences in hourly and salaried wage women's experiences regarding cancer and work management in the three months following breast cancer diagnosis. DESIGN AND SETTING: The EMployment and Potential Outcomes of Working through canceER (EMPOWER) project is a prospective longitudinal, mixed methods pilot study designed to evaluate how employment influences treatment decisions among women diagnosed with breast cancer. Participants were women diagnosed with new breast cancer and treated at one of two clinical sites of the University of Maryland Medical System. Women were enrolled in the study within three months of first breast cancer diagnosis. Study visits occurred every three months for one year. This paper reports data from for the baseline and three-month visit which had been completed by all enrollees. METHODS: Trained research personnel collected demographic information, medical history and health status, social history, employment data, cancer-related data, psychosocial adjustment, and financial wellbeing at the baseline enrollment visit. A semi-structured qualitative interview was administered at the three-month study visit to assess employment decisions and the impact of job demands, cancer care, and cancer-work fit during the three months following diagnosis. RESULT: Fifty women with new, primary diagnosis of breast cancer were enrolled in the study. Mean age of participants was 51 years, and 46% identified their race as Black or other. The majority of women disclosed their diagnosis to their employer and nearly all maintained some level of employment during the first three to six months of treatment. Women with hourly wage jobs were similar to those with salaried wage jobs with respect to demographic and social characteristics. Women with hourly wage jobs were more likely to report working in physically demanding jobs and taking unpaid leave. They were also more likely to experience side effects that required physical restrictions at work, to leave their jobs due to demands of treatment, and to report managing cancer and work concurrently as very difficult. Women in salaried wage jobs were more likely to report falling behind or missing work and working remotely as a cancer-management strategy. Women in hourly jobs more often reported difficulty managing the competing demands of cancer and work. CONCLUSION: While further study is needed, these results suggest that women in hourly and salaried workers reported similar experiences managing cancer and work, with a few key exceptions. These exceptions pertain to the nature of hourly-wage work. Cancer survivors employed in hourly jobs may be more vulnerable to poor employment outcomes due to limited access to paid time off and workplace flexibility, and challenges related to managing physical aspects of cancer and employment.

Evaluating for Differences by Race/Ethnicity in the Association Between Income and Gambling Disorder.

Multiple studies show an increased prevalence of gambling disorder among African Americans compared to whites. However, few studies take an analytic approach to understanding differences in risk factors by race/ethnicity. Income is inversely associated with gambling disorder; we hypothesized that this association would vary by race/ethnicity. The main objective was to evaluate whether the association between income and gambling disorder varies by race/ethnicity. With data from the baseline visit of a prospective cohort study, Prevention and Etiology of Gambling Addiction Study in the United States, we used multivariable logistic regression analysis to determine whether the association between income and gambling disorder varies by race/ethnicity. 1164 participants were included in the final analyses. Measures included: demographics (age, sex, race/ethnicity, education, employment, annual household income), veteran status, marital status, homelessness, smoking, substance abuse, alcohol abuse, marijuana use, and lifetime gambling disorder diagnosis as derived from Alcohol Use Disorder and Associated Disabilities Interview Schedule. There was no evidence of effect modification by race/ethnicity in the association between income and gambling disorder (global p value = 0.17). Income was associated with increased odds of gambling disorder, but only for those with low income (< $15,000; OR 2.27, 95% CI 1.46, 3.53). There was no evidence that the effect of income on gambling disorder varies by race/ethnicity. For all race/ethnicities combined, low income was associated with significantly increased odds of gambling disorder (OR 2.27, 95% CI 1.46, 3.53). Further research is needed to better understand racial/ethnic differences in gambling disorder.

Managing the cancer-work interface: the effect of cancer survivorship on unemployment.

OBJECTIVE: This study assessed differences in employment outcomes among cancer survivors using data from a nationally representative sample. METHODS: The 2011 Medical Expenditure Panel Survey (MEPS) data and the 2011 MEPS Experiences with Cancer Survivorship Supplement representing 3,360,465 people in the US population were analyzed to evaluate factors associated with unemployment among cancer survivors during the 5 years following diagnosis and treatment. The sample included adults 1) diagnosed with cancer within 5 years prior to survey completion and 2) engaged in paid employment since diagnosis. Individuals diagnosed with nonmelanoma skin cancer (n=33) were excluded from analyses. RESULTS: Data of 221 cancer survivors were used to identify factors associated with employment status at the time respondents were employed (n=155) vs unemployed (n=66). Results of bivariate analyses indicated that unemployed survivors were older, more likely to be women, more likely to be uninsured at the time of cancer diagnosis, and to report lower incomes than cancer survivors who continue to be employed. Unemployed survivors were more likely than employed survivors to have had anxiety about being forced to retire or quit early when they were employed because of cancer and to report cancer-related interference with physical and mental aspects of their job tasks; unemployed survivors also took less paid time off and were less likely to change to a flexible job schedule when they were employed. In multiple logistic regression analyses, worry about being forced to retire (protective), worry that cancer recurrence will interfere with home or work responsibilities (risk), and change to a flexible work schedule (risk) following cancer diagnosis were associated with unemployment after controlling for demographic differences between employed and unemployed cancer survivors. CONCLUSION: Findings of this study highlight the extent to which the challenges of managing the cancer-work interface create challenges to employment among cancer survivors and may lead to long-term unemployment among cancer survivors. Future studies should evaluate the strategies that the survivors could use to manage the cancer-work interface during cancer treatment to attain medical, psychological, social, and employment outcomes.