Core Outcome Measures in Effectiveness Trials

A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus

General Information

Abstract:
Chemoradiotherapy 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 healthcare professionals, trialists, and patients.

Authors:
Rebecca Fish, Caroline Sanders, Richard Adams, Julie Brewer, Sara T Brookes, Jill DeNardo, Rohit Kochhar, Mark P Saunders, David Sebag-Montefiore, Paula R Williamson*, Andrew G Renehan

Publication

Journal:
Lancet Gastroenterol Hepatol
Volume:
3
Issue:
Pages:
865 - 873
Year:
2018
DOI:
Further Study Information

Date:
Funding source(s):
NIHR Research for Patient Benefit Programme

Health Area

Disease Category
Cancer

Disease Name
Anal cancer

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Chemotherapy
Radiotherapy
Surgery

Method(s)

Consensus meeting
Delphi process
Interview
Systematic review

The core outcome set was developed in three phases, inclusive of patients and healthcare professionals at each stage: (1) a long list of outcomes was generated through systematic review and semistructured patient interviews; (2) the long outcome list was used to populate a two-phase Delphi process; and (3) the results of the Delphi survey were reviewed at a consensus meeting and a final core outcome set was determined.


Stakeholders Involved

Clinical experts
Consumers (patients)

Study Type

COS for clinical trials or clinical research

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