A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus.
Saunders, Mark P
Renehan, Andrew G
AffiliationDivision of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
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AbstractChemoradiotherapy is the primary treatment for patients with squamous cell carcinoma of the anus, but variations in the reported outcomes have restricted between-study comparisons. Treatment-related morbidity is considerable; however, no trial has comprehensively quantified long-term side-effects or quality of life. Therefore, we established the first international health-care professional and patient consensus to develop a core outcome set, using the Core Outcome Measures in Effectiveness Trials method. We used the results from our previous systematic review and combined them in this Review with patient interviews to derive a comprehensive list of outcomes, followed by a two-round Delphi survey completed by 149 participants (55 patients and 94 health-care professionals) from 11 countries. The Delphi results were discussed at a consensus meeting of health-care professionals and patients. Agreement was reached on 19 outcomes across four domains: disease activity, survival, toxicity, and life impact. Implementation of the Core Outcome Research Measures in Anal Cancer (CORMAC) set in future trials will serve as a framework to achieve standardisation, facilitate selection of health-area-specific evaluation tools, reduce redundancy of outcome lists, allow between-study comparisons, and ultimately enhance the relevance of trial findings to health-care professionals, trialists, and patients.
CitationFish R, Sanders C, Adams R, Brewer J, Brookes S, DeNardo J, et al. A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus. Lancet Gastroenterol Hepatol. 2018 Dec;3(12):865-73.
JournalLancet Gastroenterol Hepatol
- Core outcome research measures in anal cancer (CORMAC): protocol for systematic review, qualitative interviews and Delphi survey to develop a core outcome set in anal cancer.
- Authors: Fish R, Sanders C, Williamson PR, Renehan AG
- Issue date: 2017 Nov 22
- Systematic review of outcome measures following chemoradiotherapy for the treatment of anal cancer (CORMAC).
- Authors: Fish R, Sanders C, Ryan N, der Veer SV, Renehan AG, Williamson PR
- Issue date: 2018 May
- Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.
- Authors: Schlessinger DI, Iyengar S, Yanes AF, Chiren SG, Godinez-Puig V, Chen BR, Kurta AO, Schmitt J, Deckert S, Furlan KC, Poon E, Cartee TV, Maher IA, Alam M, Sobanko JF
- Issue date: 2017 Jul 12
- Development of a core outcome set for clinical trials in basal cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.
- Authors: Schlessinger DI, Iyengar S, Yanes AF, Lazaroff JM, Godinez-Puig V, Chen BR, Kurta AO, Henley JK, Chiren SG, Furlan KC, Schmitt J, Deckert S, Poon E, Sobanko JF, Cartee TV, Alam M, Maher IA
- Issue date: 2017 Oct 23
- Impact of question order on prioritisation of outcomes in the development of a core outcome set: a randomised controlled trial.
- Authors: Brookes ST, Chalmers KA, Avery KNL, Coulman K, Blazeby JM, ROMIO study group.
- Issue date: 2018 Jan 25