NIHR open research最新文献

{"title":"Occupational Therapists' perspectives of implementing a new rehabilitation intervention for visual field loss due to stroke.","authors":"Christine Hazelton, Sam Harding, Jayne Angilley, Alexandra Palombi, Audrey Bowen, Phil Clatworthy","doi":"10.3310/nihropenres.13984.1","DOIUrl":"10.3310/nihropenres.13984.1","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to explore the barriers and facilitators of implementing rehabilitation interventions for visual field loss due to stroke.</p><p><strong>Methods: </strong>The study was a qualitative exploration using one-to-one interviews coded using template analysis and the COM-B a-priori framework. Participants were five occupational therapists from hospital (n=4) and community (n=1) National Health Service (NHS) stroke care settings in England. The intervention experienced by the participant was a standardized goal-based visual scanning and search training for stroke survivors with visual field loss, delivered by occupational therapists (OTs), supported by information sheets and a dedicated website (HABIT).</p><p><strong>Results: </strong>HABIT provides a structured approach for delivering scanning and visual search training. HABIT resources aided participants' understanding and self-management. HABIT was considered similar to current practice as practiced by study participants and of most value to trainees and newly qualified therapists. However, resources had limited accessibility due to a lack of computer access and difficulty in reading text; modifications were required to make training activity examples more suitable for ward settings. Within ward settings, the delivery of HABIT was highly limited by time constraints; therapists ranked activities linked to safety and early discharge as higher priority. Clinicians noted that stroke survivors' lack of awareness of their visual loss and its impact limited their engagement with the HABIT, making delivery difficult.</p><p><strong>Conclusion: </strong>Prioritization of vision rehabilitation in highly pressurized acute settings is a key factor in implementing HABIT. The findings will enable further refinement of HABIT content and delivery to address the barriers identified and improve its suitability in acute hospital settings.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"57"},"PeriodicalIF":0.0,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12417978/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145034453","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":"Increasing research capacity in adult social care: a research capacity-building partnership in Kent and its theory of change.","authors":"Jolie R Keemink, Sarah Hotham, Wenjing Zhang, Rasa Mikelyte, Nick Smith, Ferhana Hashem, Georgina Walton, Alison Charles, Ann-Marie Towers","doi":"10.3310/nihropenres.13890.2","DOIUrl":"10.3310/nihropenres.13890.2","url":null,"abstract":"<p><p>This paper describes the development of an adult social care (ASC) research capacity-building partnership and the corresponding theory of change that underpins this work. In 2021, the National Institute for Health and Care Research (NIHR) funded six social care capacity building partnerships across England to improve the quality and quantity of social care research. These partnerships facilitate collaborative working between universities, local authorities, practitioners, providers, and people with lived experience. The Kent Research Partnership was established as one of the partnerships. Taking a co-produced approach, the Kent Research Partnership is a four-year partnership that aims to improve care quality by investing in and valuing the social care workforce and developing a culture of research and evidence-based practice and innovation. The Kent Research Partnership includes four interlinked streams of work- Communities of Practice, Researcher in Residence, Fellowships, and Access to Research. In addition, a fifth, cross-cutting workstream is dedicated to involving those with lived experience of ASC. To ensure robust programme planning and evaluation, we developed Theory of Change models for the overall partnership and each workstream. Within these models, we also how the Kent Research Partnership intends to change behaviour using the Behaviour Change Wheel as the underpinning model.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"45"},"PeriodicalIF":0.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12355171/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144877174","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":"Strategy-based cognitive rehabilitation for childhood brain tumour: Protocol for an acceptability and feasibility trial of the Fatigue, Learning, and Memory Enrichment (FLaME) intervention.","authors":"Charlotte P Malcolm, Gerard Anderson, Victoria King, Deborah Ridout, Daniel Stark, Sara Shavel-Jessop, Emily Bennett, Antony Michalski, Tara Murphy, Faraneh Vargha-Khadem","doi":"10.3310/nihropenres.13859.2","DOIUrl":"10.3310/nihropenres.13859.2","url":null,"abstract":"<p><strong>Background: </strong>Medical treatments have improved survival rates for paediatric brain tumour (PBT), but the condition and treatment continue to be associated with significant cognitive morbidity. Nearly all survivors will experience some degree of cognitive impairment (neurocognitive 'late effects') that has a cascading impact on the development of intellectual and academic skills, quality of life, mental health, vocational attainment, and functional independence. Longstanding cognitive fatigue is also a prevalent symptom for survivors of PBT and further impacts engagement with therapeutic interventions and quality of life. Cognitive rehabilitation is recommended in national healthcare guidance and frequently requested by patients and families but rarely implemented due to a limited evidence base and poor feasibility and acceptability. There are currently no therapeutic interventions for cognitive fatigue for PBT survivors.</p><p><strong>Aims & objectives: </strong>We aim to establish feasibility, acceptability, and preliminary efficacy for strategy-based cognitive rehabilitation for PBT. The study will determine if there is benefit to feasibility and acceptability when cognitive fatigue management is integrated to cognitive rehabilitation.</p><p><strong>Methods: </strong>Thirty-six 7-17 years olds diagnosed with PBT will be recruited from Great Ormond Street Hospital. Participants will be randomised to either 1) a 12-week cognitive rehabilitation intervention with integrated cognitive fatigue management, 2) a 6-week cognitive rehabilitation intervention alone, or 3) standard care. All participants will have received neuropsychological assessment identifying difficulties with cognition and fatigue. Feasibility (e.g., attrition, retention, adherence) will be assessed through the trial. Acceptability will be measured throughout using questionnaires and interviews based on the Theoretical Framework for Acceptability and satisfaction rating scale. Preliminary effectiveness data will be gathered pre- and post-intervention using standardised measures of cognitive skills, fatigue, quality of life, % school attendance, and goal-based outcomes.</p><p><strong>Outcome: </strong>The findings will be used to determine the appropriate rehabilitation intervention for a larger, multicentre randomised controlled trial.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"23"},"PeriodicalIF":0.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12413617/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145016845","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":"In what context and by which mechanisms can creative arts interventions improve wellbeing in older people? A realist review protocol.","authors":"Alexandra Caulfield, Anne Ferrey, Nia Roberts, Jeremy Leslie-Spinks, Helle Mölsted Alvesson, Geoff Wong, Trish Greenhalgh","doi":"10.3310/nihropenres.13746.2","DOIUrl":"10.3310/nihropenres.13746.2","url":null,"abstract":"<p><strong>Background: </strong>In recent years, there has been growing interest at national and international policy level in the potential of creative arts to support individual and community wellbeing. Creative arts encompass a wide range of activities, including performing arts, visual arts, design and craft, literature, culture and digital and electronic arts. Participation in creative arts has been linked to lower mental distress, increased social connection, improved quality of life, personal growth and empowerment. Despite this, it remains unclear exactly how participation in creative arts interventions can improve wellbeing in older individuals. This realist review aims to synthesize evidence on how elements of creative arts interventions improve wellbeing amongst older people, in particular when, how, for whom and to what extent they work.</p><p><strong>Methods and analysis: </strong>This review will follow the RAMESES (Realist And Meta-narrative Evidence Syntheses: Evolving Standards) quality standards and Pawson's five iterative stages to locate existing theories, search for evidence, select literature, extract data, and draw conclusions. It will be guided by stakeholder engagement with policymakers, practitioners, commissioners, and people with lived experience. A realist approach will be used to analyse data and develop causal explanations, in the form of context-mechanism-outcome-configurations (CMOCs), which explain how creative arts interventions impact wellbeing in older people. The CMOCs will be organised into one or more programme theories. Our refined programme theory will then be used to develop guidance for service providers of creative arts who want to use their services to improve wellbeing of older people.</p><p><strong>Ethics and dissemination: </strong>This research will comply with the UK Policy Framework for Health and Social Care Research. Dissemination will be guided by our stakeholder group, building on links with policymakers, commissioners, providers, and the public. A final stakeholder event focused on knowledge mobilisation will aid development of recommendations.PROSPERO registration CRD42024580770.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"19"},"PeriodicalIF":0.0,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12368484/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144981682","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":"What is Family and Group Conferencing for adults? Part 1: Characterising the model and methods of enquiry.","authors":"Sharanya Mahesh, Jerry Tew, Mary Mitchell, Kar-Man Au, Vicky Nicholls, Abyd Quinn Aziz, Miranda Johnson, T K Vincent","doi":"10.3310/nihropenres.13811.2","DOIUrl":"10.3310/nihropenres.13811.2","url":null,"abstract":"<p><strong>Background: </strong>Family and Group Conferencing (FGC) is a relatively new strengths-based approach applied to adults needing social care and mental health support in the UK. Although the approach is well established in children's services in the UK, few services currently offer FGCs to adults; therefore, there is limited evidence regarding FGCs in the adult services context in the UK. This study aims to fill this gap by examining how FGCs work and what differences they can make in people's lives.</p><p><strong>Methods: </strong>This paper (Part 1) addresses the first of two related research questions, aiming to characterize the practice model(s) that pertain to the context of adults' FGCs as currently offered. We employed a mixed methods research design drawing on data from both, previous literature as well as current practice by undertaking a comprehensive literature review, national survey and stakeholder interviews with current services and a deliberative forum involving a range of stakeholders pertaining to adult FGCs.</p><p><strong>Results: </strong>Although there is some variation in the practice model(s) offered by services, the overall approach is underpinned by a relatively consistent set of values and principles, although these are often implicit. The FGC offers a staged approach that enables people and their networks to take greater control over their support arrangements. It is seen as an appropriate service offer across all adults and mental health services with the potential to result in a range of positive outcomes (as will be discussed in Part 2).</p><p><strong>Conclusion: </strong>Central to achieving this is flexibility within the service offer to accommodate the social and cultural needs of the individual and their network, the independence of the FGC coordinator, the necessity of sufficient preparation for all participants, and rapport building in advance of the Conference.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"20"},"PeriodicalIF":0.0,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12198747/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509869","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":"Incidence, outcomes and management of spontaneous haemoperitoneum in pregnancy: a UK population-based study.","authors":"Ruth Tunn, Rema Ramakrishnan, Hilde Marie Engjom, Marian Knight","doi":"10.3310/nihropenres.13960.2","DOIUrl":"10.3310/nihropenres.13960.2","url":null,"abstract":"<p><strong>Background: </strong>Spontaneous haemoperitoneum in pregnancy (SHiP) is the occurrence during pregnancy of sudden intra-abdominal haemorrhage unrelated to extrauterine pregnancy, trauma or uterine rupture. SHiP is uncommon but is associated with preterm birth, high perinatal mortality and, more rarely, maternal mortality. We investigated the incidence of SHiP in the UK and its diagnosis, management and outcomes.</p><p><strong>Methods: </strong>This two-year, prospective surveillance study used the UK Obstetric Surveillance System to collect anonymous data on all women who gave birth in a UK consultant-led maternity unit in 2016 and 2017 and who experienced SHiP.</p><p><strong>Results: </strong>We confirmed 20 cases of SHiP, giving an estimated incidence of 1.3 cases per 100,000 maternities, or 1 per 75,614 maternities. The median gestational age at diagnosis was 35.7 weeks (IQR 29.9-38.4 weeks). A minority of affected women were receiving anticoagulant agents for prophylaxis (2/20) or treatment (4/20). The most common initial suspected diagnosis was placental abruption (7/20), followed by intra-abdominal bleeding, uterine rupture, or infection. SHiP was diagnosed using ultrasound in four women, using CT in five, and solely at surgery in 14. Aneurysms (4/20) and organ rupture or haematoma (5/20) were the most common bleeding source, and the condition was most commonly diagnosed and treated by laparotomy (11/20). Perinatal morbidity and mortality were high, with 16% of infants stillborn, an over 80% admission rate to the neonatal unit among the 16 live-born infants, major complications in a third of these infants, and one neonatal death. Maternal morbidity was also high, with 60% of women admitted to the intensive care unit, over half of whom experienced major morbidity, and one maternal death.</p><p><strong>Conclusions: </strong>SHiP is rare in the UK but when it occurs, it can be associated with major maternal morbidity and mortality, and perinatal outcomes are poor. International comparisons are complicated by differing definitions of SHiP.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"40"},"PeriodicalIF":0.0,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12198727/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509868","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":"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.13801.2","DOIUrl":"10.3310/nihropenres.13801.2","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":"How is trauma-informed care conceptualised in UK mental health services? Systematic scoping review protocol.","authors":"Ma Lourdes Casingcasing, Gary Winship, Nuria Segarra, Sarah Beach, Stefan Rennick-Egglestone","doi":"10.3310/nihropenres.13945.1","DOIUrl":"10.3310/nihropenres.13945.1","url":null,"abstract":"<p><strong>Introduction: </strong>Trauma-informed care (TIC) has attracted considerable attention globally as a framework for addressing the profound impacts of trauma on individuals and communities. Despite its widespread adoption, the definition and operationalisation of TIC remain inconsistent across contexts, including the United Kingdom. TIC represents a systemic shift in healthcare and social care practices, moving from a focus on immediate issues to addressing the underlying effects of violence, childhood adversity, and trauma. This approach is particularly pertinent in the UK, where there is growing interest in TIC across the health, social care, and criminal justice sectors.This systematic scoping review aims to shed light on how TIC is defined and applied in the UK. By synthesising existing literature, it seeks to clarify the conceptualisation of TIC, identify gaps in implementation, and contribute to ongoing efforts to standardise trauma-informed approaches. The review is motivated by the UK's proactive yet fragmented adoption of TIC, as evidenced by recent initiatives and sector-specific adaptations. By examining these developments, the review aims to inform policy and practice, ultimately enhancing the delivery of trauma-informed care in the UK.</p><p><strong>Methods: </strong>We systematically searched for primary studies in PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Medline to explore how TIC is defined in the UK. Grey documents that described TIC principles, evaluation, and implementation within mental health care services in the UK were selected. Data from selected studies and grey documents, including handbooks, policies, or training materials, were systematically extracted, focusing on the document characteristics, TIC principles, implementation strategies and evaluation methods. Studies were then selected in English from the last 15 years of work, focusing on TIC practices within the mental health care system in the UK. Data were then analysed to describe TIC principles within mental health care services, identify important concepts of TIC and explore implementation and evaluation methods. This would enable us to understand the broader components of how TIC is defined.</p><p><strong>Ethics and dissemination: </strong>This systematic scoping review did not require ethical approval. The findings will be disseminated through peer-reviewed publications in academic journals specialising in mental health, trauma, and healthcare management, conference presentations, online platforms such as the research team's website, social media channels, community organisations, advocacy groups, or patients.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"47"},"PeriodicalIF":0.0,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12438948/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145082637","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}