NIHR open research最新文献

{"title":"Using publicly available UK datasets to identify recruitment sites to maximise inclusion of under-served groups: three case studies","authors":"Alison Booth, Catriona McDaid, Ashley Scrimshire, Harvinda Singh, A. Scantlebury, C. Hewitt","doi":"10.3310/nihropenres.13551.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13551.1","url":null,"abstract":"Background There is strong evidence that those recruited into studies are not always representative of the population for whom the research is most relevant. Development of the study design and funding decisions are points in the research process where considerations about inclusion of under-served populations may usefully be made. Current practical guidance focuses on designing and modifying participant recruitment and retention approaches but an area that has not been addressed is recruitment site selection. Methods We present case studies of three NIHR funded trials to demonstrate how publicly available UK population datasets can be used to facilitate the identification of under-served communities for inclusion in trials. The trials have different designs, address different needs and demonstrate recruitment planning across Trauma centres, NHS Trusts and special educational settings. We describe our use of national freely available datasets, such as those provided by NHS Digital and the Office for National Statistics, to identify potential recruitment sites with consideration of health status, socio-economic status and ethnicity as well as clinical and risk factors to support inclusivity. For all three studies, we produced lists of potential recruitment sites in excess of the number anticipated as necessary to meet the recruitment targets. Discussion We reflect on the challenges to our approach and some potential future developments. The datasets used are all free to use but each has their limitations. Agreeing search parameters, acceptable proxies and identifying the appropriate datasets, then cross referencing between datasets takes considerable time and particular expertise. The case studies are trials, but the methods are generalisable for various other study types. Conclusion Through these exemplars, we aim to build on the NIHR INCLUDE project, by providing trialists with a much needed practical approach to embedding EDI into trial design at the grant application stage.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"82 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140709465","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":"Mobility and strength training with and without protein supplements for pre-frail or frail older adults with low protein intake: the Maximising Mobility and Strength Training (MMoST) feasibility randomised controlled trial protocol.","authors":"Kavita Biggin, Ioana R Marian, Sarah E Lamb, Alana Morris, Caoileann Murphy, Andrew Carver, Nirvana Croft, Esther Williamson","doi":"10.3310/nihropenres.13507.2","DOIUrl":"10.3310/nihropenres.13507.2","url":null,"abstract":"<p><p>Background Frailty is a common syndrome affecting older people and puts them at risk of hospitalisation, needing care or death. First signs of frailty include reduced muscle strength and mobility decline. A key cause of mobility decline as we age is sarcopenia (age related reduction in muscle strength and mass). Poor nutrition contributes to sarcopenia. A shortfall in protein is associated with reduced muscle mass and strength. This may be due to inadequate intake but also because older people have higher protein needs, especially those with multimorbidity. We need to develop effective treatment to reduce or slow the onset of frailty and mobility decline. Exercise is a recommended treatment. Protein supplements to address the shortfall in protein have the potential to enhance the benefit of regular exercise in frail or pre-frail older adults. This has yet to be definitively demonstrated. Aim To establish the feasibility of conducting an RCT evaluating mobility and strength training with or without protein supplements for people over 60 years old who are frail or pre-frail with a low protein intake. Methods A multicentre, parallel, 2-group, feasibility RCT. Participants (recruitment target = 50) with problems walking, low protein intake and classified as frail or pre-frail will be recruited from four NHS Physiotherapy community services. Participants will be randomised (secure computer-generated: 1:1) to receive 24 weeks of mobility and strength training (delivered in 16 group sessions plus home exercises) or 24 weeks of mobility and strength training with daily protein supplements. Primary feasibility objectives are to estimate 1) ability to screen and recruit eligible participants, 2) intervention fidelity, adherence, and tolerance and 3) retention of participants at follow up. Secondary objectives are to 1) test data collection procedures, 2) assess data completeness and 3) confirm sample size calculation for a definitive RCT. Registration ISRCTN Registry (ISRCTN30405954; 18/10/2022).</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"3 ","pages":"62"},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11319903/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141977408","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":"Assessment of routine pre-operative group and save testing in patients undergoing cholecystectomy: a retrospective cohort study","authors":"Lawrence O’Leary, William Sherwood, Michael Fadel, Musa Barkeji","doi":"10.3310/nihropenres.13543.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13543.1","url":null,"abstract":"Background Routine group and save (G&S) testing is frequently performed prior to cholecystectomy, despite growing evidence that a targeted approach is safe and avoids unnecessary investigations. This retrospective cohort study explored frequency of testing in our unit, and rates of and independent pre-operative risk factors for peri-operative blood transfusion. Methods Health records of 453 consecutive adults who underwent cholecystectomy in a UK NHS trust were reviewed for blood transfusion up to 30 days post-operatively. We compared the need for transfusion against patient demographics, indication and urgency of surgery, and the number of prior emergency hospital attendances with gallstone complications. Logistic regression determined whether prior attendances with complications of gallstones independently predicted the need for transfusion. Results Peri-operative blood transfusions within 30 days of operation occurred in 1.1% of cases, with no requirement for uncrossmatched blood. Patients who received a blood transfusion tended to have higher American Society of Anesthesiologists (ASA) grades (p<0.001), were more likely to have an underlying primary haematological malignancy (20.0% vs. 0.2%; p<0.001) and prior emergency hospital attendances with gallstone complications (median 4 vs. 1; p<0.001). Logistic regression showed each prior emergency attendance was associated with 4.6-fold odds of transfusion (p=0.019). Receiver operating characteristic curve analysis showed an area under the curve of 0.92. Three or more attendances predicted need for transfusion with 60.0% sensitivity and 98.0% specificity. Seventy-four percent had at least one G&S sample taken pre-operatively, costing the trust approximately £3,800 per year in materials. Conclusions Pre-operative G&S testing prior to cholecystectomy may not be routinely required. Increased frequency of prior emergency hospital attendances with gallstone complications and co-morbidities associated with coagulopathies were pre-operative risk factors for post-operative blood transfusion. More selective testing could provide large financial savings for health institutions without compromising patient safety.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"6 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140739461","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":"Research priorities for randomised controlled trials in chronic migraine preventive medication: A stakeholder consensus workshop","authors":"S. Rees, Andrew Cooklin, Callum Duncan, Manjit Matharu, Seyran Naghdi, Martin Underwood, H. Mistry","doi":"10.3310/nihropenres.13548.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13548.1","url":null,"abstract":"Background Chronic migraine is a disabling condition that can substantially impact on quality of life. People with chronic migraine have headaches on at least 15 days of every month. Preventative medications aiming to reduce number of days with migraine are available, but high-quality randomised evidence is lacking for many drugs, and it is unclear which medications should be prioritised for research. There is also no existing evidence about patient and clinicians’ priorities for research. Methods We undertook a consensus workshop with patient and healthcare professional stakeholders, using nominal group technique, to understand these stakeholders’ priorities for future randomised controlled trials. We reached a consensus on a set of research recommendations for the field. Results Eight people with chronic migraine and eleven healthcare professionals took part in an online workshop. Comparisons of calcitonin gene-related peptide monoclonal antibodies (CGRP MAbs) and OnabotulinumtoxinA (BTA) were a top priority for our group. Candesartan and Flunarizine were the top drugs the group wanted to compare against placebo. Conclusions These research recommendations should guide researchers in the field, and funders when prioritising commissioned research and assessing funding applications. Particular areas to explore further are Candesartan or Flunarizine versus placebo, and comparing and combining CGRP MAbs with other medications.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"22 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140741571","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 trial-based economic evaluation analysis of a complex digital health intervention including a computerised decision support tool: the iFraP intervention","authors":"Michele Siciliano, Sarah Bathers, Ida Bentley, L. Bullock, Andrea Cherrington, Emma M Clark, Jane Fleming, Clare Jinks, Sarah Lewis, Christian Mallen, Elaine Nicholls, Terence W O'Neill, Jo Smith, David Webb, Z. Paskins, Cynthia P Iglesias-Urrutia","doi":"10.3310/nihropenres.13575.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13575.1","url":null,"abstract":"Background Digital health interventions (DHI) are associated with significant promise. In recent years, the need to assess the value of these healthcare technologies has motivated a debate regarding the suitability of existing economic evaluation methods in the context of DHI evaluation. Some have argued that robust economic evaluation methods may not be capable of capturing relevant DHI’s characteristics. Others consider that assessing the value of DHI might not be feasible. This protocol paper challenges that view. More specifically, it describes early Health Technology Assessments (HTA) methods to rigorously assess the value for money of a complex intervention including a digital decision support tool i.e., Improving uptake of Fracture Prevention drug treatments (iFraP) as a tracer intervention. iFraP is a complex intervention consisting of a computerised decision support tool, a clinician training package, and information resources to facilitate shared decision-making, increase informed medicine initiation and reduce levels of medicine discontinuation. iFraP’s development was motivated by a view that good quality shared decision-making conversations have the potential to improve levels of osteoporosis medicine uptake. Methods An early economic evaluation of the iFraP intervention was designed to identify, measure, and evaluate the costs and health benefits of iFraP compared to usual practice in Fracture Liaison Services (FLSs). A within-trial cost-effectiveness from the perspective of the National Health Service and Personal Social Service in England will be conducted using patient’s self-reported health related quality of life (HRQoL) and resource use from the iFraP randomised controlled trial. Microanalysis will be used to estimate iFraP’s intervention cost. Finally, Bayesian Value of Information analysis will allow us to estimate an upper bound for the potential health benefits gained from reducing uncertainty on the impact of the iFraP intervention to support uptake and adherence with osteoporosis medicines. Trial registration ISRCTN10606407 - https://doi.org/10.1186/ISRCTN10606407","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"287 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140750659","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 person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial protocol","authors":"L. Bullock, Elaine Nicholls, Andrea Cherrington, S. Butler-Walley, Emma M Clark, Jane Fleming, S. Leyland, Ida Bentley, Simon Thomas, Cynthia P Iglesias-Urrutia, David Webb, Jo Smith, Sarah Bathers, Sarah Lewis, Angela Clifford, Michele Siciliano, Joanne Protheroe, Sarah Ryan, J. Lefroy, N. Dale, A. Hawarden, Sarah Connacher, Robert Horne, Terence W O'Neill, Christian D Mallen, Clare Jinks, Z. Paskins","doi":"10.3310/nihropenres.13571.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13571.1","url":null,"abstract":"Background Good quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations. Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation. Methods The iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics. Discussion The iFraP trial will answer important questions about the effectiveness of the new ‘iFraP’ osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. Trial registration: ISRCTN 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"43 14","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140751995","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":"Disciplinary behaviour management strategies  in schools and their impact on student psychosocial outcomes: A systematic review","authors":"S. Ijaz, James Nobles, Loubaba Mamluk, Sarah Dawson, Bonnie Curran, Rachael Pryor, Sabi Redwood, Jelena Savović","doi":"10.3310/nihropenres.13563.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13563.1","url":null,"abstract":"Background Disciplinary behaviour management strategies are implemented in schools to manage pupil behaviour. There is limited evidence of their intended impact on behaviour but there is growing concern around the potential negative impacts on pupil wellbeing. Methods We carried out a systematic review to examine the impact of these strategies on psychosocial outcomes in pupils (PROSPERO Registration: CRD42021285427). We searched multiple sources and double-screened titles, abstracts, and full texts. Data extraction and risk of bias assessment were done by one reviewer and checked by another. Results were narratively synthesised. Results We included 14 studies, from 5375 citations, assessing temporary suspension (n=10), verbal reprimand (n=2), and mixed strategies (n=2). Depression was the most common outcome (n=7), followed by academic grades (n=4) and behaviour in class (n=4). All except one study were at high risk of bias. We found a recurring pattern in the evidence of disciplinary strategies associated with poor mental wellbeing and behaviour in pupils. The effect on academic attainment was unclear. Conclusions Disciplinary behaviour management strategies may have negative impact on pupil mental wellbeing and class behaviour. These important consequences should be assessed in better designed studies before these strategies are implemented.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":" 99","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140384643","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":"Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review","authors":"K. Biggs, Caroline Dix, Frances Shiely, Shaun Treweek, V. Shepherd, Athene Lane, Heidi R Green, Talia Isaacs, Andrew Willis, Cindy Cooper","doi":"10.3310/nihropenres.13524.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13524.1","url":null,"abstract":"Background Participants in clinical trials often do not reflect the populations that could benefit from the treatments being investigated. There are known barriers to trial participation for under-served groups, but limited evidence on strategies to alleviate these barriers to improve representation. This scoping review aimed to identify effective interventions and design features that improve the representation `of under-served groups in trials, focusing on the UK and Ireland. Methods We included methodological research studies that reported interventions to improve representation of ethnic minority groups, socioeconomically disadvantaged groups, older people, or those with impaired capacity to consent to randomised controlled trials, conducted in the UK and Ireland, published between 2000–2021. Systematic searches were conducted in November 2021 and data were independently extracted by two authors and narratively synthesised. Results Seven studies were included: one randomised controlled study embedded in five trials, one mixed-methods study, and five studies reporting ‘lessons learnt’ from one trial. We categorised the 47 reported interventions or strategies into nine broad themes: Recruitment sites, recruitment settings, community engagement, and communication with participants, incentives, inclusion criteria, flexibility, patient documentation, and the consent process. Only 28/47 interventions were evaluated, 23 of which were comparison of recruitment pathways. The randomised study found that a £100 incentive mentioned in the invitation letter increased positive responses overall across drug trials in cardiovascular disease and hypertension, but not for older people or those living in the most deprived areas. Invitation letters via GPs and working with communities were reported as successful recruitment pathways in recruiting different under-served populations. Conclusions Interventions aiming to improve the recruitment of under-served groups in the UK and Ireland were reported across seven papers, but their effectiveness was rarely rigorously evaluated. Included studies were context specific. Using a variety of recruitment methods is likely to help achieve a more diverse cohort.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":" 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140382217","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 crossover trial of tezacaftor-ivacaftor for gut dysfunction in cystic fibrosis with magnetic resonance imaging (MRI) outcomes: a pilot study.","authors":"Christabella Ng, Neele S Dellschaft, Caroline Hoad, Luca Marciani, Robin Spiller, Colin Crooks, Trevor Hill, Alex Menys, Jochen G Mainz, Helen Barr, Penny A Gowland, Giles Major, Alan R Smyth","doi":"10.3310/nihropenres.13510.2","DOIUrl":"10.3310/nihropenres.13510.2","url":null,"abstract":"<p><strong>Background: </strong>People with cystic fibrosis (CF) can experience recurrent chest infections, pancreatic exocrine insufficiency and gastrointestinal symptoms. New cystic fibrosis transmembrane conductance regulator (CFTR) modulator drugs improve lung function but gastrointestinal effects are unclear. We aimed to see if a CFTR modulator (tezacaftor-ivacaftor,TEZ/IVA) improves gastrointestinal outcomes in CF.</p><p><strong>Methods: </strong>We conducted a randomised, double-blind, placebo-controlled, two-period crossover trial (2019-2020) at Nottingham University Hospitals. The effects of TEZ/IVA on gut physiology were measured using MRI. Participants were randomly assigned to treatment sequences AB or BA (A:TEZ/IVA, B:placebo, each 28 days), with a 28-day washout period. Participants had serial MRI scans at baseline and after 19-23 days of each treatment. Due to the COVID-19 pandemic, a protocol amendment allowed for observer-blind comparisons prior to and during TEZ/IVA. In such cases, participants were not blind to the treatment but researchers remained blind. The primary outcome was oro-caecal transit time (OCTT). Secondary outcomes included MRI metrics, symptoms and stool biomarkers.</p><p><strong>Results: </strong>We randomised 13 participants. Before the COVID-19 pandemic 8 participants completed the full protocol and 1 dropped out. The remaining 4 participants followed the amended protocol. There were no significant differences between placebo and TEZ/IVA for OCTT (TEZ/IVA >360minutes [225,>360] vs. placebo 330minutes [285,>360], p=0.8) or secondary outcomes. There were no adverse events.</p><p><strong>Conclusions: </strong>Our data contribute to a research gap in the extra-pulmonary effects of CFTR modulators. We found no effect after TEZ/IVA on MRI metrics of gut function, GI symptoms or stool calprotectin. Effects might be detectable with larger studies, longer treatment or more effective CFTR modulators.</p><p><strong>Clinicaltrialsgov registration: </strong>NCT04006873 (02/07/2019).</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"3 ","pages":"65"},"PeriodicalIF":0.0,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11320032/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141977375","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":"Improving hospital-based opioid substitution therapy (iHOST): protocol for a mixed-methods evaluation","authors":"D. Lewer, Michael Brown, Adam Burns, Niamh Eastwood, Rosalind Gittens, Adam Holland, V. Hope, Aubrey Ko, Penny Lewthwaite, Ann-Marie Morris, Adrian Noctor, Andrew Preston, Jenny Scott, Erica Smith, Sedona Sweeney, N. Tilouche, Marisha Wickremsinhe, Magdalena Harris","doi":"10.3310/nihropenres.13534.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13534.1","url":null,"abstract":"Background Opioid substitution therapy is associated with improved health and social outcomes for people who use heroin and other illicit opioids. It is typically managed in the community and is not always continued when people are admitted to hospital. This causes opioid withdrawal, discharge against medical advice, and increased costs. We are establishing a project called iHOST (improving hospital opioid substitution therapy) to address these problems. This is an applied health research project in which we will develop and evaluate an intervention that aims to improve opioid substitution therapy in three acute hospitals in England. The intervention was developed in collaboration with stakeholders including people who use opioids, hospital staff, and other professionals who work with this group. It includes five components: (1) a card that patients can use to help hospital clinicians confirm their opioid substitution therapy, (2) a helpline for patients and staff, (3) an online training module for staff, (4) a clinical guideline for managing opioid withdrawal in hospital, and (5) ‘champion’ roles at each hospital. Methods We will do a mixed-methods study including a quasi-experimental quantitative study and a qualitative process evaluation. The primary outcomes for the quantitative study are discharge against medical advice and emergency readmission within 28 days. We will do a difference-in-difference analysis comparing changes in these outcomes for patients at iHOST sites with changes for patients at control hospitals. The process evaluation will use in-depth interviews, focus groups, and site observations with people who use opioids and staff. We will assess acceptability of the intervention, barriers and facilitators to implementation, and contextual factors impacting outcomes. Impact We anticipate that iHOST will improve care for hospital patients who use illicit opioids and/or are receiving community-based opioid substitution therapy. Depending on the results, we will promote the intervention at hospitals across the UK. Dissemination, including through publication, will inform hospital-based services for people who use drugs both in the UK and other countries.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140247523","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}