Importance Although various treatments have been found in clinical trials to be effective in treating actinic keratosis (AK), researchers often report different outcomes. Heterogeneous outcome reporting precludes the comparison of results across studies and impedes the synthesis of treatment effectiveness in systematic reviews. Objective To establish an international core outcome set for all clinical studies on AK treatment using systematic literature review and a Delphi consensus process. Evidence Review Survey study with a formal consensus process. The keywords actinic keratosis and treatment were searched in PubMed, Embase, CINAHL, and the Cochrane Library to identify English-language studies investigating AK treatments published between January 1, 1980, and July 13, 2015. Physician and patient stakeholders were nominated to participate in Delphi surveys by the Measurement of Priority Outcome Variables in Dermatologic Surgery Steering Committee members. All participants from the first round were invited to participate in the second round. Outcomes reported in randomized controlled clinical trials on AK treatment were rated via web-based e-Delphi consensus surveys. Stakeholders were asked to assess the relative importance of each outcome in 2 Delphi survey rounds. Outcomes were provisionally included, pending the final consensus conference, if at least 70% of patient or physician stakeholders rated the outcome as critically important in 1 or both Delphi rounds and the outcome received a mean score of 7.5 from either stakeholder group. Data analysis was performed from November 5, 2018, to February 27, 2019. Findings A total of 516 outcomes were identified by reviewing the literature and surveying key stakeholder groups. After deduplication and combination of similar outcomes, 137 of the 516 outcomes were included in the Delphi surveys. Twenty-one physicians and 12 patients participated in round 1 of the eDelphi survey, with 17 physicians (81%) retained and 12 patients (100%) retained in round 2. Of the 137 candidate outcomes, 9 met a priori Delphi consensus criteria, and 6 were included in the final outcomes set after a consensus meeting: complete clearance of AKs, percentage of AKs cleared, severity of adverse events, patient perspective on effectiveness, patient-reported future treatment preference, and recurrence rate. It was recommended that treatment response be assessed at 2 to 4 months and recurrence at 6 to 12 months, with the AK rate of progression to cutaneous squamous cell carcinoma reported whenever long-term follow-up was possible. Conclusions and Relevance Consensus was reached regarding a core outcome set for AK trials. Further research may help determine the specific outcome measures used to assess each of these outcomes.

中文翻译：

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光化性角化病临床试验的核心结果集。

重要性尽管在临床试验中发现了各种有效治疗光化性角化病（AK）的方法，但研究人员经常报告不同的结果。异质结局报告排除了跨研究结果的比较，并妨碍了系统评价中治疗效果的综合。目的使用系统的文献综述和Delphi共识方法，为所有有关AK治疗的临床研究建立国际核心成果集。证据审查调查研究具有正式的共识流程。在PubMed，Embase，CINAHL和Cochrane图书馆中搜索了光化性角化病和治疗这两个关键词，以识别1980年1月1日至2015年7月13日期间发表的研究AK治疗的英语研究。皮肤科手术指导委员会成员的优先结果变量的测量值提名医师和患者利益相关者参加Delphi调查。邀请了第一轮的所有参与者参加第二轮。通过基于网络的e-Delphi共识调查对在AK治疗的随机对照临床试验中报告的结果进行了评估。利益相关者被要求在2轮Delphi调查中评估每个结果的相对重要性。如果至少70％的患者或医师利益相关者在1轮或2轮Delphi评估中将结果评为至关重要，并且结果在任一利益相关者组中的平均得分为7.5，则临时包括结果。数据分析于2018年11月5日至2019年2月27日进行。结果通过回顾文献并调查主要利益相关者群体，总共确定了516种结果。在重复数据删除和类似结果的组合之后，Delphi调查中包括了516个结果中的137个。共有21位医生和12位患者参加了eDelphi调查的第1轮，在第2轮中保留了17位医生（81％）和12位患者（100％），在137个候选结果中，有9个符合先验Delphi共识标准，共识会议之后的最终结果中包括6个和6个：完全清除AK，清除AK的百分比，不良事件的严重程度，患者对疗效的看法，患者报告的未来治疗偏好和复发率。建议在2到4个月评估治疗反应，在6到12个月复发，据报道，只要可能进行长期随访，AK进展为皮肤鳞状细胞癌的比率。结论和相关性就AK试验的核心结局达成了共识。进一步的研究可能有助于确定用于评估每个结果的特定结果度量。