Association between caregiving factors and depression symptoms in family caregivers of persons with disabilities during the COVID-19 pandemic in Hong Kong: a structural equation analysis

Objectives
Caregiving has been widely recognised as a potential risk factor for caregivers’ psychological well-being in previous studies. The objective of this study is to examine the association between multiple factors of the caregiving process and the depression risk of caregivers, as well as the mediating effect of caregiver burden in these associations.

Design
Cross-sectional study.

Setting
The Hong Kong Polytechnic University in Hong Kong Special Administrative Region, China.

Participants
597 family caregivers of persons with disabilities in December 2020 under the Hong Kong governmental initiative, ‘Persons with Disabilities and Rehabilitation Program’.

Main outcome and measures
Indications of depression were assessed through the application of the World Health Organization-Five Well-being Index (1998 version).

Results
A structural equation model (SEM) was applied using Analysis of Moment Structure (AMOS) 28.0 to identify the association between a series of caregiving-related factors and depression risk, as well as test the mediating role of caregiver burden in these associations. 50% of care recipients needed assistance in all four care need categories, with daily living care being the most prominent (72.4%). Caregivers dedicated around 79.6 hours (SD: 52.2) per week on caregiving duties. Nearly 44% of the caregivers had at least one diagnosed disease. Only 5% of caregivers considered that they had a poor caregiving ability, whereas 87.2% of them reported heightened caregiving pressure during the COVID-19 pandemic. In this study, the average caregiver burden score was 6.6 (SD: 3.3), and the average depression score was 6.7 (SD: 5.1). The results of the SEM model showed that care needs of care recipients (ß (95% CI): –0.201 (–0.355, –0.083), p=0.001), weekly caregiving hours (ß (95% CI): –0.126 (–0.215, –0.067), p=0.001) and presence of emotional issues (ß (95% CI): –0.329 (–0.538, –0.184), p=0.001) were positively associated with depression risk of caregivers, fully mediated by caregiver burden. Additionally, caregivers’ health status had both direct (ß (95% CI): –0.234 (–0.388, –0.101), p=0.001) and indirect (ß (95% CI): –0.126 (–0.215, –0.067), p=0.001) effects on depression, indicating that caregiver burden partially mediated this pathway (proportion mediation is 35%). A higher self-evaluation of caregiving ability was related to a lower risk of depression (ß (95% CI): 0.281 (0.169, 0.396), p=0.001), and caregiver burden did not mediate this pathway.

Conclusions
Care needs of care recipients, weekly caregiving hours, caregivers’ health status and presence of emotional issues during the COVID-19 pandemic were adversely associated with an increased depression risk for caregivers, and these were either fully or partially mediated by caregiver burden. Additionally, caregivers’ lower self-evaluation of their caregiving ability was an independent factor that directly contributes to an increased depression risk.

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Psychometric properties of early childhood development assessment tools in low- and middle-income countries: a systematic review

Objective
Valid and reliable measurement of early childhood development (ECD) is critical for monitoring and evaluating ECD-related policies and programmes. Although ECD tools developed in high-income countries may be applicable to low- and middle-income countries (LMICs), directly applying them in LMICs can be problematic without psychometric evidence for new cultures and contexts. Our objective was to systematically appraise available evidence on the psychometric properties of tools used to measure ECD in LMIC.

Design
A systematic review following the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines.

Data sources
MEDLINE, Embase, PubMed, PsycInfo, SciELO and BVS were searched from inception to February 2025.

Eligibility criteria
We included studies that examined the reliability, validity, and measurement invariance of tools assessing ECD in children 0–6 years of age living in LMICs.

Data extraction and synthesis
Each study was independently screened by two researchers and data extracted by one randomly assigned researcher. Risk of bias was assessed using a checklist developed by the study team assessing bias due to training/administration, selective reporting and missing data. Results were synthesised narratively by country, location, age group at assessment and developmental domain.

Results
A total of 160 articles covering 117 tools met inclusion criteria. Most reported psychometric properties were internal consistency reliability (n=117, 64%), concurrent validity (n=81, 45%), convergent validity (n=74, 41%), test–retest reliability (n=73, 40%) and structural validity (n=72, 40%). Measurement invariance was least commonly reported (n=16, 9%). Most articles came from Brazil, China, India and South Africa. Most psychometric evidence was from urban (n=92, 51%) or urban–rural (n=41, 23%) contexts. Study samples focused on children aged 6–17.9 or 48–59.9 months. The most assessed developmental domains were language (n=111, 61%), motor (n=104, 57%) and cognitive (n=82, 45%). Bias due to missing data was most common.

Conclusions
Psychometric evidence is fragmented, limited and heterogeneous. More rigorous psychometric analyses, especially on measurement invariance, are needed to establish the quality and accuracy of ECD tools for use in LMICs.

PROSPERO registration number
CRD42022372305.

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

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

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

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

PROSPERO registration number
CRD42024517097.

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Machine learning of blood haemoglobin and haematocrit levels via smartphone conjunctiva photography in Kenyan pregnant women: a clinical study protocol

Introduction
Anaemia during pregnancy is a widespread health burden globally, especially in low- and middle-income countries, posing a serious risk to both maternal and neonatal health. The primary challenge is that anaemia is frequently undetected or is detected too late, worsening pregnancy complications. The gold standard for diagnosing anaemia is a clinical laboratory blood haemoglobin (Hgb) or haematocrit (Hct) test involving a venous blood draw. However, this approach presents several challenges in resource-limited settings regarding accessibility and feasibility. Although non-invasive blood Hgb testing technologies are gaining attention, they remain limited in availability, affordability and practicality. This study aims to develop and validate a mobile health (mHealth) machine learning model to reliably predict blood Hgb and Hct levels in Black African pregnant women using smartphone photos of the conjunctiva.

Methods and analysis
This is a single-centre, cross-sectional and observational study, leveraging existing antenatal care services for pregnant women aged 15 to 49 years in Kenya. The study involves collecting smartphone photos of the conjunctiva alongside conventional blood Hgb tests. Relevant clinical data related to each participant’s anaemia status will also be collected. The photo acquisition protocol will incorporate diverse scenarios to reflect real-world variability. A clinical training dataset will be used to refine a machine learning model designed to predict blood Hgb and Hct levels from smartphone images of the conjunctiva. Using a separate testing dataset, comprehensive analyses will assess its performance by comparing predicted blood Hgb and Hct levels with clinical laboratory and/or finger-prick readings.

Ethics and dissemination
This study is approved by the Moi University Institutional Research and Ethics Committee (Reference: IREC/585/2023 and Approval Number: 004514), Kenya’s National Commission for Science, Technology, and Innovation (NACOSTI Reference: 491921) and Purdue University’s Institutional Review Board (Protocol Number: IRB-2023-1235). Participants will include emancipated or mature minors. In Kenya, pregnant women aged 15 to 18 years are recognised as emancipated or mature minors, allowing them to provide informed consent independently. The study poses minimal risk to participants. Findings and results will be disseminated through submissions to peer-reviewed journals and presentations at the participating institutions, including Moi Teaching and Referral Hospital and Kenya’s Ministry of Health. On completion of data collection and modelling, this study will demonstrate how machine learning-driven mHealth technologies can reduce reliance on clinical laboratories and complex equipment, offering accessible and scalable solutions for resource-limited and at-home settings.

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Prevalence of microspirometry-detected chronic obstructive pulmonary disease in two European cohorts of patients hospitalised for acute myocardial infarction: a cross-sectional study

Objectives
To establish the prevalence of clinically significant chronic obstructive pulmonary disease (COPD) and relevant characteristics in individuals with a significant smoking history who are hospitalised for acute myocardial infarction (MI).

Design
Cross-sectional study.

Setting
Hospital inpatients at 8 European centres (7 in Sweden, 1 in the UK).

Participants
518 men or women (302 in Sweden, 216 in the UK) hospitalised for acute MI, aged 40 years or older, with a smoking history of at least 10 pack-years.

Primary and secondary outcome measures
The primary outcome was prevalence of detected significant COPD (Global Initiative for Chronic Obstructive Lung Disease stages 2–4), defined as a ratio of forced expiratory volume in 1 and 6 s (FEV1/FEV6)

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Assessment of the impact of multi-cancer early detection test screening intervals on late-stage cancer at diagnosis and mortality using a state-transition model

Objective
Multi-cancer early detection (MCED) tests are novel technologies that detect cancer signals from a broad set of cancer types using a single blood sample. The objective of this study was to estimate the effect of screening with an MCED test at different intervals on cancer stage at diagnosis and mortality endpoints.

Design
The current model is based on a previously published state-transition model that estimated the outcomes of a screening programme using an MCED test when added to usual care for persons aged 50–79. Herein, we expand this analysis to model the time of cancer diagnosis and patient mortality with MCED screening undertaken using different screening schedules. Screening intervals between 6 months and 3 years, with emphasis on annual and biennial screening, were investigated for two sets of tumour growth rate scenarios: ‘fast (dwell time=2–4 years in stage I) and ‘fast aggressive’ (dwell time=1–2 years in stage I), with decreasing dwell times for successive stages.

Setting
Inputs for the model include (1) published MCED performance measures from a large case-control study by cancer type and stage at diagnosis and (2) Surveillance, Epidemiology and End Results (SEER) data describing stage-specific incidence and cancer-specific survival for persons aged 50–79 in the US for all cancer incidence.

Outcome measures
We used the following outcome measures: diagnostic yield, stage shift, and mortality.

Results
Annual screening under the fast tumour growth scenario was associated with more favourable diagnostic yield. There were 370 more cancer signals detected/year/100,000 people screened, 49% fewer late-stage diagnoses, and 21% fewer deaths within 5 years than usual care. Biennial screening had a similar, but less substantial, impact (292 more cancer signals detected/year/100,000 people screened; 39% fewer late-stage diagnoses, and 17% fewer deaths within 5 years than usual care). Annual screening prevented more deaths within 5 years than biennial screening for the fast tumour growth scenario. However, biennial screening had a higher positive predictive value (54% vs 43%); it was also more efficient per 100,000 tests in preventing deaths within 5 years (132 vs 84), but prevented fewer deaths per year.

Conclusion
Adding MCED test screening to usual care at any interval could improve patient outcomes. Annual MCED test screening provided more overall benefit than biennial screening. Modelling the sensitivity of outcomes to different MCED screening intervals can inform timescales for investigation in trials.

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Repetitive transcranial magnetic stimulation in conjunction with scalp acupuncture in treating poststroke cognitive impairment: a protocol for systematic review and meta-analysis

Introduction
Approximately 70% of patients with stroke experience varying degrees of cognitive impairment, which imposes a substantial direct and indirect socioeconomic burden. Previous studies have shown that scalp acupuncture (SA) or repetitive transcranial magnetic stimulation (rTMS) in combination with other therapies is effective for poststroke cognitive impairment (PSCI). Limited by interstudy heterogeneity and the limited number of included studies, there is insufficient evidence of the efficacy of rTMS in combination with SA in treating PSCI. Therefore, this protocol aims to investigate the effectiveness of rTMS in conjunction with SA for patients with PSCI through a comprehensive meta-analysis.

Methods and analysis
This study will undertake a comprehensive search across nine distinct databases (Web of Science, Embase, Cochrane Library, PubMed, China National Knowledge Infrastructure, Wanfang Data, China Science and Technology Journal Database, China Biology Medicine and SCOPUS). The primary outcome will encompass the Montreal Cognitive Assessment and the Mini-Mental State Examination. The secondary outcomes are the modified Barthel Index, the Rivermead Behavioral Memory Test and the Digit Span Test. The bias risk assessment tool from the Cochrane Handbook for Systematic Reviews of Interventions will be used to evaluate bias risk, and the GRADE will be applied to gauge the quality of evidence. Furthermore, we plan to perform an analysis of subgroups to investigate the heterogeneity, employ the leave-one-out approach for sensitivity evaluation and use funnel plots and Egger’s test to determine publication bias, respectively.

Ethics and dissemination
Ethical approval is not required in systematic review and meta-analysis. The review will be published in a peer-reviewed journal.

PROSPERO registration number
CRD42024571762.

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Breaking prolonged sitting with high-intensity interval training to improve cognitive and brain health in middle-aged and older adults: a protocol for the pilot feasibility HIIT2SITLess trial

Introduction
Excessive sedentary time (ST) is linked to dementia risk, poorer attentional control and episodic memory. These cognitive decrements have been associated with decreased functional connectivity (FC) in the frontoparietal network (FPN) and default mode networks (DMN) with ageing. Physical activity (PA) interventions can enhance FC in these networks, but these interventions are not designed to decrease ST among older adults. Prolonged sitting (ie, sitting continuously for ≥20 min) can acutely reduce frontoparietal brain function and attentional control, while a single PA bout lasting at least 20 min can enhance them. It has been theorised that stimulation of the cerebral norepinephrine release through peripheral increase in catecholamines may explain this effect. In contrast, the effects of shorter (

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Long-Term Outcomes of Vagus Nerve Stimulation Paired With Upper Extremity Rehabilitation After Stroke

Stroke, Ahead of Print. BACKGROUND:Persistent upper extremity (UE) impairment is common after stroke. Durable treatment benefits for chronic ischemic stroke are needed. The purpose of this report is to determine the long-term effects of vagus nerve stimulation paired with rehabilitation on impairment, activity, and participation in people with UE impairment after ischemic stroke.METHODS:This is a post hoc analysis of data from the VNS-REHAB (A Pivotal Randomized Study Assessing Vagus Nerve Stimulation [VNS] During Rehabilitation for Improved Upper Limb Motor Function After Stroke) randomized clinical trial. Here, we report unblinded, partial crossover, and pooled 1-year outcomes. Initially, 108 participants across 19 sites with chronic ischemic stroke and moderate-to-severe UE impairment were enrolled in VNS-REHAB. Participants received 18 sessions of in-clinic intensive task-specific rehabilitation and 3 months of self-initiated home-based exercise with either real (active) or sham (control) vagus nerve stimulation. Thereafter, Control participants crossed over to receive in-clinic therapy paired with active stimulation. All participants performed home-based exercises paired with self-initiated active stimulation for 1 year. The Fugl-Meyer Assessment UE, Wolf Motor Function Test, and participation outcomes were assessed through 12 months.RESULTS:Seventy-four participants (69%; 51 male; age, mean±SD, 59.6±8.9) completed 1-year follow-up and provided pooled data through 1 year. At 1 year, compared with baseline, there were improvements in impairment (Fugl-Meyer Assessment UE, 5.23 [95% CI, 4.08–6.39];P

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Association between glucose intolerance and fatty liver disease in women with previous gestational diabetes mellitus in urban Thailand: a prospective cohort study

Objectives
To examine the associations between glucose levels from the antepartum 100 g oral glucose tolerance test (OGTT) and the 6-week postpartum 75 g oral glucose tolerance test (OGTT) and fatty liver disease (FLD) at 1 year postpartum in women with a history of gestational diabetes mellitus (GDM).

Design
A prospective cohort study.

Setting
A tertiary hospital centre in Bangkok, Thailand.

Participants
A total of 130 women with a history of GDM who underwent liver fat assessment at 1 year postpartum.

Outcome measures
FLD and metabolic dysfunction-associated steatotic liver disease were assessed at 1 year postpartum, with diagnosis based on transient elastography and specific cardiometabolic criteria. The associations between OGTT glucose values and FLD were evaluated using logistic regression models, adjusted for potential confounders, including age, pre-pregnancy weight, weight and waist circumference at 1 year postpartum and exclusive breastfeeding. Receiver operating characteristic analyses were also conducted to assess the predictive performance of glucose parameters from antepartum and postpartum OGTTs.

Results
A total of 44 participants (33.8%) were diagnosed with FLD, with 97.7% meeting metabolic dysfunction-associated steatotic liver disease criteria. Elevated fasting plasma glucose levels during pregnancy (adjusted odds ratio (aOR): 1.49; 95% CI: 0.93 to 3.57), in the early postpartum period (aOR: 1.77; 95% CI: 0.92 to 5.05), or across both periods combined (aOR: 2.16; 95% CI: 0.93 to 7.41) were not independently associated with FLD. In contrast, four abnormal glucose values during pregnancy (aOR: 2.53; 95% CI: 1.03 to 7.87) and two abnormal values on the 6-week postpartum 75 g OGTT (aOR: 2.95; 95% CI: 1.06 to 11.20) were independently associated with FLD. The combined presence of abnormal OGTT values from both periods showed the strongest association with FLD (aOR: 3.04; 95% CI: 1.03 to 13.99), demonstrating high specificity (95.3%) but low sensitivity (13.6%).

Conclusions
Elevated glucose levels from the antepartum 100 g OGTT and the 6 week postpartum 75 g OGTT were associated with FLD at 1 year postpartum in women with a history of GDM. Comprehensive glucose monitoring during and after pregnancy may aid early identification of individuals at higher risk.

Trial registration number
Thai Clinical Trials Registry: Registration no. TCTR20211027007. Date of registration: 27 October 2021. Date of initial participant enrolment: 1 November 2021.

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Effect of tibialis anterior focal muscle vibration for gait rehabilitation in hemiplegic individuals during the subacute phase after stroke: the NEUROVIB-AVC study protocol – a multicentric randomised controlled trial

Introduction
Gait recovery remains one of the most determining factors in social participation for poststroke individuals, in whom ankle dorsiflexor function is closely related to gait speed. Focal muscle vibration has shown promising neurophysiological and clinical effects in neuromotor recovery. However, it remains to be determined whether tibialis anterior focal muscle vibration applied to the paretic limb could improve walking speed when implemented in early rehabilitation after stroke occurrence.

Methods and analysis
This study describes a multicentric randomised controlled trial in which 70 participants will be randomly assigned in a 1:1 ratio to the tibialis anterior focal muscle vibration group or the sham group, in addition to their conventional rehabilitation. Participants will receive 100 Hz vibration/sham for 30 min, five times per week, for 8 weeks. The primary outcome will be gait speed, as assessed through a 10 m walking test and will be compared between groups at the end of the intervention. Secondary outcomes will include gait abilities, neuromuscular clinical evaluations and neurophysiological measures. Outcomes will be assessed at baseline and across five visits during and after the intervention, until 16 weeks of follow-up.

Ethics and dissemination
Ethics approval was obtained from the French Ethics Committee ‘Protection des Personnes Nord Ouest III’ in 30 May 2023 (IDRCB: 2023-A00489-36). The results will be published in a peer-reviewed journal and presented at scientific conferences.

Trial registration number
NCT05945212.

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Female sex workers perceptions, concerns and acceptability of OraQuick HIV self-test in Woldia town, North Wollo, Ethiopia: a qualitative study

Objective
To explore female sex workers’ perception, concern and acceptability of OraQuick HIV self-test (HIVST) in Woldia town, North Wollo, Ethiopia, in 2024.

Design
The study used a phenomenological design and the Integrated Behaviour Model as a theoretical framework.

Setting
Woldia town, Ethiopia, is the capital city of North Wollo Zone.

Participants
Twenty female sex workers and 18 key informants in Woldia town were involved.

Results
Most participants had a positive attitude towards testing with these devices and anticipated positive consequences, such as enhanced privacy, decreased waiting time, reduced transportation costs, increased accessibility for immobile individuals, elevated utility in index case screening and testing programmes and the provision of confidential, trustworthy and reliable test results. Most female sex workers perceived that significant people in their social environment approved and used OraQuick HIVST. The facilitators to uptake of OraQuick HIVST among female sex workers included privacy, ease of use and nonrequierement for trained healthcare providers when testing. Thus, most female sex workers were confident in their ability to test themselves and interpret their test result using OraQuick HIVST.
To optimise uptake of testing using OraQuick, female sex workers proposed supplying kits in an easily accessible manner, increasing awareness about the kit and advocating for and promoting that the kits are strategies to facilitate HIVST uptake and maximise individuals’ self-efficacy. The perceived possible concerns or barriers to the uptake of OraQuick HIVST included a shortage of kits, doubts about reliability prior to education, absence of policies or guidelines for HIVST, lack of post-test counselling and immediate treatment for positive individuals, potential psychological trauma such as suicidal ideation or attempts, lack of linkage to care for those with reactive results and inaccurate reporting of positive results or result concealment.

Conclusion
This finding suggests that OraQuick HIVST was acceptable to female sex workers in the study area, with the majority of female sex workers having a positive attitude, supportive social norms and self-efficacy. Therefore, interventions to increase awareness, advocate for the kit and address perceived concerns or barriers to HIVST are needed to maximise its uptake in the study setting.

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Codevelopment of a complex intervention to reduce inequalities in paediatric diabetes secondary care outcomes for children with type 1 diabetes from underserved groups

Objectives
To codevelop (with children and young people with diabetes (CYPD)) an intervention to improve diabetes control and future health outcomes of CYPD from ‘underserved’ groups, to reduce treatment outcome inequalities between different socioeconomic and ethnic groups. To follow Medical Research Council guidance for complex interventions and the COM-B (Capability, Opportunity, Motivation, Behaviour) model for behaviour change intervention development.

Design
In phase 1 (previously reported), we established the evidence base, conducted literature reviews and analysed data from semistructured interviews with CYPD and their carers. In phase 2 (this report), we applied the COM-B framework to identify intervention components; in phase 3 (this report), we evaluated these components, including focus groups with CYPD, their carers’ and healthcare practitioner (HCP) surveys, using the Acceptability, Practicability, Effectiveness, Affordability, Spill-Over Effects, Equity criteria.

Setting
Secondary care; children, young people and their carers’ were approached from two large paediatric diabetes services in England, both with socioeconomically and ethnically diverse underserved populations; paediatric diabetes HCPs were surveyed across four English regions.

Participants
N=69 underserved CYPD (aged 5–19 years) and/or family members took part in interviews; N=48 paediatric diabetes HCP survey respondents (survey 1); N=34 paediatric diabetes HCP survey respondents (survey 2); N=3 young people’s advisory group participants; N=17 underserved CYPD/carers focus group participants; N=9 wider stakeholder participants.

Results
The codevelopment process and integration of COM-B established four elements for an intervention package: (1) an enhanced peer support/mentoring programme; (2) provision of a health and well-being coach to CYPD/families; (3) family/community support to address social and community issues and (4) training for HCPs, including cultural competence, poverty proofing and to emphasise the need for increased sensitivity and better supported communication in work with CYPD from underserved groups.

Conclusions
The Diversity in Diabetes codevelopment work informed an intervention to improve diabetes care in underserved groups, reflecting sociocultural contexts and plausible support options at the individual, community and clinical levels. The ‘Diversity in Diabetes’ programme will next test feasibility and further refine the intervention package in two more paediatric diabetes centres in England.

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Effects of an extended therapeutic strategy versus standard-of-care therapy on persistent acute kidney injury in high-risk patients after major surgery: study protocol for the randomised controlled single-centre PrevProgAKI trial

Introduction
Persistent acute kidney injury (AKI) is associated with an increased morbidity and mortality. In patients with an already established AKI, the new urinary biomarker C-C motif chemokine ligand 14 (CCL14) can predict a persistent AKI. However, it is still unknown whether the implementation of nephroprotective measures in patients with an already established moderate/severe AKI can positively influence the trajectory of AKI and patients’ outcome.

Methods and analysis
The PrevProgAKI trial is a randomised, controlled, single-centre trial designed to evaluate the effectiveness of nephroprotective measures in patients with established moderate/severe AKI. We aim to enrol 480 patients with moderate or severe AKI (Kidney Disease: Imroving Global Outcomes, KDIGO, stage 2 or 3) within 72 hours of major surgery. Eligible patients will be randomised to receive either standard of care (control group) or an extended therapeutic strategy that consists of different supportive measures (intervention group). The randomisation will be stratified by urinary CCL14 results (CCL14

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