Quality of life improvements in women with uterine fibroids treated with relugolix combination therapy during the LIBERTY long-term extension study: A descriptive subgroup analysis in women with anemia at baseline.

OBJECTIVE: To investigate the effects of 52 weeks of treatment with relugolix combination therapy (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) on symptoms of uterine fibroids (UF) and quality of life (QoL) in women with heavy menstrual bleeding associated with UF and anemia (hemoglobin ≤10.5 g/dL) at baseline. METHODS: This post hoc analysis included women from the LIBERTY long-term extension study with anemia (hemoglobin concentration ≤10.5 g/dL) at pivotal study baseline and documented hemoglobin values at week 52 (anemia-evaluable population). Treatment responders: women achieving a menstrual blood loss volume of <80 mL and a ≥50% reduction over the last 35 days of treatment. Anemia responders were women achieving a hemoglobin increase of >2 g/dL from baseline to week 52. Least squares (LS) mean changes from baseline in uterine fibroid symptom (UFS)-QoL symptom severity, fatigue, and health-related QoL total (HR-QoL) and (sub)scale scores were calculated. RESULTS: In total, 115 women were included in the anemia-evaluable population. Of 39 anemia-evaluable women who received continuous treatment with relugolix combination therapy for 52 weeks, 34 (87.2%) met treatment responder criteria and 23 (59.0%) were anemia responders. LS mean hemoglobin concentration increased by 29.4% at week 52. LS mean UFS-QoL symptom severity and fatigue scores decreased by 38.5 and 31.9 points, respectively, and HR-QoL total score increased by 41.6 points. CONCLUSION: In women with UF and a high disease burden due to anemia, relugolix combination therapy substantially improved hemoglobin levels, decreased distress due to symptoms, especially fatigue, over 52 weeks.

Congenital syphilis prevention in the context of methamphetamine use and homelessness.

BACKGROUND AND OBJECTIVES: Congenital syphilis (CS) is increasing in the United States and is associated with intersecting social and structural determinants of health. This study aimed to delineate birthing parent characteristics associated with CS in an adjusted model. METHODS (N = 720): People diagnosed with syphilis during pregnancy from 2017 to 2018 who were interviewed and linked to infants in the California state surveillance system were included (herein, "birthing parents"). Sociodemographic and clinical CS risk factors informed a stepwise multivariable logistic regression model in which the outcome of interest was infants born with CS. CS prevention continuums delineated the proportion of pregnant people with syphilis who completed steps (e.g., prenatal care entry, syphilis testing, treatment) needed to prevent CS; the outcome was delivering an infant without CS. We stratified continuums by homelessness and methamphetamine use to explore differences in CS outcomes. RESULTS: Of 720 birthing parents, 245 (34%) delivered an infant with CS. Although CS was initially associated with homelessness (odds ratio [OR] = 2.5, 95% confidence interval [CI]: 1.6, 4.0) and methamphetamine use (OR = 2.1, 95% CI: 1.4, 3.1), the addition of prenatal care into a final adjusted model attenuated these associations to not significant. In CS prevention continuums, delivering an infant without CS was less likely for people who reported methamphetamine use (p < .001) and/or homelessness (p < .001). However, when examining only those who received prenatal care, statistical differences for these predictors no longer existed. In the final adjusted model the following were associated with CS: no prenatal care (OR = 16.7, 95% CI: 9.2, 30.3) or late prenatal care (OR = 2.9, 95% CI: 1.9, 4.2); early stage of syphilis (OR = 2.6, 95% CI: 1.8, 3.7); living in Central California (OR = 2.1, 95% CI: 1.1, 4.2). CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: This is the first analysis to explore birthing parent characteristics associated with delivering an infant with CS in an adjusted model. We demonstrate that prenatal care, when accessed, can result in effective CS prevention among people who are unhoused and/or using methamphetamine equally well compared to counterparts without these risk factors.

Disparities in risk perception and low harm reduction services awareness, access, and utilization among young people with newly reported hepatitis C infections in California, 2018.

BACKGROUND: Newly reported hepatitis C virus (HCV) infections in California increased 50% among people 15-29 years of age between 2014 and 2016. National estimates suggest this increase was due to the opioid epidemic and associated increases in injection drug use. However, most of California's 61 local health jurisdictions (LHJs) do not routinely investigate newly reported HCV infections, so these individuals' risk factors for infection are not well understood. We sought to describe the demographics, risk behaviors, and utilization of harm reduction services in California's fastest-rising age group of people with newly reported hepatitis C infections to support targeted HCV prevention and treatment strategies. METHODS: California Department of Public Health invited LHJs to participate in enhanced surveillance if they met criteria indicating heightened population risk for HCV infection among people ages 15-29. From June-December 2018, eight LHJs contacted newly reported HCV cases by phone using a structured questionnaire. RESULTS: Among 472 total HCV cases who met the inclusion criteria, 114 (24%) completed an interview. Twenty-seven percent of respondents (n = 31) had ever been incarcerated, of whom 29% received a tattoo/piercing and 39% injected drugs while incarcerated. Among people who injected drugs (PWID)-36% (n = 41) of all respondents-68% shared injection equipment and many lacked access to harm reduction services: 37% knew of or ever used a needle exchange and 44% ever needed naloxone during an overdose but did not have it. Heroin was the most frequently reported injected drug (n = 30), followed by methamphetamine (n = 18). Pre-diagnosis HCV risk perception varied significantly by PWID status and race/ethnicity: 76% of PWID vs. 8% of non-PWID (p < 0.001), and 44% of non-Hispanic White respondents vs. 22% of people of color (POC) respondents (p = 0.011), reported thinking they were at risk for HCV before diagnosis. Eighty-nine percent of all respondents reported having health insurance, although only two had taken HCV antiviral medications. CONCLUSIONS: Among young people with HCV, we found limited pre-diagnosis HCV risk perception and access to harm reduction services, with racial/ethnic disparities. Interventions to increase harm reduction services awareness, access, and utilization among young PWID, especially young PWID of color, may be warranted.

Accurate and reproducible enumeration of T-, B-, and NK lymphocytes using the BD FACSLyric 10-color system: A multisite clinical evaluation.

Clinical flow cytometry is a reliable methodology for whole blood cell phenotyping for different applications. The BD FACSLyric™ system comprises a flow cytometer available in different optical configurations, BD FACSuite™ Clinical software, and optional BD FACS™ Universal Loader. BD FACSuite Clinical software used with BD™ FC Beads and BD CS&T Beads enable universal setup for performance QC, instrument control, data acquisition/storage, online/offline data analysis, and instrument standardization. BD Biosciences sponsored the clinical evaluation of the BD FACSLyric 10-color configuration at seven clinical sites using delinked and de-identified blood specimens from HIV-infected and uninfected subjects to enumerate T-, B-, and NK-lymphocytes with the BD Multitest™ reagents (BD Multitest IMK kit and BD Multitest 6-color TBNK). Samples were analyzed on the BD FACSLyric system with BD FACSuite Clinical software, and on the BD FACSCanto™ II system with BD FACSCanto clinical software and BD FACS 7-Color Setup beads. For equivalency between methods, data (n = 362) were analyzed with Deming regression for absolute count and percentage of lymphocytes. Results gave R2 ≥0.98, with slope values ≥0.96, and slope ranges between 0.90-1.05. The percent (%) bias values were <10% for T- and NK cells and <15% for B- cells. The between-site (n = 4) total precision was tested for 5 days (2 runs/day), and gave %coefficient of variation below 10% for absolute cell counts. The stability claims were confirmed (n = 186) for the two BD Multitest reagents. The reference intervals were re-established in male and female adults (n = 134). The analysis by gender showed statistically significant differences for CD3+ and CD4+ T-cell counts and %CD4. In summary, the BD FACSLyric and the BD FACSCanto II systems generated comparable measurements of T-, B-, and NK-cells using BD Multitest assays.

Dietary sodium reduction in New Zealand: influence of the Tick label.

BACKGROUND AND OBJECTIVES: The Tick programme of the National Heart Foundation (NHF) is the longest standing voluntary front of pack signpost nutrition logo in New Zealand. It provides a platform for collaboration with the food industry to encourage development of healthier products. This study evaluated the impact of the Tick programme on sodium in processed food. METHODS AND STUDY DESIGN: Fifty-two Tick programme products from food categories known to contribute substantially to sodium intake were identified. Sales volumes (kg) from January 2011 to December 2013 were multiplied by changes in sodium content over that time, producing an estimate of programme impact. Five semi-structured interviews with industry representatives were conducted, to look at other influences for sodium reduction, and themes identified through methods of thematic analysis. RESULTS: Over the period, the Tick programme influenced food companies to remove approximately 16 tonnes of salt through the reformulation and formulation of 52 Tick-approved breakfast cereals, edible oil spreads, cooking sauces and processed poultry products. Other factors influencing sodium reduction reported by company representatives included increased consumer and industry interest in healthier product nutrition profiles and other sodium reduction programmes targeting reformulation/formulation. CONCLUSIONS: The Tick remains a credible and well-recognized brand and may provide a competitive edge for participating food manufacturers in the current market. The Tick programme is effective in influencing industry to reduce sodium in processed foods in New Zealand. The combined impact of the Tick and other NHF programmes has the potential to reduce population sodium intake and improve health outcomes.

Overdose prevention and naloxone prescription for opioid users in San Francisco.

Opiate overdose is a significant cause of mortality among injection drug users (IDUs) in the United States (US). Opiate overdose can be reversed by administering naloxone, an opiate antagonist. Among IDUs, prevalence of witnessing overdose events is high, and the provision of take-home naloxone to IDUs can be an important intervention to reduce the number of overdose fatalities. The Drug Overdose Prevention and Education (DOPE) Project was the first naloxone prescription program (NPP) established in partnership with a county health department (San Francisco Department of Public Health), and is one of the longest running NPPs in the USA. From September 2003 to December 2009, 1,942 individuals were trained and prescribed naloxone through the DOPE Project, of whom 24% returned to receive a naloxone refill, and 11% reported using naloxone during an overdose event. Of 399 overdose events where naloxone was used, participants reported that 89% were reversed. In addition, 83% of participants who reported overdose reversal attributed the reversal to their administration of naloxone, and fewer than 1% reported serious adverse effects. Findings from the DOPE Project add to a growing body of research that suggests that IDUs at high risk of witnessing overdose events are willing to be trained on overdose response strategies and use take-home naloxone during overdose events to prevent deaths.

Release from jail: moment of crisis or window of opportunity for female detainees?

Despite extensive documentation of the reentry challenges facing female prisoners, few such studies have focused on women exiting jails. The Window Study investigated factors associated with the perceived availability of stable housing upon release from detention. Anonymous surveys were conducted with a random sample (n=148) of female detainees at the Baltimore City Detention Center from January 21 to March 17, 2005. Interviews focused on socio-demographic background, health status, recent drug use and sexual behavior history, and material and social resource availability upon release. The median age of female detainees was 37 (interquartile range [IQR]: 29, 41), 69% were African-American, and 33% identified as lesbian or bisexual. The median income in the 30 days prior to arrest was $145 (IQR: 0, 559), and the median number of prior arrests was 5 (IQR: 3, 11). In the presence of other variables familial support (Adjusted Odds Ratio [AOR] 2.57; 95% Confidence Interval [CI] 1.21, 5.47) and a monthly income of $400-799 (AOR 3.18; 95% CI 1.00, 10.07) were positively associated with perceived housing stability upon release; wanting a support group for having traded sex for money, drugs or a place to stay (AOR 0.25; 95% CI 0.10, 0.63) was significantly negatively associated with perceived housing stability upon release. This study suggests the importance of pre-release planning and continuity of care for female detainees. Interventions should emphasize access to housing, economic opportunity and family reunification. Special attention is warranted to those who have engaged in sex work, who may be marginalized from family and service-based support networks.

Fatal heroin-related overdose in San Francisco, 1997-2000: a case for targeted intervention.

Heroin-related overdose is the single largest cause of accidental death in San Francisco. We examined demographic, location, nontoxicological, and toxicological characteristics of opiate overdose deaths in San Francisco, California. Medical examiner's case files for every opioid-positive death from July 1, 1997, to June 30, 2000, were reviewed and classified as overdose deaths or other. Demographic variables were compared to two street-based studies of heroin users and to census data. From 1997 to 2000, of all heroin-related overdoses in San Francisco, 47% occurred in low-income residential hotels; 36% occurred in one small central area of the city. In 68% of deaths, the victim was reportedly alone. When others were present between last ingestion of heroin and death, appropriate responses were rare. In three cases, police arrested the person who called emergency services or others present on the scene. We recommend the development of overdose response training targeted at heroin users and those close to them, including the staff of residential hotels.