NIHR open research最新文献

{"title":"Designing a multi-arm, multi-stage platform trial for venous leg ulceration - Venous leg ulcers: management and eradication, the VEIN platform study.: Designing a platform/adaptive trial for venous leg ulcers (VLU) - The VEIN platform.","authors":"Sarah Onida, Alun Huw Davies","doi":"10.3310/nihropenres.13847.1","DOIUrl":"10.3310/nihropenres.13847.1","url":null,"abstract":"<p><strong>Background: </strong>Venous leg ulceration (VLU) is the most severe form of venous disease and an important burden to patients and society. Many treatments for VLU exist, including wound therapies, medications, and surgical interventions. However, high-level randomized trial data supporting leg ulcer treatments are lacking, limiting their adoption in clinical practice. We developed a platform trial assessing multiple interventions for VLU comprising multiple multi-arm multi-stage trials.</p><p><strong>Methods: </strong>Scoping reviews, surveys, meetings, and focus groups were conducted over five work streams to inform the development of the proposed platform trial. We involved international experts in venous disease, patients with a lived experience of VLU, healthcare professionals with an interest in VLU care, methodologists, industry partners, and other key stakeholders to help inform priority research areas and methodology, and finalize the proposed trial design.</p><p><strong>Results: </strong>Based on this feedback, the proposed multi-arm multi-stage (MAMS) platform trial will be delivered across three patient domains: patients with active ulceration present for less than six months (Domain 1), patients with active ulceration present for more than six months (Domain 2), and patients with healed ulceration (Domain 3). Interventions included wound care, medication, intervention for superficial venous reflux, and surveillance strategies delivered across community, primary, and secondary care.</p><p><strong>Conclusions: </strong>Our MAMS platform trial development highlighted many challenges and opportunities in methodology development and the potential delivery of such a study. The work performed in our work streams will help inform future research in this field.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"32"},"PeriodicalIF":0.0,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12141998/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144251198","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":"Effectiveness of mucoactives (carbocisteine and hypertonic saline) in addition to usual airway clearance management with usual airway clearance management alone in acute respiratory failure (MARCH): study protocol for a multi-centre 2x2 factorial, randomised, controlled, open-label, Phase 3, pragmatic, clinical and cost-effectiveness trial with internal pilot.","authors":"Bronwen Connolly, Naomi Dickson, Ashley Agus, Bronagh Blackwood, Mark Borthwick, Judy Bradley, Christina Campbell, Marc Chikhani, Mike Clarke, Paul Dark, Ranjit Lall, Cliona McDowell, Margaret McFarland, Michael McKelvey, Cecilia O'Kane, Brenda O'Neill, Gavin Perkins, Murali Shyamsundar, Gordon Sturmey, Clifford C Taggart, John Warburton, Barry Williams, Daniel F McAuley","doi":"10.3310/nihropenres.13905.1","DOIUrl":"10.3310/nihropenres.13905.1","url":null,"abstract":"<p><strong>Background: </strong>Usual airway clearance management in critically ill patients with acute respiratory failure includes suctioning, humidification, use of isotonic saline, and respiratory physiotherapy techniques. Escalation to use of mucoactives occurs when secretions are difficult to clear. Use of mucoactives in clinical practice for this patient population is extensive, yet empirical and variable. Carbocisteine and hypertonic saline are the most used agents, but evidence for their effectiveness is absent or minimal. The lack of existing large-scale randomised trials comparing mucoactives to usual airway clearance management alone in critically ill patients with acute respiratory failure highlights the urgency and necessity of this study.</p><p><strong>Aim: </strong>To determine whether the use of mucoactives in critically ill patients with acute respiratory failure improves clinical outcomes and is cost effective, compared to usual airway clearance management alone.</p><p><strong>Methods: </strong>A UK multi-centre, 2x2 factorial, randomised, controlled, open-label, Phase 3, pragmatic, clinical and cost effectiveness trial with internal pilot. The target sample is 1956 critically ill adults. Participants will be equally allocated across four trial arms. All participants will receive usual airway clearance management. In three intervention groups, participants will receive either carbocisteine, hypertonic saline, or a combination of carbocisteine and hypertonic saline. In the fourth comparator group, participants will receive usual airway clearance management alone. The primary outcome is the duration of mechanical ventilation with secondary clinical, safety, and health resource utilisation outcomes. The trial will be reported in accordance with CONSORT guidelines. Ethical approval was granted by Leeds East (Yorkshire & The Humber) Research Ethics Committee (reference 21/YH/0234) on 28 ^th October 2021. All participants will provide written, informed consent via either Personal or Professional Legal Representatives, and subsequently directly once capacity is regained.</p><p><strong>Trial registration: </strong>Main trial: ISRCTN17683568, https://www.isrctn.com/ISRCTN17683568, 25 ^th November 2021Study Within A Trial: ISRCTN16675252, https://www.isrctn.com/ISRCTN16675252, 3 ^rd November 2021EudraCT Number, 2021-003763-94.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"30"},"PeriodicalIF":0.0,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12163365/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144303899","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":"Pharmacist-led DE-eSCALation of opioids post-surgical dischargE (DESCALE) - A multi-centre, non-randomised, feasibility study protocol.","authors":"Emma L Veale, Johanna Theron, Melanie Rees-Roberts, Julie H Hedayioglu, Ellie Santer, Sabina Hulbert, Vanessa J Short","doi":"10.3310/nihropenres.13716.3","DOIUrl":"10.3310/nihropenres.13716.3","url":null,"abstract":"<p><strong>Background: </strong>Opioids are frequently prescribed for short-term acute pain following surgery. Used appropriately, opioids deliver extremely favourable pain relief. Used longer than 90-days, however, can result in health complications, including unintentional overdose and addiction. Globally, >40 million people are dependent on opioids and annually >100,000 die from opioid misuse. With >4.7 million surgical procedures occurring annually in the United Kingdom it is imperative that opioid-use is managed upon discharge. A declining General Practitioner (GP) workforce and increased patient numbers, however, means gaps in healthcare during transfer of care. Here we report a mixed-methods protocol to understand the feasibility, and acceptability of a clinical pharmacist (CP)-led early opioid deprescribing intervention for discharged surgical patients.</p><p><strong>Methods: </strong>DESCALE is a multicentre, non-randomised, pragmatic feasibility study. Participants aged ≥18 years who have undergone a surgical procedure at a single NHS trust in Southeast England and discharged with opioids and without a history of long-term opioid use, cancer diagnosis or study contraindications will be offered a Medicines Use Review (MUR) within 7-10 days of discharge. The MUR will be delivered by CPs at participating GP practices. Feasibility outcomes will focus on recruitment, fidelity of CPs to deliver the MUR, and barriers within primary care that affect delivery of the intervention, with a maximum sample size of 100. Clinical outcomes will focus on the number of participants that reduce or stop opioid use within 91 days. Prescribing, medical, surgical, and demographic data for individual participants will be collected and analysed to inform future trial design. Qualitative interviews with participants and associated healthcare professionals will explore acceptability and implementation of the intervention.</p><p><strong>Conclusion: </strong>Data collected with respect to opioid use post-surgery, feasibility and acceptability of the intervention, patient experience and outcome data will inform the design of future research and larger clinical trials.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"4 ","pages":"48"},"PeriodicalIF":0.0,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757927/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143049178","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":"Remote multicomponent rehabilitation compared to standard care for survivors of critical illness after hospital discharge (iRehab): a protocol for a randomised controlled assessor-blind clinical and cost-effectiveness trial.","authors":"Brenda O'Neill, Judy Martina Bradley, Bronwen Connolly, Julie Bruce, Martin Underwood, Ranjit Lall, Chen Ji, Jill Costley, Rachel Clarke, Paul Dark, Penelope Firshman, Nigel D Hart, Annette Henderson, Katherine Jones, Roger Kenyon, Jason Madan, Gavin D Perkins, Miriam Ratna, Kerry Raynes, Ella Terblanche, Rowena Williams, Mandana Zanganeh, Danny McAuley","doi":"10.3310/nihropenres.13910.1","DOIUrl":"10.3310/nihropenres.13910.1","url":null,"abstract":"<p><strong>Background: </strong>The consequences of critical illness can be substantial and multifactorial, encompassing physical deconditioning, mental health impairments, fatigue, and declines in health-related quality of life. We hypothesise that for people discharged after intensive care unit (ICU) for a critical illness, a six-week remote multicomponent rehabilitation intervention improves health-related quality of life, physical function, fatigue, mood, and other health-related outcomes after eight weeks, compared to standard care.</p><p><strong>Methods: </strong>This is a pragmatic, randomised controlled, open-label, assessor blind, multicentre, clinical and cost effectiveness trial with internal pilot and embedded process evaluation. Recruitment will take place in NHS hospitals across the UK. Adults (n=428: control n= 197; intervention: n=231) within 12 weeks of discharge from hospital following an ICU admission for critical illness, requiring mechanical ventilation ≥48hours will be recruited.The intervention is a six week multicomponent, structured, rehabilitation programme, delivered remotely by a trained intervention team. The intervention includes four components: weekly symptom management; targeted exercise; psychological support, and peer support and information. The control group will receive standard NHS care.The primary outcome is Health-related quality of life (HRQoL) at eight weeks post-randomisation measured using the EQ-5D-5L. Secondary outcomes are: HRQoL (six months), physical function, fatigue, anxiety and depression, healthcare resource use at eight weeks and six months and intervention acceptability.</p><p><strong>Conclusions: </strong>This trial will test a centrally delivered mulitcomponent rehabilitation intervention for survivors of critical illness, irrespective of geographic location or critical illness diagnosis.</p><p><strong>Trial registration: </strong>The trial is registered (04.07.2022) with the International Standard Randomised Controlled Trial Number (ISRCTN) Register ISRCTN11266403 https://doi.org/10.1186/ISRCTN11266403.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"29"},"PeriodicalIF":0.0,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12120417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144183658","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":"Protocol: Applying co-production and peer research approaches with community organisations to develop a blueprint for the centre for Co-Production and Peer Research (CoPPeR) network.","authors":"Nazish Mahmood, Rosemary R C McEachan, Bridget Lockyer, Chloe Parekh, Chris Cartwright, Daniel Balaz, Gulsoom Akhtar, Jennifer Hall, Lauren Batty, Tahira Amin, Zille Huma Dogra, Shahid Islam","doi":"10.3310/nihropenres.13886.1","DOIUrl":"10.3310/nihropenres.13886.1","url":null,"abstract":"<p><strong>Background: </strong>Community inclusive approaches in research contribute to the quality and impact of health outcomes, yet communities often lack considerable influence over research processes. The Co-Production and Peer Research (CoPPeR) network aims to redress this gap by fostering equitable partnerships between communities, researchers, and policymakers. This paper outlines the protocol for establishing the CoPPeR network in Bradford, UK, where community-driven research initiatives are crucial for addressing local health disparities.</p><p><strong>Methods: </strong>We will implement four work-packages using participatory research methods and citizen science approaches. We will collaborate with four community organisations, each located in geographically distinct neighbourhoods serving diverse communities. Together we will co-produce citizen science projects to explore the impact of local environments on residents' health and wellbeing. We will build capacity through providing funding and training to community organisations who will recruit 20 peer researchers across the four areas to design, implement, and analyse their individual research projects. We will co-evaluate the co-production processes in a concomitant way through stakeholder workshops. Finally, we will explore the readiness and opportunities for statutory health and research partners to embed the CoPPeR network.</p><p><strong>Results: </strong>Anticipated results include comprehensive case studies revealing the factors which affect health and wellbeing in each of the case study sites along with the mechanisms of co-production strategies for enhancing community influence in research. The evaluation will provide us with evidence on what works for which communities; this will be crucial to support our plans for developing a network to augment efforts to advance community inclusive approaches.</p><p><strong>Conclusion: </strong>The CoPPeR network aims to enable long-term sustainable partnership between researchers, decision makers and seldom heard communities which will enable effective co-production of research and policy. By detailing our experiences and outcomes we hope that others, both in the UK and internationally, can learn from and replicate our approach.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"27"},"PeriodicalIF":0.0,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12123296/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144201023","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":"Consumer knowledge of and engagement with traditional takeaway and dark kitchen food outlets.","authors":"Lucie Nield, Helen Martin, Claire Wall, Jo Pearce, Rachel Rundle, Simon Bowles, David Harness, Jordan D Beaumont","doi":"10.3310/nihropenres.13735.2","DOIUrl":"10.3310/nihropenres.13735.2","url":null,"abstract":"<p><strong>Background: </strong>Dark kitchens - delivery-only food outlets operating through digital technology platforms - are a contemporary addition to the food environment. Some concerns have been raised around the ability for local authorities to identify and regulate these businesses, with growing concern around the nutritional quality of foods, food safety practices and impact on the local food environment. The present work explores consumer understanding of and engagement with dark kitchen and traditional takeaway establishments.</p><p><strong>Methods: </strong>Healthy adults living in the United Kingdom completed an online survey comprising of questions measuring demographics, engagement with takeaways and dark kitchens, purchasing behaviours and decision making, and knowledge and understanding around dark kitchens. Data were analysed using descriptive statistics.</p><p><strong>Results: </strong>In total, 2,023 participants (46.3 ± 16.7 years) completed the survey. Forty percent purchased a takeaway at least weekly, often through aggregator applications (e.g., Just Eat, Deliveroo). Food was mainly purchased as a treat (79.3%), for enjoyment of the food or taste (60.8%) and for convenience (58.2%). When ordering, consumers considered the taste (88.1%), quality (83.5%), value for money (77.8%), and familiarity with (68.1%) and reputation of the business (60.0%). Only 24.7% of participants had heard of dark kitchens and 9.1% had knowingly purchased from one. After reading a working definition, 54.9% said they would purchase from a dark kitchen, but most would want to know explicitly that they were ordering from these businesses. A major concern when purchasing food from a dark kitchen or takeaway outlet was trust in the food safety and hygiene standards.</p><p><strong>Conclusion: </strong>Consumers are unfamiliar with dark kitchens and are not aware of or confident in identifying these businesses. This confusion and concerns around food safety mean dark kitchens are often viewed negatively. Consumers would prefer more transparency in where their foods are being prepared to allow for more informed decision-making.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"4 ","pages":"64"},"PeriodicalIF":0.0,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920686/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143665625","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 follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study.","authors":"Jennifer Crow, Hilary Watt, Mary Wells, Paresh Malhotra","doi":"10.3310/nihropenres.13649.3","DOIUrl":"https://doi.org/10.3310/nihropenres.13649.3","url":null,"abstract":"<p><strong>Background: </strong>Of the 150 000 people per year in the UK who have strokes, third to half will experience a so-called 'minor stroke'. Although appearing benign these strokes put a person at increased risk of further strokes and survivors are usually considered 'too good' for referral onto community stroke services. When back at home the hidden effects of stroke like fatigue and changes in mood and cognition become apparent and impact return to work, relationships and everyday activities. Alongside this, managing the risk of recurrence, highest early after an initial stroke, is a priority. People with stroke report feeling abandoned after discharge with unmet information and support needs.</p><p><strong>Methods: </strong>To address this issue, we reviewed the literature, met with people with stroke and other stakeholders to develop an early, personalised follow-up programme of care for those who currently only receive routine medical follow-up appointments. The design of this complex intervention is informed by the NIHR/MRC framework for complex intervention development and the framework of action described by O'Cathain and colleagues. The intervention is underpinned by self-determination theory. We will be conducting a randomised, mixed methods, single-centre feasibility study to explore the acceptability and feasibility of the intervention. Sixty participants will be recruited from a Hyperacute Stroke Unit and Rapid Assessment Clinic and randomised to the intervention or control group. The intervention group will receive personalised follow-up appointments at two- and six-weeks post-discharge. All participants will have outcome measures taken at baseline and twelve-weeks post-stroke. Patient reported outcomes will be reviewed to assess their suitability for a later definitive trial. Qualitative interviews will be conducted to gain a deeper understanding of life after stroke from those who did and did not receive the intervention.</p><p><strong>Conclusions: </strong>Study findings will be used to further refine the intervention, methods and outcome measurements used. These refinements will inform a future multicentre randomised controlled trial.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"4 ","pages":"44"},"PeriodicalIF":0.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11868739/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143545045","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":"Severe, uncontrolled epilepsy in pregnancy: A population-based case-control study.","authors":"Bryn Kemp, Andrew Kelso, David Williams, Marian Knight","doi":"10.3310/nihropenres.13743.2","DOIUrl":"10.3310/nihropenres.13743.2","url":null,"abstract":"<p><strong>Background: </strong>Epilepsy affects one percent of the UK population and is the most common serious neurological condition experienced during pregnancy. We compared the characteristics, clinical management, and pregnancy outcomes in women with severe, uncontrolled epilepsy to those of women with well controlled disease.</p><p><strong>Methods: </strong>We conducted a population-based case-control study in all UK consultant-led maternity units. Cases of severe uncontrolled epilepsy during pregnancy were identified prospectively and reported via the UK Obstetric Surveillance System (UKOSS). Severe epilepsy was defined <i>a-priori</i> as ≥1 of the following: admission to hospital during pregnancy to manage seizures; prescribed ≥3 antiepileptic medications; or died from epilepsy. Controls comprised women with epilepsy not meeting the case definition, identified within the same centres as cases. Pre-pregnancy epilepsy control and pregnancy outcomes were compared between groups using multivariable logistic regression.</p><p><strong>Results: </strong>We identified 94 cases between 1 October 2015 and 31 March 2017 and compared these with 186 controls. Cases were significantly more likely to be admitted to manage seizures in the year preceding pregnancy (42/94 cases vs 10/186 controls, adjusted odds ratio [aOR]=7.38 [95% CI 2.70-20.2]), and to report their most recent seizure within 3 months of pregnancy (51/94 cases vs 18/186 controls, aOR=5.86 [95% CI 2.30-15.0]). Cases were significantly more likely to deliver before 37 weeks (20/94 cases vs 8/186 controls, aOR=7.61 [95% CI 2.87-20.2]).</p><p><strong>Conclusions: </strong>Women admitted for seizure management in the year before pregnancy are at higher risk of severe epilepsy during pregnancy and of preterm birth. These women should be prioritised for discussion about pregnancy and contraception. When pregnant, they should be reviewed as early as possible by specialists in the management of epilepsy during pregnancy. Delivering messages about the importance of pregnancy planning and contraception to all women with epilepsy should be viewed as the responsibility of all clinicians involved their care.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"4 ","pages":"53"},"PeriodicalIF":0.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971622/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143797305","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 Pain mAnagement for childreN and young people attendeD by Ambulance (PANDA): protocol for a realist review.","authors":"Georgie Nicholls, Georgette Eaton, Marishona Ortega, Kacper Sumera, Michael Baliousis, Jessica Hodgson, Despina Laparidou, Aloysius Niroshan Siriwardena, Paul Leighton, Sarah Redsell, Bill Lord, Tatiana Bujor, Gregory Adam Whitley","doi":"10.3310/nihropenres.13627.3","DOIUrl":"10.3310/nihropenres.13627.3","url":null,"abstract":"<p><strong>Background: </strong>Each year in England, 450,000 children and young people (CYP) under 18 years of age are transported by ambulance to emergency departments. Approximately 20% of these suffer acute pain caused by illness or injury. Pain is a highly complex sensory and emotional experience. The intersection between acute pain, unwell CYP and the unpredictable pre-hospital environment is convoluted. Studies have shown that prehospital pain management in CYP is poor, with 61% of those suffering acute pain not achieving effective pain relief (abolition or reduction of pain score by 2 or more out of 10) when attended by ambulance. Consequences of poor acute pain management include altered pain perception, post-traumatic stress disorder and the development of chronic pain. This realist review will aim to understand how ambulance clinicians can provide improved prehospital acute pain management for CYP.</p><p><strong>Methods: </strong>A realist review will be conducted in accordance with the Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) guidance. A five-stage approach will be adopted; 1) Developing an Initial Programme Theory (IPT): develop an IPT with key stakeholder input and evidence from informal searching; 2) Searching and screening: conduct a thorough search of relevant research databases and other literature sources and perform screening in duplicate; 3) Relevance and rigour assessment: assess documents for relevance and rigour in duplicate; 4) Extracting and organising data: code relevant data into conceptual \"buckets\" using qualitative data analysis software; and 5) Synthesis and Programme Theory (PT) refinement: utilise a realist logic of analysis to generate context-mechanism-outcome configurations (CMOCs) within and across conceptual \"buckets\", test and refine the IPT into a realist PT.</p><p><strong>Conclusion: </strong>The realist PT will enhance our understanding of what works best to improve acute prehospital pain management in CYP, which will then be tested and refined within a realist evaluation.</p><p><strong>Registration: </strong>PROSPERO Registration: CRD42024505978.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"4 ","pages":"42"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11443194/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142362511","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":"Protocol for the economic evaluation of integrated community-based care compared with integrated facility-based care for HIV, hypertension and diabetes in Tanzania and Uganda (INTE-COMM trial).","authors":"Gerard Joseph Abou Jaoude, Ivan Namakoola, Faith Aikaeli, Godfather Kimaro, Faith Moyo, Francis Xavier Kasujja, Erik Van Widenfelt, Sokoine Kivuyo, Josephine Birungi, Gerald Mutungi, Omary Said Ubuguyu, Stephen Watiti, Kaushik Ramaiya, Sayoki Mfinanga, Moffat Nyirenda, Anupam Garrib, Shabbar Jaffar, Jolene Skordis, Neha Batura","doi":"10.3310/nihropenres.13794.2","DOIUrl":"10.3310/nihropenres.13794.2","url":null,"abstract":"<p><strong>Background: </strong>The number of people living with multiple chronic conditions in sub-Saharan Africa is increasing, but health facilities are unable to meet demand. To improve health system capacity and access to care, community models of HIV care have been trialled in countries such as Tanzania and Uganda. However, no evidence exists to inform policymakers on the effectiveness and cost-effectiveness of integrated community-based models of care for HIV and chronic non-communicable conditions. This protocol outlines a within-trial economic evaluation to address this gap.</p><p><strong>Methods & analysis: </strong>We will estimate the costs and cost-effectiveness of integrated community-based care for HIV, hypertension and diabetes compared with facility-based care within the INTE-COMM pragmatic cluster-randomised trial in Tanzania and Uganda. Analyses will adopt a 52-week time horizon, the duration of trial follow-up. The full enrolled trial sample will be analysed from a societal perspective, comprising provider and patient perspectives. Economic costs will be estimated, which includes valuing inputs such as donated goods or time foregone by participants because of receiving care. For provider costs, participant case report forms will inform resource use along with data from facilities and community sites. Resources will be valued using project accounts, facility spending, and locally available cost data. Patient costs will be estimated based on a care-seeking and cost questionnaire administered to participants. Estimated costs will be analysed with co-primary trial outcomes on plasma viral load suppression, glycaemia and blood pressure control to calculate incremental cost-effectiveness ratios (ICER). We will also calculate ICERs for secondary trial outcomes related to health-related quality of life and wellbeing. Cost drivers and outcomes will be varied within confidence bounds in a two-way sensitivity analysis. We will investigate equity impact by estimating the mean difference in outcomes between integrated community-based and facility-based care across household socio-economic quintiles and by measuring whether participants incurred catastrophic health expenditures.</p><p><strong>Trial registration number: </strong>The ISRCTN Registry: ISRCTN15319595. Registered on 07 June 2022: https://doi.org/10.1186/ISRCTN15319595.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"4 ","pages":"80"},"PeriodicalIF":0.0,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11868744/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143545121","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}