Ankle fracture fixation surgery may be performed with or without the use of a tourniquet. Surgeons who use a tourniquet report reduced intraoperative bleeding, which improves the visualisation of anatomical structures. This may facilitate more accurate fracture fixation and restoration of the anatomical configuration of the ankle joint, potentially leading to improved functional outcomes. An additional proposed benefit of tourniquet use is reduced operative time. In contrast, surgeons who choose not to use a tourniquet report concerns that it may exacerbate postoperative pain and increase the risk of venous thromboembolism, surgical site infection and other complications. However, existing clinical trials are limited by small sample sizes and high risk of bias, preventing the ability to draw robust conclusions. This study aimed to assess the feasibility of conducting a randomised controlled trial (RCT) to evaluate the potential benefits and risks of tourniquet use in ankle fracture fixation surgery.

This study comprises a two-centre, participant-blinded and surgeon-blinded parallel-arm RCT and an integrated qualitative interview study. A computer-generated randomisation service will allocate up to 50 patients to undergo ankle fracture fixation surgery either with or without the use of a tourniquet. Participants will be followed up for 3 months postoperatively. Primary outcomes include recruitment and retention rates, data completeness, success of blinding and adherence to allocated intervention. Secondary outcomes include postoperative pain, quality of the surgical field, intraoperative blood loss, blood transfusions, procedure duration, skin assessment, awareness of tourniquet use, health-related quality of life (EuroQol-5D-5L), Olerud-Molander Ankle Score and intraoperative and postoperative complications. The integrated qualitative study will consist of semistructured interviews with up to 12 patients and 12 trauma and orthopaedic surgeons (~24 interviews). Interviews will explore perspectives on the feasibility trial, identify factors associated with unblinding and examine barriers and potential solutions to the design and delivery of a future definitive trial. Interviews will be analysed using inductive thematic analysis.

National Research Ethics Committee (East of England-Essex) approved this study on the 8 May 2025 (REC 25/EE/0051). The results will be disseminated via peer-reviewed publication.

ISRCTN91783787.

Macrosomia is an emerging but neglected obstetric challenge in Africa, associated with potentially life-threatening complications to both the mother and the fetus, including maternal and neonatal morbidity and mortality. This study aimed to determine the pooled prevalence, associated risk factors, and neonatal and maternal outcomes of macrosomia by performing a systematic review and meta-analysis.

We conducted a systematic review and meta-analysis following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

We conducted a comprehensive search of PubMed, EMBASE and Web of Science to extract data from those that have investigated various aspects of the prevalence, risk factors and outcomes of macrosomia from the earliest records to 26 August 2025. Appropriate search terms were used for each database.

We included observational studies that examined the prevalence, risk factors and outcomes of macrosomia in Africa.

Two independent reviewers used standardised methods to search, screen and code included studies. Risk of bias was assessed using the Joanna Briggs Institute Critical Appraisal tool and the Newcastle-Ottawa Quality Assessment Scale. Meta-analyses were performed using random-effects models to estimate the pooled prevalence of macrosomia. The I² statistic was used to examine statistical heterogeneity. Egger’s test and Funnel plot were used to evaluate publication bias. Grading of Recommendations Assessment, Development and Evaluation to assess the quality of the meta-analysis.

A total of 29 studies comprising 269 934 mother–infant pairs from 9 African countries were included. The pooled prevalence of macrosomia in Africa was 6.35% (95% CI 5.22% to 7.48%), with substantial heterogeneity (I²=94.9%). Sensitivity analysis excluding one outlier study reporting a prevalence of 35.89% produced a similar pooled estimate (6.02%, 95% CI 4.94% to 7.10%). Significant risk factors for macrosomia included male neonate (OR=1.58, 95% CI 1.05 to 2.11), gestational age ≥40 weeks (OR=1.54, 95% CI 1.11 to 1.97) and history of macrosomia (OR=5.44, 95% CI 1.82 to 9.06). With respect to outcomes, macrosomia was associated with an increased risk of shoulder dystocia (OR=2.07, 95% CI 1.12 to 3.03), and a reduced risk of postpartum haemorrhage (OR=0.86, 95% CI 0.82 to 0.91), while no significant associations were observed for gestational diabetes mellitus, caesarean delivery, neonatal mortality or maternal mortality.

Macrosomia remains a significant public health concern in Africa, with a pooled prevalence of 6.35%. There are multiple risk factors associated with macrosomia in Africa, including the male sex, prolonged gestation and a prior history of macrosomia. Also, macrosomia increases the likelihood of shoulder dystocia and other delivery complications. Preventive strategies and targeted interventions are needed to reduce the burden of macrosomia in Africa. At the same time, enhanced obstetric preparedness for macrosomic deliveries is essential to mitigate the associated adverse perinatal outcomes. However, our study is limited by high heterogeneity and publication and language biases, which should be addressed in future studies.

CRD42023485419.

Obesity disproportionately affects ethnic minority populations due to structural inequalities, such as limited access to healthy food, inadequate healthcare and systemic racism. Universal weight management programmes often fail to meet the unique needs of ethnic minority populations. These universal interventions may lead to lower engagement and poorer health outcomes compared with those observed in non-minoritised ethnic groups. This systematic review will examine the impact of culturally tailored interventions to treat and manage obesity in adult ethnic minority populations on weight- and health-related outcomes (meta-analysis) and patient experience (qualitative evidence synthesis).

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. Interventions of interest will include standalone or multicomponent behavioural interventions with culturally tailored elements of design or delivery. These will be compared against standard weight management interventions or usual care in adults from ethnic minority populations living with obesity. The primary outcome is the mean percentage weight (kg) change between pre–post interventions. A search of databases (Ovid MEDLINE, Embase, APA PsycINFO, Scopus and Web of Science) was conducted in February 2025. Eligible studies include randomised controlled trials (RCTs), quasi-experimental (non-randomised trials, pre–post interventions) and qualitative research. Risk of bias will be assessed with the Cochrane Risk of Bias 2 tool and the Mixed Methods Appraisal Tool. Narrative synthesis will be performed according to the synthesis without meta-analysis guidelines. For eligible RCTs, a random-effects meta-analysis will calculate pooled effect sizes between pre–post intervention using standardised mean differences, with additional sensitivity and subgroup analyses. Qualitative evidence synthesis will be performed using semi-automated text analytics (unsupervised machine learning) and inductive thematic analysis.

Ethical approval is not required. Findings will be disseminated through peer-reviewed journal publications, conference presentations, professional organisations and patient and public networks.

CRD42025636750.

To assess the preliminary effectiveness and cost-effectiveness of a culturally tailored, music-based broadcast intervention delivered through schools and community radio to improve referral adherence among schoolchildren to inform the need for a definitive trial.

Pilot randomised interventional study.

18 schools across Unguja and Pemba islands, Zanzibar.

Schoolchildren (6–18 years old) who failed vision screening and were referred for care recruited from January to February 2024. The registered sample size reflects the full cohort, including children and adults. This manuscript reports on the child cohort only, as per the predefined analysis plan.

Group 1 received 3 months of school-based broadcasts of culturally tailored 3–6 min songs (played three times daily on 2 days per week), followed by 3 months of community radio broadcasts of additional songs (3–6 min, aired three times daily); Group 2 received the community broadcasts during the same period as Group 1.

The primary outcome was change in referral adherence assessed at two time points: 3 months after school broadcast and 3 months after community broadcast, expressed in difference-in-difference estimates and effect sizes. Secondary outcomes included reporting of adverse events and contamination, and cost-effectiveness calculated as cost per child reached and cost per referred child accessed care in study groups and combined intervention.

374 children were referred to eye care services, including 246 in Group 1 and 128 in Group 2. Referral adherence was 69.8% in Group 1 and 42.9% in Group 2 (p=0.0006). The school broadcast phase yielded an effect size of 0.26 and a cost of US$4.65 per referred child accessing services. The community broadcast produced an effect size of 0.21, with a cost of US$0.29 per person reached. The combined intervention reached individuals at a cost of US$0.37 per person. No adverse event and contamination was reported.

A combined school and community broadcast intervention improved referral adherence in this pilot trial, with evidence of cost-effectiveness. These findings support the conduct of a fully powered definitive trial.

NCT06469697.

The evidence for the optimal duration of psychotherapy for borderline personality disorder (BPD) is scarce. Two previous trials have compared different durations of psychotherapy. The first compared 6 months versus 12 months of dialectical behaviour therapy for BPD (the FASTER trial). The second compared 5 months versus 14 months of mentalisation-based therapy for BPD (the MBT-RCT trial). The primary objective of the present study will be to provide an individual patient data pooled analysis of two randomised clinical trials by combining the two short-term groups and the two long-term groups from the FASTER and MBT-RCT trials, thereby providing greater statistical power than the individual trials. Accordingly, we will evaluate the overall evidence on the effects of short-term versus long-term psychotherapy for BPD and investigate whether certain subgroups might benefit from short-term versus long-term psychotherapy.

An individual patient data pooled analysis of the FASTER trial and the MBT-RCT trial will be conducted. The primary outcome will be a composite of the proportion of participants with a suicide, a suicide attempt or a psychiatric hospitalisation. The secondary outcome will be the proportion of participants with self-harm. Exploratory outcomes will be BPD symptoms, symptom distress, level of functioning and quality of life. We will primarily assess outcomes at 15 months after randomisation for the FASTER trial and at 16 months after randomisation for the MBT-RCT trial. Predefined subgroups based on the design variables in the original trials will be tested for interaction with the intervention as follows: trial, sex (male compared with female), age (below or at 30 years compared with above 30 years) and baseline level of functioning (Global Assessment of Functioning baseline score at 0–49 compared with 50–100).

The statistical analyses will be performed on anonymised trial data that have already been approved by the respective ethical committees that originally assessed the included trials. The final analysis will be published in a peer-reviewed scientific journal and the results will be presented at national seminars and international conferences.

CRD42024612840.