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

Samuel, R.
; 
Knight, S. R.
; 
Adams, R.
; 
Das, P.
; 
Dorth, J.
; 
Finch, D.
; 
Guren, M. G.
; 
Hawkins, M. A.
; 
Moug, S.
; 
Rajdev, L.
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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.
Authors
Samuel, R.
Knight, S. R.
Adams, R.
Das, P.
Dorth, J.
Finch, D.
Guren, M. G.
Hawkins, M. A.
Moug, S.
Rajdev, L.
Sebag-Montefiore, D.
Renehan, A. G.
Fish, R.
Affiliation
NIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK. University of Leeds, Leeds Institute for Medical Research, St. James's University Hospital, Leeds, UK. Centre for Medical Informatics, Usher Institute, University of Edinburgh, Edinburgh, UK. School of Health and Wellbeing, University of Glasgow, Glasgow, UK. Centre for Trials Research, Cardiff University School of Medicine, Cardiff, UK. University of Texas MD Anderson Cancer Center, USA. Department of Radiation Oncology, University Hospitals Cleveland Medical Centre, Cleveland, USA. Colorectal and Peritoneal Oncology Centre, The Christie NHS FT, Manchester. Department of Oncology, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, Norway. Department of Medical Physics and Biomedical Engineering, University College London, London, UK. Department of Colorectal Surgery, Royal Alexandra Hospital, Paisley, UK. Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
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2024
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Samuel R, Knight SR, Adams R, Das P, Dorth J, Finch D, et al. International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set. EClinicalMedicine. 2024 Dec;78:102939. PubMed PMID: 39720423. Pubmed Central PMCID: PMC11667046. Epub 2024/12/25. eng.
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https://christie.openrepository.com/handle/10541/627846
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