Large-scale, prospective observational study of regorafenib in Japanese patients with advanced gastrointestinal stromal tumors in a real-world clinical setting.

Background: Regorafenib improves overall survival (OS) of patients with advanced progressive gastrointestinal stromal tumors (GISTs) after standard chemotherapy in phase III trials in the 3rd-line setting. This large-scale, prospective observational study evaluated the safety and effectiveness of regorafenib in Japanese patients with GIST in a real-world clinical setting. Methods: Patients with GIST received oral regorafenib at a maximum daily dose of 160 mg for weeks 1-3 of each 4-week cycle (dose could be modified at investigator's discretion). The primary objective was to assess safety, particularly significant adverse drug reactions (ADRs), as well as the frequency of occurrence of ADRs, hand and foot syndrome (HFS), discontinuation of treatment due to disease progression and adverse events. A Cox proportional hazards model was used to evaluate associations between OS or time to treatment failure (TTF) and baseline characteristics or HFS. Results: Between August 2013 and March 2021, 143 evaluable patients were enrolled. ADRs occurred in 90.2% of patients and led to treatment discontinuation in 28.3%. The most frequent ADRs were HFS, hypertension, and liver injury. The overall response rate was 11.3% and disease control rate 56.5% (RECIST) based on investigators' assessments. Median OS was 17.4 months (95% CI 14.24-23.68). Median TTF was 5.3 (95% CI 4.0-6.5) months. Improved OS and TTF responses occurred in patients with an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1. Conclusion: The outcomes in this real-world study were consistent with those seen in clinical trials. No new safety concerns were identified. Clinical trial registration: https://clinicaltrials.gov, identifier NCT01933958.

Patients with schizophrenia in Morocco during the COVID-19 pandemic: a longitudinal observational study.

BACKGROUND: During the COVID-19 pandemic, social-distancing and confinement measures were implemented. These may affect the mental health of patients with mental disorders such as schizophrenia. This study examined the clinical course of patients with schizophrenia at a public hospital in Morocco during the COVID-19 pandemic. METHODS: This longitudinal observational study was conducted across three periods in 15 months: 1 April 2020 (start of strict home confinement) to 30 June 2020 (T1), 1 July 2020 to 31 January 2021 (corresponding to the Delta wave) [T2], and 1 February 2021 to 30 June 2021 (corresponding to the Omicron wave) [T3]. Patients aged 18 to 65 years with a diagnosis of schizophrenia or schizoaffective disorder (based on DSM 5) made before the pandemic who presented to the Faculty of Medicine and Pharmacy of Rabat were invited to participate. Psychotic symptomatology was evaluated using the Positive and Negative Syndrome Scale (PANSS). Severity and improvement of mental disorder were evaluated using the Clinical Global Impression (CGI)-Severity and -Improvement subscales. Depressive symptoms were assessed using the Calgary Depression Scale (CDS). Adherence to treatments was assessed using the Medication Adherence Rating Scale (MARS). All assessments were made by psychiatrists or residents face-to-face (for T1) or via telephone (for T2 and T3). RESULTS: Of 146 patients recruited, 83 men and 19 women (mean age, 39 years) completed all three assessments. The CGI-Severity score was higher at T2 than T1 and T3 (3.24 vs 3.04 vs 3.08, p = 0.041), and the MARS score was higher at T1 and T2 than T3 (6.80 vs 6.83 vs 6.35, p = 0.033). Patient age was negatively correlated with CDS scores for depressive symptoms at T1 (Spearman's rho = -0.239, p = 0.016) and at T2 (Spearman's rho = -0.231, p = 0.019). The MARS score for adherence was higher in female than male patients at T1 (p = 0.809), T2 (p = 0.353), and T3 (p = 0.004). Daily tobacco consumption was associated with the PANSS total score at T3 (p = 0.005), the CGI-Severity score at T3 (p = 0.021), and the MARS score at T3 (p = 0.002). Patients with a history of attempted suicide had higher CDS scores than those without such a history at T1 (p = 0.015) and T3 (p = 0.018) but not at T2 (p = 0.346). CONCLUSION: Home confinement during the COVID-19 pandemic had limited negative impact on the mental health of patients with schizophrenia in Morocco.

Analyzing Pre-operative Hospital Stay and Incidence of Hospital Acquired Infection: A Retrospective Study.

Background and objectives: Healthcare-associated infections (HCAIs) pose a significant challenge, impacting patient safety and treatment effectiveness. This retrospective study investigates the correlation between pre-operative hospital stays and HCAIs in ICU cardiac surgery patients. Materials and methods: Medical records of 35 patients who died post-cardiac surgery in the ICU were analyzed, focusing on the duration of pre-operative hospitalization. Results: Prolonged pre-operative stays strongly correlate (r = 0.993) with increased HCAIs, indicating a critical risk factor. Conclusions: The duration of pre-operative hospital stays is pivotal in HCAI risk. Prospective multicenter studies are needed for validation, which is crucial for enhancing patient safety and treatment efficacy.

Utilizing self-report diaries to explore task time distribution of school nurses in UAE.

OBJECTIVE: This study aims to evaluate the roles and tasks of school nurses in the UAE, quantify the time spent on each, and identify areas for improvement in school health services. This aligns with the UAE government's initiative to enhance primary healthcare, focusing on illness prevention and health promotion for children and adolescents. METHODS: The research adopts an observational study design, utilizing self-observation through diary recordings by school nurses to collect data on their daily tasks and time allocation. A sample of total of 2024 school nurse activities were recorded and analyzed over 126 days and 1084 h of observation by eight school nurses using self-report diaries. This method allowed for the collection of detailed information on how nursing time is allocated between core and noncore tasks. RESULTS: In this study a total of 2024 tasks were observed over 1084 h. The findings reveal that core nursing tasks accounted for 78% of activities but only 53% of the total 1084 h observed, while non-nursing tasks, making up 22% of activities, disproportionately consumed 47% of the hours. This discrepancy highlights the inefficiency of time allocation, with non-nursing tasks such as administrative duties taking significantly longer than core patient care tasks. CONCLUSIONS: The study highlights a significant opportunity to enhance school health services in the UAE by optimizing the allocation of nursing time towards more illness prevention and health promotion interventions. By addressing the identified challenges, including the gaps in nurse competencies and the lack of structured practice frameworks, school health services can be improved.

Erratum: Effects of COVID-19-targeted non-pharmaceutical interventions on pediatric hospital admissions in North Italian hospitals, 2017 to 2022: a quasi-experimental study interrupted time-series analysis.

[This corrects the article DOI: 10.3389/fpubh.2024.1393677.].

Health Outcomes around Pregnancy and Exposure to HIV/Antiretrovirals (HOPE) study protocol: a prospective observational cohort study of reproductive-aged women living with HIV.

INTRODUCTION: Over 265 000 women are living with HIV in the USA, but limited research has investigated the physical, mental and behavioural health outcomes among women living with HIV of reproductive age. Health status during the reproductive years before, during and after pregnancy affects pregnancy outcomes and long-term health. Understanding health outcomes among women living with HIV of reproductive age is of substantial public health importance, regardless of whether they experience pregnancy. The Health Outcomes around Pregnancy and Exposure to HIV/Antiretrovirals (HOPE) study is a prospective observational cohort study designed to investigate physical and mental health outcomes of young women living with HIV as they age, including HIV disease course, engagement in care, reproductive health and choices and cardiometabolic health. We describe the HOPE study design, and characteristics of the first 437 participants enrolled as of 1 January 2024. METHODS AND ANALYSIS: The HOPE study seeks to enrol and follow 1630 women living with HIV of reproductive age, including those with perinatally-acquired HIV, at 12 clinical sites across 9 US states and Puerto Rico. HOPE studies multilevel dynamic determinants influencing physical, mental and social well-being and behaviours of women living with HIV across the reproductive life course (preconception, pregnancy, post partum, not or never-pregnant), informed by the socioecological model. Key research areas include the clinical course of HIV, relationship of HIV and antiretroviral medications to reproductive health, pregnancy outcomes and comorbidities and the influence of racism and social determinants of health. HOPE began enrolling in April 2022. ETHICS AND DISSEMINATION: The HOPE study received approval from the Harvard Longwood Campus Institutional Review Board, the single institutional review board of record for all HOPE sites. Results will be disseminated through conference presentations, peer-reviewed journals and lay summaries.

The Cleft Collective: protocol for a longitudinal prospective cohort study.

INTRODUCTION: Cleft lip and/or palate (CL/P) affects 1 in 700 live births globally. Children born with CL/P and their families face various challenges throughout the child's development. Extant research is often limited by small numbers and single-centre data. The Cleft Collective, a national cohort study in the UK, aims to build a resource, available to collaborators across the globe, to understand causes, best treatments and long-term outcomes for those born with CL/P, ultimately seeking to enhance their quality of life through improved understanding and care. METHODS AND ANALYSIS: A longitudinal prospective cohort study of children born with CL/P and their families. Recruitment occurs across the UK and started in November 2013. Recruitment will continue until September 2027 with an estimated final sample of 4822 children born with CL/P (1157 cleft lip including/excluding the alveolus; 2112 cleft palate only; 1042 unilateral cleft lip and palate and 511 bilateral cleft lip and palate). Biological samples are collected from all recruited members of the family. Parental and child questionnaires are collected at key time points throughout the child's development. Surgical data are collected at the time of surgical repair of the child's cleft. Consent is obtained to link to external data sources. Nested substudies can be hosted within the cohort. Regular engagement with participants takes place through birthday cards for the children, social media posts and newsletters. Patient and Public Involvement is conducted through the Cleft Lip And Palate Association and Cleft Collective Patient Consultation Group who provide insightful and essential guidance to the Cleft Collective throughout planning and conducting research. ETHICS AND DISSEMINATION: The Cleft Collective was ethically approved by the National Research Ethics Service committee South West-Central Bristol (REC13/SW/0064). Parental informed consent is required for participation. Findings from the Cleft Collective are disseminated through peer-reviewed publications, conference presentations, newsletters and social media.

Anti-saccade as a tool to evaluate cognitive impairment in vestibular migraine.

Background: Vestibular migraine (VM), an intricate subtype of migraine, amalgamates the dual attributes of migraine and vestibular disorders. In clinical settings, individuals with VM frequently articulate concerns regarding the manifestation of subjective cognitive impairment. This cognitive dysfunction is intricately linked with diminished mobility, heightened susceptibility to falls, and increased absenteeism in afflicted patients. Consequently, comprehending the features of cognitive impairment in VM patients holds potential clinical significance. The pursuit of rapid and objective methods for detection and assessment is foundational and prerequisite for efficacious cognitive management of VM patients. Methods: The study encompassed 50 patients diagnosed with vestibular migraine and recruited 50 age-sex matched healthy controls. All participants underwent anti-saccade tasks, and cognitive evaluation was performed using the MMSE and MoCA to assess overall cognitive function. Additionally, RBANS scales were employed to measure specific cognitive domains. Results: The VM patients and normal controls demonstrated statistical parity in terms of age, gender, education, weight, and BMI, with no significant differences observed. Analysis of cognitive scores divulged a marked increase in the incidence of Mild Cognitive Impairment (MCI) in VM patients compared to Healthy Controls (HCs). Both MMSE and MoCA scores were notably lower in VM patients compared to their healthy counterparts. The RBANS cognitive test indicated significant impairment in immediate memory, visuospatial construction, language, attention, and delayed memory among VM patients. Notably, the Trail Making Test and Stroop Color-Word Test revealed compromised processing speed and executive function cognitive domains. The anti-saccadic task highlighted significantly elevated anti-saccadic latency and frequency of direction errors in vestibular migraine patients. Symptom severity, illness duration, and episode frequency in VM patients positively correlated with counter-scanning errors and negatively correlated with cognitive performance across diverse cognitive domains. Conclusion: VM patients exhibit cognitive decline across multiple cognitive domains during the interictal period. This cognitive impairment may not be fully reversible, underscoring its potential clinical significance for cognitive management in VM patients. The sensitivity of anti-saccade tasks to the cognitive status of VM patients positions them as promising objective indicators for diagnosis, intervention, and evaluation of cognitive impairment effects in VM in future applications.

Mobile Health App and Web Platform (eDOL) for Medical Follow-Up of Patients With Chronic Pain: Cohort Study Involving the French eDOL National Cohort After 1 Year.

BACKGROUND: Chronic pain affects approximately 30% of the general population, severely degrades quality of life and professional life, and leads to additional health care costs. Moreover, the medical follow-up of patients with chronic pain remains complex and provides only fragmentary data on painful daily experiences. This situation makes the management of patients with chronic pain less than optimal and may partly explain the lack of effectiveness of current therapies. Real-life monitoring of subjective and objective markers of chronic pain using mobile health (mHealth) programs could better characterize patients, chronic pain, pain medications, and daily impact to help medical management. OBJECTIVE: This cohort study aimed to assess the ability of our mHealth tool (eDOL) to collect extensive real-life medical data from chronic pain patients after 1 year of use. The data collected in this way would provide new epidemiological and pathophysiological data on chronic pain. METHODS: A French national cohort of patients with chronic pain treated at 18 pain clinics has been established and followed up using mHealth tools. This cohort makes it possible to collect the determinants and repercussions of chronic pain and their evolutions in a real-life context, taking into account all environmental events likely to influence chronic pain. The patients were asked to complete several questionnaires, body schemes, and weekly meters, and were able to interact with a chatbot and use educational modules on chronic pain. Physicians could monitor their patients' progress in real time via an online platform. RESULTS: The cohort study included 1427 patients and analyzed 1178 patients. The eDOL tool was able to collect various sociodemographic data; specific data for characterizing pain disorders, including body scheme; data on comorbidities related to chronic pain and its psychological and overall impact on patients' quality of life; data on drug and nondrug therapeutics and their benefit-to-risk ratio; and medical or treatment history. Among the patients completing weekly meters, 49.4% (497/1007) continued to complete them after 3 months of follow-up, and the proportion stabilized at 39.3% (108/275) after 12 months of follow-up. Overall, despite a fairly high attrition rate over the follow-up period, the eDOL tool collected extensive data. This amount of data will increase over time and provide a significant volume of health data of interest for future research involving the epidemiology, care pathways, trajectories, medical management, sociodemographic characteristics, and other aspects of patients with chronic pain. CONCLUSIONS: This work demonstrates that the mHealth tool eDOL is able to generate a considerable volume of data concerning the determinants and repercussions of chronic pain and their evolutions in a real-life context. The eDOL tool can incorporate numerous parameters to ensure the detailed characterization of patients with chronic pain for future research and pain management. TRIAL REGISTRATION: ClinicalTrials.gov NCT04880096; https://clinicaltrials.gov/ct2/show/NCT04880096.

The association between declining lung function and stroke risk: insights from an observational study and Mendelian randomization.

Background: Stroke, prevalent globally, particularly impacts low- and middle-income countries. Decreased lung function is one of the risk factors for stroke, and there is a lack of sufficient research on the association between the two, especially based on evidence from representative large samples. We aimed to explore the association between lung function and stroke incidence. Methods: We collected data from 13,371 participants from the 2007-2012 U.S. national cross-sectional study and 11,192 participants from the Chinese national cohort study during the 2011-2018 follow-up period. Multivariate logistic regression and Cox proportional hazards regression were used to assess cross-sectional and longitudinal associations of peak expiratory flow with stroke risks. Additionally, we used publicly available GWAS data from a European population to conduct Mendelian randomization analysis, further exploring the potential causal relationship. Results: The results of the cross-sectional study suggest that a decline in peak expiratory flow may be associated with an increased risk of stroke. The cohort study revealed that, compared to the first tertile group, the risk of stroke incidence in the second and third tertile groups of PEF decreased by 19% (hazard ratio (HR) = 0.810, 95%CI = 0.684-0.960) and 21.4% (HR = 0.786, 95%CI = 0.647-0.956), respectively. Mendelian randomization analysis clarified that higher PEF levels are significantly associated with a reduced risk of stroke (OR = 0.852, 95%CI = 0.727-0.997). Conclusion: Decreased lung function is a risk factor for stroke. As a simple and accurate indicator of lung function, PEF can be used to monitor lung function in community populations and patients for primary stroke prevention.

The Incidence and Outcomes of Out-of-Hospital Cardiac Arrest During the COVID-19 Pandemic in South Korea: Multicenter Registry Study.

BACKGROUND: The COVID-19 pandemic has profoundly affected out-of-hospital cardiac arrest (OHCA) and disrupted the chain of survival. Even after the end of the pandemic, the risk of new variants and surges persists. Analyzing the characteristics of OHCA during the pandemic is important to prepare for the next pandemic and to avoid repeated negative outcomes. However, previous studies have yielded somewhat varied results, depending on the health care system or the specific characteristics of social structures. OBJECTIVE: We aimed to investigate and compare the incidence, outcomes, and characteristics of OHCA during the prepandemic and pandemic periods using data from a nationwide multicenter OHCA registry. METHODS: We conducted a multicenter, retrospective, observational study using data from the Korean Cardiac Arrest Resuscitation Consortium (KoCARC) registry. This study included adult patients with OHCA in South Korea across 3 distinct 1-year periods: the prepandemic period (from January to December 2019), early phase pandemic period (from July 2020 to June 2021), and late phase pandemic period (from July 2021 to June 2022). We extracted and contrasted the characteristics of patients with OHCA, prehospital time factors, and outcomes for the patients across these 3 periods. The primary outcomes were survival to hospital admission and survival to hospital discharge. The secondary outcome was good neurological outcome. RESULTS: From the 3 designated periods, a total of 9031 adult patients with OHCA were eligible for analysis (prepandemic: n=2728; early pandemic: n=2954; and late pandemic: n=3349). Witnessed arrest (P<.001) and arrest at home or residence (P=.001) were significantly more frequent during the pandemic period than during the prepandemic period, and automated external defibrillator use by bystanders was lower in the early phase of the pandemic than during other periods. As the pandemic advanced, the rates of the first monitored shockable rhythm (P=.10) and prehospital endotracheal intubation (P<.001) decreased significantly. Time from cardiac arrest cognition to emergency department arrival increased sequentially (prepandemic: 33 min; early pandemic: 35 min; and late pandemic: 36 min; P<.001). Both survival and neurological outcomes worsened as the pandemic progressed, with survival to discharge showing the largest statistical difference (prepandemic: 385/2728, 14.1%; early pandemic: 355/2954, 12%; and late pandemic: 392/3349, 11.7%; P=.01). Additionally, none of the outcomes differed significantly between the early and late phase pandemic periods (all P>.05). CONCLUSIONS: During the pandemic, especially amid community COVID-19 surges, the incidence of OHCA increased while survival rates and good neurological outcome at discharge decreased. Prehospital OHCA factors, which are directly related to OHCA prognosis, were adversely affected by the pandemic. Ongoing discussions are needed to maintain the chain of survival in the event of a new pandemic. TRIAL REGISTRATION: ClinicalTrials.gov NCT03222999; https://classic.clinicaltrials.gov/ct2/show/NCT03222999.

Impella versus VA-ECMO for the treatment of patients with cardiogenic shock: the Impella Network Project - observational study protocol for cost-effectiveness and budget impact analyses.

INTRODUCTION: The treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses. METHODS AND ANALYSIS: This is a prospective plus retrospective, multicentre study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This study will contribute to generate new socioeconomic evidence to inform future coverage decisions. ETHICS AND DISSEMINATION: As of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients. Study results will be published in peer-reviewed publications and disseminated through conference presentations.

Design and rationale for REVERXaL: A real-world study of patients with factor Xa inhibitor-associated major bleeds.

BACKGROUND: The prevalence of anticoagulation treatment is increasing as an aging global population faces a high burden of cardiovascular comorbidities. Direct oral anticoagulants, including factor Xa inhibitors (FXai), are replacing vitamin K antagonists as the most commonly prescribed treatment for reducing risk of thrombotic events. While the risk of FXai-associated spontaneous bleeds is established, less is understood about their management and the effect of treatment on clinical and patient-reported outcomes. The primary objectives of the REVERXaL study are to describe patient characteristics, health care interventions during the acute-care phase, in-hospital outcomes, and associations between timing of reversal/replacement agent administration and in-hospital outcomes. Secondary/exploratory objectives focus on clinical assessments and patient-reported outcome measures (PROMs) at 30 and 90 days. METHODS: REVERXaL is a multinational, observational study of hospitalized patients with FXai-associated major bleeds in Germany, Japan, the United Kingdom, and the United States. The study includes 2 cohorts of approximately 2000 patients each. Cohort A is a historic cohort for whom medical chart data will be collected from hospitalization to discharge for patients admitted for major bleeds during FXai use within 2 years prior to enrollment of Cohort B. Cohort B will prospectively enroll patients administered any reversal/replacement agent during hospitalization to manage FXai-associated major bleeds and will include the collection of clinical outcomes and PROMs data over 3 months. CONCLUSIONS: REVERXaL will generate insights on patient characteristics, treatment approaches, and associated outcomes in patients hospitalized with FXai-associated major bleeds. These data may inform clinical practice and streamline treatment pathways in this population. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; unique identifier: NCT06147830.

Chart review study of real-world clinical outcomes in patients with cutaneous T-cell lymphoma treated with extracorporeal photopheresis in the US in 2017-2019.

BACKGROUND: Response rates of approved systemic therapies for cutaneous T-cell lymphoma (CTCL) hover near 30%, suggesting unmet need. This study describes real-world treatment patterns and response rates of extracorporeal photopheresis (ECP) in CTCL patients. METHODS: A chart review was conducted in the United States of adults with CTCL who initiated ECP between January 1, 2017, and February 28, 2019, and received at least three months of ECP treatment as monotherapy or concomitant therapy. Clinical outcomes were collected quarterly for up to 18 months. RESULTS: The 52 patients were predominantly Caucasian. Half were male; median age was 69 years. Most patients had Sézary syndrome (50%) or mycosis fungoides (36.5%). Nearly 40% of patients had stage IV disease; 33% had lymph node involvement. Nineteen patients (36.5%) achieved response (>50% reduction in BSA affected); median time to response was 6.5 months. The percentage of patients rated as at least minimally improved was 59.5% at 6 months (N = 22), 75.0% at 9 months (N = 24), and 60.0% at 12 months (N = 15) after ECP initiation. CONCLUSIONS: Despite the ECP treated population in this study being older and having more advanced-stage disease than recent trials, response rates were comparable. These real-world findings support ECP as an effective treatment option for CTCL patients.

Males with patellofemoral pain have altered movements during step-down and single-leg squatting tasks compared to asymptomatic males: A cross-sectional study.

Background and Aims: Patellofemoral pain (PFP) is common in males, causing reduced physical activity and chronic pain. One proposed cause of PFP is aberrant biomechanics during tasks loading the patellofemoral joint. Consistent evidence exists for females with PFP, but it is uncertain if males with PFP have altered biomechanics. This study investigated the kinematics of males with PFP compared to pain-free males during forward step-down (StDn) and single-leg squat (SLSq). Methods: A cross-sectional study including 40 males aged 20-39 years (28.28 ± 5.46) was conducted (20 PFP, 20 pain-free). Participants performed StDn and SLSq while motion was captured with a video-based motion capture system (Motion Analysis Corporation). Triplanar peak angles and angular ranges of motion (ROM) of the trunk, pelvis, and weight-bearing hip, knee, and ankle were dependent variables. Mixed-model ANOVA tests were used to determine the presence of significant interactions and main effects of group and task. Results: Males with PFP had significantly lower peak knee adduction angles compared to pain-free males (p = 0.01). Significant group x task interactions were found for hip and pelvis ROM (p < 0.05). PFP participants had increased hip and pelvis ROM during StDn in the frontal and transverse planes but reduced or nearly equal ROM for these variables during SLSq. Peak hip adduction, hip internal rotation, contralateral pelvic drop and anterior tilt, trunk flexion, and ankle dorsiflexion were greater during StDn compared to SLSq (p < 0.05). ROM of the hip, pelvis, trunk, and ankle were greater during StDn compared to SLSq (p < 0.05). Conclusion: Males with PFP had reduced peak knee adduction angles in StDn and SLSq. Males with PFP demonstrated increased hip and pelvis ROM during StDn versus SLSq, particularly in the frontal and transverse planes. Clinicians should consider StDn as a clinical test since aberrant movement may be easier to detect than in SLSq.

Design, rationale and protocol for Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs): an observational cohort study.

INTRODUCTION: Given the increasing prevalence of both obesity and pre-diabetes in pregnant adults, there is growing interest in identifying hyperglycaemia in early pregnancy to optimise maternal and perinatal outcomes. Multiple organisations recommend first-trimester diabetes screening for individuals with risk factors; however, the benefits and drawbacks of detecting glucose abnormalities more mild than overt diabetes in early gestation and the best screening method to detect such abnormalities remain unclear. METHODS AND ANALYSIS: The goal of the Glycemic Observation and Metabolic Outcomes in Mothers and Offspring study (GO MOMs) is to evaluate how early pregnancy glycaemia, measured using continuous glucose monitoring and oral glucose tolerance testing, relates to the diagnosis of gestational diabetes (GDM) at 24-28 weeks' gestation (maternal primary outcome) and large-for-gestational-age birth weight (newborn primary outcome). Secondary objectives include relating early pregnancy glycaemia to other adverse pregnancy outcomes and comprehensively detailing longitudinal changes in glucose over the course of pregnancy. GO MOMs enrolment began in April 2021 and will continue for 3.5 years with a target sample size of 2150 participants. ETHICS AND DISSEMINATION: GO MOMs is centrally overseen by Vanderbilt University's Institutional Review Board and an Observational Study Monitoring Board appointed by National Institute of Diabetes and Digestive and Kidney Diseases. GO MOMs has potential to yield data that will improve understanding of hyperglycaemia in pregnancy, elucidate better approaches for early pregnancy GDM screening, and inform future clinical trials of early GDM treatment. TRIAL REGISTRATION NUMBER: NCT04860336.

Evaluation of the prehospital administration of tranexamic acid for injured patients: a state-wide observational study with sex and age-disaggregated analysis.

BACKGROUND: Tranexamic acid (TXA) decreases mortality in injured patients and should be administered as soon as possible. Despite international guidelines recommending TXA in the prehospital setting, its use remains low. The aim of this study was to assess the prehospital administration of TXA for injured patients in a Swiss region. METHODS: We conducted a retrospective observational study in Switzerland between 2018 and 2021. Inclusion criteria were injured patients ≥18 years for whom an ambulance or helicopter was dispatched. The exclusion criterion was minor injury defined by a National Advisory Committee for Aeronautics score <3. The primary outcome was the proportion of patients treated with TXA according to guidelines. The European guidelines were represented by the risk of death from bleeding (calculated retrospectively using the Bleeding Audit for Trauma and Triage (BATT) score). Factors impacting the likelihood of receiving TXA were assessed by multivariate analysis. RESULTS: Of 13 944 patients included in the study, 2401 (17.2%) were considered at risk of death from bleeding. Among these, 257 (11%) received prehospital TXA. This represented 38% of those meeting US guidelines. For European guidelines, the treatment rate increased with the risk of death from bleeding: 6% (95% CI 4.4% to 7.0%) for low risk (BATT score 3-4); 13% (95% CI 11.1% to 15.9%) for intermediate risk (BATT score 5-7); and 21% (95% CI 17.6% to 25.6%) for high risk (BATT score ≥8) (p<0.01). Women and the elderly were treated less often than men and younger patients, irrespective of the risk of death from bleeding and the mechanism of injury. CONCLUSION: The proportion of injured patients receiving TXA in the prehospital setting of the State of Vaud in Switzerland was low, with even lower rates for women and older patients. The reasons for this undertreatment are probably multifactorial and would require specific studies to clarify and correct them.

Impact of COVID-19 on antimicrobial stewardship program: Study protocol.

The coronavirus disease (COVID-19) pandemic affects the healthcare system worldwide and challenges many governments and institutions. Antimicrobial stewardship program advocating the wise use of antimicrobial agents. Its metrics include antimicrobial use measures, process, and outcome performance indications. We will conduct a retrospective observational study with the main hypothesis that the COVID-19 pandemic does not affect the antimicrobial stewardship program and its metrics. We will compare antimicrobial stewardship metrics (process, outcome, utilization) and antibiotic resistance two years before (2018-2019) (Group A) & two years with the COVID-19 pandemic (2020-2021) (Group B). The study will be conducted in Saqr Hospital, a secondary care hospital in the emirate of Ras Al Khaimah in the United Arab Emirates. Data will be analyzed using SPSS version 22. Numerical data will be presented as mean (SD) or median (IQR). Chi-square or Fisher's exact test will be used to analyze categorical data. The t-test or Mann-Whitney U test will be used to compare the difference of numerical variables. p < 0.05 will be considered statistically significant. Multivariate logistic regression will be used to investigate the relation between different variables with (1) cost and (2) antibiotic resistance.

Sleep Health and Anxiety Symptoms in Midlife Women: The Study of Women's Health Across the Nation (SWAN).

Purpose: To investigate the associations between anxiety symptoms in midlife women and sleep features later in life, the aim is to test the hypothesis that poor sleep, as measured by each of six individual dimensions (4 objective actigraphy measures, 2 self-reports) of sleep health, is associated with higher levels of anxiety symptoms in midlife women. Participants and Methods: The participants in this longitudinal analysis included women from the SWAN Sleep I Study, a subcohort of the community-dwelling midlife women participating in the core Study of Women's Health Across the Nation (SWAN), which was initiated in 1996. Of the 370 participants enrolled in the Sleep Study, 270 were included in the analytic sample, and 100 who did not meet the inclusion criteria were excluded. Baseline measures of six dimensions of multidimensional sleep health (actigraphy measures: efficiency, duration, mid-sleep timing, regularity; self-report measures: alertness, satisfaction) were obtained between 2003 and 2005, corresponding to SWAN core annual/biennial assessments 5-8. Associations of each dimension with self-reported anxiety symptoms (Generalized Anxiety Disorder - 7-item scale; GAD-7), collected during visits 12 (2009-2011), 13 (2011-2013), and 15 (2015-2017), were examined using mixed models. The GAD-7 outcome was measured both continuously and as a categorical variable due to its skewed distribution. Results: No statistically significant associations were found between any of the six baseline sleep health dimensions and the GAD-7 score after adjustment for covariates. Conclusion: The reasons for the lack of support for our hypothesis, despite previous evidence supporting an association between sleep and anxiety, are unclear. There is considerable overlap between anxiety and sleep symptoms, which may complicate the interpretation of our the findings. Thus, the failure to identify associations is likely multifactorial, and more studies with shorter follow-up intervals are warranted to better understand these relationships.

Language Matters: Is There Gender Bias in Internal Medicine Grand Rounds Introductions?

PURPOSE:  We performed an exploratory evaluation of gender-specific differences in speakers and their introductions at internal medicine grand rounds. METHOD:  Internal medicine grand rounds video archives from three sites between December 2013 and September 2020 were manually transcribed and analyzed using natural language processing techniques. Differences in word usage by gender were compared. RESULTS:  Four hundred and sixty-two grand rounds held at three institutions were examined. There were 167 (34.6%) speakers who were women and 316 (65.4%) who were men. The proportion of women speakers was significantly lower than that of women in the internal medicine workforce (34.6% vs. 39.2%, p = 0.04). Among 191 external speakers, only 57 (29.8%) were women. The use of professional titles was equivalent between genders. Despite equal mention of specific achievements in both male and female speaker introductions, there was a trend toward casting female speakers as being less established. CONCLUSION:  There is a need to adopt processes that will decrease inequities in the representation of women in grand rounds and in their introductions.