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Public engagement, evidence review and survey to adapt a whole-school intervention to prevent bullying in English primary schools. 公众参与、证据审查和调查以适应全校干预以防止英国小学的欺凌行为。
NIHR open research Pub Date : 2026-05-05 eCollection Date: 2025-01-01 DOI: 10.3310/nihropenres.13975.2
Rose Eagle-Hull, Neisha Sundaram, Miranda Perry, G J Melendez-Torres, Chris Bonell
{"title":"Public engagement, evidence review and survey to adapt a whole-school intervention to prevent bullying in English primary schools.","authors":"Rose Eagle-Hull, Neisha Sundaram, Miranda Perry, G J Melendez-Torres, Chris Bonell","doi":"10.3310/nihropenres.13975.2","DOIUrl":"10.3310/nihropenres.13975.2","url":null,"abstract":"<p><strong>Background: </strong>Bullying increases during primary school and causes multiple mental/physical health harms. Whole-school interventions offer a feasible means of reducing bullying but few have been evaluated in primary schools. We previously trialled the Learning Together intervention in secondary schools comprising local needs assessment, student and staff participation in decision-making through 'action groups', restorative practice, and a social and emotional skills curriculum. This intervention was effective in preventing bullying and improving mental wellbeing. We aimed to adapt Learning Together for primary schools (Learning Together Primary Schools (LTPS)). This paper reports on how we adapted intervention materials to produce the LTPS intervention through a review of research evidence, online survey, and patient and public involvement and engagement (PPIE).</p><p><strong>Methods: </strong>We conducted a rapid review of existing systematic reviews, online survey of primary schools in south-east England, and multiple PPIE workshops. PPIE was conducted with two primary schools (10 staff members and 20 pupils), with a group of 10 pupils from five primary schools, and with a group of six parents with primary-school-aged children.</p><p><strong>Conclusions: </strong>We refined our initial plans for LTPS, developing an intervention appropriate for primary schools and supported by full materials, training and external facilitation. We retained key components including restorative practice and action groups and made several refinements, including guidance for action group implementation to accommodate for primary schools' smaller capacities. No refinements were made to the intervention theory of change. We found that it is possible to refine and elaborate interventions to provide full materials and support via processes drawing on evidence review, a survey and PPIE. Although not all PPIE suggestions could be acted upon, PPIE proved valuable in ensuring the feasibility and acceptability of the intervention in primary schools. Future work will include a pilot trial to assess whether progression to a full trial is justified. Study registration ISRCTN10215449 https://doi.org/10.1186/ISRCTN10215449.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"73"},"PeriodicalIF":0.0,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12743219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145851683","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}
引用次数: 0
Randomised controlled effectiveness study (RCT) of isometric exercise (IE) in adults with stage 1 and 2 hypertension - ISOFITTER study. 成人1期和2期高血压患者等距运动(IE)的随机对照疗效研究(RCT) - ISOFITTER研究
NIHR open research Pub Date : 2026-04-14 eCollection Date: 2025-01-01 DOI: 10.3310/nihropenres.14059.3
Melanie Rees-Roberts, Ellie Santer, Rachel Borthwick, Timothy Doulton, Pauline A Swift, Tracy Pellatt-Higgins, Katerina Gousia, Douglas MacInnes, Alan West, John Darby, Anusree Biswas, Caroline Cowley, Christoher K Farmer, Jonathan Wiles
{"title":"Randomised controlled effectiveness study (RCT) of isometric exercise (IE) in adults with stage 1 and 2 hypertension - ISOFITTER study.","authors":"Melanie Rees-Roberts, Ellie Santer, Rachel Borthwick, Timothy Doulton, Pauline A Swift, Tracy Pellatt-Higgins, Katerina Gousia, Douglas MacInnes, Alan West, John Darby, Anusree Biswas, Caroline Cowley, Christoher K Farmer, Jonathan Wiles","doi":"10.3310/nihropenres.14059.3","DOIUrl":"10.3310/nihropenres.14059.3","url":null,"abstract":"<p><p>Background High blood pressure (BP) affects more than one in four adults in England and only one in three patients are being treated effectively. Treatment of high BP includes changes to lifestyle such as more physical activity and/or taking medication. However, low adoption and high attrition are common with the large amounts of exercise currently recommended (>150 minutes moderate exercise per week plus 2 strength sessions). Evidence suggests that isometric exercise (IE), holding a fixed body position for a period of time, for example a wall squat, results in greater long term BP reductions, with less time and effort, than other recommended exercise. This ISOFITTER study aims to evaluate the effectiveness of IE to help reduce BP in hypertension in a real world setting. Methods A multi-centre, randomised, controlled trial of an isometric exercise wall squat intervention for hypertension employing an effectiveness-implementation hybrid type-1 design. Adults (n = 542) with Stage 1 or Stage 2 hypertension, on no more than one antihypertensive, and no other medical contra-indications will be randomised to either a standard care plus IE intervention group or standard care control group. Blood pressure readings, fidelity measurements, medications, adverse events, quality of life, participant satisfaction and health service use will be collected at baseline, week 4, month 3 and month 6 with a subgroup (n = 50) of the IE arm invited to continue for 12 months. Qualitative participant focus groups and interviews with wider stakeholders will collect implementation data. Results The ISOFITTER study will establish effectiveness of a self-administered, home-based IE intervention in lowering blood pressure in people with uncomplicated stage 1 and 2 hypertension. Implementation evidence will support patient delivery, context for scaling up of the intervention and intervention cost. Conclusion Lifestyle changes for the treatment of hypertension in the absence of other risk factors should not be overlooked. For long term hypertension management, easily adopted, evidenced exercise interventions are needed. This study will help to address this evidence gap.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"78"},"PeriodicalIF":0.0,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12869024/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146127735","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}
引用次数: 0
Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study Protocol. 药物基因组学改善支持性护理症状前瞻性观察性研究方案。
NIHR open research Pub Date : 2026-04-10 eCollection Date: 2025-01-01 DOI: 10.3310/nihropenres.14182.2
Martyn Patel, John McDermott, William Newman, Caroline Barry
{"title":"Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study Protocol.","authors":"Martyn Patel, John McDermott, William Newman, Caroline Barry","doi":"10.3310/nihropenres.14182.2","DOIUrl":"https://doi.org/10.3310/nihropenres.14182.2","url":null,"abstract":"<p><strong>Background: </strong>People living with life limiting conditions such as incurable cancer often have problems with pain, vomiting and other symptoms which impact quality of life. Supportive and Palliative Care aims to improve people's symptoms, particularly towards the very end of life. Many medications exist that can be used to help with these symptoms, but often they do not work, or they cause side effects for the people taking them. \"Pharmacogenomics\" is a way of predicting who is more likely to have a good response to drugs, and who is more likely to get side effects, based on variation in their genes.</p><p><strong>Methods: </strong>A prospective observational study, recruiting 50 patients aged over 18, with life limiting conditions. The study aims to understand how the introduction of multi-gene pharmacogenetic test for patients receiving palliative and supportive care might impact routine prescribing practice in an acute NHS hospital setting. It will report on the nature of prescribing patterns over a 90-day period post recruitment, looking for any variation between patients with and without the presence of actionable drug-gene interactions. It will help determine the future feasibility of incorporating pharmacogenomic testing in a palliative care population based on recruitment targets versus actual recruitment achieved. A drug-gene interaction ratio for this cohort will be reported, giving an indication of the scale of the use of medications relevant to pharmacogenomics used in palliative care, and the potential scope of future interventions. The study involves the collection of a single blood sample, and genetic results will not be shared with participants.</p><p><strong>Discussion: </strong>This single site study aims to provide preliminary data to inform study design of clinical trials that can definitively address the question of clinical utility in this population, whilst also understanding the acceptability of researching this topic in this specific patient population.Trial registration ClinicalTrials.gov ID NCT06856122, registered 2025-03-04 URL: https://clinicaltrials.gov/study/NCT06856122.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 ","pages":"125"},"PeriodicalIF":0.0,"publicationDate":"2026-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13096778/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147791375","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}
引用次数: 0
Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study. 一项随机对照试验的混合方法过程评价方案,以改善骨质疏松症药物的共同决策和吸收:iFraP研究。
NIHR open research Pub Date : 2026-04-02 eCollection Date: 2024-01-01 DOI: 10.3310/nihropenres.13751.3
Laurna Bullock, Andrea Cherrington, Emma M Clark, Jane Fleming, Ida Bentley, Elaine Nicholls, David Webb, Jo Smith, Sarah Bathers, Sarah Lewis, Robert Horne, Terence W O'Neill, Christian D Mallen, Clare Jinks, Zoe Paskins
{"title":"Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study.","authors":"Laurna Bullock, Andrea Cherrington, Emma M Clark, Jane Fleming, Ida Bentley, Elaine Nicholls, David Webb, Jo Smith, Sarah Bathers, Sarah Lewis, Robert Horne, Terence W O'Neill, Christian D Mallen, Clare Jinks, Zoe Paskins","doi":"10.3310/nihropenres.13751.3","DOIUrl":"10.3310/nihropenres.13751.3","url":null,"abstract":"<p><strong>Background: </strong>High quality shared decision-making (SDM) conversations involve people with or at risk of osteoporosis and clinicians working together to decide, where appropriate, which evidence-based medicines best fit the person's life, beliefs, and values. The <b>i</b>mproving uptake of <b>Fra</b>cture <b>P</b>revention drug treatments (iFraP) intervention comprises a computerised Decision Support Tool (DST), clinician training package and information resources, designed for use in UK Fracture Liaison Service (FLS) consultations. The iFraP intervention will be tested in a pragmatic, parallel-group, individual randomised controlled trial in patients referred to four FLSs in England. This mixed methods process evaluation aims to assess which components of iFraP were delivered and how (fidelity), whether iFraP results in a change in osteoporosis drug treatment initiation rates and how, and how context affects implementation of iFraP and outcomes.</p><p><strong>Methods: </strong>We will collect quantitative data using (1) Case Report Forms completed by FLS clinicians; (2) self-reported questionnaires completed by patient participants; and (3) DST analytic data. We will collect qualitative data using (1) semi-structured interviews with patients who receive the iFraP intervention in their FLS appointment, FLS clinicians delivering iFraP appointments, and primary care clinicians that have consulted with a patient following their iFraP FLS appointment; and (2) FLS consultation recordings. A triangulation protocol will be used to integrate the quantitative and qualitative findings to generate novel insights about the intervention under evaluation.</p><p><strong>Discussion: </strong>The process evaluation, alongside the trial, will help to understand what elements of the iFraP intervention were delivered and how, the mechanisms of impact and how context affected implementation and outcomes, and intervention acceptability. Mixed methods interpretation will lead to further insights about the implementation of SDM and DSTs in-practice.</p><p><strong>Trial registration: </strong><b>ISRCTN:</b> 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"4 ","pages":"70"},"PeriodicalIF":0.0,"publicationDate":"2026-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12743211/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145851626","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}
引用次数: 0
Examining concepts related to critical illness and the management of critically ill patients: a protocol for a scoping review. 检查与危重疾病和危重患者管理有关的概念:范围审查的协议。
NIHR open research Pub Date : 2026-03-18 eCollection Date: 2026-01-01 DOI: 10.3310/nihropenres.14140.2
Kirsty Jerrard, Brenda O'Neill, Judy M Bradley, Bronwen Connolly
{"title":"Examining concepts related to critical illness and the management of critically ill patients: a protocol for a scoping review.","authors":"Kirsty Jerrard, Brenda O'Neill, Judy M Bradley, Bronwen Connolly","doi":"10.3310/nihropenres.14140.2","DOIUrl":"10.3310/nihropenres.14140.2","url":null,"abstract":"<p><strong>Background: </strong>Critically ill patients present with highly complex care needs that necessitate specialised, efficient collaboration across multidisciplinary teams. Effective communication and shared understanding of clinical concepts are imperative to delivering optimised care and enhancing patient outcomes. Concept analysis methodology offers a structured approach to clarifying complex clinical concepts to promote consistency in understanding and application. Gaining insight into concepts already described in this patient population, alongside identifying gaps, could support more collaborative understanding. This scoping review aims to systematically identify, synthesise, and map concepts underpinning the management of critically ill adult patients along the stages of the critical illness care pathway.</p><p><strong>Methods: </strong>We will search the databases MEDLINE ALL, EMBASE, CINAHL Complete, and Web of Science Core Collection from inception to date of search. Grey literature will be identified via ProQuest Dissertations & Theses Global. Reference lists of included studies will be screened to identify additional relevant literature. We will include studies using concept analysis methodology that explore, or define, concepts related to the management of critically ill adult patients at any stage of the care pathway. Screening and data extraction processes will be piloted and conducted independently and in duplicate. Extracted data will be analysed using descriptive statistics and narrative synthesis. Study characteristics will be summarised in tables. We will describe which concepts have been explored and how they have been defined, detail of the concept analysis method used, and in what populations and phases of the care pathway. Concepts will be mapped visually to illustrate their distribution across the pathway.</p><p><strong>Discussion: </strong>No reviews to date have summarised or mapped the concepts relating to the management of critically ill adult patients across the care pathway. Results of this review will inform clinical practice and help identify gaps for future research. Scoping review registration This protocol is registered on OSF https://doi.org/10.17605/OSF.IO/Z63CW.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"6 ","pages":"8"},"PeriodicalIF":0.0,"publicationDate":"2026-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12972711/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147438071","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}
引用次数: 0
Vulnerability and childhood immunization in Kenya. A systematic review of policy documents protocol. 肯尼亚的脆弱性和儿童免疫接种。对政策文件和协议进行系统的审查。
NIHR open research Pub Date : 2026-03-10 eCollection Date: 2023-01-01 DOI: 10.3310/nihropenres.13449.3
Esther Awuor Owino, David Mafigiri, Dorcas Kamuya, Caroline Jones, Primus Chi
{"title":"Vulnerability and childhood immunization in Kenya. A systematic review of policy documents protocol.","authors":"Esther Awuor Owino, David Mafigiri, Dorcas Kamuya, Caroline Jones, Primus Chi","doi":"10.3310/nihropenres.13449.3","DOIUrl":"10.3310/nihropenres.13449.3","url":null,"abstract":"<p><p><b>Introduction:</b> Whereas improved full immunization coverage for childhood vaccines have been witnessed globally in the past decades, countries in sub-Saharan Africa have registered slow progress, with variations between and within countries. This has been attributed to several factors including socio-economic, individual and health system vulnerabilities. However, lacking is a documentation of how governments are conceptualizing and addressing these vulnerabilities. We therefore plan to systematically review policy documents to examine the extent to which vulnerability issues are conceptualized and addressed in the general health sector and immunization policy documents in Kenya. <b>Methods:</b> The review will focus on the general health sector and immunization policy documents covering the period between 2000 and 2023. Documents in the English language will be reviewed. Data sources will include the official Ministry of Health website, websites of key international organizations working on immunization, checking reference lists of already identified documents, general Google searches and requesting relevant documents from stakeholders and officials. Data synthesis will follow an inductive approach, and findings will be presented in a descriptive format according to the review objectives. <b>Discussion:</b> We will assess the extent to which vulnerability issues are included and how they are defined in the general health sector and immunization policy documents. In addition, the review will examine strategies proposed, planned and/or implemented to promote access and uptake of immunization services in Kenya. Using the review findings, we will formulate recommendations to share with health and Expanded Programme on Immunization (EPI) stakeholders at the national, county, and sub-county levels.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"3 ","pages":"64"},"PeriodicalIF":0.0,"publicationDate":"2026-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12586977/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145460843","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}
引用次数: 0
Randomised controlled trial of a very brief nurse-delivered intervention followed by a digital intervention to support medication adherence and reduce blood pressure in people prescribed treatment for hypertension in primary care: protocol for the Programme on Adherence to Medication (PAM) trial. 一项非常简短的护士提供干预的随机对照试验,随后进行数字干预,以支持初级保健中高血压处方治疗患者的药物依从性和降低血压:药物依从性规划(PAM)试验方案。
NIHR open research Pub Date : 2026-02-25 eCollection Date: 2026-01-01 DOI: 10.3310/nihropenres.14136.1
Stephen Sutton, James Jamison, Katja Beardsell, Micah Fineberg, Raquel Conceição, Venus Mirzaei, Catalina Trama Alvarez, Sonia Shpendi, James Brimicombe, Debi Bhattacharya, Wendy Hardeman, Felix Naughton, Miranda Van Emmenis, Helen Eborall, Anna De Simoni, Amrit Takhar, Pankaj Gupta, Prashanth Patel, Cecilia Mascolo, Andrew Toby Prevost, Joana Carvalho de Vasconcelos, Jonathan Mant, Simon Griffin, Richard J McManus, Stephen Morris
{"title":"Randomised controlled trial of a very brief nurse-delivered intervention followed by a digital intervention to support medication adherence and reduce blood pressure in people prescribed treatment for hypertension in primary care: protocol for the Programme on Adherence to Medication (PAM) trial.","authors":"Stephen Sutton, James Jamison, Katja Beardsell, Micah Fineberg, Raquel Conceição, Venus Mirzaei, Catalina Trama Alvarez, Sonia Shpendi, James Brimicombe, Debi Bhattacharya, Wendy Hardeman, Felix Naughton, Miranda Van Emmenis, Helen Eborall, Anna De Simoni, Amrit Takhar, Pankaj Gupta, Prashanth Patel, Cecilia Mascolo, Andrew Toby Prevost, Joana Carvalho de Vasconcelos, Jonathan Mant, Simon Griffin, Richard J McManus, Stephen Morris","doi":"10.3310/nihropenres.14136.1","DOIUrl":"10.3310/nihropenres.14136.1","url":null,"abstract":"<p><strong>Introduction: </strong>Hypertension is a global health challenge accounting for 8.5 million deaths worldwide despite the availability of low-cost pharmaceutical treatment. About 14.9% of people (9.9 million) registered with primary care practices in England and Wales are prescribed medication for hypertension. However, many patients with hypertension and associated conditions do not take their medications as prescribed. Non-adherence to antihypertensive medication is associated with increased risk of suboptimal blood pressure (BP) control, complications and all-cause mortality, and increased healthcare costs. The Programme on Adherence to Medication (PAM) trial will estimate the effectiveness and cost-effectiveness of a medication adherence intervention in patients prescribed medication for hypertension with poorly controlled blood pressure in primary care.</p><p><strong>Methods: </strong>A two-arm multicentre individually randomised controlled parallel group superiority trial recruiting patients prescribed medication for hypertension with poorly controlled BP in primary care practices in England and Wales. The target sample size is 542. Participants in the Intervention group will receive a very brief intervention delivered remotely (by telephone or video call) by a practice nurse or healthcare assistant followed by a digital intervention (text messaging or smartphone app) in addition to usual care; control group participants will receive usual care alone. The primary outcome is systolic BP measured at 12 months. Medication adherence will be measured by chemical adherence testing of urine samples and self-report. An economic evaluation and a process evaluation will be undertaken.</p><p><strong>Ethics and dissemination: </strong>The Cambridge East Independent Research Ethics Committee (REC reference 19/EE/0354), the Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approved the trial. The findings will be disseminated to the scientific community, participating practitioners and patients, relevant patient groups and the public using a range of methods, including journal articles, conference presentations, newsletters and the Programme website.</p><p><strong>Trial registration number: </strong>The UK's Clinical Trial Registry ISRCTN82013652.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"6 ","pages":"18"},"PeriodicalIF":0.0,"publicationDate":"2026-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13090759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147725045","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}
引用次数: 0
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. 个体化锻炼和足部矫形器治疗足底跟痛的临床和成本效益:TREADON随机多臂多阶段适应性试验方案
NIHR open research Pub Date : 2026-02-24 eCollection Date: 2025-01-01 DOI: 10.3310/nihropenres.13930.2
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
{"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.13930.2","DOIUrl":"10.3310/nihropenres.13930.2","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":"2026-02-24","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}
引用次数: 0
The pathway to diagnosis and follow-up care for atrial fibrillation in Sri Lanka: a descriptive longitudinal study. 斯里兰卡心房颤动的诊断和后续治疗途径:一项描述性纵向研究。
NIHR open research Pub Date : 2026-02-23 eCollection Date: 2023-01-01 DOI: 10.3310/nihropenres.13497.3
Vethanayagam Antony Sheron, Tiffany E Gooden, Powsiga Uruthirakumar, Kanesamoorthy Shribavan, Mahesan Guruparan, Kumaran Subaschandren, Gregory Y H Lip, Krishnarajah Nirantharakumar, G Neil Thomas, Rajendra Surenthirakumaran, Balachandran Kumarendran, Semira Manaseki-Holland
{"title":"The pathway to diagnosis and follow-up care for atrial fibrillation in Sri Lanka: a descriptive longitudinal study.","authors":"Vethanayagam Antony Sheron, Tiffany E Gooden, Powsiga Uruthirakumar, Kanesamoorthy Shribavan, Mahesan Guruparan, Kumaran Subaschandren, Gregory Y H Lip, Krishnarajah Nirantharakumar, G Neil Thomas, Rajendra Surenthirakumaran, Balachandran Kumarendran, Semira Manaseki-Holland","doi":"10.3310/nihropenres.13497.3","DOIUrl":"10.3310/nihropenres.13497.3","url":null,"abstract":"<p><strong>Background: </strong>Early diagnosis and continuity of care is vital for atrial fibrillation (AF), to reduce stroke ; There is a lack of understanding of when and how AF is being diagnosed and managed the care pathway) in in low- and middle-income countries (LMICs). We aimed to identify the AF care pathway in Northern Province, Sri Lanka and determine how the COVID-19 pandemic impacted the care pathway.</p><p><strong>Methods: </strong>This descriptive longitudinal study utilised two quantitative questionnaires to evaluate the AF pathway: The first questionnaire (baseline) was used to identify where AF was being diagnosed and the second questionnaire (3 months following baseline) was used to identify where and how often AF follow-up care was being received. How the COVID-19 pandemic impacted the care pathway was asked in the second questionnaire. We aimed to recruit 236 adults (≥18 years) with AF from Jaffna Teaching Hospital. Data were collected between October 2020 and June 2021 and analysed using descriptive statistics.</p><p><strong>Results: </strong>151 participants were recruited (median age 57 years; 70% female). Most participants were diagnosed in the accident & emergency (38%) or inpatient department (26%), followed by an outpatient department (19%) or private facility (16%). Nearly all (97%) participants received follow-up care during the study period, with an average of 1.3 AF-related healthcare visits per person for a month; most visited an outpatient department (88%). The COVID-19 pandemic negatively impacted 39% of participants' care: healthcare visits were reduced or, delayed or medications were unattainable, and longer intervals between blood tests were experienced; however, 24% of participants were able to receive their medication by ambulance, public health staff or post during lockdowns.</p><p><strong>Conclusions: </strong>Primary care was not involved in the diagnosis of AF, indicating that most diagnoses occurr after a medical emergency. The frequency of blood tests was lower than the guideline recommendations of one per month which could in-part be due to the adverse impacts of the pandemic. Strengthening primary and community-based care may enable early diagnosis and improve continuity of care during and beyond future healthcare crises.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"3 ","pages":"63"},"PeriodicalIF":0.0,"publicationDate":"2026-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11320028/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141977410","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}
引用次数: 0
Development of a Cystic Fibrosis Weight Management Programme:  protocol for a co-design study. 囊性纤维化体重管理方案的制定:一项共同设计研究的方案。
NIHR open research Pub Date : 2026-02-20 eCollection Date: 2026-01-01 DOI: 10.3310/nihropenres.14190.2
Joanne Barrett, Anne Elizabeth Topping, Nikos Ntoumanis, Alice Margaret Turner, Helen White, Sally Amelia May Fenton
{"title":"Development of a Cystic Fibrosis Weight Management Programme:  protocol for a co-design study.","authors":"Joanne Barrett, Anne Elizabeth Topping, Nikos Ntoumanis, Alice Margaret Turner, Helen White, Sally Amelia May Fenton","doi":"10.3310/nihropenres.14190.2","DOIUrl":"10.3310/nihropenres.14190.2","url":null,"abstract":"<p><strong>Background: </strong>Since the recent introduction of highly effective modulator therapies (HEMT), adults with cystic fibrosis (CF) have experienced significant health improvements. However, HEMTs can also lead to weight gain, and over 30% of adults living with CF, are now overweight or obese. The English National Health Service digital Weight Management Programme (NHS digital WMP) is offered to adults with obesity to support weight loss. This programme may not meet the complex health needs of people living with CF and may not address the established diet and physical activity behaviours that may contribute to weight gain in this population. Methods This paper outlines the steps to co-develop a CF-specific weight management programme (CF WMP), designed to be delivered alongside an NHS digital WMP. The CF-specific programme will be developed in collaboration with people with CF who have overweight or obesity (PwCF <sup>ow/ob</sup>) and professional stakeholders, using the three phases of the Person Based Approach (PBA); planning, co-designing and optimising. Planning Mixed-methods research with PwCF <sup>ow/ob</sup> and CF health care professionals will identify the barriers and facilitators to healthy eating and physical activity experienced by PwCF <sup>ow/ob</sup>. This will inform the guiding principles to underpin the co-design of the CF WMP and how it will address the dietary and physical activity behavioural needs of PwCF <sup>ow/ob</sup> to ensure it is engaging, acceptable and motivating. Co-design: a series of participatory workshops with PwCF <sup>ow/ob</sup> and key stakeholders will use guiding principles to specify design objectives and corresponding intervention features. Optimising: think aloud interviews with PwCF <sup>ow/ob</sup> will gather feedback on the CF WMP, to iteratively refine the programme.</p><p><strong>Discussion: </strong>The resulting CF WMP will extend the usability of an NHS digital WMP to adults with CF, to better ensure it meets their needs, which have changed since the introduction of HEMT.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"6 ","pages":"7"},"PeriodicalIF":0.0,"publicationDate":"2026-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12910199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146222415","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}
引用次数: 0
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