NIHR open research最新文献

{"title":"Secure care (forensic) hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol.","authors":"Simon S Hackett, Paula Foscarini-Craggs, Katie Aafjes-van Doorn, Matthew Franklin, Muhammad Riaz, Ania Zubala, Jennifer Condie, Iain McKinnon, Arman Iranpour, Toni Leigh Harrison, Sophie Rose, Elizabeth Randell, Rachel McNamara","doi":"10.3310/nihropenres.13801.1","DOIUrl":"10.3310/nihropenres.13801.1","url":null,"abstract":"<p><strong>Background: </strong>Within the criminal Justice System in the UK one-third of prisoners self-identified as having a learning difficulty and/or disability. This is broadly consistent with formal assessment of the needs of offenders, with 29% of the offender population having a learning disability. In the UK, NHS and private/independent sector secure care (Forensic) provides assessment and treatment for men and women who have come into contact within the Criminal Justice System and have mental health needs, a personality disorder, and/or learning disability. Patients in these services are often detained under the Mental Health Act (1983) and/or have licence conditions that have been set by the Ministry of Justice.Interpersonal art psychotherapy was developed within secure care as an accessible psychological intervention for adults with mild intellectual disabilities or borderline intellectual functioning. A feasibility randomised controlled trial of interpersonal art psychotherapy showed that assessment of key feasibility objectives were met and the trial procedures were acceptable, indicating progression to a definitive trial.</p><p><strong>Methods: </strong>This is a two-arm single blind randomised controlled trial of effectiveness comparing manualised interpersonal art psychotherapy and Usual Care (UC) to UC. The Randomised Controlled Trial (RCT) will be conducted in a minimum of 10 secure care hospitals (NHS & Independent) with secure care (Forensic) facilities and will recruit 150 participants. The trial design includes an integrated assessment of cost-effectiveness.</p><p><strong>Results: </strong>Individuals with intellectual disabilities and borderline intellectual functioning were involved in the design and set up of the trial. The trial is currently open to recruitment for participants from eight NHS and private/independent secure care sites in the UK.</p><p><strong>Conclusions: </strong>A full report of study results will be published on completion of the trial.</p><p><strong>The trial has been registered: </strong>ISRCTN57406593 ( ISRCTN registry, 2024). This published protocol corresponds with version 6, dated 12.08.2024.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"21"},"PeriodicalIF":0.0,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12000804/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144060758","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":"An assessment of interobserver agreement on lesion size, morphology and clinical phenotype in cutaneous leishmaniasis caused by <i>Leishmania aethiopica</i> in Ethiopia.","authors":"Amel Beshir Mohammed, Fewzia Shikur Mohammed, Feleke Tilahun Zewdu, Shimelis Doni Nigusse, Saba Lambert, Michael Marks, Stephen L Walker, Endalamaw Gadisa","doi":"10.3310/nihropenres.13869.2","DOIUrl":"10.3310/nihropenres.13869.2","url":null,"abstract":"<p><strong>Introduction: </strong>Cutaneous leishmaniasis (CL) remains a major public health challenge, especially in endemic regions like Ethiopia, where an estimated 40,000 new cases occur annually. Effective treatment evaluation for CL relies on consistent clinical assessments, yet variability in lesion descriptions can complicate reliable outcome measures.</p><p><strong>Methods: </strong>We conducted an inter-reliability study of clinicians' evaluations of CL lesion morphology and size at ALERT Hospital, Addis Ababa. Twelve clinicians independently examined 12 patients with parasitologically confirmed CL, each clinician assessing lesion morphology, size, and severity.</p><p><strong>Results: </strong>We found high consistency in reporting major morphological categories (e.g., plaques) but significant variability in secondary features like dyspigmentation and scale, as well as mucosal involvement. Lesion size measurements showed limited variability, suggesting its reliability as a potential measure for future clinical trials. Disparities in severity assessments highlight the need for a standardized scoring system in CL.</p><p><strong>Discussion: </strong>Our findings underscore the importance of training for consistent, high-quality clinical evaluations of CL and suggests that lesion size could be a reproducible outcome measure in treatment efficacy trials.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"12"},"PeriodicalIF":0.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12134724/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144227793","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":"Clinical and cost-effectiveness of individualised exercises and foot orthoses in the treatment of plantar heel pain: protocol for the TREADON randomised multi-arm multi-stage adaptive trial.","authors":"Martin J Thomas, Gemma Hughes, Kendra Cooke, Stephanie Butler-Walley, Emma Marshall, Laura Bowyer, Simon Wathall, Jo Smith, Sarah A Lawton, June Brammar, Thomas Burnett, Chris Drake, Nadine E Foster, Gordon J Hendry, Melaine A Holden, Thomas Jaki, Royes Joseph, Anne-Maree Keenan, Jesse Kigozi, Martyn Lewis, Christian D Mallen, Hylton B Menz, Pavel Mozgunov, Edward Roddy","doi":"10.3310/nihropenres.13930.1","DOIUrl":"10.3310/nihropenres.13930.1","url":null,"abstract":"<p><strong>Background: </strong>Plantar heel pain (PHP) is the most common soft tissue foot condition and impairs mobility, physical function, ability to work, and quality of life. Systematic reviews highlight a need for high-quality randomised controlled trials (RCTs) of exercises and orthoses for PHP.</p><p><strong>Objectives: </strong>To determine the clinical and cost-effectiveness of individualised exercises and/or prefabricated foot orthoses plus self-management advice (SMA) compared to SMA alone in adults with PHP.</p><p><strong>Methods: </strong>A multi-centre four-arm two-stage adaptive parallel-group RCT with internal pilot. Up to 696 participants aged ≥18 years with PHP will be identified from general practice, physiotherapy/podiatry referrals and self-referral, and randomised 1:1:1:1 to: (1) SMA (control), (2) SMA plus individualised exercises, (3) SMA plus prefabricated foot orthoses, or (4) SMA plus individualised exercises and prefabricated foot orthoses. Outcomes will be collected by SMS text-message (weekly during weeks 1-12, monthly during months 4-12) and questionnaires at 12 weeks and 6 and 12 months. The primary outcome is change in PHP intensity (0-10 numeric rating scale) between baseline and the average over 6-12 weeks. Interim analysis when 348 participants have completed the primary outcome assessment will inform adaptation, where interventions may be dropped or the trial stopped early (for efficacy or futility). The main between-group comparison for the primary outcome will be undertaken using linear mixed modelling. Secondary outcomes will examine i) short-term pain trajectories over weeks 1-12, ii) pain at 6 and 12 months, and monthly from 3-12 months, iii) first step pain, physical function, global rating of change, pain self-efficacy, illness perceptions, ability to work, and treatment satisfaction at 12 weeks, 6 and 12 months, iv) cost-effectiveness. Patient and public partner involvement is embedded throughout.</p><p><strong>Discussion: </strong>The TREADON multi-arm multi-stage RCT will provide new evidence on the clinical and cost-effectiveness of individualised exercises and prefabricated foot orthoses for people with PHP.</p><p><strong>Trial registration: </strong><b>ISRCTN</b> 12418153. Registration date 06 December 2022 https://doi.org/10.1186/ISRCTN12418153.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"42"},"PeriodicalIF":0.0,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12141997/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144251197","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":"Affordable Cardiac Rehabilitation An Outreach Inter-Disciplinary Strategic Study (ACROSS) - Research Programme Protocol.","authors":"Rod S Taylor, Imran Bashir Chaudhry, Mithila Faraque, Panniyammakal Jeemon, Amy Blakemore, Karina Lovell, Nusrat Husain, Tahir Saghir, Saidur Rahman Mashreky, Sivadasanpillai Harikrishnan, Chaudhury Meshkat Ahmed, Abraham Samuel Babu, Alex McConnachie, Emma McIntosh, Rakhshi Memon, Sally Singh, Alastair Leyland, Bhautesh Jani, Walter Flores","doi":"10.3310/nihropenres.13957.1","DOIUrl":"10.3310/nihropenres.13957.1","url":null,"abstract":"<p><strong>Background: </strong>The evidence and infrastructure needed to access and deliver cardiac rehabilitation (CR) services are absent or lacking in low and middle-income countries (LMICs), resulting in a substantial loss of potential health and socio-economic benefits. Home-based programmes provide an affordable model of delivery that can leverage a scalable increase in CR access in LMICs. ACROSS (Affordable Cardiac Rehabilitation: An Outreach Inter-disciplinary Strategic Study) seeks to co-develop (with patients, caregivers, clinicians, and service commissioners) a culturally and contextually applicable and affordable home-based programme for people with the multimorbidity of coronary heart disease and/or heart failure with co-existing depression and/or anxiety and evaluate the acceptability, clinical effectiveness, and cost-effectiveness of its implementation in Bangladesh, India, and Pakistan and to determine its scalability and sustainability.</p><p><strong>Methods: </strong>Four linked work packages (WPs). WP1 (cultural adaptation/refinement of home-based rehabilitation): examine rehabilitation implementation barriers/enablers from multiple stakeholder perspectives and co-develop a feasible and acceptable culturally & contextually adapted home-based programme, extended to take account of co-existing depression and/or anxiety; WP2 (external pilot): assess feasibility/acceptability of the co-developed rehabilitation intervention and study design and processes necessary for a full-scale trial; WP3: (multicentre/multi-country hybrid effectiveness and implementation randomised trial) determine the clinical and cost-effectiveness of a culturally adapted home-based rehabilitation intervention for people with coronary heart disease and/or heart failure and depression and/or anxiety; WP4 (capacity building): build research and rehabilitation delivery capacity.</p><p><strong>Conclusions: </strong>The ACROSS programme overarching goal is to develop a clinically and cost-effective CR model in low-resource settings for people in Bangladesh, India, and Pakistan with a multimorbidity of heart disease and depression and/or anxiety with the potential for substantial health and socio-economic benefits.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"41"},"PeriodicalIF":0.0,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12171719/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144318895","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":"Defining a High-Quality Myalgic Encephalomyelitis/Chronic Fatigue Syndrome cohort in UK Biobank.","authors":"Gemma L Samms, Chris P Ponting","doi":"10.3310/nihropenres.13956.1","DOIUrl":"10.3310/nihropenres.13956.1","url":null,"abstract":"<p><strong>Background: </strong>Progress in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) research is being slowed by the relatively small-scale studies being performed whose results are often not replicated. Progress could be accelerated by analyses of large population-scale projects, such as UK Biobank (UKB), which provide extensive phenotype and genotype data linked to both ME/CFS cases and controls.</p><p><strong>Methods: </strong>Here, we analysed the overlap and discordance among four UKB-defined ME/CFS cohorts, and additional questionnaire data when available.</p><p><strong>Results: </strong>A total of 5,354 UKB individuals were linked to at least one piece of evidence of MECFS, a higher proportion (1.1%) than most prevalence estimates. Only a third (36%; n=1,922) had 2 or more pieces of evidence for MECFS, in part due to data missingness. For the same UKB participant, ME/CFS status defined by ICD-10 (International Classification of Diseases, Tenth Revision) code G93.3 (Post-viral fatigue syndrome) was most likely to be supported by another data type (72%); ME/CFS status defined by Pain Questionnaire responses is least likely to be supported (43%), in part due to data missingness.</p><p><strong>Conclusions: </strong>We conclude that ME/CFS status in UKB, and potentially other biobanks, is best supported by multiple, and not single, lines of evidence. Finally, we raise the estimated ME/CFS prevalence in the UK to 410,000 using the most consistent evidence for ME/CFS status, and accounting for those who had no opportunity to participate in UKB due to being bed- or house-bound.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"39"},"PeriodicalIF":0.0,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12120426/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144183166","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":"The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers.","authors":"Rebecca Milton, Susan Channon, Julia Sanders, Sara Kenyon, Aimee Middlemiss, Heather Strange, Kate Davies, Lena Choudary-Salter, Susan Barry, Tina Prendeville, Aled Jones","doi":"10.3310/nihropenres.13745.1","DOIUrl":"10.3310/nihropenres.13745.1","url":null,"abstract":"<p><strong>Background: </strong>During pregnancy, labour and early motherhood, most women in the UK receive care from different midwives. The National Health Service (NHS) policy change in England sought to introduce a model of care whereby each woman is cared for by the same midwife throughout antenatal, intrapartum and postnatal periods, supported by a small team of midwives to cover off-duty periods. This model is called the Midwifery Continuity of Carer (MCoC). The aim of this study is proposes to evaluate the implementation and delivery of MCoC across England, aiming to better understand the factors that result in different rates of progress with MCoC implementation.</p><p><strong>Aim: </strong>To identify the local, regional and national factors which contribute to variable progress with implementation of MCoC in the NHS in England?</p><p><strong>Methods: </strong>A sequential mixed-methods study, informed by implementation science frameworks will be delivered over three work packages. Work package 1: Following a literature review of the challenges and successes of previous attempts to implement MCoC. Work package 2: six case studies in NHS Trusts will be undertaken to better understand different rates of progress with MCoC implementation and people's experiences of MCoC implementation through: interview and questionnaire (maternity services staff); interviews (service-users); observation of relevant implementation meetings and organisational documentation collection. Interviews will be undertaken with national and regional stakeholders relevant to MCoC implementation. Work package 3: Data analysis will be conducted both inductively and deductively, informed by implementation science constructs.</p><p><strong>Dissemination: </strong>Study findings will be disseminated through peer-reviewed journals, conferences and events. Results will be of interest to the public, clinical and policy stakeholders in the UK and will be disseminated accordingly.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"4"},"PeriodicalIF":0.0,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11891474/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143598449","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":"Learning to read FAST MRI: Qualitative interviews with groups experienced reading mammograms.","authors":"Sam Harding, Rebecca Geach, Lyn Jones","doi":"10.3310/nihropenres.13817.2","DOIUrl":"10.3310/nihropenres.13817.2","url":null,"abstract":"<p><strong>Objectives: </strong>Abbreviated breast MRI (abMRI) is being introduced into breast screening practice worldwide. Increased provision of abMRI will require mammogram readers to learn abMRI-interpretation and the implementation of abMRI-reading into clinical practice. The present study explores the acceptability of the implementation of developed reader training, and the barriers and facilitators to training programme participation and subsequently to reading the training programme assessment task of abMRI images in a work/NHS context familiar to the individual participants.</p><p><strong>Methods: </strong>Fourteen NHS Breast Screening Programme mammogram readers, who were undertaking abMRI interpretation training, participated in semi-structured interviews. Template analysis using the a priori implementation framework, COM-B (Capability, Opportunity, Motivation, Behaviour) was undertaken.</p><p><strong>Results: </strong>The training day was well received. Participants identified that their varying ranges of knowledge and experience (capability) was accounted for. Participation in the research was appreciated by all, but especially those new to reading MRI.Radiographers commented that learning to read and understand the abMRI images was motivational, and this helped drive implementation. It was noted that organisational leadership is needed to fully enable change in practice. COVID-19 was commented on in relation to its impact on image reading.</p><p><strong>Conclusions: </strong>The project demonstrates that production of training for reading abMRI images and subsequent implementation of changes to practice needs to be carefully planned. Changes must be led by the needs of staff undertaking the tasks. When this is achieved the engagement in training is positive and the barriers are more readily removed or mitigated for both individuals and organisations.</p><p><strong>Critical relevance statement: </strong>AbMRI is part of the solution to reducing waiting times for MRI within the NHS, however, training for reading abMRI images and implementation to practice needs to be carefully planned.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"26"},"PeriodicalIF":0.0,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130769/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144217745","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":"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.13716.2","DOIUrl":"10.3310/nihropenres.13716.2","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}