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☐ ☆ ✇ BMJ Open

Single-centre, prospective cohort to predict optimal individualised treatment response in multiple sclerosis (POINT-MS): a cohort profile

Por: Christensen · R. · Cruciani · A. · Al-Araji · S. · Bianchi · A. · Chard · D. · Fourali · S. · Hamed · W. · Hammam · A. · He · A. · Kanber · B. · Maccarrone · D. · Moccia · M. · Mohamud · S. · Nistri · R. · Passalis · A. · Pozzilli · V. · Prados Carrasco · F. · Samdanidou · E. · Song · J. · W — Septiembre 25th 2025 at 11:09
Purpose

Multiple sclerosis (MS) is a chronic neurological condition that affects approximately 150 000 people in the UK and presents a significant healthcare burden, including the high costs of disease-modifying treatments (DMTs). DMTs have substantially reduced the risk of relapse and moderately reduced disability progression. Patients exhibit a wide range of responses to available DMTs. The Predicting Optimal INdividualised Treatment response in MS (POINT-MS) cohort was established to predict the individual treatment response by integrating comprehensive clinical phenotyping with imaging, serum and genetic biomarkers of disease activity and progression. Here, we present the baseline characteristics of the cohort and provide an overview of the study design, laying the groundwork for future analyses.

Participants

POINT-MS is a prospective, observational research cohort and biobank of 781 adult participants with a diagnosis of MS who consented to study enrolment on initiation of a DMT at the Queen Square MS Centre (National Hospital of Neurology and Neurosurgery, University College London Hospital NHS Trust, London) between 01/07/2019 and 31/07/2024. All patients were invited for clinical assessments, including the expanded disability status scale (EDSS) score, brief international cognitive assessment for MS and various patient-reported outcome measures (PROMs). They additionally underwent MRI at 3T, optical coherence tomography and blood tests (for genotyping and serum biomarkers quantification), at baseline (i.e., within 3 months from commencing a DMT), and between 6–12 (re-baseline), 18–24, 30–36, 42–48 and 54–60 months after DMT initiation.

Findings to date

748 participants provided baseline data. They were mostly female (68%) and White (75%) participants, with relapsing–remitting MS (94.3%), and with an average age of 40.8 (±10.9) years and a mean disease duration of 7.9 (±7.4) years since symptom onset. Despite low disability (median EDSS 2.0), cognitive impairment was observed in 40% of participants. Most patients (98.4%) had at least one comorbidity. At study entry, 59.2% were treatment naïve, and 83.2% initiated a high-efficacy DMT. Most patients (76.4%) were in either full- or part-time employment. PROMs indicated heterogeneous impairments in physical and mental health, with a greater psychological than physical impact and with low levels of fatigue. When baseline MRI scans were compared with previous scans (available in 668 (89%) patients; mean time since last scan 9±8 months), 26% and 8.5% of patients had at least one new brain or spinal cord lesion at study entry, respectively. Patients showed a median volume of brain lesions of 6.14 cm3, with significant variability among patients (CI 1.1 to 34.1). When brain tissue volumes z-scores were obtained using healthy subjects (N=113, (mean age 42.3 (± 11.8) years, 61.9% female)) from a local MRI database, patients showed a slight reduction in the volumes of the whole grey matter (–0.16 (–0.22 to –0.09)), driven by the deep grey matter (–0.47 (–0.55 to –0.40)), and of the whole white matter (–0.18 (–0.28 to –0.09)), but normal cortical grey matter volumes (0.10 (0.05 to 0.15)). The mean upper cervical spinal cord cross-sectional area (CSA), as measured from volumetric brain scans, was 62.3 (SD 7.5) mm2. When CSA z-scores were obtained from the same healthy subjects used for brain measures, patients showed a slight reduction in CSA (–0.15 (–0.24 to –0.10)).

Future plans

Modelling with both standard statistics and machine learning approaches is currently planned to predict individualised treatment response by integrating all the demographic, socioeconomic, clinical data with imaging, genetic and serum biomarkers. The long-term output of this research is a stratification tool that will guide the selection of DMTs in clinical practice on the basis of the individual prognostic profile. We will complete long-term follow-up data in 4 years (January 2029). The biobank and MRI repository will be used for collaborative research on the mechanisms of disability in MS.

☐ ☆ ✇ BMJ Open

Relationship between anti-diabetic medication use and glycaemic control: a retrospective diabetes registry-based cohort study in Singapore

Por: Chan · S. L. · Yap · C. J. Q. · Xu · Y. · Chia · S. Y. · Mohamed Salim · N. N. B. · Lim · D. M. · Choke · E. · Carmody · D. · Tan · G. C. S. · Goh · S.-Y. · Bee · Y. M. · Chong · T. T. — Septiembre 19th 2025 at 06:54
Objective

This study aimed to determine the association between diabetes mellitus (DM) medication use and glycaemic control.

Design

This was a retrospective diabetes registry-based cohort study.

Setting

Singapore.

Participants

Patients aged 18 and above with incident DM in the SingHealth Diabetes Registry from 2013 to 2020 were included. The entire study period included a 1 year baseline period, a 1 year observation period and a 3 month outcome period.

Outcome measures

Drug use was measured using the proportion of days covered (PDC), and the changes in glycated haemoglobin (HbA1c) between the outcome and baseline periods were assessed. The associations between baseline HbA1c and PDC ≥0.80 and between PDC and change in HbA1c were analysed using logistic regression and the Kruskal–Wallis test, respectively.

Results

Of 184 646 unique patients in the registry from 2013 to 2020, 36 314 met the inclusion and exclusion criteria and were included in the analysis. The median PDC for any DM drug, oral DM drugs and insulin during the observation period was 20.3%, 16.8% and 0%, respectively. Those who had good glycaemic control at baseline were less likely to receive DM drugs and those with poor baseline glycaemic control or missing baseline HbA1c were more likely to be consistent users (PDC >80%) (px 10-16).

Conclusion

The relationship between DM drug use and glycaemic control is complex and non-monotonic. Higher PDC for any DM drug and oral DM drugs during the observation period was significantly associated with clinically relevant HbA1c improvements.

☐ ☆ ✇ BMJ Open

Access to multidisciplinary outpatient heart failure clinics in Qatar: a qualitative study from the perspectives of patients and cardiologists

Por: Hajaj · A. · Grace · S. L. · Hamed Badr · A. M. · Hadi · M. A. · Abdel-Rahman · M. E. · Babu · G. R. · Turk-Adawi · K. — Septiembre 18th 2025 at 03:51
Objective

Heart failure clinics (HFCs) are associated with increased survival rates, lower hospitalisation and improved quality of life. This study investigated factors influencing patient access to multidisciplinary outpatient HFCs from the perspective of patients and cardiologists.

Design

This was a qualitative study. A trained researcher conducted semistructured face-to-face interviews with patients and online interviews with cardiologists. Interviews, conducted between March and October 2023, were audio-recorded. Transcripts were cleaned (deidentification, translation verification) and analysed by two trained researchers independently using systematic text condensation in NVivo v12. Codes were derived from the transcripts and grouped and organised into themes. Two authors independently coded data, reconciling disagreements with the senior author, followed by respondent validation. Member checking ensued.

Setting

Outpatient multidisciplinary HFCs in Qatar.

Participants

A purposive sample of patients diagnosed with heart failure who had attended at least one HFC appointment at Qatar’s Heart Hospital were approached in person or via phone, and cardiologists with the authority to make referrals to these clinics via the electronic medical record system were emailed; interviews ensued until theme saturation was achieved.

Results

26 individuals (14 patients and 12 cardiologists) participated in the interviews. Four major themes were identified: health system organisation (subthemes: benefits, HFC triage criteria, need/capacity), HFC referral processes (subthemes: electronic record system, patient communication and education), care continuity and communication (subthemes: patient navigators, clinician preferences) and access challenges (subthemes: transportation, costs).

Conclusions

Resources are needed to expand HFC capacity and coverage, leverage electronic medical record tools as well as telehealth, educate physicians and patients on referral guidelines and processes and engage primary care to ultimately improve patient outcomes.

☐ ☆ ✇ BMJ Open

Pragmatic, multicentre, factorial, randomised controlled trial of sepsis electronic prompting for timely intervention and care (SEPTIC trial): a protocol

Por: Ranard · B. L. · Qian · M. · Cummings · M. J. · Zhang · D. Y. · Lee · S. M. · Beitler · J. R. · Applebaum · J. R. · Schenck · E. J. · Mohamed · H. · Trepp · R. · Hsu · H. · Scofi · J. · Southern · W. N. · Rossetti · S. C. · Yip · N. H. · Brodie · D. · Sharma · M. · Fertel · B. S. · Adelman — Agosto 12th 2025 at 03:13
Introduction

Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving patient outcomes. International guidelines recommend hospital sepsis screening programmes, which are commonly implemented in the electronic health record (EHR) as an interruptive sepsis screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care.

Methods and analysis

The Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC) master protocol will study two distinct populations in separate trials: emergency department (ED) patients (SEPTIC-ED) and inpatients (SEPTIC-IP). The SEPTIC trials are pragmatic, multicentre, blinded, randomised controlled trials, with equal allocation to compare four SIRS-based sepsis screening alert groups: no alerts (control), nurse alerts only, prescribing clinician alerts only, or nurse and prescribing clinician alerts. Randomisation will be at the patient level. SEPTIC will be performed at eight acute-care hospitals in the greater New York City area and enrol patients at least 18 years old. The primary outcome is the percentage of patients with completion of a modified Surviving Sepsis Campaign (SSC) hour-1 bundle within 3 hours of the first SIRS alert. Secondary outcomes include time from first alert to completion of a modified SSC hour-1 bundle, time from first alert to individual bundle component order and completion, intensive care unit (ICU) transfer, hospital discharge disposition, inpatient mortality at 90 days, positive blood cultures (bacteraemia), adverse antibiotic events, sepsis diagnoses and septic shock diagnoses.

Ethics and dissemination

Ethics approval was obtained from the Columbia University Institutional Review Board (IRB) serving as a single IRB. Results will be disseminated in peer-reviewed journal(s), scientific meeting(s) and via social media.

Trial registration number

ClinicalTrials.gov: NCT06117605 and NCT06117618.

☐ ☆ ✇ BMJ Open

A whole new ball game: a retrospective cohort study using healthcare administrative data to uncover predictors of timely transition from paediatric to adult type 1 diabetes care in British Columbia, Canada

Por: Leung · J. M. W. S. · Chen · L. · Zhang · Q. · Bone · J. N. · Amed · S. — Julio 22nd 2025 at 06:08
Objectives

To assess predictors of timely transition to adult diabetes care among individuals diagnosed with type 1 diabetes during childhood and adolescence. We hypothesised that older age at the last paediatric visit and urban residency would be predictors of timely transition.

Design

Retrospective cohort study using healthcare administrative data in a jurisdiction with a universal healthcare system.

Participants

2045 adolescents and young adults diagnosed with type 1 diabetes between the ages of 0.5 and 18 years.

Primary and secondary outcome measures

We ascertained age at the last paediatric diabetes visit (LPDV), age at the first adult diabetes visit (FADV) and transition duration, defined as the time between LPDV and FADV. Timely transition was defined as a transition duration of

Results

Only 31.3% of individuals saw an adult provider within 1 year of their LPDV. Each 1-year increase in the age at LPDV was associated with increased odds of timely transition (adjusted OR 1.82, 95% CI 1.71 to 1.93, p0.05).

Conclusions

Older age at the LPDV and urban residency are associated with increased odds of timely transition. Interventions should be developed to help keep adolescents engaged in paediatric care until an older age before referring them to adult diabetes care. Limitations of this study include unmeasured confounding and limited generalisability to non-universal healthcare systems.

☐ ☆ ✇ BMJ Open

Urinary cotinine cut-off concentrations in children under 5 years for assessing environmental tobacco smoke exposure: a systematic review and meta-analysis protocol

Por: Sayed Mohamed Zain · S. M. · Abdul Shukor · I. H. · Mohamad · N. · Wan Azmi · W. N. F. · Anual · Z. F. — Mayo 16th 2025 at 05:29
Introduction

Environmental tobacco smoke (ETS) is generally known as secondhand smoke. Assessing the magnitude of children’s exposure to ETS from early infancy is essential for public health and research endeavours. Urinary cotinine is now widely recognised as the primary indicator for assessing exposure to ETS across all age groups. This systematic review and meta-analysis aim to synthesise all the published evidence on the urinary cotinine cut-off concentrations used to categorise children under 5 years as being exposed to ETS.

Methods and analysis

We will conduct a systematic review according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. A comprehensive search will be conducted from various databases including PubMed, EMBASE, Scopus and Cochrane Library. This search will be performed from the earliest published articles up to the latest available studies until February 2025. We will include all the experimental and observational studies, such as cohort, case–control and cross-sectional, that measure urinary cotinine concentrations in children under 5 years old. Data extraction will be conducted using a standardised data extraction form, and the study quality will be evaluated according to the guidelines specified by the Newcastle-Ottawa Scale. The extracted data will be pooled and combined for meta-analysis. Two reviewers will independently screen, select and assess the quality of the included study. The result will be tabulated in a table of characteristics of the included study, which consists of the cut-off cotinine concentrations, analytical technique, method referred, study design, study area and respondents’ characteristics.

Ethics and dissemination

Ethics approval is not required as this is a review of collected published data. Findings will be disseminated in peer-reviewed publications and conference presentations, as well as with key stakeholders, health policymakers and healthcare professionals.

PROSPERO registration number

CRD42024556969.

☐ ☆ ✇ BMJ Open

Patterns, socioeconomic inequalities and determinants of healthy eating in Kenya: results from a national cross-sectional survey

Por: Wambiya · E. O. A. · Donfouet · H. P. P. · Kipruto · S. · Kisia · L. · Osindo · J. · Kisiangani · I. · Oguta · J. O. · Ilboudo · P. G. · Mohamed · S. F. — Abril 14th 2025 at 16:23
Objective

The burden of non-communicable diseases is rising in low-and-middle-income countries, with diet being a key risk factor. This study aimed to assess the patterns, socioeconomic inequalities and determinants of eating healthy in Kenya. The study is the first in Kenya to use a healthy diet index to assess dietary patterns.

Design and methods

We analysed cross-sectional data from the 2015/16 Kenya Integrated Household Budget Survey. The study’s outcome variable was a continuous healthy diet index (HDI) constructed using principal component analysis from nine WHO/Food and Agriculture Organization (FAO) healthy diet recommendations. The HDI score and WHO/FAO healthy diet recommendations met were summarised for Kenyan households. Using the concentration index, we examined the socioeconomic disparities in healthy eating. In addition, multivariable linear regression was used to determine factors that influence healthy eating in Kenya.

Results

A total of 21 512 households in Kenya were included, of which 60% were rural and about two-thirds headed by males. The HDI score ranged between –1.13 and 1.70, with a higher value indicating healthier eating. Overall, the average HDI score was 0.24 (95% CI: 0.24 to 0.25), interpreted as moderate. We identified key determinants including socioeconomic status and urban–rural residency differences. Healthy eating was concentrated among higher socioeconomic households, regardless of gender or location. Higher socioeconomic status (β=0.28, 95% CI 0.26 to 0.30), rural residence (β=0.18, 95% CI 0.15 to 0.20), household head being in union (β=0.04, 95% CI 0.02 to 0.06) or employed (β=0.05, 95% CI 0.02 to 0.08) were significantly associated with increased HDI scores, whereas male-headed households and lack of education were associated with significant decreases in HDI scores on average.

Conclusions

Most Kenyan households do not meet all the healthy dietary recommendations, and socioeconomic inequalities exist in eating healthy. Targeted interventions that promote healthy eating based on key determinants in Kenya are required.

☐ ☆ ✇ BMJ Open

Effects of exercise therapy with blood flow restriction on shoulder strength: protocol for a systematic review and meta-analysis

Por: Gholipour · M. A. · Hamedi · H. · Seyedhoseinpoor · T. — Abril 9th 2025 at 21:14
Introduction

Blood flow restriction therapy (BFRT) has gained attention for its capacity to induce substantial muscle hypertrophy and strength gains even when employing relatively minimal loads. Strength training is of significant importance in the rehabilitation of patients experiencing shoulder pain, which may arise from a multitude of sources, including rotator cuff injuries, tendinopathies or postsurgical recovery. However, traditional resistance training can be challenging for these individuals due to the presence of pain and functional limitations. In this regard, BFRT in conjunction with low-load strength training may prove an efficacious alternative. The integration of BFRT into rehabilitation protocols for shoulder pain could provide a viable pathway to improving muscle strength and facilitating recovery while minimising the risk of exacerbating pain or injury. The primary objective of this study is to conduct a systematic review of the effects of training with BFRT of the upper limb on shoulder strength.

Methods and analysis

A comprehensive database search will be conducted across multiple platforms, including PubMed, Scopus, Ovid, Web of Science, EBSCO, Cochrane Central, PEDro and Google Scholar, using predefined key terms without any language restriction. The particular focus of the study will be clinical trials with a controlled group that assess the impact of BFRT on upper extremity, neck and trunk muscles in both healthy individuals and patients. The primary outcome measure will be shoulder strength and power in different directions. The Cochrane Collaboration’s Risk of Bias 2 tool will be employed for the purpose of evaluating the risk of bias inherent to the studies in question. A meta-analysis will be conducted using Stata software. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach will be employed to evaluate the quality of evidence for the primary outcomes.

Ethics and dissemination

The previously published papers will be used for all analyses in this study. Results will be disseminated through professional networks, presentations at conferences and publication in a peer-reviewed journal. No ethics approval is required.

PROSPERO registration number

CRD42024605189.

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