BMJ Open最新文献

Introduction: Human papillomavirus (HPV) vaccines have been introduced in the Chinese market since 2016. However, the HPV vaccine coverage is still remarkably low among adolescent girls in China. This study will employ discrete choice experiments (DCEs) to elicit the preferences of Chinese caregivers for HPV vaccine-related profile characteristics and service delivery methods for adolescent girls.

Methods: Two DCEs will be conducted with caregivers of girls aged 9-18 in China. The first DCE will focus on caregivers' preferences regarding the HPV vaccine-related profile for girls aged 9-18, with potential attributes including level of protection against cervical cancer, level of protection against genital warts, risk of severe side effects, number of dose(s), place of manufacture, waiting time and cost for one dose. The second DCE will assess Chinese caregivers' preferences for vaccination service delivery methods, with the potential attributes including source of recommendation, information channel, message framing, how to make an appointment, location for receiving the vaccine and incentives. A total of 300 participants will be recruited to complete the DCEs. We will summarise the key socio-demographic characteristics of participants and use latent class and mixed logit models to assess preferences and preference heterogeneity in HPV vaccination services.

Ethical and dissemination: Ethical approval was obtained from the Research and Ethics Committee at Nanjing Medical University. Findings from this study will be disseminated widely to relevant stakeholders via scheduled meetings, webinars, presentations at conferences and in peer-reviewed journal manuscripts.

Introduction: Early detection of carotid plaque prevents stroke and myocardial infarction. Individuals with fatty liver might be at an increased risk of developing carotid plaque, yet limited access to carotid artery ultrasound underscores the need for predictive models.

Aims: We aimed to construct six predictive models for males and females separately to predict carotid plaque among individuals with fatty liver disease.

Design: A cross-sectional study.

Data sources: We included 8361 participants aged ≥40 years (4871 males; 3490 females) with fatty liver who underwent at least one health check-up between 1 January 2020 and 31 December 2023.

Methods: The sex-stratified dataset was randomly divided into 70% training and 30% internal testing datasets. With 24 potential predictors, we applied four machine learning (ML) algorithms and two conventional logistic regression (LR) models: stepwise LR and LR based on ML-selected features (LR-ML) to develop sex-specific carotid plaque prediction models. The performances were evaluated by area under the receiver operating characteristic curve (AUC), sensitivity, specificity, precision, F1-score, accuracy, calibration curve and decision curve analysis.

Main outcome measures: Carotid plaque was determined when the local carotid intima-media thickness was ≥1.5 mm in any of the arterial segments.

Results: Four predictors (age, hypertension, total bilirubin, total cholesterol and white blood cell count) in males and three (age, systolic blood pressure and fasting blood glucose) in females were identified by consensus across the four ML algorithms and subsequently used to construct LR models. Among all 4 ML and two LR models, the gradient boosting machine model demonstrated the best overall performance in males (AUC=0.773, 95% CI 0.749 to 0.797), while the LR-ML model was optimal in females (AUC=0.817, 95% CI 0.791 to 0.843). Calibration and decision curve analyses further demonstrated satisfactory agreement and higher net benefit across sexes. Risk stratification identified distinct low-, intermediate- and high-risk groups with progressively higher observed prevalence of carotid plaque (20.25%, 48.58% and 69.41% in males; 15.28%, 50.89% and 66.56% in females).

Conclusion: Our findings highlight significant sex differences in practical carotid plaque prediction, providing crucial insights for public health implications in the early identification and risk assessment of carotid plaque among individuals with fatty liver.

Objective: To explore the role of senior and mid-level managers as barriers or enablers to change in tackling the discriminatory challenges experienced by Black and Minority Ethnic (BME) employees working in the National Health Service (NHS).

Design: A multi-level, multi-sourced qualitative study of five NHS Trusts in England.

Setting and participants: 26 qualitative interviews with senior leaders and BME network chairs (27 participants) and five focus groups (37 participants) with BME employees, across five NHS Trusts in England.

Results: Our findings revealed that discrimination, racial harassment, incivilities, lack of progression and exclusion experienced by BME employees appear to be deeply ingrained in the culture of the NHS. Despite numerous national and local initiatives aimed at promoting inclusivity and addressing discriminatory behaviours, our findings also revealed a notable disparity between what senior leaders thought was effective in addressing discriminatory behaviours and the actual lived experiences of BME employees. Finally, a key finding was the pivotal role middle managers played in setting the tone for whether discriminatory behaviours are challenged or allowed to persist, which directly impacts on the overall experiences of BME employees within the NHS.

Conclusions: Our results provide evidence that not only does racial discrimination continue to be experienced by NHS BME employees, but that middle managers are key to addressing and improving this situation. Despite there being national policies and initiatives addressing racial discrimination, our study found that positive change, whether at an individual or organisational level, is dependent on the actions and commitment of middle managers.

Objectives: Accurate identification of adverse events after colonoscopy is essential for quality assurance in colorectal cancer (CRC) screening. Review of medical records is labour intensive as adverse events are infrequent. The object of this study was to investigate the accuracy of claims data in identifying adverse events after colonoscopy in CRC screening.

Design: Cross-sectional, retrospective.

Setting and participants: Males and females aged 50-74 years were randomised to once-only sigmoidoscopy or biennial faecal immunochemical test in a CRC screening trial at two screening centres in Norway. Participants in the present study underwent follow-up colonoscopy from 2012 to April 2020 after initial positive screening test. We reviewed medical records for adverse events within 30 days following 11 205 colonoscopies.

Primary and secondary outcome measures: The primary outcome of the study was to assess the sensitivity of claims data from the Norwegian Patient Registry to identify lower gastrointestinal bleeding using emergency contact International Statistical Classification of Diseases and Related Health Problems 10th Revision diagnostic code sets under two definitions: a stringent definition (codes explicitly identifying bleeding) and a broad definition (including suggestive codes). Secondary outcome measures included the sensitivity to identify perforation using a stringent and a broad definition. Additionally, we assessed whether incorporating procedure codes and non-emergency contacts improved accuracy.

Results: 87 cases of lower gastrointestinal bleeding and eight perforations were confirmed. Sensitivity for bleeding differed between the centres (p<0.001). At centre 1, sensitivity was 48.6% (95% CI 31.9% to 65.6%) using the stringent and 89.2% (95% CI 74.6% to 97.0%) using the broad definition. At centre 2, sensitivity was 36.0% (95% CI 22.9% to 50.8%) and 50.0% (95% CI 35.5% to 64.5%), respectively. Combined sensitivity for perforation was 37.5% (95% CI 8.5% to 75.5%) using the stringent and 62.5% (95% CI 24.5% to 91.5%) using the broad definition. Adding procedure codes and non-emergency contacts slightly increased sensitivity but increased false positives.

Conclusions: Use of claims data underestimated adverse event rates following colonoscopy. Difference in coding practice across hospitals underscores the need for standardised reporting in screening programmes.

Trial registration number: NCT01538550.

Objectives: Early screening for autism spectrum disorder (ASD) can enhance educational and health outcomes for affected children. This narrative systematic review explores school-based screening tools used around the world to identify children with ASD and explore the differences across socio-demographic groups.

Design: Systematic review of electronic databases (EMBASE, MEDLINE, PsycINFO, Cochrane and Scopus) in October 2024 of papers published between 2011 and 2024.

Setting: Mainstream school-based settings globally.

Participants: Children aged 4-16 years old attending mainstream school.

Interventions: School-based screening tools for ASD, including all types of informant and format of tools reported in eligible studies.

Primary and secondary outcome measures: Primary outcomes included prevalence of screen positives, sensitivity and specificity of the screening tools. Secondary outcomes included participants' sex, socioeconomic status and ethnicity, and the relation of this to the primary outcomes.

Results: Of 7765 eligible articles, 14 studies were included in this review. We identified eight different school-based ASD screening tools. Study populations ranged from 103 to 16 556 children, with sensitivity and specificity varying by screening tool used, age group, setting and ASD prevalence. The percentage of children screening positive for ASD ranged from 0.7% to 8.5%. Studies were conducted in Europe (n=6), Western Pacific (n=4), the Americas (n=3) and Eastern Mediterranean (n=1) regions. No studies explicitly explored accuracy or validity outcomes based on ethnicity or socioeconomic status. Half of the 14 studies (n=7) reported the sensitivity and specificity of the screening tools; sensitivity ranged from 58% to 94% and specificity from 61% to 100%. There was insufficient evidence to recommend any single ASD screening tool.

Conclusions: ASD screening tools vary widely across the globe, with limited standardisation. Evidence is lacking on how ethnicity and socioeconomic status affect their effectiveness in schools. Given the dearth of scientific evidence in this field, collaboration among educators, researchers and policymakers is needed to establish the evidence base for universal screening, identify optimal tools, coordinate their use and ensure their validation for specific populations.

Introduction: Minimally invasive endoscopic procedures constitute the cornerstone of first-line treatment for bulbar urethral strictures, although their long-term effectiveness is limited by high recurrence rates. The Optilume drug-coated balloon (DCB) is a novel intervention combining mechanical dilation with localised delivery of paclitaxel to reduce recurrence by inhibiting scar tissue formation. While its efficacy has been demonstrated in patients with recurrent strictures, its potential as a first-line option in treatment-naïve patients remains unexplored. The FIRST-CARE trial aims to assess the efficacy and safety of Optilume DCB compared with standard endoscopic treatment in treatment-naïve patients with bulbar urethral strictures.

Methods and analysis: Design: Two-arm, randomised, single-blind (participant), investigator-initiated, parallel-group, multicentre clinical trial.

Patients: The study will enrol 140 adult male patients with treatment-naïve, single bulbar urethral strictures ≤3 cm in length.

Interventions: All patients will undergo the assigned procedure under general anaesthesia with 1.5 g intravenous cefuroxime. Optilume group patients will receive ≥5 min balloon dilation with localised paclitaxel delivery. The control group will receive standard endoscopic treatment (eg, direct visual internal urethrotomy, laser or dilatation). In both groups, a 12-14 French Foley catheter will be left in place for 3-5 days.

Primary outcome: Freedom from repeat intervention within 12 months of follow-up. Primary analysis: Time-to-event will be defined from the date of intervention to the date a repeat intervention is decided (indicated and planned) due to confirmed recurrence, with censoring at 12 months. Groups will be compared using Kaplan-Meier survival analysis and the log-rank test. Cox regression and modified Poisson regression will be used to estimate HRs and relative risks.

Ethics and dissemination: The trial is approved by the Danish National Committee on Health Research Ethics (2401370) and will be conducted in accordance with the Declaration of Helsinki and principles of Good Clinical Practice. In line with national guidelines, all eligible patients are counselled regarding available treatment options prior to enrolment. Results will be disseminated via peer-reviewed publications and scientific presentations.

Trial registration number: NCT06827210.

Objectives: Although breastfeeding is associated with lower postnatal depression and anxiety, limited research exists regarding long-term maternal mental health outcomes. This study examined the association between breastfeeding and depression and anxiety in women of later reproductive age (mid 30s to menopause).

Design: This was a 10-year prospective longitudinal cohort study. Self-reported questionnaires were used to collect lifetime breastfeeding behaviour at 10 years, and health history including depression, anxiety and medication use was collected at each study timepoint.

Setting: A tertiary level maternity hospital in Dublin, Ireland.

Participants: 168 parous women from the ROLO Longitudinal Cohort with lifetime breastfeeding behaviour and health history data available at 10 years were included (22% of total cohort). Women currently pregnant or breastfeeding at 10-year follow-up were excluded.

Results: Mean (SD) age at study end was 42.4 (3.8) years. 72.6% (n=122) of women reported ever breastfeeding. Median lifetime exclusive breastfeeding was 5.5 weeks (IQR 35.8, range 0-190). 37.5% of women (n=63) breastfed for ≥12 months over their lifetime. 13.1% (n=22) reported depression or anxiety at 10 years, and 20.8% (n=35) reported depression or anxiety over the whole study period. Ever breastfeeding was associated with less depression and anxiety at 10 years (OR 0.34, 95% CI 0.12 to 0.94, p=0.04). Ever breastfeeding, longer exclusive breastfeeding and lifetime breastfeeding ≥12 months were associated with lower depression and anxiety over the whole study period (ever breastfeeding OR 0.4, p=0.03; exclusive breastfeeding OR 0.98/week, p=0.03; lifetime breastfeeding ≥12 months OR 0.38, p=0.04).

Conclusion: There may be a protective association between breastfeeding and self-reported depression and anxiety. Further studies are required to confirm the findings.

Trial registration number: ISRCTN54392969.

Introduction: Chemotherapy is the standard second-line treatment option for advanced biliary tract cancer (BTC), but its therapeutic efficacy is suboptimal. Disitamab vedotin (RC48) and lenvatinib have demonstrated promising efficacy in human epidermal growth factor receptor 2 (HER2)-positive BTC and other malignancies. In this study, we aim to evaluate the efficacy and safety of RC48 in combination with lenvatinib in second-line or above treatment for HER2-positive advanced BTC.

Methods and analysis: This is a single-centre, single-arm, open-label, exploratory phase II clinical study in patients with HER2-positive unresectable locally advanced or metastatic BTC who have failed prior therapy. 31 patients will be enrolled in this study to receive the combination of RC48 and lenvatinib. The primary study endpoint is objective response rate, and the secondary study endpoints are disease control rate, duration of response, progression-free survival and overall survival.

Ethics and dissemination: The study has received approval from the Medical Ethics Committee of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (approval No. (2023)0367-01). Results will be disseminated through publication in peer-reviewed journals and through other appropriate media channels.

Trial registration number: ChiCTR2300076406.

Introduction: Despite advances in maternity care, stillbirth remains a major burden. It disproportionately affects black and Asian mothers, those with obesity and women over the age of 35 years. Induction of labour may benefit these women, but there is no clear evidence to guide recommendations on optimal timing of induction because of variations in the intervention and insufficient power in primary trials for rare outcomes such as stillbirth and perinatal mortality, or to assess whether effects differ by maternal characteristics. We will conduct an individual participant data (IPD) meta-analysis of randomised trials to assess the overall and differential effect of induction of labour, according to timing of induction and maternal characteristics, on adverse perinatal and maternal outcomes. We will also rank induction of labour timing strategies by their effectiveness to inform clinical and policy decision-making.

Methods and analysis: We will identify randomised trials on induction of labour by searching MEDLINE, CINAHL, EMBASE, BIOSIS, LILACS, Pascal, SCI, CDSR, ClinicalTrials.gov, ICTRP, ISRCTN registry, CENTRAL, DARE and Health Technology Assessment Database, without language restrictions, from inception to June 2025. Primary researchers of identified trials will be invited to join the OPTIMAL Collaboration and share the original trial data. Data integrity and trustworthiness assessment will be performed on all eligible trials. We will check each study's IPD for consistency with the original authors before standardising and harmonising the data. Study quality of included trials will be assessed by the Cochrane Risk of Bias tool. We will perform a series of one-and-two-stage random-effects meta-analyses to obtain the summary intervention effect on composite adverse perinatal outcome (stillbirth, neonatal death or severe morbidity requiring admission to neonatal unit) with 95% CIs and summary treatment-covariate interactions (maternal age, ethnicity, parity, socioeconomic status, body mass index and method of conception). Heterogeneity will be summarised using tau², I² and 95% prediction intervals for effect in a new study. Sensitivity analysis to explore robustness of statistical and clinical assumptions will be carried out. Small study effects (potential publication bias) will be investigated using funnel plots.

Ethics and dissemination: The study is registered on PROSPERO (CRD420251066346) and ethics approval is not required. We will disseminate findings widely to women, healthcare professionals and policymakers through academic, professional bodies and social media channels, and in peer-reviewed journals to achieve impact.

Prospero registration number: CRD420251066346.