NIHR open research最新文献

{"title":"Early special educational needs provision and its impact on unplanned hospital utilisation and school absences in children with isolated cleft lip and/or palate: a demonstration target trial emulation study protocol using ECHILD","authors":"Vincent Nguyen, Kate M Lewis, Ruth Gilbert, Lorraine Dearden, Bianca De Stavola","doi":"10.3310/nihropenres.13472.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13472.1","url":null,"abstract":"<ns3:p>Background Special educational needs (SEN) provision is designed to help pupils with additional educational, behavioural or health needs; for example, pupils with cleft lip and/or palate may be offered SEN provision to improve their speech and language skills. Our aim is to contribute to the literature and assess the impact of SEN provision on health and educational outcomes for a well-defined population. Methods We will use the ECHILD database, which links educational and health records across England. Our target population consists of children identified within ECHILD to have a specific congenital anomaly: isolated cleft lip and/or palate. We will apply a trial emulation framework to reduce biases in design and analysis of observational data to investigate the causal impact of SEN provision (including none) by the start of compulsory education (Year One – age five year on entry) on the number of unplanned hospital utilisation and school absences by the end of primary education (Year Six – age ten/eleven). We will use propensity score-based estimators (inverse probability weighting (IPW) and IPW regression adjustment IPW) to compare categories of SEN provision in terms of these outcomes and to triangulate results obtained using complementary estimation methods (Naïve estimator, multivariable regression, parametric g-formula, and if possible, instrumental variables), targeting a variety of causal contrasts (average treatment effect/in the treated/in the not treated) of SEN provision. Conclusions This study will evaluate the impact of reasonable adjustments at the start of compulsory education on health and educational outcomes in the isolated cleft lip and palate population by triangulating complementary methods under a target-trial framework.</ns3:p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135273910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Covariates of success in quitting smoking: a systematic review of studies from 2008 to 2021 conducted to inform the statistical analyses of quitting outcomes of a hospital-based tobacco dependence treatment service in the United Kingdom.","authors":"Emma S Hock, Matthew Franklin, Susan Baxter, Mark Clowes, James Chilcott, Duncan Gillespie","doi":"10.3310/nihropenres.13427.2","DOIUrl":"10.3310/nihropenres.13427.2","url":null,"abstract":"<p><strong>Background: </strong>Smoking cessation interventions are being introduced into routine secondary care in the United Kingdom (UK), but there are person and setting-related factors that could moderate their success in quitting smoking. This review was conducted as part of an evaluation of the QUIT hospital-based tobacco dependence treatment service ( https://sybics-quit.co.uk). The aim of the review was to identify a comprehensive set of variables associated with quitting success among tobacco smokers contacting secondary healthcare services in the UK who are offered support to quit smoking and subsequently set a quit date. The results would then be used to inform the development of a statistical analysis plan to investigate quitting outcomes.</p><p><strong>Methods: </strong>Systematic literature review of five electronic databases. Studies eligible for inclusion investigated quitting success in one of three contexts: (a) the general population in the UK; (b) people with a mental health condition; (c) quit attempts initiated within a secondary care setting. The outcome measures were parameters from statistical analysis showing the effects of covariates on quitting success with a statistically significant (i.e., p-value <0.05) association.</p><p><strong>Results: </strong>The review identified 29 relevant studies and 14 covariates of quitting success, which we grouped into four categories: demographics (age; sex; ethnicity; socio-economic conditions; relationship status, cohabitation and social network), individual health status and healthcare setting (physical health, mental health), tobacco smoking variables (current tobacco consumption, smoking history, nicotine dependence; motivation to quit; quitting history), and intervention characteristics (reduction in amount smoked prior to quitting, the nature of behavioural support, tobacco dependence treatment duration, pharmacological aids).</p><p><strong>Conclusions: </strong>In total, 14 data fields were identified that should be considered for inclusion in datasets and statistical analysis plans for evaluating the quitting outcomes of smoking cessation interventions initiated in secondary care contexts in the UK.</p><p><strong>Prospero registration: </strong>CRD42021254551 (13/05/2021).</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"3 ","pages":"28"},"PeriodicalIF":0.0,"publicationDate":"2023-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10596416/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50164049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Doctoral research, COVID-19, and political crisis in Ethiopia, Sudan, Rwanda, and the UK: challenges, responses, and recommendations","authors":"Jean Paul Bikorimana, Corinna Thellmann, Tseganesh Mulugeta, Dereje Wonde, Addisu Tsegaye, Badraldeen Ali Bashir Alnoor Ahmed, Ursin Bayisenge, Jeffrey Pocock","doi":"10.3310/nihropenres.13470.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13470.1","url":null,"abstract":"<ns3:p>Background Conducting doctoral research is a challenging endeavour, a challenge which as the growing literature on the subject has shown, the COVD-19 pandemic has made even more so. For some doctoral researchers, however, the pandemic has also been accompanied by political unrest and military conflict, putting them and their networks at risk and making their research especially difficult to sustain. Methods We have used a collaborative auto-ethnography, and we, a group of seven doctoral researchers based in Ethiopia, Rwanda, Sudan and UK have written our experiences. Results Drawing upon the results of a collaborative auto-ethnography (CAE), this article records and discusses the experiences of a group of doctoral researchers who with the support of their organisation, the Social Science for Severe Stigmatised Skin Diseases (5S) Foundation, have been attempting to cope with both the pandemic and internal instability and strife. After firstly setting the context, the article explains why for the purposes of this paper CAE was adopted as our method, and then documents and discusses the experiences of seven doctoral researchers based in Ethiopia, Sudan, Rwanda, and the UK, doing so in terms of four different themes: New Ways of Working and Its Impact, Change and Delay, Mental Health and Well-Being Impact, and Qualities and Capacities. Conclusion What these experiences tell us is that this group of doctoral researchers have found themselves in extremely challenging situations, which have placed exceptionally high demands on them and their support networks, and this has had an impact on their health and well-being although also been the catalyst for some more positive development. Given their lived experiences, the article finishes with a series of recommendations for future research projects of this kind.</ns3:p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"66 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136210290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness and cost-effectiveness of offering a chair-based yoga programme in addition to usual care in older adults with multiple long-term conditions: a pragmatic, parallel group, open label, randomised controlled trial","authors":"Garry Tew, Laura Wiley, Lesley Ward, Jess Hugill-Jones, Camila Maturana, Caroline Fairhurst, Kerry Bell, Laura Bissell, Alison Booth, Jenny Howsam, Valerie Mount, Tim Rapley, Sarah Ronaldson, Fiona Rose, David Torgerson, David Yates, Catherine Hewitt","doi":"10.3310/nihropenres.13465.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13465.1","url":null,"abstract":"<ns3:p>Background People with multiple long-term conditions are more likely to have poorer health-related quality of life (HRQOL). Yoga has the potential to improve HRQOL. Gentle Years Yoga© (GYY) is a chair-based yoga programme for older adults. We investigated the effectiveness and cost-effectiveness of the GYY programme in older adults with multiple long-term conditions. Methods In this pragmatic, multi-site, open, randomised controlled trial, we recruited older adults aged ≥65 years with ≥2 long-term conditions from 15 primary care practices in England and Wales. Participants were randomly assigned to usual care control or a 12-week, group-based, GYY programme delivered face-to-face or online by qualified yoga teachers. The primary outcome was HRQOL (assessed with EQ-5D-5L) over 12 months. Secondary outcomes included anxiety, depression, falls, loneliness, healthcare resource use, and adverse events. Results Between October 2019 and October 2021, 454 participants were randomly assigned to the intervention (n=240) and control (n=214) groups. Seven GYY courses were delivered face-to-face and 12 courses were delivered online. The mean number of classes attended among all intervention participants was nine (SD 4, median 10). In our intention-to-treat analysis (n=422), there was no statistically significant difference between trial groups in the primary outcome of HRQOL (adjusted difference in mean EQ-5D-5L = 0.020 [favouring intervention]; 95% CI -0.006 to 0.045, p=0.14). There were also no statistically significant differences in key secondary outcomes. No serious, related adverse events were reported. The incremental cost-effectiveness ratio was £4,546 per quality-adjusted life-year (QALY) and the intervention had a 79% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY. Conclusions The offer of a 12-week chair-based yoga programme in addition to usual care did not improve HRQOL in older adults with multiple long-term conditions. However, the intervention was safe, acceptable, and probably cost-effective.</ns3:p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136211654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Propranolol reduces risk of knee or hip replacement due to osteoarthritis: A propensity score matched cohort study-using data from the Clinical Practice Research Datalink","authors":"Georgina Nakafero, Matthew J Grainge, Ana M Valdes, Nick P Townsend, Christian Mallen, Weiya Zhang, Michael Doherty, Mamas A Mamas, Abhishek Abhishek","doi":"10.3310/nihropenres.13462.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13462.1","url":null,"abstract":"<ns3:p><ns3:bold>Background:<ns3:italic> </ns3:italic></ns3:bold>There is paucity of safe and effective analgesic drugs for osteoarthritis (OA). β-adrenoreceptor blockers have demonstrated anti-nociceptive effects in several painful conditions. We investigated whether β-blockers are associated with a reduced risk of total joint replacement (TJR) at the knee or the hip in people with incident knee or hip OA.</ns3:p><ns3:p> <ns3:bold>Methods:</ns3:bold> This was a cohort study. We used data from the Clinical Practice Research Datalink. Participants aged 40 years or older with incident knee or hip OA, prescribed β-blockers following OA diagnosis (new-user design) and their age, sex, OA location and propensity score (PS) for β-blocker prescription matched controls were included in the study. Cox-proportional hazard ratios (HRs) and 95% confidence intervals (CI) were calculated. The analyses were adjusted for factors that influence health-seeking behaviour, progression of OA, and stratified according to <ns3:italic>β</ns3:italic>-blocker classification. Data analysis was conducted using STATA-MP v15.</ns3:p><ns3:p> <ns3:bold>Results:</ns3:bold><ns3:italic> </ns3:italic>Data for 6,970 PS-matched <ns3:italic>β</ns3:italic>-blocker exposed and unexposed participants were included. Any <ns3:italic>β</ns3:italic>-blocker prescription was not associated with knee or hip TJR (aHR 1.11; 95 % CI 0.98 – 1.25). However, prescription of lipophilic non-selective β-blockers with membrane stabilising effect associated with reduced risk of knee or hip TJR (aHR 0.69; 95 % CI 0.52 – 0.93). Of these, there was a protective effect for propranolol (aHR 0.71; 95 % CI 0.53 – 0.95), the commonest prescribed drug in this class. The number needed to treat (95%CI) with propranolol for two years, in order to prevent one TJR was 32 (23-52).</ns3:p><ns3:p> <ns3:bold>Conclusions:</ns3:bold> The non-selective β-blocker propranolol reduces the risk of knee or hip TJR, consistent with its analgesic effects demonstrated in other conditions. A randomised controlled trial is required to further evaluate the analgesic potential of propranolol in OA.</ns3:p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"60 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135347078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a prospective observational cohort study of cutaneous leishmaniasis in Ethiopia","authors":"Amel Beshir Mohammed, Fewzia Dhikur Mohammed, Feleke Tilahun Zewdu, Shimelis Doni Nigusse, Yohannes Hailemichael, Teklu Cherkose, Abebaw Yeshambel Alemu, Eshetu Molla, Kidist Bobosha, Vanessa Yardley, Iris Mosweu, Mirgissa Kaba, Catherine Pitt, Elizabeth Allen, Saba Maria Lambert, Michael Marks, Stephen L. Walker, Endalamaw Gadisa","doi":"10.3310/nihropenres.13432.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13432.1","url":null,"abstract":"<ns3:p>Background: Cutaneous leishmaniasis (CL) is a skin neglected tropical disease, with an estimated 40,000 new cases each year in Ethiopia. CL causes ulcers, nodules, and plaques on the skin, and in some instances the destruction of the nasopharyngeal mucosa and cartilage. Some CL lesions may heal spontaneously, whilst other lesions may require therapies which are associated with discomfort, adverse effects, prolonged treatment, and a frequent lack of a complete response. Scarring, a sequela of CL, causes permanent disfigurement and is associated with stigma linked with a reduction in health-related quality of life. The choice of treatment for CL is based upon factors including the causative species; the number, extent, size, and location of lesions; and the availability of treatments. The development of robust evidence for CL treatment is hindered by a lack of validated and appropriate outcome measures and few data to support hypothesis-generation and trial design. There is a paucity of prospective data with well-defined treatment outcomes for CL caused by <ns3:italic>L. aethiopica</ns3:italic>. Aim: The overall aim of this study is to improve the understanding of the health and economic burden of CL. Methods: We have designed an observational, multi-centre cohort study to examine treatment outcomes for CL in Ethiopia which includes clinical outcomes, laboratory outcomes, patient reported outcome measures, scar assessments and cost effectiveness. We aim to recruit up to 750 participants across two hospital sites. We present here the protocol for this cohort study with a 12-month follow up period for each participant. Conclusions: These data will inform the design of randomized controlled trials to evaluate new treatment strategies, with appropriate economic evaluations. This will help improve evidence-based guidelines and support evidence-led policy decisions, not only in Ethiopia but also globally.</ns3:p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135481423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Local authority variation in primary school-recorded special educational needs provision among children with major congenital anomalies: A research protocol","authors":"Kate Lewis, Vincent Nguyen, Ania Zylbersztejn, Ruth Gilbert, Bianca De Stavola, Lorraine Dearden","doi":"10.3310/nihropenres.13466.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13466.1","url":null,"abstract":"<ns3:p><ns3:bold>Introduction: </ns3:bold>Special educational needs (SEN) provision has been called a 'postcode lottery’ in England, but the extent to which this represents underlying inequities has not been sufficiently investigated. This study will focus on children with similar underlying health characteristics to explore sources of systematic variation in SEN provision by local authority (LA) in England.</ns3:p><ns3:p> <ns3:bold>Methods and analysis: </ns3:bold>We will use linked individual-level state-funded hospital and school records from the Education and Health Insights from Linked Data (ECHILD) database, alongside open-source school-level data. Our cohort will be defined as singleton children with major congenital anomalies born in England between 1 September 2003 and 31 August 2012. We will identify major congenital anomalies from diagnoses in hospital records in the first year of life using European Surveillance of Congenital Anomalies (EUROCAT) guidelines. LA (152 in total) will be defined by child’s residential address reported in education records at entry into year one of school (aged five years old). SEN provision will be defined by a recording of an educational health and care plan or SEN support in any census in Reception, year one or two of primary school (ages four/five to six/seven). To quantify variation in SEN provision we will fit multilevel logistic regression models to the individual records, with a-priori selected individual-, school- and LA-level characteristics. We will report the estimated intraclass correlation coefficient at each stage of the model, signifying the percentage of remaining variation in the odds of recorded SEN provision that is due to differences between LAs.</ns3:p><ns3:p> <ns3:bold>Ethics and dissemination</ns3:bold>: We have existing research ethics approval for analyses of the ECHILD database described in this protocol. We will disseminate our findings to diverse audiences (academics, relevant government departments, service users and providers) through seminars, peer-reviewed publications, short briefing reports and infographics for non-academics (published on the study website).</ns3:p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"75 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134975536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Randomised Controlled Trial of Early Vitrectomy and Intravitreal Antibiotics for Post-operative Exogenous Endophthalmitis (EVIAN study): study protocol for a feasibility trial","authors":"Mahiul Muhammed Khan Muqit, Carlos Pavesio, Hayley Boston, Keerththika Sriharan, Yanzhong Wang, Elena Pizzo, Stephen Cobb, Christopher Spink, James Bainbridge","doi":"10.3310/nihropenres.13469.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13469.1","url":null,"abstract":"<ns3:p>Postoperative bacterial endophthalmitis is an infection of the eye's internal tissues resulting from an intraocular procedure. The condition is uncommon but can cause severe and irreversible impairment of sight. Standard management involves administration of antibiotics with or without subsequent removal of the infected vitreous gel by vitrectomy surgery. Surgical intervention is typically reserved for infections that persist despite a period of medical management alone. We aim to determine whether outcomes can be improved by performing surgery without delay. To explore the feasibility of a definitive randomised controlled trial and to determine the number of participants required, we will conduct a multicentre feasibility trial. This trial will include 40 affected individuals, allocated randomly to either standard of care, being intravitreal antibiotic administration alone, or to early vitrectomy surgery in addition to antibiotic administration. We will determine the feasibility and size of a definitive trial by evaluating the participants and the outcomes for their sight. Research Ethics Committee approval (REC 20/WM/0264). Here we describe the trial protocol. <ns3:bold>Trial registration number:</ns3:bold>ClinicalTrials.gov NCT04522661</ns3:p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"49 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135386706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deprivation, essential and non-essential activities and SARS-CoV-2 infection following the lifting of national public health restrictions in England and Wales","authors":"Susan Hoskins, Sarah Beale, Vincent Nguyen, Yamina Boukari, Alexei Yavlinsky, Jana Kovar, Thomas Byrne, Wing Lam Erica Fong, Cyril Geismar, Parth Patel, Anne Johnson, Robert Aldridge, Andrew Hayward","doi":"10.3310/nihropenres.13445.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13445.1","url":null,"abstract":"<ns3:p>Background: Individuals living in deprived areas in England and Wales undertook essential activities more frequently and experienced higher rates of SARS-CoV-2 infection than less deprived communities during periods of restrictions aimed at controlling the Alpha (B.1.1.7) variant. We aimed to understand whether these deprivation-related differences changed once restrictions were lifted. Methods: Among 11,231 adult Virus Watch Community Cohort Study participants multivariable logistic regressions were used to estimate the relationships between deprivation and self-reported activities and deprivation and infection (self-reported lateral flow or PCR tests and linkage to National Testing data and Second Generation Surveillance System (SGSS)) between August – December 2021, following the lifting of national public health restrictions. Results: Those living in areas of greatest deprivation were more likely to undertake essential activities (leaving home for work (aOR 1.56 (1.33 – 1.83)), using public transport (aOR 1.33 (1.13 – 1.57)) but less likely to undertake non-essential activities (indoor hospitality (aOR 0.82 (0.70 – 0.96)), outdoor hospitality (aOR 0.56 (0.48 – 0.66)), indoor leisure (aOR 0.63 (0.54 – 0.74)), outdoor leisure (aOR 0.64 (0.46 – 0.88)), or visit a hairdresser (aOR 0.72 (0.61 – 0.85))). No statistical association was observed between deprivation and infection (P=0.5745), with those living in areas of greatest deprivation no more likely to become infected with SARS-CoV-2 (aOR 1.25 (0.87 – 1.79). Conclusion: The lack of association between deprivation and infection is likely due to the increased engagement in non-essential activities among the least deprived balancing the increased work-related exposure among the most deprived. The differences in activities highlight stark disparities in an individuals’ ability to choose how to limit infection exposure.</ns3:p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135385943","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol.","authors":"Amanda Lewis,&nbsp;Madeleine Clout,&nbsp;Jonathan Benger,&nbsp;Philip Braude,&nbsp;Nicholas Turner,&nbsp;James Gagg,&nbsp;Emma Gendall,&nbsp;Simon Holloway,&nbsp;Jenny Ingram,&nbsp;Rebecca Kandiyali,&nbsp;Nick Maskell,&nbsp;David Shipway,&nbsp;Jason E Smith,&nbsp;Jodi Taylor,&nbsp;Alia Darweish-Medniuk,&nbsp;Edward Carlton","doi":"10.3310/nihropenres.13438.2","DOIUrl":"10.3310/nihropenres.13438.2","url":null,"abstract":"<p><strong>Background: </strong>Topical lidocaine patches, applied over rib fractures, have been suggested as a non-invasive method of local anaesthetic delivery to improve respiratory function, reduce opioid consumption and consequently reduce pulmonary complications. Older patients may gain most benefit from improved analgesic regimens yet lidocaine patches are untested as an early intervention in the Emergency Department (ED). The aim of this trial is to investigate uncertainties around trial design and conduct, to establish whether a definitive randomised trial of topical lidocaine patches in older patients with rib fractures is feasible.</p><p><strong>Methods: </strong>RELIEF is an open label, multicentre, parallel group, individually randomised, feasibility randomised controlled trial with economic scoping and nested qualitative study. Patients aged ≥ 65 years presenting to the ED with traumatic rib fracture(s) requiring admission will be randomised 1:1 to lidocaine patches (intervention), in addition to standard clinical management, or standard clinical management alone. Lidocaine patches will be applied immediately after diagnosis in ED and continued daily for 72 hours or until discharge. Feasibility outcomes will focus on recruitment, adherence and follow-up data with a total sample size of 100. Clinical outcomes, such as 30-day pulmonary complications, and resource use will be collected to understand feasibility of data collection. Qualitative interviews will explore details of the trial design, trial acceptability and recruitment processes. An evaluation of the feasibility of measuring health economics outcomes data will be completed.</p><p><strong>Discussion: </strong>Interventions to improve outcomes in elderly patients with rib fractures are urgently required. This feasibility trial will test a novel early intervention which has the potential of fulfilling this unmet need. The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF) feasibility trial will determine whether a definitive trial is feasible.</p><p><strong>Isrctn registration: </strong>ISRCTN14813929 (22/04/2021).</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"3 ","pages":"38"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10593328/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50163985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}