Effects of Gender and Country of Training on Perceived Access to Opportunities for Neurosurgical Research and Gender-Concordant Mentorship.

BACKGROUND: The current neurosurgical workforce is not large enough to address the significant burden of neurosurgical disease worldwide, and women are under-represented in this surgical specialty. However, trainee opportunities are particularly scarce in lower- and middle-income countries, where the burden of neurosurgical disease is high. Thus, the primary aim of this study was to assess the effects of gender and country on perceived access to neurosurgical research and mentorship opportunities. METHODS: A cross-sectional survey evaluating perceived access to neurosurgical research and mentorship opportunities was distributed electronically to medical students and unspecialized residents in 10 countries (Colombia, India, Ghana, Nigeria, Saudi Arabia, Spain, Uganda, the United Kingdom, the United States, and Venezuela). RESULTS: 34.0% of men versus 24.9% of women reported interest in neurosurgery (P < 0.001). Only 16.1% of trainees reported adequate access to neurosurgical research opportunities, which did not vary by gender overall (P = 0.070). However, more women reported inadequate access in the United States (P = 0.038), and more men reported inadequate access in Colombia (P = 0.043). In Colombia (P < 0.001), Nigeria (P = 0.003), Saudi Arabia (P = 0.038), the United States (P = 0.004), and Venezuela (P < 0.001), a lower proportion of women than men reported ever having a neurosurgery mentor of their same gender. 59.0% of female respondents noted that having access to female neurosurgeon mentors would increase their interest in neurosurgery, compared to 28.5% of male respondents (P < 0.001). CONCLUSIONS: More male than female medical trainees in the surveyed countries reported interest in neurosurgery. However, access to adequate neurosurgical research opportunities, although relatively low overall, did not vary by gender in most countries. Access to gender-concordant mentorship was less common for women than for men, but women expressed that enhanced access to female neurosurgeon mentors would increase their interest in the field. These findings suggest potential avenues for intervention to augment and diversify the global neurosurgical workforce.

Exploring Organizational Digital Readiness to Offer Youth E-Mentoring.

The COVID-19 pandemic prompted many youth mentoring programs to offer digital services (e-mentoring). The sustained success of these efforts depended, in large part, on organizations' digital readiness. Although there are established, broad measures of digital readiness, mentoring organizations have unique requirements for readiness that have not been previously measured. The current cross-sectional survey research study measured the state of digital readiness for youth mentoring organizations and tested the organizational E-Mentoring Readiness Scale. Ninety-five representatives from U.S. mentoring programs completed an online survey. Participants felt mentors, mentees, and families were moderately comfortable with e-mentoring. There was less confidence and comfort with the required technology and execution of e-mentoring. A confirmatory factor analysis of the E-Mentoring Readiness Scale showed two distinct but related factors with good model fit. An honest assessment using this tool may allow the youth mentoring field to move into the digital age more seamlessly.

Development of an algorithm for analysis of routes: Case studies using novice and older drivers.

INTRODUCTION: This study addresses the lack of methods to quantify driver familiarity with roadways, which poses a higher risk of crashes. METHOD: We present a new approach to assessing driving route diversity and familiarity using data from the DrivingApp, a smartphone-based research tool that collects trip-level information, including driving exposure and global positioning system (GPS) data, from young novice drivers (15-19 years old) to older drivers (67-78 years old). Using these data, we developed a GPS data-based algorithm to analyze the uniqueness of driving routes. The algorithm creates same route trip (SRT) arrays by comparing each trip of an identified user, employing statistically determined thresholds for GPS coordinate proximity and trip overlap. The optimal thresholds were established using a General Linear Model (GLM) to examine distance, and repeated observations. The Adjusted Breadth-First Search method is applied to the SRT arrays to prevent double counting or trip omission. The resulting list is classified as geographically distinct routes, or unique routes (URs). RESULTS: Manual comparison of algorithm output with geographical maps yielded an overall precision of 0.93 and accuracy of 0.91. The algorithm produces two main outputs: a measure of driving diversity (number of URs) and a measure of route-based familiarity derived from the Rescorla-Wagner model. To evaluate the utility of these measures, a Gaussian mixture model clustering algorithm was used on the young novice driver dataset, revealing two distinct groups: the low-frequency driving group with lower route familiarity when having higher route diversity, whereas the high-frequency driving group with the opposite pattern. In the older driver group, there was a significant correlation found between the number of URs and Geriatric Depression Score, or walking gait speed. PRACTICAL APPLICATIONS: These findings suggest that route diversity and familiarity could complement existing measures to understand driving safety and how driving behavior is related to physical and psychological outcomes.

Mood symptoms and gut function across the menstrual cycle in individuals with premenstrual syndrome.

Gastrointestinal (GI) symptoms such as bloating, constipation, and nausea are common in the days before menstruation, experienced by as many as 73 % of menstruating individuals. Mood may influence the link between menstrual cycle and GI symptoms, with prior studies indicating that even among healthy controls, GI symptoms worsen premenstrually and are associated with worsening mood. Associations between GI symptoms and mood are poorly understood among those with premenstrual syndrome (PMS), a cluster of mood and/or physical symptoms that occur in the week before menses affecting roughly 20 % of menstruators. Our primary aim was to examine associations between GI symptoms and mood symptoms across the menstrual cycle, in those who do and do not report PMS using a menstrual tracking app. We hypothesized that GI symptoms would be reported more frequently in the luteal phase than follicular phase, and that frequency of GI symptoms would be positively associated with mood symptoms in those with PMS. We analyzed data from 33,628 menstrual cycles across 32,241 participants, including n = 27,897 controls (29,137 menstrual cycles) and n = 4344 PMS participants (4491 menstrual cycles). GI symptoms were reported significantly more frequently in the luteal phase than the follicular phase in both control and PMS groups (p < 0.001). Mood symptoms were significantly positively associated with GI symptoms in both groups, in both follicular and luteal phases (p < 0.001). Results suggest that premenstrual GI symptoms are a common issue, and additional work is needed to explore associations between mood and GI symptoms in the context of the menstrual cycle.

Deaths of despair-associated mortality rates globally: a 2000-2019 sex-specific disparities analysis.

OBJECTIVES: The aim of this study was to explore sex-specific disparities in rates of deaths of despair across 183 countries from 2000 to 2019. STUDY DESIGN: Secondary analysis of cross-sectional population-level data. METHODS: Data were obtained from the World Health Organization Health Inequality Data Repository. We analysed data on mortality due to alcohol, drug-use disorders, and self-harm (as a proxy for suicide). We calculated the average rate of deaths of despair by year and sex, trends in these rates, and cause-specific mortality trends. We then fitted mixed-effect generalised linear models to compare mortality rates by sex and country. RESULTS: Analyses revealed significant disparities by sex, with a 3.3-fold higher rate among men than among women globally (95% confidence interval: 3.1-3.5, P < 0.001). There was a significant decline in deaths of despair globally and among both sexes during the assessed period (5% per 5 years). Lesotho, Belarus, the US, the Russian Federation, Guyana, and Slovenia ranked among the top 10 countries out of 183 with the highest mortality rates for both sexes. Canada, the Republic of Korea, Belgium, and Finland were countries with the highest mortality rates among women, whereas Ukraine, Lithuania, Mongolia, and Eswatini have the highest rates among men. In the US, 5-year mortality rates increased by 35% for women and 21% for men: drug-use mortality showed a significant increase over time, whereas suicide rates decreased for both sexes in the given country. Additionally, mortality rates from alcohol use decreased among women. CONCLUSIONS: This global analysis shed light on health disparities by sex in deaths of despair, especially concerning trends in the US. It identified countries and groups in need of targeted mental health and substance-use programs. Moreover, the disparities by sex revealed in this analysis suggest that mental health and substance-use interventions and programs may need to be more attentive to sex and/or gender, such as inequitable social norms and restrictive forms of masculinities, which have been shown to be contributing factors to deaths of despair.

Protocol for Cerebellar Stimulation for Aphasia Rehabilitation (CeSAR): A randomized, double-blind, sham-controlled trial.

In this randomized, double-blind, sham-controlled trial of Cerebellar Stimulation for Aphasia Rehabilitation (CeSAR), we will determine the effectiveness of cathodal tDCS (transcranial direct current stimulation) to the right cerebellum for the treatment of chronic aphasia (>6 months post stroke). We will test the hypothesis that cerebellar tDCS in combination with an evidenced-based anomia treatment (semantic feature analysis, SFA) will be associated with greater improvement in naming untrained pictures (as measured by the change in Philadelphia Picture Naming Test), 1-week post-treatment, compared to sham plus SFA. We will also evaluate the effects of cerebellar tDCS on naming trained items as well as the effects on functional communication, content, efficiency, and word-retrieval of picture description, and quality of life. Finally, we will identify imaging and linguistic biomarkers to determine the characteristics of stroke patients that benefit from cerebellar tDCS and SFA treatment. We expect to enroll 60 participants over five years. Participants will receive 15, 25-minute sessions of cerebellar tDCS (3-5 sessions per week) or sham tDCS combined with 1 hour of SFA treatment. Participants will be evaluated prior to the start of treatment, one-week post-treatment, 1-, 3-, and 6-months post-treatment on primary and secondary outcome variables. The long-term aim of this study is to provide the basis for a Phase III randomized controlled trial of cerebellar tDCS vs sham with concurrent language therapy for treatment of chronic aphasia. Trial registration: The trial is registered with ClinicalTrials.gov NCT05093673.

Prevalence and Profiles of Risky Driving Behavior Among US Teenagers.

This survey study updates prevalence data on risky driving behaviors in a nationally representative sample of young people in the US and characterizes profiles of drivers according to the types of risky behaviors they engaged in.

The association of COVID-19 vaccination and menstrual health: A period-tracking app-based cohort study.

Background: In initial COVID-19 clinical trials, menstrual health was not formally monitored, yet anecdotal reports of menstruation changes surfaced on social media. This study aims to assess the association between COVID-19 vaccines and menstruation using Clue, a period-tracking application. Study design: A survey assessing demographics, menstrual health, stress levels, and COVID-19 vaccination was sent to Clue users between 12/7/2021 and 2/9/2022. Inclusion criteria were (1) 18 years or older (2) currently menstruating (3) not pregnant or breastfeeding since 1/2020. Menstrual data was collected for each participant. Users with cycle lengths more than 90 days were excluded. Cycle lengths were calculated for the 6-month average pre-vaccination (PRIOR), the cycle during which vaccination was administered (DURING), the cycle following DURING (AFTER1), and the cycle following AFTER1 (AFTER2). For periods, individuals were stratified based on whether vaccination was received during their menstrual period (DURING). Period lengths were additionally calculated for the 6-month average pre-vaccination (PRIOR), the first period following vaccination (AFTER1), and the period following AFTER1 (AFTER2). For unvaccinated participants, an index date (4/1/2022) was used to similarly designate menstrual cycles and periods. For each participant, cycle length changes for DURING, AFTER1, and AFTER2 compared to PRIOR were determined. Student's t-test compared the mean of these changes between vaccinated and unvaccinated groups. Results: Of 7,559 participants, 6,897 (91 %) were vaccinated. Compared to PRIOR, individuals vaccinated during their menstrual period demonstrated a statistically significant increase in the DURING period length, but not AFTER1 (p = 0.463) and AFTER2 (p = 0.692). No statistically significant changes were observed in period lengths of those vaccinated in between periods or in cycle lengths overall. Conclusion: A small but statistically significant change in period length was observed only in individuals vaccinated for COVID-19 during their menstrual period. Providers can better counsel menstruating individuals to reduce vaccine misinformation.

Actigraphy methodology in the Kids Mod PAH trial: Physical activity as a functional endpoint in pediatric clinical trials.

Pulmonary vasodilator treatment can improve hemodynamics, right ventricular function, symptoms, and survival in pediatric pulmonary hypertension (PH). However, clinical trial data are lacking due to many constraints. One major limitation is the lack of relevant trial endpoints reflective of hemodynamics or functional status in patients in whom standard exercise testing is impractical, unreliable, or not reproducible. The Kids Mod PAH trial (Mono- vs. Duo Therapy for Pediatric Pulmonary Arterial Hypertension) is an ongoing multicenter, Phase III, randomized, open-label, pragmatic trial to compare the safety and efficacy of first-line combination therapy (sildenafil and bosentan) to first-line monotherapy (sildenafil alone) in 100 pediatric patients with PH across North America. Investigators will measure participants' physical activity with a research-grade, wrist-worn actigraphy device at multiple time points as an exploratory secondary outcome. Vector magnitude counts per minute and activity intensity will be compared between the treatment arms. By directly and noninvasively measuring physical activity in the ambulatory setting, we aim to identify a novel, simple, inexpensive, and highly reproducible approach for quantitative assessment of exercise tolerance in pediatric PH. These data will increase the field's understanding of the effect of pulmonary vasodilator treatment on daily activity - a quantitative measure of functional status and wellbeing in pediatric PH and a potential primary outcome for future clinical trials in children with cardiopulmonary disorders.

Corneal Transplant Rejection Postvaccination Among Medicare Beneficiaries.

PURPOSE: The purpose of this study was to describe the incidence of corneal graft rejection after COVID and influenza vaccination. METHODS: Patients 65 years or older undergoing penetrating keratoplasty or endothelial keratoplasty any time between 2016 and 2021 followed by COVID or influenza vaccination in 2021 among the 100% Medicare Fee-For-Service database were included. Demographic and ocular history characteristics of patients with (cases) and without graft rejection (controls) were compared using the χ 2 test. RESULTS: After COVID (n = 31,398) and influenza (n = 24,290) vaccination, 0.45% (n = 140) and 0.17% (n = 41) patients developed rejection within 90 days, respectively. There was no difference in the rate of graft rejection within 90 days relative to 90 to 180 days after vaccination after both COVID (90 days: 0.45% vs. 180 days: 0.61%, P = 0.37) and influenza (90 days: 0.17% vs. 180 days: 0.29%, P = 0.11) vaccines. For COVID vaccination, patients who underwent penetrating keratoplasty (n = 51, 0.97%; vs. endothelial keratoplasty = 89; 0.34%, P < 0.001), history of rejection up to 1 year before vaccination (n = 13; 1.30% vs. no history = 127, 0.42%; P < 0.001), and having an ocular comorbidity (n = 110, 0.54% vs. no ocular comorbidity = 30, 0.27%; P = 0.001) had higher rates of graft rejections, and most rejections were after 1 year postkeratoplasty (87.14%, n = 122). CONCLUSIONS: The incidence of graft rejection postvaccination is low compared with the overall rates of rejection in the published literature. Most post-COVID vaccination graft rejections were after 1 year postkeratoplasty when corticosteroids are expected to have been tapered to lower doses. Surgeons may counsel patients regarding graft rejection symptoms, but overall low rates may not warrant pretreatment in low-risk keratoplasty patients.

Overweight and obese women's symptoms, knowledge, and preferences regarding endometrial biopsy for endometrial cancer detection: A threshold technique survey.

Background: The incidence of endometrial cancer (EC) in the United States continues to rise, driven mainly by the obesity epidemic. We sought to determine overweight and obese women's cancer risk knowledge and preferences regarding diagnostic endometrial biopsy (EMB) for EC detection. Methods: An online survey was administered to overweight and obese women without EC recruited through the electronic medical record's online patient portal. Baseline questions queried gynecologic history, cancer risk knowledge, and factors potentially influencing decision-making for EMB. We used the threshold survey technique to identify the minimum acceptable risk (MAR) threshold at which each respondent would be willing to undergo an EMB to detect EC. Results: Of 357 respondents (median age 45 years (interquartile range [IQR]: 38-54); median BMI 39 [IQR: 36.0-44.6]), fewer than half (48.7 %) were aware that obesity is a risk factor for EC, and 10 % considered their risk of EC to be high. Almost half (42 %) of respondents reported MAR thresholds characterized as very low (0-1 %), and these were more common among respondents with higher BMIs. Forty percent identified their weight as a factor influencing their MAR threshold decision, while 76 % identified their perceived personal risk as a factor. Less than half cited immediate risks of the procedure. Conclusion: Many patients reported being willing to undergo an EMB at very low risk thresholds for EC. Perceived personal risk is a stronger factor in decision-making than immediate procedural risks. Providers should focus on communicating patients' risk to motivate EMB to detect EC where appropriate.

Advancing Transportation Equity and Safety Through Autonomous Vehicles.

Motor vehicle crashes are a leading cause of death in the United States, and disproportionately impact communities of color. Replacing human control with automated vehicles (AVs) holds the potential to reduce crashes and save lives. The benefits of AVs, including automated shuttles, buses, or cars could extend beyond safety to include improvements in congestion, reductions in emissions, and increased access to mobility, particularly for vulnerable populations. However, AVs have not attained the level of public trust that has been expected, given their potential to save lives and increase access to mobility. Public opinion surveys have highlighted safety and security concerns as reasons for this lack of confidence. In this study, we present the findings of an experiment we conducted to actively shift mindsets on AVs toward advancing health equity. We demonstrate through a nationally representative sample of 2265 U.S. adults that the public support for AVs can be improved by expanding their scope of application to include advancing social benefit. The survey began with questions on respondent's support for AVs based on a priori knowledge and beliefs. Consistent with prior surveys, baseline support (strong support and some degree of support) was low at 26.4% (95% confidence interval 24.0-29.0). After introducing information about how AVs could be used to provide mobility for older adults, those with limited income, or the vision-impaired, respondents were asked to reassess their support for AVs. Support significantly increased to include the majority of respondents. By prioritizing the deployment of AVs to serve individuals and communities in greatest need of mobility, AVs would not only demonstrate compelling social value by reducing disparities but would also gain widespread public support among the U.S. public.

Protocol for Cerebellar Stimulation for Aphasia Rehabilitation (CeSAR): A randomized, double-blind, sham-controlled trial.

In this randomized, double-blind, sham-controlled trial of Cerebellar Stimulation for Aphasia Rehabilitation (CeSAR), we will determine the effectiveness of cathodal tDCS (transcranial direct current stimulation) to the right cerebellum for the treatment of chronic aphasia (>6 months post stroke). We will test the hypothesis that cerebellar tDCS in combination with an evidenced-based anomia treatment (semantic feature analysis, SFA) will be associated with greater improvement in naming untrained pictures (as measured by the change in Philadelphia Picture Naming Test), 1-week post treatment, compared to sham plus SFA. We will also evaluate the effects of cerebellar tDCS on naming trained items as well as the effects on functional communication, content, efficiency, and word-retrieval of picture description, and quality of life. Finally, we will identify imaging and linguistic biomarkers to determine the characteristics of stroke patients that benefit from cerebellar tDCS and SFA treatment. We expect to enroll 60 participants over five years. Participants will receive 15, 25-minute sessions of cerebellar tDCS (3-5 sessions per week) or sham tDCS combined with 1 hour of SFA treatment. Participants will be evaluated prior to the start of treatment, one-week post-treatment, 1-, 3-, and 6-months post treatment on primary and secondary outcome variables. The long-term aim of this study is to provide the basis for a Phase III randomized controlled trial of cerebellar tDCS vs sham with concurrent language therapy for treatment of chronic aphasia. Trial registration: The trial is registered with ClinicalTrials.gov NCT05093673.

Revisiting the Plasmodium sporozoite inoculum and elucidating the efficiency with which malaria parasites progress through the mosquito.

Malaria is initiated when infected anopheline mosquitoes inoculate sporozoites as they probe for blood. It is thought that all infected mosquitoes are equivalent in terms of their infectious potential, with parasite burden having no role in transmission success. In this study, using mosquitoes harboring the entire range of salivary gland sporozoite loads observed in the field, we demonstrate a strong and highly significant correlation between mosquito parasite burden and inoculum size. We then link the inoculum data to oocyst counts, the most commonly-used metric to assess mosquito infection in the field, and determine the efficiency with which oocyst sporozoites enter mosquito salivary glands. Taken together our data support the conclusion that mosquitoes with higher parasite burdens are more likely to initiate infection and contribute to onward transmission. Overall these data may account for some of the unexplained heterogeneity in transmission and enable more precise benchmarks for transmission-blocking interventions.

Impact of Consolidative Radiation on Overall and Progression-Free Survival in Pediatric, Adolescent, and Young Adult Metastatic Bone and Soft Tissue Sarcoma.

PURPOSE: To determine the association between consolidative radiation (RT) and survival in children, adolescents, and young adults with metastatic sarcoma. METHODS AND MATERIALS: Eligibility criteria included patients aged ≤39 years with newly diagnosed metastatic bone or soft tissue sarcoma who completed local control of the primary tumor without disease progression. Consolidative RT was defined as RT to all known sites of metastatic disease. The Kaplan-Meier method was used to estimate overall survival (OS) and progression-free survival (PFS). The least absolute shrinkage and selection operator Cox provided adjusted estimates. To account for immortal time bias, consolidative RT was used as a time-varying covariate in a time dependent Cox model. Distant failure was estimated using the Fine-Gray model. RESULTS: Patients (n = 85) had a median age at diagnosis of 14.8 years. Most common histology was Ewing Sarcoma (45.9%) followed by rhabdomyosarcoma (40.0%). Receipt of consolidative RT was associated with Ewing Sarcoma (P < .001) and local control modality as those who underwent local control with surgery and RT compared with surgery alone were more likely to be treated with consolidative RT (P = .034). Consolidative RT was independently associated with improved OS (hazard ratio [HR], 0.41; 95% CI, 0.17-0.98; P = .045) and improved PFS (HR, 0.37; 95% CI, 0.16-0.88; P = .024) after adjusting for confounding variables and immortal time bias. Patients treated with consolidative RT also experienced a lower risk of distant failure (HR, 0.33; 95% CI, 0.17-0.64; P = .001). In an independent data set of patients with metachronous progression (n = 36), consolidative RT remained independently associated with improved OS. CONCLUSIONS: Consolidative RT was independently associated with improved OS and PFS and decreased risk of distant failure in child, adolescent, and young adult patients with metastatic sarcoma. Future work should evaluate biomarkers to optimize patient selection, timing, and dose for consolidative RT.

Gender diversity at spine surgery academic conferences: a 15-year investigation.

BACKGROUND CONTEXT: Enhancing gender diversity at academic conferences is critical for advancing women's representation and career trajectories in spine surgery. PURPOSE: To discover trends in women's representation at major spine conferences over a 15-year period. STUDY DESIGN/SETTING: Conference records from the 2007-2021 annual meetings of the Congress of Neurological Surgeons, North American Spine Society, and Scoliosis Research Society (SRS). PATIENT SAMPLE: Authors of spine-related presentations. OUTCOME MEASURES: Authorship by gender. METHODS: Retrospective bibliometric analysis with univariate and multivariate modeling to identify trends and predictors of gender diversity. RESULTS: Among 8,948 presentations, 750 (8.4%) had female first authors and 618 (6.9%) had female senior authors. There was no change in rates of female first authorship (p=.41) or senior authorship (p=.88) over time. The strongest predictors of female first authorship were having a female senior author (OR 7.32, p<.001), and delivering presentations at SRS (OR 1.95, p=.001). Factors negatively associated with female first authorship included poster format (OR 0.82, p=.039) and conference location in the United States/Canada (OR 0.76, p=.045). Similar trends were encountered for senior authorship. Productivity per senior author was similar between genders (p=.160); whereas a gender gap in productivity per first author during 2007 to 2011 (p=.020) equalized by 2017 to 2021 (p=.300). Among the 10 most productive authors of each gender, male authors delivered more presentations, but all authors shared similar format, content, and location. CONCLUSIONS: Women's representation in spine-related presentations did not increase at three major conferences over a 15-year period. Our findings regarding the positive effects of female mentorship, and international or virtual venues merit further investigation to address the gender gap. The upstream pipeline of recruiting women into academic spine surgery also needs to be addressed.

The CryoPop study: Screening for high-grade cervical dysplasia in Karnataka, India.

OBJECTIVE: To describe our experience of screening with visual inspection with acetic acid (VIA) and colposcopy to identify women with high-grade precancerous cervical lesions who were candidates for cryotherapy. Women were screened to determine eligibility for a clinical trial testing the safety and efficacy of a new, simple and inexpensive cryotherapy device (CryoPop®) targeted for use in low and middle-income countries (LMICs). DESIGN: Prospective cohort study. SETTING: Primary and urban health centres in Belagavi, Hubballi and Vijayapur, India. POPULATION: Women in the age-group 30-49 years, premenopausal, with no prior hysterectomy and no known HIV infection were eligible for screening. METHODS: Visual inspection with acetic acid was performed on eligible women following informed consent. VIA-positive women were referred for colposcopy and biopsy. Biopsies were read by two pathologists independently, with a third pathologist acting as tie-breaker if needed. MAIN OUTCOME MEASURES: The primary outcome measures were the number/proportion of women screening positive by VIA and the number/proportion of those women screening VIA-positive found to have high-grade cervical lesions on biopsy (cervical intraepithelial neoplasia 2/3 [CIN 2/3]). Demographic variables were compared between women who screened VIA-positive and those who screened VIA-negative; a separate comparison of demographic and limited reproductive variables was performed between women who had CIN 2/3 on biopsy and those without CIN 2/3 on biopsy. Chi-square or Fisher's exact tests for categorical data and t-tests or analysis of variance for numeric data were used with all tests two-sided and performed at an alpha 0.05 level of statistical significance. RESULTS: A total of 9130 women were screened with VIA between 4 July 2020 and 31 March 2021. The mean age of all women screened was 37 years (standard deviation = 5.6 years) with 6073 of the women (66.5%) in the 30-39 year range. Only 1% of women reported prior cervical cancer screening. A total of 501 women (5.5%) were VIA-positive; of these, 401 women underwent colposcopy. Of those who had colposcopy, 17 (4.2%) had high-grade lesions on biopsy, an additional 164 (40.9%) had low-grade cervical lesions on biopsy or endocervical curettage and one woman (0.2%) was found to have invasive cancer. VIA-positive women were younger and had higher levels of education and income; however, women who were VIA-positive and found to have CIN 2/3 were older, were more likely to be housewives and had higher household income than those without CIN 2/3. CONCLUSION: Despite the COVID-19 pandemic, over 9100 women were screened with VIA for precancerous lesions. However, only 17 (4.2%) were found to have biopsy-proven high-grade cervical lesions, underscoring the subjective performance of VIA as a screening method. Given that this is significantly lower than rates reported in the literature, it is possible that the prevalence of high-grade lesions in this population was impacted by screening a younger and more rural population. This study demonstrates that screening is feasible in an organised fashion and can be scaled up rapidly. However, while inexpensive and allowing for same-day treatment, VIA may be too subjective and have insufficient accuracy clearly to identify lesions requiring treatment, particularly in low-prevalence and low-risk populations, calling into question its overall cost-effectiveness.

Kids Mod PAH trial: A multicenter trial comparing mono- versus duo-therapy for initial treatment of pediatric pulmonary hypertension.

Pulmonary hypertension (PH) is a significant health problem that contributes to high morbidity and mortality in diverse cardiac, pulmonary, and systemic diseases in children. Evidence-based advances in PH care have been challenged by a paucity of quality endpoints for assessing clinical course and the lack of robust clinical trial data to guide pharmacologic therapies in children. While the landmark adult AMBITION trial demonstrated the benefit of up-front combination PH therapy with ambrisentan and tadalafil, it remains unknown whether upfront combination therapy leads to more rapid and sustained clinical benefits in children with various categories of PH. In this article, we describe the inception of the Kids Mod PAH Trial, a multicenter Phase III trial, to address whether upfront combination therapy (sildenafil and bosentan vs. sildenafil alone) improves PH outcomes in children, recognizing that marked differences between the etiology and therapeutic response between adults and children exist. The primary endpoint of this study is WHO functional class (FC) 12 months after initiation of study drug therapy. In addition to the primary outcome, secondary endpoints are being assessed, including a composite measure of time to clinical worsening, WHO FC at 24 months, echocardiographic assessment of PH and quantitative assessment of right ventricular function, 6-min walk distance, and NT-proBNP levels. Exploratory endpoints include selected biomarkers, actigraphy, and assessments of quality of life. This study is designed to pave the way for additional clinical trials by establishing a robust infrastructure through the development of a PPHNet Clinical Trials Network.

A clustered randomized control trial to assess feasibility, acceptability, and impact of implementing the birth companion intervention package in Ethiopia, Kenya, and Nigeria: study protocol.

BACKGROUND: A birth companion is a simple and low-cost intervention that can improve both maternal and newborn health outcomes. The evidence that birth companionship improves labor outcomes and experiences of care has been available for many years. Global and national policies exist in support of birth companions. Many countries including Ethiopia, Kenya, and Nigeria have not yet incorporated birth companions into routine practice in health facilities. This paper presents the protocol for a trial that aims to assess if a package of interventions that addresses known barriers can increase the coverage of birth companions. METHODS: This two parallel arm cluster randomized controlled trial will evaluate the impact of a targeted intervention package on scale-up of birth companionship at public sector health facilities in Ethiopia (five study sites encompassing 12 facilities), Kenya (two sites encompassing 12 facilities in Murang'a and 12 facilities in Machakos counties), and Nigeria (two sites encompassing 12 facilities in Kano and 12 facilities in Nasarawa states). Baseline and endline assessments at each site will include 744 women who have recently given birth in the quantitative component. We will interview a maximum of 16 birth companions, 48 health care providers, and eight unit managers quarterly for the qualitative component in each country. DISCUSSION: Ample evidence supports the contribution of birth companions to positive health outcomes for mothers and newborns. However, limited data are available on effective strategies to improve birth companion coverage and inform scale-up efforts. This trial tests a birth companion intervention package in diverse clinical settings and cultures to identify possible barriers and considerations to increasing uptake of birth companions. Findings from this study may provide valuable evidence for scaling up birth companionship in similar settings. TRIAL REGISTRATION: Trial is registered with ClinicalTrials.gov with identifier: NCT05565196, first posted 04/10/ 2022.