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Assessment of knowledge, attitudes and practices regarding antimicrobial resistance among primary health care prescribers in Imo State, Nigeria: implications for digital health readiness

Por: Basil · I. C. · Ekeleme · U. G. · Udujih · O. G. · Dozie · U. W. · Iwuala · C. · Ibe · S. · Nwoke · E. · Mbakwem · B. · Okoro · L. I. · Uzoma · F. C. · Okoroama · C. L. · Uzoma · M.-J.
Introduction

Antimicrobial resistance (AMR) is one of the most urgent global health threats, responsible for an estimated 4.95 million deaths annually, including 1.27 million directly linked to drug-resistant infections. Nigeria is particularly affected, ranking 19th globally in AMR-related mortality, with an estimated 64 500 attributable and 263 400 associated deaths in 2019. These estimates are likely conservative due to limited surveillance. Economically, AMR could cost Nigeria 5%–7% of its GDP by 2050.

Despite this burden, antibiotic misuse remains widespread, with 42% of adults and over 46% of children under 5 receiving antibiotics without prescriptions. At the primary healthcare (PHC) level, where most antibiotics are prescribed, challenges such as limited diagnostics, inconsistent prescription and poor access to digital tools hinder effective antimicrobial stewardship (AMS).

Objectives

The primary objective of this study is to assess the knowledge, attitudes and practices regarding antimicrobial resistance (AMR) among PHC prescribers in Imo State, Nigeria. A secondary objective is to explore preliminary indicators of their digital readiness to inform future technological interventions for AMS.

Design

A cross-sectional study using an online questionnaire.

Setting

PHC facilities across all 27 local government areas of Imo State, Nigeria.

Participants

A purposive sample of 547 facility-based public PHC prescribers included 84% of all facility Officers-in-Charge of health facilities in the state and 16% of other PHC workers who were involved in prescription.

Primary and secondary outcome measures

The primary outcome measures were composite scores for knowledge (adequate/inadequate), attitude (positive/negative) and prescribing practice (good/poor), derived from a validated questionnaire. Secondary measures included sources of AMR information and indicators of digital readiness.

Results

While 77.1% demonstrated adequate knowledge, only 32.7% exhibited positive attitudes and 88.5% reported poor prescribing practices. Attitude was the strongest predictor of good practice (OR=17.585, p

Conclusions

These findings underscore a critical gap between knowledge and practice, driven in part by limited access to digital decision-support tools. To address the documented gaps in tool access and training, strengthening digital inclusion through context-adapted e-learning, offline-compatible AMS tools and simplified digital antibiograms is a necessary implication for improving antibiotic stewardship and clinical outcomes at the PHC level.

Artificial intelligence to improve the detection and risk stratification of acute pulmonary embolism (AID-PE): protocol for a pragmatic quasi-experimental comparator study

Por: Gunning · S. G. S. · Page · J. · Rossdale · J. · Charters · P. F. P. · Hudson · B. · Lyen · S. · Mackenzie Ross · R. · Seatter · A. · Bartlett · J. W. · Austin · L. · Myring · G. · McLeod · H. · Mitchell · P. · Stimpson · D. · Cookson · A. · Suntharalingam · J. · Rodrigues · J. C. L.
Introduction

Pulmonary embolism (PE) is a potentially fatal condition requiring timely diagnosis and treatment. CT pulmonary angiography (CTPA) is the gold standard for diagnosis and indicates PE severity through radiological markers of right heart strain. However, accurate interpretation and communication of these findings is often suboptimal in real-world practice. Artificial intelligence (AI) could alleviate pressure on radiology services by supporting PE identification, risk stratification and worklist prioritisation. Before widespread adoption, AI tools must be rigorously validated for diagnostic accuracy, safety and clinical impact.

Methods and analysis

This pragmatic single-centre, non-randomised quasi-experimental study will evaluate the diagnostic accuracy, feasibility, and clinical-cost impact of AI-assisted PE detection and risk stratification using AIDOC and IMBIO software. We will recruit two consecutive cohorts of adult patients undergoing CTPAs for suspected PE: a comparator cohort (12 months pre-AI implementation) and an intervention cohort (12 months post-AI implementation). AI will be applied retrospectively to the comparator cohort, while in the intervention cohort, radiologists will have contemporaneous access to the AI’s interpretation of CTPA images.

A subset of retrospective scans, both PE-positive and PE-negative, will undergo expert thoracic radiologist review to establish a reference standard. Data on patient demographics, clinical management and outcomes will be collected. Clinical management pathways and patient outcomes will be compared between cohorts to assess AI’s influence on acute PE management. Health economic modelling will assess the cost-effectiveness of integrating AI technology within the diagnostic workflow of acute PE.

Ethics and dissemination

This study was approved by the UK Healthcare Research authority (IRAS 311735, 10 May 2023). Ethical approval was granted by West of Scotland Research Ethics Service (23/WS/0067, 3 May 2023). Results will be shared with stakeholders, presented at national and international conferences, and published in open-access peer-reviewed journals.

Trial registration number

NCT06093217.

Device-assessed sleep health among older patients with heart failure: a cross-sectional study using actigraphy

Por: Krishnan · S. · Taylor · S. · Edwardson · C. L. · Rowlands · A. V. · Squire · I. B. · Sze · S.
Objective

Poor sleep is common among patients with heart failure (HF) and is associated with adverse cardiovascular outcomes. The utility of actigraphy in sleep assessment, especially among older adults, remains underexplored. This study aimed to assess sleep health among older adults with HF using actigraphy and explore associations between sleep parameters and cardiac biomarkers, functional performance and quality of life (QoL).

Design

A cross-sectional study.

Setting

The study was conducted at an outpatient HF clinic within a tertiary cardiology service in a National Health Service hospital in the UK between March and October 2023.

Participants

A total of 150 older adults aged ≥65 years with a diagnosis of HF were enrolled.

Methods

Participants were given a wrist-accelerometer to wear for 7 days. On Day 0, patients completed a 4-metre walk test (4MWT), handgrip strength test (HGST), Timed Up and Go test (TUGT), Barthel Index (BI), Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and frailty assessment (Clinical Frailty Scale, CFS). Subsequently, they were fitted with an accelerometer, with the device configured to start recording the following day (Day 1). Sleep outcomes were calculated after a 7-day wear period and averaged across valid nights (minimum 3 nights of recording, noon-to-noon with ≥16 hours wear-time). Sleep parameters studied include average sleep efficiency, sleep period time window, sleep duration, sleep onset and wake up time, wake after sleep onset (WASO), sleep interruptions and Sleep Regularity Index (SRI). Inefficient sleep was defined as sleep efficiency

Outcome measures

The primary outcome measure was sleep efficiency; all other sleep parameters were classified as secondary or exploratory outcomes.

Results

Accelerometry data from 145 participants were analysed; 42% had inefficient sleep based on average sleep efficiency across valid nights. These patients had significantly higher plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (p=0.044). No statistically significant difference was noted in 4MWT, HGST, TUGT, BI, KCCQ-12 and CFS between patients with sleep efficiency

Conclusions

Older adults with HF who had inefficient sleep had significantly higher NT-proBNP levels. Lower sleep efficiency was associated with higher functional dependence and frailty. Sleep irregularity was linked to HF symptom load, frailty, functional performance and QoL, while sleep fragmentation was associated with impaired gait speed.

Interruptive versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC): protocol and statistical analysis plan for a randomised clinical trial

Por: Wright · A. P. · Choi · L. · Nairon · K. G. · Gatto · C. L. · Dear · M. L. · Van Winkle · G. · Lagalante · S. · Neal · E. B. · Wright · A. · Rice · T. W. · for the Vanderbilt Center for Learning Healthcare · Bernard · Dittus · Luther · Pulley · Self · Semler · Qian
Introduction

Statins are a cornerstone of cardiovascular disease prevention yet remain underused among eligible patients. Clinical decision support systems embedded in electronic health records (EHRs) are commonly used to encourage guideline-concordant prescribing. Interruptive reminders (eg, pop-ups) may be effective but interfere with clinical workflows and contribute to alert fatigue. Non-interruptive alerts are less intrusive, but their effectiveness remains unclear. The Interruptive versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC) trial is designed to evaluate the comparative effectiveness of interruptive and non-interruptive reminders on statin-prescribing rates.

Methods and analysis

INIRSHA-PC is a single-centre, pragmatic, three-arm, parallel-group randomised controlled trial embedded in the EHR at Vanderbilt University Medical Center. The trial will enrol adults aged 18–74 seen in primary care who are eligible for, but not currently prescribed, statin therapy. The planned sample size is 3000 patients (1000 per arm). Enrolled patients will be randomised 1:1:1 to (1) interruptive reminder, (2) non-interruptive reminder or (3) no reminder (usual care). The primary outcome is statin prescription within 24 hours of enrolment. Secondary outcomes are statin prescribing within 12 months and low-density lipoprotein cholesterol levels measured between 30 days and 12 months after enrolment. Enrolment began on 14 August 2024. The study is expected to be completed on 19 November 2025.

Ethics and dissemination

The trial has been approved by the Vanderbilt University Medical Center Institutional Review Board with waiver of patient informed consent (IRB number: 240419). Results will be disseminated through peer-reviewed publication and presentation at scientific conferences.

Trial registration number

NCT06456658.

Intradialytic kinetics of cardiac biomarkers during high-flux haemodialysis and postdilution haemodiafiltration: study protocol for a randomised crossover trial

Por: Drivsholm · C. L. · Nygaard · L. · Glerup · R. I. · Birnum · A. T. S. · Jensen · J. D. · Svensson · M.
Introduction

Cardiovascular disease (CVD) is the leading cause of mortality in patients undergoing chronic haemodialysis (HD). However, relatively few data exist regarding the influence of dialysis treatment on cardiac biomarkers such as high-sensitivity cardiac troponin I and T (hs-cTnI and hs-cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP), complicating their interpretation in the diagnosis of acute coronary syndrome and heart failure. This study aims to investigate the intradialytic kinetics of hs-cTnT, hs-cTnI and NT-proBNP, during HD and haemodiafiltration (HDF), in patients treated with chronic HD.

Methods and analysis

Single-centre, randomised, open-label, crossover study, comparing high-flux HD (FX 100 dialyser) and postdilution HDF (FX 1000 dialyser), regarding their potential clearance of hs-cTnI, hs-cTnT and NT-proBNP, in 24 stable patients treated with in-centre HD without acute CVD. The study will investigate changes in concentrations during and after high-flux HD and postdilution HDF and calculate reduction ratios, dialyser clearance and clearance by adsorption to the membrane of the selected cardiac biomarkers. Blood samples will be collected at baseline, after 10, 30, 60, 120, 180 and 240 min of dialysis and 30 min postdialysis. After 120 min of dialysis, dialysate will also be collected from the dialyser outlet line. The primary outcome is change from baseline in concentrations of hs-cTnI, hs-cTnT and NT-proBNP during high-flux HD and postdilution HDF.

Ethics and dissemination

The study has been approved by the North Denmark Region Committee on Health Research Ethics (N-20240016). Results will be published in an international peer-reviewed journal and disseminated at national and international research meetings.

Trial registration number

NCT06526702.

Online Remote Behavioural Intervention for Tics (ORBIT-UK): protocol of a single cohort usability study

Por: Hastings · O. · Brown · B. J. · Prentice · K.-M. · Babbage · C. M. · Davies · E. B. · Kilgariff · J. · Murphy · T. · McGarry · G. · Guo · B. · Greenhalgh · C. · Hollis · C. · Hall · C. L.
Introduction

Tourette syndrome is a common, disabling childhood-onset condition. Exposure and response prevention (ERP) is an effective treatment for tics, yet access remains limited due to a shortage of trained therapists and uneven geographical distribution of services. The ORBIT trial demonstrated that internet-delivered ERP is both clinically and cost-effective, but was developed on a university research platform, not suitable for widescale roll-out. To enable adoption by the National Health Service (NHS) in England, ORBIT has been redeveloped on an NHS compliant platform. This study will evaluate the usability, acceptability and preliminary outcomes of ORBIT on the new platform within an NHS tic disorder service.

Methods and analysis

This single-cohort usability study will recruit 20 children and young people (aged 9–17) with tics and their chosen supporters (parents/carers). Participants will receive a 10-week online ERP intervention supported by trained coaches. Outcomes include uptake, adherence, system usability, satisfaction and clinical measures such as the Yale Global Tic Severity Scale, Parent Tic Questionnaire and Goal-Based Outcomes. Qualitative feedback will be collected via semi-structured exit interviews. Usability metrics and adverse events will be monitored throughout.

Ethics and dissemination

The study has received ethical approval from North West Greater Manchester Research Ethics Committee (ref: 25/NW/0107). The findings from the study will inform future NHS adoption. The results will be submitted for publication in peer-reviewed journals.

Trial registration number

ISRCTN82718960. Registered 10 July 2025. https://doi.org/10.1186/ISRCTN82718960

Building a library of acute traumatic spinal cord injury images across Canada: a retrospective cohort study protocol

Por: Rotem-Kohavi · N. · Humphreys · S. · Noonan · V. K. · Cheng · C. L. · Guay-Paquet · M. · Bouthillier · M. · Valosek · J. · Karthik · E. N. · Lichtenstein · E. · Guenther · N. · Ost · K. · Attabib · N. · Hardisty · M. · Badhiwala · J. · Larouche · J. · Pahuta · M. · Christie · S. · Fehlin
Introduction

MRI is increasingly recognised as a valuable tool for assessing prognosis and predicting outcomes following traumatic spinal cord injury (SCI). Several potential MRI biomarkers have been identified, but efforts are still needed to improve the accuracy and feasibility of these biomarkers in clinical practice. This study aims to build a national Canadian SCI imaging repository for storing and analysing imaging data for SCI, with the goal of improving SCI MRI biomarkers to predict outcomes and inform clinical management.

Method and analysis

As a substudy of the Rick Hansen SCI Registry (RHSCIR), this retrospective multisite study includes individuals who sustained a traumatic cervical SCI between 2015 and 2021, were previously enrolled in RHSCIR, and had MRI scans acquired within 72 hours of injury and before any surgical intervention. Individuals with a penetrating trauma and/or with any prior spine surgery are excluded. The study principal investigator and research associates, experienced with data curation and with the standardised format and specifications of the Brain Imaging Data Structure standard, guide the site’s curator on the steps to perform image deidentification and curation to create standardised datasets across all sites. These datasets are transferred to a Digital Research Alliance of Canada (‘the Alliance’) server designated for this project and concatenated to form the national Canadian SCI imaging repository (Neurogitea). We are using a semiautomated processing pipeline to quantify lesion morphology, together with additional imaging measures that are manually extracted from the images (for instance, the relative maximal spinal cord compression and the maximum canal compromise). Through linkage to RHSCIR clinical and epidemiological data already available on eligible participants, regression analysis is planned to predict neurological outcomes at discharge, including the American Spinal Injury Association Impairment Scale grade, upper and lower extremity motor and sensory scores.

Ethics and dissemination

This protocol has been submitted by the participating sites to obtain ethics and institutional approvals prior to the study initiation at each site. All 12 sites across Canada have now obtained ethics and institutional approvals. Study results will be disseminated at local, national and international conferences and by journal publications.

Patient experiences with a smartwatch 1L-ECG versus traditional Holter monitoring for ambulatory cardiac rhythm monitoring: a qualitative study

Por: Karregat · E. P. M. · Vooijs · P. · Wierda · E. · Harskamp · R. · Lucassen · W. · Himmelreich · J. C. L. · Moll van Charante · E. P.
Objective

To explore patients’ experiences and perspectives on using a direct-to-consumer smartwatch with single-lead electrocardiography (1L-ECG) for ambulatory rhythm diagnostics in primary care.

Design

Qualitative study using semi-structured interviews and thematic analysis.

Setting

Primary care patients referred for ambulatory rhythm monitoring in a diagnostic centre.

Participant

Eighteen adults with paroxysmal palpitations, of whom nine were female patients (50%), aged 32–85 (median 66) years.

Intervention

Participants simultaneously wore a smartwatch with 1L-ECG capability (Withings ScanWatch) and a conventional Holter monitor for 7 days.

Outcome measures

Patient experiences and perceived barriers and facilitators to smartwatch use for rhythm monitoring, reported after the monitoring period.

Results

Patients found the smartwatch more user-friendly and feasible than the Holter monitor. Difficulties included uncertainty about when to initiate recordings, challenges capturing brief episodes and anxiety triggered by automated algorithm outputs. Participants emphasised the importance of accessible healthcare support for interpretation and reassurance.

Conclusions

This study shows that smartwatch-based 1L-ECG monitoring is feasible and acceptable for ambulatory rhythm diagnostics in primary care. Prior to routine implementation, it is crucial to address the identified challenges: particularly anxiety related to algorithm results, uncertainty about when to record and accessible clinician support.

Transtympanic sodium thiosulphate to prevent cisplatin-related hearing loss: a protocol for randomised controlled multicentre phase III trial, the SOUND trial

Por: Burger · A. V. M. · Duinkerken · C. W. · Jansen · J. C. · Keereweer · S. · Cals · F. L. · Stokroos · R. J. · de Boer · J. P. · Exterkate · L. · van der Velden · L.-A. · Hoetink · A. E. · Nuijen · B. · Hauptmann · M. · van Sluis · K. E. · Bruintjes · T. D. · Zuur · C. L.
Introduction

Cisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect.

Methods and analysis

The SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m2. Each subject will receive transtympanic STS injections in one ear, chosen by randomisation, before each cisplatin infusion. The contralateral ear serves as an internal control. The primary objective is efficacy (ie, clinically relevant benefit) of transtympanic STS injections against CIHL, defined as a difference in threshold shift of ≥10 decibels between baseline and 3 months after treatment in favour of the STS-treated ear. Secondary objectives include the difference in mean threshold shifts on frequencies essential for speech and extended high frequencies, as well as the difference between both ears in the gradation of hearing loss as defined by ototoxicity grading scales.

Ethics and dissemination

The medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals.

Trial registration number

CTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.

Educational outcomes for children and young people with cancer: study protocol for a population-based cohort study using linked education and hospital data from England

Por: Nath · S. · Stone · T. · Lam · J. · Feltbower · R. G. · Hargrave · D. · McCabe · M. G. · Brown · H. · Hickinbottom · L. C. L. · Jackson · K. · Paget · L. · Stanley · T. · Watts · P. S. · Harron · K.
Introduction

Childhood cancer survivors (CCSs) experience educational disruptions during and following treatment, yet robust, longitudinal evidence on educational performance remains limited. We will investigate differences in educational outcomes between CCSs and non-cancer peers during primary and secondary school. We will also explore how sociodemographic factors and age at diagnosis contribute to potential differences in General Certificate of Secondary Education (GCSE) examinations, a critical indicator of future academic and employment prospects.

Methods and analysis

We will use the Education and Child Health Insights from Linked Data (ECHILD) to capture linked health and education data for children born in National Health Service (NHS)-funded hospitals in England. We will generate birth cohorts spanning September 1997 to August 2015 (estimated sample size: ~10 million), formed of pupils expected to have undertaken national curriculum assessments between academic years 2004/2005 and 2021/2022 including Key Stage (KS) 1, 2 and 4, corresponding to ages 7, 11 and 16 respectively. Cancer diagnosis will be identified from inpatient hospital records, using International Classification of Diseases, 10th Revision codes (ICD-10). We will investigate differences between CCS and their non-cancer peers in terms of their sociodemographic characteristics and describe trends in educational performances at all KSs, recorded Special Educational Needs and Disabilities (SEND) and school absences. Differences in KS4 (GCSE) performances between CCS and non-cancer peers will be quantified, according to and accounting for geographic region, sex, deprivation, ethnicity and birth characteristics. To assess whether cancer diagnosis disrupts academic trajectories, we will restrict analysis to those with KS2 attainment data and investigate KS4 performance. We will finally explore the influence of age at diagnosis on educational performance at KS4.

Ethics and dissemination

Ethics approval was granted by NHS Health Research Authority Research Ethics Committee (20/EE/0180). Findings will be shared with academics, policymakers, children and families affected by childhood cancer, and published in journals. Code/metadata will be shared on ECHILD GitHub repository.

Realist review of informal carer involvement in the transition of medicines-related care for patients moving from hospital to home

Por: Richardson · C. L. · Cooper · M. · Atkinson · O. · Black · D. · Lindsey · L. · Cooper · C. · Nazar · H. · Wong · G. · Hughes · C.
Objective

The aim of this work was to understand carer involvement in transitions of care from hospital to home in relation to medicines management. Specifically, via a realist review, to describe how carers provide support, to what extent do they support patients and under what circumstances are carers able to provide support towards patient care in relation to medicines management.

Design

A realist review was conducted in line with a published protocol and as registered via PROSPERO (CRD42021262827). An initial programme theory (PT) was developed before searches of three databases, PubMed, CINHAL and EMBASE, were conducted in accordance with eligibility criteria. Data were extracted from eligible studies and synthesised into realist causal explanations in the form of Context-Mechanism-Outcome-Configurations (CMOCs) and the PT was refined. Throughout the review, a patient and PPIE group (n≥5) was involved, meeting five times, to inform the research focus and develop CMOCs and the PT by providing feedback and ensuring they capture the carer experience.

Results

Following title and abstract screening of 4835 papers, the final number of included articles was 208. The evidence synthesis identified 31 CMOCs which were categorised into three themes: (1) continuum of support; (2) understanding the carers’ priorities, role and responsibilities through shared decision-making (SDM) and (3) access to appropriate materials, resources and support information. These themes were formed into an updated PT with accompanying narrative that explained the transition from hospital to home involving carers in medicines management and identified possible areas for future intervention development.

Conclusion

This review provides insights and recommendations on how carers can be better supported when managing medicines when patients are discharged from hospital. Carers need a continuum of support throughout and following the transition. Healthcare professionals can support this by understanding the carer’s priorities, role and responsibilities through SDM during the hospital stay. Consequently, carers can then be offered access to appropriate materials, resources and support information which allows them to provide better care relating to medicines in the long term.

Researchers views of risk of bias in cluster randomised trials: a qualitative interview study

Por: Easter · C. L. · Kristunas · C. · Greenfield · S. · Hemming · K.
Objectives

Cluster randomised trials (CRTs) can be at risk of bias driven by differential identification and recruitment of participants across treatments, posing a threat to the validity of findings. We explored the awareness and importance, among CRT researchers, of the recommended bias mitigation measures.

Design

Qualitative interview study using semistructured interviews.

Participants

Participants were researchers involved in conducting CRTs, including investigators, statisticians and trial coordinators. 24 participants, including statisticians (n=13, 54.2%), clinical investigators (n=9, 37.5%) and trial coordinators (n=2, 8.3%), were interviewed; with representation from the UK (n=10, 41.7%), Australia (n=5, 20.8%) and the USA (n=4, 16.7%).

Results

Participants exhibited differing levels of knowledge related to biases. Some participants demonstrated high levels of knowledge, but we also identified prevalent misconceptions, with some evidence of superficial knowledge. While some participants worked in collaborative teams, other teams’ responsibilities were delineated, and this impacted on how knowledge of biases was shared and acted on. Logistical and practical issues could prevent known solutions to mitigate biases being implemented. Biases also manifested because of a perception from participant recruiters that the purpose of research is for participant benefit rather than producing generalisable knowledge; and a normalisation or expectation that CRTs produce a lower level of evidence.

Conclusions

There is an urgent need to ensure that CRTs are free from risks of bias. Mitigation measures are either not known, not practical or unconsciously subverted. More education and collaborative working might help. Preventing subconscious bias during participant recruitment and dispelling the myth that CRTs produce lower levels of evidence would require a change in culture.

Early life determinants of skeletal maturation, body composition and endocrine health in young adults (EPIPEAK): protocol for a nationwide birth cohort study

Por: Händel · M. N. · Jorgensen · N. R. · Bybjerg-Grauholm · J. · Jansen · R. B. · Eiken · P. · Tofteng · C. L. · Hermann · A. P. · Bach-Mortensen · P. · Heitmann · B. L. · Rubin · K. H. · Langdahl · B. L. · Vestergaard · P. · Abrahamsen · B.
Introduction

Early-life exposures, such as nutritional deficiencies, stress, smoking, toxins, medications, diseases, infections and inflammation may affect multiple physiological and metabolic systems in the offspring, including hormonal regulation, bone metabolism and mineralisation, and body composition. Moreover, the effect of these early-life exposures on later health may potentially be mediated through adverse neonatal epigenetic reprogramming of bone-related genes affecting health later in life, especially skeletal development and bone density. Thus, to advance this research further, the overall aim of the project is to investigate if (a) neonatal epigenetic and genetic signature; (b) maternal risk factors during preconception and pregnancy, such as medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle; (c) risk factors at birth, such as instrumental delivery, mode of delivery, medicine use, injuries, diseases, weight, size for gestational age, ponderal index, gestational age; and (d) childhood risk factors, such as diseases, medicine use, major life events, weight, growth and lifestyle are associated with hormonal status, lipids, bone turnover markers, bone mineral density, fat mass and lean body mass at age 18–19 years.

Methods and analysis

Population-based, nationwide, cross-sectional clinical study with potential for longitudinal reassessment. Danish women and men aged 18–19 years old will be selected at random from the Danish National Population Registry and invited if they have available neonatal dried blood spot cards. A total of 2000 individuals will be enrolled. The study combines register data, and neonatal epigenetic and genetic analyses from stored blood with clinical and survey data. Body composition will be measured using dual-energy X-ray absorptiometry. Adult blood and hair samples will be obtained to assess hormonal status, lipids and bone turnover markers. Height, weight, waist and hip circumference, and blood pressure will be measured. Questionnaires on well-being, sleep patterns, dietary and exercise habits, onset of puberty, use of cannabis, nicotine, alcohol and pain medication will be included. Information on medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle will be obtained from the national administrative and health registers at the time of conception and during pregnancy for the parents, as well as from the participants throughout their lifetime. Health registries include the Danish Medical Birth Register, the National Patient Register, the Danish National Prescription Register, the National Child Health Register and Statistics Denmark. Multivariate regression analyses will be performed.

Ethics and dissemination

This nationwide study has been approved by the Regional Committees on Health Research Ethics for Southern Denmark (S-20230105). The study participants will be enrolled in the study following their informed written consent. Results will be submitted for publication. The Strengthening the Reporting of Observational Studies in Epidemiology Statement guidelines will be used for reporting.

Trial registration number

NCT06509776.

Prevalence and predictors of depression and other mental health disorders in Brazilian adults with intellectual disabilities: a population-based secondary analysis

Por: Wagner · G. A. · Gerum · P. C. L. · Martins · L. F. · Silva · H. R. S. · Lima · M. · Duraes · F. R. · Covolan · L.
Objectives

To investigate the occurrence of depression and mental health disorders other than depression among Brazilian people with intellectual disabilities, analysing data from a national household survey.

Design

Cross-sectional epidemiological study using data from the 2019 National Health Survey (PNS).

Setting

Brazil, nationwide data collection in urban and rural private households.

Participants

272 499 individuals, among whom 1.2% (n=3198) reported intellectual disabilities.

Primary outcome measures

Self-reported depression and mental health disorders other than depression (anxiety, panic, schizophrenia, bipolar disorder, psychosis or obsessive–compulsive disorder (OCD)), either isolated or comorbid.

Results

Among people with intellectual disabilities, 43.2% reported at least one mental health disorder versus 13.7% without disabilities. In adults aged 0–59 years, intellectual disability was associated with higher odds of depression (adjusted OR (aOR) 3.25, 95% CI 1.76 to 6.00), mental health disorders other than depression (aOR 12.23, 95% CI 7.52 to 19.90) and depression associated with other mental health disorders (aOR 14.34, 95% CI 7.92 to 25.96). In older adults (≥60 years), risks also remained elevated: depression (aOR 1.71, 95% CI 1.04 to 2.79), mental health disorders other than depression (aOR 4.33, 95% CI 2.09 to 8.94) and depression associated with other mental health disorders (aOR 2.98, 95% CI 1.49 to 5.95). Women with intellectual disabilities were more likely to report depression and multimorbidity, while men more often reported non-depressive disorders. Poorer self-perceived health was consistently linked to worse outcomes across age groups.

Conclusions

Mental health disorders and their comorbidities are significantly more prevalent among people with intellectual disabilities in Brazil. These findings highlight the urgent need for inclusive, equitable and specialised mental healthcare policies.

Identification of gestational diabetes mellitus in European electronic healthcare databases: insights from the ConcePTION project

Por: Molgaard-Nielsen · D. · Mitter · V. · Lupattelli · A. · Hoxhaj · V. · Andaur Navarro · C. L. · Hayati · S. · Lopez-Leon · S. · Morris · J. K. · Geldof · A. · Jordan · S. · Leinonen · M. K. · Martikainen · V. · Manfrini · M. · Cammarota · L. · Neville · A. · Barrachina-Bonet · L. · Cave
Objective

To develop and compare algorithms for identifying gestational diabetes mellitus (GDM) across European electronic healthcare databases and evaluate their impact on the estimated prevalence.

Design

Multi-national cohort study using routinely collected electronic healthcare data

Setting

National and regional databases in five European countries (Norway, Finland, Italy, Spain and France), in primary and/or secondary care.

Participants

Pregnancy cohorts resulting in stillbirths or live births between 2009 and 2020, comprising 602 897 pregnancies in Norway, 507 904 in Finland, 374 009 in Italy, 193 495 in Spain and 116 762 in France.

Primary and secondary outcomes

The primary outcome was the prevalence of GDM identified using six algorithms: (1) Only diagnosis; (2) Diagnosis or prescription; (3) Two diagnoses or prescriptions (2DxRx); (4) Diagnosis including unspecified diabetes in pregnancy or prescription (DxRx broad); (5) Diagnosis excluding pre-existing diabetes in pregnancy or prescription; (6) Registration of GDM in a birth registry (BR).

Results

The strictest algorithm (2DxRx) resulted in the lowest GDM prevalence, while the broadest (DxRx broad) resulted in the highest, except in France where it was BR. In the Nordic countries, GDM prevalence varied only slightly by algorithm; greater variations were observed in other countries. The prevalence ranged from 3.5% (95% CI: 3.5% to 3.5%) to 4.6% (95% CI: 4.5% to 4.7%) in Norway; 12.1% (95% CI: 12.0% to 12.2%) to 15.8% (95% CI: 15.7% to 15.9%) in Finland, where prevalence was much higher than elsewhere. The prevalence ranged from 1.3% (95% CI: 1.3% to 1.3%) to 5.4% (95% CI: 5.3% to 5.5%) in Italy; 1.6% (95% CI: 1.5% to 1.7%) to 6.2% (95% CI: 6.1% to 6.3%) in Spain; and 1.7% (95% CI: 1.6% to 1.8%) to 5.8% (95% CI: 5.7% to 5.9%) in France.

Conclusions

In this multinational study, GDM prevalence ranged from 1.3% to 15.8% depending on the algorithm and database. Nordic countries showed smaller differences in prevalence between algorithms, while the other countries showed larger variations, likely due to differences in coding practices, healthcare systems and database coverage.

Effectiveness of a novel intervention (Super Rehab) in overweight patients with atrial fibrillation (SuRe AF): protocol for a randomised controlled trial

Por: Murphy · D. · Graby · J. · Smith · T. · Peacock · O. · Abramik · J. · Antoniades · C. · Rodrigues · J. C. L. · Thompson · D. · Khavandi · A.
Introduction

Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide, associated with significant morbidity, mortality and healthcare utilisation. AF rhythm control strategies demonstrate attrition with time. A number of modifiable AF risk factors contribute to an atrial cardiomyopathy culminating in incident AF but importantly also recurrence. We propose that a novel multidisciplinary lifestyle intervention (Super Rehab, SR) may improve symptoms and AF burden.

Methods and analysis

This is a single-centre, randomised controlled study. Patients aged ≥18 years with a body mass index ≥27 kg/m2 with paroxysmal or persistent AF will be randomised 1:1 to National Health Service (NHS) usual care (UC) or to SR (together with NHS UC). SR incorporates high-intensity exercise, personalised dietary advice and AF risk factor modification. SR will be undertaken over 12 months. In addition to baseline assessments, follow-up assessments will occur at the 6, 12 and 15-month time points. The primary outcome will be the difference in AF symptom burden at 12 months between groups. Secondary outcomes include AF burden (assessed by an implantable cardiac monitor), changes to cardiac structure and function and computed tomography-based assessment of epicardial adipose tissue.

Ethics and dissemination

Ethics approval was granted by London-Chelsea Research Ethics Committee (reference: 22/LO/0479 22/08/2022). All participants will provide written informed consent prior to enrolment. Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications. A summary will also be communicated to the participants.

Trial registration number

ClinicalTrials.gov ID NCT05596175.

Community mobilisation for adoption of clean cookstoves and clean fuel to reduce household air pollution and blood pressure in Lagos, Nigeria: protocol for a cluster-randomised trial

Por: Wright · O. · Olopade · C. O. · Aifah · A. A. · Fagbemi · T. · Hade · E. M. · Mishra · S. · Onakomaiya · D. O. · Kanneh · N. · Chen · W. · Colvin · C. L. · Ogunyemi · R. · Sogbossi · E. · Erinosho · E. · Ojengbede · O. · Taiwo · O. · Johnson · M. A. · Vedanthan · R. · Wall · S. · lwelunmor
Introduction

In Africa, 75% of households are exposed to household air pollution (HAP), a key contributor to cardiovascular disease (CVD). In Nigeria, 90 million households rely on solid fuels for cooking, and 40% of adults have hypertension. Though clean fuel and clean stove (CF-CS) technologies can reduce HAP and CVD risk, their adoption in Africa remains limited.

Methods and analysis

Using the Exploration, Preparation, Implementation and Sustainment framework, this cluster-randomised controlled trial evaluates the implementation and effectiveness of a community mobilisation (CM) strategy versus a self-directed condition (i.e., receipt of information on CF-CS use without CM) on adoption of CF-CS technologies and systolic blood pressure (SBP) reduction among 1248 adults from 624 households across 32 peri-urban communities in Lagos, Nigeria. The primary outcome is CF-CS adoption at 12 months; secondary outcomes are SBP reduction at 12 months and sustainability of CF-CS use at 24 months. Adoption is assessed via objective monitoring of stove usage with temperature-triggered iButton sensors. SBP is assessed in 2 adults per household using validated automated blood pressure monitor. Generalised linear mixed-effects regression models will be used to assess study outcomes, accounting for clustering at the level of the peri-urban communities (unit of randomisation) and households. To date, randomisation is completed, and a total of 1248 households have enrolled in the study. The final completion of the study is expected in June 2026.

Ethics and dissemination

The study was approved by the Institutional Review Boards (IRB) of NYU Grossman School of Medicine (primary IRB of record; protocol ID: i21-00586; Version 6.0 approved on 4 June 2024), and Lagos State University Teaching Hospital (protocol ID: LREC 06/10/1621). Written consent was obtained from all participants. Findings will inform scalable and culturally appropriate strategies for reducing HAP and CVD risk in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagements.

Trial registration number

NCT05048147

Validity evidence for communication skills assessment in health professions education: a scoping review

Por: Dorrestein · L. · Ritter · C. · De Mol · Z. · Wichtel · M. · Cary · J. · Vengrin · C. · Artemiou · E. · Adams · C. L. · Ganshorn · H. · Coe · J. B. · Barkema · H. · Hecker · K. G.
Objective

Communication skills assessment (CSA) is essential for ensuring competency, guiding educational practices and safeguarding regulatory compliance in health professions education (HPE). However, there appears to be heterogeneity in the reporting of validity evidence from CSA methods across the health profession that complicates our interpretation of the quality of assessment methods. Our objective was to map reliability and validity evidence from scores of CSA methods that have been reported in HPE.

Design

Scoping review.

Data sources

MEDLINE, Embase, PsycINFO, CINAHL, ERIC, CAB Abstracts and Scopus databases were searched up to March 2024.

Eligibility criteria

We included studies, available in English, that reported validity evidence (content-related, internal structure, relationship with other variables, response processes and consequences) for CSA methods in HPE. There were no restrictions related to date of publication.

Data extraction and synthesis

Two independent reviewers completed data extraction and assessed study quality using the Medical Education Research Study Quality Instrument. Data were reported using descriptive analysis (mean, median, range).

Results

A total of 146 eligible studies were identified, including 98 394 participants. Most studies were conducted in human medicine (124 studies) and participants were mostly undergraduate students (85 studies). Performance-based, simulated, inperson CSA was most prevalent, comprising 115 studies, of which 68 studies were objective structured clinical examination-based. Other types of methods that were reported were workplace-based assessment; asynchronous, video-based assessment; knowledge-based assessment and performance-based, simulated, virtual assessment. Included studies used a diverse range of communications skills frameworks, rating scales and raters. Internal structure was the most reported source of validity evidence (130 studies (90%), followed by content-related (108 studies (74%), relationships with other variables (86 studies (59%), response processes (15 studies (10%) and consequences (16 studies (11%).

Conclusions

This scoping review identified gaps in the sources of validity evidence related to assessment method that have been used to support the use of CSA methods. These gaps could be addressed by studies explicitly defining the communication skill construct(s) assessed, clarifying the validity source(s) reported and defining the intended purpose and use of the scores (ie, for learning and feedback, for decision making purposes). Our review provides a map where targeted CSA development and support are needed. Limitations of the evidence come from score interpretation being constrained by the heterogeneity of the definition of communication skills across the health professions and the reporting quality of the studies.

Factors influencing reproductive concerns and their correlation with quality of life among adolescents and young adults with acute leukaemia in Hunan province, China: a cross-sectional study

Por: Zhang · Y. · Zhang · Z. · Zhang · W. · Zeng · X. · Ma · G. · Xiao · Y. · Wong · C. L. · Chan · C. W. H. · Gu · C.
Objective

This study aimed to examine the reproductive concerns and their influencing factors among adolescents and young adults with acute leukaemia and to explore the relationship between reproductive concerns and patients’ quality of life.

Design

A cross-sectional study.

Setting

The haematology departments of four tertiary-level hospitals in Hunan province, China.

Participants

Convenience sampling method was used to recruit 233 adolescents and young adults with acute leukaemia, from June 2024 to December 2024.

Primary and secondary outcome measures

The primary outcome was assessed using the Chinese version of the Reproductive Concerns After Cancer and the secondary outcome was measured by the 12-item Short Form Health Survey.

Results

Adolescents and young adults with acute leukaemia had a mean reproductive concerns score of 55.57±7.57, a quality of life physical component summary (PCS) score of 38.54±8.58 and a mental component summary (MCS) score of 39.84±8.78. Univariate analysis showed significant differences in reproductive concerns based on fertility status, place of residence, education level, fertility counselling and family history of acute leukaemia (p

Conclusion

Adolescents and young adults with acute leukaemia exhibited moderately high levels of reproductive concerns, particularly those who had no children, had a low education level, resided in rural areas, had a family history of acute leukaemia or had received fertility counselling. Therefore, we suggest that healthcare providers prioritise addressing reproductive concerns in high-risk patients by offering tailored, high-quality and continuous fertility counselling and psychological support. Strengthening these strategies can help alleviate reproductive concerns and improve both mental health and overall quality of life in this population.

Precision computerised cognitive behavioural therapy (cCBT) intervention for adolescents with depression (SPARX-UK): protocol for the process evaluation of a pilot randomised controlled feasibility trial

Por: Khan · K. · Babbage · C. M. · Sprange · K. · Hall · C. L. · Parker · A. · Greenhalgh · C. · Jeffery · M. · Lucassen · M. · Merry · S. · Prasad · V. · Stasiak · K. · Guo · B. · Tench · C. R. · Wright · H. · Stallard · P. · Hollis · C. · on behalf of Digital Youth · on behalf of Digital Y
Introduction

While digital technologies can increase the availability and access to evidence-based interventions, little is known about how users engage with them and the mechanisms associated with effective outcomes. Process evaluations are an important component in understanding the aforementioned factors. The ‘SPARX-UK’ study is a randomised controlled pilot and feasibility trial evaluating personalised human-supported (from an ‘eCoach’) vs a self-directed computerised cognitive behavioural therapy intervention (cCBT), called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), aimed at adolescents with mild to moderate depression. We are comparing supported vs self-directed delivery of SPARX to establish which format should be used in a proposed definitive trial of SPARX. The control is a waitlist group. We will conduct a process evaluation alongside the trial to determine how the intervention is implemented and provide context for interpreting the feasibility trial outcomes. We will also look at the acceptability of SPARX and how users engage with the intervention. This protocol paper describes the rationale, aims and methodology of the SPARX-UK trial process evaluation.

Methods and analysis

The process evaluation will use a mixed-methods design following the UK Medical Research Council’s 2015 guidelines, comprising quantitative and qualitative data collection. This will include analysing data usage of participants in the intervention arms; purposively sampled, semi-structured interviews of adolescents, parents/guardians, eCoaches and clinicians/practitioners from the SPARX-UK trial; and analysis of qualitative comments from a survey from those who dropped out early from the trial. Quantitative data will be analysed descriptively. We will use thematic analysis in a framework approach to analyse qualitative data. Quantitative and qualitative data will be mixed and integrated to provide an understanding of how the intervention was implemented and how adolescents interacted with the intervention. This process evaluation will explore the experiences of adolescent participants, parents/guardians, eCoaches and clinicians/practitioners in relation to a complex digital intervention.

Ethics

Ethical approval was granted by the National Health Service (NHS) Health Research Authority South West - Cornwall & Plymouth Research Ethics Committee (Ethics Ref: 22/SW/0149).

Dissemination

Contextualising how the intervention was implemented, and the variations in uptake and engagement, will help us to understand the trial findings in greater depth. The findings from this process evaluation will also inform the decision about whether and how to proceed with a full randomised controlled trial, as well as the development of more effective interventions which can be personalised more precisely via varying levels of human support. We plan to publish the findings of the process evaluation and the wider project in peer-reviewed journals, as well as disseminate via academic conferences.

Trial registration number

ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.

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