BMJ Open

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

BackgroundAgeing is often accompanied by chronic diseases, multimorbidity, and frailty, increasing the need for clinical and social care to support healthy Ageing and manage these conditions. We are currently in the UN Decade of Ageing and there is a growing focus on the need to prevent or delay some of these conditions through the "Healthy Ageing" initiative of the World Health Organization. However, there are limited data available to inform prioritisation of interventions, particularly for countries in sub-Saharan Africa. MethodsThis study has five interlinked work packages (WPs), designed to understand the current needs for older people in Rwanda, health system capacity and possible solutions to unmet need. First, we will conduct a household survey in the City of Kigali (predominantly urban) and Northern Province Burera district (predominantly rural) to determine the burden of multimorbidity, frailty, access to care, and experiences and responsiveness of care in older people. This work will be supplemented by secondary analysis of data from the Rwandan STEPwise approach to non-communicable disease (NCD) risk factor surveillance (STEPs) survey of 2021. Second, we will conduct a health facility readiness assessment and healthcare provider survey to assess health system capacity and gaps to deliver effective primary care to older people in Rwanda. Third, to capture the voice of older people, we will explore the quality of healthcare as experienced by them using in-depth interviews (IDIs). In Fourth, we will synthesise data using mixed methods to understand barriers to access to quality of care in older agebased on a 3-delays framework (seeking, reaching, and receiving quality health care). Finally, the project will culminate in a stakeholder workshop to ensure results are contextually appropriate and disseminated, and gaps identified are prioritized to design novel interventions to promote healthy ageing in Rwanda and the region. DiscussionThis study will deliver impactful research by using multiple methodologies and working with in-country partners to develop a deep knowledge and understanding of health care systems experienced by older people in Rwanda. It will also provide a framework for sustainable healthy ageing research and policy engagement to benefit older adults living in Rwanda and inform similar work in Low- and Middle-Income countries (LMICs) during this Decade of Healthy Ageing and beyond. Strengths and limitations of this studyO_LIStrengths of this study include our cross-disciplinary mixed methods health systems research, implementation research and a large population-based survey design; C_LIO_LIOur population-based study will cover over 127 villages in the city of Kigali (predominantly urban) and Burera district in Northern part of Rwanda (predominantly rural) covering a total sample size of 4280 increasing external validity of the study; C_LIO_LIIt will provide, to our knowledge for the first time, a picture of public-sector health facility care seeking behaviors and health utilization experiences among older individuals in urban and rural Rwanda; C_LIO_LIFurther strengths include our stakeholders involvement and engagement which will lead to strategies for translation of the findings in to practice and impact; C_LIO_LILimitations of this study will include the cross-sectional nature of the study limiting our ability to assess a cause-and-effect relationship. Moreover, some of the chronic conditions (heart and respiratory disease, high cholesterol) and HIV in the study will rely on self-report of a diagnosis; C_LIO_LIOur study is further limited in that we will not collect all dimensions of the health systems responsiveness domains. Moreover, the study will not be representative of health centers and health care workers in private or higher-level health care facilities in Rwanda. C_LI

This study protocol outlines the Population Norms Study (POPUP), a multinational digital survey aimed at establishing general population norms for medical resource use, comorbidities, sick leave, caregiver support, quality of life, and functioning across eight countries: United States (US), Canada, United Kingdom (UK), the Netherlands, Belgium, Spain, Italy, and Germany. Data will be collected through an online self-administered survey in two waves: the first in Q1 2021 and the second in Q1 2023, when first-wave responders will be recontacted. A total of 15,500 responses will be gathered across both waves: 9,000 in the first wave and 4,500 re-contacts in the second, with an additional 2,000 new contacts if needed. Representative panels will be recruited by a research company from each country based on age, gender, education, and region. Participants will complete the survey after providing informed consent. No personal identifiers will be recorded. The observational study involves no medical interventions, drugs, or devices, and will be submitted for Ethical Committee approval in each country. Descriptive statistics will be used for data analysis. The results are expected to provide a baseline for comparing health outcomes in specific patient populations and quantifying disease burden.

ABSTRACT Introduction Traditional in-person fracture clinics are often overcrowded and inconvenient for patients. Virtual fracture clinics aim to address some of these concerns by improving the efficiency of the orthopaedic service and reducing unnecessary interventions while maintaining safety and quality of care. The RECITAL trial is a non-inferiority randomised controlled trial comparing follow-up care provided at a virtual fracture clinic for people with acute simple fractures to follow-up care provided at an in-person fracture clinic. This study describes the protocol for an economic evaluation of RECITAL where the primary aim is to investigate the cost-effectiveness of a virtual fracture clinic compared with traditional in-person fracture clinic care from a health system perspective. Methods and analysis The RECITAL trial recruited 312 participants with acute simple fractures and randomised them to receive follow-up care provided at a virtual fracture clinic or follow-up care provided at an in-person fracture clinic. We will conduct a within-trial analysis from a health system perspective (primary analysis), as well as a health service, patient and societal perspective. The economic evaluation will estimate the difference in the cost of resource inputs on an intention to treat basis used by participants in the two arms of the trial, allowing comparisons to be made between the in-person and virtual fracture clinics. Data for intervention costs and healthcare utilisation will be collected from trial records, hospital electronic medical records and district performance units. The results of the economic evaluation will be expressed in terms of incremental cost per utility weight gained at 12 weeks and will be plotted on a cost-effectiveness plane. Bootstrapping by resampling will be used to estimate 95% confidence intervals around costs and outcomes, and to calculate the confidence intervals around the incremental cost-effectiveness ratio. A cost-effectiveness acceptability curve (CEAC) will be plotted, which will provide information about the probability that an intervention is cost-effective, given the level of a decision makers willingness to pay for each additional outcome. Ethics and Dissemination The trail was approved by the SLHD Ethics Review Committee (RPAH Zone) (X23-0200 and 2023/ETH01038). The findings will be disseminated through a peer-reviewed journal and conference presentations. Trial registration number The trial was prospectively registered on the Australian New Zealand Clinical Trials Registry (ANZCTR; 12623000934640)

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

BackgroundAcute kidney injury is a common complication following cardiac surgery. Albumin infusions have been proposed as an intervention that reduce the risk of this complication, but existing data have shown heterogenous results. The recent completion of two randomised controlled trial of Albumin infusions in cardiac surgical patients provides the opportunity to conduct a systematic review and meta-analysis to improve the precision of the estimated treatment effect of Albumin infusions in cardiac surgery. MethodsWe will conduct a systematic review of randomised controlled trials that have evaluated the use of peri-operative Albumin infusions compared to comparator fluids in patient undergoing on-pump cardiac surgery. We will conduct a search of MEDLINE, EMBASE, CINAHL and Cochrane Central from inception to 22nd August. The review will be conducted and reported in accordance with the PRISMA 2020 statement. We will use a bayesian framework to estimate the treatment effect of albumin to prevent acute kidney injury defined according to the KDIGO criteria. ResultsThis systematic review has been prospectively registered on PROSPERO (CRD42024580170) and the formal search was conducted on 23rd August 2024. Title and abstract screening has commenced with data extraction to commence following the submission of the protocol. ConclusionThis systematic review will provide an updated systematic review and meta-analysis to inform clinicians about the role Albumin infusion in cardiac surgery.

A protocol for a retrospective observational study to investigate the effect of frailty on outcomes of older adults admitted with major trauma. Patient data will be examined held within the Trauma and Audit Research Network (TARN) database, from 23 Major Trauma Centres in England, between April 2019 and March 2020. The two research questions are: 1) Is there any association between frailty and clinical outcomes in older people admitted with serious traumatic injuries? 2) Is there any association between a geriatrician review and clinical outcomes in an older people admitted with serious traumatic injuries? Patients 65 years old or over will be included. The primary outcome will be mortality as measured by time from hospital admission to death. Secondary outcomes will include day 30 mortality, post injury complications, and length of hospital stay. A mixed-effects multivariable Cox proportional hazards model will be used to analyse the data. A statistical analysis plan has been produced separately for each research question. Signature PageThe undersigned confirm that the following protocol has been agreed and accepted and that the Chief Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to the principles outlined in the Declaration of Helsinki, the Sponsors SOPs, and other regulatory requirement. I agree to ensure that the confidential information contained in this document will not be used for any other purpose other than the evaluation or conduct of the investigation without the prior written consent of the Sponsor I also confirm that I will make the findings of the study publically available through publication or other dissemination tools without any unnecessary delay and that an honest accurate and transparent account of the study will be given; and that any discrepancies from the study as planned in this protocol will be explained. For and on behalf of the Study Sponsor O_TBL View this table: org.highwire.dtl.DTLVardef@18e4ccforg.highwire.dtl.DTLVardef@154e654org.highwire.dtl.DTLVardef@ddbe83org.highwire.dtl.DTLVardef@69943org.highwire.dtl.DTLVardef@1380f28_HPS_FORMAT_FIGEXP M_TBL C_TBL Key Study Contacts O_TBL View this table: org.highwire.dtl.DTLVardef@16b3beeorg.highwire.dtl.DTLVardef@12bb41forg.highwire.dtl.DTLVardef@3e6700org.highwire.dtl.DTLVardef@dc71c0org.highwire.dtl.DTLVardef@b00e56_HPS_FORMAT_FIGEXP M_TBL C_TBL Study Summary O_TBL View this table: org.highwire.dtl.DTLVardef@7d43f1org.highwire.dtl.DTLVardef@1f7bce9org.highwire.dtl.DTLVardef@1937d99org.highwire.dtl.DTLVardef@1ae13corg.highwire.dtl.DTLVardef@b95026_HPS_FORMAT_FIGEXP M_TBL C_TBL Plain Language SummaryThe majority of major injuries admitted to hospital are now in older people, with a fall from standing height being the most common reason for injury. Our study will look at older adults admitted to hospital with serious traumatic injuries across England and Wales. It will aim to work out firstly if there is an effect of frailty on peoples survival after injury. Frailty is the reserve a person has to cope with illness and is a measure of a person slowing down over time usually due to the collection of lots of health problems. Secondly, we will look at if being seen by an old age specialist (geriatrician) has an effect on a persons chances of surviving their injuries. The records we will look at are held collected routinely and held by a national database run by the Trauma and Audit Research Network (TARN) from the University of Manchester. They collect information from the 23 centres of major trauma excellence around the country and help researchers to work with them to access the anonymous data for specific research questions. We aim to use these results to help clinicians and health systems to improve how the fund and deliver care for older people. Funding and Support in Kind O_TBL View this table: org.highwire.dtl.DTLVardef@3d04b3org.highwire.dtl.DTLVardef@1ffbb49org.highwire.dtl.DTLVardef@60c2f4org.highwire.dtl.DTLVardef@9f54a8org.highwire.dtl.DTLVardef@6ee811_HPS_FORMAT_FIGEXP M_TBL C_TBL Role of Study Sponsor and FunderNorth Bristol Trust R&I - supporting the development of this work. No direct influence in any part of the work. TARN - supporting development of the work. Will have input into the development, analysis and write-up of the work. Study Steering Group O_TBL View this table: org.highwire.dtl.DTLVardef@145cceeorg.highwire.dtl.DTLVardef@1913ebcorg.highwire.dtl.DTLVardef@add06corg.highwire.dtl.DTLVardef@14ea160org.highwire.dtl.DTLVardef@144bacf_HPS_FORMAT_FIGEXP M_TBL C_TBL Protocol Contributors O_TBL View this table: org.highwire.dtl.DTLVardef@144a207org.highwire.dtl.DTLVardef@e9899aorg.highwire.dtl.DTLVardef@4907fcorg.highwire.dtl.DTLVardef@ab63cdorg.highwire.dtl.DTLVardef@253c97_HPS_FORMAT_FIGEXP M_TBL C_TBL No patients were involved in the development of the protocol. Study Flow Chart O_TBL View this table: org.highwire.dtl.DTLVardef@ace3bborg.highwire.dtl.DTLVardef@9b3b92org.highwire.dtl.DTLVardef@1642b13org.highwire.dtl.DTLVardef@1481209org.highwire.dtl.DTLVardef@983589_HPS_FORMAT_FIGEXP M_TBL C_TBL Study ProtocolA retrospective observational study to investigate the effect of frailty on outcomes of older adults admitted with major trauma.

AimTo explore how advocacy has been defined, conceptualised and implemented within nursing, midwifery and the allied health professions. A secondary aim is to characterize barriers and facilitators to advocacy in clinical practice. MethodsA systematic search of five bibliographic databases has been undertaken to identify primary qualitative and quantitative research relating to advocacy in nursing, midwifery and the allied health professions. Results from searches are being screened blinded and in duplicate. Given that we anticipate retrieving heterogenous studies, eligible studies will be synthesised according to best practice set out in a range of guidelines. Data SourcesCINAHL (via EBSCOHost), EMBASE (via Ovid), MEDLINE (via Ovid), PsycINFO (via EBSCOHost), Global Health (via EBSCOHost) have been searched. ResultsSearches have been completed, n=45,617 studies were retrieved which was reduced to n=25,900 studies following deduplication. Screening, which is being performed blinded and in duplicate within the web platform Rayyan, is ongoing. ConclusionsAs a result of this robust review, we anticipate generating a comprehensive report of advocacy that we have hitherto identified as being lacking. Best practice principles are being employed ensuring the eventual output is robust, transparent and useful to the clinicians likely to be accessing this information. No Patient or Public ContributionO_ST_ABSImplications for the profession and/or patient careC_ST_ABSIn order to gain a comprehensive understanding of advocacy; nurses, midwives and allied health professionals would have to obtain and consult a number of systematic reviews. This all-encompassing review will ensure that a comprehensive report that synthesizes modern data and covers the full-spectrum of advocacy domains and its implications is available. ImpactThe broad reach and ambitious nature of this review will ensure it has a significant impact. Advocacy is practiced by most healthcare staff on daily basis, however many are not aware of this and those with aspirations to engage more fully as an advocate within their role do not have a reliable and comprehensive report which would equip them with relevant knowledge relating to advocacy. Protocol RegistrationThis review was registered on PROSPERO (CRD420250640543) Key pointsO_LIAdvocacy is an important component of nursing, midwifery and allied health professional practice, however the evidence has not recently been synthesised. C_LIO_LIThis review will update and expand the scope of previous reviews, to generate a comprehensive update of advocacy. C_LIO_LIClinicians with an interest in advocacy will be able to obtain a robust and up to date overview of advocacy, which is likely to have changed recently in view of the spread of misinformation and artificial intelligence. C_LI RegistrationThis review was registered on PROSPERO (CRD420250640543)

BACKGROUNDMultimorbid patients have worse outcomes following acute hospitalisation. These include increased mortality as an in-patient and after hospital discharge, and increased morbidity and dependence requiring greater use of care facilities. The literature is unclear on the views and wishes of multimorbid patients regarding the outcomes of acute hospitalisation, specifically regarding survival with additional functional disability following acute illness. This is increasingly relevant, with the recent National Institute for Health and Care Excellence (NICE) guidance on admission to hospital and critical care being based on the presence of comorbidities and function as opposed to numerical age. ObjectivesWe performed a systematic review to assess the current qualitative literature exploring attitudes, wishes and perspectives of adult patients with multimorbidity on surviving future acute illness and subsequent acquired functional disability. METHODSO_ST_ABSEligibility criteriaC_ST_ABSEligible studies addressed the attitudes, wishes and perspectives of multimorbid adults to illness and treatment-acquired disability using qualitative methods. Information sources: A search of PubMed, Embase, and CINAHL databases was conducted from database inception through April 2020. References lists from selected papers and NICE Guidelines on Multimorbidity (NG56) were searched iteratively for additional relevant articles. Review methodsTwo researchers reviewed candidate full texts independently. Relevant data was extracted to an evidence table. The risk of bias was avoided by adhering to the previously published extensive search strategy and use of qualitative methodology. RESULTSFrom 35606 records of which 6370 were duplicates, 20 full texts were reviewed for inclusion, but none met the eligibility criteria. Coverage of domains of importance to multimorbid adults and those highlighted in the NICE guidelines on multimorbidity (NG56) by the 20 short-listed papers was determined; no publications were found to address all domains. DISCUSSIONNo studies were identified which have applied appropriate qualitative methodology to understand the wishes, attitudes, and preferences of multimorbid adults regarding treatment and outcomes of acute illness. Such enquiries need to be urgently undertaken to inform and progress policy and clinical practice relating to decisions around admission to hospital and critical care. OTHERO_ST_ABSFundingC_ST_ABSNational Institute of Health Research (NIHR) Research for Patient Benefit grant; NIHR Programme grant; NIHR Doctoral Research Fellowship. RegistrationPROSPERO International Prospective Register of systematic reviews (CRD: 42019155028) https://www.crd.vork.ac.uk/PROSPERO/

PurposeRecent comprehensive guidelines have been published on the management of inguinal hernia. Contrary to other European countries, no Portuguese hernia registry exists. This represents an opportunity to assess outcomes of hernia surgery in the Portuguese population. The primary aim is to define the prevalence of chronic pain after elective inguinal hernia repair. The secondary aims are to identify risk factors for chronic pain after elective inguinal hernia repair, to characterise the management of elective inguinal hernia in public Portuguese hospitals. MethodsProspective national cohort study of patients submitted to elective inguinal hernia repair. The primary outcome is the prevalence of chronic postoperative inguinal pain, according to the EuraHS QoL questionnaire at 3 months postoperatively. The study will be delivered in all Portuguese regions through a collaborative research network. Four 2-week inclusion periods will be open for recruitment. A site-specific questionnaire will capture procedure volume and logistical facilities for hernia surgery. ConclusionThis protocol describes the methodology of a prospective cohort study on the elective management of inguinal hernia. It discusses key challenges and describes how the results will impact future investigation. The study will be conducted across a nationwide collaborative research network, with prospective quality assurance and data validation strategies. It will provide the basis for a more accurate prediction of chronic postoperative inguinal pain and the research on adequate patient selection strategies for surgery and therapeutic strategies for postoperative pain.

Fractures of the tibia are frequently treated with an intra-medullary nail. This can be inserted through either a supra-patella or infra-patella surgical incision. Concerns over potential damage to the cartilage of the knee with supra-patella insertion has impacted upon its adoption despite benefits in terms of easier nail placement and potentially reduced blood loss and pain. This randomised pilot study will use patient reported outcome measures (PROMS) and novel MRI sequences designed to assess damage to the structure of cartilage to compare these two methods of tibial intra-medullary nailing. Twenty individuals with tibial shaft fractures will be randomised to either method of nail insertion (ten individuals in each arm). MRI scans and PROMS will be used to assess cartilage damage and general function up to 6 months post operatively. The results of the study will be used to inform a potential multi-centre study.

BackgroundOver recent years chronic stress and burnout have been reported by doctors working in general practice in the UK NHS and internationally. The COVID-19 pandemic has changed general practitioners working lives - adding potential pressures from avoiding infection and addressing pent-up demand for care, but also changing processes such as rapidly taking up remote consultations. To date, there has been a focus on exploring the impact of the pandemic on the wellbeing of hospital clinicians. No registered systematic reviews currently focus on exploring the impact of the pandemic on the mental health and wellbeing of general practitioners. Aims and objectivesTo synthesise the current international evidence base exploring the impact of COVID-19 on the mental health and wellbeing of general practitioners, and which factors are associated with their reported mental health and wellbeing during the pandemic. MethodsIn this paper we report a systematic review protocol, following PRISMA guidance. In our search strategy we will identify primary research studies or systematic reviews exploring the mental health and wellbeing of general practitioners during the COVID-19 pandemic in four databases (MEDLINE, Embase, PsychInfo and Medrxiv) and Google Scholar. We will hand-search reference lists and grey literature. Two reviewers will undertake all stages including study selection, data extraction and quality assessment, with arbitration by a third reviewer where necessary. We will use standardised quality assessment tools to ensure transparency and reduce bias in quality assessment. Depending on the quality of included studies, we may undertake a sensitivity analysis by excluding studies from narrative synthesis that are rated as low quality using the checklists. We will describe the findings across studies using narrative thematic data synthesis, and if sufficiently homogenous data are identified, we will pool quantitative findings through meta-analysis.

At the start of the COVID-19 pandemic South Western Ambulance Service Foundation Trust (SWASFT) changed its pre-hospital trauma triage tool to include an assessment of frailty, and if scored 5 or more on the Clinical Frailty Scale, the tool instructed the person to be conveyed to a trauma unit and not the major trauma centre. How the use of frailty has been operationalised and effected in daily clinical practice is unknown. There were concerns during the COVID-19 pandemic that care was being rationed by a frailty score alone, without expert oversight or appropriate training. Whether or not care rationing was appropriate at the height of the pandemic remains a philosophical question, however more research is needed into using the CFS for this type of decision making. This is relevant to using frailty scores in trauma triage tools outside of a pandemic situation, particularly when a score may prompt a change in clinical management. This study aims to explore the pathways of care that have been associated with this incorporation of frailty. In addition, it will aim to explore healthcare professionals experience of frailty scoring for trauma patients pre-hospital and at the receiving hospitals.

IntroductionMetformin has been considered for use in women who are overweight or obese and with pre-existing type 2 diabetes(T2DM) or gestational diabetes mellitus(GDM). Nevertheless, few studies have weighed the pros and cons of maternal metformin use on offspring and womens perinatal health. We determined to ascertain whether the insulin sensitiser metformin improves fetal and maternal outcomes in Pregnant women with type 2 diabetes or with a BMI no less than 24 kg/m2 Methods and analysisThe protocol was formulated according to Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Exhaustive literature searches of electronic bibliographic databases will be conducted in PubMed, EMBASE, Cochrane Library, Web of Sciences, Scopus, ClinicalTrial, OvidSP and ScienceDirect. We used a predefined data extraction table to perform data extraction, and publication bias measurement for each study will be accomplished through the Cochrane Collaboration Tool. The statistical analyses will be performed using RevMan (5.4.1; The Cochrane Collaboration) and STATA (17). Heterogeneity will be assessed using the Q and I2 test, with a value of I2 > 50% being considered substantial. The extent of publication bias will be investigated by visual assessment of a funnel plot and using Eggers test, Beggs test, and Harbords test if ten or more trials are pooled. Ethics and disseminationPatients consent and Ethical approval are not requisites. The complete analysis will be published in an international open-access journal and translational articles to disseminate the results to clinical internists. PROSPERO registration number: CRD42022347084 Strengths and limitations of this study{blacktriangleright} This review will comprehensively assess published English-language studies without period or geographical restrictions. {blacktriangleright}This system review plan strictly follows preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) {blacktriangleright}Included studies will be limited to RCTs, which have a high degree of internal consistency and are not representative of the real world. {blacktriangleright}As is the case with most meta-analyses, there may be significant and unexplained heterogeneity in this study.

The Nordic Hamstring exercise reduces hamstring strain injuries in football and other sports, but the exercise is not well adopted in practice. Barriers from practitioners include fear of performance decrements, due to lack of specificity of the exercise with high speed running. However, in theory, increased eccentric hamstring strength could transfer to faster sprinting due to higher horizontal force production. Studies on the effect of the Nordic Hamstring exercise on performance have been conflicting and no synthesis of the evidence exists. We therefore pose the following question: does including the Nordic Hamstring exercise hamper sprint or jump performance in athletes? We will answer this question by performing a systematic review of the literature, critically appraise relevant studies, and GRADE the evidence across key outcomes and perform meta-analyses, meta-regression and subgroup analyses. In this protocol we outline the planned methods and procedures. Progress reportBesides this protocol, our data extraction form and the process of data extraction has been piloted on 3 relevant studies, along with familiarization with the Risk of Bias 2.0 tool. We have also comprised a preliminary search strategy for PubMed. Supplementary filesO_LIData Extraction Form (.pdf) C_LIO_LIPopulated PRISMA-P checklist (.pdf) C_LI

IntroductionVision and hearing impairments are highly prevalent and have a significant impact on physical, psychological and social wellbeing. There is a need for accurate, contemporary national data on the prevalence, risk factors and impacts of vision and hearing loss in Australian adults. ObjectivesThe Australian Eye and Ear Health Survey (AEEHS) aims to determine the prevalence, risk factors and impacts of vision and hearing loss in both Aboriginal and Torres Strait Islander and non-Indigenous older adults. Methods and analysisThe AEEHS is a population-based cross-sectional survey which will include 5,000 participants (3250 non-Indigenous aged 50 years or older and 1750 Aboriginal and Torres Strait Islander people aged 40 years or older) from 30 sites covering urban and rural/regional geographic areas, selected using a multi-stage, random cluster sampling strategy. Questionnaires will be administered to collect data on socio-demographic, medical, ocular and otological history. The testing battery includes assessment of blood pressure, blood sugar, anthropometry, visual acuity (presenting, unaided, pinhole and best-corrected), refraction, tonometry, slit lamp and dilated eye examination, ocular imaging including optical coherence tomography (OCT), OCT-angiography and retinal photography, and automated visual fields. Audiometry, tympanometry and video otoscopy will also be performed. The primary outcomes are age-standardised prevalence of cause-specific vision and hearing impairment. Secondary outcomes are prevalence of non-blinding eye diseases (including dry eye disease), patterns in health service utilisation, universal health coverage metrics, risk factors for vision and hearing impairment, and impact on quality of life. EthicsThe protocol for this study was approved by the University of Sydney Human Research Ethics Committee (HREC-2020/818) and Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS) Research Ethics Committee (HREC-EO303-20211008). Dissemination of resultsOur findings will be disseminated through presentation at meetings and peer-reviewed publications. Findings will also be widely disseminated by project partners with the aim of improving public health policy directives and equitable service delivery to prevent avoidable vision and hearing impairment in Australia.

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.

Uncemented fixation of THA components are increasingly used. Although cemented femoral component fixation in total hip arthroplasty has shown better results in older patients, less is known about the cup side.

IntroductionAcute Liver Failure (ALF) has no effective treatment other than liver transplantation, and is commonly caused by paracetamol overdose. New treatments are needed to treat and prevent ALF. Alternatively activated macrophages (AAMs) can promote resolution of liver necrosis and stimulate hepatocyte proliferation. Using AAMs in unscheduled care requires the use of an allogeneic product. A clinical trial is needed to determine the safety and tolerability of allogeneic AAMs. Methods and analysisA single centre, open-label, dose-escalation, phase 1 randomised trial to determine whether there is dose-limiting toxicity of AAMs in patients with paracetamol-induced acute liver injury. Randomisation will occur at higher doses. Ethics and disseminationThe trial will be conducted according to the ethical principles of the Declaration of Helsinki 2013 and has been approved by North East - York Research Ethics Committee (reference 23/NE/0019), NHS Lothian Research and Development department, and the UK Medicines and Healthcare products Regulatory Agency. When the trial concludes, results will be shared by presentation and publication. Trial registration number: ISRCTN 12637839.

BackgroundClinical research is essential for medical advancement but contributes to carbon emissions through activities such as travel, data management, and laboratory processes. As healthcare systems move towards net-zero targets, there is a growing need to understand public awareness of and attitudes towards environmental sustainability in clinical research. Public and Patient Involvement (PPI) can enhance the relevance and acceptability of research, however there is limited evidence on how best to co-develop tools to assess public understanding of sustainable clinical research. MethodsThis study is a two-phase protocol. Phase I involves the co-development of an anonymous online survey with PPI partners through two structured workshops. Survey themes, topics, questions and format will be agreed collaboratively, and the co-development process will be evaluated using qualitative data collected during the workshops. These data will be analysed thematically, using Braun & Clarkes (2006) framework. Phase II involves distribution of the survey to clinical research, patient and public networks using an online platform. Survey data will be analysed using descriptive statistics for quantitative data and inductive content analysis for qualitative responses. DiscussionThis study will generate a co-developed survey instrument and provide insights into public understanding of sustainable clinical research. Reporting on both the survey findings and the PPI co-development process will inform future research and support the development of sustainable research clinical practices.