CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trialsResearch in context by Jan Rekowski, Christina Guo, Olga Solovyeva, Munyaradzi Dimairo, Mahtab Rouhifard, Dhrusti Patel, Emily Alger, Deborah Ashby, Jordan Berlin, Oliver Boix, Melanie Calvert, An-Wen Chan, Courtney H. Coschi, Johann de Bono, Thomas R. Jeffry Evans, Elizabeth Garrett–Mayer, Robert M. Golub, Kathryn S. Hayward, Sally Hopewell, John D. Isaacs, S. Percy Ivy, Thomas Jaki, Olga Kholmanskikh, Andrew Kightley, Shing Lee, Rong Liu, Israel Maia, Adrian Mander, Lynley V. Marshall, James Matcham, Richard Peck, Khadija Rerhou Rantell, Dawn P. Richards, Lesley Seymour, Yoshiya Tanaka, Moreno Ursino, Christopher J. Weir, Christina Yap

Get full text

Investigating the Efficacy of the Web-Based Common Elements Toolbox (COMET) Single-Session Interventions in Improving UK University Student Well-Being: Randomized Controlled Trial by Jeffrey Lambert, Maria Loades, Noah Marshall, Nina Higson-Sweeney, Stella Chan, Arif Mahmud, Victoria Pile, Ananya Maity, Helena Adam, Beatrice Sung, Melanie Luximon, Keren MacLennan, Clio Berry, Paul Chadwick

“…The data were analyzed using linear mixed models and reported in accordance with the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) checklist. …”
Get full text

The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial [version 2; peer review: 1 approved, 2 approved wit... by Paul Leighton, Wei Chern Gavin Fong, Ingrid Muller, Laura Howells, Arabella Baker, Eleanor J Mitchell, Eleanor Harrison, Leila Thuma, Yimin Jiang, Lucy Bradshaw, Alan Montgomery, Fiona Cowdel, Matthew J Ridd, Jane Ravenscroft, Reiko J Tanaka, Miriam Santer, Richard Swinden, Nicholas Hilken, Carron Layfield, Richard Dooley, Sophia Collins, Clare Upton, Tracy Owen, Firoza Davies, Devin Patel, Mars Eddis-Finbow, Hywel C Williams, Goldie Putrym, Kim S Thomas, Amanda Roberts

“…Exclusion criteria are: people with other types of eczema such as venous eczema, hand eczema and contact eczema; recently started a new eczema treatment; taking part in another eczema trial; Patient Oriented Eczema Measure (POEM) ≤2; planning to swim more than twice a week; unable/unwilling to change bathing practices. …”
Get full text

SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocolsResearch in context by Moreno Ursino, Guillermo Villacampa, Jan Rekowski, Munyaradzi Dimairo, Olga Solovyeva, Deborah Ashby, Jordan Berlin, Oliver Boix, Melanie Calvert, An-Wen Chan, Courtney H. Coschi, Thomas R. Jeffry Evans, Elizabeth Garrett-Mayer, Robert M. Golub, Christina Guo, Kathryn S. Hayward, Sally Hopewell, John D. Isaacs, S. Percy Ivy, Thomas Jaki, Olga Kholmanskikh, Andrew Kightley, Shing Lee, Rong Liu, Adrian Mander, Lynley V. Marshall, James Matcham, Dhrusti Patel, Richard Peck, Khadija Rerhou Rantell, Dawn P. Richards, Mahtab Rouhifard, Lesley Seymour, Yoshiya Tanaka, Christopher J. Weir, Johann de Bono, Christina Yap

“…The SPIRIT-DEFINE study is a component of the DEFINE project, which also developed the MRC/NIHR funded CONSORT-DEFINE guidance. ICR-CTSU receives programmatic infrastructure funding from Cancer Research UK (C1491/A25351; CTUQQR-Dec22/100004), which has contributed to accelerating the advancement and successful completion of this work.…”
Get full text