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.
ContributorsRobert Samuel, Stephen R. Knight, Richard Adams, Prajnan Das, Jennifer Dorth, David Finch, Marianne G. Guren, Maria A. Hawkins, Susan Moug, Lakshmi Rajdev, David Sebag-Montefiore, Andrew G. Renehan, Rebecca Fish, plus the CORMAC-2 collaborators
Disease Category: Cancer
Disease Name: Anal cancer
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Chemotherapy , Radiotherapy, Surgery
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Service commissioners
- Service providers
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Interview
- Systematic review
Four work packages will be undertaken over 2 years:
• WP1: A systematic review of the literature on anal cancer treatments will be performed to identify a comprehensive list of clinical, patient-reported, healthcare 'process', resource, composite and surrogate outcomes reported in trials of the treatment of anal cancer.
• WP2: Semi-structured interviews with anal cancer survivors will be used to identify additional outcomes to supplement the long-list.
• WP3: Surveys of key stakeholders (patients, clinicians, commissioners) in three rounds of Delphi methodology will refine the outcome long-list into a core outcome set.
• WP4: Consensus meetings with key stakeholders will ratify the core outcome set.