Department of Dermatology, Zealand University Hospital, Roskilde, Health Sciences Faculty, University of Copenhagen, Denmark.
Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, the Capital Region of Denmark, Copenhagen, Denmark.
Br J Dermatol. 2018 Mar;178(3):715-721. doi: 10.1111/bjd.16093. Epub 2018 Feb 1.
A core outcomes set (COS) is an agreed minimum set of outcomes that should be measured and reported in all clinical trials for a specific condition. Hidradenitis suppurativa (HS) has no agreed-upon COS. A central aspect in the COS development process is to identify a set of candidate outcome domains from a long list of items. Our long list had been developed from patient interviews, a systematic review of the literature and a healthcare professional survey, and initial votes had been cast in two e-Delphi surveys. In this manuscript, we describe two in-person consensus meetings of Delphi participants designed to ensure an inclusive approach to generation of domains from related items.
To consider which items from a long list of candidate items to exclude and which to cluster into outcome domains.
The study used an international and multistakeholder approach, involving patients, dermatologists, surgeons, the pharmaceutical industry and medical regulators. The study format was a combination of formal presentations, small group work based on nominal group theory and a subsequent online confirmation survey.
Forty-one individuals from 13 countries and four continents participated. Nine items were excluded and there was consensus to propose seven domains: disease course, physical signs, HS-specific quality of life, satisfaction, symptoms, pain and global assessments.
The HISTORIC consensus meetings I and II will be followed by further e-Delphi rounds to finalize the core domain set, building on the work of the in-person consensus meetings.
核心结局集（COS）是指在针对特定疾病的所有临床试验中，应测量和报告的一组商定的最小结局。化脓性汗腺炎（HS）目前尚无共识的 COS。COS 开发过程中的一个核心方面是从一长串项目中确定一组候选结局领域。我们的长列表是从患者访谈、文献系统回顾和医疗保健专业人员调查中开发出来的，并且已经在两次电子 Delphi 调查中进行了初步投票。在本文中，我们描述了两次德尔菲参与者的面对面共识会议，旨在确保从相关项目中生成领域的方法具有包容性。
考虑从候选项目的长列表中排除哪些项目，并将哪些项目聚类为结局领域。
该研究采用了一种国际和多利益相关者的方法，涉及患者、皮肤科医生、外科医生、制药行业和医疗监管机构。研究形式是正式演示、基于名义群体理论的小组工作以及随后的在线确认调查的结合。
来自 13 个国家和四大洲的 41 人参加了会议。有 9 个项目被排除在外，并且达成共识提出了 7 个领域：疾病过程、体征、HS 特定的生活质量、满意度、症状、疼痛和总体评估。
HISTORIC 共识会议 I 和 II 将通过进一步的电子 Delphi 轮次来完成核心领域集的最终确定，这是基于面对面共识会议的工作。
