Qualitative study exploring stakeholder perspectives on the use of early MRI in wrist injury pathways in the UK NHS

Objectives
Early MRI use varies in the management of acute wrist injuries in the UK, with only a minority of National Health Service (NHS) centres being able to offer this to patients. In this study, we aim to explore the perspectives of staff and patients on the use of early MRI in the management of wrist injuries.

Design
This is a cross-sectional qualitative study using semistructured, face-to-face and remote interviews. Interviews were audio recorded, transcribed verbatim and analysed using thematic analysis.

Setting
10 NHS Trusts in the UK.

Participants
We interviewed a sample consisting of 37 NHS staff members and 21 patients.

Results
We analysed the data into three overarching themes. The first theme described the negative impact of wrist injuries on both staff and patients. Staff reported an uncomfortable feeling that they had ‘short-changed’ patients with older non-MRI based pathways, and that the consequences of missing a scaphoid fracture could be a ‘horrible thing’ for patients. The second theme described how early MRI was perceived as a ‘win for everyone’. For patients, the win encompassed the relief of a speedy diagnosis which helped them to get better. Staff saw early MRI as a win because it ‘revolutionised care’ and ‘reduced the clinic footprint’. The final theme defined the key ingredients of delivering an early MRI pathway: a simple pathway with clear accountability, timely access to MRI and prompt reporting of results, a safe pathway with safety nets to avoid patients being lost, data and audit of the time to MRI and definitive treatment, bottom-up engagement, clear communication and looking after your team.

Conclusions
Our findings contribute to a better understanding of stakeholders’ perspectives on wrist injury pathways in the UK NHS.

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Exploring the acceptability, appropriateness, feasibility and satisfaction of an implementation strategy for out-of-HOspital administration of the Long-Acting combination of cabotegravir and rilpivirine as an optional therapy for HIV in Spain (the HOLA study)–a hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study: study protocol

Introduction
The HOLA study is a 12-month randomised, hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study including virologically suppressed people living with HIV (PWH). HOLA, which started in September 2023, evaluates acceptability, appropriateness, feasibility and satisfaction of out-of-hospital administration of cabotegravir and rilpivirine long-acting (CAB+RPV LA).

Methods
A total of 110 PWH who are already under treatment with CAB+RPV LA or switch their antiretroviral therapy to CAB+RPV LA will be recruited from two main hospitals in Barcelona (Germans Trias I Pujol and Vall d’Hebrón) and Costa del Sol Hospital, in Marbella. The patients will be randomised 1:1 into a hospital group (administration of CAB+RPV LA in the hospital) and the outpatient group (out-of-hospital administration), including community or primary care centres. The main objectives of the study are to compare the acceptability at month 12 of the administration of CAB+RPV LA in and out-of-hospital centres from the perspective of patients, and assess and compare the safety and tolerability of CAB+RPV LA. The study takes place at nine clinical units in Catalonia and Andalusia (three tertiary hospitals (recruiting centres), one community centre, one sexually transmitted infection clinic and four primary care centres).

Ethics and dissemination
The current publication refers to V.3.0 of the protocol, with issue date 14 April 2024, as approved by the Comité de Ética de la Investigación con medicamentos del Hospital Universitari Germans Trias i Pujol (approval number AC-23-042-HGT-CEIM). The clinical trial will be conducted according to the principles of the Declaration of Helsinki, Fortaleza, Brazil, October 2013. This study will be conducted according to Spanish regulations regarding clinical trials (Royal Decree 1090/2015) and biomedical investigations (Organic Law 14/2007 of biomedical investigation and the Royal Decree 1716/2011), and the Clinical Trial Regulation (Regulation EU No 536/2014). Confidentiality requirements will follow the required Data Protection legislation. Enrolment completion in the study is expected by the end of May 2024, with an end of study expected in May 2025. Results emerging from this study will be reported in HIV national and international meetings as well as published in international journals with a high impact factor. If the outcome is deemed positive, we will also develop and propose policy guidelines for the integration of the administration of CAB+RPV LA in alternative outpatient facilities into the standard of care in the HIV care pathway.

Trial registration number
NCT06185452/EUCT number: 2023-503963-41-00.

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Clinical factors associated with multimorbidity, polypharmacy and medication regimen complexity among adults with hypertension: a multicentre cross-sectional study

Objectives
Factors associated with multimorbidity, polypharmacy and Medication Regimen Complexity Index (MRCI) may vary across countries. However, such data are lacking in the present study setting. This study aimed to identify factors associated with multimorbidity, polypharmacy and MRCI among adults living with hypertension in public hospitals of South Gondar Zone.

Design
Multicentred cross-sectional design

Setting
Public hospitals of Comprehensive Specialised and Primary Hospitals, Ethiopia.

Participants
Adults living with hypertension who had follow-up visits at outpatient clinics and were selected by systematic random sampling from 1 December 2021 to 28 February 2022.

Primary and secondary outcome measures
Medication regimen complexity was assessed using a 65-item medication regimen complexity tool. Sociodemographic data were collected through an interview, while polypharmacy and clinical characteristics were documented using a checklist. Data were entered into SPSS V.26 and analysed using STATA V.17. A binary logistic regression model was used to determine the AOR of factors associated with multimorbidity and polypharmacy. For factors influencing MRCI, an ordinal logistic regression was used.

Results
We found participants from Nefas Mewucha Hospital (AOR = 0.3, 95% CI 0.15 to 0.59) and Mekane Eyesus Hospital (AOR = 0.17, 95% CI 0.07 to 0.38), compared with Debre Tabor Comprehensive Specialised Hospital, polypharmacy (AOR = 5.52, 95% CI 1.49 to 20.39), medium (AOR = 19.76, 95% CI 5.86 to 66.56) and high MRCI (AOR = 120.32, 95% CI 33.12 to 437.07) were associated with multimorbidity. Multimorbidity (AOR = 25.4, 95% CI 7.48 to 86.23), controlled blood pressure (AOR = 0.43, 95% CI 0.19 to 0.92) and duration of hypertension therapy 5 years or more (AOR = 2.12, 95% CI 1.08 to 4.16) were associated with polypharmacy. Whereas controlled BP (AOR = 0.48, 95% CI 0.32 to 0.72) and multimorbidity (AOR = 14.55, 95% CI 9.00 to 23.52) were significantly associated with high MRCI. The prevalence of multimorbidity, high MRCI and polypharmacy was found in 46.1%, 35.22% and 12.29% of participants, respectively.

Conclusion
A considerable proportion of participants with hypertension experienced multimorbidity, polypharmacy and high medication complexity. Polypharmacy, primary hospital setting and high MRCI were independent variables associated with multimorbidity. On the other hand, multimorbidity and controlled BP were associated with polypharmacy and MRCI. Hypertension care should consider multimorbidity, polypharmacy and medication complexity.

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Twenty-year trend in comorbidity score among adults aged 50-85 years in Lombardy, Italy: Age-Cohort-Period analysis and future trends

Objectives
To assess the effects of age, birth cohort, and period on comorbidity rates as well as project their future trends over the next 25 years.

Design
Population-based retrospective observational study.

Setting
Record linkage from the population-based healthcare utilisation database of Lombardy, Italy, between 2004 and 2023.

Participants
All beneficiaries of the Italian National Health Service (NHS) aged 50–85 years residing in Lombardy. Data were separately analysed for each year from 2004 to 2023, with thus the availability of 20 study populations.

Primary outcome measures
Comorbidities were traced via the medical services provided by the NHS, and the overall quantification was obtained by the Multisource Comorbidity Score, which was developed and validated for the Italian population. The temporal analysis of the 20 yearly temporal comorbidity rates was obtained by the Age-Cohort-Period models. The comorbidities prevalence trends were forecasted from 2025 to 2050.

Results
From 2004 to 2023, the prevalence of comorbidities declined from 46% to 40% in men and from 47% to 42% in women. An increase in prevalence between the ages of 50 and 85 years was observed for both women (from 33% to 63%) and men (from 29% to 67%). A declining prevalence was observed among cohorts born from 1922 to 1970 for both women (by 33%) and men (by 50%). A continued decline in the absolute number and prevalence rate of comorbidities is expected for both women and men until 2050.

Conclusions
The decline in ageing-related comorbidity prevalence over time may persist up to 2050. Improved medical care and public health initiatives benefiting individuals born in more recent years may counterbalance the expected trend of increasing comorbidity prevalence due to population ageing.

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Neural Mechanisms of Poststroke Urinary Incontinence: Results From an fMRI Study

Stroke, Ahead of Print. BACKGROUND:Urinary incontinence after a stroke significantly affects patient outcomes and quality of life. It is commonly associated with uninhibited detrusor contractions, but the underlying neural mechanisms remain poorly understood. This study aimed to explore the brain activity patterns associated with volitional and involuntary bladder contractions in stroke survivors.METHODS:This cohort study enrolled 15 stroke survivors with documented urinary incontinence and 9 healthy controls. Participants underwent simultaneous blood oxygen level–dependent functional magnetic resonance imaging of the brain and urodynamics, capturing 25 involuntary and 23 volitional bladder emptying events in patients with stroke and 35 volitional voiding events in healthy individuals. We used general linear modeling in functional magnetic resonance imaging analysis to discern neural activity patterns during these events and in the phases leading up to them, aiming to identify neural mechanisms underlying involuntary versus volitional urinary control. Statistical significance for neuroimaging analyses was set atP

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Mechanism-based modular psychotherapy versus cognitive behavioural therapy for adolescents and young adults with childhood trauma experiences: study protocol for a feasibility trial within the German Center for Mental Health

Introduction
Patients with mental disorders and a history of childhood trauma show an early onset of psychopathology and often a poor response to standard disorder-specific treatments. They represent a patient group which requires more personalised interventions targeting the transdiagnostic mechanisms related to early trauma and its functional consequences. The mechanism-based modular psychotherapy (MeMoPsy) approach is conceptualised as an innovative framework for psychotherapy development. It comprises independent, flexibly applicable interventions from various theoretical backgrounds and evidence-based programmes within a systematic treatment algorithm, thereby tailoring module selection to the specific needs of traumatised adolescents.

Methods and analysis
In a randomised controlled feasibility trial (RCT), N=80 outpatients between 15 and 25 years of age diagnosed with various mental disorders will receive 28 individual sessions with MeMoPsy or standard cognitive behavioural therapy. MeMoPsy includes a basic module that addresses trauma history and three additional modules focusing on functional impairments known to be associated with childhood trauma: rejection sensitivity, emotion regulation and relationship difficulties. These modules are selected based on a self-report algorithm. Techniques from mentalisation-based therapy, cognitive behavioural analysis system of psychotherapy, dialectical behaviour therapy and systemic therapy are integrated in this personalised modular procedure. This proof-of-concept study aims to provide initial evidence for acceptability, feasibility and changes in self-rated and diagnostician-rated psychopathology (post-treatment and 3 months follow-up) of MeMoPsy and elucidate the mechanisms of change using psychotherapy process research, Ecological Momentary Assessment and functional magnetic resonance imaging (fMRI).

Ethics and dissemination
This RCT obtained approval from independent ethics committees of participating centres and is accompanied by a data and safety monitoring board. Findings will be communicated within the research community as well as with patients and the public by the dissemination strategies of the German Center for Mental Health.

Trial registration number
German Clinical Trials Register DRKS00034058.

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Efficacy of deep brain stimulation in treating monogenic dystonia symptoms: protocol for a systematic review

Introduction
Complexity leads to some dystonias being considered as rare diseases with scarce synthesised evidence. Despite the deficit of scientific evidence, deep brain stimulation (DBS) is currently an effective treatment for dystonias using different brain targets, providing significant improvement of dystonic symptoms regardless of their cause. However, there is considerable variability and non-response rate due to factors such as classification, semiology, duration, aetiology and genetic cause of the disease. This protocol presents the methodology of a planned systematic review to assess the efficacy of DBS as a treatment for monogenic dystonia symptoms, a broad spectrum of pathogenic dystonias due to variants in single genes not yet explored.

Methods and analysis
This protocol follows the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols guidelines. With the aim to test the efficacy of DBS in monogenic dystonias, the research question in population, intervention, comparator and outcomes format will cover patients with monogenic dystonia treated with DBS with a minimum of 3 months’ follow-up after surgery. The outcomes will be assessed using generic and specific scales to measure the efficacy and safety of the intervention. The search will be performed in generic and specific databases and bibliographic resources from 2000. We will include systematic reviews, randomised controlled trials and primary studies in English. In this protocol, the initial search strategy in MEDLINE is presented. Additionally, the protocol provides a description of the prospective assessment of the risk of bias in the selected studies. If studies appear homogeneous and the sample of patients is sufficiently large, a meta-analysis and a subgroup analysis are planned.

Ethics and dissemination
Ethics committee approval is not required. The results of the review will be published through an open access journal.

PROSPERO registration number

CRD42023448145

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Associations among health-related quality of life, mental resilience and social support in patients early after surgery for osteoporotic vertebral compression fractures: a longitudinal study

Objective
This study aims to explore the profile of health-related quality of life (HRQoL) of postoperative osteoporotic vertebral compression fracture (OVCF) patients through a longitudinal investigation, especially in the early postoperative phase, discern the effect of mental resilience and social support on postoperative HRQoL and further explore the mechanisms by which mental resilience exerts influences on HRQoL.

Design
This longitudinal observational study was conducted to examine the HRQoL of OVCF patients during the early postoperative period. Data collection occurred at three distinct time points: baseline assessment on postoperative day 1 (T1), followed by subsequent evaluations at 1 month (T2) and 3 months (T3) postsurgery.

Setting
Zhoupu Hospital, in Shanghai, China.

Participants
A total of 155 postoperative OVCF patients completed the baseline survey, with 150 and 140 participants completing the follow-up at T2 and T3.

Outcome measures
Primary end-point variables were HRQoL, mental resilience and social support. Secondary end-point outcomes included demographic data and disease-related information.

Results
The baseline data indicated that the average age of participants was 69.6 years, ranging from 53 to 92 years, with females accounting for 69.0%. There was no significant difference in demographic characteristics, such as age, gender and other factors, between the follow-up and the lost (p >0.05). Although the level of HRQoL, mental resilience and social support still remain at relatively lower levels at three separate times, they gradually elevated with time. Both mental resilience (r=0.293, p

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Understanding Infection, Viral Exacerbation and Respiratory Symptoms at Admission-Longitudinal (UNIVERSAL) study: a prospective observational cohort study protocol

Background
Respiratory viral infections (RVIs) are a significant cause of morbidity and hospital admission worldwide. However, the management of most viral infection-associated diseases remains primarily supportive. The recent COVID-19 pandemic has underscored the urgent need for a deeper understanding of RVIs to improve patient outcomes and develop effective treatment strategies. The Understanding Infection, Viral Exacerbation and Respiratory Symptoms at Admission-Longitudinal Study is an observational study which addresses this need by investigating the heterogeneity of RVIs in hospitalised adults, aiming to identify clinical and biological predictors of adverse outcomes. This study aims to bridge critical knowledge gaps in the clinical course and the economic impact of RVIs by characterising the phenotypic diversity of these infections and their recovery patterns following hospital admission and thus assisting with the optimal design of future interventional studies.

Methods and analysis
This prospective longitudinal observational study (V.6, 20 September 2023) will be conducted across multiple UK secondary care sites from August 2022 onwards, with an aim to enrol 1000 participants testing positive for RVI. Adults admitted with respiratory symptoms who test positive for RVIs via the BioFire® FilmArray® System or other validated diagnostic PCR tests will be enrolled. The data collected include patient demographics, clinical history, comorbidities and symptoms experienced prior to, during and after hospitalisation with follow-up after discharge at weeks 1, 2, 4, 8, 12 and 26. In addition, biological samples are collected at multiple time points during the hospital stay. The primary endpoints are to study the impact of different RVIs and identify predictors of disease progression and length of stay. Secondary endpoints include time to recovery and healthcare cost. Exploratory endpoints focus on biomarker profiles associated with virus type and clinical outcomes.

Ethics and dissemination
The study protocol received ethical approval from the relevant committees (English Ethics Reference Number: 22/WM/0119; Scottish Ethics Reference Number: 22-SS-0101, 20/09/2023). For patients who lack the capacity to consent, the study complies with the Mental Capacity Act 2005, using a consultee process where a family member, carer or an independent clinician may provide assent on behalf of the patient. Data from all the study centres will be analysed together and disseminated through peer-reviewed journals, conference presentations and workshops. The study group will ensure that participants and their families are informed of the study findings promptly and in an accessible format.

Trial registration number
ISRCTN49183956.

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Study protocol: diagnosis of atrial fibrillation in postoperative thoracic surgery using a smartwatch, an open-label randomised controlled study (THOFAWATCH trial)

Introduction
Postoperative atrial fibrillation (POAF) affects approximately 20% of patients undergoing thoracic surgery and is associated with severe complications such as stroke, myocardial infarction, heart failure, and increased mortality. Early diagnosis is critical to mitigate these risks, but conventional monitoring is limited in detecting asymptomatic episodes. Smartwatches equipped with single-lead ECG and atrial fibrillation (AF) detection algorithms offer a novel approach for early POAF detection. This study aims to evaluate the effectiveness of smartwatch-based monitoring compared with standard care in identifying POAF following thoracic surgery.

Methods and analysis
The THOFAWATCH trial is a randomised, bicentric open-label study enrolling 302 adult patients undergoing major thoracic surgery (pneumonectomy or lobectomy) with one-lung ventilation. Eligible patients will be randomised into two groups: (1) the ‘Smartwatch Monitoring’ group, where participants will undergo rhythm monitoring using a smartwatch and (2) the ‘Conventional Monitoring’ group, receiving standard care without smartwatch monitoring. In the intervention group, any smartwatch-detected POAF episodes will be confirmed by 12-lead ECG. The primary outcome is the incidence of POAF within 7-day postsurgery. Secondary outcomes include the rate of asymptomatic POAF, cardiovascular prognosis evaluated at 2 and 6 months (composite major adverse cardiovascular events outcome), feasibility of smartwatch usage (device usage time and success rate of single-lead ECGs) and recurrence or management of AF at follow-up. Inclusion criteria include adults ( >18 years) undergoing scheduled thoracic surgery and able to use the smartwatch device. Exclusion criteria encompass patients with prior AF, those requiring telemetry, or undergoing reoperations. Statistical analysis will assess the primary outcome using 2 or Fisher’s exact test (α=5%), while secondary outcomes will include descriptive and inferential statistics, with analysis conducted using SAS V.9.4.

Ethics and dissemination
Ethical approval for this bicentric study has been granted by the institutional review board (IRB) of the University Hospital of Amiens (Comité de Protection des Personnes sud-ouest et outre-mer 1, 21050 Toulouse, France, registration number ID RDB: 2022-A02028-27 in November 2024). The trial is registered under ClinicalTrials.gov (ID: (NCT06724718)). Results will be disseminated through peer-reviewed publications and scientific conferences to inform clinical practice regarding POAF detection and management following thoracic surgery.

Trial registration number
NCT06724718; clinical trial.

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Randomised controlled trial of a psychosocial digital health application to promote coping for caregivers of patients undergoing haematopoietic stem cell transplantation: a study protocol for the BMT-CARE app

Introduction
Caregivers of patients undergoing haematopoietic stem cell transplantation (HSCT) experience tremendous psychological distress before, during and after HSCT. However, few interventions are tailored to the protracted needs of these caregivers while considering scalability and accessibility. We previously developed an evidence-based intervention for caregivers of patients undergoing HSCT that improved quality of life (QOL), caregiving burden and mood. We have since adapted this clinician-delivered intervention into a self-administered, digital health application (BMT-CARE app) and are currently evaluating the effect of this intervention on QOL in caregivers of patients receiving HSCT.

Methods and analysis
The study design is a non-blinded randomised controlled trial of a digital health intervention for caregivers of patients undergoing HSCT at the Massachusetts General Hospital Cancer Center. We are enrolling and randomising 125 caregivers to receive the BMT-CARE app or usual care in a 1:1 assignment, stratifying by transplant type (autologous vs allogeneic). Caregivers assigned to the BMT-CARE app complete five self-guided modules designed to improve coping and stress management prior to and up to 60 days post-HSCT. The modules include interactive, gamified features and video vignettes to optimise engagement. Participants complete questionnaires at baseline and days 10, 60 and 100 post-HSCT. The primary outcome is comparison of QOL at day 60 post-HSCT. Secondary outcomes include caregiver burden, anxiety and depression symptoms, as well as post-traumatic stress symptoms. We are also exploring the usability of the BMT-CARE app to inform refinements prior to future testing.

Ethics and dissemination
The study is funded by the Leukemia and Lymphoma Society and approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board (Protocol #22–634 v.1.5). The results of this study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. Results will be disseminated at scientific meetings and in peer-reviewed journals.

Trial registration number
NCT05709912; Pre-results.

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Perioperative metformin use in patients undergoing total joint replacement surgery: protocol for a randomised, placebo-controlled pilot study

Introduction
Patients with poor perioperative glycaemic control after total joint arthroplasty are at an increased risk of complications, mortality, delayed return to function and increased costs of care. Although correction of hyperglycaemia has been shown to improve patient outcomes, there is a lack of consensus regarding optimal perioperative glucose management after total joint replacement surgery. This pilot study aims to assess the feasibility of performing a multicentre randomised controlled trial to investigate the effect of perioperative metformin use on glycaemic control in the setting of total joint arthroplasty.

Methods and analysis
This blinded, placebo-controlled, pilot randomised controlled trial will enrol 40 participants aged 18–99 years undergoing total hip or knee arthroplasty at a single academic tertiary centre. Patients will be randomly allocated to two groups of 20 participants each and will receive metformin or a placebo, respectively, for 2 weeks preoperatively, continued on the day of surgery, and up to 2 days postoperatively. The primary outcome is a composite of four endpoints to assess study feasibility: timely recruitment, timely study drug administration, protocol adherence and retention. Secondary outcomes include perioperative glycaemic variability, sliding scale insulin utilisation, hospital length of stay and 90-day rates of infection, mortality and readmission. Analyses will be on an intention-to-treat basis.

Ethics and dissemination
The protocol was approved by Oregon Health & Science University Institutional Review Board, STUDY00025798. Written informed consent will be obtained for study participation. Findings will be disseminated via publication in peer-reviewed journals and conference presentations.

Trial registration number
NCT06280274.

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Lung ultrasound for the diagnosis and monitoring of pneumonia in a tuberculosis-endemic setting: a prospective study

Lung ultrasound (LUS) has proven high diagnostic accuracy for community-acquired pneumonia (CAP) in developed countries. However, its diagnostic performance in resource-limited settings with high pulmonary tuberculosis (TB) incidence is less established. Additionally, the role of LUS in monitoring CAP progression remains underexplored.
Objectives
To validate the diagnostic performance, monitoring and prognostic utility of LUS for CAP in a high pulmonary TB incidence setting.

Design
Prospective single-centre cohort study.

Setting
Pulmonary department of a tertiary hospital in Vietnam.

Participants
A total of 158 patients suspected of having CAP were enrolled, with 136 (mean age 62 years, 72.8% male) included in the final analysis.

Interventions
Patients underwent LUS and chest X-ray (CXR) within 24 hours of admission, with a follow-up LUS on days 5–8.

Primary and secondary outcome measures
The primary outcome was the diagnostic accuracy of LUS and CXR compared with discharge diagnosis. Secondary outcomes included the accuracy compared with CT scan results, changes in LUS parameters—consolidation size, number and Lung Ultrasound Score (LUSS)—and their association with in-hospital mortality.

Results
LUS demonstrated higher sensitivity than CXR (96.0% (95% CI 90.0% to 99.0%) vs 82.8% (95% CI 73.9% to 89.7%)). LUS specificity was 64.9% (95% CI 47.5% to 80.0%), compared with 54.1% (95% CI 36.9% to 70.5%) for CXR. The moderate specificity for LUS was due to sonographic-similar conditions, notably TB in 5.1% of patients. Consolidation size and numbers showed marginal resolution, while LUSS showed more pronounced decreases over time. The baseline LUSS showed limited discriminative ability for predicting mortality (area under the curve, AUC 0.65, 95% CI 0.55 to 0.75), while follow-up LUSS and changes in LUSS (LUSS) demonstrated higher levels of discrimination (AUC 0.81 (95% CI 0.71 to 0.89) and 0.89 (95% CI 0.80 to 0.95), respectively). For each one-point increase in LUSS, the odds of in-hospital mortality went up by 70% (p=0.002). An improved LUSS effectively ruled out mortality (negative predictive value 97.4%).

Conclusion
Although LUS is highly sensitive for diagnosing CAP, its specificity in TB-endemic regions warrants further caution. Serial LUS assessments, particularly monitoring LUSS changes, are valuable for tracking disease progression and prognostication, with increasing LUSS indicating potential clinical deterioration.

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Prognostic factors of disability progression in multiple sclerosis in real life: the OFSEP-high definition (OFSEP-HD) prospective cohort in France

Purpose
To determine prognostic factors of disability in multiple sclerosis (MS), that is, (1) identify determinants of the dynamics of disability progression; (2) study the effectiveness of disease-modifying treatments (DMTs); (3) merge determinants and DMTs for creating patient-centred prognostic tools and (4) conduct an economic analysis.

Participants
Individuals registered in the French Observatoire Francais de la Sclérose en Plaques (OFSEP) database were included in this OFSEP-high definition cohort if they had a diagnosis of MS, were ≥15 years old and had an Expanded Disability Status Scale (EDSS) score

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Development of the International Classification of Functioning, Disability and Health Core Sets for children and youth with deafblindness: protocol for a multistudy collaboration across regions of WHO

Introduction
While the International Classification of Functioning, Disability and Health (ICF) Core Sets have been developed for deafblindness across the lifespan, there are currently no Core Sets specifically designed for children and youth with deafblindness. Children with deafblindness often experience unique challenges not captured in existing Core Sets, requiring a specialised framework to assess their functioning, activity limitations, participation restrictions and environmental factors. This project aims to develop ICF Core Sets specifically for children and youth with deafblindness, capturing their daily functioning and providing a comprehensive understanding of their needs.

Methods and analysis
This multimethod research project will follow the standardised ICF Core Set development methodology as outlined by the ICF Research Branch. The project will consist of several studies, beginning with a systematic literature review to synthesise existing knowledge on the functioning and needs of children and youth with deafblindness. To capture lived experiences, qualitative interviews will be conducted with parents, caregivers and adolescents with deafblindness, providing in-depth insights into their daily challenges and strengths. An international survey will be distributed to professionals in healthcare, education and policy to gather expert perspectives on key factors influencing the lives of this population. Additionally, an empirical multicentre study will be carried out to explore the challenges faced by the population in clinical settings. Together, these methods will inform the development of a tailored ICF Core Set for children and youth with deafblindness, aiming to identify and classify the most relevant factors impacting their functioning, activity limitations, participation restrictions and environmental influences.

Ethics and dissemination
Ethical approval will be obtained for all stages of the project, in the relevant locations, ensuring the protection of participant rights and confidentiality. The findings from this project will be disseminated through peer-reviewed scientific publications, presentations at local, national and international conferences, and stakeholder reports aimed at healthcare providers, educators and policymakers. These results will inform future practices, interventions and policies to better support children and youth with deafblindness.

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