Department of Dermatology and Allergy, University Hospital, LMU Munich, Frauenlobstr. 9-11, 80337, Munich, Germany.
Department of Dermatology, Venereology and Allergology, Ruhr-University, Gudrunstr. 56, 44791, Bochum, Germany.
Trials. 2019 Oct 11;20(1):589. doi: 10.1186/s13063-019-3696-6.
Actinic keratoses (AK) are common skin lesions that can progress to invasive squamous cell carcinoma of the skin. A variety of lesion- or field-targeted treatment options exist and their efficacy has been demonstrated in numerous randomised controlled trials (RCTs). However, the reported endpoints are highly heterogeneous, making it difficult to assess and compare distinct treatment options and to reach an evidence-based choice of therapy.
A systematic literature search will be conducted to analyse which endpoints are reported in RCTs. The focus will be on effectiveness, tolerability, cosmesis, and patient satisfaction. The reported endpoints of these studies, as well as their frequency and data collection times, will be documented in a standardised way to generate a comprehensive list of reported endpoints. In order to complete the identified outcomes in the literature search, focus groups on affected patients and structured interviews with board-certified dermatologists will be conducted to identify both patient- and practice-relevant endpoints. After the identification phase, the evaluation of the endpoints follows. In a two-stage Delphi procedure, experts including patient representatives will evaluate the endpoints in a standardised and transparent manner. A final face-to-face consensus meeting will be conducted after the last Delphi round in which a final list of core outcomes will be consented.
The development of a standardised endpoint set for the treatment of AK will contribute to improving the comparability of therapeutic options. Our catalogue will enhance the synthesis of evidence for the future by reducing heterogeneity in outcomes between RCTs and hence contribute to improving the quality of research, evidence-based and patient-centred treatment.
Core Outcome Measures for Effectiveness ( COMET ) database. Registered in December 2018.
光化性角化病（AK）是常见的皮肤病变，可进展为皮肤侵袭性鳞状细胞癌。存在多种病变或区域性靶向治疗选择，其疗效已在多项随机对照试验（RCT）中得到证实。然而，报告的终点高度异质，使得难以评估和比较不同的治疗选择，并达成基于证据的治疗选择。
将进行系统文献检索，以分析 RCT 中报告的哪些终点。重点将放在有效性、耐受性、美容效果和患者满意度上。将以标准化的方式记录这些研究报告的终点及其频率和数据收集时间，以生成报告终点的综合清单。为了在文献检索中完成确定的结局，将对受影响的患者进行焦点小组讨论，并对经过董事会认证的皮肤科医生进行结构化访谈，以确定患者和实践相关的终点。在确定阶段之后，将对终点进行评估。在两阶段 Delphi 程序中，包括患者代表在内的专家将以标准化和透明的方式评估终点。最后一轮 Delphi 之后将举行面对面的共识会议，以达成最终的核心结局清单。
制定 AK 治疗的标准化终点集将有助于提高治疗选择的可比性。我们的目录将通过减少 RCT 之间结局的异质性来增强对未来证据的综合，从而有助于提高研究质量、基于证据和以患者为中心的治疗。
有效性的核心结局测量（COMET）数据库。于 2018 年 12 月注册。
