BMJ Open

IntroductionIn contrast to high-income countries, palliative care services are limited and largely undertaken by informal caregivers, often family members, in low- and lower-middle-income countries (LMICs). This review aims to explore the family caregiver experience in providing palliative care to adult cancer patients in LMICs. Methods and AnalysisThis qualitative systematic review will be conducted using a comprehensive search strategy on PubMed (MEDLINE), EMBASE, CINAHL, and PsycINFO without language or date restrictions. Open Universitys CORE database will be searched for grey literature. Review questions will follow the PICo framework (population, phenomena of interest, and contexts). Qualitative or mixed-method studies on the experience of family caregivers of adult cancer patients (above 18 years) receiving palliative care in LMICs will be included. Study quality will be assessed using the Joanna Briggs Institute (JBI) critical appraisal tools. Findings will be synthesized using meta-aggregation, or with a narrative synthesis if pooling is not feasible. Review process will follow the JBI methodology for systematic reviews of qualitative evidence and will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework. Ethics and DisseminationNo ethical approval is required as the study involves secondary data analysis of published literature. Ethical principles of accurate reporting and transparency will be upheld. Findings will be published in peer-reviewed open-access journals and presented at academic conferences. Recommendations will be shared with policymakers and healthcare organizations responsible for the provision of palliative care for cancer patients in LMICs. PROSPERO registration numberCRD420251010556 Article SummaryO_ST_ABSStrengths and Limitations of this studyC_ST_ABSO_LIFour databases, as well as grey literature, will be searched using the extensive search strategy by a multidisciplinary team with expertise in systematic reviews and cancer care in LMICs. C_LIO_LIA rigorous methodology will be adhered to throughout the study as per the JBI guidelines for qualitative systematic reviews. C_LIO_LIWhile language was not limited in the search, due to translation constraints, only selected non-English articles will be reviewed. This limitation may introduce language bias through the exclusion of some non-English qualitative study articles. C_LIO_LIDue to the limited number of qualitative studies on cancer palliative care in LMICs and possible low quality of available studies, the certainty of evidence generated through this systematic review may be limited. C_LI

IntroductionOne in five pregnant women have multiple long-term conditions in the United Kingdom (UK). Studies have shown that maternal multiple long-term conditions are associated with adverse outcomes. This observational study aims to compare maternal and childrens outcome for pregnant women with multiple long-term to those without multiple long-term conditions. Methods and analysisPregnant women aged 15 to 49 years old with a conception date between 2000 and 2019 in the UK will be included. The data source will be routine health records from all four UK nations (Clinical Practice Research Datalink [CPRD, England], Secure Anonymised Information Linkage [SAIL, Wales], Scotland routine health records and Northern Ireland Maternity System [NIMATS]), and the Born in Bradford prospective birth cohort. The exposure of two or more pre-existing, long-term physical or mental health conditions will be defined from a list of health conditions predetermined by women and clinicians. The association of maternal multiple long-term conditions with (i) antenatal, (ii) peripartum, (iii) postnatal and long-term, and (iv) mental health outcomes, for both women and their children will be examined. Outcomes of interest will be guided by a core outcome set. Comparisons will be made between pregnant women with and without multiple long-term conditions using logistic and Cox regression. Generalised estimating equation will account for the clustering effect of women who had more than one pregnancy episode. Where appropriate, multiple imputation with chained equation will be used for missing data. Federated analysis will be conducted for each dataset and results will be pooled using meta-analysis. Ethics and disseminationApproval has been obtained from the respective data sources in each UK nation: CPRD: Independent Scientific Advisory Committee (reference: 20_181R); SAIL: Information Governance Review Panel; Scotland: National Health Service Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP), The University Teaching and Research Ethics Committee (UTREC) from the University of St Andrews; NIMATS: Honest Broker Service Governance Board; Born in Bradford: Bradford National Health Service Research Ethics Committee (ref 07/H1302/112). Study findings will be submitted for publications in peer reviewed journals and presented at key conferences for health and social care professionals involved in the care of pregnant women with multiple long-term conditions and their children. ARTICLE SUMMARYO_ST_ABSStrengths and limitations of this studyC_ST_ABSO_LIThe study will utilise rich data sources from routine health records from all four UK nations and a birth cohort. C_LIO_LIBeyond examining maternal outcomes, linked mother baby data and the birth cohort data will allow for the exploration of childrens outcomes. C_LIO_LIKey limitations include missing data, misclassification bias due to inaccurate clinical coding and residual confounding. C_LI

BackgroundEmpathy appears to decline throughout medical school and is highly variable among qualified healthcare practitioners. To address these problems, the Leicester Medical School has designed an enhanced empathy curriculum that runs throughout all five years of medical school. The impact of this curriculum must be measured. ObjectiveTo evaluate the impact of the enhanced empathy curriculum using qualitative and quantitative data. Study designProspective longitudinal study SettingLeicester medical school ParticipantsAll students (from year one to five) at the Leicester Medical School will be eligible for participation. There are currently approximately 300 students in each of the five years of medical school and we anticipate that we will recruit approximately 100 medical students per medical school year for the quantitative data (total of 500 students) and approximately 10 students per medical school year for the qualitative data (total of 50 students). Data collectionWe will annually collect the following data for a period of seven years to ensure a comprehensive dataset for three full cohorts of medical students. The main reason for selecting the seven-year timeframe is that the empathy curriculum recently started in medical school (2022-2023 academic year), and it takes a few years for it to stabilise and yield meaningful results. O_LIStudent empathy levels (for example, using the student version of the self-reported Jefferson Scale for Empathy (JSE-S) and the observer-reported Consultation and Relational Empathy (CARE) measure). C_LIO_LISatisfaction with the empathy curriculum (using routinely collected student survey data). C_LIO_LISatisfaction with the overall medical school curriculum (using routinely collected student survey data). C_LIO_LIStudent experiences of the empathy curriculum (using qualitative student interviews with a purposive sample of five to 10 medical students from each year). C_LIO_LIStudent well-being data (for example, the frequency and severity of well-being issues). C_LI Reporting elementsWe will report on: O_LINumber of individuals at each stage of the study. C_LIO_LIDescriptive data that includes (student characteristics and potential confounders). C_LIO_LIOutcome data (empathy levels, student satisfaction with curriculum, student experience). We will also report on the relationships between these data (for example between empathy levels and student satisfaction with curriculum). C_LI DisseminationFindings will be disseminated through international conferences, news and peer-reviewed journals. FundingThis study is funded by the Stoneygate Trust. The funder had no role in any part of the development or writing of this paper. EthicsThe project and associated documents were approved by the University of Leicester Research Ethics Board (Ethical approval number: 42404-lk252-ls:medicine).

IntroductionThere have been longstanding concerns regarding an increased risk of suicide amongst healthcare workers. The Covid-19 pandemic has placed an additional burden on staff, yet few studies have investigated the impact of the pandemic on their risk of suicide and self-harm. We aimed to investigate the cumulative incidence, prevalence, and correlates of suicidal ideation, suicide attempts, and non-suicidal self-injury amongst healthcare workers during the Covid-19 pandemic. Methods and AnalysisNHS Check is an online survey that was distributed to all staff (clinical and non-clinical), students, and volunteers in 18 NHS Trusts across England during the Covid-19 pandemic. Data collected in wave 1 (collected between April 2020 and January 2021) and wave 2 (collected 6 months after wave 1) will be analysed. The full cohort of wave 1 participants will be weighted to represent the age, sex, ethnicity, and roles profile of the workforce at each Trust, and the weighted prevalence and cumulative incidence of suicidal ideation, suicide attempts, and non-suicidal self-injury will be described. Two-level random effects logistic regression models will be used to investigate the relationship between suicidal behaviour and self-harm, and demographic characteristics (age, sex, ethnicity) and workplace factors (concerns regarding access to personal protective equipment, re-deployment status, moral injury, confidence around raising and the management of safety concerns, support by supervisors or managers, satisfaction with standard of care provided). Results will be stratified by role (clinical/non-clinical). Changes in this protocol compared with the original versionO_LIAll variables describing workplace factors will be analysed as binary variables for consistency. C_LIO_LIThe responses to two questions on raising, and the management of, safety concerns will be analysed separately rather than combined to minimise loss of information. C_LIO_LIBinary suicide-related outcomes will be used in the logistic regression analyses, where the presence of an outcome represents its occurrence within the previous one (wave 2) or two months (wave 1), specifically. This was previously not specified. C_LI

IntroductionHealth Advocacy (HA) is acknowledged as a core competence in medical education. However, varying and sometimes conflicting conceptualizations of HA exists, making it challenging to integrate the competence consistently. While this diversity highlight the need for a deeper understanding of HA conceptualizations, a comprehensive analysis across the continuum of medical education is absent in the literature. This protocol has been developed to clarify the conceptual dimensions of the HA competence in literature as applied to medical education. Methods and analysisThe review will be conducted in line with the JBI methodology for scoping reviews. A comprehensive literature search was developed and already carried out in eight academic databases and Google Scholar, without restrictions on publication date, geography or language. Articles that describe the HA role among students and physicians that receive or provide medical education will be eligible for inclusion. Two independent reviewers will independently complete title and abstract screening, prior to full-text review of selected articles and data extraction on the final set. A descriptive-analytical approach will be applied for summarizing the data. Ethics and disseminationThis scoping review does not involve human participants, as all evidence is sourced from publicly available databases. Therefore, ethical approval is not required for this study. The findings from this scoping review will be disseminated through submission to a high-quality peer-reviewed journal and presented at academic conferences. By clarifying the conceptualizations of HA, this review aims to contribute to a shared narrative that will strengthen the foundation for integrating the HA role into medical education. Trial registration numberA preliminary version of this protocol was registered on the Open Science Framework (OSF) on 9 December 2024, and can be accessed at the following link: osf.io/6f94y. Article Summary Strengths and limitations of this study{Rightarrow} This review will maintain consistency and meet the quality standards established by other scoping reviews by adhering to the JBI methodology for scoping reviews and following to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension checklist specifically designed for scoping reviews (PRISMA-ScR). {Rightarrow}Two independent reviewers will conduct the title and abstract screening, full text screening and data extraction, including pilot exercises, to enhance the systematic rigor of the screening process and increase the reliability of the results. {Rightarrow}The search strategy is systematically developed in collaboration with a medical librarian, who also serves as a co-author on this project. {Rightarrow}This review ensures inclusivity by avoiding language restrictions, designing data visualizations for colorblind readers, and committing to open-access resources to align with FAIR (findable, accessible, interoperable and reusable) principles. {Rightarrow}This review aims to pave the way toward a shared understanding of the health advocacy competence in medical education. However, while it contributes valuable insights to the discourse, it does not possess the capacity to inform policy or practice changes in the field.

Risks for digital exclusion include older age, disability, and deprivation. No literature exists examining frailty as an additional possible risk factor. Many studies have shown frailty to be a more accurate predictor of adverse outcome in healthcare than age alone. Understanding risk factors for digital exclusion may help healthcare services appropriately tailor interventions. The Healthier Together integrated care system (HTICS) in Bristol is developing video consultations for clinics. The aim of this prospective observational cross-sectional study is to identify whether living with frailty is a risk factor of digital exclusion from video consultation. Data will be collected using a structured survey including patients from three sites across the Heal secondary care services at North Bristol Trust, and then two subsequent sites will be included across HTICS. Data will be collected on known risk factors for digital exclusion, frailty using the Clinical Frailty Scale, and will cover four domains for digital exclusion as defined by NHS Digital: access, skill, motivation, and confidence. Data will be presented with descriptive statistics. The association between frailty and outcomes will be analysed with a multivariable logistic regression. Key Study Contacts O_TBL View this table: org.highwire.dtl.DTLVardef@14fdb5org.highwire.dtl.DTLVardef@1c8373org.highwire.dtl.DTLVardef@1fa2036org.highwire.dtl.DTLVardef@58d5f0org.highwire.dtl.DTLVardef@4582d1_HPS_FORMAT_FIGEXP M_TBL C_TBL Study Summary O_TBL View this table: org.highwire.dtl.DTLVardef@18f811forg.highwire.dtl.DTLVardef@665478org.highwire.dtl.DTLVardef@339489org.highwire.dtl.DTLVardef@5cdca2org.highwire.dtl.DTLVardef@99494f_HPS_FORMAT_FIGEXP M_TBL C_TBL Funding and Support in Kind O_TBL View this table: org.highwire.dtl.DTLVardef@19c1314org.highwire.dtl.DTLVardef@1a8bf4aorg.highwire.dtl.DTLVardef@1a6cc8borg.highwire.dtl.DTLVardef@1bed21dorg.highwire.dtl.DTLVardef@d4a73b_HPS_FORMAT_FIGEXP M_TBL C_TBL Role of Study Sponsor and FunderThe pilot at North Bristol Trust (NBT) is overseen by Neuromusculoskeletal (NMSK) Division governance. NBT NMSK Division takes responsibility for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting. Governance oversight for Hospital at Home was registered with NBT NMSK, and for primary care with Horfield Health Centre. Roles and ResponsibilitiesO_ST_ABSStudy Flow ChartC_ST_ABS O_TBL View this table: org.highwire.dtl.DTLVardef@12f400corg.highwire.dtl.DTLVardef@1160de1org.highwire.dtl.DTLVardef@e95a6borg.highwire.dtl.DTLVardef@2f349aorg.highwire.dtl.DTLVardef@126928f_HPS_FORMAT_FIGEXP M_TBL C_TBL

BackgroundAmong doctors in the United Kingdom, there is growing sentiment regarding delaying specialist training, emigrating to practice medicine abroad, or leaving the profession altogether. This may have significant implications for the future of the profession in the UK. The extent to which this sentiment is also present in the medical student population is unknown. MethodsThe AIMS study is a national, multi-institution, cross-sectional study of all medical students at all medical schools in the United Kingdom. It will be administered via an online questionnaire and disseminated through a collaborative network recruited for this purpose. Our primary outcome is to determine current medical students career intentions after graduation and upon completing the Foundation Programme, and to establish the motivations behind these intentions. Secondary outcomes include determining which, if any, demographic factors alter the propensity to pursue different career paths available to a medical graduate, determining which specialties medical students plan on pursuing and understanding current views on the prospect of working in the National Health Service (NHS). Both quantitative analysis and thematic analysis will be used. DiscussionDoctors career satisfaction within the NHS is a well-researched topic, however, there is a shortage of high-powered studies able to offer insight into medical students outlook on their future careers. It is anticipated that the results from this study will bring clarity to this issue. Identified areas of improvement in medical training or within the NHS could be targeted to improve doctors working conditions and help retain medical graduates. Results may also aid future workforce planning efforts. Trial RegistrationNot Applicable.

IntroductionThe NHS cervical screening programme (NHSCSP) currently involves a healthcare professional collecting a cervical sample in a healthcare setting. This method of screening has barriers associated with access to screening appointments, and the poor acceptability of the speculum examination. Primary screening through HPV testing has led to the development of self-sampling screening methods including vaginal and urine self-sampling, with many UK studies comparing these screening methods with the current NHSCSP. It is not known what features of self-sampling influence individuals preferences and cervical screening uptake. To understand these preferences, we plan to undertake a discrete choice experiment (DCE). This protocol aims to describe the steps taken to design the DCE and the proposed approach to fielding the DCE to identify preferences for different sampling approaches in cervical screening. Methods and analysisAn online survey comprising a DCE was designed to understand preferences of individuals for self-sampling methods within the NHSCSP. Attributes and levels for the DCE were generated through an iterative process including a literature review of qualitative studies about self-sampling cervical screening methods, input from cervical screening clinical experts and a patient and public involvement group (n=6). A D-efficient design was used to create choice sets for the DCE survey. Regression based analysis will be used to estimate the impact of each attribute and level on individual choices. Ethics and disseminationThis study has been approved by The University of Manchester Proportionate Research Ethics Committee (2024-20767-37669). The results of the DCE will be submitted for publication in a relevant peer review journal and the results will be presented at national and international conferences. STRENGTHS AND LIMITATIONS OF THIS STUDYO_LITo our knowledge, this study will be the first to quantify stated preferences for self-sampling methods within a CSP focusing on all individuals who are eligible for screening in the UK. C_LIO_LIThe attributes and levels will be selected based on previous qualitative work as well as from multiple discussions with relevant stakeholders, including clinicians and public contributors. C_LIO_LIThe results will contribute towards understanding what aspects of self-sampling methods within a CSP are important for the target population. C_LIO_LISince the survey will only be available online, there is a potential to miss individuals without technological access and literacy. C_LI

IntroductionIn 2020, the UK government established a large-scale testing programme to rapidly identify individuals in England who were infected with SARS-CoV-2 and had COVID-19. This comprised part of the UK governments COVID-19 response strategy, to protect those at risk of severe COVID-19 disease and death and to reduce the burden on the health system. To assess the success of this approach, the UK Health Security Agency (UKHSA) commissioned an independent evaluation of the activities delivered by the National Health System (NHS) testing programme in England. The primary purpose of this evaluation will be to capture key learnings from the rollout of testing to different target populations via various testing services between October 2020 and March 2022 and to use these insights to formulate recommendations for future pandemic preparedness strategy. In this protocol, we detail the rationale, approach and study design. Methods and analysisThe proposed study involves a stepwise mixed-methods approach, aligned with established methods for the evaluation of complex interventions in health, to retrospectively assess the combined impact of key asymptomatic and symptomatic testing services nationally. The research team will first develop a Theory of Change, formulated in collaboration with testing service stakeholders, to understand the causal pathways and intended and unintended outcomes of each testing service and explore contextual impacts on each testing services intended outcomes. Insights gained will help identify indicators to evaluate how the combined aims of the testing programme were achieved, using a mixed methods approach. Ethics and disseminationThe study protocol was granted ethics approval by the UKHSA Research Ethics and Governance Group (reference NR0347). All relevant ethics guidelines will be followed throughout. Findings arising from this evaluation will be used to inform lessons learnt and recommendations for UKHSA on appropriate pandemic preparedness testing programme designs; findings will also be disseminated in peer-reviewed journals and at academic conferences. This will be the first evaluation to produce a portfolio of evidence in relation to the testing effectiveness and public health impact of the national testing programme in England, encompassing behavioural, economic, equity and public health impacts. These findings will strengthen the evidence base with regards to the effectiveness of COVID-19 testing and identify which aspects are necessary to prioritise in mitigating future pandemic threats when deploying a complex public health intervention such as testing. Transparency declarationThe lead author (the manuscripts guarantor) affirms that the manuscript is an honest, accurate and transparent account of the study being reported; no important aspects of the study have been omitted, and any discrepancies from the study as planned have been explained. Strengths and limitations of this protocolO_LIStrengths of this mixed methods evaluation protocol include the use of theory-based, complex evaluation approaches and an iterative and participatory approach with the stakeholder (UKHSA) to the evaluation process. C_LIO_LIGiven the scale and complexity of the COVID-19 testing response in England, there is a scarcity of previous relevant research, either in England or appropriate international comparators, warranting the mixed methods evaluation approach we will employ. C_LIO_LITo the best of the authors knowledge, this is the first national-scale evaluation of the COVID-19 testing programme in England to incorporate the broadest scope of testing services, a programme that formed an integral part of the UK pandemic response strategy. The approach proposed could be applied to the evaluation of pandemic responses in other contexts or to other types of interventions. C_LIO_LIWhereas most complex interventions are ideally accompanied by a prospective evaluation design initiated at the time of the intervention or earlier, this study will predominantly comprise a retrospective evaluation and is therefore limited by the quality of existing research and the data available to the research team at the time of conducting the evaluation, within the specified eight-month period allocated by UKHSA. As the UK government is in the process of consolidating data and policy related to the COVID-19 pandemic and subject to an independent inquiry, certain datasets may not be available to the researchers at the time of conducting the evaluation. C_LIO_LIThe scope of testing services to be evaluated and the selection of methods has been guided by the study sponsor team within UKHSA and must be achievable within the timeframe of the funding allocated to the study (eight months). Therefore, some trade-offs had to be made in terms of selecting research methods that would be feasible within this time constraint. For future evaluations, a mixed methods approach could be complemented by qualitative interviews with members of the public to gauge their experiences of testing and test-related behaviours, as well as an evaluation of other testing services that were out of scope for this research, including in prisons, the private sector and the events testing programme. C_LI

IntroductionSmoking is one of the lifestyle choices associated with an increased risk of chronic health conditions and poorer COVID-19 outcomes. Because it is known that the lungs recover after quitting smoking, a direct comparison of the severity of COVID-19 infection in current and former smokers needs to be investigated. Methods and analysisThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) 2015 Checklist was used. Non-randomized studies will be searched in PubMed, Cochrane CENTRAL library, Embase, and Epistemonikos from December 2019 to the present. Hand-searching of grey literature, key journals, and reference lists will be conducted This review will include studies of current and former smokers, with the main outcome being ICU admission, assisted respiration, or death. Two independent reviewers will select primary studies and abstract data from them. The Newcastle-Ottawa checklist will be used to assess the risk of bias, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework will be used to assess the quality of cumulative evidence. RevMan 5.4 will be used for data analysis. The I2 statistic will be used to evaluate heterogeneity. For similar studies, the fixed-effect method of a meta-analysis will be used; otherwise, a random-effect model will be used. The qualitative synthesis will be used for studies that are ineligible for the quantitative approach. Ethical consideration and disseminationBecause published data will be reviewed, no ethical approval is required. Our findings will be presented at national and/or international conferences, and they will be published in a peer-reviewed journal. PROSPERO registration number CRD42022368552 ARTICLE SUMMARY Strengths and limitations of this studyO_LIThis is a focused research question comparing the current and ex-smokers risk of contracting the severe form of COVID-19. C_LIO_LIThis systematic review and meta-analysis will provide evidence of the dangers of smoking during the COVID-19 pandemic. C_LIO_LIThe PRISMA-P reporting guidelines were strictly followed while writing this protocol. C_LIO_LIStudy selection will be carried out by two independent reviewers and a third person will intervene if a disagreement arises. C_LIO_LIA potential limitation is that an observational study design will be used in this systematic review. C_LI

A protocol for a retrospective cohort study and interrupted time series analysis to investigate the effect of successive COVID related "lockdown" restrictions on major trauma presentations and patient outcomes in English hospitals. The study specifically aims to assess: 1) The impact of successive "lockdowns" on the volume, demographics, injury mechanism, severity, treatment and outcomes of major trauma in England. 2) If the implementation of "lockdowns" affected major trauma related mortality. A patient cohort will be derived from the Trauma and Audit Research Network (TARN) database, for all trauma receiving hospitals in England, between 1st of January 2017 to 1st of September 2021. This period encompasses two national "lockdown" periods (23rd March 2020 to 29th June 2020 and 2nd Nov 2020 to 16th May 2021) in England. A time series will be used to illustrate changes in the volume and mechanism of injury associated with successive "lockdowns". Demographic characteristics and features of the clinical care pathways will be compared during the "lockdown" and equivalent pre-COVID periods. To specifically assess if there were any changes in risk adjusted mortality associated with the "lockdowns" interrupted time series analysis will be conducted.

BackgroundNew HIV diagnoses are increasing among women aged 40-65 years in England. HIV Pre-Exposure Prophylaxis (PrEP), the use of antiretrovirals for HIV prevention, is an effective chemoprophylactic strategy, as part of a comprehensive prevention package, for HIV. Granular data on knowledge about, and access to HIV PrEP for women aged 40-65 years, is lacking. This project will be a secondary analysis of a survey of adults in Brighton and Hove, England. It aims to investigate the sociodemographic and sexual behaviour factors that are associated with HIV PrEP awareness and HIV PrEP use in women aged 40-65 years in Brighton and Hove. Methods Health Counts 2024, a cross-sectional, self-completion health-related survey was conducted in Brighton and Hove in March 2024. The primary outcomes will be HIV PrEP awareness and HIV PrEP use among women aged 40-65 years in Brighton and Hove and will be analysed using descriptive statistics appropriate to distribution. The secondary outcomes will be to determine whether there are associations between sexual behaviours and/or sociodemographic factors and HIV PrEP awareness and HIV PrEP use for women aged 40-65 years in Brighton and Hove. These will be analysed using descriptive statistics and multifactorial logistic regression models from which odds ratios and 95% confidence intervals will be reported. Ethics and disseminationEthical approval for the Health Counts survey was obtained from the NHS Health Research Authority (HRA: Ref: 23/LO/0825) and the London - Bromley Research Ethics Committee (Ref: 23/LO/0825). Ethical approval for the community enrolment and supported completion pathway was granted by the University of Brighton Cross-School Research Ethics Committee C (2023-12553). Findings from this analysis will be disseminated to stakeholders via a scheduled public engagement event ( Valuing the voices of women in coastal communities), presentations at conferences and in peer-reviewed journals. Strengths and limitations of this analysisO_LIWe will be the first to examine HIV PrEP awareness and HIV PrEP use, and sociodemographic and sexual behavioural correlates among women aged 40-65 years in the UK. C_LIO_LI Health Counts 2024 was extensively developed, piloted, and tested to ensure accessibility and therefore representativeness of results. C_LIO_LILack of HIV PrEP awareness and HIV PreP use among women may limit statistical analysis. C_LIO_LICultural sensitivity and stigma around sexual health behaviour may limit response rates on relevant questions and therefore may limit statistical analysis. C_LIO_LIGeneralisability of the findings may be limited due to known regional differences in population awareness of HIV PrEP. C_LI

IntroductionIn sub-Saharan Africa, most people pay for healthcare directly out-of-pocket (OOP). This makes it harder for countries in the region to achieve Universal Health Coverage (UHC), as many people cant afford care, resulting in poor health, and some people being pushed deeper into poverty due to the high cost of care. To reduce this burden and move closer to UHC, many African countries have introduced health insurance to raise funds for healthcare and reduce direct OOP spending. To make the health insurance more effective, its important to understand how willing people are to pay for health insurance, how much can be raised relative to GDP, and what factors influence their willingness to pay (WTP). This information can help shape health financing policies in the region. Methods and AnalysisA systematic search will be conducted using PubMed, Google Scholar, Science Direct, relevant references from selected studies and grey literature that would be identified from the databases searched. The search will cover all available studies that focus on WTP for health insurance in sub-Saharan Africa from inception to 31st May 2025. Key outcomes will include the percentage of people willing to pay, amount to be raised relative to GDP per capita, and the factors that frequently influence WTP. Each study will be carefully reviewed using the STROBE (strengthening the reporting of observational studies in Epidemiology) tool for quality, and the results will be combined and analysed using quantitative methods. Ethics and DisseminationSince this is a systematic review that does not involve recruiting or studying people directly, ethics approval is not required. The findings will be disseminated through conferences, symposia, and published in a peer-reviewed journal. They will also be shared with policymakers and the general public interested in health financing. PROSPERO registration numberCRD420251027763 STRENGTHS AND LIMITATIONS OF THIS STUDYO_LIFollows a structured and transparent systematic review methodology. C_LIO_LIUses STROBE tool for critical appraisal of included studies. C_LIO_LIIncludes standardization of amounts to be raised across countries using GDP per capita. C_LIO_LIEmploys vote-counting to identify influencing factors. C_LIO_LILimited to studies conducted in Sub-Saharan African countries published in English C_LI

PurposeThe Mother and Child Covid-19 study is a cohort recruiting pregnant women and their children in Cantabria, North of Spain, during COVID-19 pandemic in order to ascertain Consequences of SARS-CoV-2 infection on pregnant women and their descendants. This article reports the cohort profile and preliminary results as recruitment is still open. ParticipantsThree sub-cohorts can be identified at recruitment. Sub-cohort 1 includes women giving birth between 23rd March and 25th May 2020; they have been retrospectively recruited and could have been exposed to COVID-19 only in their third trimester of pregnancy. Sub-cohort 2 includes women giving birth from 26th May 2020 on; they are being prospectively recruited and could have been exposed to COVID-19 in both their second and third trimesters of pregnancy. Sub-cohort 3 includes women in their 12th week of pregnancy prospectively recruited from 26th May 2020 on; they could have been exposed to COVID-19 anytime in their pregnancy. All women are being tested for SARS-CoV-2 infection using both RT-PCR for RNA detection and ELISA for anti-SARS-CoV-2 antibodies. All neonates are being tested for antibodies using immunochemoluminiscency tests; if the mother is tested positive for SARS-CoV-2 RNA, a naso-pharyngeal swab is also obtained from the child for RT-PCR analysis. Findings to dateAs of 22nd October, 1167 women have been recruited (266, 354 and 547 for sub-cohorts 1, 2 and 3, respectively). Fourteen women tested positive to SARS-CoV-2 RNA by the day of delivery. All fourteen children born from these women tested negative for SARS-CoV-2 RNA. Future plansChildren from women included in sub-cohort 3 are expected to be recruited by the end of 2020. Children will be followed-up for one year in order to ascertain the effect that COVID-19 on their development. ARTICLE SUMMARYStrengths and limitations StrengthsO_LIThis cohort would ascertain the effect of COVID-19 in both mother and children whatever the trimester of the infection. C_LIO_LIIt would also compare health care provided to pregnant women during the COVID-19 pandemic with that provided in the same hospital before the emergence of COVID-19. C_LIO_LIThe cohort is recruited in Spain, one of the developed countries earlier and more affected by COVID-19. C_LI LimitationsO_LIThe study could be underpowered according to the prevalence reported in a Spanish national study. C_LIO_LIInformation regarding exposure to people infected by SARS-CoV-2 or risk activities is self-reported. C_LI

Introductionthe COVID-19 pandemic amplified the need for robust multi-sectoral coordination; yet the specific mechanisms, benefits, and challenges of such collaboration particularly in low-and middle-income countries (LMICs) remain poorly synthesised. ObjectiveTo identify the key elements, benefits, challenges, and improvement strategies of multi-sectoral coordination during COVID-19, with comparative insight between LMICs and high-income countries (HICs). Eligibility criteriaEmpirical studies (qualitative, quantitative, or mixed-methods) published in English between 1 January 2020 and 15 August 2024 that examine any coordination mechanism (e.g., task forces, public-private partnerships, inter-agency committees) related to COVID-19 response. Information sourcesPubMed, EBSCOhost, Emerald Insight, Google Scholar, and targeted grey-literature repositories will be searched; reference lists and citation chaining will supplement database queries. Risk-of-bias assessmentTwo reviewers will independently appraise qualitative studies with CASP and non-randomised quantitative studies with ROBINS-I; disagreements will be resolved by consensus or third-reviewer adjudication. Data synthesisOwing to the anticipated dominance of qualitative evidence, a CFIR-anchored framework synthesis will be conducted. Quantitative findings will be narratively summarised and, where outcomes are commensurate, explored for fixed-effect pooling. Subgroup analyses will contrast LMIC versus HIC contexts; sensitivity analyses will exclude studies at serious/critical risk of bias. Confidence in cumulative evidence will be graded with CERQual (qualitative) and GRADE (quantitative). Ethics and disseminationNo new human data will be collected; therefore additional REC approval is unnecessary. The overarching PhD project holds approvals from the University of KwaZulu-Natal (BREC/00007520/2024) and Kenyas NACOSTI (NACOSTI/P/24/37716). Results will be disseminated via open-access publication, conference presentation, and policy briefs to Nairobi County health stakeholders. Strengths and Limitations of This StudyO_LIComprehensive multi-database and gray-literature searching will minimise retrieval bias C_LIO_LITwo reviewers will independently screen, extract and appraise studies, enhancing methodological rigour. C_LIO_LIFramework synthesis mapped to the consolidated framework for implementation research (CFIR) domains provides a transparent, theory-driven structure for integrating heterogeneous qualitative evidence. C_LIO_LICASP and ROBINS-I instruments will standardise risk-of-bias assessment across qualitative and non-randomised quantitative studies. C_LIO_LILimitation: English-language restriction and the paucity of quantitative studies preclude meta-analysis and may introduce language bias. C_LI

IntroductionGovernments create policies to address societal needs and then assess their effectiveness through policy metrics. The UK Rare Diseases Framework and its England Rare Diseases Action Plans aim to improve the lives of people with lived experience of rare diseases and their carers. Reaching these goals requires more effective engagement with those least likely to interact with NHS services. This paper outlines a protocol to identify relevant high-level policy metrics while engaging underserved and underrepresented groups. Methods and AnalysisA long list of candidate metrics for the 36 Actions linked to the four Priority Areas of the Framework was compiled from government logic models. The list was discussed in three workshops, and irrelevant, ambiguous, or time-irrelevant metrics were removed. Additional metrics were identified through an evidence review and expert opinion. In the first round of a two-round eDelphi study, shortlisted metrics will be grouped into the four Priority Areas: Faster Diagnosis, Increased Healthcare Professional Awareness, Better Care Coordination, and Improved Access to Specialist Care, Treatment, and drugs. An eDelphi panel of 50 people living with rare disease or their carers, as well as 50 professional stakeholders, will rate each metric on a 1-9 scale. The sample size allows for 20% attrition. Consensus for inclusion or exclusion will be based on 70% agreement (7-9 for very valuable, 1-3 for not valuable), with fewer than 15% rating the metric at the opposite end of the scale. Metrics will be included or excluded if consensus is reached in both groups; otherwise, they will remain under consideration in Round 2. In Round 1, eDelphi participants may propose additional metrics, which will be included in Round 2. After two rounds, a final set of policy metrics will be selected. Any discrepancies in Round 2 ratings will be explored through further research. Ethics and DisseminationThe Coventry University Group Research Ethics Committee has approved the study (P183377). The results will be disseminated to people with lived experience of rare disease and professional stakeholders through conferences, events, and newsletters and submitted to a peer-reviewed journal. If adopted, the identified metrics will inform decision-making on rare disease policies in England and beyond. Registration DetailsISRCTN41639707 ARTICLE SUMMARYO_ST_ABSStrengths and limitations of this studyC_ST_ABSO_LIThe studys strength lies in its equal representation of individuals with lived experience of rare diseases and professional stakeholders, ensuring contextually relevant and widely accepted policy metrics. C_LIO_LIEfforts are made to include underserved groups, ensuring the meaningful representation of underrepresented sub-populations. C_LIO_LIThe findings will primarily apply to the England Rare Diseases Action Plans, limiting their generalisability to other countries or healthcare systems. C_LIO_LIThe heterogeneity of the study population may pose challenges in reaching consensus, potentially impacting the robustness of the agreed-policy metrics. C_LIO_LIDespite targeted recruitment efforts, challenges in including underserved groups may result in a less representative sample, affecting the studys generalisability. C_LI

IntroductionAdolescent idiopathic scoliosis (AIS) is one of the most common paediatric spinal complaints (2-3% of children < 16 years). Regular physical activity is recommended and has been associated with significant improvements in quality of life, reduced pain, and improved function in AIS. However, participation rates remain low amongst individuals with AIS with limited research examining why. This qualitative study aims to identify factors influencing participation in sports, exercise, and physical activities in AIS. Methods and analysisA qualitative interpretive hermeneutic phenomenology study will be conducted. This study will use a subtle-realist view to enable a focus on the most common experiences of individuals with AIS considering factors influencing participation in exercise, sports, and physical activity. This will be a secondary data analysis (SDA) of a single centre qualitative study completed at a tertiary scoliosis centre during 2022. Participant data drawn from semi structured interviews of individuals <18 years old with a diagnosis of AIS will be included in a six-phase thematic analysis. Rigor will be enhanced through a qualitative checklist, reflexivity, researchers with expertise in the phenomena of interest, and additional researchers from the parent study to critique. Patient and public involvement has been utilised since conceptualisation to improve transparency of reporting. Ethics and disseminationFull ethical approval was given for this SDA and the parent study by the Health Research Authority (IRAS 289888) and Health and Care Research Wales approval (REC reference: 21/WM/0076). Dissemination will be via peer reviewed publication and conference presentation with results being used to inform future research projects. Registration detailsNo prior registration has been used for this protocol due to the empirical nature of this secondary data analysis. Strengths and LimitationsO_LIThis project will be conducted with a multidisciplinary research team with expertise in qualitative research, spinal conditions and AIS, and patient and public involvement. C_LIO_LIThis study has ethical strengths in its efficiency of data capture from a single parent study. This is significantly cheaper with standardised procedures, less requirement on children suffering from AIS, and relieves the burden of further participant recruitment. C_LIO_LIThe nature of SDA requires researcher reflexivity and involvement of the primary researcher from parent study to ensure that there is no loss of contextual information or a lack of immersion in the data. C_LIO_LIThe sample will be limited to a single centre study with sampling limited to specialist scoliosis clinics giving opportunity for inferential generaslisation, but lacking opportunity for broad basis generalisations or subgroup analysis. C_LIO_LIThe primary aim of parent study was to assess the content validity of the SRS-22r rather than assessment of factors influencing exercise. However, the interview topic guide was reviewed by the secondary data analyst as well as the wider research team to ensure the capture of appropriate and relevant data for this study. C_LI

IntroductionRandomised controlled trials (RCTs) investigate the safety and efficacy of interventions. It has become clear however that some RCTs include fabricated data. The INSPECT-SR tool assesses the trustworthiness of RCTs in systematic reviews of healthcare-related interventions. However, where individual participant data (IPD) can be obtained, a more thorough assessment of trustworthiness is possible. Consequently, INSPECT-SR recommends obtaining IPD to resolve uncertainties, though there is no consensus on appropriate methods for forensic analysis of raw data. Our aim is to evaluate IPD checks to establish which are worthwhile, and how they can be implemented in a new tool, INSPECT-IPD (Investigating Problematic Clinical Trials with Individual Participant Data). Methods and analysisUsing international expert consensus and empirical evidence, the INSPECT-IPD tool will be developed using five stages: (1) compiling a list of IPD trustworthiness checks, (2) evaluating the usefulness and ease of interpretation of the checks when applying them to a collection of presumed authentic and fabricated IPD datasets, (3) a Delphi survey to determine which checks are supported by expert consensus, (4) a series of consensus meetings for selection of checks to be included in the draft tool and finally (5) prospective testing of the draft tool in: a) the production of systematic reviews, and b) the journal editorial process for RCT submissions, leading to refinement based on user feedback. Ethics and disseminationThe University of Manchester ethics decision tool determined that ethical approval was not required (18 June 2024). This project includes secondary research and surveys of healthcare researchers on topics relating to their work. All results will be published as preprints and open-access articles, and the final tool will be freely available. STRENGTHS AND LIMITATIONS OF THIS STUDYO_LIAn international consensus process and empirical evidence will be used to develop the tool. C_LIO_LIThe development and dissemination of the tool will involve key stakeholders. C_LIO_LIIn the absence of a gold-standard test for problematic data, this tool should not be interpreted as a diagnostic instrument for trustworthiness. Instead, it will assist researchers in assessing the trustworthiness of a study. C_LIO_LIThe tool will only be applicable when individual participant data (IPD) can be accessed. Where IPD can be accessed, the ability to assess trustworthiness will be improved. C_LI

IntroductionIn postpartum haemorrhage (PPH), coagulation factors, mainly fibrinogen, are exhausted early during the course of the disease, which can easily lead to disseminated intravascular coagulation (DIC) and cause maternal mortality. Although some studies have reported the efficacy of point-of-care testing (POCT) devices in detecting hypofibrinogenaemia, little research has been conducted on their usefulness in the diagnosis of PPH. We plan to perform a systematic review of the diagnostic accuracy of existing POCT devices for the diagnosis of hypofibrinogenaemia in PPH. Methods and analysisWe plan to identify studies using POCT devices for PPH and perform a systematic review and meta-analysis of their accuracy of diagnosing hypofibrinogenaemia. The results of fibrinogen measurements using the conventional Clauss method are used as reference standards. Literature searches will be conducted using electronic databases (MEDLINE, Embase, Cochrane Database, and Web of Science), and two reviewers will screen independently from the search results. The eligible literature will be used to synthesise true positive, false positive, true negative, and false negative results for the diagnosis of hypofibrinogenaemia. We will estimate the diagnostic accuracy of POCT devices for diagnosing hypofibrinogenaemia in patients with PPH using the Reitsma-type bivariate random-effects synthesis model and the hierarchical summary receiver operating characteristic curve. Ethics and disseminationThis systematic review will be conducted through the secondary use of literature extracted from electronic databases. There are no ethical issues associated with this research. The final integrated results will be submitted to a peer-reviewed journal. Protocol registrationThe study protocol was registered with University Hospital Medical Information Network Clinical Trials (UMIN000048272) and PROSPERO (CRD42023394785). Strengths and limitations of the studyO_LIStudies on the usefulness of POCT devices in the diagnosis of PPH are limited. Our study will perform a systematic review of the diagnostic accuracy of existing POCT devices for the diagnosis of hypofibrinogenaemia in PPH. C_LIO_LIThe study will estimate the diagnostic accuracy of POCT devices using the Reitsma-type bivariate random-effects synthesis model and the hierarchical summary receiver operating characteristic curve. C_LIO_LIThe threshold for diagnosing hypofibrinogenaemia, the definition of PPH, and the POCT devices used may vary between studies and could be a potential source of heterogeneity. Since most primary studies are observational, it is expected that many unpublished studies will exist. C_LIO_LIThe applicability of the study results may be limited since this systematic review only pertains to the use of POCT devices in pregnant patients with PPH. The number of studies may be limited since there is a wide variety of POCT devices used in PPH. C_LI

IntroductionThe growing burden of cardiovascular disease (CVD) threatens the sustainability of our healthcare systems. In the Netherlands, two-thirds of CVD-related healthcare is delivered in primary care practices, primarily by practice nurses. Given the increasing staffing shortages and the substantial heterogeneity of the population of primary care patients at increased risk of CVD, cardiovascular risk management strategies should be better tailored to individual patients needs and risk profiles. Therefore, we developed the PROSPERA program, aimed at the population of patients enrolled in integrated care programs for cardiovascular risk management in primary care. Methods and analysisThe PROSPERA study is a pragmatic 1:1 cluster randomized controlled trial in 22 primary care practices in the greater Leiden and the Hague region in The Netherlands, investigating real-world effectiveness of the PROSPERA program with care as usual. The PROSPERA program is a multilevel complex intervention, including a population-level risk stratification and three individual patient-level components: a healthcare professional training program in cardiovascular risk communication, a lifestyle questionnaire (Lifestylecheck), and a clinical decision support tool (U-Prevent). Patients between 40-90 years of age enrolled in integrated care programs for increased cardiovascular risk are included. The primary outcome is defined as successful achievement of all protocol-defined cardiovascular preventive treatment goals, measured as the difference between the proportion of patients who meet the outcome in the intervention versus the control group at 18 months. Secondary outcomes include implementation outcomes, healthcare professionals satisfaction on usability of the PROSPERA program, patient experience with shared decision making and decisional conflict, and outcomes on cost-effectiveness. Ethics and disseminationConsent for the use of routine healthcare data is obtained through an opt-out procedure for participating practices. Digital informed consent will be obtained for the study questionnaires for patients and healthcare professionals. Main findings on effectivity, efficacy and implementation will be disseminated via peer-reviewed journals and via (inter)national conferences. Trial registration numberNCT06593704 Strengths and limitations of this studyO_LIThe PROSPERA program was co-developed with stakeholders and refined via a preceding qualitative study, ensuring better integration with clinical workflows. C_LIO_LIThe pragmatic design of this study allows for broad inclusion at the level of the population at increased risk of CVD, enhancing representativeness and inclusivity. C_LIO_LIUse of the Extramural Leiden Medical Center Academic Network (ELAN) data infrastructure enables comprehensive collection of healthcare data. C_LIO_LIThe complexity of the current information- and technology (IT) infrastructure prototype is a constraint, but is expected to be simplified in the future. C_LIO_LIPotential cross-over contamination cannot be prevented, as control practices may have informal access to some PROSPERA components, although these are not yet widely implemented. C_LI