المؤلفون: Toader, Alice-Maria, Campbell, Marion K., Quint, Jennifer K., Robling, Michael, Sydes, Matthew R, Thorn, Joanna, Wright-Hughes, Alexandra, Yu, Ly-Mee, Abbott, Tom. E. F., Bond, Simon, Caskey, Fergus J., Clout, Madeleine, Collinson, Michelle, Copsey, Bethan, Davies, Gwyneth, Driscoll, Timothy, Gamble, Carrol, Griffin, Xavier L., Hamborg, Thomas, Harris, Jessica, Harrison, David A., Harji, Deena, Henderson, Emily J., Logan, Pip, Love, Sharon B., Magee, Laura A., O’Brien, Alastair, Pufulete, Maria, Ramnarayan, Padmanabhan, Saratzis, Athanasios, Smith, Jo, Solis-Trapala, Ivonne, Stubbs, Clive, Farrin, Amanda, Williamson, Paula

مصطلحات موضوعية: Healthcare systems data, Outcomes, Data validity, Registries, Routinely collected data, Clinical trials

الوصف: Background: Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, issues to be considered before the decision to use HSD for outcome data in a clinical trial is finalised, a methodological question prioritised by the clinical trials community. Methods: The PRIMORANT study had three phases. First, an initial workshop was held to scope the issues faced by trialists when considering whether to use HSDs for trial outcomes. Second, a consultation exercise was undertaken with clinical trials unit (CTU) staff, trialists, methodologists, clinicians, funding panels and data providers. Third, a final discussion workshop was held, at which the results of the consultation were fed back, case studies presented, and issues considered in small breakout groups. Results: Key topics included in the consultation process were the validity of outcome data, timeliness of data capture, internal pilots, data-sharing, practical issues, and decision-making. A majority of consultation respondents (n = 78, 95%) considered the development of guidance for trialists to be feasible. Guidance was developed following the discussion workshop, for the five broad areas of terminology, feasibility, internal pilots, onward data sharing, and data archiving. Conclusions: We provide guidance to inform decisions about whether or not to use HSDs for outcomes, and if so, to assist trialists in working with registries and other HSD providers to improve the design and delivery of trials.

العلاقة: https://nottingham-repository.worktribe.com/output/30927415Test; Trials; Volume 25; Issue 1; https://nottingham-repository.worktribe.com/file/30927415/1/s13063-024-07926-zTest

الإتاحة: https://doi.org/10.1186/s13063-024-07926-zTest
https://nottingham-repository.worktribe.com/file/30927415/1/s13063-024-07926-zTest
https://nottingham-repository.worktribe.com/output/30927415Test

المؤلفون: Bryant, Maria, Burton, Wendy, Collinson, Michelle, Martin, Adam, Copsey, Bethan, Groves-Williams, Dawn, Foster, Alexis, Willis, Thomas A, Garnett, Philip, O'Cathain, Alicia

الوصف: INTRODUCTION: One-fifth of children start school already overweight or living with obesity, with rates disproportionately impacting those living in the most deprived areas. Social, environmental and biological factors contribute to excess weight gain and programmes delivered in early years settings aim to support families to navigate these in order to prevent obesity. One of these programmes (Health, Exercise and Nutrition for the Really Young, HENRY) has been delivered in UK community venues (hereon named 'centres') in high deprivation areas since 2008 and aims to help families to provide a healthy start for their preschool children. We aim to establish the effectiveness and cost-effectiveness of HENRY, including its potential role from a wider systems perspective. METHODS AND ANALYSIS: This is a multicentre, open-labelled, two-group, prospective, cluster randomised controlled trial, with cost-effectiveness analysis, systems-based process evaluation and internal pilot. Primary analysis will compare body mass index (BMI) z-score at 12 months in children (n=984) whose parents have attended HENRY to those who have not attended. Secondary outcomes include parent and staff BMI and waist circumference, parenting efficacy, feeding, eating habits, quality of life, resource use and medium term (3 years) BMI z-scores (child and siblings). 82 centres in ~14 local authority areas will be randomised (1:1) to receive HENRY or continue with standard practice. Intention-to-treat analysis will compare outcomes using mixed effects linear regression. Economic evaluation will estimate a within-trial calculation of cost-per unit change in BMI z-score and longer-term trajectories to determine lifelong cost savings (long-term outcomes). A systems process evaluation will explore whether (and how) implementation of HENRY impacts (and is impacted by) the early years obesity system. An established parent advisory group will support delivery and dissemination. ETHICS AND DISSEMINATION: Ethical approval has been granted by the University ...

وصف الملف: text

العلاقة: https://eprints.whiterose.ac.uk/211568/1/e081861.full.pdfTest; Bryant, Maria orcid.org/0000-0001-7690-4098 , Burton, Wendy orcid.org/0000-0001-7885-5971 , Collinson, Michelle et al. (7 more authors) (2024) Effectiveness and cost-effectiveness of a sustainable obesity prevention programme for preschool children delivered at scale 'HENRY' (Health, Exercise, Nutrition for the Really Young) : protocol for the HENRY III cluster randomised controlled trial. BMJ Open. e081861. ISSN 2044-6055

الإتاحة: https://doi.org/10.1136/bmjopen-2023-081861Test
https://eprints.whiterose.ac.uk/211568Test/
https://eprints.whiterose.ac.uk/211568/1/e081861.full.pdfTest

المؤلفون: Airlie, Jennifer, Burton, Louisa-Jane, Copsey, Bethan, English, Coralie, Farrin, Amanda, Fitzsimons, Claire F, Holloway, Ivana, Horrocks, Judith, Johansson, Jessica Faye, Mead, Gillian, Forster, Anne

المساهمون: Airlie, Jennifer, Burton, Louisa-Jane, Copsey, Bethan, English, Coralie, Farrin, Amanda, Fitzsimons, Claire F, Holloway, Ivana, Horrocks, Judith, Johansson, Jessica Faye, Mead, Gillian, Forster, Anne

الوصف: Introduction Sedentary behaviour (sitting or lying during waking hours without being otherwise active) is strongly associated with adverse health outcomes, including all-cause, cancer and cardiovascular mortality in adults. Stroke survivors are consistently reported as being more sedentary than healthy age-matched controls, spending more hours sedentary daily and sustaining longer unbroken bouts of sedentary time. An evidence-based and clinically feasible intervention (‘Get Set Go’) was developed. A pragmatic definitive trial to evaluate Get Set Go was planned; however, due to the unprecedented effects of the COVID-19 pandemic on National Health Service (NHS) services this study was reduced in size and scope to become an external pilot trial. We report the protocol for this external pilot trial, which aims to undertake a preliminary exploration of whether Get Set Go is likely to improve ability to complete extended activities of daily living in the first year post-stroke and inform future trial designs in stroke rehabilitation. Methods and analysis This study is a pragmatic, multicentre, two-arm, external pilot cluster randomised controlled trial with embedded process and economic evaluations. UK-based stroke services will be randomised 1:1 to the intervention (usual care plus Get Set Go) or control (usual care) arm. Fifteen stroke services will recruit 300–400 stroke inpatient and carer participants, with follow-up at 6, 12 and 24 months. The proposed primary endpoint is stroke survivor self-reported Nottingham Extended Activities of Daily Living scale at 12 months. Endpoint analyses will be exploratory and provide preliminary estimates of intervention effect. The process evaluation will provide valuable information on intervention fidelity, acceptability and how it can be optimised. Ethics and dissemination The study has been approved by Yorkshire and The Humber – Bradford-Leeds Research Ethics Committee (Ref: 19/YH/0403). Results will be disseminated through journal publications and conference presentations. ...

العلاقة: https://resolver.sub.uni-goettingen.de/purl?gro-2/132053Test

الإتاحة: https://doi.org/10.1136/bmjopen-2023-074607Test
https://resolver.sub.uni-goettingen.de/purl?gro-2/132053Test

المؤلفون: Copsey, Bethan

المساهمون: Cook, Jonathan A., Buchanan, James, Fitzpatrick, Ray, Dutton, Susan J., Lamb, Sarah E.

مصطلحات موضوعية: 616.7, Osteoarthritis, Clinical trial, Sample size, Randomised trial

الوصف: The sample size of a clinical trial is the number of participants the trial aims to recruit. Sample size is a critical aspect of clinical trial design and has ethical and financial implications. The sample size depends on the target difference, the difference in outcome that the trial is powered to detect. This thesis aims to improve methods for specifying the target difference in randomised trials of osteoarthritis. I conducted a systematic review of sample size calculations in hip and knee osteoarthritis trials published in 2016. It found that most sample size calculations were poorly reported and could not be reproduced. The target difference in the sample size calculation was commonly justified by a published minimum clinically important difference (MCID). Several versions of the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) were commonly used in hip and knee osteoarthritis trials. It was often unclear which version was used, hindering interpretation of trial results. I conducted a discrete choice experiment examining patient preferences when choosing between osteoarthritis medications. Duration of treatment effect was shown to be important to participants, viewed with similar importance to the amount of symptom relief provided and risks of the treatment. I analysed a cohort of people with osteoarthritis and showed that MCID estimates for the WOMAC varied across different follow-up time points. However, there was no visual trend in the change in MCID estimates over time. Longitudinal methods were feasible to calculate MCID estimates, but did not improve precision. A simulation study that I conducted found that the pattern of the treatment effect (its duration and consistency) affected the optimal statistical method of analysis for a randomised trial using the WOMAC as the primary outcome. Future research is needed to examine whether the findings are generalisable to different datasets, outcome measures and health conditions.

الوصول الحر: https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.791739Test

المؤلفون: Johansson, Jessica Faye, Shannon, Rosie, Mossabir, Rahena, Airlie, Jennifer, Ozer, Seline, Moreau, Lauren A, Farrin, Amanda, Mead, Gillian, English, Coralie, Fitzsimons, Claire F, Clarke, David J, Forster, Anne, on behalf of the RECREATE Programme Management Group, RECREATE Programme Management Group, Birch, Karen, Carter, Gillian, Copsey, Bethan, Day, Florence, Fitzsimons, Claire, Lawton, Rebecca, Marsden, Laura, Moreau, Lauren, Patel, Anita, Yaziji, Nahel

مصطلحات موضوعية: Rehabilitation medicine

الوصف: Introduction Stroke survivors spend long periods of time engaging in sedentary behaviour (SB) even when their functional recovery is good. In the RECREATE programme, an intervention aimed at reducing SB (‘Get Set Go’) will be implemented and evaluated in a pragmatic external pilot cluster randomised controlled trial with embedded process and economic evaluations. We report the protocol for the process evaluation which will address the following objectives: (1) describe and clarify causal assumptions about the intervention, and its mechanisms of impact; (2) assess implementation fidelity; (3) explore views, perceptions and acceptability of the intervention to staff, stroke survivors and their carers; (4) establish the contextual factors that influence implementation, intervention mechanisms and outcomes. Methods and analysis This pilot trial will be conducted in 15 UK-based National Health Service stroke services. This process evaluation study, underpinned by the Medical Research Council guidance, will be undertaken in six of the randomised services (four intervention, two control). Data collection includes the following: observations of staff training sessions, non-participant observations in inpatient and community settings, semi-structured interviews with staff, patients and carers, and documentary analysis of key intervention components. Additional quantitative implementation data will be collected in all sites. Training observations and documentary analysis data will be summarised, with other observational and interview data analysed using thematic analysis. Relevant theories will be used to interpret the findings, including the theoretical domains framework, normalisation process theory and the theoretical framework of acceptability. Anticipated outputs include the following: recommendations for intervention refinements (both content and implementation); a revised implementation plan and a refined logic model. Ethics and dissemination The study was approved by Yorkshire & The Humber - Bradford Leeds ...

وصف الملف: text/html

العلاقة: http://bmjopen.bmj.com/cgi/content/short/13/9/e075363Test; http://dx.doi.org/10.1136/bmjopen-2023-075363Test

الإتاحة: https://doi.org/10.1136/bmjopen-2023-075363Test
http://bmjopen.bmj.com/cgi/content/short/13/9/e075363Test

المؤلفون: Sykes, Michael, Copsey, Bethan, Finch, Tracy, Meads, David, Farrin, Amanda, McSharry, Jenny, Holman, Naomi, Young, Bob, Berry, Alex, Ellis, Kat, Moreau, Lauren, Willis, Thomas, Alderson, Sarah, Girling, Melissa, O’Halloran, Elaine, Foy, Robbie

المساهمون: Health Services and Delivery Research Programme

المصدر: Implementation Science ; volume 18, issue 1 ; ISSN 1748-5908

مصطلحات موضوعية: Public Health, Environmental and Occupational Health, Health Informatics, Health Policy, General Medicine

الوصف: Background People with type 1 diabetes and raised glucose levels are at greater risk of retinopathy, nephropathy, neuropathy, cardiovascular disease, sexual health problems and foot disease. The UK National Institute for Health and Care Excellence (NICE) recommends continuous subcutaneous ‘insulin pump’ therapy for people with type 1 diabetes whose HbA1c is above 69 mmol/mol. Insulin pump use can improve quality of life, cut cardiovascular risk and increase treatment satisfaction. About 90,000 people in England and Wales meet NICE criteria for insulin pumps but do not use one. Insulin pump use also varies markedly by deprivation, ethnicity, sex and location. Increasing insulin pump use is a key improvement priority. Audit and feedback is a common but variably effective intervention. Limited capabilities of healthcare providers to mount effective responses to feedback from national audits, such as the National Diabetes Audit (NDA), undermines efforts to improve care. We have co-developed a theoretically and empirically informed quality improvement collaborative (QIC) to strengthen local responses to feedback with patients and carers, national audits and healthcare providers. We will evaluate whether the QIC improves the uptake of insulin pumps following NDA feedback. Methods We will undertake an efficient cluster randomised trial using routine data. The QIC will be delivered alongside the NDA to specialist diabetes teams in England and Wales. Our primary outcome will be the proportion of people with type 1 diabetes and an HbA1c above 69 mmol/mol who start and continue insulin pump use during the 18-month intervention period. Secondary outcomes will assess change in glucose control and duration of pump use. Subgroup analyses will explore impacts upon inequalities by ethnicity, sex, age and deprivation. A theory-informed process evaluation will explore diabetes specialist teams’ engagement, implementation, fidelity and tailoring through observations, interviews, surveys and documentary analysis. An ...

الإتاحة: https://doi.org/10.1186/s13012-023-01293-0Test

المؤلفون: Khan, Tasneem, Copsey, Bethan, Carder, Paul, Johnson, Stella, Imran, Mohammed, Wang, Kaiwen, Alderson, Sarah

المصدر: BJGP Open ; ISSN:2398-3795

مصطلحات موضوعية: United Kingdom, analgesics, opioid, anti-inflammatory agents, non-steroidal, general practice, inappropriate prescribing, prescriptions, socioeconomic factors, general practitioners, primary healthcare

الوصف: Overprescribing of potentially harmful medication in UK general practice has a complex association with socioeconomic deprivation.

العلاقة: https://doi.org/10.3399/BJGPO.2023.0156Test; https://pubmed.ncbi.nlm.nih.gov/38253399Test

الإتاحة: https://doi.org/10.3399/BJGPO.2023.0156Test
https://pubmed.ncbi.nlm.nih.gov/38253399Test

المؤلفون: Clark, Joseph, Copsey, Bethan, Wright-Hughes, Alexandra, McNaught, Emma, Bijsterveld, Petra, McCormack, Terry, Foy, Robbie, Wilkes, Scott, Dickson, Jon Mark, Meads, David, Farrin, Amanda, Johnson, Miriam

مصطلحات موضوعية: Health Sciences, Sciences

الوصف: INTRODUCTION Unmet needs in patients with cancer and their carers are common but poorly identified and addressed. The Needs Assessment Tool-Cancer (NAT-C) is a structured consultation guide to identify and triage patient and carer unmet needs. The NAT-C is validated, but its effectiveness in reducing unmet patient and carer needs in primary care is unknown. METHODS AND ANALYSIS Cluster randomised controlled trial with internal pilot and embedded process evaluation to test the clinical and cost effectiveness of the NAT-C in primary care for people with active cancer in reducing unmet patient and carer need, compared with usual care. We will recruit 1080 patients with active cancer (and carers if relevant) from 54 general practices in England.Participating practices will be randomised 1:1 to either deliver an NAT-guided clinical consultation plus usual care or to usual care alone. Consenting participants with active cancer and their carers (if nominated) will be asked to complete study questionnaires at baseline, 1 and 3 months for all, 6 months except for those recruited outside of the last 3 months of recruitment, and attend an NAT-C appointment if allocated to an intervention practice. An internal pilot will assess: site and participant recruitment, intervention uptake and follow-up rates. The primary outcome, the proportion of patients with an unmet need on the Supportive Care Needs Survey Short Form 34 at 3 months postregistration, will be analysed using a multilevel logistic regression. Mixed-methods process evaluation informed by Normalisation Process Theory will use quantitative survey and interview data from clinicians and key stakeholders in cancer care to develop an implementation strategy for nationwide rollout of the NAT-C if the intervention is cost-effective. ETHICS AND DISSEMINATION Ethical approval from London-Surrey REC (20/LO/0312). Results will be peer-reviewed, published and made available to research participants. TRIAL REGISTRATION NUMBER ISRCTN15497400.

وصف الملف: application/pdf

العلاقة: http://sure.sunderland.ac.uk/id/eprint/17534/1/CANAssess%20protocol.pdfTest; Clark, Joseph , Copsey, Bethan , Wright-Hughes, Alexandra , McNaught, Emma , Bijsterveld, Petra , McCormack, Terry , Foy, Robbie , Wilkes, Scott , Dickson, Jon Mark , Meads, David , Farrin, Amanda and Johnson, Miriam (2022) Cancer patients' needs assessment in primary care: study protocol for a cluster randomised controlled trial (cRCT), economic evaluation and normalisation process theory evaluation of the needs assessment tool cancer (CANAssess). BMJ open, 12 (5). p. 211. ISSN 2044-6055

الإتاحة: https://doi.org/10.1136/bmjopen-2021-051394Test
http://sure.sunderland.ac.uk/id/eprint/17534Test/
http://sure.sunderland.ac.uk/id/eprint/17534/1/CANAssess%20protocol.pdfTest
https://bmjopen.bmj.com/content/12/5/e051394Test

المؤلفون: Speich, Benjamin, Odutayo, Ayodele, Peckham, Nicholas, Ooms, Alexander, Stokes, Jamie R., Saccilotto, Ramon, Gryaznov, Dmitry, von Niederhäusern, Belinda, Copsey, Bethan, Altman, Douglas G., Briel, Matthias, Hopewell, Sally

المساهمون: Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

المصدر: Trials ; volume 23, issue 1 ; ISSN 1745-6215

مصطلحات موضوعية: Pharmacology (medical), Medicine (miscellaneous)

الوصف: Background To assess the quality of reporting of RCT protocols approved by UK research ethics committees before and after the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline. Methods We had access to RCT study protocols that received ethical approval in the UK in 2012 ( n =103) and 2016 ( n =108). From those, we assessed the adherence to the 33 SPIRIT items (i.e. a total of 64 components of the 33 SPIRIT items). We descriptively analysed the adherence to SPIRIT guidelines as proportion of adequately reported items (median and interquartile range [IQR]) and stratified the results by year of approval and sponsor. Results The proportion of reported SPIRIT items increased from a median of 64.9% (IQR, 57.6–69.2%) in 2012 to a median of 72.5% (IQR, 65.3–78.3%) in 2016. Industry-sponsored RCTs reported more SPIRIT items in 2012 (median 67.4%; IQR, 64.1–69.4%) compared to non-industry-sponsored trials (median 59.8%; IQR, 46.5–67.7%). This gap between industry- and non-industry-sponsored trials increased in 2016 (industry-sponsored: median 75.6%; IQR, 71.2–79.0% vs non-industry-sponsored: median 65.3%; IQR, 51.6–76.3%). Conclusions The adherence to SPIRIT guidelines has improved in the UK from 2012 to 2016 but remains on a modest level, especially for non-industry-sponsored RCTs.

الإتاحة: https://doi.org/10.1186/s13063-022-06516-1Test

المؤلفون: Speich, Benjamin, Gryaznov, Dmitry, Busse, Jason W., Gloy, Viktoria L., Lohner, Szimonetta, Klatte, Katharina, Taji Heravi, Ala, Ghosh, Nilabh, Lee, Hopin, Mansouri, Anita, Marian, Ioana R., Saccilotto, Ramon, Nury, Edris, Kasenda, Benjamin, Ojeda–Ruiz, Elena, Schandelmaier, Stefan, Tomonaga, Yuki, Amstutz, Alain, Pauli–Magnus, Christiane, Bischoff, Karin, Wollmann, Katharina, Rehner, Laura, Meerpohl, Joerg J., Nordmann, Alain, Wong, Jacqueline, Chow, Ngai, Hong, Patrick Jiho, Mc Cord – De Iaco, Kimberly, Sricharoenchai, Sirintip, Agarwal, Arnav, Schwenkglenks, Matthias, Hemkens, Lars G., von Elm, Erik, Copsey, Bethan, Griessbach, Alexandra N., Schönenberger, Christof, Mertz, Dominik, Blümle, Anette, von Niederhäusern, Belinda, Hopewell, Sally, Odutayo, Ayodele, Briel, Matthias

المساهمون: Kesselheim, Aaron S., Swiss Federal Office of Publich Health, Swiss National Science Foundation, Research Foundation of the University of Basel, NIHR Pre-Doctoral Fellowship, Alexander von Humboldt-Stiftung, János Bolyai Research Scholarship of the Hungarian Academy of Sciences

المصدر: PLOS Medicine ; volume 19, issue 4, page e1003980 ; ISSN 1549-1676

الوصف: Background We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. Methods and findings We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine ( ClinicalTrials.gov ); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials ...

الإتاحة: https://doi.org/10.1371/journal.pmed.1003980Test