Improving the Detection, Assessment, Management and Prevention of Delirium in Hospices (the DAMPen-D study): protocol for a co-design and feasibility study of a flexible and scalab... by Najma Siddiqi, Chao Huang, Maureen Twiddy, Miriam Johnson, Margaret Ogden, Kathryn Sartain, Imogen Featherstone, Jason Boland, Mark Pearson, Catriona Jackson, Gillian Jackson

“…Descriptive statistics, rapid thematic analysis and a realist logic of analysis will be used be used to analyse quantitative and qualitative data, as appropriate.Ethics and dissemination Ethical approval obtained: Hull York Medical School Ethics Committee (Ref 21/23), Health Research Authority Research Ethics Committee Wales REC7 (Ref 21/WA/0180) and Health Research Authority Confidentiality Advisory Group (Ref 21/CAG/0071). …”
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What are the barriers and facilitators to self-management of chronic conditions reported by women? A systematic review by Dawn Dowding, Rohna Kearney, Lucy Dwyer

“…Data relevant to the topic will be extracted and critical appraisal of all included publications undertaken.Ethics and dissemination No ethical or Health Research Authority approval is required to undertake the systematic review. …”
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Understanding recruitment to a perioperative randomised controlled trial: protocol for a mixed-methods substudy nested within a feasibility trial of octreotide infusion during live... by Duncan Wagstaff, S Ramani Moonesinghe, Jez Fabes, Michael Spiro, Edgar Brodkin, Ee-Neng Loh, Vivienne Hannon

“…Findings from both workstreams will be formatively fed back to the trials team to enable iterative improvement to recruitment processes.Ethics and dissemination Approval has been granted by Greater Manchester West Research Ethics Committee (ref 20/NW/0071), the Health Research Authority and the local Research and Development offices. …”
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Protocol for a first-in-human feasibility study of T regulatory cells (TR004) for inflammatory bowel disease using (ex vivo) Treg expansion (TRIBUTE) by Jennifer Clough, Peter Irving, A Toby Prevost, Graham M Lord, Joana Vasconcelos, James B Canavan, Beverley Rodger, D Macallan

“…The primary endpoint is defined as the occurrence of dose-limiting toxicity occurring within 5 weeks post-infusion.Ethics and dissemination The study protocol and related documents have been approved by a NHS Research Ethics Committee, the Health Research Authority and the Medicines and Healthcare products Regulatory Agency for Clinical Trial Authorisation. …”
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Comparison of glycosylated fibronectin versus soluble fms-like tyrosine kinase/placental growth factor ratio testing for the assessment of pre-eclampsia: protocol for a multicentre... by Marcus Green, Chao Wang, Sarah Fisher, Amarnath Bhide, Ramesh Ganapathy, Basky Thilaganathan, Nouran Elbarbary

“…Maternal and neonatal outcome data will be collected to compare the sensitivity and specificity of the tests, with the primary outcome being delivery for pre-eclampsia within 4 weeks.Ethics and dissemination Ethical approval has been obtained from the Health Research Authority and Health and Care Research Wales Ethics Committee. …”
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Protocol for a multicentre randomised controlled trial examining the effects of temporarily pausing Bruton tyrosine kinase inhibitor therapy to coincide with SARS-CoV-2 vaccination... by Abhishek Abhishek, Jonathan A Cook, Helen M Parry, Anne Francis, Lelia Duley, Vicki S Barber, Paul Moss, Nicholas Peckham

“…The model will be adjusted for randomisation factor (first line or subsequent line of therapy), and prior infection status obtained from prerandomisation antinucleocapsid antibodies as fixed effects.Ethics and dissemination This study has been approved by Leeds East Research Ethics Committee and Health Research Authority (REC Reference:22/YH/0226, IRAS ID: 319057). …”
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The Acute VertEbRal AugmentaTion (AVERT) study: protocol for a randomised controlled, feasibility trial of spinal medial branch nerve block in hospitalised older patients with vert... by Avril Drummond, Opinder Sahota, Simon Bishop, Dritan Pasku, Apostolos Fakis, Anastasios Bastounis, Chia Wei Tan, Maribel Cameron, Yuriy Arlachov, Michal Czernicki

“…AVERT (Acute VertEbRal AugmentaTion) has received approval by the Health Research Authority (reference IRAS 293210) and is sponsored by Nottingham University Hospitals NHS Trust (reference 21HC001). …”
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Identifying biomarkers for epilepsy after cerebral malaria in Zambian children: rationale and design of a prospective observational study by Bo Zhang, Archana A Patel, Gretchen L Birbeck, Maitreyi Mazumdar, Suzanna Mwanza, Rosemary Nyirongo, Dixon Berejena, Joseph Kasolo, Tina Mwale, Violet Nambeye, Kafula Lisa Nkole, Nfwama Kawatu, Alexander Rotenberg

“…We will test the performance of these EEG and clinical metrics in predicting development of epilepsy through multivariate logistic regression analyses.Ethics and dissemination This study has been approved by the Boston Children’s Hospital Institutional Review Board, University of Zambia Biomedical Research Ethics Committee, and National Health Research Authority of Zambia. Results will be disseminated locally in Zambia followed by publication in international, open access, peer-reviewed journals when feasible.…”
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Protocol for Rhapsody: a longitudinal observational study examining the feasibility of speech phenotyping for remote assessment of neurodegenerative and psychiatric disorders by Allan H Young, Rebecca Strawbridge, Ammar Al-Chalabi, Dag Aarsland, Aleksandra Podlewska, Ray Chaudhuri, Elliot Hampsey, Marton Meszaros, Caroline Skirrow, Rosie H Taylor, Lazarus Chok, Jack Weston, Emil Fristed, Olabisi Awogbemila

“…Acoustic features analysed include mel-frequency cepstrum coefficients, formant frequencies, intensity and loudness, whereas text-based features such as number of words, noun and pronoun rate and idea density will also be used.Ethics and dissemination The study received ethical approval from the Health Research Authority and Health and Care Research Wales (REC reference: 21/PR/0070). …”
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Intervening to eliminate the centre-effect variation in home dialysis use: protocol for Inter-CEPt—a sequential mixed-methods study designing an intervention bundle by Sarah Damery, Kerry Allen, Lisa Dikomitis, Harry Hill, David Coyle, Maatla Tshimologo, Mark Lambie, Simon J Davies, Iestyn Williams, James Fotheringham, Louise Phillips-Darby, Ivonne Solis-Trapala

“…Patient and public engagement and involvement is embedded throughout the project.Ethics and dissemination Ethics approval has been granted by the Health Research Authority reference 20-WA-0249. The intervention bundle will comprise components for all stake holder groups: commissioners, provider units, recipients of dialysis, their caregivers and families. …”
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NIFTy: near-infrared fluorescence (NIRF) imaging to prevent postsurgical hypoparathyroidism (PoSH) after thyroid surgery—a phase II/III pragmatic, multicentre randomised controlled... by Deborah D Stocken, Maureen Twiddy, Hisham Mehanna, Jonathan Wadsley, Neil Corrigan, Katie Gordon, Julie Croft, Neil Sharma, Anna Perry, Mark Strachan, Gemma Ainsworth, Elizabeth Glenister, Sabapathy Prakash P Balasubramanian

“…Phase III secondary outcomes include protracted hypoparathyroidism, hypercalcaemia, complications, length of stay, readmissions and patient reported quality of life using the Short Form 36 Health Survey Questionnaire and Hypoparathyroid Patient Questionnaire instruments.Ethics and dissemination NIFTy is funded by National Institute for Health and Care Research Efficacy and Mechanism Evaluation Programme (Grant Ref: 17/11/27) and approved by a Research Ethics Committee (reference: 21/WA/0375) and Health Research Authority (HRA). Trial results will be disseminated through conference presentations, peer-reviewed publication and through relevant patient groups.Trial registration number ISRCTN59074092.…”
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Barriers and facilitators to facility-based delivery in rural Zambia: a qualitative study of women’s perceptions after implementation of an improved maternity waiting homes interve... by Peter C Rockers, Godfrey Biemba, Davidson H Hamer, Nancy A Scott, Jeanette L Kaiser, Taryn Vian, Rachel M Fong, Thandiwe Ngoma, Jody R Lori, Michelle Munro-Kramer, Misheck Bwalya, Gertrude Musonda, Eden Ahmed Mdluli, Viviane Rutagwera Sakanga, Kayla J Kuhfeldt

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Improving the diagnostic accuracy of referrals for papilloedema (DIPP) study: protocol for a mixed-methods study by Luke Bennetto, Beth Stuart, Jonathan Benger, Matthew J Ridd, Helen Bolton, William Hollingworth, Michael Bowen, Amar Shah, Samuel William David Merriel, Alyson Huntley, Victoria Wilson, Maria Theresa Redaniel, Paul Roy, Denize Atan, Frank Moore, Olivia Skrobot, Mary-Ann Sherratt, Marcia Lucraft, Christina Stokes

“…We will create a range of educational materials and a website designed for health professionals and patients to support the national roll-out and implementation of DIPP study guidelines.Ethics and dissemination Ethical approval was granted by the University of Bristol Faculty of Health Sciences Ethics committee (FREC reference: 12457) and Health Research Authority (IRAS no.: 320395). Results of the study will be published on our DIPP study website and disseminated to our stakeholder groups through peer-reviewed journal publications and conference presentations.…”
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Protocol for a randomised phase 3 trial evaluating the role of Finasteride in Active Surveillance for men with low and intermediate-risk prostate cancer: the FINESSE Study by Samuel Smith, Peter Sasieni, William Cross, Richard Bryant, Steven Kennish, James Catto, Rachel Hubbard, Simon Faulkner, Rohit Chahal, Mohantha Dooldeniya, Marcus Cumberbatch, Bernard North, Alastair D Lamb, Roseann Kealy, Selina Bhattrai

“…Analysis is Intention to Treat.Ethics and dissemination The study received Health Research Authority and South-Central Oxford Research Ethics Committee (14/12/2021: 21/SC/0349) and CTA/MHRA (29/12/2021: 21304/0274/001–0001) approvals. …”
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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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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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