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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.

Do self-reported and objective hearing measures similarly relate to general and domain-specific cognition? Observational cohort study of older adults in England

Por: OShea · B. Q. · Milan · R. A. · Gross · A. L. · Powell · D. S. · Kobayashi · L. C. · Steptoe · A.
Objectives

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.

Design

Observational cohort study.

Setting

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.

Participants

N=1119 adults aged ≥62 years.

Primary outcome measures

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.

Results

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.

Conclusions

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.

Rurality, type 2 diabetes and risk of cardiovascular events in Alberta, Canada: a retrospective cohort study

Por: Nagy · D. K. · Bresee · L. C. · Eurich · D. T. · Simpson · S. H.
Objective

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.

Design

Retrospective cohort study.

Setting

Administrative data from Alberta, Canada between 2008 and 2023.

Participants

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

Primary and secondary outcome measures

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.

Results

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).

Conclusions

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.

Comprehensive framework for prioritisation of health technologies for updating of essential medicines list to primary healthcare engaging stakeholders: a mixed-methods study protocol

Por: de Oliveira · J. C. · Paganelli · M. O. · de Oliveira · A. M. · Carrillo · J. F. S. · Moura · M. D. G. · Yamauti · S. M. · Lopes · L. C.
Introduction

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).

Methods and analysis

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.

Ethics and dissemination

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.

Gender differences in clinical features, comorbidities and prognostic outcomes in idiopathic pulmonary fibrosis--a retrospective cohort analysis from the British Thoracic Society Interstitial Lung Disease Registry

Background

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.

Objective

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

Method

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.

Results

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

Conclusion

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.

Barriers to mental health services for children and adolescents with autism spectrum disorder in Brazil: protocol for a qualitative evidence synthesis and citizen panel (BARRIER-Free-BR Project)

Por: Lopes · L. P. N. · Boeira · L. d. S. · Figueiredo Modesto · A. C. · Ramos-Silva · A. · Menin · V. P. · Abe · F. C. · Lopes · L. C.
Introduction

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.

Methods

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.

Ethics and dissemination

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).

Trial registration number

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

Incorporating behavioural and psychological factors into cardiovascular disease risk prediction models: protocol for a systematic review

Por: Tang · C. · Ng · N. C.-S. · Ming · L. C. · Wong · R. S.-Y.
Objectives

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.

Design

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

Data sources

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

Eligibility criteria

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.

Data extraction and synthesis

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.

Ethics and dissemination

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

PROSPERO registration number

CRD420251014218.

Healthcare utilisation and barriers to healthcare after violence and rape in the Norwegian population: a cross-sectional, multimethod study

Por: Skauge · A. D. · Aakvaag · H. F. · Strom · I. F. · Nissen · A. · Seifert · L. C. · Överlien · C. · Dale · M. T. G.
Objectives

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.

Design and setting

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).

Participants

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%).

Outcome measures

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.

Results

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

Conclusions

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.

Heidelberg Perioperative Deep Data Study (HeiPoDD): study protocol for a prospective cohort study for prediction of complications after high-risk non-cardiac surgery in a German university hospital

Por: Jung-König · M. · Hölzer · H. T. · Tenckhoff · S. · Kumar · S. · Etheredge · M. · Schaack · D. · Hölle · T. · Schuster · L. C. · Nusshag · C. · Rath · M. · Uhl · C. · Pianka · F. · Michalski · C. W. · Hohenfellner · M. · Arif · R. · Karck · M. · Böckler · D. · Probst · P. · Diener
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Heidelberg Perioperative Deep Data Registry and Biomaterial Bank (HeiPoDD Registry and Bio Bank): study protocol for a prospective single-centre registry and biobank for patients undergoing high-risk non-cardiac surgery in a German university hospital

Por: Hölzer · H. T. · Niklas · C. · Tenckhoff · S. · Feisst · M. · Hölle · T. · Dugas · M. · Zental · N. · Kumar · S. · Schaack · D. · Schuster · L. C. · Etheredge · M. · Dehne · S. · Michalski · C. · Probst · P. · Diener · M. · Weigand · M. A. · Klotz · R. · Larmann · J.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

DRKS00025924, registered on 2021-11-12.

What are the Aboriginal worldviews of disability in the Fitzroy Valley? Aboriginal Participatory Action Research to develop strategies for decolonising disability services

Por: Stubbs · T. · Bedford · M. · Bear · E. · Carter · E. · Pickard · A. · Davies · J. · Thomas · S. · Martiniuk · A. L. C. · Elliott · E. J. · Rice · L. J.
Objectives

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.

Design

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.

Setting

Fitzroy Valley in the Kimberley region, Western Australia.

Participants

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

Results

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.

Conclusions

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.

Study protocol for a pragmatic randomised controlled trial in Belgian primary care and hospital settings on the effectiveness of an eHealth self-management support programme consisting of pain education and coaching of activity needs in breast cancer surv

Por: De Groef · A. · Dams · L. · Moseley · G. L. · Heathcote · L. C. · Wiles · L. K. · Catley · M. · Vogelzang · A. · Hibbert · P. · Morlion · B. · Van Overbeke · M. · Tack · E. · Van Dijck · S. · Devoogdt · N. · Gursen · C. · De Paepe · A. L. · Mertens · M. · van Olmen · J. · Willem · L. · Tja
Introduction

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).

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

ClinicalTrials.gov Identifier: NCT06308029.

Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care use

Por: Tiemes · V. · Leming · K. A. · Borgdorff · H. · Bruijnzeels · M. A. · van Gestel · L. C. · Adriaanse · M. A. · van der Wel · M. · van den Akker-van Marle · E. M. · Numans · M. E. · Vos · R. C.
Introduction

‘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.

Methods and analysis

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.

Outcomes

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.

Ethics and dissemination

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.

Trial registration number

NCT05878054.

Chronic health consequences of the COVID-19 pandemic on school workers: a cross-sectional post-pandemic analysis

Por: Watts · A. W. · Pitblado · M. · Li · S. · Irvine · M. A. · Golding · L. · Coombs · D. · OReilly · C. · OBrien · S. F. · Goldfarb · D. M. · Masse · L. C. · Lavoie · P.
Importance

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.

Objectives

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.

Design

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.

Setting

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

Participants

Active school staff employed in these three school districts.

Exposure

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

Main outcomes

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.

Results

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

Conclusions

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.

Systematic review protocol for effectiveness and cost-effectiveness of non-surgical interventions to prevent diabetes progression in adults with prediabetes

Por: Sui · C. F. · Ming · L. C. · Soh · Y. C. · Ng · C. H. · Al-Worafi · Y. M. · Hussain · Z.
Introduction

Prediabetes (PD), defined by impaired glucose tolerance or impaired fasting glucose, represents a growing global health challenge, with a prevalence projected to increase substantially. PD is a critical intervention target because of its high annual progression rate (5–10%) to type 2 diabetes mellitus (T2DM) and elevated cardiovascular disease (CVD) risk. Non-surgical interventions (NSIs), particularly lifestyle modifications (LMs) and pharmacological therapies, are the cornerstone of PD management, demonstrating efficacy and cost efficiency over surgical options. However, despite LM’s ability to reduce T2DM incidence by 40–70% in trials such as the Diabetes Prevention Program, real-world implementation faces barriers, including resource intensity and complex delivery requirements, which increase upfront costs. We aim to review scientific literature reporting on the effectiveness and cost-effectiveness of NSIs for preventing the progression of PD to T2DM among adults.

Methods and analysis

A comprehensive systematic search will be conducted across major biomedical databases (PubMed, Scopus, Cochrane Library, Web of Science) for records published up to July 2024. We will include studies involving adults diagnosed with PD according to the American Diabetes Association (ADA) or WHO criteria, focusing on LM and pharmacological treatments. Observational and interventional study designs, including economic evaluations, will be considered. Primary outcome: diabetes incidence (ADA or WHO glycaemic criteria). Secondary outcomes: (1) CVD risk factors, (2) health utilities and (3) healthcare cost analyses. The protocol adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 guidelines and is registered with PROSPERO (CRD42024561294). Data extraction and quality assessment will be performed by two reviewers, with discrepancies resolved by the consensus of a third reviewer. Data will be narratively synthesised; if the data allow, a meta-analysis will be conducted.

Ethics and dissemination

This systematic review was exempt from ethical approval as it involved no collection of individual patient data and posed no confidentiality risks. The findings will be shared via publication in a peer-reviewed journal or presentation at relevant conferences.

PROSPERO registration number

CRD42024561294.

Diabetes and cognitive health in India: a nationally representative survey of adults aged 45 years and older

Por: Flood · D. · Green · H. · Gross · A. · Kobayashi · L. C. · Levine · D. A. · Lee · J. · Wixom · C. R. · Langa · K. M.
Objectives

Most research on the relationship between diabetes and cognitive health has used data from high-income countries. This study described this relationship in India, the world’s most populous country.

Design

Cross-sectional analysis of the baseline wave of the nationally representative Longitudinal Ageing Study in India, conducted from 2017 to 2019.

Setting

All 36 Indian states and union territories.

Participants

57 905 adults aged 45 years or older.

Main outcome measures

Scaled cognitive scores (mean of 0 and SD of 1) and cognitive impairment defined as a cognitive score 1.5 SD or below the age-matched and education-matched mean. Diabetes was defined as a self-report of a prior diabetes diagnosis made by a health professional or having a measured haemoglobin A1c ≥6.5%.

Results

In age-adjusted and sex-adjusted models, people with diabetes had cognitive scores that were 0.24 SD higher (95% CI 0.22 to 0.26) and had a 1.2% (95% CI 0.6% to 1.7%) lower prevalence of cognitive impairment than people without diabetes. Differences persisted even when adjusting for demographic, socioeconomic and geographical characteristics. Rural versus urban residence modified the relationships of diabetes with cognitive score (p=0.001) and cognitive impairment (p=0.003). In fully adjusted models, rural respondents with diabetes had 0.05 SD (95% CI 0.03 to 0.07) greater cognitive scores and 1.6% (95% CI 0.9% to 2.4%) lower prevalence of cognitive impairment than those without diabetes. In urban areas, respondents with and without diabetes had similar cognitive scores and prevalence of cognitive impairment.

Conclusions

Middle-aged and older adults with diabetes living in India had better cognitive health than those without diabetes. Rural versus urban area of residence modified this relationship. Urban–rural differences, the nutrition transition and social conditions likely influenced the cross-sectional relationship between diabetes and cognitive health in India, leading to different associations than reported in other countries.

Enhancing cognitive function in breast cancer survivors through community-based aerobic exercise training: protocol for a Hybrid Type I effectiveness-implementation study employing a randomised controlled design

Por: Ehlers · D. K. · Austin · J. D. · Ernst · B. · Page · L. L. · Ofori · E. · Porter · G. C. · Fanning · J. · Hickman · G. · McKim · P. · Cole · M. · Donaldson · M. · Braden · B. B. · Kunze · K. L. · Butterfield · R. J. · Baxter · L. C. · Ahles · T. A. · Estabrooks · P.
Introduction

Despite growing evidence to characterise cancer-associated cognitive decline (CACD) in women with breast cancer, interventions to mitigate CACD are limited. Emerging evidence suggests aerobic exercise may enhance cognition after breast cancer diagnosis and treatment; yet, CACD remains an understudied outcome of exercise, and few high-quality studies have been conducted. In addition to knowledge gaps in effectiveness, the translation of exercise interventions to community settings remains challenging. The Breast cancer Reasoning and Activity INtervention (BRAIN) investigates the effectiveness of aerobic exercise training, delivered in a community-based setting, for improving cognitive function in women with breast cancer and gathers information on the implementation success of the intervention.

Methods and analysis

This Hybrid Type I effectiveness–implementation study is conducted at an academic medical centre in the southwestern United States in partnership with a non-profit, community health and wellness organisation. The study enrols 160 women diagnosed with stage I–IIIa breast cancer and within 3–36 months of treatment completion into a 1:1 randomised controlled trial. Individuals randomised to the exercise group receive a 6-month, individually tailored aerobic exercise programme delivered by exercise trainers employed at local community fitness centres. The programme is progressive in nature and designed to help participants achieve aerobic exercise levels consistent with guidelines for cancer survivors. Individuals randomise to the control group receive a 6-month health education control intervention delivered virtually by hospital-based health educators. Cognitive performance (primary), self-reported cognition, patient-reported outcomes, physical activity and cardiorespiratory fitness are measured at baseline, 6 months (postintervention) and 12 months (follow-up). Brain structure and function are measured via magnetic resonance imaging (MRI) at baseline and 6 months. Implementation outcomes are defined by the RE-AIM framework, which includes reach, effectiveness, adoption, implementation and maintenance. RE-AIM outcomes are measured at baseline, 6 months, 12 months and ongoing during the study.

Ethics and dissemination

This study was approved by the Mayo Clinic Institutional Review Board (#23-000020). All participants provide informed consent prior to participation. Findings will be disseminated to scientific, clinical and community audiences through manuscripts, presentations and newsletters.

Trial registration number

NCT04816006.

Brachial plexus nerve block versus haematoma block for closed reduction of distal radius fracture in adults: The BLOCK Trial - a protocol for a multicentre randomised controlled trial

Por: Dupont Harwood · C. · Jellestad · A.-S. L. · Bahuet · A.-X. R. · Knudsen · R. L. · Andersen · L. C. · Mathiesen · O. · Asko Andersen · J. · Jakobsen · J. C. · Rothe · C. · Jorgensen · C. C. · Viberg · B. · Brorson · S. · Brabrand · M. · Gundtoft · P. H. · Terndrup · M. · Lange · K. H.
Introduction

Distal radius fractures account for one-fifth of all fractures in the active elderly population and may cause chronic pain, loss of hand function and reduced work productivity, imposing a significant socioeconomic burden. Most are initially treated with closed reduction and casting, but 30% subsequently require surgery due to insufficient realignment. The current approaches for analgesia for closed reduction are suboptimal. A brachial plexus nerve block provides complete pain relief and muscle relaxation distal to the elbow, potentially creating better conditions for realignment of the fractured bone ends. This may ultimately translate into reduced need for surgery and result in better functional outcomes and fewer complications compared to a haematoma block, which is the current standard care in Denmark.

Methods and analysis

The BLOCK Trial is an investigator-initiated, parallel-group, allocation-concealed, outcome assessor and analyst-blinded, superiority, randomised, controlled, clinical multicentre trial performed at 11 Danish emergency departments. Eligible adult patients with a distal radius fracture who need closed reduction will be included and allocated 1:1 to either an ultrasound-guided brachial plexus nerve block or a haematoma block. The primary outcome is the proportion of patients with distal radius fracture surgery 90 days after closed reduction. We will include 1716 participants to detect or discard a relative risk reduction of surgery of 20%. Secondary outcomes include treatment-related complications, patient-reported wrist function, pain during closed reduction and proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.

Ethics and disseminationf

The trial is approved by the Danish Medicines Agency and the Danish Research Ethics Committees (EU CT number: 2024-512191-35-00). All results will be summarised on www.theblocktrial.com, clinicaltrials.gov and euclinicaltrials.eu after publication. Primary and secondary outcome results from 0 to 90 days will be presented in the main article and submitted to a peer-reviewed journal. Results from outcomes on the 12-month follow-up will be presented separately.

Trial registration number

NCT06678438.

Developing an evidence brief for policy on implementing deprescribing practices across different levels of healthcare: a protocol

Por: Moura · M. D. G. · Lopes · L. P. N. · de Oliveira · J. C. · Neiva · L. · Fulone · I. · Mazzei · L. G. · Santos · D. M. d. S. S. d. · Lopes · L. C.
Objectives

To identify and contextualise evidence-based strategies for implementing deprescribing practices at different levels of healthcare in Brazil, through the development of an evidence brief for policy that includes stakeholder deliberation and considers barriers, facilitators and equity aspects.

Methods and analysis

This protocol outlines the development of an evidence brief for policy using a mixed-methods design. It involves synthesising evidence for health policies by integrating global research and local evidence through three stages: stakeholder exchange, evidence brief development and external endorsement. The Supporting Policy-Relevant Reviews and Trials tools for evidence-informed health policies will guide both the synthesis of strategies and the facilitation of deliberative dialogues. The synthesis will encompass evidence from systematic reviews and meta-analysis on deprescribing strategies across healthcare levels, focusing on effectiveness, harms, costs, perceptions, barriers, facilitators and equity. Studies proposing strategies not yet implemented will be excluded. Study selection and data extraction will be conducted independently and in duplicate. The methodological quality of included studies will be assessed using the A Measurement Tool for Assessing the Methodological Quality of Systematic Reviews-2 criteria. Synthesised evidence will be used to develop evidence-based strategies, which will then be presented in deliberative dialogues for endorsement by stakeholders and adaptation to the Brazilian context. Endorsement rates will be classified as high, moderate or low based on predefined criteria.

Ethics and dissemination

This study was approved by the University of Sorocaba Research Ethics Committee (certificate 82098324.7.0000.5500). Informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD42024548845.

Methods of assessment of diabetic retinopathy in low- and middle-income countries: a protocol for scoping review

Por: Kousha · O. · Gil · L. C. · Panggalo · I. · Blaikie · A. · Ellis · J.
Introduction

Globally, over a hundred million people are estimated to suffer from diabetic retinopathy (DR), which is a major complication of diabetes mellitus (DM). The prevalence of DM is projected to increase from the current 537 million by almost 50%, to 783 million by 2045. As a result, DR is one of the fastest rising causes of preventable blindness. Three out of four people suffering from DM live in low- and middle-income countries (LMICs), where resources for both diagnosis and treatment are lacking. There has been a reduction in the rate of blindness from DR in high-income countries, while an opposite trend has been noted in LMICs, contributing to this massive morbidity burden. This scoping review aims to ascertain the methods used to assess DR in LMICs.

Methods and analysis

The scoping review will adhere to the Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Review (PRISMA-ScR) guidelines and the Arksey and O’Malley (2005) methodology framework. A systematic search of peer-reviewed literature will be carried out for all papers up to 15 May 2025 by identifying studies from electronic databases, including Embase, Medline and CENTRAL (Cochrane Library). A hand search of the associated reference lists of included studies and grey literature will also be conducted. The identified studies will be screened based on agreed eligibility (inclusion/exclusion) criteria by two independent reviewers, with any disagreements resolved via arbitration from a third reviewer. The data will be thematically summarised according to different aspects of DR assessment methods, and key findings will be elicited. The key findings will provide a comprehensive and clear understanding of the assessment methods used to identify DR in LMICs.

Ethics and dissemination

Ethical approval was not sought for this work as only publicly available information is used. The results will be disseminated through a peer-reviewed publication, conference presentations and meetings with stakeholders.

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