BMJ Open

IntroductionMusculoskeletal conditions have high, and increasing, incidence and prevalence. Although there are many clinical guidelines available for common conditions, most are poor quality and sparsely adopted into practice. We aim to improve patient outcomes by developing robust Best Practice Guidelines (BPG) to get research findings into practice for a range of common musculoskeletal conditions. Methods and analysisMixed methods with systematic review of high-quality studies and qualitative elicitation of both patients perspectives and expert clinical reasoning through in-depth interviews will form the basis for the BPGs. A segregated convergent synthesis, informed throughout by stakeholder engagement, will guide the format and structure of the BPGs. Ethics, outputs and disseminationEthical approval for the qualitative studies and implementation events will be obtained from university and health service research ethics committees. Educational packages for each BPG condition will be hosted online and be available for students, clinicians, and education providers. Dissemination will follow traditional routes including publications and presentations; alongside innovative approaches such as collaboration with higher education institutions, online hosting, adoption by professional bodies, and a social media campaign. Implementation will occur adaptively in multiple national contexts to reflect local requirements and resources, deploying participatory and implementation methods that are contextually and culturally appropriate. KEY MESSAGESO_LIWhat is already known on this topic - Clinical guidelines for the management of musculoskeletal conditions are common, but have limitations regarding quality, applicability, editorial independence, and patient perspective. They are rarely adopted into clinical practice. C_LIO_LIWhat this study adds - We have developed a robust (supported by Patient and Participant Involvement) mixed-methods approach that integrates the three components of evidence-based medicine: synthesis of high-quality evidence, patients perspectives/values, and expert clinical reasoning. We have also developed an education, dissemination, and implementation approach to facilitate international adoption of these guidelines. C_LIO_LIHow this study might affect research, practice or policy - The guideline development methods will integrate the three pillars of evidence-based practice and ensure they are robust and clinically applicable. Creation of educational material combined with an implementation and dissemination plan will support adoption into clinical practice of different countries and cultures, designed to lead to improved patient outcomes. C_LI

IntroductionAcross Europe, many people with HIV are diagnosed late despite repeated contact with hospital services for HIV indicator conditions. These conditions flag a possible underlying HIV infection for which HIV testing is recommended. They provide an opportunity to identify people with HIV, yet implementation of indicator condition based testing remains insufficient in hospital practice. The #aware.hiv Europe study was developed to address this gap by embedding HIV teams into routine care to normalise HIV testing. Methods and analysis#aware.hiv Europe is a stepped-wedge cluster randomised trial in 30 hospitals across ten European countries. Five clusters of 6 hospitals each will sequentially transition from control to implementation periods when local HIV teams led by an infectious diseases specialist will be installed. Intervention activities include hospital-wide peer audit and feedback on missed testing opportunities, targeted education, stigma reduction activities, and strengthening of linkage to HIV prevention and care. Patients with predefined HIV indicator conditions are identified using International Classification of Diseases, 10th Revision (ICD-10) diagnosis codes, confirmed through manual review. The primary outcome is the change in HIV testing rate among patients with confirmed HIV indicator conditions. Secondary outcomes include HIV case detection, cascades of diagnosis, care and prevention, variation in testing practices, healthcare professional knowledge and stigma, and implementation outcomes. Analyses will use mixed effects regression models accounting for clustering and time within the stepped-wedge design. Ethics and disseminationThe study has ethical approval in all hospitals to use routinely collected clinical data under exemption from informed consent for patient level data. Results will be disseminated through peer reviewed publications, conferences, and collaboration with clinical and community partners with the goal to inform HIV testing policies. Trial registrationClinicalTrials.gov NCT06900829. https://clinicaltrials.gov/study/NCT06900829 Strengths and limitations of this study+ Large, multinational, real-world, stepped-wedge, cluster randomized trial design. + Primary outcome derived from routinely collected clinical data, using a GDPR- and GCP-compliant approach with exemption from informed consent. + Hospital-wide intervention targeting care professionals, delivered through proactive expert HIV teams across departments powered to conclude on hard HIV care cascade clinical endpoints and stigma reducing interventions. + Implementation science design informed by established frameworks (CFIR and RE-AIM) to strengthen cross-continental generalisability. - Variation in healthcare systems and baseline testing practices across countries may contribute to heterogeneity in implementation and outcomes. - Despite standardised SOPs, local clinical judgement influences the assessment of HIV indicator conditions.

IntroductionAlzheimers disease (AD) is imposing an increasing public health and socioeconomic burden. In China, rapid population ageing is sharply increasing disease burden. Previous studies have shown that AD-related costs are mainly driven by long-term informal care. However, evidence in China remains limited by an incomplete cost framework, and insufficient consideration of caregivers burden and indirect costs. Notably, the National Dementia Action Plan (2024-2030), issued by the Chinese government, marks a major shift to early detection and comprehensive care of AD, highlighting the urgent need for nationally representative economic evidence to support policy implementation. This study aims to evaluate the economic burden and quality of life of AD patients and their caregivers in mainland China, and is the first nationwide study to include individuals with amnestic mild cognitive impairment (aMCI), providing foundational data for future health technology assessment (HTA) of early AD interventions. Methods and analysisBaseline characteristics will be presented and compared using t-tests or chi-square tests. Economic burden will be estimated by calculating the per capita cost and weighted national total based on provincial numbers of AD patients. Indirect costs will be assessed using locally adapted replacement cost approach and forgone wages approach. The analysis will be stratified by disease severity and age. Future burden will be projected by linking data from China Statistical Yearbook 2025 and the United Nations World Population Prospects 2024. Unmet care needs, AD-related catastrophic health expenditure (CHE), and AD dependency ratio (ADDR) will also be assessed. Ethics and disseminationEthics approval was obtained from the Ethics Committee of Xuanwu Hospital, Capital Medical University. The study has been registered at ClinicalTrials.gov and the Chinese Clinical Trial Registry (ChiCTR). The results from this study will be actively disseminated through research articles and conference presentations. Trial registration numberNCT05995418; ChiCTR2300074723. Strengths and limitations of this studyO_LIThis study employs a two-stage probability sampling design across 602 cognitive centres in 31 provinces, ensuring strong national representativeness of the Chinese population. C_LIO_LIIt is the first national health economics study to prospectively include patients with amnestic mild cognitive impairment (aMCI), addressing a critical evidence gap in the early stage of disease and providing data for future evaluation of the cost-effectiveness of early screening and interventions. C_LIO_LIThe integration of clinical characteristics, economic burden, and quality of life scales provides a multidimensional framework for future policy evaluations and health technology assessment (HTA). C_LIO_LIThe calculation of indirect costs relies heavily on caregivers self-reported data regarding care time and missed work, which may introduce recall bias. C_LIO_LIThe use of a nested subsample for the 12-month follow-up may introduce loss-to-follow-up bias, although appropriate statistical weighting techniques will be applied to mitigate this. C_LI

1. PurposeSpontaneous preterm birth (sPTB), particularly early preterm birth and mid-trimester loss, remains poorly understood and difficult to predict. The INSIGHT cohort was established to create a deeply phenotyped, longitudinal pregnancy dataset integrating clinical data and biological sampling to investigate the mechanisms of cervical shortening and sPTB, with a focus on linking innate immune responses, the vaginal microbiome, and host biology to identify early biomarkers of risk. 2. Participants2272 pregnant women (8+0 -28+0 weeks gestation) were enrolled as high or low risk of preterm birth based on obstetric history, cervical length, cervical procedures, multiple pregnancy, or Mullerian anomalies. Serial clinical data and biological samples, including cervicovaginal specimens and blood, were collected throughout pregnancy. 3. Findings to dateThe cohort has generated comprehensive multi-omic data, including transcriptomic, microbiome, metabolomic, proteomic, and immune profiling. Key findings demonstrate that maternal plasma cfRNA can predict early sPTB months before clinical presentation, and that integration of cervicovaginal microbiota, metabolites, and host immune markers improves risk prediction and provides mechanistic insight into inflammatory pathways leading to sPTB. 4. Future plansRecruitment concluded in 2023, with final visits occurring in 2024. Ongoing analyses focus on refining predictive models, defining biological subtypes of preterm birth, and translating integrated biomarker panels into clinically scalable risk stratification tools. STRENGTHS AND LIMITATIONS OF THIS STUDYO_LILarge, prospective longitudinal cohort (Strength): Ten years of recruitment with repeat sampling enabled detailed study of biological pathways leading to sPTB. C_LIO_LIBroad risk spectrum with clear definitions (Strength): Inclusion of both high and low-risk women using pre-specified clinical criteria supported robust comparative analyses and biomarker discovery. C_LIO_LIMulticentre NHS recruitment (Strength): Inclusion of several sites, particularly the diverse Lambeth population at St Thomas, enhanced population diversity and external validity. C_LIO_LIHospital-based, high-risk enrichment (Limitation/Strength): Recruitment from specialist preterm birth clinics and secondary/tertiary care may limit generalisability to lower-risk or primary care populations. However, it did ensure many preterm birth events were captured prospectively in this study. C_LIO_LIIncomplete follow-up and limited late sampling (Limitation): Attrition and sampling only up to a prespecified gestation (defined by standard clinical pathway) reduced full pregnancy coverage of longitudinal data. C_LI

IntroductionIn many Low- and Middle-Income countries (LMIC), access to psychological therapies for psychosis remains extremely limited, contributing to significant treatment gaps and persistent inequalities in care. Novel interventions that are effective, scalable, and culturally acceptable across diverse settings are urgently needed. AVATAR therapy is an innovative digital intervention for distressing voices in psychosis, developed in the UK. The therapy enables voice-hearers to engage in a series of facilitated dialogues with a customized computer-based representation of their main distressing voice. AVATAR3 represents the first initiative to contextually adapt AVATAR therapy and evaluate its acceptability in two LMIC settings (Ethiopia and India). Methods and analysisWe will establish Innovation and Implementation Hubs in Addis Ababa, Ethiopia (Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa) at Addis Ababa University (AAU) and Mental Health Service Users Association (MHSUA), Ethiopia) and New Delhi, India (All India Institute of Medical Sciences). Phase 1 employs formative work and diverse stakeholder engagement to inform context-specific adaptations. Reflexive thematic analysis will be used, with data synthesis informed by the Cultural Adaptation of Scalable Psychological Interventions (CASPI) framework and Ecological Validity Model (EVM). Phase 2 tests adapted AVATAR therapy through a parallel case series (n=15 per site, targeting 70% completion rate) measuring feasibility, acceptability, and safety indicators at baseline, 12-weeks, and 24-weeks. Qualitative research will explore the experiences of participants (n=10) and therapists (n=8) at each site. Ethics and disseminationEthical approval has been obtained from Addis Ababa University College of Health Science Institutional Review Board, All India Institute of Medical Sciences (AIIMS) Institutional Review Board and the Kings College London (study sponsor) Research Ethics Committee. Findings will be disseminated to inform the implementation of AVATAR therapy across diverse international settings. Strengths and limitations of this studyO_LIInterdisciplinary and participatory approach C_LIO_LIContextual adaptation of a digital innovation C_LIO_LIExpert by experience leadership and involvement from the conception of the study C_LIO_LIThe study will develop tools and share learning to support future digital mental health innovation across diverse international settings C_LIO_LIThe case-series at each site will not have a control group C_LI

ObjectivesUsing qualitative methods, this study aimed to provide a comparative overview of the similarities and differences in perspectives towards AI in healthcare in two different stakeholder groups: healthcare practitioners and patients. It also aimed to investigate whether these perspectives may influence the adoption of AI in healthcare. DesignThis study was conducted using semi-structured interviews. Qualitative data from the interviews were analyzed using both deductive and inductive coding, followed by a thematic analysis to identify the prevailing categories for further discussion. SettingThe study was conducted within the Department of Surgical Oncology and Gastrointestinal Surgery of Erasmus Medical Center in Rotterdam, the Netherlands. ParticipantsA total of 30 participants were recruited using purposive sampling based on predefined inclusion characteristics. This included 18 healthcare professionals (subdivided into 10 surgeons and 8 nurses), and 12 patients. The inclusion criterion for healthcare professionals included surgeons specializing in gastro-intestinal surgery, while the inclusion criterion for patients included those patients who had undergone gastro-intestinal surgery within the past 12 months at the time interviews were conducted. Exclusion criteria involved excluding patients with major health complications. Outcome measuresThe studys central objective was to develop a set of thematic domains that characterize how both groups of stakeholders view the integration of AI in healthcare, encompassing their attitudes towards trust, acceptance, and responsibility. Additionally, it aimed to compare perspectives between healthcare professionals and patients in order to identify areas of convergence and divergence. ResultsThe analysis comprised a total of 3 main thematic categories, with 10 subcategories. The main thematic categories which emerged were AI Knowledge, Ethics, and Operational and Clinical Implications. While clinicians largely focused on validation, monitoring, administrative labor, and clinical integration, patients emphasized the importance of human attention, of being heard, and of maintaining trust in their clinician. ConclusionComparing the attitudes and perspectives of both healthcare practitioners and patients revealed the importance of taking into consideration both groups of stakeholders. While both groups tend to raise concerns about similar themes connected to responsibility, it is clear that this concern involves complex dynamics present in the epistemic environment of healthcare. Strengths and limitationsO_LIThis study uniquely compared healthcare practitioners and patients perspectives within a single qualitative design, using similar interview guides to enable direct cross-stakeholder comparison. C_LIO_LIThe study examined perceptions of an AI model that had been designed and validated for clinical use, enhancing the practical relevance of the findings. C_LIO_LIThe relatively small sample size may have limited the diversity of perspectives captured and reduced transferability. C_LIO_LIAs the study was conducted in a single academic hospital in the Netherlands, the findings may not be generalizable to other healthcare settings or national contexts. C_LI

BackgroundPerinatal mood and anxiety disorders (PMAD) cause substantial morbidity and mortality globally. Kenya, like many low- and middle-income countries, experiences severe shortage of specialized mental healthcare workers and poor coverage of screening and management for PMAD. Provision of screening and treatment by lay and non-specialist providers in the context of routine maternal child health services may enhance access to mental health services and improve outcomes. Methods and analysisIn a hybrid type II cluster randomized clinical trial in 20 facilities in Western Kenya, we will evaluate the clinical, service delivery, and implementation outcomes of a stepped-care model integrating: 1) screening of all pregnant women for depression and anxiety symptoms, 2) Problem Management Plus (PM+) counseling delivered by trained lay providers, and 3) telepsychiatry for women with severe symptoms, suicidality, or inadequate response to PM+. The intervention package also includes a bundle of implementation strategies such as audit and feedback, process mapping, health educational health talks, and procurement of antidepressants for all sites. In addition, intervention sites will receive provider training, structured supervision and financial compensation for providers. Facilities will be randomized 1:1 to intervention and enhanced standard of care (basic screening and referral to specialist care), using restricted randomization. We will enroll a total of 2,970 women. Women will be eligible if they are pregnant and [≥]20 weeks gestation, attending antenatal care at the facility, [≥]14 years old, and screen positive for PMAD symptoms (Patient Health Questionnaire [PHQ]-2[≥]3 and/or Generalized Anxiety Disorder-[GAD]-2[≥]3). Assessments will be conducted at enrollment (pregnancy), 6 weeks, 14 weeks, and 6 months postpartum among participants in both study arms to align with routine well-baby visits. Primary outcomes are PMAD symptoms (PHQ-9 and GAD-7 score) change at 14 weeks postpartum using an intent-to-treat analysis. Secondary outcomes include quality of life at 14 weeks postpartum, PM+ mechanism of action, and adverse pregnancy outcomes at 6 weeks postpartum. Using mixed methods, we will evaluate acceptability and fidelity of the intervention and compare service delivery and other implementation outcomes (penetration, efficiency, equity, cost) across arms and alongside multilevel drivers of implementation success. Ethics and disseminationThe study protocol was approved by Kenyatta National Hospital/University of Nairobi (P425/04/2023) and the University of Washington (STUDY00017933). All participants will provide written informed consent. Findings will be published in peer-reviewed journals and international conferences. Trial registration numberNCT06456307 Strengths and limitations of this studyStrengths include: O_LIThis is among the first studies to evaluate a stepped care intervention for perinatal mental health that has been integrated into routine public maternal child health services in a low-resource setting C_LIO_LIThis is among the first studies to evaluate telepsychiatry as part of an integrated care model in a low-resource setting. C_LIO_LIThis study combines 3 evidence-based and resource-appropriate interventions, that have the potential to be scalable in this context C_LIO_LIThe study will generate not only clinical effectiveness data but also data on implementation outcomes in the context of service provision by routine providers, which will enable holistic evaluation of the interventions potential C_LIO_LIThis is a large randomized controlled trial conducted in a mix of rural and urban clinics in Kenya, increasing generalizability across geographical contexts C_LI Limitations include: O_LIPM+ is provided in-person and transportation barriers may prevent clients consistent attendance C_LIO_LIThe implementation strategies used include financial support for providers and essential medications, limiting generalizability C_LI

Introduction: Newborn babies frequently encounter acute respiratory failure requiring assisted ventilation. Acute respiratory failure in infants commonly present in a form of respiratory distress syndrome. There are several studies that documented factors associated with CPAP failure rates among preterm newborns worldwide. However, they were either statistically underpowered or defined by overt design errors. The proposed study will estimate incidence rate and predictors of Continuous Positive Airway Pressure (CPAP) failure among preterm newborns delivered at representative hospitals in a typical urban area of Africa. Methods and analysis: a prospective longitudinal cohort observational, analytical study will be conducted at neonatal and emergency units of all Dar es Salaam public regional referral hospitals from March to (and including) August 2026. Newborns with CPAP failure will be the target population. Newborns without CPAP failure will be the control group. Follow up for each child will commence from the moment the child is subjected to CPAP until CPAP failure is clinically evident or day seven of life, whichever comes first. Interval assessment of the SAS scores (for CPAP potency) will be done using Silverman-Anderson score sheet in 4-6 hours intervals (unless otherwise dictated by the child clinical situation). The main outcome/dependent variable will be proportion of new CPAP failure per newborn-time of follow up. A multivariable linear model will be used to account for independent predictors of CPAP failure. Unless otherwise stated, an alpha-level of 5% will be used as a limit of type 1 error in findings. Ethics and Dissemination process: The study has received an IRB certificate (IRB reference: KU/IREC/27/10/639) from the Institutional Research Ethics Committee of KU. Permission to recruit the affected children has been sought from Municipals based hospitals directors of Amana, Mwananyamala and Temeke regional referral hospitals respectively. Written informed consent will be sought from mothers of all recruited newborn babies.

ObjectiveAvoidable perinatal brain injury, including preventable hypoxicischaemic encephalopathy (HIE), remains a major global challenge for maternity care. In the UK, progress is hindered by weaknesses in infrastructure of routinely collected perinatal data. We sought to develop a strategy to support improvement in data relating to potentially avoidable HIE. DesignOnline survey of UK-based professionals, structured discussions with a multidisciplinary advisory group, and three workshops with patient/family representatives. SettingUnited Kingdom. Main outcome measuresCo-created recommendations for improving the consistency, comprehensiveness, linkage, quality, and practical use of routinely collected UK maternity and neonatal data related to potentially avoidable HIE. ResultsBetween 85-98% of survey participants (N=411) rated most of the data items proposed as characterising avoidable brain injury as important. They also identified data gaps, particularly for intrapartum risk factors. Participants wanted accessible, unitlevel feedback and capabilitybuilding for interpreting data, while cautioning against sharing data with families without context. The advisory group (n=35) and patient/family representatives (n=9) converged on 15 recommendations covering: definitions; a core item catalogue and shared data dictionary; electronic patient record interoperability; workflowintegrated data capture; secure individuallevel linkage with longerterm followup; strengthened audit and feedback; and improved capture and sharing of data relevant to families. ConclusionsThe recommendations offer a roadmap for developing an integrated data source that builds on existing datasets of routinely collected maternity and neonatal data. Even a basic version of this data source would already help promote actionable use of data and guide investments in digital infrastructure that enables continuous improvement cycles. Key messagesO_ST_ABSWhat is already known on this topicC_ST_ABSO_LIEfforts to reduce avoidable perinatal brain injury in the UK are hindered by fragmented maternity and neonatal data systems, including inconsistent definitions, limited linkage across datasets, duplication in data entry practices, and incomplete coverage of key data items. C_LI What this study addsO_LIThis study presents strategic recommendations for improving UK data on potentially avoidable perinatal brain injury, collaboratively developed with maternity and neonatal professionals, data specialists, and patient and family representatives. C_LIO_LIThe 15 recommendations set out ways to strengthen definitions, comprehensiveness, standardisation, linkage, quality, and practical use of routinely collected data relevant to avoidable perinatal brain injury. C_LI How this study might affect research, practice or policyO_LIThe set of recommendations offers a roadmap for developing an integrated data source that builds on existing datasets of routinely collected maternity and neonatal data. C_LIO_LIEven a basic version of an integrated data source would already help promote meaningful and actionable use of data for prevention of perinatal brain injury, and guide future investment in digital infrastructure that enables continuous improvement cycles. C_LI

Background The role of minimally-invasive cytoreductive surgery (MI-CRS) in low volume peritoneal disease has been explored but lacks robust evidence demonstrating oncological adequacy and non-inferiority to open CRS. The major challenges of MI-CRS are its technical complexity and chances of missing disease which could have detrimental oncological outcomes. The only means of resolving the dilemma of missed disease is to convert the procedure to open surgery and confirming the findings of MI approach. The Minimally InvaSive CYTOreductive surgery (MIS-CYTO) study is a prospective observational study that will evaluate the oncological adequacy of MI-CRS at systematic mini-laparotomy in patients with low volume peritoneal disease. Methods This single-arm study which will include 100 patients with primary and secondary peritoneal malignancies with a peritoneal cancer index (PCI)< 10 treated by MI-CRS. Patients will be recruited over 3 years and followed up for 5 years. All patients will undergo a staging laparoscopy (SL) with video documentation according to the study format. Patients who undergo subsequent MI-CRS will be included in the per-protocol population. At the end of MI-CRS video documentation of the resection sites is performed followed by a systematic mini-laparotomy for exploration of the abdominal cavity for any residual disease. The presence of residual disease will be confirmed on pathological evaluation. The primary end point is the incidence of missed disease during MI-CRS that is detected during mini-laparotomy. Quality assessment of SL and MI-CRS will be performed by an independent two-member committee. Patients undergoing conversion to open cytoreductive surgery will comprise the comparator group for studying the secondary end-point which include the sites of missed disease, perioperative outcomes and survival outcomes. Survival endpoints will be measured from the date of surgery to the event: overall survival (OS) will be defined by death due to any cause, and progression-free or relapse-free survival (PFS/RFS) by any recurrence or death whichever comes first. Ethics and Registration The study protocol is approved by the ethics committee of Shalby Cancer and Research Institute on 7th October 2024 (EC/069/02). The study is registered under the Clinical Trials Registry of India; subsidiary of clinicaltrials.gov (CTRI/2024/11/076312). Strengths and limitations The study will be the first to demonstrate the oncological adequacy or inadequacy of the MI-CRS The methodology and surgical protocol are robust and should minimize heterogeneity in surgical practices in the study If the oncological inadequacy of MI-CRS is not demonstrated, its use should be limited in patients with limited peritoneal disease. Two independent experts will review the adequacy of staging laparoscopy and MI-CRS both The stringent methodology could be a deterrent for surgeons/ centres to participate in the study, specifically performing a systematic mini-laparotomy for those surgeons who prefer to deliver specimens through a natural orifice.

ObjectivesTo evaluate the effect of surgical hubs on the volume of surgeries, patient waiting times, and length of hospital stay for elective hip and knee replacements in the English NHS. DesignA retrospective longitudinal study using a difference-in-differences approach to compare changes in outcomes at NHS trusts that opened surgical hubs with those that did not. SettingThe study was set in the English NHS, using administrative data from NHS acute trusts providing elective hip and knee replacements between April 2014 and September 2024. ParticipantsThe study included 76 NHS trusts. The treatment group consisted of 29 trusts that opened a surgical hub for trauma and orthopaedic surgery during the study period. The control group consisted of 47 trusts that did not. 48 trusts that performed fewer than 1,000 relevant procedures over the ten-year period or that reported data for fewer than 41 of the 42 quarters in the sample period were excluded. InterventionThe phased introduction of surgical hubs dedicated to elective procedures at 29 NHS trusts between Q1 2020 and Q3 2024. Main outcome measuresThe three main outcomes were, measured at the trust-quarter level: the total number of elective primary hip and knee replacements (surgical volume), the average length of stay in hospital, and the average waiting time from being added to the waiting list to hospital admission. ResultsThe opening of a surgical hub was associated with an increase of 43.75 hip and knee replacement surgeries per quarter (95% CI: 22.22 to 65.28), which represents a 19.1% increase compared to the pre-hub mean. Length of stay was reduced by 0.32 days (95% CI: - 0.48 to -0.16), a 7.8% reduction. There was no statistically significant effect on average waiting times (-14.96 days, 95% CI: -33.11 to 3.19). ConclusionsSurgical hubs appear to be effective at increasing the number of hip and knee replacements and reducing the time patients spend in hospital. However, in this study, they did not lead to a statistically significant reduction in waiting times overall.

IntroductionCurrent UK guidelines recommend measurement of symphyseal fundal height and measurement of maternal blood pressure and urinalysis, with the aim of detecting women at increased risk of fetal growth restriction (FGR) and preeclampsia. Between 2008 and 2013 we conducted a prospective cohort study recruiting 4,512 nulliparous women at the Rosie Hospital, Cambridge, where we performed serial ultrasonic imaging and serial blood sampling and generated a novel screening test for preeclampsia and FGR. The method involved measuring the ratio of two placental biomarkers (soluble fms-like tyrosine kinase receptor-1 [sFLT1] and placenta growth factor [PlGF]) at [~]36 weeks of gestational age (wkGA) and combining the result with maternal characteristics and ultrasonic imaging. Women who screened positive had a [~]50% risk of a composite outcome, consisting of preeclampsia {+/-} delivery of a baby with a birth weight <3rd percentile for sex and gestational age {+/-} perinatal morbidity or death. It is plausible that screening and intervention using this method might improve pregnancy outcome. Methods and analysisNulliparous women with an apparently normal singleton pregnancy will be recruited at their dating ultrasound scan. Blood will be obtained at this visit, at their anomaly scan (20wkGA), and at two research appointments (28wkGA and 36wkGA) when research ultrasound scans will be performed. Blood for DNA will be obtained from the father of the baby where possible and the placenta will be sampled following birth. At 36wkGA, women will be consented for participation in the randomised controlled trial (RCT) element of the study and their risk of term preeclampsia and FGR will be assessed using the novel approach. Women who screen high-risk will then be randomly allocated to either having the result revealed or masked. Women randomised to having the result revealed will be offered early delivery and/or enhanced monitoring. Where the result is masked, there will be no communication between the research team and the participant, and she will continue to receive routine care at the Rosie Hospital. The primary outcome is a composite of preeclampsia, FGR and perinatal morbidity and mortality. The study will also generate data and biological samples to support future research in novel screening methods and disease mechanisms. Ethics and disseminationThe study received ethical approval from the East of England Research Ethics Committee. All women provide written informed consent to participate in the cohort. Women provide a second written informed consent to participate in the RCT. The study results will be disseminated by presentation at international conferences and publication in peer reviewed journals. Trial registration07/10/2019 ISRCTN12181427 (https://doi.org/10.1186/ISRCTN12181427) Strengths and limitations of the study [Table 1]

Aim To examine ethnic inequalities in recruitment outcomes and workforce representation across pay bands among nursing and midwifery staff, and to assess whether routinely collected administrative data can generate reproducible indicators for workforce equality monitoring. Design Retrospective observational study. Methods We analyzed routinely collected administrative data from one NHS Board in Scotland. This included annual staff-in-post data for 2021/22 to 2024/25 and pooled recruitment data on interviewed candidates and conditional job offers for 2021/22 to 2023/24. Ethnicity was grouped as White and non-White. Analyses focused on Bands 5, 6 and 7. Recruitment outcomes were assessed using relative risks for receipt of a conditional job offer among interviewed candidates, comparing White and non-White applicants. Workforce representation across pay bands was assessed using representation quotients. Analyses were descriptive and unadjusted. Results White applicants were more likely than non-White applicants to receive a conditional job offer following interview across all pay bands examined. Inequalities were also evident at Band 5, the usual entry point to registered practice. Workforce composition analyses showed a corresponding gradient in representation, with non-White staff overrepresented in Band 5 and underrepresented in Bands 6 and 7, with little change over the study period. Conclusion Routinely collected administrative data can generate reproducible indicators of ethnic inequality in recruitment and workforce representation. Embedded within existing workforce systems, such analyses could strengthen workforce equality monitoring, support benchmarking and enhance accountability across healthcare settings. Impact Utilising routine administrative data for workforce equality monitoring can support policy and practice aimed at improving accountability, retention and workforce sustainability across health systems. Reporting Method This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guidelines. Patient or Public Involvement This study did not include patient or public involvement in its design, conduct, or reporting.

Introduction Creativity is important in surgery for problem-solving in the operating room and the development of surgical innovations that improve patient outcomes. However, our limited understanding of what the characteristics and competencies of the highly creative surgeon are has inhibited our ability to develop the tools, programs and interventions necessary for cultivating the creativity of surgeons. We present the protocol for the INSPIRE Study, which aims to identify the factors associated with high creative achievement in surgeons. Methods and Analysis We have designed a sequential mixed-method study, including a cohort study accompanied by qualitative semi-structured interviews. The primary objective of this study will be to identify factors associated with high creative achievement in surgeons, to be assessed through direct involvement in innovation or invention, or a top score (10 out of 10) on any domain in the Inventory of Creative Activities and Achievements questionnaire. We plan to measure 39 different personal, domain-specific, domain-general, and environmental/motivational variables, chosen based on previous literature and on exploratory grounds, to be assessed as possible factors of creative potential. Multivariable logistic regression is planned, with high creative achievement as the dependent variable and all 39 potential factors of creative potential as independent variables. Ethics and Dissemination Ethics approval from the Hamilton Integrated Research Ethics Board has been obtained and no harm is expected due to participation in this study. To facilitate knowledge translation, we plan to publish the feasibility data and results in peer-reviewed journals, and present at international surgical and creativity conferences.

BackgroundPatient safety remains a global priority, yet adverse events persist due to gaps in communication, information, training and safety culture. Rapid response systems standardise observation models are widely used to recognise deterioration and guide escalation and response for ward patients in hospitals. A notable gap concerns the role of planning for further care, can improve hospital resource prioritisation as healthcare professionals respond to patients deterioration in daily practice. Engaging healthcare professionals as key stakeholders to ensure relevance, we identified unanswered research questions on hospital patient safety and rapid response systems and prioritised the top ten research needs. Aim and methodsWe conducted a hospital-tailored, modified James Lind Alliance Priority Setting Partnership (JLA PSP) with healthcare professionals as key stakeholders to identify and prioritise rapid response system related patient safety research needs and evidence uncertainties. The modified JLA process included five stages: (1) establish the Priority Setting Partnership; (2) identify uncertainties; (3) summarise and refine submissions with evidence checks. (4) priority setting; and (5) verify and finalise a top ten list, with evidence checks and project-group oversight throughout. ResultsA modified JLA PSP resulted in the stakeholders co-producing a list of research priorities. The top three priorities addressed implementation strategies, intervention effectiveness, and optimising hospital patient safety through clinical protocols and rapid response system activation thresholds. Additional priorities addressed ethical, educational, and organisational factors, highlighting evidence gaps which recognised and responded to patient deterioration and the need for safer transitions across levels of hospital care. The modified JLA PSP was feasible for co-producing a clinically relevant, practice-oriented research agenda. ConclusionsA transparent, systematic, stakeholder-driven process generated hospital patient safety research priorities for rapid response systems that reflect stakeholder needs and target key evidence gaps guiding future research and strengthening patient safety practice in hospitals and, in primary care.

BackgroundRandomized controlled trials (RCTs) often have incomplete methods reporting despite widespread adoption of the CONSORT guideline. The editorial process is supposed to detect these shortcomings and request clarifications from authors, which is time-consuming. We developed an LLM-based CONSORT Rohe Nordberg Report that highlights which CONSORT items appear fully or partially reported and checks page references claimed by authors, and then creates follow up questions for authors to more easily correct missing information. MethodsThis parallel-arm, superiority RCT will randomize eligible RCT submissions (after desk screening) 1:1 into intervention (editorial team and authors receive the Rohe Nordberg Report) or control (standard editorial review only). The primary outcome is whether manuscripts improve their reporting of CONSORT items in the Methods and Results sections between the original submission and first revision. This will be assessed by blinded human reviewers who evaluate the textual changes for improvements between the original and revised manuscripts for each relevant CONSORT item. Secondary outcomes include time to editorial decisions, rejection and non-resubmission rates, if authors can correctly identify where CONSORT items are reported, and extent of revisions. Human evaluators will be blinded to whether the manuscript was in the intervention or control group. DiscussionBy providing authors and the editorial team with specific follow up questions for each underreported CONSORT item, we hypothesize that basic underreporting will be more efficiently detected and corrected. Using blinded human reviewers as the primary outcome assessors ensures a rigorous, unbiased evaluation. If successful, this approach may help align manuscripts more closely with CONSORT standards, ultimately benefiting evidence synthesis. Trial Registration[To be registered prior to enrollment; e.g., ClinicalTrials.gov or ISRCTN] 1. Administrative Information1.1 TitleLLM-Generated CONSORT Rohe Nordberg Report for Increased Reporting: Protocol for a Parallel-Arm Randomized Controlled Trial. IRB registered name: LLM-Generated CONSORT Report Phase III Trial 1.2 Trial RegistrationThis trial will be registered before enrollment commences in a publicly accessible registry (e.g., ClinicalTrials.gov or ISRCTN). The trial identifier will be inserted here upon registration. All items from the World Health Organization Trial Registration Data Set will be provided at the time of registration, including: primary registry and trial ID, date of registration, secondary IDs, source of funding, contact for public and scientific queries, title, research ethics review, study design, study setting, interventions, eligibility criteria, primary outcome, key secondary outcomes, target sample size, recruitment status, and results dissemination plan. 1.3 Protocol VersionVersion 1.0 26 March 2026 [Subsequent amendments will be tracked by version number, date, and a summary of changes.] 1.4 FundingOpen Philanthropy, grant title "From Manual to Machine: Validating and Scaling LLM-Based CONSORT Compliance Assessment for Evidence-Based Medicine Publishing" Participating journals provide in-kind editorial resources (staff time, system access) to facilitate trial conduct. 1.5 Roles and ResponsibilitiesO_ST_ABSProtocol contributorsC_ST_ABSAuden Nordberg Krauska (University of Wisconsin-Madison; krauska@wisc.edu): conceived the study design, wrote the initial protocol draft Karl Rohe (University of Wisconsin-Madison): primary investigator, co-developed the LLM-based CONSORT and RoB 2 systems Gary Collins (University of Birmingham): senior methodologist, contributed to trial design and statistical analysis plan Sara Schroter (British Medical Journal): research editor, contributed to trial design and implementation plans Hyunseung Kang (University of Wisconsin-Madison): aided in statistical analysis plan Trial sponsorUniversity of Wisconsin-Madison, Department of Statistics, 1300 University Avenue, Madison, WI 53706. Role of sponsor and fundersThe research team leads trial design, data collection, analysis, interpretation, and reporting. The sponsor and funders have no role in data collection, management, analysis, interpretation of data, writing of the report, or the decision to submit the report for publication. The funder provides financial support only. Participating journal editorial teams are consulted for feasibility and operational feedback but do not have authority over data analysis or reporting. Trial oversight groupsThe trial will be coordinated by Karl Rohe and Auden Nordberg Krauska (University of Wisconsin-Madison), with methodological input from Gary Collins (University of Birmingham). Day-to-day operations, including manuscript tracking, diff file preparation, and data management will be carried out by Auden Nordberg Krauska and trained undergraduate research assistants at UW-Madison. Sara Schroter, Research Editor at The BMJ, will facilitate integration with the journals editorial workflow and monitor recruitment progress. This group will meet as needed to review trial progress and resolve operational issues.

ObjectiveUnlike several other fields of healthcare, little is known about the size of therapist effects on patient outcomes following rehabilitation for musculoskeletal conditions. We aimed to estimate the proportion of variance in patient outcomes from a structured rehabilitation program explained by therapist effects. MethodsFor our observational cohort study we accessed data from the national multicentre Good Life with osteoArthritis in Denmark (GLA:D) osteoarthritis management program. Analyses included 23,021 consecutive eligible adults with hip or knee osteoarthritis (mean (SD) age 65.0 (9.8) years, 71% female) treated by 657 therapists between October 2014 and February 2019. The primary outcome was [&ge;]30% reduction in pain intensity on 0-100 VAS at 3 months. Therapist effects were estimated as the variance partition coefficient (intra-class correlation coefficient (ICC)) from two-level random intercept logistic regression models before and after adjusting for patient-level case-mix factors and therapist-level characteristics (number of patients treated, days since therapist certification). Analyses were repeated for a range of secondary outcomes using multiply imputed data and complete-case analysis. Results52% of patients reported a [&ge;]30% reduction in pain intensity on 0-100 VAS at 3 months. In the null model the ICC was 0.007 (95%CI: 0.005, 0.009), which changed little after adjusting for patient- and therapist-level covariates. Upper confidence limits for ICC estimates across all secondary outcomes in multiply imputed and complete case analyses were less than 0.03. ConclusionsIn a nationally implemented osteoarthritis management program delivered by trained healthcare professionals, therapist effects made a minimal contribution to variation in patient outcomes. KEY MESSAGESO_ST_ABSWhat is already known on this topicC_ST_ABS Therapist effects - defined as the effect of a given therapist on patient outcomes as compared to another therapist - have been observed in several fields of healthcare and have important consequences for selection, training, and service improvement. In musculoskeletal rehabilitation five previous studies suggest that 1-12% of variation in patient-reported outcomes may be attributable to therapist effects, but these estimates were based on relatively small datasets resulting in substantial uncertainty. What this study addsOur cohort study analysed registry data from 2014-2019 on 23,021 patients and 647 trained therapists from the nationally implemented GLA:D structured osteoarthritis management program in Denmark. We found that therapist effects accounted for less than 3% of total variation in patient-reported pain and quality of life outcomes 3 months after beginning the program How this study might affect research, practice, or policyOur findings suggest that contextual factors that relate to therapist effects - therapist characteristics or therapist-patient interaction and alliance - make a minimal contribution to variation in patient outcomes from this structured, group-based rehabilitation intervention. Any contextual effects must be attributable to alternative sources, e.g. patient expectations, intervention setting.

Background Trials in occupational populations, such as surgeons, face feasibility challenges due to high workload, restricted availability, and clinical heterogeneity, which may compromise recruitment, adherence, and retention. Objective To prespecify the feasibility framework and progression criteria for an internal pilot phase embedded within a pragmatic randomized controlled trial (RCT) comparing Mechanical Diagnosis and Therapy with generalized exercise in surgeons with chronic spinal pain. Design Protocol for a prespecified internal pilot phase embedded within a pragmatic, two-arm, parallel-group RCT. Methods The internal pilot will include the first four months of recruitment and aims to randomize at least 12 participants. Feasibility will be assessed across predefined domains, i.e., recruitment, eligibility, consent, intervention uptake, adherence, retention, data completeness, and treatment fidelity. Each domain is operationally defined and linked to prespecified progression criteria to ensure interpretability and decision-making utility. Criteria will be interpreted collectively to guide trial continuation. A minimal qualitative process evaluation will be embedded. Ethics and dissemination The host trial has received ethical approval (N-20240046) and is registered at ClinicalTrials.gov (NCT07293130). The findings from the internal pilot will be reported in a separate feasibility manuscript.

OBJECTIVE To guide treatment of adults with rotator cuff tendinopathy (RoCuTe) by evaluating the relative efficacy of treatments, benchmarked against minimal intervention, for the co-primary outcomes of pain, function and quality-of-life (QoL) across short, medium, and long-term follow-up. DESIGN Systematic review with Bayesian predictive and network meta-analyses for synthesising complex interventions, guided by stakeholder involvement. FUNDING Private Physiotherapy Education Foundation (UK) Silver Jubilee Award. DATA SOURCES PubMed, Embase, Web of Science, CINAHL, and SPORTDiscus, searched to 22/8/2025. ELIGIBILITY CRITERIA FOR SELECTING STUDIES High-quality (PEDro score equal or above 7) randomised controlled trials comparing any intervention with another active or minimal intervention for patients clinically diagnosed with RoCuTe of either traumatic or insidious presentation; and reporting outcomes for pain, function and/or QoL. METHODS Title and abstract screening, full-text screening, and quality assessments were completed by two reviewers. Data extraction used the Elicit AI tool and was manually checked. Interventions were classified by treatment focus. Guided by patient and public involvement, pooled results from active interventions at short (1 to 12 weeks included), mid (>12 weeks to <12 months) and long-term (12 months included or more) were calculated for the primary analysis using Bayesian predictive meta-analysis models of within group change scores. Outcomes were benchmarked against an empirically derived minimal-intervention comparator (wait-and-see or sham). As a secondary analysis, network meta-analyses were conducted to synthesise relative effects and provide comparative rankings of active interventions. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool, and certainty of evidence evaluated using GRADE. RESULTS We retained and analysed 140 high-quality studies that included 10,260 patients, 55.9% female, with a mean age of 48 (SD 8) years. Minimal interventions were associated with small short-term improvements, modest medium-term improvements and some regression in the long-term; in pain (0 to 100 scale: short=2.6; mid=23.3; long=21.1), function (standardised mean change (SMC): short=0.13; mid=0.87; long=0.76), and QoL (SMC: short=0.05; mid=0.33). At all timepoints, all active interventions with sufficient data were superior to minimal intervention for pain (0 to 100 scale: short = 18.1 to 37.9 [14 categories]; mid = 25.8 to 34.8 [8 categories]; long = 30.8 to 45.0 [6 categories]), function (SMC: short = 1.1 to 2.4 [14 categories]; mid = 1.1 to 2.0 [11 categories]; long = 1.0 to 1.8 [10 categories]), and QoL (short = 0.8 to 1.7 [7 categories]; mid = 0.9 to 1.8 [6 categories]). Certainty varied widely. Accordingly, three recommendation groups were defined based on the availability of comparative evidence and presence of higher-certainty findings. The strongest recommendation group included strengthening, range-of-motion exercises, complex interventions and movement pattern retraining. CONCLUSIONS A range of active treatments were superior to minimal intervention at each time point, so a wait-and-see approach should not be used, even in in the short-term. The most credible evidence was for interventions with a focus on strengthening, range-of-motion exercises, movement pattern retraining, and complex interventions. Clinicians should prioritise active management and deploy personalised clinical reasoning to tailor treatment to patient preferences and the available resources. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42024584126

BackgroundThe public health grant is used by upper-tier and unitary local authorities in England to fund public health services. Public health grant allocations have declined by 26% per person since 2015/16, with cuts being made without any adjustment based on population needs, resulting in absolute cuts often being greater for more deprived local authorities. This study seeks to investigate how these cuts have affected spending decisions across different areas of public health and how changes in spend relate to population health needs. MethodsIn this longitudinal ecological study, data on local government revenue expenditure and financing to 146 upper-tier local authorities in England were extracted from the Ministry of Housing, Communities, and Local Government for the years 2017/18, 2018/19 2019/20 and 2022/23. Demand for each function of the public health grant was proxied using a publicly available indicator of need. Descriptive analyses explored changes to grant expenditure over time by function and IMD quintile. A compositional regression model was developed to account for the relatedness of spend data. The significance of associations between indicators of need and spend on functions of the grant was tested using MANOVA, producing Pillais Trace statistics as an indication of the effect size of each explanatory variable relative to others. FindingsPublic health grant spending reductions were widespread. More deprived local authorities often experienced deeper absolute cuts against a backdrop of greater need, with spend being protected across all IMD quintiles in only three areas: childrens 0 to 5 non-prescribed functions, health protection, and public mental health. In the multivariate regression, there was limited relationship between indicators of health need and patterns of grant spend between public health categories. InterpretationThere is no clear relationship between potential indicators of need and expenditure of the public health grant in different reporting categories. Instead, spending decisions are being driven by other factors that may include historic spend, wider local priorities and financial pressures. These findings suggest a review of the public health grant formula to support local authority public health teams to more strategically apportion spend based on population health need. O_LIWhat is already known on this topic O_LILocal authority public health teams in England receive a ring-fenced grant from central government which was originally based on an allocation formula that has not been updated since 2012/13. C_LIO_LIThe grant has been cut substantially over the past decade, often with larger absolute cuts for more deprived local authorities. C_LIO_LINo previous study has investigated how public health teams allocate a diminishing grant across competing areas of public health need and how this may vary by deprivation. C_LI C_LIO_LIWhat this study adds O_LIThis study found limited evidence that indicators of health need have driven public health grant allocation in related spend categories, nor any differences by deprivation. Our analysis is the first to explore multiple indicators of need and to employ compositional regression to account for corelations between categories of grant spend. C_LI C_LIO_LIHow this study might affect research, practice and policy O_LIThis study supports a review of the public health grant funding formula to better distribute the public health grant according to local population health need. C_LI C_LI