BMJ Open
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Preprints posted in the last 30 days, ranked by how well they match BMJ Open's content profile, based on 554 papers previously published here. The average preprint has a 0.77% match score for this journal, so anything above that is already an above-average fit.
Morrissey, D.; Sharif, F.; Fearon, A.; Neal, B. S.; Bremer, T.; Swinton, P.; Newman, P.; Lack, S.; Cooper, K.; Rabello, R.; D2P Group,
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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
Vliegenthart-Jongbloed, K. J.; Bunea, O.-M.; Fijołek, F.; Razzolini, I. P.; Barber, T. J.; Bernardino, J. I.; Nozza, S.; Psomas, C. K.; De Scheerder, M.-A.; Vasylyev, M.; Voit, F. M.; Jordans, C. C. E.; Willemsen, R.; van Wingerden, M. D.; Bienkowski, C.; Miron, V. D.; Felder, A.-K.; Hanssen, B.; Hontelez, J.; Li, Y.; Stutterheim, S.; Skrzat, A.; Sandulescu, O.; Rokx, C.; #aware.hiv Europe,
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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.
Jackson, R.; Valensin, C.; Chin-Smith, E.; Suff, N.; Shennan, A. H.; Hezelgrave, N. L.; Tribe, R. M.
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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
Ward, T.; Alem, A.; Craig, T. K. J.; Sinha Deb, K.; Devi, S.; Fekadu, A.; Gumley, A.; Hanlon, C.; Kelly, R.; Manyazewal, T.; Misganaw, E.; Murcutt, I.; Oshodi, E.; Patil, V.; Sharan, P.; Tesfaye, Y.; Verma, R.; Ul-Haq, S.; Rus-Calafell, M.; Choudhary, R.; Getachew, M.; Hardy, A.; Wondiye, M.; Mihretu, A.; Sood, M.
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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
Wen, J.; Anteneh, Z.; Castelli, A.; Street, A.; Gutacker, N.; Scantlebury, A.; Glerum-Brooks, K.; Davies, S.; Bloor, K.; Rangan, A.; Castro Avila, A.; Lampard, P.; Adamson, J.; Sivey, P.
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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.
Boldbaatar, A.; Strahle, S.; Shamsuddin, A.; Henderson, D.
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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.
Obasohan, P. E.; Palmer, J.; Alderson, D.; Yu, D.; Gronne, D. T.; Roos, E. M.; Skou, S. T.; Peat, G. M.
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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 [≥]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 [≥]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.
Kjaergaard, C.; Madeleine, P.; Dalboege, A.; Steinhilber, B.; Olesen, A. V.; Nielsen, T. K.
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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.
Pasin, C.; Jackson, S. S.; Thynne, L.-E.; McWade, B.; Westerman, T.; Ball, R.; Kavanagh, J.; O'Callaghan, S.; Ring, K.; Orkin, C.; Berner, A. M.
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ObjectivesTo estimate current, and 5- and 10-year projected, number of cases of cancer per year in transgender and gender diverse (TGD) people in England, overall and by tumour type, accounting for uptake of gender affirming care (GAC). DesignPopulation-based epidemiological modelling study using an age-stratified Monte Carlo simulations approach and the NORDPRED method for predictions. SettingModels estimating cancer case numbers for TGD people in England based on publicly available 2023 cancer surveillance data and survey-based 2025 GAC access, and predicted at 5 and 10 years hence. ParticipantsTGD people aged 15 years and above. Main outcome measuresPrimary cancer cases per year overall, by gender, age group, tumour type, and current and planned GAC. ResultsThe estimated TGD population size in England is 441547 (95% uncertainty interval (UI) 429207- 452890). Total cases per year of cancer in TGD people is expected to be 966 (95% UI 882-1069) excluding non-melanoma skin. Most cases are expected to occur in people aged 60-64. The top 5 expected cancers in TGD people are breast (19%, n = 187, 95% UI 149-241), colorectal (12%, n = 117, 95% UI 106-129), lung (11%, n = 108, 95% UI 96-122), melanoma (7.1%, n = 69, 95% UI 64-74) and urinary (6.2%, n = 60, 95% UI 54-67). Total cases of cancer in TGD people are estimated to be 1740 (95% UI 1584-1934) in 5 years and 2258 (95% UI 2066-2507) in 10 years (excluding non-melanoma skin). If TGD people were able to access their planned level of GAC, this would reduce these figures to 1555 (95% CI 1386-1766) and 2012 (95% CI 1797-2282) respectively. ConclusionsThis study provides prediction of cancer cases in TGD people in England, supporting the planning of service provision and training. This is vital, as with increasing disclosure, and long wait times for GAC, cancer cases in TGD people are predicted to increase. Summary BoxesO_ST_ABSWhat is already known on this topicC_ST_ABSThe annual number of cases of cancer in transgender and gender diverse (TGD) people in England is currently unknown as gender incongruence is not collected as part of the National Cancer Registration and Analysis Service. Some gender-affirming care (GAC) interventions are known to modulate cancer risk. Use of testosterone and chest reconstruction for transmasculine people is known to reduce their incidence of breast cancer compared to cisgender women. Use of oestradiol alongside medical or surgical androgen suppression has been shown to reduce the incidence of prostate cancer in transfeminine people while increasing their risk of breast cancer, compared to cisgender men. What this study addsThis study found that there are likely to be approximately 966 cases of cancer (excluding non-melanoma skin) in TGD people per year in the UK. Though total annual cases of cancer in TGD people are expected to be 2258 in 10 years, improved access to gender-affirming care could reduce total cases to 2012 (a 11% reduction). These figures provide additional justification for funding to improve access to GAC via the National Health Service (NHS), as well as for training on the oncological needs of this population.
Mikolic Brence, P.; Bregar, B.; Vatovec, K.; Bertole, T.; Ferlan Istinic, M.; Oreski, S.; Vinko, M.
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Introduction: Frailty is a dynamic condition associated with increased vulnerability to adverse health outcomes in older adults. While previous research has primarily focused on deficit-based mental health factors, such as depression and loneliness, less is known about the role of positive mental health determinants, including well-being, resilience and social connectedness, in the development and progression of frailty. Understanding both risk and protective factors is essential for informing public health strategies aimed at promoting healthy ageing. This study aims to examine the longitudinal relationship between mental health and frailty in a nationally sampled population of adults aged 50 years and older in Slovenia. Methods and analysis: This longitudinal observational study will collect data at four time points over a two-year period (January 2026-March 2028). A stratified random sample of community-dwelling adults aged 50-84 years will be drawn from the national population registry, with 5,000 individuals invited to participate in the first wave. Frailty, mental health and a set of social, psychological, and health-related factors will be assessed. Data will be analyzed using a combination of descriptive, inferential and longitudinal statistical methods to examine associations between frailty and mental health over time. Potential explanatory factors will also be explored within the longitudinal framework, and additional analyses will assess the impact of attrition. Ethics and dissemination: The study has been approved by the Ethics and Deontology Committee of the National Institute of Public Health. Participation is voluntary, and informed consent will be obtained from all participants. Data will be anonymized and handled in accordance with applicable data protection regulations. Findings will be disseminated through peer-reviewed publications, conference presentations and public health reports to inform strategies for promoting healthy ageing.
Ashikali, E.-M.; Vallet, F.; Rouzinov, S.; Maisonneuve, H.; Busnel, C.
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Background: With an aging population and increasing comorbidities, supporting people to remain at home for as long as possible is essential. A major challenge in home care is ensuring coordinated, interprofessional collaboration among all actors involved: patients and their close ones, health and social care professionals, and the broader health and social network. To address this challenge, a new organizational model promoting reinforced interprofessional collaboration, the "Reseau Interprofessionnel Ambulatoire de Proximite" (Local Interprofessional Outpatient Network; RIAP) has recently been developed in the canton of Geneva. The aim of this paper is to present the protocol for a research project evaluating both the effectiveness and implementation of this model. Methods: This is a type-2 hybrid effectiveness implementation study guided by the RE-AIM framework, aiming to evaluate the RIAP organizational model and its implementation, context, and outcomes. This multi-method study will examine the RIAP model under real-world conditions. Routinely collected data on patient outcomes and institutional processes will be used to compare the RIAP model with usual care. Questionnaires will assess patients' perceptions of continuity of care, professionals' perceptions of interprofessional collaboration, and stakeholders' views on the acceptability of the model. Open-ended questions will be included to explore experiences and insights in greater depth, complemented by qualitative data on barriers and facilitators to implementation. Financial indicators will also be analyzed to contextualize the model within the institutional setting. Results: The EFFI-RIAP project began in October 2025 and has a planned duration of 22 months. The project will primarily rely on the reuse of institutional routine data, complemented by questionnaires and interviews scheduled for September 2026. At the time of submission, study preparation and institutional data processing are ongoing. Discussion: This research will provide insights into the clinical, organizational, and implementation-related effects of the RIAP model compared with usual care. The natural deployment of new RIAP teams will enable investigation of the organizational model under real-world conditions. The combined evaluation of the effectiveness and implementation of RIAP will assess the model's added value, inform refinement, and identify potential barriers and facilitators relevant to implementation in other teams.
Dornisch, A.; Rojo Domingo, M.; Alexander, R. V.; Conlin, C. C.; Do, S.; McKay, R. R.; Moiseenko, V.; Liss, M. A.; Liu, J.; Pawlicki, T.; Pena, S.; Qiao, E. M.; Rose, B. S.; Rupareliya, R.; Sandhu, A. P.; Scholey, J.; Seyedin, S. N.; Urbanic, J. J.; Wei, L.-J.; Seibert, T. M.
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Definitive radiotherapy (RT) for prostate cancer (PC) with dose intensification and/or focal boosting has excellent oncologic outcomes, but many patients experience adverse events. Dose escalation to the whole prostate improves outcomes at the expense of increased late adverse events. Intraprostatic recurrence after definitive RT typically occurs at the site of the primary tumor, suggesting that dose to the site of the dominant lesion is an important predictor of future failure. The efficacy and safety of tumor-focused RT compared to that of standard RT for definitive treatment of localized PC has not been assessed. RadTARGET (RAdiation Dose TAiloRing Guided by Enhanced Targeting) is a phase II randomized trial that aims to demonstrate superior safety of image-guided, tumor-focused RT compared to standard RT for acute genitourinary (GU) or gastrointestinal (GI) in the setting of definitive RT for intermediate- and high-risk PC. The study intervention is image-guided, tumor-focused RT with dose intensification of cancer visible on imaging and dose de-intensification to remaining prostate. Patients will be randomized to two arms: those who receive standard RT dose and those that receive tumor-focused RT. The study population will be patients with intermediate- or high-risk PC planning to undergo definitive RT with or without systemic therapy. The primary endpoint to compare between randomized arms is acute GU or GI grade [≥]2 adverse events. Participant and study duration are 5 years and 8 years, respectively. RadTARGET will compare the efficacy and safety of tumor-focused RT to that of standard RT for definitive treatment of localized PC. We hypothesize that the tumor-focused approach will substantially reduce adverse events after prostate RT while retaining high efficacy. If this hypothesis is confirmed, we will conclude that a phase III randomized control trial is warranted to formally establish oncologic non-inferiority compared to the current standard of whole-gland dose escalation.
Wiseman, J.; Sibley, S.; Perez-Patrigeon, S.; Mekhaeil, M.; Hanley, M.; Hunt, M.; Boyd, T.; Grant, B.; Boyd, J. G.
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IntroductionThere is increasing interest in the peripheral administration of vasopressors for two main reasons: (1) to expedite vasopressor initiation in patients with refractory shock and (2) to avoid the potential complications associated with central venous catheter placement. The current evidence on the use of peripheral vasopressor administration is primarily based on single-center observational studies. There are inconsistencies in the administration of peripheral vasopressors, including catheter gauge and location, monitoring practices, vasopressor concentrations, and duration of use. This has made it difficult for institutions to develop best practice guidelines. A randomized controlled trial is needed to address this knowledge gap. Methods and analysisThe Peripheral Use of Low-dose Vasopressors for Safety and Efficacy (PULSE) in the intensive care unit is a prospective, unblinded feasibility study. Eligible patients will be 18 years or older, have no existing central venous catheter or peripherally inserted central catheter and have the presence of shock requiring a minimum vasopressor dose of any of the following: norepinephrine 0.0625 mcg/kg/min, phenylephrine 0.625 mcg/kg/min, and epinephrine 0.0625 mcg/kg/min. Fifty patients will be randomized 1:1 into either the peripheral venous catheter or central venous catheter group. The primary outcome is feasibility, defined as (1) a recruitment rate of 4 participants per month, (2) a data capture rate of [≥]90%, and (3) a <50% conversion rate from peripheral to central access. The secondary outcomes include the safety of peripheral vasopressor use, alive and central-line-free days, the number of attempts needed to place a catheter, volume status, in-hospital mortality rate, ICU and hospital length of stay, and patient-centred important outcomes. ImplicationsThe data collected from this study will inform the design of a definitive randomized controlled trial to assess the safety and efficacy of protocol-driven peripheral vasopressor administration. Ethics and disseminationThis study received approval (6042888) from the Queens University Health Sciences/Affiliated Teaching Hospitals Research Ethics Boards. Results of this study will be presented at critical care conferences and submitted for publication. Trial registration numberNCT06920173 (https://clinicaltrials.gov/study/NCT06920173).
Varela-Mato, V.; Ngina, D.; Orton, E.; Barnes, J.
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Background Parenting practices shape children's emotional, social, and cognitive developmental wellbeing. Yet, many families face complex challenges that increase the risk of poor outcomes and demand on social care. The Sutton Parenting Offer (SPO) is a universal, peer-led parenting offer that provides early, non-stigmatising support to families with children aged 0-25 years. It combines evidence-based programmes with informal workshops and peer networks delivered through Family Hubs. This present study is an evaluation protocol of the parenting offer. Aim This evaluation aims to explore how, why, and in what contexts SPO supports families in engaging, sustaining positive change, and generating wider system value. Methods A mixed-methods realist evaluation approach will be used to evaluate SPO across four work packages: engagement pathways, early changes and peer-led ecosystems, long-term change, and system value for money. Data sources will include attendance data (anonymised service records), survey data (entry and exit), and qualitative data (dyad interviews, story circles, and stakeholder-value mapping workshops). The COM-B and the Theoretical Domains Framework (TDF) will guide the analysis of behavioural data. Quantitative data will be analysed descriptively and using paired parametric and non-parametric tests, while qualitative data will be analysed thematically following a realist-informed approach to refine context-mechanism-outcome (CMO) configurations. Discussion This protocol presents the first realist informed evaluation of a universal parenting program in a local authority setting. The evaluation will generate evidence on how, when and why a universal, community-based, and peer-led model such as the Sutton Parenting Offer engages families and generates change. The findings will be useful to inform future parenting service design and implementation in local contexts in England.
Hoque, A.; Rahman, M.; Basak, S. K.; Mamun, A. A.
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BackgroundIn the absence of structured donor registries, social media platforms have become a dominant mechanism for blood donor recruitment in many low-resource settings. However, the implications of this shift for transfusion timeliness and system reliability remain unclear. ObjectiveTo evaluate the impact of social media-sourced donors on transfusion delay, donor reliability, and hemovigilance-related outcomes compared with conventional donor pathways. MethodsThis prospective analytical study included 400 transfusion episodes across tertiary hospitals in Bangladesh. Donor sources were categorized as social media (SM) or conventional (CON). The primary outcome was delay-to-transfusion. Secondary outcomes included donor-related irregularities, documentation completeness, near-miss events, and acute transfusion reactions. Multivariable logistic regression identified predictors of delay [≥]4 hours. ResultsSocial media-sourced donors were associated with significantly longer transfusion delays (5.98 vs 2.97 hours; p<0.001). Delay [≥]4 hours occurred in 83.6% of SM cases versus 17.6% of CON cases (OR 23.78). Donor-related irregularities were observed in 85% of SM episodes and absent in CON donors. Safety outcomes did not differ significantly between groups. Social media donor sourcing remained the strongest independent predictor of delay (adjusted OR 18.09). ConclusionUnregulated social media-based donor recruitment introduces substantial delays and undermines system reliability without improving access. Integration of digital tools into regulated donor systems is essential to strengthen transfusion timeliness and hemovigilance in resource-limited settings.
Dol, J.; Pritchett, C.; Larocque, L.; Bentley, J.; Brooks, M.; Elliott Rose, A.; Rosen, N.; Davies, E.; Yeluri, M.; Gosse, M.
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Background/Objectives: Women+ (e.g., women and individuals assigned female at birth) experience disproportionate health risks and persistent gaps in access to care, despite regionally coordinated health systems. Women+ health research remains significantly underfunded and understudied, contributing to inequities in diagnosis, treatment, and outcomes. This study aims to collaboratively identify and prioritize the most pressing unanswered research questions related to women+ health in the Maritime provinces of Canada. Methods: This study will use a modified Priority Setting Partnership (PSP) methodology based on the James Lind Alliance framework. A mixed-methods participatory approach will be used, including bilingual online surveys (French, English) and a one-day consensus workshop. Participants will include women+, healthcare professionals, researchers, policymakers, and the public residing in the Maritime provinces (Nova Scotia, New Brunswick, and Prince Edward Island). An initial survey will collect research uncertainties through open-ended questions. A second interim survey will rank verified uncertainties, followed by a facilitated workshop to achieve consensus on the Top 10 research priorities. Qualitative data will be analyzed using content analysis, and descriptive statistics will summarize participant demographics. Anticipated Results: This project is expected to generate a collaboratively developed, evidence-informed Top 10 list of research priorities for women+ health in the Maritimes. The process will also identify thematic gaps in existing research and assess feasibility considerations to inform future study design and implementation. Conclusions: By centering women+ voices and engaging diverse interest holders, this study will establish a shared regional research agenda to guide future research, funding, and policy initiatives for women+ health research.
Sato, T.; Ishiseki, M.; Kataoka, Y.; Someko, H.; Sato, H.; Minami, K.; Kaneko, T.; Takeda, H.; Crosby, A.
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ObjectivesAlarm fatigue is a patient safety concern in ICUs, yet no validated instrument exists to assess alarm fatigue among healthcare professionals in non-Western settings. This study aimed to cross-culturally adapt the Charite Alarm Fatigue Questionnaire (CAFQa) into Japanese and evaluate its reliability and validity among ICU nurses and physicians. MethodsThe Japanese CAFQa was cross-culturally adapted following the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines, including forward translation, back-translation, expert panel review, and cognitive interviews. A multicenter cross-sectional validation study was performed across eight ICUs at five hospitals in Japan. A total of 129 participants (103 nurses and 26 physicians) completed the Japanese CAFQa, the NIOSH Brief Job Stress Questionnaire, and the Insomnia Severity Index (ISI). Structural validity, internal consistency, test-retest reliability (n = 102), convergent validity, and known-groups validity were assessed. ResultsCFA confirmed the two-factor structure with acceptable fit (CFI = 0.922, RMSEA = 0.041, SRMR = 0.076), with standardized factor loadings ranging from 0.33 to 0.82. The two factors were not correlated (r = 0.05). Cronbachs alpha was 0.688 for the overall scale, 0.805 for Alarm Stress, and 0.649 for Alarm Coping. Test-retest ICCs ranged from 0.616 to 0.753. The CAFQa total score correlated with the NIOSH total (r = 0.261) and the ISI total (r = 0.338). Healthcare professionals with [≥]4 years of ICU experience had higher Alarm Coping scores than those with 1-3 years (median 7.0 vs 6.5), and physicians scored higher on Alarm Coping than nurses (median 8.0 vs 7.0). ConclusionsThe Japanese CAFQa demonstrated acceptable structural validity, reliability, and convergent and known-groups validity, providing the first validated tool for quantitatively measuring alarm fatigue in Japan. Implications for Clinical PracticeThe Japanese CAFQa enables ICU managers to quantify alarm fatigue at individual and unit levels, identify high-risk staff, and evaluate the effectiveness of alarm management interventions.
Sajnani, N.; Foster, M. W.; Oshodi, Y.; Sodimu, K. A.; Kolnik, M.; Pokorn, M.; Simpson, N.; Shaw, T.; Willmoth, S.; Marino, M.; Trinder, L.; Akisanya, E.; Onyekachi, E.; Bahr, E.; Blanchette, V.; Assistant, R.; Bolt, E.; Gong, Q.; Fenning, H. M.; Komolafe, D. O.; Murden, R.; Omuku, N.; Rowe, C.; Sanhueza, C.; Steer, T.; Trupp, M. D.; White, N.; Wu, Y.
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ObjectiveThis study investigated how hospital murals influence the experiences of patients, healthcare staff, and visitors across four sites. BackgroundEvidence shows that visual art in healthcare settings can improve well-being but few studies focus specifically on murals or compare their effects across cultural contexts. The Hospital Murals Evaluation project addresses this gap through an investigation of murals in hospitals in Nigeria, Slovenia, the United Kingdom, and the United States. MethodsUsing a mixed methods cross-sectional design, the study integrated surveys, interviews, and participatory photography. A total of 525 unique responses were collected from 229 patients (131 adult, 98 pediatric), 245 staff, 49 visitors, and 2 undisclosed. ResultsInterviews across all three participant groups (n=115) revealed themes of positive affects, perception of care, as well as stress or indifference. Surveys (n=327) showed moderate positive correlations between mural viewing and positive emotions among patients, and between mural exposure and well-being, positive emotions, social connection, and workplace belonging among staff in the UK and USA, with null findings for staff in Nigeria and Slovenia. Participatory photography (n=83) illustrated how murals conveyed comfort, though abstract or poorly placed murals sometimes evoked discomfort. Meta-inferences across the methods indicate that viewing murals were associated with positive emotions for patients and did not induce negative emotions for staff or visitors. ConclusionMurals act as health-promoting infrastructure that can enhance well-being, foster positive experiences, and signal intentions of care. The findings highlight the need for culturally attuned designs to create healthcare environments that nurture well-being.
Smith, M.; Dixon, S.; Ziyenga, S.; Hirst, J. A.; Bankhead, C. R.; Nicholson, B. D.
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Hormone replacement therapy (HRT) with oestrogen and progestogen is a common medical treatment for alleviating symptoms of menopause. Since 2015, its use has been increasing in the UK. Unscheduled bleeding can be a symptom of endometrial cancer, and guidelines state that women experiencing this should have an urgent referral for suspected endometrial cancer. However, unscheduled bleeding is also common in women taking HRT, particularly in the first few months after starting HRT or if there is a change in regimen. Current guidelines may result in women on HRT receiving referrals that are not necessary and undergoing unpleasant and invasive tests such as hysteroscopy. However, there is a lack of current information to guide recommendations. This protocol describes a cohort study in the ORCHID-e database of anonymised patient records from English primary care. We will use a cohort of women aged over 40 years starting on HRT with oestrogen and progestogen, age matched to women who have not started HRT. Exposure will be a prescription for oestrogen containing HRT with no previous prescription for oestrogen containing HRT in the previous year. Index date in each matched set will be the date of this prescription. Prescriptions for progestogen containing drugs will not be used to define the exposure, but this information will be extracted to describe the study population and for sensitivity analyses. Outcomes will be consultations for unscheduled bleeding, urgent referrals for suspected endometrial cancer, and diagnosis of endometrial cancer. Women will be followed up until they change exposure status or are otherwise censored. Women who start taking HRT in follow-up will re-enter the cohort in the exposed group. We will describe proportions of women with a code for consulting with unscheduled bleeding, proportions of those women referred for further investigation on the pathway for suspected endometrial cancer, and proportions diagnosed with endometrial cancer within one year of referral. We will investigate the diagnostic accuracy of unscheduled bleeding for endometrial cancer separately for women on HRT and those not on HRT. Analyses will be done by 6-month categories of time since index, age, calendar year, sociodemographic variables, risk factors for endometrial cancer, type of HRT.
Lacomba-Arnau, E.; Da Rocha Oliveira, R.; Monteiro, S.; Pauly, C.; Vaillant, M.; Celebic, A.; Bulaev, D.; Fischer, A.; Fagherazzi, G.; Fernandez, G.; Shulz, M.; Perquin, M.
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Methods: DigiCog is a single-center cross-sectional study conducted within the Luxembourgish Predi-COVID cohort (NCT04380987). Participants aged 25-65 years, with and without persistent COVID-19 symptoms, are invited to participate. Cognitive assessments are performed during face-to-face sessions by trained nurses and neuropsychologists using both the VMTech device and standardized neuropsychological tests. Additional data on PCC symptom status, CR, sociodemographic characteristics, fatigue, and psychological factors are also collected. Agreement between digital and standard cognitive assessments will be evaluated using Cohen's kappa coefficient, with sensitivity, specificity, and receiver operating characteristic analyses as secondary measures. Cognitive performance will be compared between participants with and without PCC, and associations with CR proxies will be explored.