Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes: the Youth Empowerment Skill... by Nick Sevdalis, Khalida Ismail, Tayana Soukup, Trevor Murrells, Dulmini Kariyawasam, Stephen Thomas, Judith Parsons, Angus Forbes, Rita Forde, Maria Baldellou Lopez, Marie Jones, Martha Ford-Adams, Nardos Yemane, Siobhan Pender, Alex Silverstien

“…Study findings will be used to optimise the intervention components, outcome measures and recruitment methods to inform a subsequent definitive trial.Ethics and dissemination The protocol has ethical approval from the UK Health Research Authority (approval IRAS project ID: 279877). …”
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Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial by Robert Clarke, Emma J Crosbie, Basil G Issa, John Belcher, Helen Clarke, Anthony Howell, Michelle Harvie, Hannah Harrison, Cheryl Lombardelli, Suzanne Krizak, Katharine Sellers, Yit Y Lim, Caroline Parkin, Shruthi Patel, Anthony J Maxwell, Julie Wisely, Sacha J Howell

“…The trial will also assess longer-term adherence and weight loss success across the 12-month programme in both the immediate and control groups.Ethics and dissemination Approval for this study has been obtained from the Health Research Authority and Health and Care Research Wales (approval 20/NW/0095). …”
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Qualitative application of the diffusion of innovation theory to maternity waiting homes in rural Zambia by Jeanette L. Kaiser, Rachel M. Fiorillo, Taryn Vian, Thandiwe Ngoma, Kayla J. Kuhfeldt, Michelle L. Munro-Kramer, Davidson H. Hamer, Misheck Bwalya, Viviane R. Sakanga, Jody R. Lori, Eden Ahmed Mdluli, Peter C. Rockers, Godfrey Biemba, Nancy A. Scott

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MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty – protocol for a double-blind, randomised controlled proof-of... by Andrew Clegg, James Wason, Miles Witham, Nina Wilson, Claire J Steves, Helen C Hancock, Avan A P Sayer, Leanne Marsay, Claire McDonald, Thomas von Zglinicki, Katherine J Rennie, Penny Bradley, Stephen Connolly, Shaun Hiu, Laura Robertson, Laura Simms, Alison J Steel, Bryony Storey

“…The primary outcome measure is the four metre walk speed at the 4-month follow-up visit.Ethics and dissemination The trial has been approved by the Liverpool NHS Research Ethics Committee (20/NW/0470), the Medicines and Healthcare Regulatory Authority (EudraCT 2020-004023-16) and the UK Health Research Authority (IRAS 275219). Results will be made available to participants, their families, patients with sarcopenia, the public, regional and national clinical teams, and the international scientific community.Trial registration number ISRCTN29932357.…”
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Clinical and cost-effectiveness of Knee Arthroplasty versus Joint Distraction for Osteoarthritis (KARDS): protocol for a multicentre, phase III, randomised control trial by Deborah D Stocken, Dennis G McGonagle, David Murray, Catherine Reynolds, Catherine Fernandez, David R Ellard, Andrew Metcalfe, Hemant Sharma, Paul Harwood, Hamish Simpson, Hemant Pandit, Susanne Arnold, Cerys Joyce Tassinari, Ruchi Higham, Isabelle Louise Smith, Ruben Mujica-Mota, Thomas William Hamilton, Julie Croft

“…Per patient cost difference between KR and KJD and cost per quality-adjusted life year (QALY) gained over 24 months will be estimated within trial, and incremental cost per QALY gained over 20 years by KJD relative to KR predicted using decision analytic modelling.Ethics and dissemination Ethics approval was obtained from the Research Ethics Committee (REC) and Health Research Authority (HRA). Trial results will be disseminated at clinical conferences, through relevant patient groups and published in peer-reviewed journals.Trial registration number ISRCTN14879004; recruitment opened April 2021.…”
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Yorkshire Lung Screening Trial (YLST): protocol for a randomised controlled trial to evaluate invitation to community-based low-dose CT screening for lung cancer versus usual care... by Richard D Neal, Kevin Franks, David Torgerson, Rachael L Murray, David R Baldwin, Michael Darby, Henrik Moller, Richard Booton, Una MacLeod, Sam M Janes, Samantha L Quaife, Sebastian Hinde, Matthew EJ Callister, Suzanne Rogerson, Rhian Gabe, Mark Sculpher, Philip AJ Crosbie, Irene Simmonds, Martyn Kennedy, Nazia Ahmed, Ann Cochrane, Mike Messenger, Puvanendran Tharmanathan

“…Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies.Ethics and dissemination The study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. …”
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Treating common mental disorder including psychotic experiences in the primary care improving access to psychological therapies programme (the TYPPEX study): protocol for a stepped... by David Fowler, Jesus Perez, Peter B Jones, Debra Russo, Clare Knight, Mary Dixon-Woods, Allan B Clark, Margaret Heslin, Sarah Byford, Paul French, Thomas Kabir, Jan Stochl, Mona Kanaan, James Clarke, Nick Grey, Ann Marie Swart, Polly-Anna Ashford, Ushma Patel, Freya Stuart, Hannah Murray, J Hodgekins, Nesta Reeve, Nicola Marshall, Michelle Painter, Maria Leathersich, Martin Pond

“…The primary outcome will be the proportion of patients with common mental disorder psychotic experiences who have recovered by the end of treatment as measured by the official IAPT measure for recovery.Ethics and dissemination The study received the following approvals: South Central—Berkshire Research Ethics Committee on 28 April 2020 (REC reference 20/SC/0135) and Health Research Authority (HRA) on 23 June 2020. An amendment was approved by the Ethics Committee on 01 October 2020 and HRA on 27 October 2020. …”
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plaTform fOr Urinary tract infection diagnostiC evAluatioN (TOUCAN): a protocol for a prospective diagnostic accuracy study of point-of-care testing in patients suspected of acute... by Thomas R Fanshawe, Philip J Turner, Gail N Hayward, Margaret Glogowska, Alastair D Hay, Michael Moore, Mark Lown, Christopher C Butler, Mandy Wootton, Mark H Wilcox, Jane Freeman, Nicola Kenealy, Valerie Tate, Owain Llion, Rebecca Lowe

“…Secondary outcomes will include the symptom profile of patients presenting with uncomplicated UTI, a theoretical determination of how use of POCT results might change prescribing, an understanding of POCT failure rate and qualitative capture of the experiences of those using the POCT to deliver the study in primary care clinics.Ethics and dissemination Ethical approval was received from the London Central Research Ethics Committee (23/LO/0371) and the UK Health Research Authority. We will publish the findings of The plaTform fOr Urinary tract infection diagnostiC evAluatioN evaluations in peer-reviewed medical journals and more broadly following a dissemination plan formulated by a communications specialist in consultation with patients and the public.Trial registration number ISRCTN80937472.…”
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Impact of prior SARS-CoV-2 infection and COVID-19 vaccination on the subsequent incidence of COVID-19: a multicentre prospective cohort study among UK healthcare workers – the SIRE... by Nick Andrews, Mary Ramsay, Maria Zambon, Victoria Hall, Sarah Wallace, Susan Hopkins, Jean Timeyin, Tim J G Brooks, Amoolya Vusirikala, Meera Chand, Andre Charlett, Sakib Rokadiya, Colin S Brown, Madhumita Shrotri, Peter D Kirwan, Michele Cole, Natalie Gillson, Ana Atti, Sarah Foulkes, Andrew Taylor-Kerr, Blanche Oguti, Jasmin Islam

“…Secondary outcomes include incidence and prevalence (both RNA and antibody) of SARS-CoV-2, viral genomics, viral culture, symptom history and antibody/neutralising antibody titres.Ethics and dissemination The study was approved by the Berkshire Research Ethics Committee, Health Research Authority (IRAS ID 284460, REC reference 20/SC/0230) on 22 May 2020; the vaccine amendment was approved on 12 January 2021. …”
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Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a m... by Ernest Choy, Kerenza Hood, Emma Thomas-Jones, Eleanor Barnes, Keith Wilson, Christian H Ottensmeier, Debbie Harris, Adrian Hill, Mark Tuthill, Richard Adams, Catherine Porter, Katie Ewer, Sian Griffin, Rebecca Tangney, Joanne Euden, Shirley Pringle, Lawrence Raisanen, Ruby Ray, Lisette Sheena Nixon, Melanie Varley, Craig Bodman, Paola Cicconi, Vivien Dagley, Steven Knapper

“…The immunological effect of the study interventions will be determined by comparison of the results of immunological assessments at baseline and subsequent timepoints.Ethics and dissemination The trial protocol was approved by the research ethics committee of the National Health Service (reference 22/HRA/0359), Health Research Authority and Health and Care Research Wales on 25 July 2022. …”
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Life after prostate cancer diagnosis: protocol for a UK-wide patient-reported outcomes study by David H Brewster, Victoria Cairnduff, Eila Watson, Amy Downing, Adam W Glaser, Penny Wright, William Cross, Conan Donnelly, Anna Gavin, Carol Rivas, Richard Wagland, Peter Selby, Luke Hounsome, Therese Kearney, Rebecca Mottram, Majorie Allen, Oonagh McSorley, Hugh Butcher, Paul Kind, James W H Catto, Dyfed Huws, Emma McNair, Lauren Matheson, Johana Nayoan, Mike Horton, Jessica Corner, Julia Verne

“…To ensure detailed understanding of issues of importance, qualitative interviews will be undertaken with a sample of men who complete the survey across the UK (n=∼150) along with a small number of partners/spouses (n=∼30).Ethics and dissemination The study has received the following approvals: Newcastle and North Tyneside 1 Research Ethics Committee (15/NE/0036), Health Research Authority Confidentiality Advisory Group (15/CAG/0110), NHS Scotland Public Benefit and Privacy Panel (0516-0364), Office of Research Ethics Northern Ireland (16/NI/0073) and NHS R&D approval from Wales, Scotland and Northern Ireland. …”
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Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational study by Thomas Lee, Sandeep Singh, Phyo Kyaw Myint, Sheila Jones, Ben Carter, Susan Moug, Terry Quinn, Michael Thomas, Emma Bhatti, Angeline Price, Fenella Barlow-Pay, Siobhan Duffy, Lyndsay Pearce, Arturo Vilches-Moraga, Michael Stechman, Philip Braude, Emma Mitchell, Alessia Verduri, Kathryn McCarthy, Jonathan Hewitt, Charlotte Davey, Kiah Lunstone, Alice Cavenagh, Charlotte Silver, Thomas Telford, Rebecca Simmons, Dolcie Paxton, Francis Rickard, Mark Holloway, James Hesford, Tarik Jichi, Norman Galbraith, Jenny Edwards, Carly Bisset, Ross Alexander, Abigail Ingham, Roxanna Short, Aine McGovern, Jemima Collins, Eilidh Bruce, Alice Einarsson, Enrico Clini, Giovanni Guaraldi, Madeline Garcia, Shefali Sangani, Thomas Kneen, George Kyriakopoulos, Denise Tan

“…All analyses will be presented as crude and adjusted HR and OR with associated 95% CIs and p values.Ethics and dissemination This study has been registered, reviewed and approved by the following: Health Research Authority (20/HRA1898); Ethics Committee of Hospital Policlinico Modena, Italy (369/2020/OSS/AOUMO); Health and Care Research Permissions Service, Wales; and NHS Research Scotland Permissions Co-ordinating Centre, Scotland. …”
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PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal use of antibiotics in the emergency department (PRONTO): protocol for a multicentre, open-label,... by David Taylor-Robinson, Steve Goodacre, Neil French, Richard Body, Kerenza Hood, Emma Thomas-Jones, Jane Daniels, Sarah Walker, Ingeborg Welters, Mike Bradburn, Paul Schmidt, Enitan Carrol, Lucy Brookes-Howell, Sarah Milosevic, Andrew Tabner, Philip Pallmann, Stephen Aston, Gavin Barlow, Emma Richards, Emmanuel Nsutebu, Philip Howard, Matthew Inada-Kim, Stacy Todd, Fiona McGill, Martin Llewelyn, Louis Wihelmus Niessen, Joanne Euden, Julie Carman, Stephanie Gilbert, Sam Clarkstone, Jacqui Hughes, Lena Meister, Angela Brain, Matthew Scarborough, Sian O'Shea, Claire James

“…The study has an internal pilot phase and group-sequential stopping rules for effectiveness and futility/safety, as well as a qualitative substudy and a health economic evaluation.Ethics and dissemination The trial protocol was approved by the Health Research Authority (HRA) and NHS Research Ethics Committee (Wales REC 2, reference 20/WA/0058). …”
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The Protocol for the Multi-Ethnic, multi-centre raNdomised controlled trial of a low-energy Diet for improving functional status in heart failure with Preserved ejection fraction (... by Noelle Robertson, Melanie J Davies, Thomas Yates, Gerry P McCann, Gaurav Singh Gulsin, Emer M Brady, Joanne V Wormleighton, Eylem Levelt, Oliver Rider, Jiliu Pan, Christopher Miller, Iain Squire, Mehak Asad, Fardad Soltani, Michelle Hadjiconstantinou, Rachel L Brown, Joanna M Bilak

“…Key secondary endpoints include symptoms and quality of life measured by the KCCQ score.Ethics and dissemination The Health Research Authority Ethics Committee (REC reference 22/EM/0215) has approved the study. …”
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EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents by Melanie Gündert, Anette-Gabriele Ziegler, Peter Achenbach, Olga Kordonouri, Agnieszka Szypowska, Ezio Bonifacio, Parth Narendran, Christiane Winkler, R Ribeiro, Sandra Hummel, Przemysława Jarosz-Chobot, Emanuele Bosi, R Lahesmaa, K Casteels, M Peakman, P Jarosz-Chobot, O Kordonouri, Chantal Mathieu, Vito Lampasona, J F Raposo, H Hyöty, F Pociot, João Filipe Raposo, R Berner, R Bergholdt, E Bonifacio, Flemming Pociot, B Petersen, J Van Rampelbergh, L Overbergh, B Van der Schueren, V Lampasona, C Winkler, R Coelho, O Cohen, C Mathieu, E Bosi, Stefanie Arnolds, Lut Overbergh, Zdenek Sumnik, A Koralova, G Sebastiani, Luisa Hoffmann, Mirjam Kohls, Regine Bergholdt, Bianca K Hoefelschweiger, Jurgen Vercauteren, P Gillard, J Vercauteren, A G Ziegler, P Achenbach, F Haupt, S Hummel, T Pieber, J Mader, S Moitzi, S Del Prato, B Torbeyns, Z Sumnik, O Cinek, V Neuman, B Berka, J Antvorskov, J H Klaebel, J E Laiho, F Reschke, T von dem Berge, A Hommel, A Loff, G Gemulla, N Zubizarreta, L Piemonti, F Dotta, A Szypowska, K Karczewski, E Niemoeller, M Baccara-Dinet, K Fogh, M I Buompensiere, C Hurtado del Pozo, E Latres, G Agiostratidou

“…H-22053116; Swedish Ethical Review Authority, Nr. 2023-00312-01; National Health Service Health Research Authority and Health Care Research Wales, IRAS (Integrated Research Application System) project ID 309252; Italian National Institute of Health, National ethics committee for clinical trials of public research bodies (EPR) and other national public institutions, Prot. …”
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FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregn... by Kerry Woolfall, Jamie J Kirkham, Jane Sandall, Mariana Popa, Enrico Lopriore, Mark Turner, Shakila Thangaratinam, Aris T Papageorghiou, Andrew Sharp, Lawrence Impey, Andy Healey, Jessica Mendoza, Asma Khalil, Dharmintra Pasupathy, Brigitte Vollmer, Zarko Alfirevic, Rajeswari Parasuraman, Jan Deprest, Richard Edmund Ashcroft, Kurt Hecher, Smriti Prasad, Baskaran Thilaganathan, Richard J Jackson, Tracy Karen Mitchell, Natasha Fenwick, Monique C Haak, Liesbeth Lewi, Shauna Leven, Fabricio Da Silva Costa, Odai Yaghi, Tracey Ricketts, George Attilakos, Carolyn Bailie, Christine Cornforth, Mark Denbow, Louise Hardman, Jane Harrold, Joel Marsden, Tommy Mousa, Surabhi Nanda, Michelle Watson, Karen Wilding, Dilly Anumba, Edward D Johnstone, Yoav Yinon, Ahmet Baschat

“…Engagement of at least 50 UK clinicians is planned for WP3.Ethics and dissemination This study has received ethical approval from the Health Research Authority (HRA) South West—Cornwall and Plymouth Ethics Committee (REC reference 20/SW/0156, IRAS ID 286337). …”
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