NIHR open research最新文献

{"title":"Qualitative study of experience of acceptance and commitment therapy (ACT+) amongst Survivors' Rehabilitation Evaluation after Cancer (SURECAN) trial participants and therapists: A protocol.","authors":"Sheila Donovan, Trudie Chalder, Dipesh Gopal, Imran Khan, Ania Korszun, Elisavet Moschopoulou, Damien Ridge, Clare Robinson, Stephanie Taylor","doi":"10.3310/nihropenres.13382.2","DOIUrl":"10.3310/nihropenres.13382.2","url":null,"abstract":"<p><strong>Background: </strong>This interview study forms part of a mixed methods process evaluation of the Survivors' Rehabilitation Evaluation after Cancer (SURECAN) trial to understand the experiences of participants (who are living with and beyond cancer) in receiving a form of acceptance and commitment therapy, and therapists providing the intervention. SURECAN is a multi-centre, pragmatic, individual participant randomised controlled trial of an intervention based on acceptance and commitment therapy supplemented by support for return to meaningful work and/or physical activity (ACT+). This qualitative study addresses the ways in which participants believe they benefit from ACT+ (or not), and how the ACT+ intervention might best be implemented into routine National Health Service (NHS) care.</p><p><strong>Methods: </strong>The study investigates experiences of ACT+ by different participants to understand how we can optimise the ACT+ intervention and its delivery (assuming the intervention is successful). We will conduct individual interviews with participants who have taken part in the active arm of the SURECAN trial to understand their experiences of engaging with and receiving ACT+, their perceptions of the impact of the therapy, and relevant contextual factors influencing these experiences. In particular, we will focus on comparing our interview findings between those trial participants who improved and those who failed to improve (or worsened), in terms of quality of life following ACT+. Additionally, we will conduct individual interviews with therapists who have delivered ACT+ as part of the SURECAN trial, to understand their experiences of delivering ACT+.</p><p><strong>Conclusions: </strong>Consistent with other qualitative protocols, this protocol is not registered. Instead, it is shared as a means of documenting ahead of time, how we are endeavouring to understand the ways in which a newly trialled talking therapy is received by patients and therapists, and how (if successful) it might be incorporated into the NHS.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"3 ","pages":"24"},"PeriodicalIF":0.0,"publicationDate":"2024-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11319895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141977409","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":"Stakeholder views on the barriers and facilitators of psychosocial interventions to address reduction in aggressive challenging behaviour in adults with intellectual disabilities.","authors":"Athanasia Kouroupa, Leila Hamza, Aisha Rafiq, Angela Hassiotis, Penny Rapaport, Andrew Jahoda, Laurence Taggart, Liz Steed, Sally-Ann Cooper, Craig Melville, Louise Marston, Rachel Royston, Afia Ali","doi":"10.3310/nihropenres.13437.1","DOIUrl":"10.3310/nihropenres.13437.1","url":null,"abstract":"<p><p>Success of psychosocial interventions in reducing aggressive challenging behaviour is likely to be related not only to mechanistic aspects but also to therapeutic and system factors. The study aims to examine the facilitators and barriers that influence whether psychosocial interventions for aggressive challenging behaviour in adults with intellectual disabilities lead to positive change. We conducted 42 semi-structured interviews with adults with intellectual disabilities who display aggressive challenging behaviour, family/paid carers, and professionals engaged in or delivering a psychosocial intervention across the UK. Data were analysed thematically using a framework approach. Stakeholders considered therapeutic and supportive relationships and personalised care as facilitating factors in addressing aggressive challenging behaviour. The operational structure of community intellectual disability services and conflicting expectations of professionals and carers were the main contextual barriers that impeded the implementation of psychosocial interventions in adults with intellectual disabilities. Findings highlight the valued components that maximise positive change in adults with intellectual disabilities who display aggressive challenging behaviour. Several operational adjustments including referral criteria, roles of professionals and workforce issues need to be addressed in services to maximise the implementation of psychosocial interventions leading to reduction in aggressive challenging behaviour in this population.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":" ","pages":"40"},"PeriodicalIF":0.0,"publicationDate":"2023-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10593323/pdf/nihropenres-3-14575.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47880979","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":"Determining the optimal diagnostic and risk stratification approaches for people with hypertension in two rural populations in Kenya and The Gambia: a study protocol for IHCoR-Africa Work Package 2","authors":"Alexander D Perkins, Juliet O. Awori, Modu Jobe, Ruth K Lucinde, Meike Siemonsma, R. Oyando, David A Leon, Emily Herrett, Andrew M Prentice, Anoop SV Shah, Pablo Perel, Anthony O. Etyang","doi":"10.3310/nihropenres.13509.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13509.1","url":null,"abstract":"Background Sub-Saharan Africa (SSA) has one of the highest prevalences of hypertension worldwide. The impact of hypertension is of particular concern in rural SSA, where access to clinics and hospitals is limited. Improvements in the management of people with hypertension in rural SSA could be achieved by shifting diagnosis and care from the clinic to the community. To develop such a community-centred programme we need optimal approaches to identify and risk stratify patients with elevated blood pressure. The aim of the study is to improve the evidence base for diagnosis and risk estimation for a community-centred hypertension programme in two rural settings in SSA. Methods We will conduct a cross-sectional study of 1250 adult participants in Kilifi, Kenya and Kiang West, The Gambia. The study has five objectives which will determine the: (1) accuracy of three blood pressure (BP) measurement methods performed by community health workers in identifying people with hypertension in rural SSA, compared to the reference standard method; (2) relationship between systolic BP and cardiovascular risk factors; (3) prevalence of hypertension-mediated organ damage (HMOD); (4) accuracy of innovative point-of-care (POC) technologies to identify patients with HMOD; and (5) cost-effectiveness of different combinations of BP and HMOD measurements for directing hypertension treatment initiation. Expected findings This study will determine the accuracy of three methods for community BP measurement and POC technologies for HMOD assessment. Using the optimal methods in this setting it will estimate the prevalence of hypertension and provide the best estimate to date of HMOD prevalence in SSA populations. The cost-effectiveness of decision-making approaches for initiating treatment of hypertension will be modelled. These results will inform the development of a community-centred programme to improve care for hypertensive patients living in rural SSA. Existing community engagement networks will be used to disseminated within the research setting.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"83 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138951278","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Natural language processing for detecting adverse drug events: A systematic review protocol","authors":"Imane Guellil, Jinge Wu, Aryo Pradipta Gema, Farah Francis, Yousra Berrachedi, Nidhaleddine Chenni, Richard Tobin, Clare Llewellyn, Stella Arakelyan, Honghan Wu, Bruce Guthrie, Beatrice Alex","doi":"10.3310/nihropenres.13504.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13504.1","url":null,"abstract":"Background Detecting Adverse Drug Events (ADEs) is an emerging research area, attracting great interest in the research community. Better anticipatory management of predisposing factors has considerable potential to improve outcomes. Automatic extraction of ADEs using Natural Language Processing (NLP) has a great potential to significantly facilitate efficient and effective distillation of such knowledge, to better understand and predict risk of adverse events. Methods This systematic review follows the six-stage including the literature from 6 databases (Embase, Medline, Web Of Science, ACM Guide to Computing Literature, IEEE Digital Library and Scopus). Following the title, abstract and full-text screenings, characteristics and main findings of the included studies and resources will be tabulated and summarized. The risk of bias and reporting quality was assessed using the PROBAST tool 1 . Results We developed our search strategy and collected all relevant publications. As of October 2023, we have completed the first two stages of the systematic review. We identified 178 studies for inclusion through the academic literature search (where data was extracted from 118 papers). Further refinement of the eligibility criteria and data extraction has been ongoing since August 2022. Conclusion In this systematic review, we will identify and consolidate information and evidence related to the use and effectiveness of existing NLP approaches and tools for automatically detecting ADEs from free text (discharge summaries, General Practitioner notes, social media, etc.). Our findings will improve the understanding of the current landscape of the use of NLP for extracting ADEs. It will lead to better anticipatory management of predisposing factors with the potential to improve outcomes considerably. Our results will also be valuable both to NLP researchers developing methods to extract ADEs and to translational/clinical researchers who use NLP for this purpose and in healthcare in general.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"122 30","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138959071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enablers and barriers to engaging under-served groups in research: Survey of the United Kingdom research professional's views.","authors":"Dorothy Coe, Theophile Bigirumurame, Meera Burgess, John Rouse, Caroline Wroe","doi":"10.3310/nihropenres.13434.2","DOIUrl":"10.3310/nihropenres.13434.2","url":null,"abstract":"<p><strong>Background: </strong>There is a known lack of diversity in research participant populations. This impacts on the generalisability of findings and affects clinician prescribing. In the United Kingdom the research community defines those who are underrepresented as under-served. They are commonly those affected by health inequality and disparity. The notion of under-served is complex, with numerous papers identifying multiple factors that contribute to being under-served and in turn suggesting many strategies to improve engagement.</p><p><strong>Methods: </strong>Research professionals in the UK were invited to complete an online survey. The broad aim was to explore their views on under-served groups. The findings were analysed using statistical and qualitative methods to identify enablers and barriers to engaging the under-served. Descriptive statistics were utilised with associations compared univariately by chi-square test and logistic regression for multivariable analysis.</p><p><strong>Results: </strong>A total of 945 completed responses were received. Those identified as under-served in this study reflected the previous body of works with a broader descriptor of ethnic and cultural minorities and the addition of adolescents and young adults. Language and literacy skills had the most impact on being under-served. Only 13% of respondents said they felt equipped to meet the needs of the under-served. The main strategy to increase diversity was community engagement and movement of research delivery into the community. The barriers were funding and time. Training needs identified were linked to community engagement, cultural competence and consent processes.</p><p><strong>Conclusions: </strong>The UK findings from research professionals reflected the previous literature. Adolescents and young people were added to those identified as under-served. Enablers included community outreach and improvement to communication. Barriers were time, funding, organisational processes and lack of focus. Issues were identified with translation and interpretation services. Training requirements focus on methodologies and methods to engage and the consent processes of those from under-served groups.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"3 ","pages":"37"},"PeriodicalIF":0.0,"publicationDate":"2023-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11319909/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141977378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving the usability of open health service delivery simulation models using Python and web apps.","authors":"Thomas Monks, Alison Harper","doi":"10.3310/nihropenres.13467.1","DOIUrl":"10.3310/nihropenres.13467.1","url":null,"abstract":"<p><p>One aim of Open Science is to increase the accessibility of research. Within health services research that uses discrete-event simulation, Free and Open Source Software (FOSS), such as Python, offers a way for research teams to share their models with other researchers and NHS decision makers. Although the code for healthcare discrete-event simulation models can be shared alongside publications, it may require specialist skills to use and run. This is a disincentive to researchers adopting Free and Open Source Software and open science practices. Building on work from other health data science disciplines, we propose that web apps offer a user-friendly interface for healthcare models that increase the accessibility of research to the NHS, and researchers from other disciplines. We focus on models coded in Python deployed as streamlit web apps. To increase uptake of these methods, we provide an approach to structuring discrete-event simulation model code in Python so that models are web app ready. The method is general across discrete-event simulation Python packages, and we include code for both simpy and ciw implementations of a simple urgent care call centre model. We then provide a step-by-step tutorial for linking the model to a streamlit web app interface, to enable other health data science researchers to reproduce and implement our method.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"3 ","pages":"48"},"PeriodicalIF":0.0,"publicationDate":"2023-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10593330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50164052","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":"Connected communities | Learning lessons from person-centred community-based support services’ implementation.","authors":"Danielle L. Christian, Kathryn Berzins, J. C. Weldon, Madalina Toma, Mark Gabbay, Caroline L Watkins, Julien Forder","doi":"10.3310/nihropenres.13494.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13494.1","url":null,"abstract":"Background Person-centred community-based support services (PCCBSS) are an array of non-clinical services provided by organisations such as NHS Trusts, voluntary sector organisations, or local authorities. All PCCBSS involve an individual (variously known as a 'social prescriber’, ‘link worker’, ‘signposter’, ‘navigator’, ‘connector’ or ‘neighbourhood coach’) who talks with a service user before directing them to a range of relevant community sources of social, emotional, and practical support. Despite much recent investment in social prescribing, and its increased prominence within the policy context across England, little is understood about how PCCBSS are implemented. Research is required across different contexts to describe PCCBSS implementation; in particular, how social care providers successfully interact to support the implementation of PCCBSS, and how services responded to circumstances imposed by the COVID-19 pandemic. Purpose The aim of this post-implementation mixed-methods study is to explore how PCCBSS are implemented and become part of usual working practice. Using three services in North West England as case studies, we will examine factors influencing PCCBSS implementation and establish where there is learning for the wider adult social care system. Focus The study comprises two work packages (WPs): WP1: collecting data by reviewing service documents from three PCCBSS case studies; WP2: interviewing staff and service users (≤20 participants per PCCBSS); Key implementation data will be systematically abstracted (from WPs1&2) into a coding frame; combining contextual determinants from the Consolidated Framework for Implementation Research (CFIR) with process-related domains from Normalization Process Theory (NPT). Key outputs The findings from WP1 and WP2 will be presented in the form of an illustrated ‘pen portrait’, developed collaboratively with Applied Research Collaboration North West Coast ARC NWC public advisers, to illustrate how implementation evolved for each of the PCCBSS across key time-points in the process (initiation; operation; maintenance). The findings will also inform an online implementation toolkit providing recommendations for setting up future PCCBSS.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139232436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A randomised crossover trial of tezacaftor-ivacaftor for gut dysfunction in cystic fibrosis with magnetic resonance imaging (MRI) outcomes.","authors":"C. Ng, N. Dellschaft, C. Hoad, L. Marciani, R. Spiller, Colin Crooks, Trevor Hill, A. Menys, J. G. Mainz, Helen Barr, P. Gowland, G. Major, Alan R Smyth","doi":"10.3310/nihropenres.13510.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13510.1","url":null,"abstract":"Background People with cystic fibrosis (CF) can experience recurrent chest infections, pancreatic exocrine insufficiency and gastrointestinal symptoms. New cystic fibrosis transmembrane conductance regulator (CFTR) modulator drugs improve lung function but gastrointestinal effects are unclear. We aimed to see if a CFTR modulator (tezacaftor-ivacaftor,TEZ/IVA) improves gastrointestinal outcomes in CF. Methods We conducted a randomised, double-blind, placebo-controlled, two-period crossover trial (2019-2020) at Nottingham University Hospitals. The effects of TEZ/IVA on gut physiology were measured using MRI. Participants were randomly assigned to treatment sequences AB or BA (A:TEZ/IVA, B:placebo, each 28 days), with a 28-day washout period. Participants had serial MRI scans at baseline and after 19-23 days of each treatment. Due to the COVID-19 pandemic, a protocol amendment allowed for observer-blind comparisons prior to and during TEZ/IVA. In such cases, participants were not blind to the treatment but researchers remained blind. The primary outcome was oro-caecal transit time (OCTT). Secondary outcomes included MRI metrics, symptoms and stool biomarkers. Results We randomised 13 participants. Before the COVID-19 pandemic 8 participants completed the full protocol and 1 dropped out. The remaining 4 participants followed the amended protocol. There were no significant differences between placebo and TEZ/IVA for OCTT (TEZ/IVA >360minutes [225,>360] vs. placebo 330minutes [285,>360], p=0.8) or secondary outcomes. There were no adverse events. Conclusions Our data contribute to a research gap in the extra-pulmonary effects of CFTR modulators. We found no effect after TEZ/IVA on MRI metrics of gut function, GI symptoms or stool calprotectin. Effects might be detectable with larger studies, longer treatment or more effective CFTR modulators. ClinicalTrials.gov registration NCT04006873 (02/07/2019)","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139228113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Equity, vulnerability and childhood immunization in Kenya and Uganda. A review of policy documents protocol.","authors":"Esther Owino, David Mafigiri, Dorcas Kamuya, Caroline Jones, Primus Chi","doi":"10.3310/nihropenres.13449.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13449.1","url":null,"abstract":"Introduction Inequities in access and uptake of vaccines remains to be a challenge to the full realization of benefits they stand to offer. In the case of childhood immunization, improved full immunization coverage has been witnessed globally in the past decades but countries in sub-Saharan Africa have registered slow progress, with variations between/within countries. This has been attributed to several challenges/vulnerability factors. Consequently, current global efforts to promote access to immunization have focused on the issue of equity, which is now a strategic priority in key international policy documents such as the World Health Organization immunization agenda 2030 among others. It is therefore important to understand the context and efforts being made by individual countries to realize equity. We plan to undertake a systematic policy document review to understand the immunization context in Kenya and Uganda by examining the extent to which equity and vulnerability issues are framed and addressed in key health sector and policy documents in both countries. Methods The systematic review will focus on key health sector and immunization policy documents in Uganda and Kenya between 2000 and 2023. Documents in the English language will be reviewed. Data sources will include official ministry of health websites for each country, websites of key international organizations working on immunization, general google searches and requesting for relevant documents from immunization stakeholders and officials in both countries. Data synthesis will follow a deductive and inductive approach. Findings will be presented in a descriptive format and in line with review objectives. Discussion We will assess the extent to which equity and vulnerability issues are included and how they are defined in the health sector and immunization policy documents. In addition, the review will examine strategies proposed, planned and/or implemented to promote equitable access and uptake of immunization services in the two countries.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"467 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139239698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mobility and strength training with and without protein supplements for pre-frail or frail older adults with low protein intake: the Maximising Mobility and Strength Training (MMoST) feasibility randomised controlled trial protocol","authors":"Kavita Biggin, I. Marian, Sarah E. Lamb, Alana Morris, Caoileann Murphy, Andrew Carver, Nirvana Croft, E. Williamson","doi":"10.3310/nihropenres.13507.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13507.1","url":null,"abstract":"Background Frailty is a common syndrome affecting older people and puts them at risk of hospitalisation, needing care or death. First signs of frailty include reduced muscle strength and mobility decline. A key cause of mobility decline as we age is sarcopenia (age related reduction in muscle strength and mass). Poor nutrition contributes to sarcopenia. A shortfall in protein is associated with reduced muscle mass and strength. This may be due to inadequate intake but also because older people have higher protein needs, especially those with multimorbidity. We need to develop effective treatment to reduce or slow the onset of frailty and mobility decline. Exercise is a recommended treatment. Protein supplements to address the shortfall in protein have the potential to enhance the benefit of regular exercise in frail or pre-frail older adults. This has yet to be definitively demonstrated. Aim To establish the feasibility of conducting an RCT evaluating mobility and strength training with or without protein supplements for people over 60 years old who are frail or pre-frail with a low protein intake. Methods A multicentre, parallel, 2-group, feasibility RCT. Participants (recruitment target = 50) with problems walking, low protein intake and classified as frail or pre-frail will be recruited from four NHS Physiotherapy community services. Participants will be randomised (secure computer-generated: 1:1) to receive 24 weeks of mobility and strength training (delivered in 16 group sessions plus home exercises) or 24 weeks of mobility and strength training with daily protein supplements. Primary feasibility objectives are to estimate 1) ability to screen and recruit eligible participants, 2) intervention fidelity, adherence, and tolerance and 3) retention of participants at follow up. Secondary objectives are to 1) test data collection procedures, 2) assess data completeness and 3) confirm sample size calculation for a definitive RCT. Registration ISRCTN Registry (ISRCTN30405954; 18/10/2022).","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139241989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}