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Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) - protocol of a feasibility pilot randomised controlled trial

Por: Guzzetta · A. · Bancale · A. · Bedoshvili · A. · Bosanquet · M. · Chorna · O. · Corsi · G. · Del Secco · S. · Elliott · C. · Fiori · S. · Fripp · J. · Gole · G. A. · Gordon · A. · Harpster · K. · Hunt · R. W. · Leishman · S. · Mori · R. · Morgan · C. · Novak · I. · Pagnozzi · A. M. · Pannek
Introduction

Visual impairment is reported to affect 40%–50% of children with cerebral palsy (CP). Vision difficulties in the context of rehabilitation are often under-recognised, under-treated and therefore under-studied, pointing to an urgent need for the development of evidence-based vision interventions for infants and toddlers with cerebral vision impairment (CVI). We present the protocol of a multisite pragmatic pilot randomised controlled trial (RCT) of feasibility, acceptability and preliminary efficacy of an early vision-awareness and parent-directed environmental enrichment programme for infants with or at risk of CP under 7 months corrected age (CA) with vision impairment.

The main objective is to determine the feasibility and acceptability of the Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) intervention. We will estimate the preliminary effects of the programme on infants’ visual functions and early development, as compared with standard community-based care (SCC).

Methods and analysis

A two-group RCT will be conducted. Infants at 3–6 months at entry, with severe visual impairment and at high risk of CP, will be enrolled and randomised (n=16 per group) to receive the VISIBLE intervention compared to SCC. Randomisation will be completed through an independent automated process (Research Electronic Data Capture). VISIBLE intervention will be delivered by a therapist through home visits (90–120 min) once every 2 weeks. Completion of 10 visits (80% of the intervention target dose) within 6 months is required for adherence to the VISIBLE trial. Outcome will be assessed at 12 months CA. Visual function will be evaluated with the Infant Battery for Vision, motor outcomes with the Peabody Developmental Motor Scales, Second Edition. Developmental quotients, infant quality of life, parent well-being and parent-infant relationship will be also monitored through standardised tools.

Ethics and dissemination

The enrolling sites have historically demonstrated rapid and effective translation of successful evidence-based interventions into routine clinical practice, as well as the dissemination of the findings through local, national and international scientific meetings.

Trial registration number

ACTRN12618000932268.

Patients experiences of the path to sarcoma diagnosis: a qualitative systematic review and thematic synthesis

Por: Schambye · M. E. R. · Kotter · M. F. · Rosing · J. A. M. · Dybdal · D. · Mathiasen · R. · Hjalgrim · L. L.
Objective

To explore existing qualitative research on patients’ experiences from the onset of symptoms to the diagnosis of sarcoma, with the purpose of identifying patient-perceived barriers at both patient and healthcare system levels and to highlight opportunities for improvement.

Design

Systematic review of qualitative studies using thematic synthesis.

Methods

We systematically searched Medline [Ovid], Embase [Ovid], PsycINFO [EBSCOhost] and CINAHL [EBSCOhost] from database inception to 11 April 2025 for qualitative studies reporting sarcoma patients’ experiences during their diagnostic trajectory. The final search was conducted on 11 April 2025. All articles were screened against predefined inclusion and exclusion criteria and methodological quality was appraised using the Critical Appraisal Skills Programme qualitative checklist. Six studies conducted in Australia, the Netherlands and the UK were included. Data were analysed using a thematic synthesis approach guided by Thomas and Harden (2008). Confidence in the synthesised findings was assessed using the Grading of Recommendations Assessment, Development and Evaluation - Confidence in the Evidence from Reviews of Qualitative Research (GRADE-CERqual) approach.

Results

Four overarching themes emerged: patients’ experience and interpretation of symptoms, diagnostic pathways, healthcare system factors, and reflections and recommendations. Key contributors to delayed diagnosis were symptom normalisation, misattribution by both patients and healthcare professionals, limited continuity of care and communication challenges. These findings were consistent across multiple countries, indicating relevance and validity in many settings. Patients emphasised the importance of disease awareness, persistence of patients and coordinated care.

Conclusions

Diagnostic delays in sarcoma are influenced by both patient and healthcare systemic factors. Addressing these factors requires increased disease awareness among healthcare professionals and the public, improved coordination within the healthcare system, and targeted research to guide future interventions. This review provides cross-country insights into barriers to early sarcoma diagnosis, informing future priorities in clinical practice and research.

PROSPERO registration number

CRD420251030726.

Challenging history taking encounters: a systematic review, meta-analysis and phenomenological framework

Por: Hossain · S. · Murray · K. · Zhang · L. · Jassem · A. M. · Clarke · J. · Somers · J. · Dias · R. · Uridge · A. · Sharma · S. · Teodorczuk · A. · Keijzers · G. · McConnell · H. · Sun · J. · Amey · L. · Broadley · S. A.
Objectives

All physicians will experience challenging history taking encounters, where communication is impaired and negatively impacts the diagnostic process. The aims of this systematic review were to (1) undertake a meta-analysis of the frequency of challenging encounters; (2) collate adverse outcomes of challenging encounters; (3) identify underlying causes of challenging encounters; (4) identify strategies to deal with different challenges; and (5) align these strategies with our published phenomenological framework of history taking challenges.

Design

This was a systematic review and meta-analysis of prevalence data adhering to the Preferred Reporting Items for Systematic reviews and Meta-Analyses and the Meta-analyses of Observational Studies in Epidemiology guidelines.

Data sources

A literature search in MEDLINE, Embase and Cochrane databases was performed on 12 July 2020, and updated on 4 August 2025, focusing on challenging history taking encounters in any clinical setting.

Eligibility criteria

Articles reporting on the frequency, adverse outcomes, causative factors or strategies used to address challenges in the history taking process in any clinical area of medicine.

Data extraction and synthesis

Factors associated with challenging history encounters (causative or consequential) were categorised using inductive coding and referenced to a phenomenological framework. Meta-analysis was used to estimate the prevalence of history taking encounters using a restricted maximum likelihood model with 2 and I2 as tests for heterogeneity and funnel plot with Egger’s test for publication bias.

Results

73 articles were included in the analysis. The overall prevalence of challenging history taking encounters was 19.5% (95% CI 14.2% to 24.7%). Adverse outcomes of patient dissatisfaction (level 1 evidence) and diagnostic uncertainty (level 3 evidence) were identified. Factors associated with (n=22) and strategies to mitigate challenging encounters (n=13) were categorised. Correlation of factors and strategies with a phenomenological approach created a framework to assist novice history takers in approaching such circumstances.

Conclusions

Challenging history taking encounters are common. Little is known of the relative importance of factors associated with challenging history taking encounters or the impact of suggested strategies. Many of the suggested strategies to facilitate meaningful communication in these situations involve a departure from standard history taking. More research is required to better define the nature of challenges encountered in history taking with a view to develop better educational models for trainee physicians.

Factors associated with fatigue in patients with systemic lupus erythematosus in an outpatient tertiary care setting: a cross-sectional cohort study

Por: Chapman · M. · Rizvi · A. M. · Qutab · M. · Munday · A. · Biehl · A. · Manna · Z. · Hasni · S.
Objectives

Fatigue is one of the most common and debilitating symptoms experienced by patients with systemic lupus erythematosus (SLE). Previous studies revealed the association of fatigue with various SLE and non-SLE-related factors. This study aims to explore the prevalence of fatigue and the factors that are associated with fatigue experienced by SLE patients in an outpatient rheumatology clinic setting.

Design

Prospective, observational study using a sample of convenience.

Setting

Outpatient rheumatology clinic at a tertiary care centre.

Participants

Consecutive subjects with SLE presenting for their outpatient visits enrolled in the ongoing Institutional Review Board-approved ‘Pathogenesis and Natural History of SLE’ protocol.

Primary and secondary outcome measures

Disease activity and organ damage accrual were measured by Safety of Estrogens in Lupus Erythematosus: National Assessment Version of the Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) and Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR DI), respectively. Fatigue was measured by the self-reported Fatigue Severity Scale (FSS), and a score of ≥4 was used to define clinically significant fatigue. Correlation analyses were done to determine the association between fatigue and patient demographics, and SLE disease activity and damage indices. Results were considered as statistically significant at p

Results

183 patients completed the study, with a significant proportion (144/183) belonging to ethnic minorities. The overall FSS score was mean (±SD) 4±1.8 and SELENA-SLEDAI score of 3±2.6. The group reporting significant FSS scores ≥4 (N=95) included a higher proportion of White patients, more organ damage (SLICC/ACR DI score mean (±SD) 1.9±1.9) and higher body mass index (BMI) mean (±SD) 29.6±6.7 kg/m2; as compared with the group with FSS scores 2 (p=0.03).

Conclusions

Our study found that organ damage accrual, specifically pulmonary fibrosis and neuropathy as measured by SLICC-ACR DI and high BMI, is associated with clinically significant fatigue in SLE. Furthermore, our results support previous findings that fatigue is independent of SLE disease activity. Findings of our study need to be replicated in independent SLE cohorts measuring fatigue at multiple time points. Mechanistic studies are needed to better understand pathogenesis of fatigue in SLE.

Priorities for the development of a new rapid diagnostic test for patients with fever: a cross-sectional online survey among hospital physicians across Europe

Por: Bonnet · G. · Nielsen · M. J. · Foss · A. M. · Lewin · A. · Nijman · R. G. · Fitchett · E. · Carrol · E. · Yeung · S. · the DIAMONDS consortium · Bonnet · Nielsen · Foss · Lewin · Nijman · Fitchett · Carrol · Yeung
Objective

This study aimed to understand hospital doctors’ priorities (target use cases and aetiologies) for the development of a new rapid diagnostic test for patients with fever.

Design

A cross-sectional online survey.

Setting

Europe-wide.

Participants

Secondary and tertiary care doctors involved in patient assessment and diagnosis across Europe.

Intervention

Online survey from April to September 2024.

Main outcome measures

Importance of developing a new test on a scale of 1–10 for up to 19 ‘use cases’ (types of febrile presentations in specific demographic groups): use case scores and ranks and differences across subgroups of respondents, with free text to capture additional suggestions; respondents’ preferences (multiple choice) regarding which aetiologies should be included in a new test.

Results

265 respondents from 30 European countries (out of 270 starting the survey) were included in the analysis. Top priorities included febrile immunocompromised patients and fever without a focus for both paediatric and adult use cases, and 1–3 months old febrile infants. Rankings were similar across clinician subgroups despite some differences in average scores. 92% (243/263), 95% CI 89% to 95%, of respondents would find a ‘generic’ test for bacterial aetiology useful, even if it does not differentiate between Gram-positive and Gram-negative aetiologies. 54% (63/116), 95% CI 45% to 63%, of respondents would find a ‘generic’ test for inflammatory aetiology useful when seeking to diagnose children for whom Kawasaki’s disease (KD) is on the differential, even in the absence of any KD-specific test, 83% (96/116), 95% CI 75% to 89%, would find such a ‘generic’ test useful if they could use it alongside a KD test when desired.

Conclusion

Clinicians prioritise the most vulnerable patients (because of age or comorbidities) and unclear presentations (fever without a focus) for the development of a new fever diagnostic test. Even relatively simple (eg, bacterial, inflammatory) tests could provide added value to most clinicians.

What factors influence patient participation in an artificial intelligence-based initiative to optimise referrals from primary to specialist haematology care? A multicentre retrospective observational study in four Spanish hospitals

Objectives

Increasing demand for haematological specialist care makes the optimisation of referrals and outpatient workflow a priority. Automated placing of standardised test orders prior to the first appointment may provide haematologists with necessary information to reach diagnoses and initiate treatment at the first patient encounter, reducing low-value follow-up appointments. We aimed to evaluate rates of patient participation in an initiative using artificial intelligence to place standardised test orders as well as reasons for non-participation, differences in the number of participants and non-participants discharged back to primary care with a diagnosis or appropriate treatment plan, and potentially avoidable referrals.

Design

A retrospective, multicentric cohort study.

Setting

Four academic hospitals in Madrid, Spain.

Participants

18 190 patients referred for a first haematologist appointment for 11 included presenting complaints.

Intervention

Referral notes from primary care were classified using natural language processing and automated placement of standardised test order sets was carried out prior to first appointment for participating patients.

Outcome measures

We compared demographic differences between participants and non-participants, the main motives for not participating, and the number of patients discharged back to primary care at first appointment with a diagnosis and treatment plan. Most frequent International Classification of Diseases, tenth revision codes for each of the included presenting complaints were described.

Results

During the study period, 18 190 (41%) patients were referred for a first haematologist appointment for presenting complaints included in the intervention (‘eligible patients’), of which 612 (3.3%) patients agreed to participate in the intervention. Participants were significantly younger than non-participants. Most common motives for not participating were administrative reasons (6268, 76.9%). Only 122 (1.5%) patients expressed explicit unwillingness to participate. A significant increase in the number of patients discharged upon first appointment was observed for participants (146 (23.9%) vs 3375 (19.36%); p=0.041), signifying a 22% relative reduction in avoidable follow-up. The diagnosis ‘haematological disorders ruled out’ was constantly observed as one of the ten most common diagnoses made by the haematology specialist for all but one of the included presenting complaints.

Conclusion

Natural language processing of referrals from primary to specialist haematology care with automated placing of standardised test orders can decrease low-value follow-up appointments. Explicit refusal to participate was low. Participants tended to be younger than non-participants, underlining the importance of designing strategies to target the older population in order to improve participation.

Telerehabilitation versus face-to-face programme on electrical stimulation and neck exercises for non-specific neck pain: a study protocol for a randomised controlled trial

Introduction

Neck pain is a common issue among the working-age population, with a high recurrence rate and one of the highest healthcare costs globally. Exercise is proposed as one of the key components in managing this condition, and electrotherapy is established as a safe and proven analgesic measure. Telemedicine improves access to healthcare by removing geographical barriers and reducing costs, allowing consultations from any location and supporting the work-life balance of the patient.

Objective

The aim of this study is to compare the efficacy of e-Health versus a face-to-face programme in the therapeutic management of non-specific neck pain through exercise and analgesic electrotherapy.

Methods and analysis

A randomised clinical trial with 100 participants suffering from non-specific neck pain will be conducted. Participants will be evenly divided into two groups to receive analgesic electrotherapy combined with a cervical exercise programme delivered either via an e-Health programme or face-to-face programme. A total of 24 sessions will be administered over 8 weeks. Data collected will include demographic and clinical information, disability, pain intensity, fear of movement, sleep quality, catastrophising, quality of life and range of motion. Assessments will be conducted at the start of the study (baseline), at 8 weeks (post-treatment), and 2 months after completing the intervention (follow-up).

Ethics and dissemination

This protocol has been approved by the Andalusian Biomedical Research Ethics Coordinating Committee (SICEIA) with number register (SICEIA-2024-000820) on 25 September 2024. Findings will be disseminated through publications in peer-reviewed journals and presentations at international and national conferences.

Trial registration number

ClinicalTrials.gov (NCT06842381).

Implementing Transitional Care Interventions for Surgical Patients: A Scoping Review

ABSTRACT

Aims

To synthesise the evidence on implementation strategies used to implement transitional care interventions for adult surgical patients.

Design

Scoping review.

Data Sources

Medline, CINAHL and EMBASE were searched in August 2023 and updated June 2025, followed by citation searches. Studies were screened independently by two researchers, and one extracted data, another verified its accuracy. Studies about transitional care interventions for adult surgical patients were coded according to the ‘Five classes of implementation strategies’ and the ‘Patterns, Advances, Gaps, Evidence for practice and Research recommendations’ framework, to illuminate the review findings.

Results

Based on 27 studies included in the scoping review, staff education, changes to staffing and electronic systems, and change management techniques were frequently used implementation strategies. Implementation strategies were mostly used with patients undergoing colorectal and cardiac surgery in Asia and the United States. Scale-up strategies and capacity-building initiatives for people in charge of spearheading the change initiatives were less common.

Conclusions

To further the field, future research could focus on capacity-building and scale-up strategies, fidelity reporting, and financial implications of implementation in a wider range of surgical populations and settings. Work is needed to effectively implement surgical transitional care interventions in real-world settings.

Implication for the Profession and/or Patient Care

Our findings provide strategies for hospital leaders to adopt when implementing transitional care interventions for surgical patients.

Reporting Method

Scoping Reviews (PRISMA-ScR) checklist.

Patient or Public Contribution

Determined review focus, interpreted findings, and contributed to manuscript.

Review Registration

The Open Science Framework.

Ageing phenotypes and behavioural determinants of health on age acceleration: the Cancer Survivors Trajectories of Ageing Research (C*STAR) study protocol

Por: Zaujan · N. A. M. · Shahril · M. R. · Shahar · S. · Mohamad Hanif · E. A. · Ab Muin · N. F. · Sharif · R. · Subramaniam · P. · Abdullah · A. · Fenech · M.
Introduction

Age acceleration in survivors of breast cancer is a critical issue because cancer and its treatment can increase structural and numerical chromosomal aberrations, while simultaneously shortening telomere length and changing ageing phenotype. Therefore, the current study will be using machine learning architectures to accurately predict the factors that contribute to age acceleration among survivors of breast cancer.

Methods and analysis

The Cancer Survivors’ Trajectories of Ageing Research (C*STAR) is a hospital-based cross-sectional study involving multi-ethnic Malaysian survivors of breast cancer and a non-breast cancer control group, frequency-matched by age group (±5 years), sex and ethnicity. The three main stages of this study will be conducted in the predictive model development. First, a set of validated questionnaires will be used to collect the data on modifiable factors of ageing phenotypes and behavioural determinants of health. Second, 3 mL non-fasting blood samples will be collected, and lymphocytes will be isolated to determine telomere length using real-time PCR as a biomarker of age acceleration. Lastly, a machine learning architecture will be deployed to identify modifiable factors that may contribute to age acceleration in survivors of breast cancer and controls, with these factors used as input and ageing biomarkers of telomere length as output. The study outcomes may serve as guidance to enhance the quality of life of survivors of breast cancer and hinder the recurrence of cancer while ageing successfully.

Ethics and dissemination

Ethical approval was obtained from the Research Ethics Committee, Universiti Kebangsaan Malaysia (JEP-2022-700) to carry out this study. Written informed consent will be obtained from each survivor of breast cancer and each cancer-free woman prior to participation. The results of this study will be published for future research and clinical applications.

Stimulating amyloid-{beta} clearance in cerebral amyloid angiopathy with low-sodium oxybate and/or non-invasive vagus nerve stimulation (Clear-Brain): study protocol for a randomised pre-post trial

Por: Schriemer · S. E. · Hirschler · L. · van Etten · E. S. · van Zwet · E. W. · Lammers · G. J. · Liebler · E. J. · van Walderveen · M. A. A. · Slats · A. M. · van Es · A. C. G. M. · Verbeek · M. M. · van Osch · M. J. P. · Wermer · M. J. H. · Fronczek · R.
Introduction

Cerebral amyloid angiopathy (CAA) is caused by the accumulation of amyloid-beta (Aβ) in the cerebrovasculature. The glymphatic system is thought to be involved in the clearance of cerebral waste products, including Aβ. Stimulation of the glymphatic system through enhancing deep sleep with low-sodium oxybate (LXB) or inhibition of cortical spreading depolarisations via non-invasive vagus nerve stimulation (nVNS) could potentially increase clearance of Aβ and hence improve disease course.

Methods and analysis

We will perform a pre-post trial to assess whether treatment with LXB, nVNS or a combination of both interventions can enhance the clearance of Aβ in patients with CAA. A total of 60 participants, 30 with sporadic CAA and 30 with Dutch-type CAA, will be randomly assigned to receive either LXB, nVNS or both interventions, resulting in three groups (20 in each group: LXB, nVNS and both). The study spans 6 months, comprising a 3-month observational phase and a 3-month intervention phase. The primary outcome measure will be the morning levels of Aβ40 and Aβ42 in cerebrospinal fluid (CSF) before and after the intervention. We will assess possible disease progression with (non-)haemorrhagic imaging markers on 7-Tesla MRI at baseline, before and after intervention, as a secondary outcome. Additionally, the activity of the glymphatic system by means of fluid dynamics will be assessed with CSF-Selective T2-weighted Readout with Acceleration and Mobility encoding (CSF-STREAM) on 7-Tesla MRI.

Ethics and dissemination

The study was reviewed and approved by the Medical Research Ethics Committee Leiden The Hague Delft (P23.100) on 8 April 2024. The first participant was enrolled on 27 March 2025. Study results will be published in peer-reviewed journals and presented at scientific conferences. Additionally, study updates and results will be shared with participants via our newsletter twice a year.

Trial registration

EU CT number 2023–5 06 128-10-00, Universal Trial Number U1111-1295-1113, ClinicalTrials.gov NCT06421532.

Alloplastic total temporomandibular joint (TMJ) replacement registry: a protocol for a prospective global multicentre observational cohort study

Por: Thor · A. · Bengtsson · M. · Dowgierd · K. · Epifanov · S. · Fichter · A. M. · Jelovac · D. · Korn · P. N. · Nilsson · J. L. · Pastore · G. · Rughubar · V. · Smolka · W. · Talvilahti · J. · Thiem · D. · Thieringer · F. · Ulmner · M. · Wolvius · E. B. · Zubillaga Rodriguez · I. · Kumar · V
Introduction

Total alloplastic replacement of the temporomandibular joint (TMJ) is a viable treatment option for severe TMJ disorders (TMDs) unresponsive to conservative approaches, as well as for reconstruction of congenital or acquired TMJ defects. However, clinical data on indications, outcomes, complications and long-term effects remain limited, and no global registry currently exists. This study aims to address this gap by establishing an international registry to collect data from patients undergoing total alloplastic TMJ replacement systematically. The registry will document clinical indications and disease progression, explore relationships between treatments, outcomes and quality of life, identify predictors of favourable outcomes and inform future research.

Methods and analysis

This international, prospective, multicentre, observational registry will enrol approximately 200 patients with TMD requiring total alloplastic TMJ replacement, with follow-up lasting up to 5 years postoperatively. The data collected will include underlying disease, treatment details, functional outcomes, patient-reported outcomes and procedure-related adverse events. The registry will also monitor patients who decline surgery and record their reasons. All treatments will adhere to the standard of care at each participating centre.

Ethics and dissemination

Ethics approval was obtained from the responsible ethics committee (EC) at each participating site prior to TMJ surgery. All patients will be enrolled following an informed consent process approved by the relevant EC. Study results will be disseminated through peer-reviewed publications.

Approving ECs include: Krishnadevaraya College of Dental Sciences and Hospital EC, KCDS/Ethical Comm/54/2022–23; Ethikkommission Nordwest- und Zentralschweiz, 2019–02387; University of Belgrade School of Dental Medicine EC, 36/19; National Videnskabsetisk Komité, 2401881; University of KwaZulu-Natal Biomedical Research EC, BREC/00001592/2020; Etikprövningsmyndigheten, 2019–04477; Ethikkommission Medizinische Hochschule Hannover, 8660_BO_K_2019; Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig, 080/21-lk; Comité de Ética de la Investigación con Medicamentos Hospital Universitario 12 de Octubre, 19/392; Landesärztekammer Rheinland-Pfalz EC, 2025–18012-andere Forschung/nachberatend; Local Ethical Committee at National Medical and Surgical Centre named after NI Pirogoov, LEC meeting 5; Ethikkommission bei der LMU München, 19–589; Komisja Bioetyczna przy Warmiłsko-Mazurskiej Izbie Lekarskiej w Olsztynie, 12/2021; De Medisch Ethische Toetsings Commissie Erasmus MC, MEC-2019–0696 and Comissão Nacional de Ética em Pesquisa, 3.825.711.

Trial registration number

NCT03991728.

Impact of disease burden on VO2max, physical performance and frailty in ankylosing spondylitis: a comparative cross-sectional study

Por: Tariq · A. · Ammar · M. · Saad · A. · Zadeh · S. A. M.
Objective

To examine the association between spinal mobility, disease activity, frailty and cardiorespiratory fitness (maximal oxygen uptake (VO2max)) in patients with ankylosing spondylitis (AS).

Methods

A cross-sectional comparative study was conducted at the University of Lahore and seven government hospitals (March–August 2025) including 74 patients with AS (40–55 years, modified New York criteria) and 77 age-matched and sex-matched healthy controls. Assessments included disease activity (Bath Ankylosing Spondylitis Disease Activity Index), functional limitation (Bath Ankylosing Spondylitis Functional Index), spinal mobility (Bath Ankylosing Spondylitis Metrology Index (BASMI)), chest expansion, frailty (Fatigue, Resistance, Ambulation, Illnesses, Loss of weight scale), pulmonary function and cardiorespiratory fitness (VO2max) via symptom-limited cardiopulmonary exercise testing. Functional performance was measured with the 6 min walk test (6MWT), and physical activity with the International Physical Activity Questionnaire (IPAQ). Data were analysed using t-tests, 2 tests, correlations and regression models to examine associations between clinical measures and cardiorespiratory fitness.

Results

Among 151 participants (74 AS, 77 controls), AS patients showed significantly reduced pulmonary function (forced expiratory volume in one second 83.5% vs 91.2%, forced vital capacity 85.1% vs 93.0%), lower VO2max (27.8 vs 33.4 mL/kg/min), impaired spinal mobility (BASMI 5.1 vs 1.2) and decreased chest expansion (2.8 vs 5.6 cm; all p2max was inversely correlated with disease activity, spinal stiffness, frailty and structural damage and positively correlated with chest expansion, 6MWT and activity levels. AS status, higher disease activity, greater spinal stiffness and reduced chest expansion independently predicted low physical activity.

Conclusion

AS is associated with impaired pulmonary function, reduced spinal mobility and lower cardiorespiratory fitness, with disease activity, stiffness and restricted chest expansion potentially influencing physical activity and overall functional capacity.

Prevalence of potentially inappropriate medication prescribing, inappropriate medication use, prescription omission and drug interactions among older adults in Ethiopia: a systematic review and meta-analysis

Por: Yazie · T. S. · Alemu · M. A. · Zewdu · W. S. · Asmare Emiru · Z. · Tarekegn · G. Y. · Meharie · B. G. · Belete · A. M. · Debasu Addisu · Z.
Objective

To determine the prevalence of potentially inappropriate prescribing (PIP), potentially inappropriate medication (PIM), potential prescription omission (PPO), potentially harmful drug–drug interactions (PDDI) and identify associated factors among older Ethiopians.

Design

Systematic review and meta-analysis

Data source

We searched PubMed, HINARI, Scopus and Web of Science databases to identify eligible studies published up to 31 October 2025.

Study selection

Observational studies reported the prevalence of PIP, PIM, PPO and PDDI among older adults from any healthcare settings were screened.

Data extraction and synthesis

Two independent reviewers selected studies, extracted data and assessed the risk of bias. The quality and risk of bias of the studies were assessed using the Newcastle-Ottawa scale and Hoy risk of bias tool, respectively, while the certainty of evidence of outcomes was assessed using Grading of Recommendations, Assessment, Development and Evaluation based on Cochrane recommendations. We used a random-effects model for analyses to estimate the pooled prevalence and associated factors. All data analyses were done using Stata V.17 software.

Main outcomes and measures

The national prevalence of PIP, PIM, PPO and PDDI was estimated as main outcomes. Variations were estimated based on regions, age groups, outcome evaluation tool, disease type and healthcare setting.

Results

The review included 25 studies (n=5662 participants) for PIP or PIM, 14 studies (n=2706 participants) for PDDI and 6 studies (n=1342 participants) for PPO. The pooled prevalence estimate was 41% (95% CI 33% to 48%), I2=96.87% for PIP, 37% (95% CI 31% to 44%), I2=96.33% for PIM, 55% (95% CI 36% to 73%), I2=99.00% for PDDI and 14% (95% CI 6% to 24%), I2=95.07% for PPO. The majority of the studies have very good quality (very good=13, good=1, satisfactory=11 for PIP and PIM; very good=11, satisfactory=3 for PDDI; very good=6 for PPO) and low risk of bias (low risk=18, moderate risk=7 for PIP and PIM; low risk=12, moderate risk=2 for PDDI and low risk=6 for PPO), while all studies for each outcome have low certainty of evidence. Subgroup analyses revealed significant regional and contextual variations. Polypharmacy was significantly associated with PIP (OR=3.72, 95% CI 2.53 to 5.46, p2=69.56%), PIM (OR=4.20, 95% CI 2.91 to 6.06, p2=57.83%) and PDDI (OR=4.51, 95% CI 3.05 to 6.69, p2=0.00%), while hypertension (OR=2.46, 95% CI 1.38 to 4.36, p2=0.00%) was associated with PIP.

Conclusions and relevance

This review found a high prevalence of PIP, PIM, PDDI and PPO among older adults in Ethiopia, with notable heterogeneity across regions. Polypharmacy was associated with PIP, PIM and PDDI, while hypertension showed association with PIP. Despite generally good study quality, the certainty of evidence was low for the included studies due to the cross-sectional design nature, with high heterogeneity. Therefore, these findings should be interpreted cautiously. This study indicates a high burden of inappropriate medication prescribing and its associated factors, underscoring the importance of further robust studies to clarify prescribing practices and associated factors.

PROSPERO registration number

CRD42024556744.

Delivering hospital care at home in a Dutch Tertiary University Hospital: protocol for a prospective feasibility cohort study evaluating a Virtual Ward for early discharge of inpatients

Por: van Herwerden · M. C. · Scholte · N. T. B. · Mkrtchjan · A. · Feyz · L. · Mol · A. P. · Aitken · J. · de Boer · R. A. · Chandoesing · P. P. · Gommers · D. A. M. P. J. · De Haan · B. · Den Hoed · C. M. · van den Hoogen · M. W. F. · Peeters · R. P. · Wlazlo · N. · Van Der Boon · R. M.
Introduction

Virtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.

Methods and analysis

The VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.

The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.

The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.

Ethics and dissemination

The study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.

Trial registration number

ClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.

Breast cancer screening best practices: a Canadian multidisciplinary consensus-based approach for primary care providers

Por: Pathak · N. · Corrado · A. M. · Seely · J. M. · Heisey · R. · Lofters · A. · Cil · T. · Sussman · J. · Zhong · T. · Amir · E. · Isenberg · A. · Nadler · M. B.
Objectives

International guidelines on breast cancer (BC) screening have differing recommendations leading to uncertainty on best practices for primary care providers. The purpose of this study was to create a Canadian best practices document on BC health and screening for primary healthcare providers through multidisciplinary consensus using Nominal Group Technique and Delphi method.

Participants

A 9-member multidisciplinary expert group and a patient advocate participated in the consensus methods and voting. Experts included those involved in BC management and two primary care physicians. Twenty-nine experts across BC disciplines participated in external review.

Primary and secondary outcomes

Two study objectives included (1) building consensus on key ‘best practice’ behaviours related to BC-related health and screening and (2) building consensus on specific definitions related to BC screening.

Results

The final consensus document consists of 65 statements grouped in five categories with companion resources to support uptake of all best practices. Categories include identification and work-up for diagnostic imaging, risk factors and identifying individuals eligible for high-risk screening, shared decision-making, decisions and referrals for BC screening and screening outcomes. Special areas of focus were shared decision-making, age to initiate screening, and BC screening in special populations.

Conclusions

We created a comprehensive consensus document distilling the latest evidence to provide practical Canadian consensus-based advice on specific ‘best practice behaviours’ related to BC health and screening to serve as a resource for providers.

Dietary practices among antenatal women in Sri Lanka: prevalence and associated factors

Objective

To assess the prevalence and associated factors of dietary practices among antenatal women in Colombo district, Sri Lanka.

Design

This descriptive cross-sectional study examined dietary practices among antenatal mothers in four Medical Officer of Health areas in Colombo, Sri Lanka. A total of 422 participants were selected using stratified random sampling. Data were collected via a validated Food Frequency Questionnaire and analysed using SPSS V.26. Dietary diversity, food variety and animal-source food consumption were assessed. Poisson regression identified predictors of dietary practices, adjusting for socio-economic and pregnancy-related factors. The statistical significance was set at p

Results

Of the 380 antenatal mothers (mean age: 30.72±3.96 years), most were married (98.2%) with 73.7% living in urban areas. Regarding dietary practices, 64.7% had high dietary diversity, while 35.3% had low diversity. Of the sample, 52.1% had a high food variety score and 64.7% had a high animal-source food score. More than half (64.7%) had appropriate dietary practices. Fruits, vitamin A-rich vegetables and rice were the most consumed foods. Key factors influencing dietary practices included age, religion, education, employment and geographical location.

Conclusions

This study highlights the prevalence and factors influencing dietary practices among antenatal mothers. Although the predominant mothers had fair dietary diversities, a considerable number were found to have poor dietary practices. Better dietary practices were associated with major educational attainment, formal employment status and selected residential areas, while younger age, low educational qualification and housewife status were associated with poorer nutrition. The findings indicate that there is an urgent need for interventions related to nutrition for specific vulnerable groups so that they can improve their maternal nutrition and produce better pregnancy outcomes through education and support programmes.

Essential newborn care practices and determinants in Ethiopia: a multilevel analysis of national survey data

Por: Mekonnen · T. S. · Delie · A. M. · Hailu · M. · Mehari · M. G. · Bizuneh · G. K. · Mengistie · B. A.
Objectives

To assess the prevalence and determinants of essential newborn care (ENC) practices among Ethiopian mothers using the 2023 Performance Monitoring for Action (PMA) dataset.

Design

A cross-sectional analysis of the nationally representative 2023 PMA Ethiopia survey.

Participants

A total of 1933 mothers with complete data on ENC practices were included.

Setting

Ethiopia, using a multi-stage stratified cluster sample.

Primary outcome measures

ENC, defined as the adoption of at least four of five WHO-recommended practices: immediate drying, delayed bathing, skin-to-skin contact, clean cord care and early initiation of breastfeeding.

Results

Overall, 32.1% (95% CI 28.1% to 36.0%) of mothers practised at least four ENC components. Coverage was highest for immediate drying (95.4%) and delayed bathing (87.3%), but lower for skin-to-skin contact (53.6%) and clean cord care (64.5%). Health facility delivery showed a strong association with higher ENC practice (adjusted OR (AOR)=106.00; 95% CI 46.14 to 243.54). Mothers who were spouses, rather than household heads, had higher odds of practising ENC (AOR=2.88; 95% CI 1.20 to 6.89) and those mothers with parity two or three had higher odds of practising ENC compared with first-time mothers (AOR=2.00; 95% CI 1.33 to 3.02 and AOR=3.39; 95% CI 1.76 to 6.53, respectively). Lack of postnatal care attendance was negatively associated with ENC (AOR=0.56; 95% CI 0.37 to 0.85). Regional disparities were observed, with mothers in the Southern Nations, Nationalities and Peoples’ region being significantly less likely to practise ENC compared with those in Addis Ababa (AOR=0.31; 95% CI 0.15 to 0.64). All results are based on weighted data to ensure national representativeness.

Conclusion

The prevalence of ENC practices remains low in Ethiopia. Health facility delivery, maternal role in the household, parity and region of residence were significant predictors of ENC practice. Strengthening facility-based delivery, promoting maternal empowerment and addressing regional disparities are essential to improving newborn health outcomes in the country and achieving Sustainable Development Goal 3.

Barriers to and enablers of prophylactic compression use by people at risk of venous leg ulcer recurrence: a qualitative study

Por: Alkahtani · A. M. · Dumville · J. · Mott · L. · Armitage · C.
Background

Venous leg ulcers (VLUs) are complex, chronic wounds that often recur after healing. The ongoing use of compression hosiery is the primary strategy to reduce the risk of VLU recurrence. However, adherence to this prophylactic treatment is low, undermining treatment effectiveness and placing a substantial burden on individuals with a history of VLUs and on healthcare systems. Understanding the factors influencing people’s adherence to compression hosiery for secondary VLU prevention is essential to support approaches to promote uptake.

Objectives

The study aimed to (1) draw on the Capabilities, Opportunities and Motivations of Behaviour (COM-B) model and the Theoretical Domains Framework (TDF) to explore factors influencing individuals’ use of prophylactic compression hosiery for the secondary prevention of VLUs and (2) use the behaviour change wheel to identify intervention strategies to support the ongoing use of prophylactic compression hosiery by individuals after VLU healing.

Design

A descriptive, interpretive qualitative study involving individuals with a history of healed VLUs. Semistructured interviews were conducted with people who had experienced healed VLUs. The interviews were guided by the COM-B model. Framework analysis was conducted using deductive coding informed by the TDF and inductive coding to capture emerging themes linked to barriers to and enablers of the target behaviour (ongoing compression use). Data management was aided by NVivo software, and coding was conducted by two researchers.

Settings

Interventions were conducted in person, by telephone or online, based on participants’ preferences, at community leg clubs or in their homes, from April 2024 to January 2025.

Participants

Participants with experience of healed VLUs were recruited from three National Health Service (NHS) trusts and community leg clubs in the North of England.

Results

A total of 15 participants were interviewed, comprising 4 males and 11 females aged between 49 and 89 years. Our analysis identified six factors that may influence individuals’ use of prophylactic compression hosiery following VLU healing: knowledge, skills, environmental context and resources, emotion, social influences and beliefs about consequences. Deficits in knowledge, skills and resources, such as limited availability of prophylactic compression sizes, delays in prophylactic compression delivery and limited access to NHS services after healing, were primary barriers to people’s use of compression hosiery in this context. Conversely, positive beliefs about the benefits of ongoing use of prophylactic compression hosiery were a strong enabler. Emotion and social influences were identified as both barriers and enablers: fear of recurrence and social support encouraged adherence, while stigma and negative feelings hindered it. We identified six intervention functions (education, training, persuasion, environmental restructuring, modelling and enablement) and eight linked behaviour change techniques that could be explored further to support people’s ongoing use of prophylactic compression therapy. These techniques include providing information about antecedents, discussing health and emotional consequences, instruction, demonstration, rehearsal, social support, framing/reframing and vicarious reinforcement.

Conclusions

The identified intervention functions and behaviour change techniques provide theoretically informed insights for designing interventions to support sustained use of prophylactic compression hosiery following VLU healing. Key barriers to address include addressing gaps in individuals’ knowledge about prophylactic compression therapy, prioritising posthealing VLU services, ensuring timely access to appropriately fitted compression and enhancing social support networks.

Feasibility of a mobile health intervention to motivate adolescent fitness and high-intensity exercise adherence (Motivating Adolescent Fitness (MOTAFIT)): protocol for a randomised controlled trial

Por: Koep · J. L. · Sansum · K. M. · Low · J. · Smith · K. J. · Cocks · M. · McManus · A. M.
Introduction

Most adolescents fail to achieve recommended levels of vigorous-intensity physical activity, despite the established benefits for cardiorespiratory fitness and vascular health. Supervised interventions can be effective, but are resource-intensive and lack scalability. Mobile health (mHealth) technologies may provide a cost-effective and accessible approach to support structured, individualised training for adolescents. The Motivating Adolescent Fitness (MOTAFIT) trial will assess the feasibility and acceptability of an mHealth-supported exercise intervention for adolescents to inform the design of a definitive randomised controlled trial (RCT).

Methods and analysis

MOTAFIT is a three-arm feasibility RCT targeting 120 adolescents aged 13–16 years from the Okanagan Valley, British Columbia. Participants will be randomised (1:1:1) to: (1) MOTAFIT, (2) active control or (3) control group. The 12-week intervention targets ≥40 min/week of vigorous-intensity exercise (≥80% HRmax), co-designed with an exercise specialist and supported by mHealth technology. Primary outcomes for feasibility, including recruitment, retention, adherence, fidelity and acceptability, will be assessed as part of a process evaluation. Secondary measures (cardiorespiratory fitness, vascular health and blood pressure) will provide preliminary estimates to guide future sample size calculations.

Ethics and dissemination

The study has received approval from the University of British Columbia Clinical Research Ethics Board (H22-03183) and the University of Victoria Human Research Ethics Board. Parental consent and adolescent assent will be obtained prior to participation. Findings will be disseminated via peer-reviewed publications, conferences and community engagement.

Trial registration number

NCT06409793.

Understanding the impact of temporary childbirth migration on maternal and child health: study protocol of a community-based prospective cohort study in India

Por: Patil · R. · El Ayadi · A. M. · Tonde · K. · Choudhari · B. · Bhujbal · S. · Murro · R. · Agarwal · D. · Charlebois · E. · Bansal · P. · Nitnaware · N. · Kalantri · A. · Mundra · A. · Goyal · N. · Raut · A. · Rongsen-Chandola · T. · Juvekar · S. K. · Diamond-Smith · N.
Introduction

Temporary childbirth migration (TCM), where women return to their natal homes for pregnancy, delivery or postpartum for a limited duration, is a long-standing sociocultural practice in India. While often motivated by familial support and traditional norms, its implications for maternal and child health and health system engagement remain poorly understood. This study aims to quantify the impact of TCM on maternal and newborn outcomes and to explore how continuity of perinatal care and social support mediate these relationships.

Methods and analysis

We are conducting a three-site, community-based, prospective cohort study across the Health and Demographic Surveillance System sites of Vadu (Maharashtra), Sevagram (Maharashtra) and DEESHA (Delhi). A total of 3000 pregnant women will be enrolled in pregnancy (

Ethics and dissemination

This study has been approved by the Ethics committees at the KEM Hospital Research Centre Pune (KEMHRC/RVM/EC/1931), Society for Applied Studies (SAS/ERC/TCM Study/2024), Mahatma Gandhi Institute of Medical Sciences (MGIMS/lEC/COMMED/8412023) and University of California San Francisco (22-36484). All research activities are conducted in accordance with Indian Council of Medical Research Guidelines for biomedical research and the Declaration of Helsinki. On study completion, findings will be disseminated to diverse local, national and global stakeholders and published in academic journals.

Trial registration number

CTRI/2024/02/062881.

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