Comparison of treatment effectiveness can be affected by the lack of uniformity in reported outcomes of clinical studies of treatment of cutaneous squamous cell carcinoma (cSCC). An expert working group defined seven core outcomes to help streamline the comparability of trial results.
In this study, the research group sought to develop a core outcome set—a minimum set of agreed-upon outcomes for measure in clinical trials of a given disease—for cSCC therapies. Through a systematic literature review and interview with 28 stakeholders, 109 outcomes were initially identified.
The group then consolidated this list to 55 candidate outcomes, which were then rated by 19 physician and 10 patient stakeholders over two rounds of Delphi exercises. Only outcomes scored as critically important (score = 7, 8, or 9) by 70% of patients and 70% of physicians were provisionally included in the exercises. At a consensus meeting, 44 international experts and patients discussed the list and voted to create a final core set.
The final core set of outcomes include serious or persistent adverse events, patient-reported quality of life, complete response, partial response, recurrence-free survival, progression-free survival, and disease-specific survival.
“cSCC researchers should consider reporting these outcomes,” concluded the group. However, they noted that further work is needed to identify which measures should be reported for each of the seven outcomes.
Reference
Reynolds KA, Schlessinger SI, Yanes AF, et al. Development of a core outcome set for cutaneous squamous cell carcinoma trials: identification of core domains and outcomes. Br J Dermatol. Published online November 25, 2020. doi:10.1111/bjd.19693
