TY - JOUR
T1 - International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2)
T2 - defining the outcomes from the CORMAC core outcome set
AU - plus the CORMAC-2 collaborators
AU - Samuel, Robert
AU - Knight, Stephen R.
AU - Adams, Richard
AU - Das, Prajnan
AU - Dorth, Jennifer
AU - Finch, David
AU - Guren, Marianne G.
AU - Hawkins, Maria A.
AU - Moug, Susan
AU - Rajdev, Lakshmi
AU - Sebag-Montefiore, David
AU - Renehan, Andrew G.
AU - Fish, Rebecca
AU - Rodriguez-Bigas, Miguel A.
AU - Adusumilli, Pratik
AU - Mohamed, Ahmed Allam
AU - Gallego, Mario Alvarez
AU - Angenete, Eva
AU - Appelt, Ane
AU - Berbee, Maaike
AU - Brogden, Danielle
AU - Brown, Peter
AU - Buckley, Lucy
AU - Casanova, Nathalie
AU - Cooper, Rachel
AU - Couto, Nuno
AU - Coyne, Peter
AU - Cuming, Tamzin
AU - Deijin, Charlotte
AU - Dennis, Kristopher
AU - Eng, Cathy
AU - Gilbert, Alexandra
AU - Gilbert, Duncan
AU - Goodman, Karyn
AU - Jadon, Rashmi
AU - Johnsson, Anders
AU - Kar, Arunansu
AU - Ludmir, Ethan
AU - Lydrup, Marie Louise
AU - Lyra-Gonzalez, Ivan
AU - Manfrida, Stefania
AU - Muirhead, Rebecca
AU - O'Dwyer, Sarah
AU - Rackley, Thomas
AU - Raszewski, Lukasz
AU - Samuel, Leslie
AU - Saunders, Mark
AU - Scarsbrook, Andrew
AU - Segelov, Eva
AU - Simmons, Timothy
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/12
Y1 - 2024/12
N2 - 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.
AB - 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.
KW - Anal cancer
KW - Chemoradiotherapy
KW - Consensus
KW - Core outcome set
KW - Delphi
KW - Outcomes
UR - http://www.scopus.com/inward/record.url?scp=85211028201&partnerID=8YFLogxK
U2 - 10.1016/j.eclinm.2024.102939
DO - 10.1016/j.eclinm.2024.102939
M3 - Review article
AN - SCOPUS:85211028201
SN - 2589-5370
VL - 78
JO - eClinicalMedicine
JF - eClinicalMedicine
M1 - 102939
ER -