Circulation, Volume 150, Issue Suppl_1, Page A4146010-A4146010, November 12, 2024. Background:Pre-eclampsia (PE) affects approximately 4 million women annually, characterized by sudden-onset hypertension ( >20 weeks gestation) and proteinuria. It is a leading cause of maternal and perinatal morbidity and mortality and increases long-term cardiovascular risks for mothers and infants. This study examines the long-term risk of arrhythmias in women with PE to improve future cardiovascular outcomes.Methods:This observational cohort study utilized the US Collaborative Network to analyze electronic medical records from 64 healthcare organizations. We identified 7,463 women with PE and 7,463 matched women without PE, following them from their first pregnancy to the incidence of arrhythmia, death, or study end. Primary outcomes included heart failure, cardiac arrhythmias, atrial fibrillation/flutter, supraventricular tachycardia, and ventricular fibrillation. Incidence rates and adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using Cox proportional hazards models over a median follow-up of 1 year.Results:Women with PE had significantly higher risks of heart failure (HR 6.39, 95% CI: 3.48–11.74, p = 0.007), cardiac arrhythmias (HR 1.70, 95% CI: 1.35–2.13, p < 0.001), and atrial fibrillation/flutter (HR 2.73, 95% CI: 1.22–6.13, p = 0.011). No significant difference was observed for supraventricular tachycardia (HR 0.93, 95% CI: 0.44–1.98, p = 0.116), while the risk of ventricular fibrillation was 49% higher in the PE cohort (HR 1.49, 95% CI: 1.01–2.19, p = 0.044).Conclusion:Women with pre-eclampsia have significantly higher risks of developing heart failure, cardiac arrhythmias, and atrial fibrillation/flutter compared to those without PE. No significant difference was found in the risk of supraventricular tachycardia, while the risk of ventricular fibrillation was moderately higher. These findings underscore the need for targeted cardiovascular monitoring in women with a history of PE.
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HIV risk assessment tools for identifying individuals who could benefit from pre-exposure prophylaxis: a systematic review protocol
Background
Pre-exposure prophylaxis (PrEP) is a highly effective, safe and acceptable intervention for preventing HIV infection. However, identifying individuals who could best benefit from PrEP remains a significant challenge. Existing HIV risk assessment tools vary in performance depending on context. This systematic review aims to synthesise evidence on their diagnostic performances to predict incident HIV infection.
Methods and analysis
This protocol is informed and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Protocols. We will search MEDLINE (Ovid), Embase (Ovid) and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases (January 1998–May 2024) for observational and relevant interventional studies assessing the diagnostic performance of HIV risk tools to predict incident HIV for PrEP eligibility. There will be no restrictions on study language or location. Two reviewers will conduct the search, data extraction and risk of bias assessment using the Johanna Briggs Institute Critical Appraisal Checklist for Diagnostic Studies. Standardised templates will be used in Covidence for data extraction. We will conduct a meta-analysis if appropriate, otherwise, a narrative review. We will use the PRISMA guidelines to guide reporting.
Ethics and dissemination of research
Ethical approval is not required as data is publicly available. This review will inform updates to Canadian HIV PrEP guidelines and guide healthcare professionals in using HIV risk assessment tools for identifying PrEP candidates. Findings will be presented at guideline panel meetings and submitted for publication in a peer-reviewed journal and conferences.
PROSPERO registration number
CRD42024543975.
Phase IV adaptive randomised clinical trials evaluating efficacy and cost-efficacy of pre-emptive pharmacogenetic genotyping strategies in the Spanish National Health System: iPHARMGx Master Protocol and PREVESTATGx nested clinical trial
Introduction
Genetic variations impact drug response, driving the need for personalised medicine through pre-emptive pharmacogenetic testing. However, the adoption of pre-emptive pharmacogenetic testing for commonly prescribed drugs, such as statins, outside of tertiary hospitals is limited due to a lack of pharmacoeconomic evidence to support widespread implementation by healthcare policy-makers. The Spanish Consortium for the Implementation of Pharmacogenetics (iPHARMGx Consortium) addresses this by developing a clinical trial master protocol that will govern multiple nested adaptive clinical trials that compare genotype-guided treatments to standard care in specific drug–gene–population triads, asses their cost-efficacy and identify novel biomarkers through advanced sequencing techniques. The first of these studies aims to assess whether a pre-emptive statin therapy genotyping scheme reduces the incidence of statin-associated muscle symptoms (SAMS) in a population at risk of cardiovascular disease susceptible of receiving high-intensity or moderate-intensity doses of statins: The PREVESTATGx trial.
Methods and analysis
the PREVESTATGX trial is a multicentre, adaptive randomised controlled pragmatic phase IV clinical trial nested to the iPHARMGx master protocol with two parallel arms, aiming for superiority. Randomisation will be conducted on an individual basis with a centralised approach and stratification by centre. After inclusion in the trial and genotyping has been performed, subjects will be randomly allocated to experimental group (pharmacogenetic genotype-guided statin prescription) or standard-of-care statin prescription (as deemed by attending physician). The main objective is to assess the efficacy of a statin pre-emptive genotyping strategy in reducing the incidence of SAMS. A total of 225 subjects will be recruited among the 10 participating centres if no futility/efficacy boundary is reached in the prespecified interim analyses. Recruitment will be carried out during a 12-month period and subjects will be followed for a 9-month period.
Ethics and dissemination
The PREVESTATGx trial received ethical approval on 24 April 2024. Results will be disseminated via publication in peer-reviewed journals as well as presentation at international conferences. Trial results will be submitted for publication in an open-access peer-reviewed medical speciality-specific publication.
Trial registration number
EU CT number: 2023-509418-12-00/Clinical trial Identifier (ClinicalTrials.gov): NCT06262685. Protocol version 1.2 12 April 2024 (includes non-substantial modification number 14 June 2024). Trial registration of this study can be located at both the EU Clinical Trials Register available from https:// euclinicaltrials.eu/search-for-clinical-trials/?lang=en and https://clinicaltrials.gov. Registration on both websites was done before the enrolment of the first patient complying with European regulations. EU Clinical Trials Register is a primary registry according to the WHO.
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Evaluation of occupational therapy in persons with COVID-19: a pre-post observational cohort study
Background
Persons with COVID-19 may experience limitations in daily functioning and can be referred to occupational therapy.
Objectives
To evaluate changes in daily functioning, cognitive complaints, fatigue and self-management of persons with COVID-19 who received occupational therapy in primary care.
To get insights in the volume and duration of occupational therapy.
Design
A pre-post observational cohort study from October 2020 until April 2021.
Setting
Fifty-eight occupational therapy practices in primary care throughout the Netherlands participated with 68 occupational therapists.
Participants
228 adults (≥18 years) with COVID-19, referred to occupational therapy, gave informed consent and participated in the pre-post evaluation. The mean age was 49 years (SD 13) and 79% of the patients was female. The most frequently reported complaints included fatigue and cognitive complaints.
Interventions
Occupational therapy using Dutch guidelines for occupational therapy in clients with COVID-19.
Outcome measures
Performance and satisfaction with performance using the Canadian Occupational Performance Measure (COPM); the impact of Cognitive Complaints on Participation (CoCo-P); and daily activities, self-management and perceived contribution of occupational therapy using the Patient Reported Outcome Measure for Occupational Therapy (PROM-OT).
Results
COPM-performance score improved with a mean difference of 2.9 points (95% CI 2.7 to 3.2), and COPM-satisfaction score improved with 3.2 points (95% CI 2.9 to 3.5). CoCo-P score improved with a mean difference of 20.9 points (95% CI from 14.4 to 27.4), and PROM-OT improved with 42.8 points (95% CI from 40.2 to 45.4). Participants received a median of seven sessions of occupational therapy (IQR 5–10) with a median duration of 18 weeks (IQR 12–25). They valued the contribution of occupational therapy to their improved functioning with a mean score of 8 (SD 1.4) and recommended this to others with a mean score of 9 (SD 1.2).
Conclusions
Persons with COVID-19 who received occupational therapy in primary care improved significantly in daily functioning and highly valued occupational therapy.
Sex Differences in the Pre- and In-Hospital Setting of Patients With Stroke Are Driven by Higher Age and Stroke Severity
Stroke, Ahead of Print. BACKGROUND:Sex critically determines stroke pathophysiology and recovery. To reveal potential gaps in stroke care, we analyzed sex-specific differences in the stroke patient hospital admission and treatment process.METHODS:In this single-center retrospective analysis, we screened all patients referred to our stroke center between 2014 and 2020 with suspicion of stroke (n=7112). Patients with different cerebrovascular events and stroke mimics were included. We collected demographic hospitalization and 90-day follow-up data and stratified results according to sex. In a logistic regression analysis for 90-day functional outcome, we estimated the effect of sex corrected for the clinically most relevant confounders.RESULTS:Of 7102 patients, 56.7% were male and 43.3% female. Women were older (median, 76.3 years; interquartile range (IQR), 64–84, versus 70.7; IQR, 59–79;P