International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set

Samuel, Robert, Knight, Stephen R., Adams, Richard ORCID: https://orcid.org/0000-0003-3915-7243, Das, Prajnan, Dorth, Jennifer, Finch, David, Guren, Marianne G., Hawkins, Maria A., Moug, Susan, Rajdev, Lakshmi, Sebag-Montefiore, David, Renehan, Andrew G., Fish, Rebecca, Rodriguez-Bigas, Miguel A., Adusumilli, Pratik, Mohamed, Ahmed Allam, Gallego, Mario Alvarez, Angenete, Eva, Appelt, Ane, Berbee, Maaike, Brogden, Danielle, Brown, Peter, Buckley, Lucy, Casanova, Nathalie, Cooper, Rachel, Couto, Nuno, Coyne, Peter, Cuming, Tamzin, Deijin, Charlotte, Dennis, Kristopher, Eng, Cathy, Gilbert, Alexandra, Gilbert, Duncan, Goodman, Karyn, Jadon, Rashmi, Johnsson, Anders, Kar, Arunansu, Ludmir, Ethan, Lydrup, Marie-Louise, Lyra-Gonzalez, Ivan, Manfrida, Stefania, Muirhead, Rebecca, O'Dwyer, Sarah, Rackley, Thomas, Raszewski, Lukasz, Samuel, Leslie, Saunders, Mark, Scarsbrook, Andrew, Segelov, Eva, Simmons, Timothy, Sutton, Paul, Symons, Nicholas and Williamson, Deborah 2024. International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set. EClinicalMedicine 78 , 102939. 10.1016/j.eclinm.2024.102939

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Abstract

Variation in outcomes definitions and reporting limit the utility of clinical trial results. The Core Outcome Research Measures in Anal Cancer (CORMAC) project developed a core outcome set (COS) for chemoradiotherapy trials for anal squamous cell carcinoma (ASCC) through an international healthcare professional and patient consensus process. The CORMAC-COS comprises 19 outcomes across 4 domains (disease activity, survival, toxicity, life impact). In CORMAC-2 we have established standardised definitions for the 11 disease activity and survival outcomes in the CORMAC COS. Definitions were agreed through a 3 step process, initially identifying existing definitions through systematic review (registered with PROSPERO, CRD42016036540), using these to populate a two-round Delphi questionnaire completed by 51 experts from 13 countries, and finally ratification through an online consensus meeting. Standardising the definitions for these core outcomes facilitates real world utilisation of the CORMAC-COS, thereby increasing the quality of data available for clinical decision-making and ultimately enhancing patient care.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	Elsevier
ISSN:	2589-5370
Date of First Compliant Deposit:	19 December 2024
Last Modified:	19 Dec 2024 15:00
URI:	https://orca.cardiff.ac.uk/id/eprint/174789

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