The complex and dynamic care context of terror attacks must be better understood to reduce deaths. This study was designed to understand the tension between saving lives and maximising safety for emergency responders attending active terror incidents.

Qualitative study exploring the experience of survivors and emergency responders (armed and unarmed police, paramedics, doctors and fire officers) present in the hot (unsafe) zone of five major terror attacks in the UK since 2000. We used reflexive thematic data analysis to build qualitative case studies, comparing similarities and tensions between perspectives of different participant groups.

In our analysis of over 2000 min of interview data from 26 participants, we found a common view that the priority during a terror-related mass casualty event was to save lives. However, responder groups maintained distinct mental models that shaped their operational priorities regarding treatment for those injured within the hot zone. All responders expressed willingness to take self-assessed risks to save lives, but better interagency communication was noted to be required to achieve this safely. All responders felt it was vital to have experienced health professionals present to triage and facilitate urgent treatment and extraction decisions. Armed police commanders had dual responsibilities to achieve rapid care delivery while preventing further terrorist-inflicted injuries. Operationally, this was perceived as leading to a lack of shared mental models between responders regarding what is ‘unsafe’ due to zoning, rather than communication of risk, potentially delaying vital care delivery. There were mixed survivor perspectives regarding the risks that responders should be exposed to, but broad agreement that there was a notable absence of health professionals present in the hot zone during the immediate aftermath of attacks.

There is strong professional and public support for improving care delivery, including potential hot zone working, to minimise the therapeutic vacuum in active terrorist attacks. Better risk communication and better shared mental models are necessary to balance responder risk with care delivery to maximise lives saved as safely as possible.

Mycoplasma pneumoniae (MP) is a major cause of community-acquired pneumonia in children. In East Asia, the prevalence of macrolide-resistant MP (MRMP) has surged, leading to treatment failures and prolonged illness. While doxycycline is an effective alternative, its use in young children has historically been limited due to concerns about tooth discolouration. This study aims to evaluate the efficacy and safety of doxycycline compared with azithromycin as a first-line treatment for children with pneumonia suspected of MRMP infection.

This is a multicentre, randomised, open-label, parallel-group superiority trial conducted at 14 tertiary hospitals in South Korea. A total of 208 children (aged 3–17 years) with pneumonia and confirmed or suspected MP infection will be randomised 1:1 to receive either doxycycline (4 mg/kg/day in two divided doses for 7–14 days) or azithromycin (10 mg/kg on day 1, then 5 mg/kg on days 2–5) (). Randomisation will be stratified by age (3–7 years vs 8–17 years). A standardised ‘rescue therapy’ protocol ensures patient safety by allowing control group patients to switch to doxycycline if no clinical improvement is observed within 48–72 hours. The primary outcome is the defervescence rate within 72 hours after randomisation. Secondary outcomes include treatment failure rate, length of hospital stay, symptom duration and adverse events. Safety assessment will specifically include tooth discolouration evaluation at Day 28, focused on children aged

This study has been approved by the Institutional Review Boards (IRB) of all participating centres. Written informed consent will be obtained from parents or legal guardians, and assent will be obtained from children aged 7 years and older. Results will be disseminated through peer-reviewed publications and conference presentations.

NCT07306234.

To develop, train and test a deep learning model Image-based PROgnostication applied to Chest X Rays (IPRO-X) tool that predicts the inpatient (IP) admission risk in patients with suspected pneumonia presenting to the emergency department (ED).

The study consists of a retrospective (training) and prospective non-interventional shadow deployment (validation) of a deep learning model.

Three-hospital tertiary care system with two EDs.

Consecutive adult patients (18 years old or older) who presented to the ED from December 2022 to February 2023 with a chief clinical complaint potentially related to pneumonia were reviewed for eligibility (n=5567), with a final number of 3677 included in the validation study.

IPRO-X was developed using standard two-dimensional convolutional neural network InceptionNet architecture and processes chest radiographs (CXRs) acquired at admission generating a continuous value from 0 (IP-negative) to 1 (IP-positive). We examined IPRO-X’s ability to predict IP admission using accuracy, area under the curve (AUC), receiver operating characteristic, sensitivity, specificity, positive predictive value and negative predictive value. IPRO-X scores were compared against observed outcomes (admission and discharge) to determine clinical utility in an ED setting. Four thresholds were defined from the retrospective phase: Youden optimal, highest specificity and thresholds equivalent to 30-day mortality rates of Pneumonia Severity Index (PSI) Risk class IV and Confusion, Respiratory Rate, Blood Pressure and Age 65 or older Score (CRB-65) scores 1 and 2. Performance was also analysed per group of chief complaints.

In the validation set, 3677 patients (1777 (48%) female, median age 56 years (min 18, max 99)) were included. IPRO-X predicted IP admissions with an AUC of 0.795, and in the pneumonia-specific chief complaints, AUC increased to 0.828, whereas in non-related pneumonia chief complaints, the AUC decreased to 0.755. IPRO-X score was significantly higher in admitted patients compared with discharged patients (p

IPRO-X applied to CXR of patients with signs and symptoms commonly related to pneumonia in the ED can accurately predict IP admission.

Perinatal mood and anxiety disorders affect more than one in five pregnant individuals. Despite the large percentage of individuals impacted by mood disorders, they continue to remain underdiagnosed and undertreated. Recent interventions such as risk prediction modelling offer opportunities to predict patients at risk prior to symptom onset. Leveraging technology platforms such as electronic health records allow for timely diagnosis and intervention. To date, there are no established clinical decision support (CDS) tools. We hypothesise that subjects who use a CDS aid will find them acceptable, appropriate and feasible.

We will conduct a pilot randomised clinical trial at three Weill Cornell Medicine clinics with randomisation at the clinician level. Patients in the control arm will receive usual care, while those in the intervention arm will receive CDS. The primary implementation outcomes are the acceptability, appropriateness and feasibility. The effectiveness outcomes are mental health service utilisation, EuroQol 5 Dimensions questionnaire (EQ-5D), Edinburgh Postnatal Depression Scale and social support measured by the perceived support scale. We hypothesise that stakeholders will find the CDS acceptable, and the intervention arm will have lower mental health service needs compared with control.

This study has been approved by the Weill Cornell Medicine Internal Review Board. IRB Protocol# 23-07026254.

NCT06818734.

To assess the beneficial and harmful effects of regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes.

Systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.

CENTRAL, MEDLINE, Embase, LILACS and other sources from inception to 30 January 2026.

Randomised clinical trials comparing regular human insulins versus rapid-acting insulin analogues (insulin aspart, lispro, glulisine) in children and adolescents with type 1 diabetes.

Data were analysed using meta-analysis and trial sequential analysis. Risk of bias was assessed using the Cochrane Risk of Bias tool, V.2, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Severe hypoglycaemia, ketoacidosis and serious adverse events.

10 trials randomising 1107 participants were included. The certainty of evidence was very low mainly due to high risk of bias and small sample sizes. Meta-analysis showed no evidence of a difference between regular human insulins and rapid-acting insulin analogues on severe hypoglycaemia (risk ratio (RR) 1.28, 95% CI 0.81 to 2.03; I²=0.0%; p=0.2851; nine trials), ketoacidosis (RR 0.88, 95% CI 0.26 to 2.93; I²=0.0%; p=0.8593; two trials) and serious adverse events (RR 1.00, 95% CI 0.44 to 2.25; I²=0.0%; p=0.9958; two trials). Trial sequential analysis showed that all meta-analyses of primary outcomes were underpowered.

Current research shows no differential effects between regular human insulins and rapid-acting insulin analogues for children and adolescents with type 1 diabetes, but the evidence is very uncertain.

CRD42024508625.

To examine how household members, community health research workers (CHRWs) and broader social networks influenced pregnant women’s capabilities, opportunities and motivations to consume a daily balanced-energy protein (BEP) supplement or a multiple micronutrient supplement (MMS) in the context of an effectiveness trial in rural Bangladesh.

In-depth interviews, group interviews, focus group discussions, thematic analysis using the Capability, Opportunity, Motivation-Behaviour (COM-B) framework.

Gaibandha, Bangladesh.

Women (n=32) who had completed participation in the TARGET-BEP randomised trial, their husbands (n=13) and mothers-in-law (n=13), who participated in 13 group interviews, and CHRWs (n=39) who participated in six focus group discussions.

Capability to adhere to BEP and MMS was strengthened when family members understood the value of supplements and actively supported supplementation. Children emerged as unexpected facilitators, reminding mothers to consume supplements and tracking intake. Opportunity to use supplements consistently was enhanced by women’s educational attainment and the availability of household resources. Finally, motivation to take the supplements was influenced by many actors including neighbours, who could offer support but also often transmitted rumours and taboos, and CHRWs, who adeptly adapted adherence messages to the local context and to women’s specific concerns.

To improve antenatal supplement adherence and maternal–infant health in Bangladesh and similar contexts, pregnancy nutrition programmes should move beyond the woman-as-sole-agent paradigm by: (1) co-designing messages for husbands, mothers-in-law, children and neighbours in conversation with effective community health workers, such as those working in the TARGET-BEP trial; (2) equipping community health workers with flexible, family-engaging counselling strategies; and (3) complementing women’s education gains with gender-transformative and family-inclusive interventions.

ClinicalTrials.gov NCT05576207

To investigate how patients with sarcoma present prior to diagnosis—through a general practitioner (GP) or another healthcare professional (HCP)—and describe presenting symptoms.

International observational cohort study.

Data were obtained from the longitudinal ‘QUality of life and Experiences of Sarcoma Trajectories’ (QUEST) cohort study, conducted across the Netherlands, the United Kingdom (UK), Australia and New Zealand.

Among 572 patients, 487 (85.1%) started their diagnostic trajectory at the GP (subcohort 1) and 85 (14.9%) with another HCP (subcohort 2)—mainly medical specialists treating unrelated conditions (36/85; 42.4%). Soft tissue sarcoma patients most often reported swelling, whereas bone sarcoma patients reported unexplained pain. Notably, 31/85 (36.5%) of subcohort 2 were asymptomatic. Reasons for delaying GP visits included assuming symptoms were minor and expecting them to resolve. Patients sought care when, among others, symptoms persisted and worsened.

Most patients first consulted a GP, underlining the role of primary care in sarcoma diagnosis internationally. Due to rarity and nonspecific symptoms, faster diagnosis remains challenging, requiring improvements in both primary and specialist care.

NCT03441906; Results.

The length of hospital stay for patients with physical illnesses is longer for those with mental health comorbidity, particularly in the presence of severe physical multimorbidity. Integrating psychosocial risk screening at hospital admission, with a subsequent care pathway, could address psychosomatic and social care needs early and reduce length of stay. However, implementation may be hindered by organisational factors such as increased staff workload and timely integration into existing processes. In addition, patient factors such as low acceptance of screening and follow-up may affect uptake. This pilot study aims to assess the feasibility of implementing this integrated approach to screening and follow-up in preparation for a confirmatory trial.

The present study is a single centre, randomised feasibility study conducted on a pilot ward. Patients will be enrolled and assigned to the intervention or the control group. Only the intervention group will receive tablet-based psychosocial risk screening conducted by ward physicians or medical students in their practical year. If the psychosomatic screening is positive and the patient agrees, he or she is referred to the psychosomatic consultation service. If the social service screening is positive, the patient will be seen by a social worker. The main objective of this study is to assess the feasibility of conducting a full-sized confirmatory trial. An informed consent rate of 30% of eligible patients is set as the feasibility criterion. A study period of 4 months is planned for the feasibility study. The feasibility study will be analysed using descriptive statistics.

The study protocol was approved by the Ethics Committee of the Medical Faculty of Heidelberg University (S-301/2024) on 24 May 2024. The results of this feasibility study will be published in a peer-reviewed journal.

NCT06651164.

To identify barriers and facilitators to implementing an electronic shared decision-making tool for managing anticoagulant-related drug-drug interactions that affect bleeding risk in routine clinical care.

Preimplementation qualitative study using semistructured interviews.

Three academic medical centres in the southeastern and western USA. Interviews were conducted between 27 March and 25 September 2024.

36 participants, including 19 clinicians involved in prescribing or managing anticoagulants and seventeen patients prescribed anticoagulants, were recruited using purposive and convenience sampling.

Participants identified multiple barriers and facilitators to tool implementation. Common barriers included limited visit time, challenges integrating the tool into existing workflows, role and scope-of-practice constraints, and variation in patient digital literacy. Facilitators included clear visualisation of bleeding risk, access to supporting evidence, familiar interface design and perceived potential to support patient engagement and shared decision-making. Several determinants functioned as both barriers and facilitators, depending on clinical context and user role.

This preimplementation qualitative study identified context-specific determinants that influence the adoption of an electronic shared decision-making tool for anticoagulant-related drug–drug interactions. Findings highlight the importance of early attention to workflow integration, role alignment and usability to support uptake in routine care. Addressing these factors during design and implementation may inform strategies to support adoption and future evaluation in real-world clinical settings.

Functional seizures (FS) are events that resemble epileptic seizures, but are not attributed to brain pathology and are instead thought to be due to psychological factors. A small, multisite, open-label, single-arm, pilot trial of a breathing intervention known as breathing control training (BCT) found it to be safe and effective in reducing seizure frequency in FS. We propose a protocol for a study to confirm these results.

A 24-week, multicentre, individually-randomised, assessor-blinded, two-arm, parallel-group efficacy and acceptability trial of BCT versus control (Befriending) in 220 participants ≥16 years of age with FS. Eligible participants will be randomly allocated to receive two sessions of either BCT or Befriending over a 4-week period. Sessions will be delivered by a respiratory physiotherapist at a clinical care site or via telehealth. They will complete assessments prior to commencing treatment and at 4, 12 and 24 weeks after their initial session of BCT/Befriending. The trial will be conducted alongside treatment as usual. An economic evaluation including cost-utility and cost-effectiveness analyses will be carried out from health sector and societal perspectives.

The study has been approved by The Austin Health Human Research Ethics Committee (HREC/84335/Austin-2022) and the New Zealand Central Health and Disability Ethics Committee (2022 FULL 12324). Findings will be reported to trial participants and consumers; presented at local, national and international conferences; and disseminated by a peer-reviewed scientific journal.

Atrial fibrillation (AF) is the leading cause of cardioembolic stroke and is associated with increased stroke severity and fatality. Early identification of AF is essential for adequate secondary prevention but remains challenging due to its often asymptomatic or paroxysmal occurrence. Artificial intelligence (AI) offers new possibilities by integrating biomarkers, clinical phenotypes, established risk factors and imaging features to define a personalised ‘digital twin’ model. The TAILOR study aims to (1) examine prospective detection of AF using monitoring devices, (2) investigate novel prognostic MRI markers in patients with an AF-related stroke (AFRS) and (3) validate AI-based models for outcome prediction in AFRS.

This prospective multicentre observational cohort study includes patients aged 40 years and above, with neuroimaging-confirmed diagnosis of ischaemic stroke, recruited from two sites: Hospital del Mar Barcelona (Spain) and Radboud University Medical Centre (The Netherlands). For the first sub-study (n=300), patients will undergo clinical assessment at baseline, 3 months and 12 months, and patch-based or Holter cardiac monitoring. The second sub-study (n=200) involves repeated brain MRI and cognitive examination after AFRS. Finally, AI-driven ‘digital twin’ models developed on retrospective TARGET datasets will be prospectively evaluated in TAILOR using temporal and centre-stratified analyses for advanced predictive tools for AF and AFRS outcomes.

The TAILOR study was approved by local ethics boards in Barcelona (CPMP/ICH/135/95) and Medical Research Ethics Committee Oost-Nederland (NL86346.091.24). Patients will be included after providing informed consent. Study results will be presented in peer-reviewed journals and at global conferences.

The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.

We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.

This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.

NCT06042621.

Frontotemporal dementia (FTD) remains challenging to diagnose owing to the marked clinical heterogeneity associated with the disease. This heterogeneity stems from the complex interplay of various clinical phenotypes, genetic mutations and underlying neuropathologies, such as TDP-43 and tau proteinopathies. Currently, there is no single confirmed biomarker that can reliably diagnose disease, specifically disease stage, disease subtype and underlying neuropathology. Recent research has indicated that neuroimaging techniques hold the most promise for the discovery of FTD biomarkers. We propose a protocol for a systematic review and meta-analysis to identify MRI and fluorodeoxyglucose positron emission tomography (FDG-PET) biomarkers associated with clinical, genetic and pathological subtypes of FTD. We aim to address the following research questions: can regional MRI volumetry and FDG-PET hypometabolism differentiate (1) FTD patients from healthy controls; (2) sporadic cases of FTD from healthy controls; (3) genetic cases of FTD (MAPT, GRN, and C9orf72 mutations); and (4) underlying neuropathology, specifically discriminating between tau- and TDP-43-based FTD?

Literature searches will be performed across three databases: Ovid Medline, Ovid Embase and Web of Science. Publications that have fewer than five participants, are non-human-based, not written in the English language or contain unpublished data will be excluded. Two independent investigators will screen and subsequently evaluate which publications to include. Should any disagreements arise, a third investigator will settle the discrepancy. After the random-effects meta-analysis has been used to extract and pool the data, I² analysis will be used to quantify heterogeneity.

Ethics approval will not be required for this research. On completion, the systematic review and meta-analysis will be published in a peer-reviewed journal.

CRD42024545302.

To explore the association between the degree of coronary artery calcium (CAC) and the progression of calcific aortic valve disease (CAVD).

A single-centre retrospective cohort study using a hospital-based database.

A total of 2898 patients who underwent coronary CT angiography and serial echocardiograms at ≥6 months apart were included. Initial echocardiography was performed within 6 months from the time of CCTA.

CAC was divided into four groups: 0, 1–99, 100–399 and ≥400 (Agatston units, AU). The progression of CAVD was defined in two ways: progression 1 as at least one grade of progression, progression 2 as at least moderate aortic stenosis (AS) at follow-up.

At the initial CAVD grade, patients with at least mild AS tended to increase with increasing CAC (p

CAC was significantly associated with the progression of CAVD. Particularly, CAC≥400 was linked to progression toward significant AS.

To evaluate temporal trends in the epidemiology of hip osteoarthritis (OA) in the USA from 1990 to 2019, with stratification by sex and geographic region.

Cross-sectional time-series analysis using secondary data from the Global Burden of Disease (GBD) study.

US population-based analysis, stratified by the four US Census Bureau regions: Northeast, Midwest, South and West.

De-identified, aggregate population-level data representing all adults in the USA from 1990 to 2019, drawn from the GBD database.

Age-standardised rates per 100 000 population for years lived with disability (YLDs), prevalence and incidence of hip OA. Outcomes were stratified by sex and region. Statistical significance was defined as p

Between 1990 and 2019, hip OA in the USA increased by 23.91% in YLDs, 24.67% in prevalence and 25.22% in incidence. In 2019, the mean YLDs were 28.30 in women versus 25.48 in men; prevalence was 49.55 versus 41.08; and incidence was 919.29 versus 818.10 (all p

There has been a substantial rise in the burden of hip OA in the USA over the past three decades. Women and residents of the Northeastern USA are disproportionately affected. These findings underscore the need for targeted public health strategies that account for geographic and sex-based disparities in hip OA burden.

The TRAjectory of knee heaLth in runners (TRAIL) study is a prospective cohort study investigating the long-term knee health trajectories of runners with and without a heightened osteoarthritis risk. This study aims to describe the recruitment results and baseline characteristics of the TRAIL cohort.

Runners aged 18–50 years and running ≥3 times and ≥10 km per week on average in the past 6 months were eligible. Participants were recruited via running podcasts, running clubs and social media between July 2020 and August 2023. Data were collected at study enrolment and at a face-to-face baseline testing session, which occurred a median of 33 weeks (IQR 18 to 86 weeks) after enrolment. Follow-up data collection is ongoing.

Out of 462 runners who completed an online registration form, 268 runners enrolled, of which 135 had a history of knee surgery (46% females) and 133 were non-surgical controls (50% females). 60% of the surgery group had undergone anterior cruciate ligament reconstruction, 33% meniscus and/or cartilage surgery, and 7% other knee surgery. 54 participants previously enrolled were unable to continue in the study before attending baseline data collection. Of the 214 runners who remained in the study and attended baseline data collection, 108 had a history of knee surgery (49% females) and 106 did not have a history of knee surgery (51% females).

Participants will be followed for 10 years through ongoing patient-reported outcomes and continuous monitoring of training loads using wearable devices. At baseline, 4- and 10-year follow-up, knee MRI and knee-health patient-reported outcomes will be collected to evaluate structural and symptomatic knee osteoarthritis progression. Data will inform guidelines for safe running practices and rehabilitation post-knee surgery.

Young-onset type 2 diabetes (YOD), diagnosed before 40 years of age, entails a high disease burden and potential for early dependence on disability benefits. The risk of type 2 diabetes (T2D) varies with socio-economic status and ethnic background, yet the relationship between these factors and age at diagnosis is insufficiently explored. We aimed to study associations between YOD and living on disability benefits, educational level and country background.

Cross-sectional data on 8640 individuals with T2D, linked to data on educational level and country background, were compared with population data from the same residential areas. Similar comparisons were made for data on disability benefits among 3854 individuals of working age (

The risk of being dependent on disability benefits was three times higher in YOD (adjusted incidence rate ratio, aIRR (95% CI) 3.1 (2.7 to 3.5)) and twice as high in later-onset T2D (1.9 (1.8 to 2.1)) as in the general population. People of Norwegian background with low educational levels had threefold higher YOD risk (3.3 (2.4 to 4.4)) than those with a tertiary degree, while people of non-Western backgrounds with low educational levels had a smaller increase in YOD risk (1.5 (1.1 to 2.1)). People of non-Western backgrounds had higher YOD risk than those of Norwegian background (4.2 (3.5 to 5.0)), while people of south Asian background had an even greater relative YOD risk (9.0 (7.3 to 11.0)), threefold higher than for later-onset T2D (3.2 (2.8 to 3.7)).

Lifetime risk of being dependent on disability benefits was substantially higher for individuals with YOD than in later onset T2D. Non-Western and particularly south Asian backgrounds were associated with increased YOD risk. Low education was an important YOD risk factor only for people with Norwegian background.

The mental health of people living with HIV (PLWH) is a growing concern globally, particularly in sub-Saharan Africa (SSA), where there is limited access to mental healthcare, with evidence showing high levels of depression, anxiety and neurocognitive disorders among this population. While Mental Health Disorders (MHDs) can impede HIV care and promote adverse health outcomes, there is limited literature on MHDs among PLWH. This scoping review will explore the existing literature on the burden and factors associated with MHDs among adults living with HIV in SSA.

Arksey and O’Malley’s methodological framework will guide the search of this scoping review. Relevant original research articles published in English from 1 January 2000 to 31 May 2025 on MHDs among PLWH in SSA will be identified through searches in the African Index Medicus, African Journal Online, PubMed and Embase databases. Four independent reviewers, working in pairs (one reviewer and one verifier), will screen the titles, abstracts and later the full texts, adopting the population, concept and context framework. Other coauthors will serve as tiebreakers whenever there is disagreement on the eligibility. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews flowchart will be presented. We will perform a narrative synthesis to report our findings.

This scoping review protocol does not require ethical approval, as it relies solely on publicly available existing data and does not involve human participants. We will disseminate the findings from this review through peer-reviewed publications and presentations at local and international conferences.

The protocol was registered in the Open Science Framework (https://osf.io/8ymqu).

Cleft lip and palate significantly impact a child’s speech and facial appearance. Children undergo cleft repairs in infancy, but poor results from these initial repairs often lead to secondary surgery. In the late 1990s, cleft care provision in the UK was centralised to approximately 11 managed clinical networks or centres. This centralisation has been associated with improvements in speech and aesthetic outcomes, but little is known about the effect of centralisation on the use of secondary surgery. The purpose of this study was to compare the cumulative incidence of secondary cleft surgeries before and after centralisation and the proportion of children achieving good clinical outcomes without secondary surgery.

Retrospective, cross-sectional.

Two cross-sectional studies of 5-year-old children with non-syndromic unilateral cleft lip and palate were conducted, one precentralisation and one postcentralisation.

The cumulative incidence of secondary surgery from birth through age 5 was compared precentralisation and postcentralisation using Fisher’s exact test, as were facial appearance and speech outcomes at age 5. Risk ratios (RR) were estimated using log-binomial multivariable regression models that adjusted for sex and age at evaluation.

Postcentralisation, the proportion of children achieving good or excellent facial appearance increased from 16% to 42% (p

Centralisation of cleft care was associated with improved outcomes of primary lip and palate repairs and a corresponding reduction in secondary surgery.