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 601 papers previously published here. The average preprint has a 0.79% match score for this journal, so anything above that is already an above-average fit.
Treleaven, E.; Chaudhary, I.; Dwan, M.; Ghimire, R.; Noppert, G. A.; Kubale, J.; Sharma, A.; Sharma, Y.; Hashikawa, A.; Axinn, W. G.; Ghimire, D. J.
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Abstract Introduction: Diarrheal diseases and acute respiratory infections (ARI) disproportionately affect young children and families facing disadvantages at the individual, household, and neighborhood level. This unequal burden especially impacts children in low-and middle-income countries, such as Nepal. Data limitations impede the ability to understand children's illness episodes and treatment trajectories across the course of early childhood and their relationship to household- and neighborhood-level social determinants of health. The Chitwan Valley Family Study (CVFS) is a 30-year panel study providing a wealth of information about household- and neighborhood-level social determinants in Southern Nepal. Drawing on a cohort of young children in CVFS households, this study will measure incidents of acute illness among children under five and leverage existing data from the panel study to understand how intergenerational disadvantages, place, and other social determinants affect the frequency and duration of childhood illness and subsequent healthcare utilization. Methods and Analysis: This study will use daily symptom diaries to track children's illness symptoms (diarrhea, fever, cough, runny nose, difficulty breathing or wheezing, fatigue, loss of appetite) over the course of a year. Mother respondents will complete a baseline interview, daily symptom diaries, and a weekly phone interview with a trained interviewer to describe the prior week's symptoms and, in the case of any symptoms, healthcare utilization, treatment, expenditures, and related information. All eligible children aged 3-59 months may participate in two waves of 52 weeks of data collection. We will measure the frequency and duration of diarrhea and ARI, healthcare utilization outcomes, socio-economic status, and distance to healthcare facilities, then merge these measures with prior CVFS data related to parents' childhood circumstances, health facility characteristics, and neighborhood characteristics. Ethics and Dissemination: We received IRB approval from the Nepal Health Research Council and the University of Michigan. Informed consent will be obtained from respondents for all aspects of data collection. Identifying information will be restricted to the data collection team in Nepal and stored separately from survey data. Interviewers will check that all children with danger signs identified according to WHO/UNICEF Integrated Management of Childhood Illness clinical guidelines have received adequate treatment; a study nurse will follow up and refer those who have not. We will disseminate study findings to respondents, local partners, and nationally in Nepal, as well as in academic journals and at conferences. Datasets will be available for public and restricted-use through the Data Sharing for Demographic Research program at the Inter-university Consortium for Political and Social Research at the University of Michigan.
Fabian-Therond, C.; Ahuja, S.; Papachristou Nadal, I.; Holt, R. I.; Watson, S. I.; Hussain, S.; Choudhary, P.; Ajjan, R.; Harris, R.; Peck, M.; Mohammadi, J.; Sims, S.; Fiorentino, F.; Due-Christensen, M.; Huber, J.; Fisher, L.; Hardenberg, K.; Stadler, M.; Jin, H.; Halliday, J. A.; Sturt, J.; on behalf of the D-stress study collaborators,
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Introduction Diabetes distress describes the psychological and emotional burden of living with diabetes and is associated with reduced self-management and adverse diabetes outcomes. Clinical guidelines recommend routine assessment and management of diabetes distress, but this is not always implemented. Therefore, there is a need to develop approaches to deliver emotional health support in routine clinical care more effectively. We describe here the protocol for a study to I) assess the feasibility of implementation of the D-stress Pathway, comprising Enhanced Usual Care (EUC) and an online, group-based, psychological diabetes distress reduction intervention called REDUCE, ii) evaluate the feasibility of the study protocol iii) detect an effect signal of diabetes distress score and Interstitial Glucose Time in Range and iv) refine initial programme theories of how both interventions (EUC and REDUCE) work, for whom, and under what circumstances. Methods This feasibility study includes a multicentre trial within a cohort design (TWICs) where sites have a staggered exposure to the interventions alongside a realist process evaluation. Four UK NHS diabetes services will recruit 80 adults with type 1 diabetes ([≥]1 year) using continuous glucose monitoring (CGM) ([≥]3 months). All participants will receive EUC and provide monthly data over 7 months on diabetes distress (measured by the Type 1 Diabetes Distress Assessment System (T1DDAS) and interstitial glucose measured by using continuous glucose monitoring. Participants with elevated diabetes distress, will be offered the six-week, group-based, online REDUCE intervention plus EUC, compared to EUC alone. Up to twenty participants with type 1 diabetes, ten family members/friends, sixteen healthcare professionals delivering EUC and five REDUCE facilitators will be interviewed to explore their experience of receiving training and delivering the D-stress Pathway. Up to 20 EUC consultations and REDUCE sessions will be observed. Analysis Feasibility will be assessed against pre-specified progression criteria and analysed descriptively using summary statistics. Primary outcomes include baseline level of diabetes distress, recruitment rate, intervention uptake, and data completeness, which will be analysed descriptively. Qualitative data will be analysed using framework analysis guided by realist programme theories developed for this study. Ethics Ethics approval has been granted by NHS Research Ethics Committee (REC) (Bromley REC: 25/LO/0469) and Health Research Authority obtained. All participants will provide informed consent. Trial registration no: Registered at ClinicalTrials.gov number NCT07193446 on 26/11/2025. Protocol and statistical analysis plan: The trial protocol and statistical analysis plan can be accessed at ClinicalTrials.gov.
Jaber, A.; Hughes, L.; Cameron, A. C.; Quinn, T. J.
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Background: Systematic reviews of clinical prediction models increasingly include studies using artificial intelligence (AI) and machine learning (ML) methods alongside traditional multivariable regression approaches. A previously published Excel tool enabled standardised data extraction using the CHARMS checklist and risk of bias assessment using PROBAST. The recent publication of the PROBAST+AI framework, which distinguishes the assessment of model development quality from the assessment of model evaluation risk of bias and assesses applicability in both parts, necessitates an updated digital instrument applicable across prediction modelling methods. Methods: We updated an open-access Excel tool to incorporate the full PROBAST+AI framework. The updated template incorporates structural separation between assessment of model development quality and model evaluation risk of bias, with applicability assessed in both parts. It also incorporates updated signalling questions, including those addressing methodological issues particularly relevant to AI/ML, and automates the generation of summary tables and graphical displays. Results: The updated tool (CHARMS & PROBAST+AI Template) contains 11 worksheets and supports data extraction and appraisal for up to 30 prediction models. Dedicated, linked worksheets enable separate assessment of model development and model evaluation, with Domain 4 distinguishing among Apparent, Internal, and External evaluation settings. Key updates include dedicated assessments for predictor pre-processing, class imbalance handling and recalibration, data leakage prevention, and replication of the full model development pipeline within resampling procedures. Automated sheets dynamically format tables and summary charts covering PROBAST+AI parts. Conclusions: The CHARMS & PROBAST+AI Excel template provides a standardised, user-friendly, and rigorous digital framework for systematic reviewers appraising traditional statistical and AI-driven clinical prediction models.
Hill, A.-M.; Morris, M. E.; Flicker, L.; Etherton-Beer, C.; Semciw, A.; McPhail, S. M.; Said, C. M.; Shorr, R. I.; Bulsara, C.; Harding, K.; Page, A. T.; Rasmussen, B.; Bulsara, M.; Heng, H.; Francis-Coad, J.; Mace, K.; Woltsche, R.; Hahn, K.-A.; Phan, U.; Watson, C.; Peterson, S.; Campbell, D.; Haines, T.
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Background Falls in hospitals are associated with injuries, deaths and poor patient outcomes. Although clinical guidelines recommend educating hospital patients about how to prevent falls, not all hospitals systematically deliver evidence-based patient falls education. The primary aim of this study is to implement and evaluate the effectiveness of delivering a research-informed education program called the Safe Recovery Program with ward support on rates of falls and falls-related injuries in hospitals. The secondary aims include measuring changes in patient and staff knowledge and awareness about falls prevention and identifying barriers and facilitators to staff and patients taking action to reduce hospital falls. Methods The trial will adhere to the Consolidated Standards of Reporting Trials guidelines. Twelve wards will be recruited from five Australian hospitals over a 65-week period. A stepped-wedge cluster randomised controlled trial design will be used with unidirectional crossover from control to experimental conditions together with randomisation of when each cluster makes the transition. The crossovers will occur at 12 timepoints, each five weeks apart. Alongside the trial, patients and staff on participating wards will be recruited for interviews and qualitative data analyses will be conducted to understand how to optimise implementation. The experimental condition involves usual care plus delivery of the Safe Recovery Program. For the Safe Recovery Program, supervised allied health assistants will deliver brief falls education programs to all suitable patients in designated wards, reinforced by all ward staff. Falls champions, who are registered nurses and allied health professionals, will provide Safe Recovery Program training for staff, using a train-the-trainer model. The ward staff will also be trained in how to support hospital patients to adopt safe behaviours. The primary outcome will be falls per 1000 patient bed days. The secondary outcomes will be: (i) injurious falls per 1000 patient bed days (ii) patient and staff changes in falls awareness, knowledge and motivation; and (iii) barriers and enablers to hospital staff engaging in behaviour change and program implementation. An economic evaluation will also be conducted to estimate the incremental cost effectiveness of implementing the Safe Recovery intervention. Ethics and Dissemination Ethics approvals have been obtained from The Royal Melbourne Hospital Human Research Ethics Committee (HREC/113864/MH-2024). The findings will be disseminated through peer-reviewed journals, workshops and conferences. Consumer team investigators will guide the communication of findings to the target audiences, including older patients, hospital staff, healthcare managers and policy makers. Trial Registration Number: ACTRN12624001469505
OLVG hospital, ; Hoonhout, O.
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Rationale: Dislocation is the leading reason for early revision surgery. To address the problem of dislocation, the dual-mobility (DM) cup was developed in France in the 1970s. This cup should provide more stability and biomechanically reduce the risk of dislocation. In the Netherlands, most DM cups are placed in specific patients, e.g. with cognitive impairment and for revisions due to recurrent dislocations. Despite the increased and, in some countries, broad use of DM cups, high quality evidence of their (cost)effectiveness is lacking. This study aims to perform a trial to fill this gap in knowledge. Much of the information needed to judge the effectiveness of DM cups is already incorporated in the Dutch Arthroplasty Register (LROI). This register lends itself perfectly for a nested RCT towards this aim. Objective: The primary objective is to investigate whether there is a difference in the number of hip dislocations following primary total hip arthroplasty (THA), using the posterolateral approach, with a DM cup compared to a unipolar cup in elderly patients 1 year after surgery. The secondary objectives are: to investigate whether there is a difference in the number of revisions; to investigate what the cost-effectiveness and cost-utility is of a DM cup compared to a unipolar cup at 1 year follow-up; to investigate whether there is a difference in the number of hip dislocations and revisions between a DM cup and a unipolar cup 2 years after surgery; to investigate whether there is a difference in patient reported outcomes between a DM cup compared to a unipolar cup 1 and 2 years after surgery; to compare the number of hip dislocations, revisions and PROM data between patients in the randomized DM group and patients in an observational cohort DM group. Finally, long-term survival of DM and unipolar cups will be evaluated based on revision and mortality data registered in the LROI. Study design: Prospective multi-center international wide within the European Union (EU), single blinded RCT, nested in the national registry. Study population: Patients [≥] 70 years old, undergoing an elective primary THA. Intervention (if applicable): The intervention group receives a THA with a dual mobility cup, the control group receives a THA with a unipolar cup. Main study parameters/endpoints: Primary: The number of dislocations. Secondary: costs, patient reported outcomes and implant survival.
Afifah, N.; Koesoemadinata, R. C.; Ardiansyah, E.; Wahyudi, K.; Lestari, B. W.; van Crevel, R.; Graham, S.; McAllister, S. M.; Sharples, K.; Hill, P. C.; Alisjahbana, B.
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Introduction: Most people with tuberculosis (TB) reside in countries with limited resources for prompt TB diagnosis, resulting in diagnosis and treatment delays and ongoing community transmission. Current TB diagnostics rely on sputum, while some people with presumptive TB cannot produce adequate sample. A new generation near-point-of-care (NPOC) tests using sputum or tongue swabs may provide more accessible TB diagnosis. Methods: In this pragmatic cluster randomised controlled trial (cRCT) in Indonesia, a multi-component public health intervention will include: (a) introduction of NPOC MiniDock MTB test (Guangzhou Pluslife Biotech, China) on sputum, tongue swab, or both specimens, (b) optimisation of clinical algorithms incorporating the new test, (c) a promotional package to encourage patient attendance and test utilisation, and (d) TB household contact investigation, including the new test, by community health volunteers. We will randomly stratify 40 community health centre (CHC) areas into intervention and control arms (1:1) in Bandung District. The intervention will be administered in healthcare facilities (HCFs) and in the community of the intervention areas. The control areas will continue standard of care with no intervention, except TB notification refresher training, which will be delivered in both areas before intervention roll-out. The primary outcome is the number of TB cases diagnosed and notified by HCFs per population attending them. It will be measured by abstracting data on TB case notification and the number of HCF attendees over 12 months following completion of the intervention roll-out, compared to 12 months preceding any trial activities. Discussion: This trial will evaluate the effect of an intervention package incorporating the first-in-class NPOC on TB diagnosis and notification. The trial results will inform policy to improve TB diagnostic efforts in Indonesia and other high burden TB countries. Trial Registration: ClinicalTrials.Gov, NCT07293455.
SHI, J.; Gu, Q.; Pan, J.; Yang, A.; Fan, M.
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To evaluate the cost-utility and 5-year budget impact of first-line olaparib plus abiraterone versus abiraterone alone for metastatic castration-resistant prostate cancer (mCRPC) in China after the eleventh round of volume-based procurement (VBP). The intention-to-treat (ITT) population was assigned primary decision-analytic weight; the prespecified BRCA1/2-mutated (BRCAm) subgroup was a supporting analysis.
Gerling, M.; Moro, C. F.; Limbecker, C.; Viljamaa, A.; Harrizi, S.; Hamidi, Y.; Hailer, A.-K.; Sterner, J.; Sparrelid, E.; Bozoky, L.; Tidholm Qvist, E.; Baumgartner, R.; Salmonson Schaad, M.; Bozoky, B.; Geyer, N.; Engstrand, J.
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Purpose The Karolinska Liver Metastases (KaroLiver) cohort was established to investigate associations between clinical characteristics and histopathological features in patients treated with curative intent for colorectal cancer liver metastases (CRLM). The cohort combines whole-slide digital histopathology images with detailed oncological, surgical, radiological and survival data, enabling comprehensive analyses of treatment trajectories, clinical outcomes and metastatic tumour biology. Participants KaroLiver is a retrospective observational cohort comprising all consecutive patients who received curative-intent, liver-directed treatment for CRLM at Karolinska University Hospital in Stockholm, Sweden. The hospital is the primary regional referral centre for HPB surgery, serving the population of approximately 2.5 million people in the Stockholm-Gotland healthcare region. Patient enrolment is continuously updated in accordance with amended ethical approvals and evolving scientific questions. The cohort currently comprises 811 patients who underwent 1204 liver interventions between February 2012 and January 2022. Detailed clinical, oncological, surgical, pathological, molecular, recurrence and survival data are collected. Findings to date Median overall survival (OS) in the current cohort is 51.0 months (95% CI 46.2-57.1 months), and median recurrence-free survival (RFS) is 10.4 months (95% CI 9.2-11.9 months). The five-year OS rate is 44.9% (95% CI 41.2-48.8%). Studies using the cohort have so far identified a liver injury-derived stromal capsule in a subset of metastases, associated with improved survival. The cohort has also enabled the identification of histopathological markers of tumour biology, sex-based differences in treatment and survival, and associations between post-hepatectomy liver failure and oncological outcomes. Future plans Current research priorities include advanced histology-based prognostic scoring, sex differences in recurrence and retreatment, tumour biology and outcomes in early-onset versus average-onset CRLM, as well as CT- and MRI-based radiomics, all integrated within KaroLiver's histopathological framework. Data sharing is supported, given that regulatory requirements are met. Retrospective accrual and outcome updates will continue for current and future studies, subject to the required approvals.
Reza, L.; Arbai, Z.; Ward, H.; Payne, L.; Kinross, J.; Patel, V.
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Background Virtual hospital (VH) pathways support early discharge through remote monitoring, but limited evidence has hindered implementation in colorectal surgery. This study aimed to define patient- and carer-relevant outcomes and experiences of VH following colorectal surgery. Methodology A patient and public involvement and engagement (PPIE) consultation was conducted with 8 participants (7 patients, 1 carer; 4 women, 4 men) who had experienced VH following bowel resection at a high-volume robotic unit. Purposive sampling ensured that 50% of participants had experienced readmission. The 90-minute session was delivered via Microsoft Teams. Data were analysed using reflexive thematic analysis. Results Seven themes were identified: readmission, remote monitoring, carer burden, recovery, equity, readiness for discharge, and information delivery. Patients supported early discharge when remote monitoring enabled timely detection of complications and readmission pathways were efficient. Readmission was not perceived as failure but as appropriate escalation. Dissatisfaction with readmission was related to delays in emergency care. Remote monitoring provided psychological safety, with patients feeling held at home. Carers assumed substantial, often unrecognised, quasi-clinical roles. Recovery was defined by return to function rather than length of stay. Equity concerns were evident, with VH favouring those with adequate support at home, digital literacy, and language proficiency. Discharge readiness was both clinical and psychological. Information delivery at discharge was often poorly retained and requires reinforcement preoperatively at every encounter with patients and carers. Conclusions VH pathways are acceptable and valued. Readmission is a marker of system responsiveness rather than failure of early discharge on VH. Psychological preparedness, carer support, and equitable access are critical to successful and scalable implementation of early discharge using a virtual hospital.
Essue, B.; Parida, S.; Saleh, M.; Habib, A. K.; Nayak, D.; Mutungi, K.; Midega, M.; Muriithi, L.; Arruda-Caycho, I.; Bernardini, L.; Kashyap, M.; Rodin, D.
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Background: Gaps in health financing drive delayed diagnosis, catastrophic health expenditure, treatment discontinuation, and excess mortality and morbidity in breast cancer, effects compounded by gender inequalities that shape household resource allocation, care-seeking behaviour, and spending decisions for conditions disproportionately affecting women. Despite this, the economic burden of breast cancer and the gender dynamics that mediate it remain poorly characterised in middle-income country settings. This study examines the economic burden of breast cancer in India and Kenya and assesses how gender inequalities shape treatment decision-making, health outcomes, and caregiving experiences. Methods: This will be a mixed-methods, longitudinal, prospective cohort study of newly diagnosed breast cancer patients, with a health economics and gender analysis. Participants will be surveyed twice, at baseline and 6-months post treatment commencement either in person or by phone. A sub-sample of participants and their caregivers will participate in semi-structured interviews to explore household economic consequences of treatment, treatment-seeking decisions, and the gendered dimensions of both. Quantitative data will be analysed using descriptive statistics and regression modelling to identify determinants of catastrophic health expenditure and economic burden. Thematic analysis will be conducted and triangulated with quantitative findings to provide a comprehensive account of financial and gendered impacts across both settings. Discussion: The study will generate comparative evidence on the economic burden of breast cancer across two developing health system contexts. Findings will inform priority setting and benefit package design by identifying the drivers of economic burden and treatment discontinuation in these contexts, and making visible the household and caregiving costs that financing policy rarely captures.
Song, K. R.; Nisar, I.; Lee, J.; Yang, L.; Kim, D. R.; Riskiana, A.; Telele, N. F.; Hotwani, A. F.; Ansari, N.; Nausheen, S.; Sheikh, L.; Chen, W.; Yu, X.; Wang, R.; Blunt, M.; Talaat, K. R.; Kmush, B.; Jehan, F.; Lynch, J. A.
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Introduction Hepatitis E virus (HEV) in pregnancy is associated with high maternal and perinatal morbidity and mortality. The safety and efficacy of the recombinant protein HEV vaccine (HEV239, Hecolin) have been established in non-pregnant adult populations but there is limited information among pregnant women. This trial has two co-primary objectives: 1) to assess pregnancy-related and/or serious safety events among pregnant women between 14 and 34 weeks of gestation receiving two Hecolin doses four weeks apart compared to placebo recipients, and 2) to determine immune non-inferiority of pregnant recipients of two Hecolin doses four weeks apart compared to non-pregnant women. Methods and Analysis This is a multi-site, randomized, observer-blinded, placebo-controlled vaccine safety and immunogenicity trial in pregnant women and non-pregnant women of reproductive age in Karachi, Pakistan. A total of 2,358 healthy women will be enrolled, including 2,208 pregnant women between 14 and 34 weeks of gestation, who will be randomized in a 1:1 ratio (stratified by gestational age, 14-27 and 28-34 weeks) to receive either Hecolin or a normal saline placebo in two doses administered 1 month apart during pregnancy and a third dose administered postpartum, approximately 5 months after the second dose. A third arm of 150 non-pregnant women aged 16-45 years will receive Hecolin on 0, 1, and 6 months. The co-primary outcomes will be (i) the proportion of pregnancy-related AESIs and SAEs in pregnant participants from the first dose until the end of study follow-up, compared with placebo, and (ii) the geometric mean concentration (GMC) of anti-HEV IgG at four weeks after the second dose, comparing pregnant vaccine recipients with non-pregnant vaccine recipients (non-inferiority margin of 0.67 for the GMC ratio). Immunogenicity will be evaluated in a pre-specified subset of 300 participants receiving Hecolin, including 150 pregnant participants and 150 non-pregnant participants. Secondary outcomes will include maternal, neonatal, and infant safety outcomes, as well as immunogenicity according to the number of Hecolin doses received and the trimester of vaccination. Ethics and Dissemination The trial was approved by the National Bioethics Committee (NBC) of Pakistan (Reference number: 4-87/NBC-910), the institutional Ethics Review Committee (ERC) of the Aga Khan University (Reference number: 8298), and the Institutional Review Board (IRB) of the International Vaccine Institute (IVI) (Reference number: 2022-007). All participants will provide written informed consent in accordance with Good Clinical Practice. The results will be submitted to World Health Organization (WHO) Strategic Advisory Group of Experts in Immunization (SAGE), and disseminated through conference presentations, and peer-reviewed publications.
Fisher, L.; Polwart, C.; Wood, C.; Goldacre, B.; Anderson, L.; Isherwood, J.; Hindocha, S.; MacKenna, B.; Speed, V.
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Background The number of novel cancer therapies approved for use in England by the National Institute for Health and Care Excellence is increasing. Monitoring the adoption of new therapies is important to assess equity of access and evaluate real-world prescribing practices. OpenPrescribing Hospitals has recently been launched to facilitate analysis of open secondary care medicines data in England. Using this platform, we set out to describe the use of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors, including the frequency of dose reductions, within National Health Service (NHS) hospitals in England between January 2019 and December 2024. Methods The monthly proportion of each CDK4/6 inhibitor relative to total CDK4/6 inhibitor use was calculated at hospital level. Regional variation was assessed across Cancer Alliances by comparing the proportions of each CDK4/6 inhibitor used within each alliance in 2021 and 2024. Use of lower strength palbociclib and abemaciclib was used as a proxy for dose reductions. Findings There was more than a 3-fold increase in the use of CDK4/6 inhibitors between 2019 and 2024. In 2019, 78.6%, 11.9% and 9.5% of CDK4/6 inhibitors used were palbociclib, abemaciclib and ribociclib, compared with 40.2%, 41.2% and 18.6% in 2024. There was variation in the relative percentage change in use of each agent by Cancer Alliance. Use of lower strengths was common for both palbociclib (60%) and abemaciclib (63%). Interpretation Changes in usage appeared responsive to publication of key evidence and regulatory milestones. There was a higher apparent frequency of dose reductions than reported in clinical trials. OpenPrescribing Hospitals is an accessible, publicly available tool for understanding uptake and use of medicines in NHS hospitals in England.
Bandara, W. S. K.; Galappatthy, P.; Samaranayake, N. R.; Ranaweera, D. -
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High-alert medications are a leading cause of preventable patient harm worldwide, but there was no any high alert medicine list or error prevention strategy for Sri Lankan hospitals. This study addresses that gap by using interviewer administered questionnaire [n=315], five stakeholder consultative meetings [n=62] including multidisciplinary clinicians to reach consensus, followed by interviewer administered questionnaire [n=45], semi-structured three focus group discussions [n=45] to explore implementation barriers. Our findings identified [n=100] medicines as high-alert for acute care settings, and [n=40] medicines for community settings. I believe this article will be of interest and benefit to the readers of your journal. I declare that this manuscript is original, has not been published before and is not currently being considered for publication elsewhere.No conflicts of interest exist. Ethical approval was obtained from the Ethics Review Committee of Faculty of Medicine, University of Colombo (Reference number: 18-008) and approval were renewed annually as required and Ethical Review Committees of National Hospital of Sri Lanka (Reference number: AAj/ETH/COM/2017) and Colombo South Teaching Hospital (Reference number: PL/MO/2018-2019).All approval covered the full data collection period. Permission to photograph hospital pharmacies were obtained from chief pharmacist of participating hospital and no patient-identifiable information is shown.Written informed consent was obtained from all participants. The high alert medicine lists for acute and community settings are provided as S1 and S2 appendices.As corresponding author, I confirm that the manuscript has been read and approved for submission by all the named authors.
Tawalbeh, R.; Ellis, J. L.; Ebersole, K. T.; Litwack, K.
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Abstract Introduction: Cardiac rehabilitation (CR) is key for secondary prevention; however, participation remains low due to persistent barriers. Identifying strategies used by high-performing programs may inform approaches to improve patient engagement and outcomes. Purpose: To identify strategies associated with improved participation and adherence in CR programs from the perspective of leaders in high-performing sites. Methods: Semi-structured interviews were conducted with 10 CR leaders from urban, suburban, and rural programs ranked in the top 10% on at least two objective performance measures (e.g., participation and adherence rates) but moderate or low on others. Data were analyzed using thematic analysis to identify strategies associated with high performance. Results: Programs with high participation and adherence rates consistently implemented proactive, patient-centered strategies to address barriers. Individualized care approaches tailored to language, culture, health literacy, and age were commonly used to improve engagement among Hispanic, Black, and older adult populations. High-performing programs addressed structural barriers such as insurance and transportation through flexible scheduling, community partnerships, and targeted outreach. Strong coordination with referring providers and effective transitions from inpatient to outpatient care were associated with higher enrollment and sustained participation. Additional strategies included staff development through ongoing education, use of digital tools for patient tracking, and implementation of virtual and hybrid CR models. Integration of psychological support further enhanced patient engagement. Conclusion: High-performing CR programs employ coordinated, patient-centered, and system-level strategies associated with improved participation and adherence. These findings provide actionable approaches to enhance accessibility and improve programs and patients outcomes in CR across diverse settings. Keywords: Cardiac rehabilitation; participation; adherence; health disparities; implementation strategies
Phiri, A.; Chinula, E.; Jangwa, C.; Khosa, E.; Tarimo, N.; Bickton, F. M.
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Frontline healthcare workers (HCWs) during the COVID-19 pandemic in Malawi included physiotherapists. This study explored the experiences of those physiotherapists to help prepare workforce support plans in the future in the advent of a new disease outbreak. This phenomenological qualitative study was conducted between 2 May and 15 June 2024 at two tertiary hospitals in Southern Malawi namely, Queen Elizabeth Central Hospital (QECH) and Zomba Central Hospital (ZCH). Participants were purposely sampled and included physiotherapists who had been involved in caring for patients with COVID-19 at the two hospitals. Data was collected from 11 participants (9 from QECH and 3 from ZCH) using physical in-depth interviews. The recorded interviews were transcribed verbatim and transcripts analyzed using a deductive thematic approach. Themes were broadly categorized into positive and negative experiences. Among positive experiences, participants reported that physiotherapy interventions facilitated quick recovery of patients. In some instances where oxygen cylinders were not enough or had run out of oxygen, physiotherapy interventions were lifesaving. Additionally, the COVID-19 pandemic raised awareness of physiotherapy's role in COVID-19 management and resulted in permanent employment for several physiotherapists. Under the theme of negative experiences, participants faced challenges with team recognition, communication, staff shortages, inadequate equipment, and no local physiotherapy guidelines. The findings suggest Malawis healthcare system needs better pandemic preparedness and stronger interdisciplinary care.
Rajasingam, S. L.; Macdonald, P.; Sethi, J.; Taylor-Gonzalez, A.; Hall, A.; Meyenburg, I. T.
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Background: Internationally, workforce planning models are focussed on balancing supply and demand, rarely addressing factors such as demographic shifts and evolving health needs. There is a clear imperative for improved workforce planning to ensure adequate staff numbers to deliver audiology safely and effectively but there is still no consensus on safe minimum staffing levels or the optimal skill mix for high-quality audiology services. Methods: This research aimed to establish markers of quality in audiology service provision and estimate the audiology workforce requirements to meet current and projected demand for services, based on population changes and anticipated changes in demand. Following stakeholder engagement, a needs-based model was developed by (1) analysing NHS England's national Audiology stocktake dataset to determine current workforce, (2) creating an epidemiological model to predict changes in service population over next 5 and 10 yrs (3) use of BAA endorsed estimates delivered in East of England on staff grade required per activity. [SR1.1] Results: The estimates for 10-year adult and paediatric audiology whole time equivalent (WTE) safe minimum staffing levels for England (bands 2-7, current waiting times maintained) based on a population change model (Model 1), and two further models for paediatrics specifically (Model 2 and Model 3) were as follows: for adult audiology Model 1 estimates a 7.40% increase by 2035 (to 1125.18 WTE). For paediatric audiology Model 1 estimates a -6.3% (to 593.47 WTE) decrease due to underlying paediatric population decline in England, whereas the case complexities considered in Model 2 (1072.33 WTE) and Model 3 estimate a 10-year increase of 71.23% ( to 1072.33 WTE) and 59.17% (to 996.82 WTE) respectively. Conclusions: This is the first study to conduct a needs-based assessment of workforce requirements for audiology services. Given the substantial need for audiology staff, investment in workforce recruitment and training is essential to ensure that future activity levels meet population needs. Consideration of changing demographics is required for planning future workforce specialisation. Further analysis to address workforce equity, the impact of changes in skill mix and service delivery models and local area demographics/prevalence variation is required alongside potential efficiencies.
Witham, M.; Evison, F.; Bellass, S.; Cooper, R.; Gallier, S.; Pretorius, S.; Sapey, E.; Suklan, J.; Sayer, A. A.
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Study Objective Little is known about where in hospital care for multiple long-term conditions (MLTC) is delivered. We aimed to describe pathways of care (ward transfers) and outcomes for people admitted to hospital for unscheduled care by MLTC status and other key sociodemographic characteristics. Design and setting Analysis of routinely-collected electronic health records from a large acute UK hospital. Participants Adult unscheduled care admissions from 1st July 2018 to 30th June 2019. The presence of two or more of 59 long-term conditions was ascertained using ICD-10 codes from previous hospital discharges. Main outcome measures Markov state transition probabilities were derived for ward moves and compared for MLTC vs no MLTC, age, sex, ethnicity and neighbourhood deprivation. Outcomes (length of stay, death, readmission, move from definitive ward) and time spent in emergency and assessment departments were compared between subgroups. Results A total of 33,252 adults, mean age 56.0 (SD 21.9) years were analysed; 14,834 (42.4%) had MLTC. People with MLTC were more likely to die in hospital (4.2 vs 1.9%, p<0.001), transfer to internal medicine wards or older peoples medicine wards, were less likely to transfer to surgical wards, had longer median length of stay (1.83 vs 0.69 days, p<0.001), stayed longer in acute medical units (15.5 vs 9.6 hours, p<0.001), and were more likely to move from their definitive ward (18.2 vs 16.4%, p=0.002). Conclusion Unscheduled hospital care pathways are complex and differ for people with MLTC, who have worse outcomes and may be less likely to receive optimal care.
Lenihan, S.; Barr, M.; Coates, K.; Kedroff, L.; Battle, C.; Sorice, V.; Faghy, M. A.; Edwards, J.; Papaioannou, D.; Young, T.; Rombach, I.; Carlton, E.; Goodacre, S.; Mani, N.
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Background: Pain management post-rib fractures is often difficult. High pain levels can lead to altered respiratory mechanics and delayed complications such as poor mobility. Whilst as-needed Opioids are the mainstay of treatment, the potential negative side effects have led to research into alternatives such as kinesiotaping, single-shot chest wall regional anaesthesia, and incentive spirometry. Methods: A systematic review was undertaken using Medline (Ovid), Emcare, CINAHL, and the Cochrane Library. Article review and selection were undertaken by two independent reviewers using Covidence. Quality was assessed through the Mixed Methods Appraisal Tool (MMAT). Where appropriate, meta-analysis was undertaken using R studio with a REML random effects model. Forest plots were completed, and Higgins I2 and Chi2 were calculated. Results: Kinesiotaping demonstrates a reduced pain score than medication alone (SMD: -1.87, 95% CI [-2.65, -1.08]), as did single-shot chest wall regional anaesthesia (SMD: -0.79 [-1.15, -0.01]). The regional anaesthesia group had lower opioid consumption (SMD -0.84 [-2.18, 0.50]) and reduced length of hospital stay (SMD: -0.18 [-0.39, 0.03]) but no change in the risk of complications (RR: 0.92 [0.36, 2.36]). The incentive spirometry group had an increased risk of complications (RR: 3.35 [0.68, 16.44]); however, the causative effect could not be inferred due to significant confounding variables. Conclusions: Low-to-moderate certainty evidence suggests that kinesiotaping and single-shot chest wall regional anaesthesia may reduce pain in adult emergency department patients with rib fractures. However, evidence is insufficient to show a clear benefit for opioid reduction, length of stay, or complications. The current evidence does not support routine use of incentive spirometry in this setting, but the evidence is severely confounded by baseline injury severity in the current published studies.
Corcoran, D.; Szoeke, C.; Apostolopoulos, V.; Feehan, J.
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This study aimed to quantify the longitudinal tracking and cross-sectional construct validity of a single-item questionnaire measuring recreational physical activity frequency (RPAF) in the Womens Healthy Ageing Project. At baseline, 474 participants aged 45-55 reported RPAF from 1993 to 2014. Longitudinal tracking of the RPAF item was assessed as a consecutive-wave and baseline-referenced measure using linear weighted kappa (LWK), Spearman correlations, exact agreement and within-one-category agreement. Construct validity in the form of convergent and known-group validity was assessed using the International Physical Activity Questionnaire (IPAQ) leisure activity domains, Short Form 36 physical function (SF-36-PF) subscale, Timed Up and Go (TUG), hand grip strength (HGS) and waist-to-height ratio (WHtR). 474 participants provided baseline RPAF data. Pairwise longitudinal samples ranged from 176 to 459 across the study. Consecutive-wave LWK ranged from 0.38 to 0.49, and Spearman correlations ranged from 0.44 to 0.57. Exact and within-category agreement ranged from 41.4%-50.8% and 72.0%-79.0%. Baseline-referenced LWK ranged from 0.22 to 0.47, with Spearman correlations of 0.29 to 0.56. RPAF correlated with total IPAQ leisure score (rs = 0.60), IPAQ walking score (rs = 0.58), SF-36-PF (rs = 0.33) and TUG score (rs = -0.25). No significant correlation was identified between RPAF, HGS or WhTR. RPAF discriminated known groups for WHO guideline-sufficient activity, SF-36-PF, and TUG fall risk. The RPAF item demonstrated fair-to-moderate agreement in consecutive waves, with weaker baseline-referenced tracking. Cross-sectional validity was highest with total IPAQ leisure activity. The item may provide a pragmatic measure for RPAF in womens cohort studies.
Sarkar, T.; Sultana, T.; Nimmy, S. J.; Islam, S.; Islam, M. A.; Jahan, F.; Khan, S. H.; Chowdhury, K. I. A.; Hossen, M. T.; Nayem, M. A.; Homaira, N.; Haque, F.; Naser, A. M.; Shahabuddin, A. S. M.; Hasan, S. M.; Russel, S.; Seale, H.; Qadri, F.; Satter, S. M.; Islam, S.
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Background: Human papillomavirus (HPV) is the leading cause of cervical cancer and the vaccine is the key preventive measure. In 2023, Bangladesh launched a school-based HPV vaccination campaign for girls aged 10-14 years. However, vaccine uptake among this group in urban settings remains suboptimal. This study explored adolescent girls (aged 10-14 years) understanding attitude, and motivation towards the vaccine, as well as the practical challenges impacting on vaccine uptake. Methods: From April to June 2024, a qualitative study was undertaken in two urban slums in Dhaka, Bangladesh. Through a combination of convenience and snowball sampling, we conducted 15 in-depth interviews and one focus group discussion using the World Health Organizations Behavioral and Social Drivers (BeSD) tool. Interviews were conducted in the native Bengali language, audio recorded, and transcribed verbatim. Framework analysis was performed to emerge key themes and generate study findings. Results: A total of 26 girls with a mean age of 12.65 (SD: 1.23) participated in the study. While some participants believed that the HPV vaccine could reduce the infection during menstruation or prevent childbirth-related complications, there was uncertainty regarding the appropriate age for vaccination. Concerns were raised about menstrual irregularities, infertility, and the potential negative impact on marital prospects. Students spoke about being subjected to inappropriate jokes from their male peers. Male guardians were identified as the key decision makers and were perceived to be against the need for this vaccine. Operational barriers including inaccessible digital registration, limited information about the vaccine, and lack of systematic follow-up constrained the participation in the school-based HPV campaign. Conclusions: Adolescents in urban slums faced multi-layered barriers, including knowledge gaps, cultural barriers, and accessibility challenges to HPV vaccination. Strengthening adolescent-friendly communication, engaging parents, teachers and male students, simplifying registration, adequate vaccine supply and ensuring supportive school-based vaccination processes are critical to improving equitable coverage and acceptance.