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AnteayerBMJ Open

Mindsets and menses: decoding young womens attitudes towards menstrual leave - an observational study from South India

Por: George · N. · Mahendran · P. · Kulothungan · K. · Dharmaraj · R. B. · Muniyapillai · T. · Subramanian · T. · Muthu Ranga Babu · A. · Arumugam · A. · Subramanian · S. · Shabash Khan · S. · Selvam · S. · Veeraragavan Suresh Babu · A.
Objective

The primary objective of this study is to investigate the perceived need and attitudinal perspectives regarding menstrual leave policies among young women in rural South India. The secondary objective was to determine the socio-demographic, menstrual and workplace-related factors associated with attitudes towards menstrual leave among young women.

Design

An analytical cross-sectional study was performed from May 2023 to August 2023.

Setting

In a rural district of Tamil Nadu, South India.

Participants

The study encompassed 955 young female students above 18 years of age enrolled in educational institutions in a rural district of Tamil Nadu, India. Participants were pursuing diverse professional programmes including medical, dental, allied health sciences, pharmacy and engineering courses.

Outcome measures

The primary outcomes included assessment of basic menstrual characteristics (age of menarche, regularity, product usage and pain experiences), pain evaluation using the WaLIDD scale (which measured working ability, anatomical pain location, pain intensity via Wong Baker scale and pain duration) and attitude assessment through a 10-dimension Likert scale. The attitude assessment explored both supportive factors (pain management, environmental considerations, medical leave allocation, menstruation normalisation and performance impact) and potential concerns (medicalisation, perceptions of fragility, stigma, disclosure issues and abnormal leave usage). Secondary outcome measures encompassed the analysis of factors influencing these attitudes, followed by a multivariable linear regression model to identify significant predictors.

Results

Among 955 female students (mean age 19.56±1.33 years), the majority supported menstrual leave for maintaining hygiene (82.3%) and managing dysmenorrhoea (75.8%). A substantial proportion (64.4%) viewed it as a means of normalising menstruation discourse, while 61.6% believed it could enhance workplace performance. However, concerns existed about medicalising menstruation (47.9%) and reinforcing gender stereotypes (43.4%). Multivariate analysis revealed that medical students (B=0.67, 95% CI: 1.34 to 2.00), those with graduate-educated fathers (B=1.64, 95% CI: 0.31 to 2.97), earlier age at menarche (B=–0.23, 95% CI: –0.45 to –0.01) and participants reporting menstrual interference with daily activities (B=0.96, 95% CI: 0.02 to 0.89) held significantly more positive attitudes.

Conclusion

While young women generally support menstrual leave policies, particularly for hygiene and pain management, there are significant concerns about workplace stigmatisation and gender stereotyping. Educational background, parental education and personal menstrual experiences significantly influence attitudes toward menstrual leave. These findings suggest the need for carefully structured menstrual leave policies that balance biological needs with workplace/student place equality concerns.

Crowded housing, indoor environment and childrens respiratory, allergic and general health in Sweden: a cross-sectional study

Por: Eiffener · E. · Murekatete · R. · Merritt · A.-S. · Georgelis · A. · Fahlen Zelander · C. · Al-Nahar · L. · Jakobsson · K. · Albin · M. · Bergström · A. · Jonsson · M. · Eriksson · C.
Objectives

The aim of this study was to analyse associations between crowded housing and children’s indoor living environment, respiratory and allergic disorders and general health.

Design

A cross-sectional study.

Setting

Sweden, using data from the Swedish National Environmental Health Survey 2019.

Participants

The study sample included 48 512 children (aged 6–10 months, 4 years and 12 years). We also investigated associations in vulnerable subgroups, such as children with asthma and those living under unfavourable socioeconomic conditions.

Primary and secondary outcome measures

Primary outcomes in the living environment were at least one sign of mould, poor indoor air quality, unpleasant odours, too warm indoors in summer and too cold indoors in winter. Primary outcomes for children’s health were asthma, airway problems, breathing difficulties, rhinitis symptoms, mould and mites allergy, pollen allergy, furred pet allergy and good general health.

Results

About one in five children lived in an overcrowded home. Factors from the indoor living environment such as perceived poor indoor air quality and mould were significantly associated with crowded housing. Moreover, children who lived in overcrowded conditions were less likely to report good general health than children in non-crowded households (OR 0.64, 95% CI 0.54 to 0.76). This association was even stronger in children with asthma (OR 0.51, 95% CI 0.34 to 0.77). Few significant associations were, however, observed with the respiratory and allergic health outcomes.

Conclusions

Crowded housing is associated both with a poor indoor environment and with poorer general health in children. Children with asthma may experience even poorer general health.

Psychological outcomes in paediatric major trauma patients who require invasive management: protocol for a systematic review and meta-analysis

Por: Hibberd · O. · Thomas · C. E. · Gentle · S. · Angus · S. · Karageorgos · S. · Phillips · V. · Thomas · S. H.
Introduction

Paediatric major trauma patients with more severe injuries and physiological or biochemical abnormalities as a result of the injury are more likely to require invasive management in the form of an operation/interventional radiology (IR). Adverse psychological outcomes, such as post-traumatic stress disorder, anxiety, depression and adjustment disorder, are frequently observed in paediatric patients with major trauma. Similarly, it is recognised that children and adolescents who have invasive management are also at an increased risk of adverse psychological outcomes. However, it is not known to what extent major trauma patients requiring invasive management are at risk of adverse psychological outcomes compared with those managed conservatively. This study aims to determine whether paediatric major trauma patients who require an operation/IR have increased odds of having an adverse psychological outcome compared with those who are managed conservatively.

Methods and analysis

The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines will be used to construct this review. The databases Medline (via Ovid), Embase (via Ovid), PsycInfo (via Ebscohost) and Cinahl (via Ebscohost) will be searched from inception to February 2025. Both title and abstract screening and full-text screening will be done by two reviewers, with an adjudicating third reviewer. For randomised controlled trials, the Cochrane Risk of Bias Tool will be employed, while for non-randomised studies, the Newcastle-Ottawa Quality Assessment Scale will be used. We will assess bias using contoured funnel plots (with p set at 0.01, 0.05 and 0.10), non-parametric trim-fill analysis, leave-one-out analysis and Galbraith plotting. We will execute formal (Egger) testing for funnel plot asymmetry and also calculate prediction intervals if sufficient study N of 10 is accrued. Certainty and confidence in cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Ethics and dissemination

Ethical review is not required as no original data will be collected. Results will be disseminated through peer-reviewed publications and at academic conferences.

PROSPERO registration number

CRD42025643459.

Creating an evidence map of the safety profile of spironolactone across all clinical indications to establish whether it may be a safe treatment in female adolescent acne: a protocol for a scoping review

Por: Sexton · F. C. · Attard · M. · OHiggins · L. · Moledina · Z. · Fordham · J. · Ramesh · G. · Law · J. · George · S. · Burden-Teh · E.
Introduction

Spironolactone is a useful and effective acne treatment option for adult female patients. We aim to establish whether spironolactone could be a safe treatment for the management of acne in the female adolescent population as well. The objective of this scoping review is to provide an evidence map of the safety profile of spironolactone in the paediatric population aged 0–17 across all clinical indications.

Methods and analysis

This scoping review will be conducted according to the Joanna Briggs Institute scoping review protocol. Relevant publications will be searched on the MEDLINE, Embase and Web of Science databases from inception until July 2025. The authors of included studies will be contacted using contact details provided in the manuscript to check for any further published or unpublished data on the review question. An initial search will be conducted using keywords to identify relevant articles. After identifying the research strategy, articles will be extracted into a reference management tool, and a two-part study selection process will be systematically applied by two reviewers. The first part consists of screening titles and abstracts to define the eligibility of each article. In the second part, the full texts will be screened and only relevant articles will be kept. All articles related to the safety of spironolactone in children and adolescents across all clinical indications will be included. Data will be extracted using a scoping review management software such as Covidence, collated and charted to summarise all the relevant methods, outcomes and key findings in the articles.

Ethics and dissemination

This scoping review will provide an extensive overview of the available safety evidence for the use of spironolactone in children and teenagers. Since the scoping review methodology consists of reviewing and collecting data from publicly available materials, this study does not require ethics approval. The results will be disseminated in a peer-reviewed publication.

Analysis of buprenorphine distribution patterns among pharmacies and hospitals in the USA from 2019 to 2023

Por: Gikoska · M. · Florio · A. K. · George · A. · Piper · B. J.
Background

Opioid use disorder (OUD) is a debilitating condition characterised by the overuse of opioid medications and the development of physical and/or psychological dependence. Consequences of this condition include chronic impairment, distress and later life-altering health conditions such as overdose, all of which have been highlighted by the prominence of OUD in the USA in recent years. Buprenorphine is a standard OUD treatment and commonly used for pain management. Understanding changes in distribution patterns across the USA is vital for continuing to improve outcomes for OUD patients.

Methods

This study used the Drug Enforcement Administration’s Automated Reports and Consolidated Ordering System (ARCOS) and the US Census Bureau Population Estimates databases to analyse changes in buprenorphine distribution among pharmacies and hospitals from 2019 to 2023, to determine temporal patterns and to identify state-level disparities using the data. The data were corrected for population to identify patterns of buprenorphine distribution in the USA from 2021 to 2022 and 2022 to 2023 through examining percent changes in milligrams per 100 population at the national and state levels.

Results

The year-to-year percent change of national buprenorphine distribution from pharmacies has remained positive but changed from a 12.2% increase from 2019 to 2020 (figure 4) to a four per cent increase every year from 2020 to 2023. From 2021 to 2022, there was a +4.9% increase in total grams of buprenorphine distributed to pharmacies and a 95% CI [–5.1, 14.9], with the District of Columbia, South Dakota and Nebraska outside of the 95% CI. Distribution to hospitals increased by 10.2% [-32.3, 52.7] during 2021–2022, with Hawaii, New Hampshire and Delaware being outside of 95% CI. From 2022 to 2023, there was an increase of +5.7% and 95% CI [–3.5, 14.9] in pharmacy distribution, with states including Washington, Rhode Island and Kansas remain outside of the 95% CI. Hospital distribution has decreased from twenty per cent between 2019 and 2020 (figure 4) to eighteen per cent between 2022 and 2023.

Conclusion

Following increases in buprenorphine distribution during the COVID pandemic, a consistent increase has continued year-over-year in most states and the country overall by both pharmacies and hospitals. Some states (eg, Rhode Island, Georgia, District of Columbia) have not followed this pattern. Notably, Hawaii went from the most negative percent change in hospital distribution to the most positive change in the timeframe analysed. This may offer opportunities to analyse more specific impacts of the increased buprenorphine distribution on populations and their outcomes associated with OUD.

Evaluation of a virtual reality-directed brain-gut behavioural treatment inpatient program for patients with inflammatory bowel disease: protocol for a pilot feasibility trial

Por: Gutermuth · B. · Jordan · A. · Hodish · G. · Sturgeon · J. A. · DeJonckheere · M. · Berinstein · J. A. · Sheehan · J. · Bishu · S. · Higgins · P. D. · Cohen-Mekelburg · S.
Introduction

Pain is one of the most bothersome symptoms that affects patients with inflammatory bowel disease (IBD) but is often inadequately treated. Inadequate pain control in the inpatient setting not only impacts patients’ experience but increases opioid use and hospital length of stay. Opioids are often considered first-line treatment for severe pain but are associated with significant morbidity and mortality in IBD. Non-steroidal anti-inflammatory drugs are a non-opioid analgesic option, but concerns regarding their contribution to IBD flares have limited their use. Brain-gut behavioural therapies (BGBT), such as cognitive behavioural therapy, meditation and gut-directed hypnotherapy, are effective for pain management and have a role in the treatment of IBD symptoms. However, the use of BGBT in IBD is challenging, given limited access to behavioural health specialists, especially in the inpatient setting. Virtual reality (VR)-directed BGBT programmes can bridge this gap and enhance pain treatment for inpatients with IBD. Therefore, in this study, we aim to establish feasibility and acceptability for a VR-directed BGBT inpatient programme for patients with IBD.

Methods and analysis

We will recruit 40 patients with IBD who are hospitalised at Michigan Medicine and who endorse IBD-related pain. We will assess patient-reported outcomes (pain rating, IBD-specific symptoms, perceived stress, mood) before and after treatment, cumulative inpatient analgesic requirements and hospital length of stay. Our primary objective will be to establish intervention feasibility defined by the frequency and percentage of enrolled participants that use the VR-directed BGBT inpatient intervention in any capacity. Our secondary objective will be to evaluate intervention acceptability by conducting semistructured interviews with study participants. We will also explore the preliminary effectiveness of VR-directed BGBT on patient-reported outcomes and healthcare utilisation as compared with historic controls.

Ethics and dissemination

The study was approved by the institutional review board of the University of Michigan Medical School on 10 October 2023 (HUM00240999). All human subjects will be required to sign an informed consent document prior to study participation. Study findings will be reported through peer-reviewed publication.

Trial registration number

NCT06188793.

Prevalence of autism among adults in Canada: results from a simulation modelling study

Por: Collins · E. · Edjoc · R. · Farrow · A. · Dharma · C. · Georgiades · S. · Holmes · K. · Orchard · C. · ODonnell · S. · Palmeter · S. · Salt · M. · Al-Jaishi · A.
Objective

To estimate the prevalence of autism among adults living in Canada.

Design

A Monte Carlo simulation modelling approach was employed. Input parameters included adult population estimates and mortality rates; autism population all-cause mortality risk ratios; and autism prevalence estimates derived from child and youth data due to the lack of adult data. This approach was executed through 10 000 simulations, with each iteration generating a distinct data scenario. Prevalence estimates were reported as the mean with the 2.5th and 97.5th percentiles, corresponding to a 95% simulation interval (SI).

Setting

Where possible, Canadian data sources were used, including the 2019 Canadian Health Survey on Children and Youth and Statistics Canada mortality rates and population estimates.

Primary outcome measure

National prevalence estimates of autistic adults living in private dwellings in Canada, with variations in prevalence by sex at birth and province/territory considered.

Results

The findings suggest the prevalence of autism among adults in Canada to be 1.8% (95% SI 1.6%, 2.0%). National prevalence estimates by sex at birth were 0.7% (95% SI 0.6%, 0.9%) for females and 2.9% (95% SI 2.6%, 3.2%) for males. Provincial/territorial estimates ranged from 0.7% in Saskatchewan (95% SI 0.3%, 1.3%) to 3.6% in New Brunswick (95% SI 2.4%, 5.1%).

Conclusions

The limited availability of data on autistic adults constrains our ability to fully understand and address their unique needs. In this study, autism prevalence was estimated based on diagnosed cases, which excludes individuals without a formal diagnosis. Additionally, other factors such as data availability and methodological assumptions may influence the modelling of prevalence estimates. As a result, our findings should be interpreted within the context of these limitations. Nevertheless, this study provides a valuable reference point for understanding autism prevalence among adults in Canada.

Self-reported disability trajectories and their predictors among patients receiving care by physical therapists for musculoskeletal conditions: a retrospective analysis of registry data

Por: A Lentz · T. · Ikeaba · U. · Alhanti · B. · Lutz · A. · George · S. Z. · Cook · C. · Thigpen · C.
Objectives

To identify clustered trajectories of self-reported disability following the initiation of care by a physical therapist in outpatient orthopaedic settings and to determine baseline factors that distinguish between different trajectories.

Design

Retrospective cohort study using electronic health record and patient-reported outcome data.

Setting

Data were extracted from the ATI Patient Outcomes Registry, encompassing patient encounters from over 900 ATI outpatient physical therapy clinics in 26 states across the USA.

Participants

Patients receiving physical therapy after surgery were excluded. The final analytical sample included 597 245 unique patients initiating care between 1 January 2016 and 31 December 2021 for management of a spine, upper extremity or lower extremity musculoskeletal condition.

Interventions

Patients received treatments which could include strengthening and range of motion exercises, manual therapy, education, functional training and pain-relieving modalities.

Primary and secondary outcome measures

The primary outcome was trajectory of self-reported, joint-specific disability measure scores up to 6 months following initial evaluation.

Results

Three distinct disability trajectory clusters were identified (proportion of sample; beta coefficient (95% CI)): significant immediate worsening (3.4%; –1.31 (–1.33, –1.28)), significant gradual improvement (61.4%; (0.36 (0.35, 0.36)) and minimal change (35.2%; –0.20 (–0.21, –0.19)). Results were similar when stratified by primary diagnosis of upper extremity, lower extremity or spine conditions, with small differences in the relative proportion of trajectory class membership by body region. Predictive factors for less favourable disability trajectories included older age, lower physical and mental health scores, body region, higher social deprivation index, insurance type and certain comorbidities.

Conclusions

Most patients showed improvement in disability after exposure to treatment by a physical therapist, but a notable proportion experienced minimal change or worsening. Multiple demographic, physical, mental and social health factors differentiated trajectory class membership, highlighting opportunities to improve how and to whom this type of guideline-supported non-pharmacological care is delivered.

Timely post-discharge medication reviews to Improve Continuity--the Transitions Of Care stewardship (TIC TOC) study in rural and regional Australia: a parallel-group randomised controlled trial study protocol

Por: Penm · J. · Yeung · K. · Moles · R. J. · Criddle · D. · Elliott · R. A. · Rigby · D. · Shakib · S. · Sanfilippo · F. M. · Carter · S. R. · Budgeon · C. · Nguyen · K. · Yates · P. · Phillips · K. · Yik · J. · McMillan · F. · Hawthorne · D. · Fleming · C. · Packer · A. · Krogh · L. · Poon · S.
Introduction

Transition of care from hospital is a period when the risks of medication errors and adverse events are high, with 50% of adults discharged having at least one medication-related problem. Pharmacist-led medication reviews can reduce medication errors and unplanned readmission when completed promptly post-discharge; however, they are underutilised. A Transition of Care Stewardship pharmacist has been proposed to facilitate and coordinate a patient’s discharge process and facilitate a timely post-discharge medication review. Access to pharmacist medication review in rural and regional areas can be limited. This protocol describes a randomised controlled trial (RCT) to determine whether a virtual Transition of Care Stewardship pharmacist reduces medication-related harm in rural and regional Australia.

Method and analysis

Multicentre RCT involving patients at high risk of medication-related harm discharged from regional and rural hospitals to a domiciliary residence. Eligible patients must be aged≥18 years, admitted under a medical specialty, be discharged to a domiciliary setting, have a regular general practitioner (GP) or be willing to visit a GP or an Aboriginal Medical Service after discharge for medical follow-up, have a Medicare card and be at high risk of readmission. High risk of readmission is defined as either a previous admission to the hospital or Emergency Department (ED) presentation in the past 6 months AND≥three regular medications OR on at least ONE high-risk medication. A total of 922 participants will be recruited into the study. Enrolled participants will be randomised to the intervention or control (usual care). The intervention will include a virtual Transition Of Care Stewardship pharmacist to ensure that patients receive discharge medication reconciliation, medication counselling, medication list and communicate directly with primary care providers to facilitate a timely post-discharge medication review. Usual care will include informing the patient’s clinical inpatient treating team that the patient is at high risk of medication misadventure and may benefit from a post-discharge Home Medicines Review (a GP-referred pharmacist medication review funded by the Australian Government).

Data analysis will be performed on a modified intent-to-treat basis. The primary outcome assessed is a composite of a first unplanned medication-related hospitalisation or ED presentation within 30 days of hospital discharge. Comparisons between the intervention and usual care groups for the primary outcome will be made using a mixed-effects logistic regression model, adjusting for site-level clustering as a random effect.

Ethics and dissemination

This study is approved to be conducted at the Western New South Wales Local Health District via the Research Ethics and Governance Information System (approval number: 2023/ETH00978). To ensure the needs of Aboriginal and Torres Strait Islander patients are appropriately addressed, ethics for this study were submitted and approved by the Aboriginal Health and Medical Research Council (approval number: 2148/23). Manuscripts resulting from this trial will be submitted to peer-reviewed journals. Results may also be disseminated at scientific conferences and meetings with key stakeholders.

Trial registration number

ACTRN12623000727640.

Prenatal detection of congenital heart defects using the deep learning-based image and video analysis: protocol for Clinical Artificial Intelligence in Fetal Echocardiography (CAIFE), an international multicentre multidisciplinary study

Por: Patey · O. · Hernandez-Cruz · N. · DAlberti · E. · Salovic · B. · Noble · J. A. · Papageorghiou · A. T. · CAIFE Research Group · Adu-Bredu · Ahuja · Aye · Black · Bo · Brent · Carvalho · Craik · Cavallaro · SivaCosta · DAlberti · Eccleston · Everingham · FreitasPaganoti · Farmer
Introduction

Congenital heart defect (CHD) is a significant, rapidly emerging global problem in child health and a leading cause of neonatal and childhood death. Prenatal detection of CHDs with the help of ultrasound allows better perinatal management of such pregnancies, leading to reduced neonatal mortality, morbidity and developmental complications. However, there is a wide variation in reported fetal heart problem detection rates from 34% to 85%, with some low- and middle-income countries detecting as low as 9.3% of cases before birth. Research has shown that deep learning-based or more general artificial intelligence (AI) models can support the detection of fetal CHDs more rapidly than humans performing ultrasound scan. Progress in this AI-based research depends on the availability of large, well-curated and diverse data of ultrasound images and videos of normal and abnormal fetal hearts. Currently, CHD detection based on AI models is not accurate enough for practical clinical use, in part due to the lack of ultrasound data available for machine learning as CHDs are rare and heterogeneous, the retrospective nature of published studies, the lack of multicentre and multidisciplinary collaboration, and utilisation of mostly standard planes still images of the fetal heart for AI models. Our aim is to develop AI models that could support clinicians in detecting fetal CHDs in real time, particularly in nonspecialist or low-resource settings where fetal echocardiography expertise is not readily available.

Methods and analysis

We have designed the Clinical Artificial Intelligence Fetal Echocardiography (CAIFE) study as an international multicentre multidisciplinary collaboration led by a clinical and an engineering team at the University of Oxford. This study involves five multicountry hospital sites for data collection (Oxford, UK (n=1), London, UK (n=3) and Southport, Australia (n=1)). We plan to curate 14 000 retrospective ultrasound scans of fetuses with normal hearts (n=13 000) and fetuses with CHDs (n=1000), as well as 2400 prospective ultrasound cardiac scans, including the proposed research-specific CAIFE 10 s video sweeps, from fetuses with normal hearts (n=2000) and fetuses diagnosed with major CHDs (n=400). This gives a total of 16 400 retrospective and prospective ultrasound scans from the participating hospital sites. We will build, train and validate computational models capable of differentiating between normal fetal hearts and those diagnosed with CHDs and recognise specific types of CHDs. Data will be analysed using statistical metrics, namely, sensitivity, specificity and accuracy, which include calculating positive and negative predictive values for each outcome, compared with manual assessment.

Ethics and dissemination

We will disseminate the findings through regional, national and international conferences and through peer-reviewed journals. The study was approved by the Health Research Authority, Care Research Wales and the Research Ethics Committee (Ref: 23/EM/0023; IRAS Project ID: 317510) on 8 March 2023. All collaborating hospitals have obtained the local trust research and development approvals.

1-year survival in critically ill elderly medical patients treated with a conservative or an invasive approach (OCTO-REVERSE study): a nationwide observational study

Por: Leclaire · C. · Georges · A. · de Stampa · M. · Aegerter · P.
Objective

To determine whether an invasive approach is associated with favourable long-term outcomes among elderly medical patients in the intensive care unit (ICU), compared with a conservative approach.

Design

Nationwide observational study (OCTO-REVERSE study) using data prospectively collected in the National French Healthcare Database (covering 99% of the population, 66 million people).

Setting

Comprehensive multicentre study through the linkage of large-scale national registries (including all public or private facilities) from 2013 to 2018 to avoid ambiguities related to the COVID-19 pandemic.

Participants

All non-surgical patients aged 80 years or older admitted to an ICU in France during the period (n=107 014 patients at 822 hospitals).

Outcome measures

The main outcome was the 1-year survival rate. The association of the two approaches with 1-year survival was estimated using a time-dependent Cox model and a propensity score (PS) adapted to time-to-event analysis, yielding the average treatment effect in the treated and extended weighted Kaplan–Meier curves.

Results

107 014 patients were categorised into two groups based on the type of care received: invasive (n=51 680 (48%) received invasive ventilation and/or vasopressor support) or conservative (n=55 334 (52%) received neither). 1-year survival rate was significantly lower in the invasive group than in the conservative group (27% vs 59% estimated with extended time-dependent Kaplan–Meier method). The risk of death in the invasive group remained significantly higher after time-dependent PS weighting (HR 1.64; 95% CI 1.60 to 1.69; p

Conclusion

Among the whole population of critically ill elderly medical patients in France, the invasive approach was unknowingly associated with end-of-life care in nearly three quarters of cases. Further research is needed to align intensive care with compassionate goals.

Risk predictors of severe adverse maternal outcomes in pre-eclampsia: a systematic review and meta-analysis protocol

Por: Dasari · H. · Hammache · M. · Deveaux-Cattino · B. · Foroutan · F. · Hales · L. · Bourgeois · S. · Keepanasseril · A. · Nerenberg · K. · Grandi · S. M. · DSouza · R. · Daskalopoulou · S. S. · Malhame · I.
Introduction

Pre-eclampsia (PE) remains a major contributor to maternal morbidity and mortality globally. Early identification of risk factors and evaluation of prognostic models for severe adverse maternal outcomes are essential for improving management and reducing complications. While numerous studies have explored potential risk markers, there is still no consensus on the most reliable factors and models to use in clinical practice. This systematic review aims to consolidate research on both individual predictors and prognostic models of severe adverse maternal outcomes in PE, providing a comprehensive overview to support better clinical decision-making and patient care.

Methods and analysis

This review follows the Meta-analyses Of Observational Studies in Epidemiology (MOOSE) guidelines and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Protocol 2015 checklist. A systematic search will be performed using a detailed strategy across Medline, Embase, Cochrane, ProQuest dissertations, and grey literature from inception to 2 April 2024. Eligible studies will include those investigating clinical, laboratory-based, and sociodemographic predictors of severe adverse maternal outcomes in PE. Two reviewers will independently assess titles, abstracts, full texts, and extract data and assess study quality using the Quality In Prognostic Studies (QUIPS) tool for studies on risk predictors and the Prediction model Risk of Bias Assessment Tool (PROBAST) for prognostic models. The inclusion criteria will encompass cohort, case-control, and cross-sectional studies published in English and French involving women diagnosed with PE and reporting on the risk prediction for adverse maternal outcomes. The main outcomes of interest will include severe maternal morbidity and mortality during pregnancy, delivery, or within the postpartum period. Analyses will include both narrative synthesis and, where appropriate, meta-analysis using random-effects models. Pooled estimates will be calculated, with publication bias assessed through funnel plots and statistical tests (eg, Begg’s and Egger’s). Heterogeneity will be primarily assessed through visual inspection of forest plots, supported by statistical measures, such as the I² test, with further exploration through sensitivity, subgroup, and meta-regression analyses.

Ethics and dissemination

This systematic review will be based on published data and will not require ethics approval. Results will be disseminated through peer-reviewed publications and presentations at academic conferences.

PROSPERO registration number

CRD42024517097.

Prospective observational study to assess the performance accuracy of clinical decision rules in children presenting to emergency departments with possible cervical spine injuries: the Study of Neck Injuries in Children (SONIC)

Por: Phillips · N. · Askin · G. N. · Davis · G. A. · OBrien · S. · Borland · M. L. · Williams · A. · Kochar · A. · John-Denny · B. · Watson · S. · George · S. · Davison · M. · Dalziel · S. · Tan · E. · Chong · S.-L. · Craig · S. · Rao · A. · Donath · S. M. · Selman · C. J. · Goergen · S. · Wilson
Introduction

Paediatric cervical spine injury (CSI) is uncommon but can have devastating consequences. Many children, however, present to emergency departments (EDs) for the assessment of possible CSI. While imaging can be used to determine the presence of injuries, these tests are not without risks and costs, including exposure to radiation and associated life-time cancer risks. Clinical decision rules (CDRs) to guide imaging decisions exist, although two of the existing rules, the National Emergency X-Radiography Low Risk Criteria and the Canadian C-Spine Rule (CCR), focus on adults and a newly developed paediatric rule from the Pediatric Emergency Care Applied Research Network (PECARN) is yet to be externally validated. This study aims to externally validate these three CDRs in children.

Methods and analysis

This is a multicentre prospective observational study of children younger than 16 years presenting with possible CSI following blunt trauma to 1 of 14 EDs across Australia, New Zealand and Singapore. Data will be collected on presenting features (history, injury mechanism, physical examination findings) and management (diagnostic imaging, admission, interventions, outcomes). The performance accuracy (sensitivity, specificity, negative and positive predictive values) of three existing CDRs in identifying children with study-defined CSIs and the specific CDR defined outcomes will be determined, along with multiple secondary outcomes including CSI epidemiology, investigations and management of possible CSI.

Ethics and dissemination

Ethics approval for the study was received from the Royal Children’s Hospital Melbourne Human Research Ethics Committee in Australia (HREC/69436/RCHM-2020) with additional approvals from the New Zealand Human and Disability Ethics Committee and the SingHealth Centralised Institutional Review Board. Findings will be disseminated through peer-reviewed publications and future management guidelines.

Trial registration number

Registration with the Australian New Zealand Clinical Trials Registry prior to the commencement of participant recruitment (ACTRN12621001050842). 50% of expected patients have been enrolled to date.

Primary care providers experience and satisfaction with personalised breast cancer screening risk communication: a descriptive cross-sectional study

Por: Omeranovic · A. · Lapointe · J. · Fortier · P. · Bergeron · A.-S. · Dorval · M. · Chiquette · J. · Boubaker · A. · Eloy · L. · Turgeon · A. · Lambert-Cote · L. · Joly · Y. · Brooks · J. D. · Walker · M. J. · Stockley · T. · Pashayan · N. · Antoniou · A. · Easton · D. · Chiarelli · A. M.
Objective

To describe primary care providers’ (PCPs) experience and satisfaction with receiving risk communication documents on their patient’s breast cancer (BC) risk assessment and proposed screening action plan.

Design

Descriptive cross-sectional study.

Setting

A survey was distributed to all 763 PCPs linked to 1642 women participating in the Personalized Risk Assessment for Prevention and Early Detection of Breast Cancer: Integration and Implementation (PERSPECTIVE I&I) research project in Quebec, approximately 1–4 months after the delivery of the risk communication documents. The recruitment phase took place from July 2021 to July 2022.

Participants

PCPs.

Main outcome measures

Descriptive analyses were conducted to report participants’ experiences and satisfaction with receiving risk communication. Responses to two open-ended questions were subjected to content analysis.

Results

A total of 168 PCPs answered the survey, from which 73% reported being women and 74% having more than 15 years of practice. Only 38% were familiar with the risk-based BC screening approach prior to receiving their patient risk category. A majority (86%) agreed with the screening approach and would recommend it to their patients if implemented at the population level. A majority of PCPs also reported understanding the information provided (92%) and expressed agreement with the proposed BC screening action plan (89%). Some PCPs recommended simplifying the materials, acknowledging the potential increase in workload and emphasising the need for careful planning of professional training efforts.

Conclusion

PCPs expressed positive attitudes towards a risk-based BC screening approach and were generally satisfied with the information provided. This study suggests that, if introduced in Canada in a manner similar to the PERSPECTIVE I&I project, risk-based BC screening would likely be supported by most PCPs. However, they emphasised the importance of addressing concerns such as professional training and the potential impact on workload if the approach were to be implemented at the population level. Future qualitative studies are needed to further explore the training needs of PCPs and to develop strategies for integrating this approach with the high workloads faced by PCPs.

Obesity-fertility cohort study: protocol for the assessment of children aged 6-12 years and their mothers

Por: Thibodeau · A. · Jean-Denis · F. · Harnois-Leblanc · S. · Perron · P. · Mathieu · M.-E. · Dallaire · F. · Morisset · A.-S. · Brochu · M. · Baillargeon · J.-P.
Introduction

Maternal preconception obesity and adverse gestational metabolic health increase the risk of childhood obesity in offspring, but the preconception period may be an opportune time to intervene, given the motivation of the mother and the epigenetic changes that may be beneficial for the gametes during this period. However, there is a lack of studies evaluating children born to women who have had a preconception intervention. Our group has therefore designed an ancillary study to assess children born to women enrolled in the obesity-fertility randomised controlled trial (RCT), who were 6–12 years of age, with the objective of evaluating the effect of a lifestyle intervention delivered during preconception and pregnancy on adiposity and cardiometabolic parameters in the offspring. This manuscript details the study protocol.

Methods and analysis

This is an ancillary nested cohort study of the obesity-fertility RCT. Women with obesity and infertility were recruited at an academic fertility clinic and randomised to the control group, which followed usual care, or to the intervention group, which received a lifestyle intervention alone for the first 6 months and then in combination with fertility treatments for up to 18 months or until the end of pregnancy. Those who have given birth to a single child are invited to participate in this follow-up study with their child aged 6–12 years. This study started in November 2023 and is expected to end in May 2025. The primary outcome is age-adjusted and sex-adjusted body mass index z-scores in children. Secondary outcomes are anthropometry, body composition, lifestyle, physical fitness level and blood or saliva markers of cardiometabolic health in both mothers and children. Of the 130 women who participated in the obesity-fertility RCT, 52 mother-child dyads (24 in the control group; 28 in the intervention group) were potentially eligible for this follow-up study. Comparisons between groups will be performed using unpaired tests and adjusted for potential confounders using multivariable regression models. This study will provide important new data on the impact of a preconception lifestyle intervention, maintained throughout pregnancy, on the health trajectory of children and mothers 6–12 years after delivery.

Ethics and dissemination

The study has been approved by the institutional research ethics review boards of the Centre intégré universitaire de santé et de services sociaux de l’Estrie – Centre hospitalier universitaire de Sherbrooke. The results will be widely disseminated to the scientific community, relevant health professionals and general public.

Trial registration number

ClinicalTrials.gov (NCT06402825).

Study protocol: diagnosis of atrial fibrillation in postoperative thoracic surgery using a smartwatch, an open-label randomised controlled study (THOFAWATCH trial)

Por: Huette · P. · Beyls · C. · Diouf · M. · Ibrahima · A. · Haye · G. · Guilbart · M. · Lefebvre · T. · Bayart · G. · Lhotellier · F. · Radji · M. · Walczak · K.-A. · Caboche · M. · De Dominicis · F. · Georges · O. · Berna · P. · Merlusca · G. · Hermida · A. · Traulle · S. · Dupont · H. · Mahjou
Introduction

Postoperative atrial fibrillation (POAF) affects approximately 20% of patients undergoing thoracic surgery and is associated with severe complications such as stroke, myocardial infarction, heart failure, and increased mortality. Early diagnosis is critical to mitigate these risks, but conventional monitoring is limited in detecting asymptomatic episodes. Smartwatches equipped with single-lead ECG and atrial fibrillation (AF) detection algorithms offer a novel approach for early POAF detection. This study aims to evaluate the effectiveness of smartwatch-based monitoring compared with standard care in identifying POAF following thoracic surgery.

Methods and analysis

The THOFAWATCH trial is a randomised, bicentric open-label study enrolling 302 adult patients undergoing major thoracic surgery (pneumonectomy or lobectomy) with one-lung ventilation. Eligible patients will be randomised into two groups: (1) the ‘Smartwatch Monitoring’ group, where participants will undergo rhythm monitoring using a smartwatch and (2) the ‘Conventional Monitoring’ group, receiving standard care without smartwatch monitoring. In the intervention group, any smartwatch-detected POAF episodes will be confirmed by 12-lead ECG. The primary outcome is the incidence of POAF within 7-day postsurgery. Secondary outcomes include the rate of asymptomatic POAF, cardiovascular prognosis evaluated at 2 and 6 months (composite major adverse cardiovascular events outcome), feasibility of smartwatch usage (device usage time and success rate of single-lead ECGs) and recurrence or management of AF at follow-up. Inclusion criteria include adults (>18 years) undergoing scheduled thoracic surgery and able to use the smartwatch device. Exclusion criteria encompass patients with prior AF, those requiring telemetry, or undergoing reoperations. Statistical analysis will assess the primary outcome using 2 or Fisher’s exact test (α=5%), while secondary outcomes will include descriptive and inferential statistics, with analysis conducted using SAS V.9.4.

Ethics and dissemination

Ethical approval for this bicentric study has been granted by the institutional review board (IRB) of the University Hospital of Amiens (Comité de Protection des Personnes sud-ouest et outre-mer 1, 21050 Toulouse, France, registration number ID RDB: 2022-A02028-27 in November 2024). The trial is registered under ClinicalTrials.gov (ID: (NCT06724718)). Results will be disseminated through peer-reviewed publications and scientific conferences to inform clinical practice regarding POAF detection and management following thoracic surgery.

Trial registration number

NCT06724718; clinical trial.

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