The significant morbidity and mortalities from, and the recurrent outbreaks of, the vaccine-preventable infectious diseases (VPDs) of childhood could be due not only to non-receipt of recommended vaccinations but also to untimely receipt, which impairs the validity of immunisation coverage and protection against VPDs. This study explored the determinants of untimely receipt and non-receipt of routine childhood immunisation and made recommendations for policy and practice.

This qualitative study was based on the Adapted Omale INDEPT FORCIS Framework – Determinants of Routine Childhood Vaccination Receipt Conceptual Framework.

From 22 August 2022 to 9 September 2022, 15 semi-structured, face-to-face focus group discussions were conducted in English, pidgin English and the local language with 127 purposively selected consenting parents of infants aged 0–2 months (with other key community members) and primary healthcare workers involved in the provision of routine childhood immunisation in Ebonyi state, Nigeria.

Data analysis involved deductive (and some inductive) thematic analysis.

There were many underlying determinants of untimely receipt and non-receipt of routine childhood immunisation, which included individual-related factors (mothers’ unfavourable experiences and perceptions and lack of knowledge about childhood diseases, vaccines/vaccinations and the vaccination system, relocation/travel from place of residence, children and/or mothers being ill); childhood disease-related, vaccination-related and the vaccination system-related factors (diseases not always severe/fatal, vaccinations causing side-effects, vaccination system constraints in availability, accessibility, affordability and acceptability); family and other individual-related factors; and broader context-related sociopolitical, cultural, economic, infrastructural, historic and health system factors.

The evidence demonstrates many specific and fundamental complex and interrelated determinants of untimely receipt and non-receipt of routine childhood immunisation and emphasises the need for multifaceted and innovative actions in dealing with the determinants in the drive to address the high morbidity and mortalities and recurring outbreaks of VPDs in Ebonyi state, Nigeria, and similar settings.

A significant number of women die from pregnancy and childbirth complications globally, particularly in low and middle-income countries. Receiving at least four antenatal care (ANC) visits is important in reducing maternal and perinatal deaths. However, few studies have investigated the factors linked to the completion of ≥4 ANC visits in Nepal.

To investigate factors associated with attending ≥4 ANC visits in Sarlahi district of southern Nepal.

A secondary analysis was conducted on data from the Nepal Oil Massage Study (NOMS), a cluster-randomised, community-based longitudinal pregnancy trial including 34 village development committees. We investigated the associations between attendance of ≥4 ANC visits and socioeconomic, demographic, morbidity and pregnancy history factors using logistic regression; generalised estimating equations were used to account for multiple pregnancies per woman. All pregnancies resulting in a live birth (LB) (n=31 867) were included.

Attendance of ≥4 ANC visits.

31.4% of those pregnancies received 4+ ANC visits. Significant positive associations included socioeconomic factors such as participation in non-farming occupations for women (OR=1.52, 95% CI 1.19 to 1.93), higher education (OR=1.79, 95% CI 1.66 to 1.93) and wealth quintile (OR=1.44, 95% CI 1.31 to 1.59), nutritional status such as non-short stature (OR=1.17, 95% CI 1.07 to 1.27), obstetric history such as adequate interpregnancy interval (OR=1.31, 95% CI 1.19 to 1.45) and prior pregnancy but no LB (OR=2.14, 95% CI 1.57 to 2.92), symptoms such as vaginal bleeding (OR=1.35, 95% CI 1.11 to 1.65) and awareness of the government’s conditional cash transfer ANC programme (OR=2.26, 95% CI 2.01 to 2.54). Conversely, identifying as the Shudra caste (OR=0.56, 95% CI 0.47 to 0.67), maternal age below 18 or above 35 (OR=0.81, 95% CI 0.74 to 0.88; OR=0.77, 95% CI 0.62 to 0.96), preterm birth (OR=0.41, 95% CI 0.35 to 0.49), parity ≥1 (OR=0.66, 95% CI 0.61 to 0.72) and the presence of hypertension during pregnancy (OR=0.79, 95% CI 0.69 to 0.90) were associated with decreased likelihood of attending ≥4 ANC visits.

These findings demonstrate the importance of socioeconomic factors, including education, caste, wealth and occupation in completion of ≥4 ANC visits. In addition, biological factors including birth spacing, pregnancy complications and nutrition are important. The association with awareness of the government’s conditional cash transfer programme is a motivation for a full evaluation of whether expanding that programme might improve prenatal care.

The clinicaltrial.gov trial registration number for NOMS was NCT01177111.

This study assessed the feasibility of implementing a phase 3 field-based clinical trial protocol to evaluate paediatric praziquantel (PED-PZQ) for the treatment of Schistosoma mansoni infection in children aged 3 months to 6 years in endemic areas of Brazil, focusing on operational aspects such as recruitment logistics, documentation management, investigational product handling and protocol adherence.

Pilot and feasibility study for a phase 3 clinical trial, comprising two components: a randomised, open-label, parallel-group, two-arm trial and a single-arm trial.

Conde, Bahia, Brazil, from December 2024 to January 2025.

Two trials aim to screen 5774 participants from three rural areas in Bahia and three in Sergipe, states in northeastern Brazil, and enrol 403 children eligible for either randomisation or allocation. Trial 1 will randomise (1:1 ratio) 240 children aged 4–6 years into the PED-PZQ treatment arm or the standard praziquantel (PZQ) 1. Trial 2 will enrol 163 children aged 3 months to 3 years, all receiving PED-PZQ. Both trials are open label. Eligible participants shall meet age criteria, test positive for S. mansoni and fulfil other inclusion criteria. In the first recruiting centre, Conde (Bahia), it was estimated that 650 participants would need to be screened for trial 1 and 552 for trial 2, assuming schistosomiasis prevalence of 5% and 4%, respectively. This pilot study reports on the first 60 participants enrolled.

The primary outcome of this pilot study is the feasibility of implementing the research protocol in a real-world field setting, focusing on key aspects such as study documentation challenges, participant safety, investigational medicinal product custody chain and protocol adherence. In addition to providing preliminary data on the parasitological cure rate, secondary outcomes include the prevalence of S. mansoni infection and the reduction in S. mansoni egg count (Kato-Katz method). Furthermore, the occurrence and severity of drug-related adverse events are monitored from drug administration to day 21 post-treatment, alongside changes in renal, hepatic and cardiac functions assessed through biochemical markers.

A total of 60 participants were recruited, and 55 provided stool samples for screening. The pilot phase demonstrated the feasibility of implementing the clinical protocol under field conditions, with successful completion of all planned procedures and minimal protocol deviations. Operational challenges were identified mainly in documentation processes, participant recruitment and investigational product management and were addressed through preventive and corrective quality assurance actions. The experience also highlighted logistical and infrastructural barriers typical of field-based trials in remote endemic areas, which informed adjustments for the subsequent phase 3 study. Preliminary parasitological results indicated an overall S. mansoni prevalence of 9.1% (5/55), with 21% in trial 1 and 2.8% in trial 2. All infected participants met the eligibility criteria, received treatment and completed follow-up. Four achieved a parasitological cure, and one case of treatment failure was observed (trial 1, PZQ group). Two mild adverse events (diarrhoea) were reported, with no serious complications or clinically significant changes in biochemical parameters.

This pilot study demonstrated the feasibility of implementing a field-based phase 3 clinical trial protocol for PED-PZQ in endemic areas of Brazil. The findings confirm that the protocol can be successfully applied in primary care settings, despite operational challenges related to recruitment, logistics and documentation. The study also provided preliminary evidence supporting the safety and effectiveness of the paediatric formulation and highlighted the need to revise prevalence assumptions to improve future screening strategies. Overall, the experience offers valuable insights to guide the large-scale phase 3 trial and supports the incorporation of PED-PZQ into national schistosomiasis control policies.

Brazilian Clinical Trials Registry; RBR-86kcy37.

Population ageing is a global phenomenon that has resulted in an increase in the number of patients with chronic diseases and geriatric syndromes. Frailty, sarcopenia and neurocognitive disorders are among the most prevalent conditions affecting older adults and have a direct effect on their quality of life, and can impact the burden and budgets of health systems. Recently, the oral microbiome has gained attention as it may be a factor that potentially influences the onset and progression of these syndromes. However, this is still a new line of research that has not been deeply explored. This scoping review protocol aims to explore how the oral microbiome may be associated with the onset of prevalent geriatric syndromes, frailty, sarcopenia and neurocognitive disorders, providing a picture of the current evidence and potential gaps for future research.

The scoping review will follow the Johanna Briggs Institute (JBI) methodology and will be reported accordit to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines (PRISMA-ScR). Searches will be conducted in Medline, Embase, Cochrane Central, CINAHL, LILACS and Epistemonikos from inception to December 2025. Independent reviewers will perform the study selection and data extraction. A descriptive analysis of information will be conducted, highlighting oral microorganisms associated with these syndromes and emerging trends in the evidence. Original research studies in any language will be included. We will include randomised controlled trials, cohort studies, case–control studies and other relevant designs if they investigate the oral microbiome and its relation to geriatric syndromes in adults aged 65 or older, regardless of geographic location or setting.

Ethics approval is not required.

Hypertension is the leading risk factor for death globally. Undiagnosed hypertension is common, but the incidence in hospitalised patients is unclear. There are calls for universal facility-based screening for hypertension among all attending patients. The hospital inpatient setting, where blood pressure (BP) is measured routinely and repeatedly, presents an ideal opportunity. However, international hypertension guidelines do not include inpatient BP thresholds for diagnostic or treatment purposes. We investigated the performance of current UK community BP thresholds for diagnosing hypertension in the hospital setting.

Investigate the diagnostic performance of the current UK ambulatory BP diagnostic thresholds for systolic and diastolic hypertension in the hospital setting against the reference test of community-based ambulatory BP monitoring (ABPM).

A prospective diagnostic accuracy study.

Hospital inpatients admitted to three UK centres were approached. Follow-up ABPM was delivered in the community.

Eligible patients were aged between 18 and 80 years, with no prior diagnosis of, or prescription for hypertension, and whose mean cumulative daytime BP was 120 mm Hg to 179 mm Hg systolic and ≤109 mm Hg diastolic from the 24th hour of their hospital admission.

Participants received 24-hour ABPM 4–26 weeks post-discharge, as the reference test for hypertension, with UK diagnostic thresholds of an average daytime BP of ≥135 mm Hg systolic and ≥85 mm Hg diastolic applied. Participants found to be severely hypertensive at the ABPM fitting appointment were also considered reference-test positive but did not proceed with ABPM.

The diagnostic performance of a mean daytime in-hospital BP of ≥135 mm Hg systolic or ≥85 mm Hg diastolic (index test) for the prediction of hypertension diagnosed on ABPM (reference test) was assessed using sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) as primary outcome measures. Additionally, we explored the accuracy of a range of alternative in-hospital systolic and diastolic BP thresholds against the same reference test.

351 participants were enrolled and 206 completed the study protocol. The average age of the 206 participants was 53 years, 55% were male, and 91 (44%) had daytime community hypertension on ABPM reference testing. Of 107 participants with raised in-hospital daytime BP, 59 (55%) had daytime community hypertension. When assessing the performance of the index test for detecting daytime community hypertension, sensitivity was 65% (59/91, 54% to 75%) and specificity was 58% (67/115, 49% to 67%). The PPV was 55% (59/107, 45% to 65%) and NPV was 68% (67/99, 58% to 77%), respectively. A further 45/206 participants (23%) had night-time community hypertension when assessed using European diagnostic thresholds for nocturnal hypertension (120 mm Hg systolic or 70 mm Hg diastolic), while 25/107 of those with raised in-hospital daytime BP (23%) had night-time community hypertension. When assessing the performance of the index test for detecting either day or night-time community hypertension, sensitivity was 62% (84/135, 53% to 70%) and specificity was 68% (48/71, 55% to 78%). The PPV was 79% (84/107, 70% to 86%) and NPV was 48% (48/99, 38% to 59%).

Undiagnosed hypertension is common in hospitalised patients, particularly those with raised in-hospital BP. While in-hospital BP alone is an imperfect predictor and should not be used as a stand-alone diagnostic test, this could serve as a trigger for further assessment of BP in the community after discharge.

The study protocol was registered with the ISCTRN Registry (ISRCTN80586284).

In chronic kidney disease (CKD), anaemia develops and evolves as kidney dysfunction progresses. The treatment of anaemia is described in clinical practice guidelines (CPGs), which are designed to report the most relevant evidence for clinical practice in disease management. This study will analyse CPGs for transparency, methodological quality and quality of recommendations for their implementation over time, and also compare recommendations for the treatment of anaemia outlined in these documents.

CPGs will be identified by conducting a systematic search of the data sources CINAHL, Embase, MEDLINE, Scielo, Scopus, ProQuest, Trip Database, Virtual Health Library, Web of Science, and guidelines on websites, published between January 2009 and December 2025. Three reviewers will, independently, evaluate the methodological quality of the guidelines using the Appraisal of Guidelines for REsearch and Evaluation II (AGREE-II) tool and the quality of recommendations using the AGREE – Recommendations Excellence tool. The treatment recommendations for anaemia in CKD will be summarised and compared. Results will be presented in tables and descriptive statistics will be compiled for all domains of the tools.

This is a literature-based study and, therefore, no ethical approval will be required. Results of the study can be submitted for publication in high-impact, peer-reviewed scientific journals, and also presented at national and international conferences.

CRD42024629656.

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.

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 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.

We compared associations between self-reported and HearCheck screening device measures of hearing difficulty with subsequent general and domain-specific cognitive function in a population-based sample of older English adults.

Observational cohort study.

Population-based sample of older adults in wave 7 of the English Longitudinal Study of Ageing (ELSA) in 2014/15 and its Healthy Cognitive Ageing Project (HCAP) in 2018.

N=1119 adults aged ≥62 years.

Factor scores for general cognitive function and domains of memory, language, orientation and executive function were derived from the HCAP neuropsychological test battery (mean of 0 and SD of 1 for each). Hearing difficulty was assessed using a self-reported 5-point Likert-type scale and the HearCheck screening device, which administered a series of six tones in each ear.

According to the HearCheck device, 48% of participants had a mild or moderate-to-severe hearing difficulty, while 25% self-reported fair or poor hearing. In multivariable-adjusted, population-weighted linear regression models, hearing difficulty identified via HearCheck was associated with worse general cognitive function (β=–0.34 SD units; 95% CI –0.60 to –0.07 for moderate-to-severe hearing difficulty vs good hearing) as well as worse function in domains of memory, language and executive function, each with a dose-response relationship. Self-reported hearing difficulty was not associated with general or domain-specific cognitive function.

Peripheral hearing ability, as captured by the HearCheck screening device, may have stronger relevance for later-life cognitive outcomes than the broader construct of perceived hearing difficulty in one’s daily environment that is captured by a self-reported measure.

To describe the association between place of residence in Alberta, Canada, and cardiovascular event risk among adults newly treated with metformin for type 2 diabetes.

Retrospective cohort study.

Administrative data from Alberta, Canada between 2008 and 2023.

Adult new metformin users, categorised by residence (rural, urban, metropolitan) from postal codes 1 year before metformin.

Cause-specific hazard models were constructed for the primary composite outcome (cardiovascular mortality, hospitalisation for an acute coronary syndrome or stroke) and each of the secondary outcomes (components of the primary outcome and all-cause mortality). Models were adjusted for baseline demographics, healthcare utilisation and diabetes complications.

A total of 236 005 adult new metformin users were identified and distributed across the rural-urban continuum (66% metropolitan, 10% urban, 24% rural). Mean age was 55 years, 55% were men, and mean follow-up time was 5.7 years. There were 19 059 primary composite outcome events, and rural residents were more likely to experience the outcome, adjusted HR (aHR): 1.09 (95% CI 1.06 to 1.13), compared with metropolitan. A significant interaction between residence and cardiovascular event history was identified. When stratified, risk of the primary outcome among those without cardiovascular history and living in a rural area was aHR: 1.16 (95% CI 1.11 to 1.20). Among rural residents with cardiovascular history, the risk was aHR: 0.84 (95% CI 0.78 to 0.91).

Quantifying the association between residence and risk of cardiovascular events may focus the allocation of healthcare resources. Development of targeted intervention programmes should focus on primary prevention in rural areas and secondary prevention in metropolitan areas.

Health systems must guarantee access to quality, safe and effective medicines. Essential medicine lists (EMLs) are crucial prioritisation tools to inform coverage decisions and steward limited health resources under the context of universal healthcare. This study aims to develop a consolidated framework for prioritising the assessment of health technologies to review and update EML for treating diseases or health problems managed in primary healthcare (PHC).

A mixed-methods approach was designed to validate the framework. An initial scoping systematic review will be conducted to search for studies that describe criteria used to prioritise the assessment of health technologies for PHC. The relevant studies will be examined using the Joanna Briggs Institute methodological framework for scoping review studies. A comprehensive search was conducted in the following sources: PubMed, Embase, Cochrane Library, Virtual Health Library (LILACS, WHO IRIS, IBECS, PAHO-IRIS, PAHO, LIS, BRISA), Health System Evidence, Global Healths, Health Evidence and Epistemonikos from the inception until February 2025. Two review authors will screen and extract data independently. The extracted data will be qualitatively analysed and presented in a diagrammatic or tabular form, alongside a narrative summary, in line with Preferred Reporting Items for Systematic Reviews and Meta-Analysis: Extension for Scoping Reviews reporting guidelines. An iterative process online using the Delphi hybrid with stakeholders through predetermined consensus thresholds, a combination of a four-point Likert scale and open-ended questions will be conducted to select and validate the criteria identified in the scoping review.

We will provide a consolidated framework to inform decision-makers for prioritising the assessment of health technologies for the national EML for PHC. This is an important step in using evidence to inform public health policies. We plan to share findings through a variety of means, including publications in peer-reviewed journals, presentations at national conferences, invited workshops and webinars, email discussion lists affiliated with our institutions and professional associations, and academic social media.

Idiopathic pulmonary fibrosis (IPF), an unknown aetiology type of interstitial lung disease (ILD), carries the poorest prognosis and is more common in males and the elderly. Gender differences in baseline presentation, lung function and comorbidities may have an impact on prognostic outcomes.

The aim of this study was to explore gender differences in clinical features, comorbidities and outcomes in IPF in a UK cohort.

This was a retrospective cohort study analysing data from the British Thoracic Society UK IPF ILD Registry from January 2013 to February 2024. We compared baseline characteristics between males and females, and a survival analysis in both genders was performed using the Cox proportional hazards model.

We identified 6666 IPF patients with a mean age at diagnosis of 74.1±8.1. Our cohort was predominantly male (5197, 78%), with a higher proportion of current and ex-smokers compared with females (69.9% vs 59.9%, p

Gender differences in baseline characteristics and prognostic factors were observed in IPF. A gender-based approach in managing IPF is warranted, and further studies are needed to clarify these differences and their impact on IPF management.

The perspectives of stakeholders directly affected by mental health services for autism spectrum disorder (ASD) are essential for the quality of these services. However, it is crucial that these perspectives are informed by the best available evidence and adapted to the local context. This study aims to analyse barriers related to mental health services for children and adolescents with ASD from the perspective of families and caregivers, considering social, racial and gender aspects.

Three steps will be taken: stakeholder engagement through an online meeting to refine the research question and understand the magnitude of the problem; (b) qualitative evidence synthesis using five databases and grey literature to identify studies that have collected and analysed qualitative data on barriers to mental health services for children and adolescents with ASD in Brazil. Only studies conducted in Brazil that consider the perspectives of family members and caregivers will be included. (c) A citizen panel with families of children and adolescents with ASD will be used to discuss and validate the synthesis findings.

We will provide a set of evidence-informed and stakeholder-experienced barriers to mental health services for children with ASD in Brazil. This represents an effort to engage stakeholders in evidence descriptions to inform policy. We plan to disseminate the findings through various means, including peer-reviewed journal publications, presentations at national conferences, invited workshops and webinars, patient associations and academic social media platforms. The project was approved by the Ethics Committee for Research at the University of Sorocaba (approval number 78747224.7.0000.5500).

Open Science Framework—10.17605/OSF.IO/DVAKG.

This systematic review aims to: (1) evaluate how behavioural and psychological factors have been incorporated into cardiovascular disease (CVD) risk prediction models; (2) assess their impact on model performance metrics such as area under the curve (AUC) and net reclassification index (NRI); and (3) identify which specific variables are most consistently associated with predictive improvements. This protocol is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocols (PRISMA-P) 2015, and the systematic review will follow the Cochrane Handbook and report findings based on PRISMA 2020.

A systematic review protocol developed in accordance with the (PRISMA-P) 2015 guidelines.

Systematic searches will be carried out in PubMed, Scopus, Web of Science and Google Scholar, limited to studies published from 2019 to 2024.

Peer-reviewed original studies involving adult populations (≥18 years) at risk of CVD, incorporating at least one behavioural or psychological variable into a CVD risk prediction model. Studies must report model performance metrics such as AUC or NRI. Studies focusing solely on biochemical or demographic factors, paediatric populations, or non-CVD outcomes will be excluded.

Two independent reviewers will screen eligible studies, extract data and assess study quality using the Newcastle-Ottawa Scale and Quality in Prognostic Studies tool. A narrative synthesis will be performed, with meta-analysis conducted if feasible.

Ethical approval is not required for this study. Findings will be disseminated through peer-reviewed publication and conference presentations.

CRD420251014218.

Despite the important role of healthcare services in trauma recovery, many survivors of violence do not seek help. This study aims to examine rates of healthcare utilisation, including differences for physical violence versus rape, gender and physical injury (vs no injury) and obstacles to seeking care within 6 months following incidents of physical violence and rape.

The participants were randomly chosen from the National Population Registry in Norway and invited to participate in a telephone survey on violence exposure and health between June 2021 and June 2022 (N=4299, 49% women).

The sample included 1768 violence-exposed individuals. Of the women (n=749), 82.1% had experienced physical violence and 40.3% had experienced forcible rape. Of the men, most had experienced physical violence (98.6%) and a small percentage had experienced rape (3.5%).

Logistic regression models were used to investigate whether healthcare seeking differed by gender, type of violence (rape vs physical violence) and severity (physical injury). Barriers to accessing healthcare were also investigated using descriptive statistics and content analysis.

Healthcare seeking rates were low after rape (16.9%) and physical violence (24.2%), with somewhat higher rates among individuals experiencing both types of violence (39.9%). There were no statistically significant differences in the odds of healthcare utilisation between the three types of violence exposures when we controlled for gender, physical injury, violence characteristics and sociodemographic factors. Men were more likely than women to have sought healthcare (adjusted OR (aOR): 1.37, 95% CI: 1.02 to 1.85, p=0.042). Physical injury was strongly associated with greater healthcare utilisation (aOR: 6.39, 95% CI: 4.85 to 8.41, p

Few victims seek healthcare shortly after experiencing rape or physical violence. Quantitative and qualitative findings indicate that many seek healthcare exclusively for severe physical injury. These results emphasise the need to improve health services’ outreach to victims of violence, who are at heightened risk of mental health issues and chronic illnesses.

Perioperative adverse events increase morbidity and mortality. The rate and severity of complications and the risk for subsequent mortality are increased after high-risk procedures and in elevated-risk patients. Over the past decades, a multitude of prognostic studies identified perioperative risk factors at the population level. However, to allow for the advancement of precision surgery strategies, improved risk prediction on the individual patient level is warranted. Comprehensive, consecutive, multisource, structured, high-quality patient-related and procedure-related data sets, together with thorough follow-up and combined with state-of-the-art machine-learning analyses, are needed to facilitate precise prediction of perioperative complications. Therefore, we designed and currently conduct the Heidelberg Perioperative Deep Data study (HeiPoDD). Here, we report the rationale and design of the HeiPoDD study.

HeiPoDD is a prospective, single-centre, exploratory cohort study aiming to build up a large-scale deep-data base and corresponding biomaterial collection. 1040 adult patients planned for elective high-risk, non-cardiac surgery for any indication at Heidelberg University Hospital, Germany will be included. The obtained study-specific data set includes clinical data, lab values, genome- and proteome analysis as well as plasma, serum and peripheral blood mononuclear cells (PBMC) collected before and at days 1, 3 and 7 postsurgery. Urine samples are collected before and at day 1 postsurgery. Structured follow-up for perioperative complications such as redo-surgery, length of intensive care stay or length of hospital stay is conducted at days 30, 90 and 1 year postsurgery and for disease progression and survival after 3 and 5 years postsurgery. All study data will be transferred to the HeiPoDD registry to allow merging with all available routine clinical data from the hospital information system including imaging studies as well as haemodynamic and respiratory biosignals. Biomaterials will be stored in the HeiPoDD biomaterial bank to allow further analyses.

The trial protocol and amendments were approved by the ethics committee of the University of Heidelberg (S-758/2021). The protocol is registered with the German Clinical Trial Register (DRKS00024625). Participating patients’ data will be recorded only in pseudonymised form. After completion of the study, data collected during the study will be kept on file for up to 30 years. Biomedical samples collected during the study and entered into the biobank will be held for the same amount of time. The findings will be disseminated in peer-reviewed academic journals.

Outcome after surgery depends on both patient-related as well as procedure-related risks. Complications after surgery are a significant burden to patients and to the health system. A vast amount of often unstructured data from different sources are generated during surgery, which contain valuable information associated with outcome. Advances in computer hardware and machine learning now increasingly facilitate the development of prediction models in standardised, parametric, information-rich areas such as the perioperative setting. For the development and validation of risk scores and prediction models, high-fidelity data sources are required to arrive at meaningful and reliable predictions. However, data quality standards in retrospective studies are rarely met. Therefore, the prospective Heidelberg Perioperative Deep Data Registry and Biomaterial Bank (HeiPoDD - Registry and Bio Bank) was started to implement a clinical data base and a corresponding biobank merging the entirety of available clinical records.

The HeiPoDD - Registry and Bio Bank is a study-driven, prospective, single-centre observational registry data base and biomaterial bank. It contains data and material from eligible patients who give informed consent and undergo elective non-cardiac high-risk surgery at the surgical centre of the Heidelberg University Hospital. The screening for eligibility started in January 2022, with no maximum sample size specified in advance. Routine data are recorded and stored during hospital stay and potential readmissions within 90 days after index surgery. The data are merged with the potentially available genome, proteome, flow cytometry, and bio signal data. Endpoints are obtained from routine observations, stored data in the hospital information system and follow-up visits. Further, data and biological specimens from separate perioperative studies with the patients’ consent can be transferred into the HeiPoDD - Registry and Bio Bank as well. This large-scale data collection will allow the calculation of endpoint-specific prediction models using logistic regression models as well as machine learning models. The first 1040 patients included in the HeiPoDD - Registry and Bio Bank are also included in the HeiPoDD study.

The trial protocol and subsequent amendments were approved by the ethics committee of the University of Heidelberg (S-745/2021). Participating patients’ data will be entered only in pseudonymised form. Data and biomaterials will be kept for up to 30 years. The findings will be disseminated in peer-reviewed academic journals.

DRKS00025924, registered on 2021-11-12.

Aboriginal and Torres Strait Islander people living with disability have unequal access to health and disability support services. The impacts of colonialism and the deficit-based, Western medical model of disability have been identified as barriers to services in remote Aboriginal communities. This study explored different perceptions of disability and identified strategies to help bridge the gap between Aboriginal community members in the Fitzroy Valley and Western health and disability support services.

Aboriginal Participatory Action Research approach with in-depth interviews. Transcripts were analysed using reflexive thematic analysis. Preliminary results were presented to community representatives for contextualisation, validation and to co-design recommendations.

Fitzroy Valley in the Kimberley region, Western Australia.

Aboriginal community members with lived experience of disability (n=7) and health and disability support service providers (n=12).

Eight themes were identified: (1) Aboriginal kinship systems are a community strength and support for people living with disability; (2) Aboriginal people from the Fitzroy Valley perceive disability as a social construct; (3) Western medical model of disability differs from Aboriginal perceptions of disability; (4) Aboriginal people from the Fitzroy Valley perceive different types of disabilities in various ways; (5) good awareness of fetal alcohol spectrum disorder in the Fitzroy Valley, but more education is wanted; (6) focus on functional needs and supports for disability; (7) barriers to disability services and (8) decolonise disability services. Community co-designed recommendations focus on centring the Aboriginal worldviews of disability in the Fitzroy Valley.

Decolonising disability services is needed to improve access for Aboriginal and Torres Strait Islander communities. This should involve adapting the current Western medical model of services to enable strengths-based diagnostic and support services that align with Aboriginal and Torres Strait Islander kinship systems, cultures and ways of being. Community leadership must play a central role in this shift.

Persistent pain after finishing breast cancer treatment is a common and disabling problem. The current state-of-the-art pain management advocates, in addition to biomedical (non-)pharmacological approaches, a biopsychosocial rehabilitation approach to address persistent pain, combining pain science education with promoting an active lifestyle through self-regulation techniques. We propose testing an innovative eHealth self-management support programme for this purpose in the breast cancer population with persistent pain after finishing cancer treatment. This delivery mode is believed to reduce barriers to pain self-management by providing timely, safe and cost-effective assistance addressing the biopsychosocial needs of patients. Utilising a chatbot format, the eHealth programme delivers pain science education and promotes physical activity (PA), personalised through decision-tree-based algorithms to support pain self-management. The programme aims to empower patients with understanding, coping skills and self-management techniques to reduce pain-related disability and enhance participation in daily life. The primary objective is to determine programme effectiveness compared with (1) usual care (superiority) and (2) a similar face-to-face pain self-management support programme (non-inferiority).

A pragmatic, three-arm randomised controlled trial was started in April 2024 at the University Hospitals of Antwerp and Leuven and primary care settings in Belgium. Participants are breast cancer survivors with persistent pain after finishing cancer treatment. Two hundred seventy participants will be randomised to one of three trial arms: (1) eHealth self-management support programme, (2) usual care or (3) a face-to-face self-management support programme. The ‘eHealth self-management support programme’ begins with a pain science education (PSE) module to initially convey key pain-related concepts and provide personalised pain management tips. Then, the programme progresses to daily activity planning to promote an active lifestyle. Guided by the Health Action Process Approach (HAPA) model, participants set and review daily activity goals and track progress. The eHealth self-management programme uses a chatbot and is accessible on any digital device. The ‘usual care programme’ involves sending the participants a study-specific brochure by postal mail and does not include any formal PSE and/or PA programmes. They may pursue or continue self-initiated care. In Belgium, usual care primarily involves pharmacological treatment, general advice on PA and the provision of informational brochures. The ‘face-to-face self-management support programme’ mirrors the eHealth intervention, combining PSE with PA coaching. It starts with three individual sessions with a trained physical therapist for biopsychosocial assessment and PSE, followed by six sessions on goal setting and active lifestyle coaching. The educational content is delivered both verbally and in written form. The primary outcome will be pain-related disability 6 months after baseline assessment. As a key secondary outcome, the effect on pain beliefs and attitudes will be investigated after the educational part of the eHealth and face-to-face programme (ie, at 6 weeks after baseline). Other secondary outcomes related to other dimensions of pain and physical-, psychosocial- and health-economic outcomes will be assessed at 12 weeks and 6 and 12 months after baseline as well.

The study will be conducted in accordance with the Declaration of Helsinki (2024). The protocol has been approved by the ethical committee of the University Hospitals of Leuven and Antwerp. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. Ethical Committee of the University Hospitals Leuven and Antwerp: BUN B3002023000132.

ClinicalTrials.gov Identifier: NCT06308029.

‘Hotspotters’ are patients with complex care needs, defined by problems in multiple life domains and high acute care use. These patients often receive mismatched care, resulting in overuse of care and increased healthcare costs. As reliable data on effective interventions for this population are scarce, the goal of this study is to assess the cost-effectiveness of proactive, personalised, integrated care for this group.

The Hotspotters Project is planned as a stepped wedge cluster randomised controlled trial in 20 primary care practices in the Netherlands. All practices and participants will begin with standard care during the control period (2–8 months), followed by an intervention (12 months) consisting of a positive health intake with goal setting, multidisciplinary meetings, a personalised care plan and proactive care management. The study will conclude with a follow-up (2–8 months), resulting in a total study duration of 22 months. We plan to include 200 patients with (a) problems on two or more life domains and (b) at least two acute care encounters in the previous year. Possible Hotspotters are identified using an Adjusted Clinical Groups-based algorithm or via a local primary healthcare team.

Questionnaires and routine care data will be used to gather data on cost-effectiveness, which will then be assessed using multilevel analysis, with levels for the individual, cluster and duration of control period. Secondary outcomes will include psychological outcomes on self-regulation (proactive coping, patient activation, self-efficacy and intention), experience of care (satisfaction, perceived autonomy support and qualitative data from focus groups) and quality of life, qualitative analysis of the Positive Health approach, implementation outcomes and process evaluation including integration of care.

The Ethics Committee of Leiden University Medical Centre granted approval (METC-LDD, P21.123). Results will be shared through peer-reviewed publication and (inter)national conference presentations.

NCT05878054.

The COVID-19 pandemic dramatically affected schools. However, there are insufficient data on the chronic physical and mental health consequences of the pandemic in school workers.

To determine the prevalence and the functional and mental health impact of pandemic-related chronic health symptoms among school workers towards the end of the COVID-19 pandemic.

Cross-sectional analysis of health questionnaires and serology testing data (nucleocapsid, N antibodies) collected between January and April 2023, within a cohort of school workers.

Three large school districts (Vancouver, Richmond, Delta) in the Vancouver metropolitan area, Canada (representing 186 elementary and secondary schools in total).

Active school staff employed in these three school districts.

COVID-19 infection history by self-reported viral and/or nucleocapsid antibody testing.

Self-reported, new-onset pandemic-related chronic health symptoms that started within the past year, lasting at least 3 months, after a positive viral test among those with a known infection.

Of 1128 school staff enrolled from 185/186 (99.5%) schools, 1086 (96.3%) and 998 (88.5%) staff completed health questionnaires and serology testing, respectively. The N-seroprevalence adjusted for clustering by school and test sensitivity and specificity was 84.7% (95% Credible Interval (95% CrI): 79.2% to 91.8%) compared with 85.4% (95% CrI: 81.6% to 90.3%) in a community-matched sample of blood donors. Overall, 31.1% (95% CI: 28.4% to 34.0%) staff reported new-onset chronic symptoms. These symptoms were more frequently reported in staff with viral test-confirmed infections (38.0% (95% CI: 34.3% to 41.9%)) compared with those with positive serology who were unaware that they had COVID-19 (14.3% (95% CI: 7.6% to 23.6%); p

The pandemic had major health impacts on school workers. To our knowledge, this study is among the first to concurrently quantify a broad range of chronic physical and mental health impacts, highlighting the need for further research and targeted health programmes to address this significant burden.