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.

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.

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.

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.

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.

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.].

Risk of severe cardiovascular events following COPD exacerbations: results from the EXACOS-CV study in Spain.

INTRODUCTION AND OBJECTIVES: This real-world study-the first of its kind in a Spanish population-aimed to explore severe risk for cardiovascular events and all-cause death following exacerbations in a large cohort of patients with chronic obstructive pulmonary disease (COPD). METHODS: We included individuals with a COPD diagnosis code between 2014 and 2018 from the BIG-PAC health care claims database. The primary outcome was a composite of a first severe cardiovascular event (acute coronary syndrome, heart failure decompensation, cerebral ischemia, arrhythmia) or all-cause death following inclusion in the cohort. Time-dependent Cox proportional hazards models estimated HRs for associations between exposed time periods (1-7, 8-14, 15-30, 31-180, 181-365, and > 365 days) following an exacerbation of any severity, and following moderate or severe exacerbations separately (vs unexposed time before a first exacerbation following cohort inclusion). RESULTS: During a median follow-up of 3.03 years, 18 901 of 24 393 patients (77.5%) experienced ≥ 1 moderate/severe exacerbation, and 8741 (35.8%) experienced the primary outcome. The risk of a severe cardiovascular event increased following moderate/severe COPD exacerbation onset vs the unexposed period, with rates being most increased during the first 1 to 7 days following exacerbation onset (HR, 10.10; 95%CI, 9.29-10.97) and remaining increased > 365 days after exacerbation onset (HR, 1.65; 95%CI, 1.49-1.82). CONCLUSIONS: The risk of severe cardiovascular events or death increased following moderate/severe exacerbation onset, illustrating the need for proactive multidisciplinary care of patients with COPD to prevent exacerbations and address other cardiovascular risk factors.

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.

Observational studies: practical tips for avoiding common statistical pitfalls.

This Personal View is intended for early-career researchers who are not yet experts in statistics. The Personal View focuses on common but usually avoidable flaws in the context of observational studies. I point out how study design, data collection, and statistical methods impact statistical results and research conclusions. With particular attention to study planning, sample selection, biases, lack of transparency and results misinterpretations.

Exploring the capacities of ChatGPT: A comprehensive evaluation of its accuracy and repeatability in addressing helicobacter pylori-related queries.

BACKGROUND: Educational initiatives on Helicobacter pylori (H. pylori) constitute a highly effective approach for preventing its infection and establishing standardized protocols for its eradication. ChatGPT, a large language model, is a potentially patient-friendly online tool capable of providing health-related knowledge. This study aims to assess the accuracy and repeatability of ChatGPT in responding to questions related to H. pylori. MATERIALS AND METHODS: Twenty-one common questions about H. pylori were collected and categorized into four domains: basic knowledge, diagnosis, treatment, and prevention. ChatGPT was utilized to individually answer the aforementioned 21 questions. Its responses were independently assessed by two experts on H. pylori. Questions with divergent ratings were resolved by a third reviewer. Cohen's kappa coefficient was calculated to assess the consistency between the scores of the two reviewers. RESULTS: The responses of ChatGPT on H. pylori-related questions were generally satisfactory, with 61.9% marked as "completely correct" and 33.33% as "correct but inadequate." The repeatability of the responses of ChatGPT to H. pylori-related questions was 95.23%. Among the responses, those related to prevention (comprehensive: 75%) had the best response, followed by those on treatment (comprehensive: 66.7%), basic knowledge (comprehensive: 60%), and diagnosis (comprehensive: 50%). In the "treatment" domain, 16.6% of the ChatGPT responses were categorized as "mixed with correct or incorrect/outdated data." However, ChatGPT still lacks relevant knowledge regarding H. pylori resistance and the use of sensitive antibiotics. CONCLUSIONS: ChatGPT can provide correct answers to the majority of H. pylori-related queries. It exhibited good reproducibility and delivered responses that were easily comprehensible to patients. Further enhancement of real-time information updates and correction of inaccurate information will make ChatGPT an essential auxiliary tool for providing accurate H. pylori-related health information to patients.

Age-specific Multimorbidity Patterns and Burden on All-Cause Mortality and Public Direct Medical Expenditure: A Retrospective Cohort Study.

OBJECTIVE: To evaluate age-specific multimorbidity patterns and morbidity burden on mortality and healthcare expenditure across age groups. PATIENTS AND METHODS: Retrospective observational study between January 1, 2009 to December 31, 2017 using electronic health records in Hong Kong: Individuals were stratified by age (< 50, 50-64, 65-79, ≥ 80), and sub-classified by number of morbidities (0, 1, 2, 3, ≥ 4) out of 21 common chronic conditions. Clustering analyses were conducted to identify specific patterns of multimorbidity. Association between the number as well as combinations of morbidities and all-cause mortality and public expenditure was examined. RESULTS: 4,562,832 individuals with a median follow-up of 7 years were included. Mental disorders were the top morbidities among young individuals, while cardiovascular diseases were prevalent in the elderly. An increased number of morbidities was associated with a greater relative risk for mortality and medical expenditure, and this relationship was stronger among younger patients. Compared to individuals in the same age group without morbidity, the hazard ratios (HR; 95% CI) of all-cause mortality in patients aged < 50 and ≥ 80 with two comorbidities 3.81 (3.60-4.03) and 1.38 (1.36-1.40), respectively, which increased to 14.22 (9.87-20.47) and 2.20 (2.13-2.26), respectively, as the number of morbidities increased to ≥ 4. The stroke-hypertension cluster was shown to be associated with the highest HR of mortality 2.48 (2.43-2.53) among all identified clusters arising from the clustering analysis. CONCLUSION: Given the stronger association between multimorbidity and all-cause mortality and greater opportunity costs in younger populations, prevention and management of early-onset multimorbidity are warranted. (248 words).

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.

Eyelid sebaceous gland carcinoma: a protocol for a systematic review and meta-analysis of clinicopathological studies of prevalence.

INTRODUCTION: Sebaceous gland carcinoma (SGC) of the eyelid is an aggressive tumour with the ability to metastasise and an increased morbidity. Controversies regarding the epidemiology of this malignant eyelid tumour is widespread in the scientific literature. Western reports repeatedly describes eyelid SGC as a rare occurring tumour in general, accounting for 1%-3% of all eyelid tumours, however studies from Asia have uncovered a higher frequency of eyelid SGC including 54% of all eyelid tumours in Japan, and 43%-56% in India. We wish to retrieve observational data of eyelid SGC prevalence in proportion to total eyelid tumours, from pathological studies published worldwide to resolve this controversy. METHODS AND ANALYSIS: We will search Ovid Medline, EMBASE, Cochrane Central Register of Controlled Trials, Scopus and Google Scholar to identify published reports on eyelid SGC prevalence proportions, aiming to clarify the incidence of the tumour. We will include observational clinicopathological studies reporting prevalence with confirmed histopathology. No limitations on publication date or language will be applied. Data from the individual studies and study quality will be extracted by two individual reviewers. Study quality will be assessed using the JBI Critical Appraisal Instrument for Studies Reporting Prevalence Data. Raw proportions will be transformed and pooled using a random effects model for meta-analysis. And subgroup analysis according to geography will be performed. If data are deemed unsuitable for a meta-analysis, a narrative synthesis will be presented. We will judge the certainty of evidence and present whether this has an overall effect on the results. The results may shed light on a long-standing academic disparity of the scientific literature. ETHICS AND DISSEMINATION: This systematic review does not require ethical approval. The results of this proposed review will be the subject to a publication in an international peer-reviewed journal within the ophthalmic or pathological specialty. PROSPERO REGISTRATION NUMBER: CRD42023487141.

Road safety implications of the partial legalisation of cannabis in Germany: protocol for a quasi-experimental study.

INTRODUCTION: Germany is reforming its legal approach to cannabis, allowing the possession and cultivation of cannabis for recreational purposes. The objective of this study is to investigate the impact of the policy reform on (1) The prevalence of cannabis use in the general population and (2) Driving under the influence of cannabis (DUIC) among regular users. METHODS AND ANALYSIS: A quasi-experimental research design will be employed, with repeated cross-sectional surveys on self-reported DUIC and cannabis use conducted at three measurement points in Germany (intervention group) and Austria (control group) over a 2-year observation period (2023-2025). Data will be collected from approximately 50 000 individuals aged between 18 years and 64 years. To minimise reporting biases in the measurement of DUIC, we will use direct and indirect assessments via crosswise model and motor vehicle accident data from official statistics. In a difference-in-difference framework, regression analyses and interrupted time series analysis will be carried out for hypothesis testing. ETHICS AND DISSEMINATION: Participants will be informed about voluntary participation, data protection laws and the option to delete data on request. Ethical approval was obtained from the Local Psychological Ethics Committee of the Centre for Psychosocial Medicine in Hamburg, Germany (reference number: 0686). Findings will be disseminated through scientific networks and will be key for a comprehensive evaluation of the cannabis law reform. The findings will facilitate the design and implementation of road safety measures.

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.

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.

The impact of different strategies for modeling associations between medications at low doses and health outcomes: a simulation study and practical application to postpartum opioid use.

Pharmacoepidemiological studies commonly examine the association between drug dose and adverse health outcomes. In situations where no safe dose exists, the choice of modeling strategy can lead to identification of an apparent safe low dose range in the presence of a non-linear relationship or due to the modeling strategy forcing a linear relationship through a dose of 0. We conducted a simulation study to assess the performance of several regression approaches to model the drug dose-response curve at low doses in a setting where no safe range exists, including the use of a (1) linear dose term, (2) categorical dose term, and (3) natural cubic spline terms. Additionally, we introduce and apply an expansion of prior work related to modeling dose-response curves at low and infrequently used doses in the setting of no safe dose ("spike-at-zero" and "slab-and-spline"). Furthermore, we demonstrate and empirically assess the use of these regression strategies in a practical scenario examining the association between the dose of the initial postpartum opioid prescribed after vaginal delivery and the subsequent total dose of opioids prescribed in the entire postpartum period among a cohort of opioid-naïve women with a vaginal delivery enrolled in a State Medicaid program (2007-2014).

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.

Compliance of healthcare workers in a psychiatric inpatient ward to infection control practices during the COVID-19 pandemic: a participant observation study supplemented with a self-reported survey.

BACKGROUND: As an emerging infectious disease with a heterogenous and uncertain transmission pattern, coronavirus disease 2019 (COVID-19) has created a catastrophe in healthcare-associated infections (HAIs) and posed a significant challenge to infection control practices (ICPs) in healthcare settings. While the unique characteristics of psychiatric patients and clinical settings may make the implementation of ICPs difficult, evidence is lacking for compliance with ICPs among healthcare workers (HCWs) in a psychiatric setting during the COVID-19 pandemic. METHODS: A cross-sectional multi-method study based on participant unobtrusive observation coupled with the completion of a self-administered ICP survey was conducted to assess compliance with ICPs among HCWs in a psychiatric inpatient ward in a regional hospital. An online checklist, called eRub, was used to record the performance of HCWs in hand hygiene (HH) and other essential ICPs. Furthermore, a well-validated questionnaire (i.e., Compliance with Standard Precautions Scale, CSPS) was used to collect the participants' self-reported ICP compliance for later comparison. RESULTS: A total of 2,670 ICP opportunities were observed from January to April 2020. The overall compliance rate was 42.6%. HCWs exhibited satisfactory compliance to the wearing of mask (91.2%) and the handling of clinical waste (87.5%); suboptimal compliance to the handling of sharp objects (67.7%) and linen (72.7%); and poor compliance to HH (3.3%), use of gloves (40.9%), use of personal protective equipment (20%), and disinfection of used surface/area (0.4%). The compliance rates of the nurses and support staff to HH were significantly different (χ2 = 123.25, p < 0.001). In the self-reported survey, the overall compliance rate for ICPs was 64.6%. CONCLUSION: The compliance of HCWs in a psychiatric inpatient ward to ICPs during the COVID-19 pandemic ranged from poor to suboptimal. This result was alarming. Revisions of current ICP guidelines and policies that specifically target barriers in psychiatric settings will be necessary.

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.