Schlessinger Daniel I, Iyengar Sanjana, Yanes Arianna F, Lazaroff Jake M, Godinez-Puig Victoria, Chen Brian R, Kurta Anastasia O, Henley Jill K, Chiren Sarah G, Furlan Karina C, Schmitt Jochen, Deckert Stefanie, Poon Emily, Sobanko Joseph F, Cartee Todd V, Alam Murad, Maher Ian A
Department of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
Department of Dermatology, Saint Louis University School of Medicine, St. Louis, MO, USA.
Trials. 2017 Oct 23;18(1):490. doi: 10.1186/s13063-017-2244-5.
Basal cell carcinoma is the most common skin cancer worldwide. Treatment options include both surgical and topical modalities. Although risk of metastasis is low, basal cell carcinoma can be invasive and infiltrate important underlying structures such as bone or cartilage. While many clinical trials examining therapies for basal cell carcinoma exist, the lack of consensus in outcome reporting across all trials poses a concern. Proper evaluation and comparison of treatment modalities is challenging. In order to address the inconsistencies present, this project aims to determine a core set of outcomes which should be evaluated in all clinical trials of basal cell carcinoma.
METHODS/DESIGN: Outcomes will be extracted over four phases: (1) a systematic literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Potential outcomes will then be examined by the Steering Committee, who may add or remove outcomes. The Delphi process will then be performed to condense the list of outcomes generated. Two rounds of Delphi surveys will be performed with two groups of participants - physicians and patients. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. For the duration of the study, we will be in collaboration with both the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN).
This study aims to develop a core outcome set to guide assessment in clinical trials on basal cell carcinoma. The end-goal is to improve the consistency of outcome reporting and allow proper evaluation of treatment effectiveness.
基底细胞癌是全球最常见的皮肤癌。治疗选择包括手术和局部治疗方法。尽管转移风险较低，但基底细胞癌可能具有侵袭性，并浸润重要的深层结构，如骨骼或软骨。虽然存在许多针对基底细胞癌治疗方法的临床试验，但所有试验在结果报告方面缺乏共识令人担忧。对治疗方式进行恰当的评估和比较具有挑战性。为了解决目前存在的不一致性问题，本项目旨在确定一组核心结果，应在所有基底细胞癌的临床试验中对其进行评估。
方法/设计：结果将分四个阶段提取：（1）系统的文献综述，（2）患者访谈，（3）其他已发表的资料来源，以及（4）利益相关者的参与。然后，指导委员会将审查潜在的结果，其可能会增加或删除某些结果。随后将进行德尔菲法以精简所产生的结果列表。将对两组参与者——医生和患者——进行两轮德尔菲调查。在德尔菲法实施之后，将与相关利益者召开一次共识会议，以进一步选择结果，同时考虑参与者的评分。在会议结束时，成员将进行投票并决定最终推荐的一组核心结果。在研究期间，我们将与有效性试验核心结局指标（COMET）倡议以及Cochrane皮肤组——核心结局指标集倡议（CSG - COUSIN）合作。
本研究旨在制定一组核心结局指标，以指导基底细胞癌临床试验的评估。最终目标是提高结果报告的一致性，并允许对治疗效果进行恰当评估。
