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

被引：2

作者：

Samuel, Robert ^{[1
,2
]}

Knight, Stephen R. ^{[3
,4
]}

Adams, Richard ^{[5
]}

Das, Prajnan ^{[6
]}

Dorth, Jennifer ^{[7
]}

Finch, David ^{[1
,8
]}

Guren, Marianne G. ^{[9
]}

Hawkins, Maria A. ^{[10
]}

Moug, Susan ^{[11
]}

Rajdev, Lakshmi ^{[12
]}

Sebag-Montefiore, David ^{[2
]}

Renehan, Andrew G. ^{[1
,8
]}

Fish, Rebecca ^{[1
,8
]}

机构：

[1] Univ Manchester, Manchester Acad Hlth Sci Ctr, Sch Med Sci, Sch Med Sci,Div Canc Sci, Manchester, England

[2] Univ Leeds, St Jamess Univ Hosp, Leeds Inst Med Res, Leeds, England

[3] Univ Edinburgh, Usher Inst, Ctr Med Informat, Edinburgh, Scotland

[4] Univ Glasgow, Sch Hlth & Wellbeing, Glasgow City, Scotland

[5] Cardiff Univ, Sch Med, Ctr Trials Res, Cardiff, Wales

[6] Univ Texas MD Anderson Canc Ctr, Houston, TX USA

[7] Univ Hosp Cleveland Med Ctr, Dept Radiol, Cleveland, OH USA

[8] Christie NHS FT, Colorectal & Peritoneal Oncol Ctr, Manchester, England

[9] Univ Oslo, Oslo Univ Hosp, Dept Oncol, Oslo, Norway

[10] UCL, Dept Med Phys & Biomed Engn, London, England

[11] Royal Alexandra Hosp, Dept Colorectal Surg, Paisley, Scotland

[12] Icahn Sch Med Mt Sinai, Tisch Canc Inst, New York, NY USA

来源：

ECLINICALMEDICINE | 2024年 / 78卷

关键词：

Core outcome set; Outcomes; Anal cancer; Consensus; Delphi; Chemoradiotherapy; SQUAMOUS-CELL CARCINOMA; CLINICAL-PRACTICE GUIDELINES; END-POINT DEFINITIONS; POST CHEMORADIOTHERAPY; RANDOMIZED-TRIAL; EORTC QLQ-ANL27; RADIOTHERAPY; CHEMORADIATION; MITOMYCIN; FLUOROURACIL;

D O I：

10.1016/j.eclinm.2024.102939

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 fi nally 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. Copyright (c) 2024 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

引用

页数：13

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