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☐ ☆ ✇ BMJ Open

Anatomic versus reverse total shoulder replacement for patients with osteoarthritis and intact rotator cuff: the RAPSODI-UK randomised controlled trial protocol

Por: Rodrick · H. L. · Dias · J. · Watts · A. C. · Walton · M. J. · Brealey · S. · Page · R. · Foster · N. E. · Boland · K. · Cunningham · L. J. · Fairhurst · C. · Geoghegan · J. · Greenwood · W. · Hewitt · C. · Kirwan · C. · Leggett · H. · McDaid · C. · Parkes · M. · Parrott · S. · Powell · R. — Diciembre 12th 2025 at 18:11
Introduction

Shoulder osteoarthritis most commonly affects older adults, causing pain, reduced function and quality of life. Total shoulder replacements (TSRs) are indicated once other non-surgical options no longer provide adequate pain relief. Two main types of TSRs are widely used: anatomic TSR (aTSR) and reverse TSR (rTSR). It is not clear whether one TSR type provides better short- or long-term outcomes for patients, and which, if either, is more cost-effective for the National Health Service (NHS).

Methods and analysis

RAPSODI-UK is a multi-centre, pragmatic, two-parallel arm, superiority randomised controlled trial comparing the clinical- and cost-effectiveness of aTSR versus rTSR for adults aged 60+ with a primary diagnosis of osteoarthritis, an intact rotator cuff and bone stock suitable for TSR. Participants in both arms of the trial will receive usual post-operative rehabilitation. We aim to recruit 430 participants from approximately 28 NHS sites across the UK. The primary outcome is the Shoulder Pain and Disability Index (SPADI) at 2 years post-randomisation. Outcomes will be collected at 3, 6, 12, 18 and 24 months after randomisation. Secondary outcomes include the pain and function subscales of the SPADI, the Oxford Shoulder Score, health-related quality of life (EQ-5D-5L), complications, range of movement and strength, revisions and mortality. The between-group difference in the primary outcome will be derived from a constrained longitudinal data analysis model. We will also undertake a full health economic evaluation and conduct qualitative interviews to explore perceptions of acceptability of the two types of TSR and experiences of recovery with a sample of participants.

Ethics and dissemination

Ethics committee approval for this trial was obtained (London - Queen Square Research Ethics Committee, Rec Reference 22/LO/0617) on 4 October 2022. The results of the main trial will be submitted for publication in a peer-reviewed journal and using other professional and media outlets.

Trial registration number

ISRCTN12216466.

☐ ☆ ✇ BMJ Open

Exploring a panel of serum biomarkers for cancer risk in patients with non-specific symptoms: a comparative analysis of feature selection methods

Por: Monroy-Iglesias · M. J. · Santaolalla · A. · Martin · S. · North · B. · Moss · C. · Haire · K. · Jones · G. · Steward · L. · Cargaleiro · C. · Bruno · F. · Millwaters · J. · Basyal · C. · Weild · S. · Russell · B. · Van Hemelrijck · M. · Dolly · S. — Diciembre 10th 2025 at 11:59
Objectives

Delays in cancer diagnosis for patients with non-specific symptoms (NSSs) lead to poorer outcomes. Rapid Diagnostic Clinics (RDCs) expedite care, but most NSS patients do not have cancer, highlighting the need for better risk stratification. This study aimed to develop biomarker-based clinical prediction scores to differentiate high-risk and low-risk NSS patients, enabling more targeted diagnostics.

Design

Retrospective and prospective cohort study.

Setting

Secondary care RDC in London.

Participants

Adult patients attending an RDC between December 2016 and September 2023 were included. External validation used data from another RDC.

Outcome measures

The primary outcome was a cancer diagnosis. Biomarker-based risk scores were developed using Latent Class Analysis (LCA) and Least Absolute Shrinkage and Selection Operator (LASSO). Model performance was assessed using logistic regression, receiver operating characteristic curves (AUROC) and decision curve analysis.

Results

Among 5821 RDC patients, LCA identified high white cell count, low haemoglobin, low albumin, high serum lambda light chain, high neutrophil-to-lymphocyte ratio, high serum kappa light chain (SKLC), high erythrocyte sedimentation rate (ESR), high C-reactive protein (CRP) and high neutrophils as cancer risk markers. LASSO selected high platelets, ESR, CRP, SKLC, alkaline phosphatase and lactate dehydrogenase. Each one-point increase in score predicted higher odds of cancer (LCA: AOR 1.19, 95% CI 1.16 to 1.23; LASSO: AOR 1.29, 95% CI 1.25 to 1.34). Scores ≥2 predicted significantly higher cancer odds (LCA: AOR 3.79, 95% CI 2.91 to 4.95; LASSO: AOR 3.44, 95% CI 2.66 to 4.44). Discrimination was good (AUROC: LCA 0.74; LASSO 0.73). External validation in 573 patients confirmed predicted increases in cancer risk per one-point LASSO score rise (AOR 1.28, 95% CI 1.15 to 1.42), with a borderline increase for LCA (AOR 1.16, 95% CI 1.06 to 1.27).

Conclusion

Biomarker-based scores effectively identified NSS patients at higher cancer risk. LCA captured a broader biomarker range, offering higher sensitivity, while LASSO achieved higher specificity with fewer markers. These scores may also help detect severe benign conditions, improving RDC triage. Further validation is needed before broader clinical implementation.

☐ ☆ ✇ BMJ Open

Transforming first response through non-police, community safety response programmes: a peer-reviewed and grey literature scoping review protocol

Por: Todd · T. L. · Lappen · H. · Neath · S. · Markham · M. J. · Purtle · J. · Allen · B. · Rouhani · S. · Friedman · B. — Diciembre 5th 2025 at 09:25
Introduction

Police are frequently dispatched to a wide range of 911 calls, including mental and behavioural health crises, despite lacking the training, resources and time to respond effectively. In particular, people with serious mental illness are at elevated risk of experiencing excessive use of force, arrest and continued criminal legal involvement following police contact. Following the murder of George Floyd and other highly publicised police killings, Community Safety Response (CSR) programmes, staffed by unarmed peers, mental health professionals and other trained responders, have proliferated to provide non-police responses to mental and behavioural health and other quality-of-life concerns. CSR programmes have expanded rapidly, yet the evidence base remains fragmented and largely outside the peer-reviewed literature.

Methods and analysis

This scoping review will synthesise peer-reviewed and grey literature from 2020 to present on CSR programmes operating in North America. Guided by Joanna Briggs Institute methodology and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) standards, we will search multiple databases (Medline, PsycINFO, Embase, SocIndex, Web of Science, Policy Commons) and employ complementary grey literature search strategies, including targeted website searches, reference tracking and review of internal and external reports and evaluations. Inclusion criteria require that programmes provide non-police first response to calls traditionally served by law enforcement and include information on programme operations or outcomes. Two reviewers will independently screen and extract data on process metrics including operational characteristics, dispatch, funding, services provided and outcomes such as populations served, diversion from police, service linkage and use of force.

Ethics and dissemination

No ethical review for this study is required as it will not include human subjects or any identifiable information. Findings will provide the first national synthesis of CSR programme models, operations and outcomes. Results will inform policy-makers, practitioners, researchers and community members. Findings will be disseminated through peer-reviewed publications and public-facing products to support implementation, scale-up and sustainability of CSR programmes.

☐ ☆ ✇ BMJ Open

Psychometric Evaluations of the Hospital Survey on Patient Safety Culture Version 2.0 in Ethiopia (E-HSoPSC 2.0): A Cross-Sectional Study

Por: Fekadu · G. · Marshall · A. P. · Muir · R. · Tobiano · G. · Ireland · M. J. — Noviembre 30th 2025 at 04:37
Objectives

To evaluate the psychometric properties of the Hospital Survey on Patient Safety Culture (HSoPSC) version 2.0 in Ethiopian public hospitals.

Design

A cross-sectional study.

Settings

Five public hospitals in Eastern Ethiopia.

Participants

Healthcare professionals (N=582).

Main outcome measure

An adapted and contextualised version of HSoPSC 2.0 was used to conduct structural validity using exploratory and confirmatory factor analyses (EFA and CFA). Convergent and discriminant validity were evaluated through item loadings and interfactor correlations, respectively. Reliability was measured using McDonald’s omega and Cronbach’s alpha.

Results

CFA indicated a poor model fit for the original 10-factor, 32-item HSoPSC 2.0 across all statistical indices: relative chi-square (²/df=7.71), root mean square error of approximation (RMSEA=0.108), standardised root mean square residual (SRMR=0.088), comparative fit index (CFI=0.814) and Tucker-Lewis’s index (TLI=0.780). Consequently, a comprehensive EFA was conducted, which identified a revised model comprising 5-factor, 21-item. This model accounted for 62.8% of the total variance and demonstrated strong construct validity, with excellent fit indices (²/df=3.67, RMSEA=0.068, SRMR=0.034, CFI=0.969, TLI=0.945). Internal consistency, assessed via McDonald’s omega and Cronbach’s alpha, exceeded the acceptable threshold of 0.70 across all dimensions, except for Response to Error (0.66). The convergent and discriminant validity of the new model was confirmed, ensuring an accurate representation of the underlying constructs.

Conclusions

The original HSoPSC 2.0 with 10-factor, 32-item failed to demonstrate structural validity in the Ethiopian healthcare context. In contrast, a revised 5-factor, 21-item model showed strong validity and acceptable reliability. This adapted version provides a culturally and contextually relevant tool for assessing patient safety culture in Ethiopian healthcare settings.

☐ ☆ ✇ BMJ Open

Is harmonisation of curriculum enough to ensure clinical competencies of graduates? Experience of faculty and students from two health training institutions in Tanzania: a qualitative study

Por: Sirili · N. · Temba · P. · Yoram · F. · Kitambala · E. · Hamad · A. K. · Sabas · D. · Mloka · D. · Moshi · M. J. · Mselle · L. T. — Noviembre 28th 2025 at 03:17
Objective

The growing complexity of global health issues underscores the need for a skilled workforce, achievable through competency-based training (competency-based curricula, CBC) that integrates knowledge and practice. Starting from 2022, medical and nursing CBC were harmonised across universities in Tanzania to ensure all graduates attain nationally defined core competencies. The reform aligned programme structure, learning outcomes and assessment methods to promote consistency and interprofessional collaboration. However, questions remain about whether harmonisation alone can ensure the development of practical clinical competencies among students. This study explored the experiences of medical and nursing faculty and students in implementing clinical training as a component of CBC in two health training institutions in Tanzania.

Design

An exploratory qualitative case study was conducted with 67 participants, using 8 in-depth interviews with administrators and 8 focus group discussions with faculty and students. Data were analysed using Braun and Clarke’s thematic approach.

Setting

Two private, faith-based medical universities in the United Republic of Tanzania.

Participants

The study purposefully recruited a total of 67 participants. The participants included university administrators (including Deputy Vice Chancellors for Academics, quality assurance officers and deans), medical and nursing faculty and students (fourth-year medical and third-year nursing students).

Results

Two main themes emerged: challenges in implementing clinical training and strategies used to enforce clinical training. Key challenges included curriculum design gaps, inadequate faculty and clinical instructors, a large number of students and a shortage of hospital staff. Strategies used were utilisation of clinical skills and simulation laboratories, involvement of non-academic clinical specialists’ staff, use of student-centred learning methodologies and leveraging regional, district and specialised private hospitals for clinical teaching.

Conclusions

Despite notable challenges in clinical training, the institutions in this study have implemented proactive strategies to support clinical training. Based on the findings, stakeholders should invest in increasing faculty and clinical instructors and expanding clinical placements to regional, district and private hospitals.

☐ ☆ ✇ BMJ Open

Acute stroke management in the Caribbean: a scoping review protocol

Por: Clervius · H. · Wroblewski · T. H. · Bennett · N. · Wells · M. J. · Lee · M. · Crandon · D. · Then · R. · Aidoo-Frimpong · G. · Etienne · M. · Dos Santos Rubio · E. J. · March-Downer · T. · Inoa · V. · Barthelemy · E. J. · Gordon Perue · G. — Noviembre 25th 2025 at 06:15
Introduction

Stroke is a leading cause of death and disability in the Caribbean, yet there is limited published information on the availability and utilisation of diagnostic imaging and treatment methods. Inequities in healthcare infrastructure, access to neuroimaging and acute treatment options may contribute to poorer outcomes following stroke, particularly in the low-resource settings that characterise most of the Caribbean region. The objective of this review is to map the literature on access to diagnostic and therapeutic modalities for adult stroke care in the Caribbean to identify potential limitations in acute treatment and examine how restricted access may impact outcomes. The resulting data can help inform strategies for improving access to stroke care in resource-limited communities.

Methods and analysis

We will apply a three-step strategy based on the Joanna Briggs Institute methodological framework: first, a limited search to identify relevant articles; second, selection of key search terms; third, implementation into a comprehensive search strategy. The query will range from 1 January 1995 to 1 June 2025 (date of final search). Search results will be extracted and screened by two independent reviewers, and findings will be presented in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. We will consider studies focusing on ischaemic and haemorrhagic stroke in the Caribbean, emphasising access to diagnostic imaging, stroke centres, prehospital management and emergent treatment. Studies examining acute stroke management capacity within the region will be considered. Studies will be excluded if they: focus exclusively on primary stroke prevention, postacute care, longitudinal care pathways for stroke victims or paediatric populations; are unrelated to stroke diagnosis or treatment or are conducted outside the Caribbean.

Ethics and dissemination

This protocol aims to perform secondary analysis of previously published literature; therefore, ethical approval is not required. The results of this review will be disseminated through academic conferences and peer-reviewed publication.

☐ ☆ ✇ BMJ Open

Association between glucosamine use and albuminuria in the UK: a cohort and Mendelian randomisation study

Por: Hayward · S. J. · Constantinescu · A. · Hazelwood · E. · Butler · M. J. · Vincent · E. E. · Satchell · S. C. — Noviembre 21st 2025 at 14:06
Background

Glucosamine is a commonly used ‘over the counter’ dietary supplement. Previous research has identified an association between glucosamine use and several positive health outcomes. However, a plausible biological mechanism for these associations has not yet been identified, meaning the causality of these relationships remains unclear. A protective effect of glucosamine on the vascular endothelium has been suggested as one such possible mechanism. Albuminuria is an early marker of endothelial dysfunction within the kidney and is associated with progression of kidney disease and adverse cardiovascular outcomes. In order to provide insights into the potential biological mechanisms underlying a protective association of glucosamine use with health outcomes, we evaluated evidence for an association between glucosamine use and albuminuria in UK Biobank (N=436 200).

Methods

Univariable and multivariable ordinal logistic regression were performed to evaluate evidence for an association between self-reported glucosamine use and albuminuria (measured as urine albumin creatinine ratio (uACR) categories). As a secondary analysis, we performed Mendelian randomisation (MR) to demonstrate the difficulties in inferring causality in this relationship using currently available data, using summary genetic data from UK Biobank and CDKGen (N=67 452).

Results

We found that people who used glucosamine were more likely to be in a lower uACR group (OR 0.81, 95% CI 0.80 to 0.83, px10–16). This association was robust to sensitivity analyses and was maintained after adjustment for age, sex and measures of obesity. In our MR analysis, we found little evidence for an association of genetically proxied glucosamine use on albuminuria (change in log uACR (mg/g) per SD change in genetic liability=1.11, 95% CI –3.01 to 5.23, p=0.60).

Conclusions

We found that detectable albuminuria was common in UK Biobank participants and we are the first to show that use of glucosamine supplements was associated with lower levels. Though this fits with a plausible biological role of the vascular endothelium in a potential protective effect of glucosamine use on many health outcomes, whether this relationship is causal or confounded remains unclear. We further discuss the inherent difficulties in using genetic instruments to proxy supplement use in MR analyses and highlight the need for a genome-wide association study of measured circulating glucosamine levels.

☐ ☆ ✇ BMJ Open

Examining the pathway to specialist care for children and young people with late presentation of chronic kidney disease in the UK: a qualitative study

Por: Plumb · L. · Sinha · M. · Ridd · M. J. · Caskey · F. · Ben-Shlomo · Y. · Owen-Smith · A. — Noviembre 10th 2025 at 05:24
Objective

Detecting chronic kidney disease (CKD) early can provide opportunities to optimise native kidney function, prevent further decline and plan for timely kidney transplantation if required. Understanding how children are found to have kidney disease and present to specialist kidney care may help tailor interventions to support a timelier diagnosis. The aim of this study was to examine the pathway to specialist care for UK children who present late to nephrology with advanced CKD (requiring kidney replacement therapy within 90 days of first nephrology review) to determine whether there are modifiable aspects to presentation and diagnosis.

Design

Semi-structured, in-depth qualitative study. A topic guide based on the theoretical framework of health behaviour by Scott et al, The Model of Pathways to Treatment, was developed to capture differences in symptom appraisal and help-seeking before reaching nephrology care.

Setting

UK paediatric nephrology units (n=4) between December 2017 and December 2020.

Participants

Children and young people who experienced a late presentation of CKD and their parents/carers.

Results

Twenty-two participants participated across 19 interviews: seven children (two male, median age 16, IQR 13–17.5 years) and 15 parents. A typology of presentation to healthcare was identified: commonly, families reported repeated cycles of primary care help-seeking before onward referral to specialist care, although long appraisal intervals were also noted. In all cases, secondary care referral led to onward nephrology care involvement. Narratives highlighted that not all cases of late presentation could be avoided.

Conclusions

A typology of symptom appraisal and help-seeking can inform interventions to improve CKD detection. Interventions that support symptom appraisal and consideration of targeted CKD testing in children may help reduce appraisal and help-seeking intervals, respectively.

☐ ☆ ✇ BMJ Open

Morphine for chronic breathlessness (MABEL) in the UK: a health economic evaluation of a multisite, parallel-group, dose titration, double-blind, randomised, placebo-controlled trial

Por: Atter · M. J. · Hall · P. · Evans · R. A. · Norrie · J. · Cohen · J. · Williams · B. · Chaudhuri · N. · Bajwah · S. · Higginson · I. · Pearson · M. · Currow · D. · Stewart · G. · Fallon · M. · Johnson · M. — Noviembre 5th 2025 at 06:23
Objectives

To compare costs and health consequences and to assess the cost-effectiveness of using low-dose oral long-acting morphine in people with chronic breathlessness.

Design

Within-trial planned cost-consequences and cost-effectiveness analysis of data from a multisite, parallel-group, double-blind, randomised, placebo-controlled trial of low-dose, long-acting morphine.

Setting

11 hospital outpatients across the UK.

Participants

Consenting adults with chronic breathlessness due to long-term cardiorespiratory conditions.

Intervention

5–10 mg two times a day oral long-acting morphine with a blinded laxative for 56 days.

Primary outcome measures

Mean and SD of healthcare resource use (HRU) by trial arm; mean differences and 95% CI of costs between trial arms.

Secondary outcome measures

Mean differences in 28- and 56-day quality-adjusted life years (QALYs based on EuroQol five-dimension five-level score), Short Form-six dimensional scores and ICEpop CAPability-Supportive Care Measure scores; cost-utility of long-acting morphine for chronic breathlessness.

Results

143 participants (75 morphine and 67 placebo) were randomised; 140 (90% power, males 66%, mean age 70.5 (SD 9.4)) formed the modified intention-to-treat population (participants receiving at least one dose of study medication). There were more inpatient and fewer outpatient services used by the morphine group versus the placebo. In the base-case analysis at 56 days, long-acting morphine was associated with similar mean per-patient costs and QALYs. There was an increase of £24 (95% CI –£395 to £552) and 0.002 (95% CI –0.004 to 0.008) QALYs. Hospitalisations were the main driver of cost differences. The corresponding incremental cost-effectiveness ratio was £12 000/QALY, with a probability of cost-effectiveness of 54% at a £20 000 willingness-to-pay threshold. In the scenario analysis that excluded costs of adverse events considered unrelated to long-acting morphine by site investigators and researchers, the probability of cost-effectiveness increased to 73%.

Conclusion

Oral morphine for chronic breathlessness is likely to be a cost-effective intervention provided adverse events are minimised, but the effect on outcome is small and cautious interpretation is warranted.

Trial registration number

ISRCTN87329095.

☐ ☆ ✇ BMJ Open

The DEXACELL trial--a protocol for a pragmatic, multicentre, double-blind, placebo-controlled, randomised, parallel group, phase 3 superiority trial to assess the effectiveness and cost-effectiveness of DEXAmethasone as an adjunctive therapy for the manag

Por: Joyce · K. · Lear · R. · Hamilton · F. W. · Arnold · D. · Chaudhuri · E. · Connors · J. · Cook · H. · Creanor · S. · Dawe · P. · Goodwin · E. · Hawton · A. · Hayward · C. · Lasserson · D. S. · Ridd · M. J. · Rowe · D. · Shipley · D. · Taylor · H. · Wainman · H. E. · Williams · O. M. · Carlto — Octubre 30th 2025 at 04:18
Introduction

Cellulitis is a common bacterial skin infection causing significant pain, swelling and impact on daily activities, frequently leading to emergency department presentations and hospital admissions. While antibiotics are the mainstay of treatment, they do not directly address inflammation, often resulting in persisting or worsening symptoms in the initial days. Corticosteroids, with their potent anti-inflammatory effects, have shown benefit in other acute infections but are not currently standard care for patients with cellulitis. This trial aims to determine if adjunctive oral dexamethasone can reduce pain and improve outcomes in adults with cellulitis presenting to UK urgent secondary care settings.

Methods and analysis

This is a pragmatic, multicentre, double-blind, placebo-controlled, randomised, parallel group, phase 3 superiority trial, with an internal pilot and parallel health economic evaluation. Adult patients (≥16 years) with a clinical diagnosis of cellulitis (at any body site except the orbit) presenting to urgent secondary care will be screened for eligibility. 450 participants will be randomised (1:1) to receive either two 8 mg doses of oral dexamethasone or matched placebo, administered approximately 24 hours apart, in addition to standard antibiotic therapy. The primary outcome is total pain experienced over the first 3 days postrandomisation, calculated using the standardised area under the curve from pain scores (Numerical Rating Scale 0–10) across up to seven timepoints. Secondary outcomes include health-related quality of life (EuroQol 5 Dimension 5 Level), patient global impression of improvement, analgesia and antibiotic usage, hospital (re)admissions, complications, unscheduled healthcare use, cellulitis recurrence and cost-effectiveness at 90 days. The primary estimand will apply a treatment policy approach to intercurrent events.

Ethics and dissemination

The trial has received ethical approval from South Central—Oxford B Research Ethics Committee (reference: 24/SC/0289) and will be conducted in compliance with Good Clinical Practice and applicable regulations. Informed consent will be obtained from all participants. A model consent form can be seen in . Findings will be disseminated through peer-reviewed publications and conference presentations, and to patient groups and relevant clinical guideline committees.

Trial registration number

ISRCTN76873478.

☐ ☆ ✇ BMJ Open

Comparison of the effectiveness of fast-acting insulin aspart with rapid-acting insulin analogues on glycaemic control: a retrospective cohort study using patient data from primary care practices in England

Por: Davies · M. J. · Alibegovic · A. C. · Jensen · A. B. · Kelkar · P. · Nordsborg · R. B. · Thamattoor · U. K. · Braae · U. C. — Octubre 29th 2025 at 16:48
Objectives

This study compared the effectiveness of first-time use of faster aspart with rapid-acting insulin analogues in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D).

Design, setting

This retrospective cohort study used data from 1 January 2017 to 8 May 2021 captured in the Clinical Practice Research Datalink Aurum database in the UK.

Interventions

Patients with T1D or T2D either initiating faster aspart or another rapid-acting insulin analogue (‘new users’) or switching from a rapid-acting insulin analogue to faster aspart or to another rapid-acting insulin analogue (‘switchers’) were included. The index date was the date of first prescription of faster aspart or a rapid-acting insulin analogue, or of switching to a different rapid-acting analogue or to faster aspart.

Participants

A total of 9695 and 2170 patients were included in the new users (T1D, 1737; T2D, 7958) and switchers cohorts (T1D, 1764; T2D, 406), respectively.

Primary and secondary outcome measures

Glycated haemoglobin (HbA1c) change at 6 months, occurrence of hypoglycaemia from index to 12 months post-index and treatment persistency from index to discontinuation or censoring.

Results

Numerically greater reductions were observed with faster aspart than rapid-acting insulins in T1D switchers and new users in change in HbA1c at 6 months. Patients with T1D who switched to faster aspart experienced a significant reduction in rate of hypoglycaemia (p=0.0021). Treatment persistency was higher with faster aspart than with rapid-acting insulins among T1D switchers. No distinction in treatment persistency was observed between the treatment groups for T1D new users or T2D switchers.

Conclusions

Reductions in HbA1c were numerically larger with faster aspart in three of four subgroups. There was higher treatment persistency with faster aspart vs rapid-acting insulin analogues among T1D switchers.

Trial registration number

NN1218-4967.

☐ ☆ ✇ BMJ Open

Portable devices for the diagnosis of glaucoma: a scoping review

Por: Garba · F. · Kyari · F. · Burton · M. J. · Adler · S. H. · Khan · Z. · Bello · M. · Evans · J. · Gordon · I. · Hu · V. H. · Nolan · W. — Octubre 22nd 2025 at 07:34
Background

Glaucoma is a leading cause of irreversible blindness worldwide. Early detection and continuous monitoring are essential to preventing vision loss, yet traditional diagnostic tools remain largely inaccessible in low-resource settings.

Purpose

This scoping review aimed to map the existing evidence on the use of portable devices for the detection, diagnosis and monitoring of glaucoma.

Methods

We conducted a scoping review in accordance with the Joanna Briggs Institute Manual and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A comprehensive search was performed across major databases to identify studies that evaluated handheld tonometers, portable fundus cameras and visual field testing devices. Data were extracted on study design, population characteristics, devices used, comparators and reported outcomes.

Results

A total of 216 studies published between 1975 and 2024 were included. Most studies (90.3%) were method agreement studies, primarily focused on intraocular pressure (IOP) devices. Only two studies evaluated all three glaucoma assessment domains (IOP, visual fields and fundus imaging). Most studies were conducted in high-income countries, with a smaller number from low- and middle-income countries. Despite variability in performance, many devices demonstrated acceptable agreement with gold standard methods and were assessed in a range of clinical and community settings.

Conclusion

This review highlights the range and characteristics of portable glaucoma devices and their potential for enhancing access to diagnosis and monitoring, particularly in underserved settings. However, the predominance of method agreement studies and the limited integration of multimodal assessments point to gaps in the literature. Future research should focus on comprehensive diagnostic pathways using multiple portable tools and on expanding evaluations in low-resource settings to inform policy and service planning.

☐ ☆ ✇ BMJ Open

Psychosocial interventions for diabetes distress in culturally diverse populations: a systematic scoping review

Por: Weerasinghe · S. A. · Wang · G. · Izadikhah · Z. · Goh · Y. · Ireland · M. J. — Octubre 21st 2025 at 08:30
Objectives

Diabetes distress, arising from the relentless demands of diabetes management, is notably higher in culturally diverse groups. Psychosocial interventions may reduce diabetes distress through cultural tailoring that addresses beliefs and language barriers. This scoping review aimed to map the availability, key features and impact of psychosocial interventions addressing diabetes distress in culturally diverse groups.

Design

This scoping review followed the Arksey and O’Malley framework.

Data sources

Five databases (PubMed, PsycINFO, Cochrane Library, CINAHL and Web of Science) were searched for peer-reviewed publications (2013–2024).

Eligibility criteria

The included studies involved participants from culturally diverse groups who were diagnosed with diabetes and engaged in psychosocial interventions. Our search did not restrict diabetes type, but all included studies enrolled adults with type 2 diabetes. Studies in English, with no restrictions on study design and geographical location were included. The review excluded studies focusing on caregivers of patients with diabetes, healthcare providers, Native and Indigenous groups, and lifestyle interventions focused on physiological outcomes.

Data extraction and synthesis

Study characteristics, participant demographics, intervention features and outcomes (including participant satisfaction and attrition) were extracted and synthesised thematically by intervention type. Findings are presented narratively.

Results

The review included 13 studies. All psychosocial interventions included diabetes education alongside psychosocial strategies, with most being short-term (four months or less) and delivered in person. Small to moderate reductions in diabetes distress were observed in all but three studies. Empowerment-based interventions produced short-term reductions; longer interventions showed more gradual change. These interventions also improved knowledge of diabetes management, self-efficacy, self-management behaviours and social support. In contrast, peer-led interventions showed limited effectiveness in improving psychosocial outcomes. Mixed evidence was found for the value of family-based interventions.

Conclusion

This review recommends the integration of psychosocial interventions into healthcare plans and highlights several gaps in the evidence base, including limited cultural adaptations beyond linguistic modifications, and a limited focus on South Asian and Middle Eastern populations. Future research should consider multi-site RCTs, longitudinal designs and refinement of intervention designs to improve accessibility, cultural relevance, and sustainability over time.

☐ ☆ ✇ BMJ Open

Mechanisms of change in naturalistic mental health care settings: study protocol for a longitudinal multimethod study

Por: Heim · P. · Brose · A. · Böttche · M. · Peters · E. M. J. · Ehrenthal · J. C. · Knaevelsrud · C. · Kerber · A. — Octubre 21st 2025 at 08:30
Introduction

Mental disorders are among the leading causes of the global burden of disease and are often associated with severe functional impairment and high societal costs. Psychotherapeutic, psychopharmacological and internet-based mental health interventions have proven to be helpful, but challenges remain, including only moderate response rates, high relapse rates and barriers to accessing mental healthcare. Much of the existing evidence stems from studies conducted in controlled, often standardised settings that only partially reflect real-world conditions, contributing to a ‘scientist-practitioner gap’. Moreover, the mechanisms of change, such as the interaction between treatment intensity, common factors (eg, the therapeutic relationship) and specific intervention techniques, have not been sufficiently investigated. In particular, the relationship of changes in personality functioning (PF) with mental and physical health has not yet been extensively researched.

Methods and analysis

The PSYMPACT (Psychological Impact Factors of Mental Health Treatments) study will use a longitudinal study design with a naturalistic sample (N 3000) to examine changes in psychopathology, PF and allostatic load in psychotherapeutic, psychopharmacological and internet-based treatments. The aim is to identify factors contributing to improvements and deteriorations in mental and physical health across different settings, including common and specific factors. Additionally, to provide patient perspectives, qualitative interviews will be conducted with individuals with varying levels of severity of mental health problems. Allostatic load will be assessed using repeated hair cortisol measurements. Furthermore, ecological momentary assessment will be used to examine the diurnal variability of PF as well as its more momentary correlates and longer-term outcomes. The central research questions and aims include (1) the assessment of common factors across different treatment settings, (2) associations of specific and common factors with improvements in mental health, including PF, (3 and 4) the importance of treatment intensity and interaction effects with common and specific factors, (5) the association of changes in psychopathology with changes in allostatic load, (6) the trait and state variability of PF, (7) the identification of patients who deteriorate under specific treatments and (8) patients’ perspectives on the effectiveness of different treatment modalities.

Ethics and dissemination

Approval was obtained from the Ethics Committee of the Department of Education and Psychology at the Freie Universität Berlin, Germany. Results will be submitted to peer-reviewed specialised journals and presented at national and international conferences.

Registration details

Before data collection started in November 2024, the study was registered in the German Clinical Trials Register (https://www.drks.de/search/de/trial/DRKS00035560).

☐ ☆ ✇ BMJ Open

Patterns of follow-up testing of abnormal eGFR and UACR for the detection of chronic kidney disease in Australian primary care: analysis of a national general practice dataset

Por: Li · A. K. · Kotwal · S. · Wallace · H. · Ketema · D. B. · Wick · J. · Neuen · B. L. · Falster · M. O. · Lin · J. · Pearson · S.-A. · Peiris · D. · Jardine · M. J. · Woodward · M. · Chalmers · J. · Ronksley · P. E. · Jun · M. — Octubre 15th 2025 at 09:50
Objective

To evaluate the patterns of abnormal estimated glomerular filtration rate (eGFR) and urine albumin–creatinine ratio (UACR) follow-up testing for the detection of chronic kidney disease (CKD) in Australian general practices.

Design

Retrospective, population-based observational study.

Setting and participants

2 717 966 adults who visited a MedicineInsight participating general practice between 1 January 2012 and 31 December 2020, had ≥1 serum creatinine measurement (with or without a UACR measurement) and did not have CKD at baseline.

Main outcome measure

‘Guideline-concordant follow-up’ was defined as having a record of a repeat eGFR or UACR testing (assessed separately) within 6 months following the abnormal (eGFR2; UACR≥2.5 mg/mmol in males, ≥3.5 mg/mmol in females) incident result. Multivariable logistic regression was used to identify patient factors associated with receiving appropriate follow-up testing.

Results

A total of 220 841 and 114 889 patients with an abnormal incident eGFR and UACR result, respectively, were identified. Nearly half (45.0%) of the patients with an abnormal eGFR result and over two-thirds (69.7%) of the patients with an abnormal UACR result did not have a follow-up test within 6 months. Patient factors associated with a higher likelihood of follow-up eGFR testing included indicators of poorer baseline health and greater CKD risk, such as comorbid diabetes (adjusted OR 1.36, 95% CI 1.32 to 1.40) or more severe incident eGFR (adjusted ORs for eGFR categories 30–44, 15–29 and

Conclusions

In this large, population-based study, we observed substantial gaps in the follow-up of abnormal eGFR and UACR for the detection of CKD in primary care settings. Effective strategies to optimise follow-up testing for CKD detection are needed.

☐ ☆ ✇ BMJ Open

Systematic protocol to identify 'clinical controls for paediatric neuroimaging research from clinically acquired brain MRIs

Por: Zimmerman · D. · Mandal · A. S. · Jung · B. · Buczek · M. J. · Schabdach · J. M. · Karandikar · S. · Kafadar · E. · Gardner · M. · Daniali · M. · Mercedes · L. · Kohler · S. · Abdel-Qader · L. · Gur · R. E. · Roalf · D. R. · Satterthwaite · T. D. · Williams · R. · Padmanabhan · V. · Seid — Octubre 15th 2025 at 09:50
Introduction

Progress at the intersection of artificial intelligence and paediatric neuroimaging necessitates large, heterogeneous datasets to generate robust and generalisable models. Retrospective analysis of clinical brain MRI scans offers a promising avenue to augment prospective research datasets, leveraging the extensive repositories of scans routinely acquired by hospital systems in the course of clinical care. Here, we present a systematic protocol for identifying ‘scans with limited imaging pathology’ through machine-assisted manual review of radiology reports.

Methods and analysis

The protocol employs a standardised grading scheme developed with expert neuroradiologists and implemented by non-clinician graders. Categorising scans based on the presence or absence of significant pathology and image quality concerns facilitates the repurposing of clinical brain MRI data for brain research. Such an approach has the potential to harness vast clinical imaging archives—exemplified by over 250 000 brain MRIs at the Children’s Hospital of Philadelphia—to address demographic biases in research participation, to increase sample size and to improve replicability in neurodevelopmental imaging research. Ultimately, this protocol aims to enable scalable, reliable identification of clinical control brain MRIs, supporting large-scale, generalisable neuroimaging studies of typical brain development and neurogenetic conditions.

Ethics and dissemination

Studies using datasets generated from this protocol will be disseminated in peer-reviewed journals and at academic conferences.

☐ ☆ ✇ BMJ Open

A prospective protocol for remotely investigating brain-behaviour-genetics associations in adolescent patients in a paediatric health system with pre-existing clinical brain MRIs

Por: Mercedes · L. · Buczek · M. J. · Kafadar · E. · DiDomenico · G. · Jung · B. · Zimmerman · D. · Schabdach · J. M. · Himes · M. M. · Sotardi · S. · Vossough · A. · Driesbaugh · K. H. · Moore · T. · Barzilay · R. · Calkins · M. E. · Gur · R. E. · Roalf · D. R. · Satterthwaite · T. D. · Whit — Octubre 15th 2025 at 09:50
Introduction

Adolescence is a critical period marked by rapid brain development and the onset of many mental health disorders. Brain MRI studies during adolescence, especially when paired with behavioural phenotypes and information about genetic risk factors, hold promise to advance early identification of mental health risk and spur the creation of targeted treatments to improve patient function, prognosis and quality of life. However, prospective neuroimaging is costly and time-intensive, and individuals who participate may not be reflective of the general population. These challenges are compounded when examining adolescents, as many families lack the time, energy or resources to participate in studies that use research-grade imaging. Repurposing clinical MRIs obviates many of the challenges of neuroimaging research. Here, we describe the brain-behaviour-genetics study protocol. This protocol describes procedures used to recruit participants with recent high-quality clinical brain MRIs and prospectively acquire genetic and sociobehavioural data, resulting in a highly cost-efficient design that harnesses a vast and underused neuroscientific resource.

Methods and analysis

The brain-behaviour-genetics protocol aims to recruit 1000 adolescents who have clinical brain MRIs contained in Children’s Hospital of Philadelphia’s electronic health record. One or both parents of the adolescent proband will be recruited when possible. Parents and adolescents will complete a series of self-report scales spanning the domains of mental health, trauma, risk and resilience. Saliva samples will be collected from the adolescent and at least one biological parent, using an at-home saliva collection kit. Subsequent analysis will examine associations between brain development, genetics and behavioural measures in adolescence.

Ethics and dissemination

Approval for the study had been obtained from the Children’s Hospital of Philadelphia’s institutional review board (IRB #23–0 20 851). Results will be published in peer-reviewed journals.

☐ ☆ ✇ BMJ Open

Cohort of allergic rhinitis evaluation of effectiveness and safety of herbal medicine (CARE-HM): protocol for the clinic-based multicentre Korean Medicine Registry

Por: Kim · S.-D. · Lee · B. · Chang · G. T. · Lee · E. K. · KM Doctors Group · H. C. · Ko · M. M. · Kim · A. · Kim · Y. E. · Seo · S.-M. · Son · M. J. — Octubre 15th 2025 at 09:50
Background

Allergic rhinitis (AR) is a common chronic inflammatory condition that significantly impairs quality of life (QoL) through symptoms such as nasal congestion, rhinorrhoea, sneezing and itching. Conventional treatments often show limitations, prompting interest in complementary therapies like herbal medicine (HM). HM is widely used in East Asian countries and has demonstrated potential in modulating immune responses and reducing AR symptoms. In Korea, a government pilot project expanded in 2024 to include AR under limited insurance coverage for HM, highlighting the need for robust clinical evidence on its safety and effectiveness.

Methods and analysis

This study is a multicentre, prospective registry conducted in 21 Korean Medicine (KM) clinics across Republic of Korea. The registry systematically collects real-world data on HM treatments for AR, focusing on patient demographics, treatment patterns and clinical outcomes. Participants meeting predefined criteria will receive HM or other KM therapies as part of routine care. Data will be collected bi-weekly for the first 4 weeks, with additional follow-ups at 6 and 12 months. Primary outcomes include changes in Total Nasal Symptom Score, QoL scores and safety evaluations, analysed using descriptive and inferential statistical methods.

Ethics and dissemination

This study was approved by the Institutional Review Board of Kyung Hee University on 11 December 2024 (Approval No. KHSIRB-24–631). The study findings will be published in peer-reviewed journals and presented at academic conferences.

Trial registration number

KCT0010172.

☐ ☆ ✇ BMJ Open

Evaluating practices in the management of youth nicotine vaping in hospital-based child and youth mental health and addictions settings in Canada: protocol for a mixed-methods study

Por: Mahdi · A. · Alfadhli · L. · Chadi · N. · Etches · S. · Ignaszewski · M. J. · Panesar · B. · Porath · A. · Desclouds · P. · Constantakis · S. · Samaan · Z. · Hatcher · S. · Brouwers · M. · Rosic · T. — Octubre 10th 2025 at 11:24
Introduction

Nicotine vaping is common among children and youth, and even more so among those with mental health concerns. Identifying and managing nicotine vaping in child and youth mental health treatment settings is key to addressing this modifiable risk factor for poorer physical and mental health in young people. Recommendations exist for screening, assessment and treatment of youth vaping; however, it remains unclear whether current practices in child and youth mental health programmes align with recommended standards.

Methods and analysis

An explanatory sequential mixed methods design with three stages will be employed. In the first stage, a cross-sectional survey will be distributed to all eligible Canadian hospitals to identify practices in assessment and treatment of nicotine vaping within their child and youth mental health and addictions programmes. This survey will also assess barriers and facilitators for the uptake of the 2021 Canadian Paediatric Society recommendations on management of youth vaping. Semi-structured focus groups and interviews will be conducted in stage two, with clinicians, managers, youth and caregivers. Qualitative data will be analysed using a reflexive thematic approach. In stage three, findings and proposed behaviour change interventions will be reviewed at a knowledge mobilisation meeting with the goal of developing a national knowledge mobilisation plan to improve assessment and treatment of youth vaping in hospital-based mental health and addictions programmes.

Ethics and dissemination

This study has received ethics approval from the Research Ethics Board at the Children’s Hospital of Eastern Ontario (Protocol #25/19X). Participants will provide informed consent prior to participating. Results will be published in peer-reviewed journals and presented at scientific conferences. Summaries will be provided to the funders of the study and to participating hospitals.

☐ ☆ ✇ BMJ Open

Development and validation of diagnostic and prognostic prediction tools for dental caries in young children through prospective and cross-sectional observational studies: a protocol

Por: Khazaei · Y. · Kodikara · S. · Butler · C. A. · Messina · N. L. · Le Cao · K.-A. · Dashper · S. G. · Silva · M. J. — Octubre 6th 2025 at 02:14
Introduction

Dental caries is the most common oral disease worldwide, affecting up to 90% of children globally. It can lead to pain, infection and impaired quality of life. Early prevention is a key strategy for reducing the prevalence of dental caries in young children. Valid and reliable diagnostic or prognostic tools that enable accurate individualised prediction of current or future dental caries are essential for facilitating personalised caries prevention and early intervention. However, no efficacious tools currently exist in early childhood—the optimal period for disease prevention. We aim to develop and validate diagnostic and prognostic prediction tools for dental caries in young children, using a combination of environmental, physical, behavioural and biological early life data.

Methods and analysis

Data sources include two prospective studies, with a total sample size of approximately 600 children. These cohorts have collected detailed demographic, antenatal, perinatal and postnatal data from medical records and parent-completed questionnaires and biological samples including a dental plaque swab. Candidate predictor variables will include sociodemographic characteristics, health history, behavioural and microbiological characteristics. The outcome variable will be the presence, incidence or severity of dental caries diagnosed using the International Caries Detection and Assessment System. Statistical and machine learning approaches will be used for selection of predictor variables and model development. Internal validation will be conducted using resampling methods (i.e., bootstrapping) and nested cross-validation. Model performance will be evaluated using standard performance metrics such as accuracy, discrimination and calibration. Where feasible, external validation will be performed in an independent cohort. Model development and reporting will be guided by the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) statement and the Prediction model Risk Of Bias Assessment Tool (PROBAST) guidelines.

Ethics and dissemination

This study has ethical and governance approval from The Royal Children’s Hospital Melbourne Human Research Ethics Committee (HREC/111803/RCHM-2024). Results of this study will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number

Infant2Child: ACTRN12622000205730—pre-results; MisBair: NCT01906853—post results.

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