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We aimed to evaluate the feasibility of an online self-sampling pilot intervention for HIV testing addressed to gay, bisexual, and other men who have sex with men (GBMSM) and trans women (TW) users of dating apps in Spain. The website https://www.testate.org/ was designed to offer self-sampling kits for HIV testing and online consultation of the results. It was advertised on gay dating apps. Participants requested the delivery of a saliva self-sampling kit by mail and a postage-paid envelope to send the sample to the reference laboratory. An anonymous acceptability survey was conducted. The cascade of care was estimated. From November 2018 to December 2021, 4623 individual users ordered self-sampling kits, 3097 returned an oral fluid sample to the reference laboratory (67.5% return rate). 87 reactive results were detected. 76 were confirmed to be HIV-positive, we estimated an HIV prevalence of 2.45% (95% CI 1.9–3.0%). 100% of those referred to specialized care are in treatment. 45.8% of participants took more than one test. 23 incident cases were detected among repeat testers, of which 20 were confirmed. The estimated incidence was 1.00 confirmed case per 100 individual-years of follow-up. 98.01% of participants would recommend it to a friend. The most identified advantages were convenience and privacy. We demonstrated that the online offer of oral self-sampling kits for HIV detection and reporting results online among GBMSM and TW users of dating apps is feasible. The intervention counted with a high acceptability and high efficacy (in terms of reactivity, confirmation and linkage to care rates). [ABSTRACT FROM AUTHOR]

Background: Pedestrians and cyclists are often referred to as "vulnerable road users," yet most research is focused on fatal crashes. We used fatal and nonfatal crash data to examine risk factors (i.e., relationship to an intersection, urbanicity, crash circumstances, and vehicle type) for police-reported pedestrian and cyclist injuries on public roads among children aged 0–9 and aged 10–19. We also compared risk factors among these two age groups with adults aged 20–29 and aged 30–39. Methods: Crash data were obtained for 2016–2020 from the National Highway Traffic Safety Administration's Fatality Analysis Reporting System for fatal crash injuries and Crash Report Sampling System for nonfatal crash injuries. We collected data on victim demographics, roadway, and vehicle- and driver-related factors. Descriptive analyses were conducted between and within pedestrian and cyclist victims. Results: We analyzed 206,429 pedestrian injuries (36% in children aged 0–19) and 148,828 cyclist injuries (41% in children aged 0–19) from 2016 to 2020. Overall, child pedestrians had lower injury rates than adults, but children aged 10–19 had greater cycling crash rates than adults. Almost half of the pedestrian injuries in children aged 0–9 were "dart-out" injuries (43%). In the majority of the cyclist injuries, children in both age groups failed to yield to vehicles (aged 0–9 = 40% and aged 10–19 = 24%). For children and all ages included in the study, the fatality risk ratio was highest when pedestrians and cyclists were struck by larger vehicles, such as trucks and buses. Further exploration of roadway factors is presented across ages and transportation mode. Conclusion: Our findings on child, driver, vehicle, and roadway factors related to fatal and nonfatal pedestrian and cyclist injuries may help to tailor prevention efforts for younger and older children. [ABSTRACT FROM AUTHOR]

Purpose: Vitamin A deficiency (VAD) remains a significant contributor to childhood morbidity and mortality in developing countries; therefore, the implementation of sustainable and cost-effective approaches to control VAD is of utmost pertinence. This study aims to investigate the efficacy of red palm olein (RPO)-enriched biscuit supplementation in improving vitamin A, haematological, iron, and inflammatory status among vitamin A-deficient schoolchildren. Methods: We conducted a double-blinded, randomised controlled trial involving 651 rural primary schoolchildren (8–12 years) with VAD in Malaysia. The schoolchildren were randomised to receive either RPO-enriched biscuits (experimental group, n = 334) or palm olein-enriched biscuits (control group, n = 317) for 6-month duration. Results: Significant improvements in retinol and retinol-binding protein 4 levels were observed in both groups after supplementation (P < 0.001). The improvement in retinol levels were similar across groups among subjects with confirmed VAD (P = 0.40). Among those with marginal VAD, greater improvement in retinol levels was recorded in the control group (P < 0.001) but lacked clinical significance. The levels of α- and β-carotenes, haematological parameters (haemoglobin, packed cell volume, mean corpuscular volume and mean corpuscular haemoglobin) and iron enhanced more significantly in the experimental group (P < 0.05). The significant reduction in the prevalence of microcytic anaemia (− 21.8%) and high inflammation (− 8.1%) was only observed in the experimental group. Conclusion: The supplementation of RPO-enriched biscuits enhanced levels of provitamin A carotenes, iron, and erythropoiesis, and exhibited anti-inflammatory effects. Therefore, the incorporation of RPO into National Nutritional Intervention Programs may be a potential measure to improve the health status of vitamin A-deficient children, among various other interventions. Clinical trial registration: ClinicalTrials.gov (NCT03256123). [ABSTRACT FROM AUTHOR]

Background: Currently available antiretroviral 2-drug regimen (2DR) fixed dose combinations may not be suitable for specific situations including the presence of resistance associated mutations (RAM) or drug − drug interactions (DDI). The data on the use of the non-nucleoside reverse transcriptase inhibitor doravirine (DOR) and the integrase inhibitor dolutegravir (DTG) as an alternative 2DR remain scarce. Methods: People living with HIV with DOR + DTG as a 2DR are being followed in a prospective observational study. Results: This analysis describes 85 participants with a median age of 57 years. Median CD4-nadir was 173/µl and a majority (66%) had a history of HIV-associated or AIDS-defining conditions. Antiretroviral history was mostly extensive, and documentation of RAM was frequent. The main reasons for choosing DOR + DTG were DDI (29%), tolerability (25%), and cardiovascular risk reduction (21%). Plasma viral load at switch was < 50 copies/ml in all but 3 instances, median CD4 count was 600/µl. DOR + DTG was later changed to another regimen in 10 participants after a median of 265 days, the other 75 participants have remained on DOR + DTG for a median of 947 days. Conclusion: DOR + DTG as a 2DR proved to be a durable treatment option even in extensively pretreated individuals. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures that facilitate self-report by children are needed to reduce the bias of proxy report. We previously developed an electronic Pediatric Asthma Symptom Diary (ePASD) to assess the severity of daily asthma symptoms and proximal impacts in children aged 6–11 years with mild to severe asthma. The ePASD, administered via a digital application with visuals, sounds, and text, is uniquely designed to minimize the importance of reading skills on children's ability to self-report accurately. Here, we describe the ePASD's psychometric properties. Methods: Ninety-one children aged 6–11 years with mild to severe asthma and their caregivers participated in 2 study visits, which consisted of training on the provisioned device and completing asthma-specific clinical outcome assessment (COA) questionnaires. The children self-completed the ePASD at home twice daily for 8 consecutive days. The scoring of the ePASD was guided by factor analyses, inter-item correlations, and internal consistencies. Reliability, discriminating ability, construct validity, and responsiveness were evaluated for ePASD items and candidate scores. Results: All COAs included in the study—the ePASD, Asthma Control Questionnaire (ACQ), Childhood Asthma Control Test, Pediatric Asthma Quality of Life Questionnaire–Standardized (PAQLQ[S]), and global ratings—demonstrated that the children exhibited few asthma-related symptoms and impacts at all timepoints, and consequently, showed little change over time. Internal consistencies (all Cronbach's alphas ≥ 0.52) and test-retest reliabilities (all intraclass correlation coefficients ≥ 0.60) were largely satisfactory. Patterns of convergent and divergent correlations supported the construct validity of ePASD scores. The ePASD symptom scores correlated moderately to strongly with PAQLQ(S) Symptom scores (all correlations ≥ − 0.46) and with ACQ scores (all correlations ≥ 0.42), as predicted. Evidence of the discriminating ability of ePASD items and composite scores was demonstrated by known-groups analyses. Conclusions: The ePASD is a reliable and valid measure of asthma symptoms and proximal impacts in children aged 6–11 years with mild, moderate, or severe asthma. These results lay the psychometric groundwork for use of the ePASD in future clinical trials for the management of pediatric asthma. An ongoing pediatric asthma treatment trial is anticipated to provide evidence of the ePASD's responsiveness to change. [ABSTRACT FROM AUTHOR]

Background: Several studies have found an association between diabetes mellitus, disease severity and outcome in COVID-19 patients. Old critically ill patients are particularly at risk. This study aimed to investigate the impact of diabetes mellitus on 90-day mortality in a high-risk cohort of critically ill patients over 70 years of age. Methods: This multicentre international prospective cohort study was performed in 151 ICUs across 26 countries. We included patients ≥ 70 years of age with a confirmed SARS-CoV-2 infection admitted to the intensive care unit from 19th March 2020 through 15th July 2021. Patients were categorized into two groups according to the presence of diabetes mellitus. Primary outcome was 90-day mortality. Kaplan–Meier overall survival curves until day 90 were analysed and compared using the log-rank test. Mixed-effect Weibull regression models were computed to investigate the influence of diabetes mellitus on 90-day mortality. Results: This study included 3420 patients with a median age of 76 years were included. Among these, 37.3% (n = 1277) had a history of diabetes mellitus. Patients with diabetes showed higher rates of frailty (32% vs. 18%) and several comorbidities including chronic heart failure (20% vs. 11%), hypertension (79% vs. 59%) and chronic kidney disease (25% vs. 11%), but not of pulmonary comorbidities (22% vs. 22%). The 90-day mortality was significantly higher in patients with diabetes than those without diabetes (64% vs. 56%, p < 0.001). The association of diabetes and 90-day mortality remained significant (HR 1.18 [1.06–1.31], p = 0.003) after adjustment for age, sex, SOFA-score and other comorbidities in a Weibull regression analysis. Conclusion: Diabetes mellitus was a relevant risk factor for 90-day mortality in old critically ill patients with COVID-19. Study registration: NCT04321265, registered March 19th, 2020. [ABSTRACT FROM AUTHOR]

Introduction: Breastfeeding has significant health benefits for infants and birthing persons, including reduced risk of chronic disease. The American Academy of Pediatrics recommends exclusively breastfeeding infants for 6 months and recently extended its recommendation for continuing to breastfeed with supplementation of solid foods from one to two years. Studies consistently identify lower breastfeeding rates among US infants, with regional and demographic variability. We examined breastfeeding in birthing person-infant pairs among healthy, term pregnancies enrolled in the New Hampshire Birth Cohort Study between 2010 and 2017 (n = 1176). Methods: Birthing persons 18–45 years old were enrolled during prenatal care visits at ~ 24–28 weeks gestation and have been followed since enrollment. Breastfeeding status was obtained from postpartum questionnaires. Birthing person and infant health and sociodemographic information was abstracted from medical records and prenatal and postpartum questionnaires. We evaluated the effects of birthing person age, education, relationship status, pre-pregnancy body mass index, gestational weight gain (GWG), smoking and parity, and infant sex, ponderal index, gestational age and delivery mode on breastfeeding initiation and duration using modified Poisson and multivariable linear regression. Results: Among healthy, term pregnancies, 96% of infants were breastfed at least once. Only 29% and 28% were exclusively breastfed at 6-months or received any breastmilk at 12-months, respectively. Higher birthing person age, education, and parity, being married, excessive GWG, and older gestational age at delivery were associated with better breastfeeding outcomes. Smoking, obesity, and cesarean delivery were negatively associated with breastfeeding outcomes. Conclusions: Given the public health importance of breastfeeding for infants and birthing persons, interventions are needed to support birthing persons to extend their breastfeeding duration. Significance: What is already known? The benefits of breastfeeding to child and birthing person health are well-documented, however, rates of breastfeeding initiation and duration continue to fall short of health-based guidelines. Regional differences exist and certain rural New England states tend to have amongst the highest breastfeeding rates in the US. What this study adds? This study of n = 1176 birthing persons-infant pairs enrolled in the New Hampshire Birth Cohort Study, a rural, general population pregnancy cohort, suggests that factors influencing breastfeeding outcomes align closely with studies conducted in urban settings and using nationally-representative surveys. [ABSTRACT FROM AUTHOR]

Introduction: The physiological changes in mother-infant pairs during pregnancy increase the susceptibility to a series of infections, including those of the oral cavity. Therefore, the oral and systemic health of pregnant women is related to adverse pregnancy outcomes. Objective: This cross-sectional study aimed to evaluate the systemic profile and periodontal status of women with a high-risk pregnancy. Methods: Eighty-nine pregnant women at risk of preterm labor admitted to a hospital in southern Brazil were interviewed and received a periodontal examination. Data related to obstetric complications during pregnancy (pre-eclampsia, infections, medication use, and gestational diabetes) and systemic diseases were collected from medical records. The periodontal parameters of probing pocket depth, bleeding on probing, and clinical attachment level were evaluated. The data were tabulated, and statistical analysis was performed (p < 0.05). Results: The mean age of participants was 24 years (SD = 5.62). Gingival bleeding was recorded in 91% of the participants. The prevalence of gingivitis was 31.46%, and periodontitis was 29.21%. No association between systemic conditions and periodontal disease was observed. Conclusions and Implications for Practice: Periodontal inflammation was not associated with the systemic profile during pregnancy. However, women with high-risk pregnancies showed higher levels of gingival inflammation, emphasizing the importance of dental care during pregnancy. Significance: The gestational period is marked by a series of physiological changes that can be influenced by local and systemic conditions. Thus, investigating the periodontal status of pregnant women considered at risk for premature birth and evaluating associations with the systemic health of these patients can present important risk indicators for maternal and fetal health. [ABSTRACT FROM AUTHOR]

The correlation of female sexual dysfunction (FSD) with the degree of glycemic control, the duration and complications of diabetic disease and cardiovascular risk factors are not so clear. The aim of this study was to assess the prevalence of FSD in a sample of females with type 2 diabetes mellitus (T2DM), and to identify factors involved in its pathogenesis. We enrolled 81 females who have T2DM. We administered the female sexual function index (FSFI), self-rating anxiety scale (SAS) and self-rating depression scale (SDS) questionnaires. We also estimated anthropometric parameters, glyco-metabolic control, comorbidities, autonomic nervous system assessment, some adipocytokines and ongoing therapy. 87% of participants were affected by FSD. There was evidence of an inverse correlation between the total score of the FSFI questionnaire and the mean of the values ​​of HbA1c in the previous years. There was an inverse correlation with the duration of diabetes and homeostasis model assessment of insulin resistance index in participants not affected by FSD. Participants with FSD have a higher prevalence of anxiety (p = 0.043) and participants with depression and ischemic heart disease scored less on the FSFI questionnaire (p = 0.005 and p = 0.010, respectively). Homocysteine ​​and E-selectin values ​were higher in participants with FSFI (p = 0.002, and p = 0.017, respectively). Most of the enrolled females with T2DM had FSD. Glycemic control, ischemic heart disease, endothelial dysfunction, autonomic neuropathy, and psychological conditions, such as anxiety and depression, seem to have a close correlation with FSD. An early diagnosis of FSD can help to improve not only participants' quality of life, but also to early identify and treat risk factors related not only to FSD, but also to cardiovascular risk. Therefore, we highly recommend that clinicians have a high index of suspicion for FSD in females with T2DM. [ABSTRACT FROM AUTHOR]

Background: The Symptoms of Infection with Coronavirus-19 (SIC) is a 30-item patient-reported outcome (PRO) measure scored by body system composites to assess signs/symptoms of coronavirus disease 2019 (COVID-19). In addition to cross-sectional and longitudinal psychometric evaluations, qualitative exit interviews were conducted to support the content validity of the SIC. Methods: In a cross-sectional study, adults diagnosed with COVID-19 in the United States completed the web-based SIC and additional PRO measures. A subset was invited to participate in phone-based exit interviews. Longitudinal psychometric properties were assessed in ENSEMBLE2, a multinational, randomized, double-blind, placebo-controlled, phase 3 trial of the Ad26.COV2.S COVID-19 vaccine. Psychometric properties evaluated included structure, scoring, reliability, construct validity, discriminating ability, responsiveness, and meaningful change thresholds of SIC items and composite scores. Results: In the cross-sectional study, 152 participants completed the SIC (mean age, 51.0 ± 18.6 years) and 20 completed follow-up interviews. Fatigue (77.6%), feeling unwell (65.8%), and cough (60.5%) were symptoms most frequently reported. SIC inter-item correlations were all positive and mostly moderate (r ≥ 0.3) and statistically significant. SIC items and Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) scores correlated as hypothesized (all r ≥ 0.32). Internal consistency reliabilities of all SIC composite scores were satisfactory (Cronbach's alpha, 0.69–0.91). SIC composite scores correlated moderately (r = 0.30–0.49) to strongly (r ≥ 0.50) with PROMIS-29 scores and Patient Global Impression of Severity (PGIS) ratings (all P < 0.01). A variety of signs/symptoms were cited in exit interviews, and participants considered the SIC straightforward, comprehensive, and easy to use. From ENSEMBLE2, 183 participants with laboratory-confirmed moderate to severe/critical COVID-19 were included (51.5 ± 14.8 years). Strong test-retest reliabilities were observed for most SIC composite scores (intraclass correlations ≥ 0.60). Statistically significant differences across PGIS severity levels were found for all but 1 composite score, supporting known-groups validity. All SIC composite scores demonstrated responsiveness based on changes in PGIS. Conclusions: The psychometric evaluations provided strong evidence for the reliability and validity of the SIC for measuring COVID-19 symptoms, supporting its use in vaccine and treatment trials. In exit interviews, participants described a broad range of signs/symptoms consistent with previous research, further supporting the content validity and format of the SIC. Plain english summary: Coronavirus disease 2019 (COVID-19) is a serious disease that continues to evolve globally. Researchers developed the Symptoms of Infection with Coronavirus-19 (SIC), a 30-item questionnaire designed for patients to report signs and symptoms of COVID-19. In this study, the researchers formally analyzed how well the SIC measures the patient experience with COVID-19, using survey and clinical trial data as well as telephone interviews. Adults with COVID-19 and at least 2 bothersome symptoms completed the web-based survey, and some of these individuals also participated in in-depth interviews. Participants in a clinical trial for a COVID-19 vaccine also completed the SIC measure. The SIC was compared with other commonly used questionnaires that evaluate patient experience. The most commonly reported symptoms of COVID-19 were fatigue, feeling unwell, cough, weakness, and headache. The items for individual symptoms (e.g., "cough") and combined scores for body systems (e.g., "respiratory system") performed well in statistical analyses. Participants found the SIC to be straightforward, comprehensive, and easy to use. The SIC may prove useful in the future for vaccine and treatment trials for COVID-19. [ABSTRACT FROM AUTHOR]

Background: The Symptoms of Infection with Coronavirus-19 (SIC) is a 30-item patient-reported outcome measure to evaluate the presence and severity of COVID-19 signs/symptoms in adults. This study expanded the context of use of the adult SIC among adolescents aged 12–17 years and supported a pediatric adaptation (the Pediatric SIC [PedSIC]) for caregiver assessment of signs/symptoms in children aged < 12 years. Methods: Draft versions of the PedSIC and reference materials containing sign/symptom definitions for adolescents, based on an assessment of the reading level of SIC items by a professional linguist, were developed to facilitate accurate completion of the SIC by adolescents and observer-report (PedSIC) by caregivers. For adolescents, reference materials were intended to provide definitions for selected signs/symptoms identified to have a higher reading level. Iterative rounds of cognitive debriefing interviews were conducted from November 2020 to January 2021 to evaluate adolescent understanding of the SIC reference materials and inform refinement of the PedSIC for caregivers of children too young to reliably self-report. Participants were identified via databases of individuals who previously expressed interest in participating in qualitative research and were then screened for eligibility. Recruitment quotas were established to improve sample diversity. Thematic analysis and descriptive statistics were used to assess qualitative and demographic data, respectively. Results: Nine healthy adolescents (mean [SD, range] age, 14 [1.76, 12–17] years, 56% female, 22% non-White; round 1, n = 6; round 2, n = 3) and 17 caregivers (mean [SD, range] age, 34 [6.28, 26–41] years, 59% female, 35% non-White; round 1, n = 9; round 2, n = 8) were interviewed. Adolescents understood the majority of signs/symptoms (22 of the 30 SIC items) without assistance or use of the reference materials during the cognitive debriefing interview. Definitions were added to the reference materials for 5 additional items, and clarifications provided to existing definitions for 3 items. Seven observer-report (PedSIC) items were modified following feedback from caregivers of healthy young children. Reference materials (similar to those for adolescent use) were developed to support caregiver understanding of the intent of the PedSIC items collecting input from children ages ≥ 5– < 12 years. Conclusions: Results support using the SIC, PedSIC, and their associated reference materials to evaluate the presence and severity of COVID-19 signs/symptoms in adolescents and children aged < 12 years via caregiver-supported report, respectively. [ABSTRACT FROM AUTHOR]

In a previous effort we showed that compared with immigrants who are permanent residents, undocumented immigrants are more likely to binge drink, but less likely to drink while impaired (DWI) partly due to their limited amount of driving. This report examines a related risk: riding with an impaired driver (RWI). Data came from an ongoing longitudinal sample of Latino immigrants to Miami-Dade County, FL. Descriptive analyses and regression techniques were applied. While DWI rates among Latino immigrants is heavily limited by their access to a car, RWI rates were not restricted by driving limitations, nor related to participants' legal immigration status (LIS). RWI rates were linked only to heavy drinking. Because it is not affected by driving limitations, RWI for these Latino immigrants is perhaps a more immediate risk than DWI. Addressing RWI among Latino immigrants should be a priority for traffic safety to Miami/Dade country. [ABSTRACT FROM AUTHOR]

Background: This study aimed to develop and provide a psychometric and feasibility pilot evaluation of the Heart Failure (HF) Symptom Tracker (HFaST), a new patient-reported tool designed to facilitate communication between patients and health care providers (HCPs) in routine clinical care. The HFaST enables patients to identify worsening HF symptoms, with a long-term goal of preventing hospitalizations or emergency room visits. Methods: The HFaST was developed drawing on evidence from the literature, qualitatively with cognitive interviews (12 patient/caregiver and 8 HCPs), and evaluated quantitatively (psychometric, feasibility assessment). The HFaST was administered for 7 consecutive days to 100 individuals diagnosed with HF during a multisite, non-interventional US pilot study. Health care providers then completed a survey assessing the feasibility and importance of the HFaST in clinical practice. Qualitative development included a literature review and cognitive interviews with patients, caregivers, and HCPs. The psychometric properties of the HFaST were evaluated using classical test theory methods. Descriptive statistics provided insight into HCPs' perceptions of the feasibility of using the HFaST in clinical practice. Results: A preliminary set of 40 items was developed for the symptom tracker and iteratively reduced to 10 items based on the qualitative phase. Test-retest reliability (weighted kappa 0.71–0.97), discriminating validity, and construct validity of the HFaST were acceptable. HCPs rated the HFaST as a good (70%) or excellent (30%) means of tracking HF symptoms. Six HFaST items were ultimately retained, covering concepts of fatigue, shortness of breath (3 items), swelling, and rapid weight gain. Conclusions: The 6-item HFaST is an easy-to-use tool designed to raise patients' awareness of HF symptoms and facilitate communication with HCPs. Future research should evaluate HFaST implementation in clinical practice and effectiveness as an intervention to potentially prevent hospitalizations and emergency room visits. [ABSTRACT FROM AUTHOR]