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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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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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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