Department of Dermatology, Northwestern University, Chicago, IL, USA.
University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Br J Dermatol. 2021 Jun;184(6):1113-1122. doi: 10.1111/bjd.19693. Epub 2021 Jan 11.
The lack of uniformity in the outcomes reported in clinical studies of the treatment of cutaneous squamous cell carcinoma (cSCC) complicates efforts to compare treatment effectiveness across trials.
To develop a core outcome set (COS), a minimum set of agreed-upon outcomes to be measured in all clinical trials of a given disease or outcome, for the treatment of cSCC.
One hundred and nine outcomes were identified via a systematic literature review and interviews with 28 stakeholders. After consolidation of this long list, 55 candidate outcomes were rated by 19 physician and 10 patient stakeholders, in two rounds of Delphi exercises. Outcomes scored 'critically important' (score of 7, 8 or 9) by ≥ 70% of patients and ≥ 70% of physicians were provisionally included. At the consensus meeting, after discussion and voting of 44 international experts and patients, the provisional list was reduced to a final core set, for which consensus was achieved among all meeting participants.
A core set of seven outcomes was finalized at the consensus meeting: (i) serious or persistent adverse events, (ii) patient-reported quality of life, (iii) complete response, (iv) partial response, (v) recurrence-free survival, (vi) progression-free survival and (vii) disease-specific survival.
In order to increase the comparability of results across trials and to reduce selective reporting bias, cSCC researchers should consider reporting these core outcomes. Further work needs to be performed to identify the measures that should be reported for each of these outcomes.
由于治疗皮肤鳞状细胞癌（cSCC）的临床研究报告结果缺乏一致性，使得跨试验比较治疗效果的工作变得复杂。
制定一个核心结局集（COS），这是一个用于评估特定疾病或结局治疗的所有临床试验中都要测量的最小公认结局集。
通过系统文献回顾和对 28 名利益相关者的访谈，确定了 109 个结局。在对这份长清单进行整合后，由 19 名医生和 10 名患者利益相关者在两轮 Delphi 练习中对 55 个候选结局进行了评分。患者和医生均有≥70%的人评分“非常重要”（7、8 或 9 分）的结局被初步纳入。在共识会议上，44 名国际专家和患者进行了讨论和投票后，对临时名单进行了缩减，最终确定了一个最终的核心结局集，所有与会者都对其达成了共识。
在共识会议上确定了一个包含七个结局的核心集：（i）严重或持续的不良事件，（ii）患者报告的生活质量，（iii）完全缓解，（iv）部分缓解，（v）无复发生存，（vi）无进展生存和（vii）疾病特异性生存。
为了提高试验间结果的可比性，并减少选择性报告偏倚，cSCC 研究人员应考虑报告这些核心结局。需要进一步开展工作，确定应报告每个结局的哪些指标。
