NIHR open research最新文献

{"title":"Protocol for a trial-based economic evaluation analysis of a complex digital health intervention including a computerised decision support tool: the iFraP intervention","authors":"Michele Siciliano, Sarah Bathers, Ida Bentley, L. Bullock, Andrea Cherrington, Emma M Clark, Jane Fleming, Clare Jinks, Sarah Lewis, Christian Mallen, Elaine Nicholls, Terence W O'Neill, Jo Smith, David Webb, Z. Paskins, Cynthia P Iglesias-Urrutia","doi":"10.3310/nihropenres.13575.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13575.1","url":null,"abstract":"Background Digital health interventions (DHI) are associated with significant promise. In recent years, the need to assess the value of these healthcare technologies has motivated a debate regarding the suitability of existing economic evaluation methods in the context of DHI evaluation. Some have argued that robust economic evaluation methods may not be capable of capturing relevant DHI’s characteristics. Others consider that assessing the value of DHI might not be feasible. This protocol paper challenges that view. More specifically, it describes early Health Technology Assessments (HTA) methods to rigorously assess the value for money of a complex intervention including a digital decision support tool i.e., Improving uptake of Fracture Prevention drug treatments (iFraP) as a tracer intervention. iFraP is a complex intervention consisting of a computerised decision support tool, a clinician training package, and information resources to facilitate shared decision-making, increase informed medicine initiation and reduce levels of medicine discontinuation. iFraP’s development was motivated by a view that good quality shared decision-making conversations have the potential to improve levels of osteoporosis medicine uptake. Methods An early economic evaluation of the iFraP intervention was designed to identify, measure, and evaluate the costs and health benefits of iFraP compared to usual practice in Fracture Liaison Services (FLSs). A within-trial cost-effectiveness from the perspective of the National Health Service and Personal Social Service in England will be conducted using patient’s self-reported health related quality of life (HRQoL) and resource use from the iFraP randomised controlled trial. Microanalysis will be used to estimate iFraP’s intervention cost. Finally, Bayesian Value of Information analysis will allow us to estimate an upper bound for the potential health benefits gained from reducing uncertainty on the impact of the iFraP intervention to support uptake and adherence with osteoporosis medicines. Trial registration ISRCTN10606407 - https://doi.org/10.1186/ISRCTN10606407","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"287 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140750659","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 person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial protocol","authors":"L. Bullock, Elaine Nicholls, Andrea Cherrington, S. Butler-Walley, Emma M Clark, Jane Fleming, S. Leyland, Ida Bentley, Simon Thomas, Cynthia P Iglesias-Urrutia, David Webb, Jo Smith, Sarah Bathers, Sarah Lewis, Angela Clifford, Michele Siciliano, Joanne Protheroe, Sarah Ryan, J. Lefroy, N. Dale, A. Hawarden, Sarah Connacher, Robert Horne, Terence W O'Neill, Christian D Mallen, Clare Jinks, Z. Paskins","doi":"10.3310/nihropenres.13571.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13571.1","url":null,"abstract":"Background Good quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations. Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation. Methods The iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics. Discussion The iFraP trial will answer important questions about the effectiveness of the new ‘iFraP’ osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. Trial registration: ISRCTN 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"43 14","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140751995","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":"Disciplinary behaviour management strategies  in schools and their impact on student psychosocial outcomes: A systematic review","authors":"S. Ijaz, James Nobles, Loubaba Mamluk, Sarah Dawson, Bonnie Curran, Rachael Pryor, Sabi Redwood, Jelena Savović","doi":"10.3310/nihropenres.13563.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13563.1","url":null,"abstract":"Background Disciplinary behaviour management strategies are implemented in schools to manage pupil behaviour. There is limited evidence of their intended impact on behaviour but there is growing concern around the potential negative impacts on pupil wellbeing. Methods We carried out a systematic review to examine the impact of these strategies on psychosocial outcomes in pupils (PROSPERO Registration: CRD42021285427). We searched multiple sources and double-screened titles, abstracts, and full texts. Data extraction and risk of bias assessment were done by one reviewer and checked by another. Results were narratively synthesised. Results We included 14 studies, from 5375 citations, assessing temporary suspension (n=10), verbal reprimand (n=2), and mixed strategies (n=2). Depression was the most common outcome (n=7), followed by academic grades (n=4) and behaviour in class (n=4). All except one study were at high risk of bias. We found a recurring pattern in the evidence of disciplinary strategies associated with poor mental wellbeing and behaviour in pupils. The effect on academic attainment was unclear. Conclusions Disciplinary behaviour management strategies may have negative impact on pupil mental wellbeing and class behaviour. These important consequences should be assessed in better designed studies before these strategies are implemented.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":" 99","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140384643","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":"Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review","authors":"K. Biggs, Caroline Dix, Frances Shiely, Shaun Treweek, V. Shepherd, Athene Lane, Heidi R Green, Talia Isaacs, Andrew Willis, Cindy Cooper","doi":"10.3310/nihropenres.13524.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13524.1","url":null,"abstract":"Background Participants in clinical trials often do not reflect the populations that could benefit from the treatments being investigated. There are known barriers to trial participation for under-served groups, but limited evidence on strategies to alleviate these barriers to improve representation. This scoping review aimed to identify effective interventions and design features that improve the representation `of under-served groups in trials, focusing on the UK and Ireland. Methods We included methodological research studies that reported interventions to improve representation of ethnic minority groups, socioeconomically disadvantaged groups, older people, or those with impaired capacity to consent to randomised controlled trials, conducted in the UK and Ireland, published between 2000–2021. Systematic searches were conducted in November 2021 and data were independently extracted by two authors and narratively synthesised. Results Seven studies were included: one randomised controlled study embedded in five trials, one mixed-methods study, and five studies reporting ‘lessons learnt’ from one trial. We categorised the 47 reported interventions or strategies into nine broad themes: Recruitment sites, recruitment settings, community engagement, and communication with participants, incentives, inclusion criteria, flexibility, patient documentation, and the consent process. Only 28/47 interventions were evaluated, 23 of which were comparison of recruitment pathways. The randomised study found that a £100 incentive mentioned in the invitation letter increased positive responses overall across drug trials in cardiovascular disease and hypertension, but not for older people or those living in the most deprived areas. Invitation letters via GPs and working with communities were reported as successful recruitment pathways in recruiting different under-served populations. Conclusions Interventions aiming to improve the recruitment of under-served groups in the UK and Ireland were reported across seven papers, but their effectiveness was rarely rigorously evaluated. Included studies were context specific. Using a variety of recruitment methods is likely to help achieve a more diverse cohort.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":" 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140382217","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: a pilot study.","authors":"Christabella Ng, Neele S Dellschaft, Caroline Hoad, Luca Marciani, Robin Spiller, Colin Crooks, Trevor Hill, Alex Menys, Jochen G Mainz, Helen Barr, Penny A Gowland, Giles Major, Alan R Smyth","doi":"10.3310/nihropenres.13510.2","DOIUrl":"10.3310/nihropenres.13510.2","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinicaltrialsgov registration: </strong>NCT04006873 (02/07/2019).</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"3 ","pages":"65"},"PeriodicalIF":0.0,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11320032/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141977375","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 hospital-based opioid substitution therapy (iHOST): protocol for a mixed-methods evaluation","authors":"D. Lewer, Michael Brown, Adam Burns, Niamh Eastwood, Rosalind Gittens, Adam Holland, V. Hope, Aubrey Ko, Penny Lewthwaite, Ann-Marie Morris, Adrian Noctor, Andrew Preston, Jenny Scott, Erica Smith, Sedona Sweeney, N. Tilouche, Marisha Wickremsinhe, Magdalena Harris","doi":"10.3310/nihropenres.13534.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13534.1","url":null,"abstract":"Background Opioid substitution therapy is associated with improved health and social outcomes for people who use heroin and other illicit opioids. It is typically managed in the community and is not always continued when people are admitted to hospital. This causes opioid withdrawal, discharge against medical advice, and increased costs. We are establishing a project called iHOST (improving hospital opioid substitution therapy) to address these problems. This is an applied health research project in which we will develop and evaluate an intervention that aims to improve opioid substitution therapy in three acute hospitals in England. The intervention was developed in collaboration with stakeholders including people who use opioids, hospital staff, and other professionals who work with this group. It includes five components: (1) a card that patients can use to help hospital clinicians confirm their opioid substitution therapy, (2) a helpline for patients and staff, (3) an online training module for staff, (4) a clinical guideline for managing opioid withdrawal in hospital, and (5) ‘champion’ roles at each hospital. Methods We will do a mixed-methods study including a quasi-experimental quantitative study and a qualitative process evaluation. The primary outcomes for the quantitative study are discharge against medical advice and emergency readmission within 28 days. We will do a difference-in-difference analysis comparing changes in these outcomes for patients at iHOST sites with changes for patients at control hospitals. The process evaluation will use in-depth interviews, focus groups, and site observations with people who use opioids and staff. We will assess acceptability of the intervention, barriers and facilitators to implementation, and contextual factors impacting outcomes. Impact We anticipate that iHOST will improve care for hospital patients who use illicit opioids and/or are receiving community-based opioid substitution therapy. Depending on the results, we will promote the intervention at hospitals across the UK. Dissemination, including through publication, will inform hospital-based services for people who use drugs both in the UK and other countries.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"5 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140247523","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":"Prevalence, risks and outcomes of frailty in People Experiencing Homelessness: a protocol for secondary analysis of Health Needs Audit data.","authors":"Jo Dawes, Kate Walters, Rachael Frost, Emmanouil Bagkeris, Alexandra Burton, Debra Hertzberg, Andrew Hayward","doi":"10.3310/nihropenres.13545.1","DOIUrl":"10.3310/nihropenres.13545.1","url":null,"abstract":"<p><p>Frailty describes a health state related to ageing where people become less resilient to health challenges and more likely to have adverse outcomes if they become unwell. People experiencing homelessness (PEH) are known to have poor health, with research suggesting that many become frail at a younger age than the general population. Previous research using small-scale primary data collection suggests that the prevalence of frailty in homeless populations varies widely (16-55%), with variations in sample sizes and settings partially accounting for differences in current estimates. The prevalence, risks, and outcomes of frailty in PEH are poorly understood. We propose to carry out a secondary analysis of existing health survey data collected from 2,792 PEH. This will involve creating a Frailty Index (FI) to identify frail people within the dataset. Regression analyses will be used to identify associations between potential risk factors and outcomes of frailty in this population. This protocol will: 1) Outline the creation of a FI to assess the frailty prevalence within a dataset of health information collected from a cohort of PEH and 2) Describe proposed methods of regression analysis for identification of associations between frailty and risks factors/outcomes of frailty in the cohort of PEH within the dataset. The processes described in this paper can inform future development of FIs in other datasets. It is expected that the FI created will be an appropriate and robust method for identifying frailty in a cohort of PEH and results of the secondary data analysis will provide a more robust estimate of the associations between frailty and risk factors/outcomes.</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"4 ","pages":"9"},"PeriodicalIF":0.0,"publicationDate":"2024-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11375403/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142141923","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":"Autonomy & advocacy in planning for a medical emergency: Adults with a learning disability and family carers’ experiences and perceptions of the Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) process","authors":"Amy M. Russell, Jacqui M Lovell, J. Harlock, Frances Griffiths, A. Slowther","doi":"10.3310/nihropenres.13555.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13555.1","url":null,"abstract":"Background The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) is designed to facilitate meaningful discussions between healthcare professionals, patients, and their family about preferences for treatment in future medical emergencies. People with a learning disability may face particular barriers in completing health care plans and receiving emergency treatment, however little is known about their preferences towards emergency care treatment planning. This study explores the views of people with a learning disability, and family carers about ReSPECT. Methods Online, arts-based interactive workshops were held with people with a learning disability to explore how they felt about emergency care treatment planning, and to co-produce materials to support ReSPECT conversations. Carers of people with a learning disability participated in focus groups or interviews. Data from workshops, focus groups and interviews were analysed thematically. Results Themes identified were: Getting the Process Right, Lack of trust as a barrier to ReSPECT planning, and Person-Centred Care. All groups supported the ReSPECT process. They felt that ReSPECT plans could support person-centred care, enhancing the autonomy of a person with a learning disability and supporting the advocacy of carers. However, drawing on their previous experiences of the health care system some expressed doubt that their wishes, as reflected in the recommendations, would be carried out. Suggestions were made for improving the ReSPECT process for people with a learning disability and used to develop resources to support ReSPECT planning. Conclusions Emergency care planning and ReSPECT are viewed positively by people with a learning disability and family carers. To ensure this works well for people with a learning disability attention should be given to reasonable, personalised adjustments to support their participation in planning conversations. There is a wider challenge of fostering trust in the health care system regarding treatment of people with a learning disability.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"50 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140257002","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":"Baseline Characteristics in the Remote Diet Intervention to REduce long-COVID Symptoms Trial (ReDIRECT).","authors":"Laura Haag, Janice Richardson, Caroline Haig, Yvonne Cunningham, Heather Fraser, Naomi Brosnahan, Tracy Ibbotson, Jane Ormerod, Chris White, Emma McIntosh, Kate O'Donnell, Naveed Sattar, Alex McConnachie, Mike Lean, David Blane, Emilie Combet","doi":"10.3310/nihropenres.13522.1","DOIUrl":"10.3310/nihropenres.13522.1","url":null,"abstract":"<p><strong>Background: </strong>The persistence of symptoms for ≥12 weeks after a COVID-19 infection is known as Long COVID (LC), a condition with unclear pathophysiology and no proven treatments to date. Living with obesity is a risk factor for LC and has symptoms which may overlap with and aggravate LC.</p><p><strong>Methods: </strong>ReDIRECT is a remotely delivered trial assessing whether weight management can reduce LC symptoms. We recruited people with LC and BMI >27kg/m ². The intervention was delivered remotely by dietitians, with online data collection (medical and dietary history, COVID-19 infection and vaccination, body composition, LC history/symptoms, blood pressure, quality of life, sociodemographic data). Participants self-selected the dominant LC symptoms they most wanted to improve from the intervention.</p><p><strong>Results: </strong>Participants (n=234) in England (64%) and Scotland (30%) were mainly women (85%) of white ethnicity (90%), with 13% living in the 20% most deprived areas, a mean age of 46 (SD10) years, and median BMI of 35kg/m ² (IQR 32-40). Before starting the study, 30% reported more than one COVID-19 infection (82% confirmed with one or more positive tests). LC Diagnosis was mainly by GPs (71%), other healthcare professionals (9%), or self-diagnosed (21%). The median total number of symptoms was 6 (IQR 4-8). Self-selected dominant LC symptoms included fatigue (54%), breathlessness (16%), pain (12%), anxiety/depression (1%) and \"other\" (17%). At baseline, 82% were taking medication, 57% reported 1+ other medical conditions. Quality of life was poor; 20% were on long-term sick leave or reduced working hours. Most (92%) reported having gained weight since contracting COVID-19 (median weight change +11.5 kg, range -11.5 to +45.3 kg).</p><p><strong>Conclusions: </strong>Symptoms linked to LC and overweight are diverse and complex. Remote trial delivery enabled rapid recruitment across the UK yet certain groups (e.g. men and those from ethnic minority groups) were under-represented.</p><p><strong>Trial registration: </strong>ISRCTN registry ( ISRCTN12595520, 25/11/2021).</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"4 ","pages":"7"},"PeriodicalIF":0.0,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11320183/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141984138","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":"Managing hypertension in rural Gambia and Kenya: Protocol for a qualitative study exploring the experiences of patients, health care workers, and decision-makers","authors":"Brahima A. Diallo, Syreen Hassan, N. Kagwanja, R. Oyando, Jainaba Badjie, N. Mumba, Andrew M Prentice, Pablo Perel, Anthony O. Etyang, Ellen Nolte, Benjamin Tsofa","doi":"10.3310/nihropenres.13523.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13523.1","url":null,"abstract":"Background Hypertension is the single leading risk factor for premature death in Sub-Saharan Africa (SSA). Prevalence is high, but awareness, treatment, and control are low. Community-centred interventions show promise for effective hypertension management, but embedding sustainably such interventions requires a good understanding of the wider context within which they are being introduced. This study aims to conduct a systematic health system assessment exploring the micro (patients/carers), meso (health care workers and facilities), and macro (broader system) contexts in rural Gambia and Kenya. Methods This study will utilise various qualitative approaches. We will conduct focus group discussions with hypertensive patients to map a ‘typical’ patient journey through health systems. We will conduct in-depth interviews with patients, health care workers, and decision-makers to explore their experiences of managing hypertension and assess the capacity and readiness of the health systems to strengthen hypertension management in rural Gambia and Kenya. We will also review national guidelines and policy documents to map the organisation of services and guidance on hypertension diagnosis and control. Thematic analysis approach will be used to analyse data, guided by the cumulative complexity model, and theories of organisational readiness and dissemination of innovations. Expected findings This study will describe the current context for the diagnosis and management of hypertension from the perspective of those involved in seeking (patients), delivering (health care workers) and overseeing (decision-makers) health services in rural Gambia and Kenya. It will juxtapose what should be happening according to health system guidance and what is happening in practice. It will outline the various barriers to and facilitators of hypertension control, as perceived by patients, providers, and decision-makers, and the conditions that would need to be in place for effective and sustainable implementation of a community-centred intervention to improve the diagnosis and management of hypertension in rural settings.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"42 32","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139961643","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}