BMJ Open最新文献

Introduction: Children with bilateral cerebral palsy (BCP) frequently develop progressive gait impairments driven in part by muscle weakness. Although power training, which involves high-velocity loaded movements, can enhance functional capacity, its substantial physical demands often limit feasibility in this population. Blood flow restriction (BFR) training has emerged as a promising alternative, capable of eliciting comparable physiological benefits while using low-intensity exercise. This study evaluates the feasibility, safety and clinical effects of integrating BFR with treadmill training in children with BCP, an innovative approach that may deliver the advantages of intensive strengthening while reducing physical burden.

Methods and analysis: This single-centre pilot study uses a double-baseline design with 13 participants with BCP (Gross Motor Function Classification System II-III), aged 8-18. The protocol consists of a 10-week usual care period followed by a 10-week Blood Flow Restriction Treadmill Training (BFR-TT) intervention, with three sessions per week. Feasibility targets were defined as completion of at least 80% of at least 80% of sessions. Safety is monitored through pain scales and adverse events. Outcomes assess body function (strength, GAITRite), activity (walking speed, walking endurance and motor function) and participation (daily activities), comparing changes between the usual care and BFR-TT periods.

Ethics and dissemination: This study was approved by the French Protection of Persons Committee (2024-A00791-46). Results will be published in peer-reviewed journals and presented at international conferences.

Trial registration number: NCT06533956.

Purpose: The Infant Gut Bacterial Study in Nigeria (INBUGS-NG) investigates how delivery mode, antibiotic exposure, feeding practices and environmental factors shape gut microbiome development and acquisition of antibiotic resistance genes (ARGs) during the first year of life in northern Nigeria.

Participants: Between February and July 2024, 90 mother-infant dyads were enrolled at a tertiary hospital in Kano city, Nigeria. This was a prospective longitudinal cohort with follow-ups at 10 scheduled time points: days 0, 1, 3, 5, 7, 14, 28, 90, 180 and 365. We also intensified stool sampling after infant antibiotic administration, enabling dense early-life sampling. To date, the cohort has contributed 480 infant stool samples, 232 maternal rectal swabs, 254 breast milk samples and 806 environmental samples (total 1772). In parallel, socio-demographic, clinical and cultural data were collected using Research Electronic Data Capture (REDCap) and household visit diaries.

Findings to date: Baseline data show that 84/90 mothers (93.3%) received postpartum antibiotics, and 26/90 infants (28.9%) received antibiotics within the first 3 months of life. Only 8% of infants were exclusively breastfed, with early water supplementation common. Caesarean deliveries accounted for 25% of births, and the mean gestational age was 38.5 weeks. Across the cohort, high retention was achieved, and the study has generated a unique long-read metagenomic resource from an African infant population, with analyses ongoing.

Future plans: Shotgun long-read metagenomic sequencing (Oxford Nanopore) will enable strain-level and plasmid-level profiling of microbial communities and ARGs. Planned analyses include associations between early-life exposures and resistome dynamics, as well as cross-cohort comparisons with a parallel study in Pakistan. Follow-up will continue through 12 months.

Objective: To identify predictors of treatment changes and to evaluate the effectiveness and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) initiating tofacitinib in a real-world setting.

Design: The non-interventional study ESCALATE-RA included 1518 patients with RA from Germany. RA treatment, including all changes in therapy, was documented for 24 months starting from the initial intake of tofacitinib.

Participants: All patients started with tofacitinib therapy, either as monotherapy or in combination with methotrexate (MTX).

Primary and secondary outcome measures: The impact of several factors of interest on the number and timing of treatment changes was assessed as primary outcome using Cox proportional hazards models. Further outcomes were tofacitinib drug survival and the use of follow-up disease-modifying antirheumatic drugs after first treatment change. We also assessed the effectiveness, concomitant glucocorticoid (GC) use, PROs (such as functional ability, patient satisfaction, pain and quality of life) and safety. Analyses were based on observed data.

Results: 'Lack of efficacy' (HR 3.30) and 'intolerance' (HR 4.43) leading to termination of tofacitinib were key factors favouring therapy changes. Higher patient satisfaction was significantly associated with a reduced likelihood of treatment changes (HR 0.82). Increasing GC doses were associated with a higher probability of step-up/switch changes (HR 1.21). The estimated tofacitinib drug survival was 48% at the end of study. Proportions of patients achieving low disease activity (both Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) Δ62%) and remission (SDAI Δ25%, CDAI Δ28%) increased from baseline under tofacitinib and were comparable between monotherapy and combination therapy with MTX. Mean concomitant GC dose decreased (2 mg/day). PROs indicated reduced pain and fatigue, while functional ability and quality of life improved. 63.9% of the patients experienced a treatment-emergent adverse event (AE), 8.8% a treatment-emergent AE of special interest and deaths occurred in 0.5%.

Conclusion: Key factors for therapy changes in patients with RA treated with tofacitinib were lack of efficacy and intolerance. Higher patient satisfaction was associated with a reduced probability of treatment changes, while increased GC doses led to a higher likelihood of step-ups/switches. Patients demonstrated a marked reduction in disease activity for up to 24 months, along with improvements in functional ability, pain and quality of life. Observed AEs were consistent with the known safety profile of tofacitinib.

Trial registration number: NCT03387423.

Introduction: For adolescents living with higher body weight, changing lifestyle behaviours can be met with challenges due to psychosocial factors, such as mental health and emotional challenges. Few behavioural interventions have included skill development to manage these mental health and emotional challenges.

Methods and analysis: The feasibility of a dialectical behavioural therapy (DBT)-enhanced lifestyle intervention will be evaluated through a pilot randomised controlled trial. We will recruit 90 adolescents aged 14-17 years with a body mass index Z-score >1.4 and mild-to-moderate depressive symptoms to participate with a caregiver in the trial. Adolescents will be randomised 2:2:1 to one of the three study arms: (A) behavioural lifestyle intervention with DBT skills training, (B) behavioural lifestyle intervention alone (ie, without DBT skills training) or (C) control. The interventions will include two sessions weekly for 16 weeks that include (1) one modified DBT skills training with two facilitators, supervised by a clinical psychologist, combined with one behavioural lifestyle session delivered by a dietitian and/or a kinesiologist and (2) two behavioural lifestyle sessions alone. DBT skills training will consist of teaching mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness and walking the middle path modules. Behavioural sessions will be guided by evidence-based practices for goal setting, dietary counselling, improving sleep, reducing screen time and structured physical activity. The main outcomes are enrolment rates, adherence to the intervention and retention rates for follow-up measurements. The secondary outcome will be changes in the quality of life (Pediatric Quality of Life Inventory) and daily physical activity levels between baseline and immediately post-intervention. Adolescents will participate in a focus group incorporating photo elicitation to explore satisfaction, acceptability and perceived benefits of the study arms.

Ethics and dissemination: This study has received ethical approval from the University of Manitoba's Biomedical Research Ethics Committee (HS24295-H2020:427), Hamilton Health Sciences & McMaster University (HiREB 18159) and The Conjoint Health Research Ethics Board (CHREB), University of Calgary (REB24-1084). Results will be disseminated through publication in peer-reviewed journals and be relevant to researchers and clinicians involved in paediatrics and paediatric weight management.

Trial registration number: NCT05338944.

Objective: To explore long-term physical activity (PA) among patients 2 years post-transcatheter aortic valve replacement (TAVR) and assess the impact of syncope history on post-TAVR activity.

Design: This was a cross-sectional study conducted using an on-site questionnaire.

Setting: In this cross-sectional study, we used convenience sampling to recruit participants from the outpatient department at a tertiary hospital in Shanghai, China, between July 2023 and December 2023.

Participants: Patients who had undergone TAVR for 2 years or more were included in the study.

Primary and secondary outcome measures: The self-reported PA levels were assessed using the validated Chinese version of the International Physical Activity Questionnaire-Short Form. Additionally, medical records of the patients were thoroughly reviewed to accurately document the history of syncope for everyone.

Result: Via convenience sampling, we recruited 179 consecutive participants aged 60 years and older who underwent TAVR. Only 36.31% (65/179) of patients remained physically active ≥2 years post-TAVR, with 27.37% having a syncope history. After adjusting for potential confounders, a history of syncope was independently associated with significantly lower levels of long-term PA (adjusted OR 0.287, 95% CI 0.122 to 0.675). This negative association was particularly pronounced among men and individuals with a normal body mass index (BMI).

Conclusion: A history of syncope is a strong independent predictor of reduced PA in the long term after TAVR. These findings highlight that patients with a history of syncope, especially men and those with normal BMI, represent a high-risk subgroup warranting particular attention in post-TAVR care. Targeted assessment and rehabilitation strategies should be considered for this population, and further research is needed to elucidate the underlying mechanisms.

Objectives: The aims of this study were to explore how health visitors (HVs) and community health nurses (CHNs) assess unsettled baby behaviours, how their perceptions of these behaviours influence decisions about support offered, and how able they feel to deliver support to families of unsettled babies.

Design: Qualitative semi-structured interviews were conducted, recorded and transcribed. Data were analysed using Reflexive Thematic Analysis.

Setting: Potential participants were invited nationally via social media and via Health Visiting Service managers from an NHS Trust. Interviews took place remotely.

Participants: 17 HVs and 3 CHNs were purposively selected to include a wide range of perspectives.

Results: Three themes were developed, (1) HVs' perceptions of parents' sense-making which explains how HVs/CHNs understand parents' beliefs around unsettled babies; (2) care pathway which highlights the importance HVs place on creating emotional space for the baby, the parent and the health visitor within the pathway (containment); and (3) service delivery decline, which outlines the impact of funding cuts to the services on the HVs' ability to provide support for families. Lastly, a new concept - the Tipping Point model - was created to holistically conceptualise the experiences of HVs providing support for unsettled babies in the UK.

Conclusions: Policy makers need to organise services to value and support the role of the health visiting team in 'containment'. HVs identified a training need around assessing and advising about unsettled babies to place them in a stronger position to support families. Further research is needed into different models of support for families of unsettled babies from the wider primary care team and/or from digital services.

Objective: To explore how health and social care professionals (HSCPs) in the UK conceptualise and respond to cognitive dysfunction in depression, including its potential long-term implications for brain health and dementia risk.

Design: A qualitative, semi-structured interview study. Data was analysed using a code-book approach to thematic analysis.

Setting and participants: The study was conducted in the UK, with HSCPs from diverse professional backgrounds including general practitioner, psychology, psychiatry, mental health nursing, psychological well-being practitioner and occupational therapy. A total of 12 participants were recruited via purposive and convenience sampling.

Results: Three master themes were developed, (1) Cognitive dysfunction in depression, (2) Persistence of cognitive dysfunction and (3) Depression and dementia risk. HSCPs expressed challenges in screening for cognitive dysfunction in depression, particularly as dementia-related screening tools were used which may not be sensitive enough to detect depression-related cognitive deficits. A number of potential explanations were reported as to why cognitive dysfunction may persist after mood symptoms have lifted. These included substance misuse, role of education, neurological conditions and depression as a prodrome to dementia. Depression as a potential risk factor for poorer brain health in the context of dementia risk reduction was not communicated in clinical settings to service users. Barriers to communication included lack of evidence base on depression as a potential risk factor, as well as lack of guidance on communication practices in the context of mental health issues.

Conclusions: Cognitive dysfunction in depression is a complex phenomenon and remains under-explored. Challenges around identification and screening indicate a need for validation studies of cognitive screening measures for use in mood disorders, as well as pilot, acceptability and feasibility trials of interventions targeting cognitive functioning in mood disorders. Mixed-methods research is warranted to understand whether guidance on communicating depression as a risk factor for brain health is required and/or justified.

Background: Chronic non-specific low back pain (CNLBP) is a multifactorial disease involving physical dysfunction and psychological distress. Acupuncture and mindfulness-based stress reduction (MBSR) are two non-pharmacological therapies recommended by guidelines, which have been proven effective in improving the clinical symptoms of CNLBP. However, the efficacy of their combined use has yet to be explored. This study aims to explore whether the combination of acupuncture and MBSR would have different synergistic effects in patients with CNLBP compared with acupuncture or MBSR alone.

Methods and analysis: This protocol describes a randomised controlled trial with a 2×2 factorial design involving 120 CNLBP patients. Participants will be randomly allocated to four groups: (1) acupuncture, (2) MBSR, (3) acupuncture combined with MBSR, and (4) health education. The intervention period is 6 weeks. The outcome measurements will include the Visual Analogue Scale (VAS), Tactile Acuity Test, Short-form of McGill Pain Questionnairethe(SF-MPQ); Roland-Morris Functional Disability Questionnaire (RMDQ), Oswestry Disability Index(ODI), the Five Facet Mindfulness Questionnaire (FFMQ), the 21-item Depression Anxiety Stress Scales (DASS-21), the Regulatory Self-Efficacy Scale (RESE), the Beck Depression Inventory (BDI-II), the Beck Anxiety Inventory (BAI), the Fear-Avoidance Beliefs Questionnaire (FABQ) and the Pain Catastrophizing Scale (PCS);Pain Sensitivity Questionnaire(PSQ); Pittsburgh Sleep Quality Index(PSQI). All evaluations will be conducted at the baseline stage as well as 6 weeks and 4 months after the implementation of the intervention measures.

Ethics and dissemination: Ethics approval was obtained from the Ethics Committee of the Affiliated Rehabilitation Hospital of the Fujian University of Traditional Chinese Medicine (2024KY-041-04). The results of the study will be disseminated through peer-reviewed publications and at scientific conferences.

Trial registration number: ITMCTR2025000764.

Introduction: Oral health is an integral part of overall health and well-being, yet oral diseases remain highly prevalent, affecting an estimated 3.7 billion people worldwide. The greatest burden arises from periodontitis, tooth loss and oral cancers, while untreated dental caries continue to be the most common condition globally. Despite advances in preventive technologies, community-based programmes and clinical innovations, the global burden of oral diseases has not proportionately declined. This highlights a persistent evidence-practice gap in oral health, where effective interventions have not been translated into routine practice at scale. Implementation research provides a valuable lens to understand how oral health interventions can be adopted, adapted and sustained in diverse real-world contexts. However, evidence on implementation strategies, frameworks and contextual factors in oral health remains fragmented, with no comprehensive synthesis to date.

Methods and analysis: The review will follow Joanna Briggs Institute methodology for scoping reviews. A three-step search strategy will be applied to locate published and unpublished literature, including PubMed, Scopus, PsycINFO, Embase and grey literature sources such as World Health Organisation and Centers for Disease Control and Prevention publications, government and non-governmental organisation reports and academic theses. No date restrictions will be applied. Duplicates will be removed using Zotero. Following screening and full-text review in JBI SUMARI, data will be extracted using a predesigned tool and synthesised descriptively. Results will be presented in evidence tables and a narrative synthesis, supported by figures and thematic mapping of strategies, frameworks and contextual factors.

Ethics and dissemination: Ethics approval is not required for this scoping review. The findings will be disseminated through peer-reviewed journal publications and conference presentations.

Introduction: A significant proportion of adults in England and Wales report experiencing childhood trauma, which is often associated with poor health and negative social outcomes including a significant increase in the risk of poor mental health outcomes in adulthood. This proposed scoping review adopts a broad definition of childhood trauma and applies both a salutogenic framework and ecological systems theory to explore how protective factors at five ecological levels can support mental well-being. The review will also examine how protective factors vary across different population groups and contexts.

Methods and analysis: The scoping review will follow the Joanna Briggs Institute (JBI) protocol for scoping reviews. The databases that will be searched are Embase, PubMed, Web of Science, PsycINFO, CINAHL and Medline. Studies will be included if they include protective factors and involve adults aged 18 and over who have experienced childhood trauma, whether self-identified, retrospectively self-reported or measured using a validated instrument. Studies will be excluded if they focus on participants under the age of 18.All search results will be uploaded to Covidence, duplicates removed, and titles/abstracts screened by at least two reviewers based on inclusion criteria. Full texts of potentially relevant sources will be imported into EndNote 21. Reasons for exclusions will be documented and disagreements resolved through discussion or a third reviewer. The full process will be reported using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. Data will be extracted by at least two reviewers using a tool developed by the team based on the JBI guidance. A best-fit framework analysis will be used, using a matrix developed by the researchers including the four salutogenic domains and the five levels of the ecological framework.

Ethics and dissemination: Formal ethical approval is not necessary for this scoping review as it does not involve the collection of primary data. The outcomes of this study will be disseminated through peer-reviewed journal articles, conference/seminar presentations, and developed into resources for stakeholders and collaborators.

Trial registration number: Open Science Framework (DOI 10.17605/OSF.IO/CJRUY).