Schlessinger Daniel I, Iyengar Sanjana, Yanes Arianna F, Chiren Sarah G, Godinez-Puig Victoria, Chen Brian R, Kurta Anastasia O, Schmitt Jochen, Deckert Stefanie, Furlan Karina C, Poon Emily, Cartee Todd V, Maher Ian A, Alam Murad, Sobanko Joseph F
Department of Dermatology, Feinberg School of Medicine, Northwestern University, 676 North St. Clair Street, Suite 1600, Chicago, IL, 60611, USA.
Department of Dermatology, St. Louis University School of Medicine, St. Louis, MO, USA.
Trials. 2017 Jul 12;18(1):321. doi: 10.1186/s13063-017-2069-2.
Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The outcome heterogeneity and reporting bias of these studies leave clinicians unable to accurately compare studies. Core outcome sets (COSs) are an agreed minimum set of outcomes recommended to be measured and reported in all clinical trials of a given condition or disease. Although COSs are under development for several dermatologic conditions, work has yet to be done to identify core outcomes specific for SCC.
METHODS/DESIGN: Outcome extraction for COS generation will occur via four methods: (1) systematic literature review; (2) patient interviews; (3) other published sources; and (4) input from stakeholders in medicine, pharmacy, and other relevant industries. The list of outcomes will be revaluated by the Measuring PRiority Outcome Variables via Excellence in Dermatologic surgery (IMPROVED) Steering Committee. Delphi processes will be performed separately by expert clinicians and patients to condense the list of outcomes generated. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. At the end of the meeting, members will vote and decide on a final recommended set of core outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) organization and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN) will serve as advisers throughout the COS generation process.
Comparison of clinical trials via systematic reviews and meta-analyses is facilitated when investigators study outcomes that are relevant and similar. The aim of this project is to develop a COS to guide use for future clinical trials.
鳞状细胞癌（SCC）是一种常见的皮肤癌，存在转移风险。对SCC治疗的临床研究很常见，但所报告的结果差异很大、有所遗漏或与临床无关。这些研究的结果异质性和报告偏倚使临床医生无法准确比较各项研究。核心结局集（COS）是一组商定的最小结局集，建议在给定病症或疾病的所有临床试验中进行测量和报告。尽管针对几种皮肤病正在制定COS，但尚未开展工作来确定SCC特有的核心结局。
方法/设计：通过四种方法提取用于生成COS的结局：（1）系统文献综述；（2）患者访谈；（3）其他已发表的资料来源；（4）医学、药学和其他相关行业利益相关者的意见。结局清单将由皮肤病手术卓越测量优先结局变量（IMPROVED）指导委员会重新评估。专家临床医生和患者将分别进行德尔菲法，以精简生成的结局清单。在德尔菲法之后，将与相关利益相关者举行共识会议，以进一步选择结局，同时考虑参与者的评分。会议结束时，成员将进行投票并决定最终推荐的核心结局集。有效性试验核心结局测量（COMET）组织和Cochrane皮肤组 - 核心结局集倡议（CSG - COUSIN）将在整个COS生成过程中担任顾问。
当研究人员研究相关且相似的结局时，通过系统评价和荟萃分析对临床试验进行比较会更加容易。本项目的目的是制定一个COS，以指导未来临床试验的使用。
