Obstetric and neonatal outcomes in South Africa.

Background: Background epidemiologic population data from low- and middle-income countries (LMIC), on maternal, foetal and neonatal adverse outcomes are limited. We aimed to estimate the incidence of maternal, foetal and neonatal adverse outcomes at South African maternal vaccine trial sites as reported directly in the clinical notes as well as using the 'Global Alignment of Immunization Safety Assessment in Pregnancy' case definitions (GAIA-CDs). GAIA-CDs were utilized as a tool to standardise data collection and outcome assessment, and the applicability and utility of the GAIA-CDs was evaluated in a LMIC observational study.

A Descriptive Cohort Study of Drug Utilization Patterns Among Patients Hospitalized With Coronavirus Disease 2019 in the United States, January 2021-February 2022.

Background: There is a dearth of drug utilization studies for coronavirus disease 2019 (COVID-19) treatments in 2021 and beyond after the introduction of vaccines and updated guidelines; such studies are needed to contextualize ongoing COVID-19 treatment effectiveness studies during these time periods. This study describes utilization patterns for corticosteroids, interleukin-6 (IL-6) inhibitors, Janus kinase inhibitors, and remdesivir among hospitalized adults with COVID-19, over the entire hospitalization, and within hospitalization periods categorized by respiratory support requirements.

Methods: This descriptive cohort study included United States adults hospitalized with COVID-19 admitted from 1 January 2021 through 1 February 2022; data included HealthVerity claims and hospital chargemaster.

Comparative safety of conjugated estrogens/bazedoxifene versus estrogen/progestin combination hormone therapy among women in the United States: a multidatabase cohort study.

Objective: To assess the risk of select safety outcomes including endometrial cancer, endometrial hyperplasia, and breast cancer among women using conjugated estrogens/bazedoxifene (CE/BZA) as compared with estrogen/progestin combination hormone therapy (EP).

Methods: We conducted a new-user cohort study in five US healthcare claims databases representing more than 92 million women. We included CE/BZA or EP new users from May 1, 2014, to August 30, 2019.

Benefit-risk profile of tofacitinib in patients with moderate-to-severe chronic plaque psoriasis: pooled analysis across six clinical trials.

Background: Although existing psoriasis treatments are effective and well tolerated in many patients, there is still a need for new effective targeted treatment options. Tofacitinib is an oral Janus kinase inhibitor that has been investigated in patients with moderate-to-severe chronic plaque psoriasis.

Objectives: To consider the benefits and risks of tofacitinib in patients with moderate-to-severe psoriasis.

Safety signal detection and evaluation in clinical development programs: A case study of tofacitinib.

Adverse events are anticipated during a clinical development program. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We describe here the process undertaken by Pfizer to investigate a safety signal for pancreatic cancer with tofacitinib.

Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial.

Background: Duration of bladder catheterisation after female genital fistula repair varies widely. We aimed to establish whether 7 day bladder catheterisation was non-inferior to 14 days in terms of incidence of fistula repair breakdown in women with simple fistula.

Methods: In this randomised, controlled, open-label, non-inferiority trial, we enrolled patients at eight hospitals in the Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone, and Uganda.

Safety of adult medical male circumcision performed by non-physician clinicians in Kenya: a prospective cohort study.

Background: Male circumcision reduces the risk of heterosexually acquired HIV infection in men by approximately 60%. The Government of Kenya is rolling out voluntary medical male circumcision (VMMC) services, but struggles with health worker shortages, particularly with physician shortages.

Objective: To evaluate the safety of male circumcision performed by non-physician clinicians in Kenya.

Clinical procedures and practices used in the perioperative treatment of female genital fistula during a prospective cohort study.

Background: Treatment and care for female genital fistula have become increasingly available over the last decade in countries across Africa and South Asia. Before the International Federation of Gynaecology and Obstetrics (FIGO) and partners published a global fistula training manual in 2011 there was no internationally recognized, standardized training curriculum, including perioperative care. The community of fistula care practitioners and advocates lacks data about the prevalence of various perioperative clinical procedures and practices and their potential programmatic implications are lacking.

Profiles and experiences of women undergoing genital fistula repair: findings from five countries.

This article presents data from 1354 women from five countries who participated in a prospective cohort study conducted between 2007 and 2010. Women undergoing surgery for fistula repair were interviewed at the time of admission, discharge, and at a 3-month follow-up visit. While women's experiences differed across countries, a similar picture emerges across countries: women married young, most were married at the time of admission, had little education, and for many, the fistula occurred after the first pregnancy.

Development and comparison of prognostic scoring systems for surgical closure of genitourinary fistula.

Objective: The purpose of this study was to test the diagnostic performance of 5 existing classification systems (developed by Lawson, Tafesse, Goh, Waaldijk, and the World Health Organization) and a prognostic scoring system that was derived empirically from our data to predict fistula closure 3 months after surgery.

Study Design: Women with genitourinary fistula (n = 1274) who received surgical repair services at 11 health facilities in sub-Saharan Africa and Asia were enrolled in a prospective cohort study. Using one-half of the sample, we created multivariate generalized estimating equation models to obtain weighted prognostic scores for components of each existing classification system and the empirically derived scoring system.

Determinants of postoperative outcomes of female genital fistula repair surgery.

Objective: To determine predictors of fistula repair outcomes 3 months postsurgery.

Methods: We conducted a multicountry prospective cohort study between 2007 and 2010. Outcomes, measured 3 months postsurgery, included fistula closure and residual incontinence in women with a closed fistula.

Factors influencing choice of surgical route of repair of genitourinary fistula, and the influence of route of repair on surgical outcomes: findings from a prospective cohort study.

Objective: The abdominal route of genitourinary fistula repair may be associated with longer term hospitalisation, hospital-associated infection and increased resource requirements. We examined: (1) the factors influencing the route of repair; (2) the influence of the route of repair on fistula closure 3 months following surgery; and (3) whether the influence of the route of repair on repair outcome varied by whether or not women met the published indications for abdominal repair.

Design: Prospective cohort study.

Factors influencing urinary fistula repair outcomes in developing countries: a systematic review.

We reviewed literature examining predictors of urinary fistula repair outcomes in developing country settings, including fistula and patient characteristics, and perioperative factors. We searched Medline for articles published between January 1970 and December 2010, excluding articles that were (1) case reports, cases series or contained 20 or fewer subjects; (2) focused on fistula in developed countries; and (3) did not include a statistical analysis of the association between facility or individual-level factors and surgical outcomes. Twenty articles were included; 17 were observational studies.

Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial.

Background: A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount.

Factors affecting vasectomy acceptability in Tanzania.

Context: Calls for increased inclusion of men in matters of reproductive health emphasize the need for research into vasectomy acceptability and decision making. Vasectomy is a safe, simple and effective method of contraception, but is underused worldwide.

Methods: Focus group discussions and in-depth interviews were conducted with potential and actual sterilization clients and their partners in the Kigoma Region of Tanzania.

Injecting and sexual risk correlates of HBV and HCV seroprevalence among new drug injectors.

We examine injecting and sexual risk correlates of hepatitis B (HBV) and hepatitis C (HCV) seroprevalence among new injecting drug users (IDUs) (age 18-30 years, injecting < or =6 years). Participants were interviewed/serotested (HIVab, HBVcAb, HCVab) in New York City, February 1999-February 2003. Gender-stratified, multivariate logistic regression was conducted.

Gender differences in injection risk behaviors at the first injection episode.

Objectives: To examine gender differences in drug injection equipment sharing at injecting initiation.

Methods: Young injecting drug users (IDUs) in New York City February 1999-2003 were surveyed about injection risk behaviors and circumstances at initiation. Analyses were gender-stratified and excluded participants who initiated alone.

Transitions to injecting drug use among noninjecting heroin users: social network influence and individual susceptibility.

Objectives: To determine the incidence/predictors of transitions to injecting among noninjecting heroin users (NIUs).

Methods: Street-recruited NIUs in New York City, March/1996-March/2003, were interviewed for a prospective cohort study about social network influence (communication promoting injecting; exposure to injectors) and individual susceptibility. A transition to injecting was the first drug injection following baseline.