Laboratory of Investigative Dermatology, The Rockefeller University, New York City, New York.
The Rockefeller University, New York City, New York.
JAMA Dermatol. 2021 Apr 1;157(4):449-455. doi: 10.1001/jamadermatol.2020.5467.
Standard morphological terminology and definitions are vital for identification of lesion types in the clinical trial setting and communication about the condition. For hidradenitis suppurativa (HS), morphological definitions have been proposed by different groups, representing various regions of the world, but no international consensus has been reached regarding such definitions. A lack of globally harmonized terminology and definitions may contribute to poor-quality data collection in clinical trials as well as poor communication among clinicians, investigators, and patients.
To establish and validate consensus definitions for typical morphological findings for HS lesions.
This study was conducted from August 2019 to August 2020. A Delphi study technique was used to assess agreement and then resolve disagreement on HS terminology among international experts. After an initial preparation phase, the process consisted of 3 rounds. In each round, participants reviewed preliminary definitions and rated them as "keep, with no changes," "keep, with changes," or "remove." Eight HS primary lesions, including papule, pustule, nodule, plaque, ulcer, abscess, comedo, and tunnel, were selected because they are most frequently used in HS clinician-reported outcome measures. The initial definitions were based on extant literature, and modifications were made between rounds based on qualitative thematic analysis of open-ended responses or discussion. Consensus was defined as greater than 70% to accept a definition. Consensus stability across rounds was defined as less than 15% change in agreement. Reliability was evaluated using the Gwet agreement coefficient. Validation was based on assessment of face validity and stability across rounds.
A total of 31 experts participated. All 8 HS primary lesion definitions achieved greater than 70% consensus by Delphi round 3. Stability was achieved for papule, pustule, and abscess. The Gwet agreement coefficient increased from 0.49 (95% CI, 0.26-0.71) in round 1 to 0.78 (95% CI, 0.64-0.92) in round 3. Face validity was supported by expert endorsement to keep terms in survey responses. Previously unmeasured variation among clinicians' definition of tunnels was identified, and consensus was achieved.
An international group of experts agreed on definitions for morphological features of HS lesions frequently included in HS clinical trials. These international consensus terms and definitions are needed to support consistency of lesion identification and quantification in clinical trials.
标准形态学术语和定义对于在临床试验中识别病变类型以及交流病情至关重要。对于化脓性汗腺炎（HS），不同地区的不同团体已经提出了形态学定义，但尚未就这些定义达成国际共识。缺乏全球协调的术语和定义可能会导致临床试验中数据收集质量差，以及临床医生、研究人员和患者之间的沟通不畅。
确定并验证 HS 病变典型形态学发现的共识定义。
本研究于 2019 年 8 月至 2020 年 8 月进行。采用 Delphi 研究技术评估国际专家对 HS 术语的一致性，并解决分歧。在初始准备阶段之后，该过程包括 3 轮。在每一轮中，参与者都审查了初步定义，并将其评为“保留，无更改”、“保留，有更改”或“删除”。选择了包括丘疹、脓疱、结节、斑块、溃疡、脓肿、粉刺和隧道在内的 8 种 HS 原发性病变，因为它们是 HS 临床医生报告的结果测量中最常使用的。初始定义基于现有文献，并且在轮次之间基于对开放式回复或讨论的定性主题分析进行了修改。共识定义为超过 70%的人接受定义。共识的稳定性通过比较轮次之间的一致性变化来定义，变化小于 15%。可靠性使用 Gwet 一致性系数进行评估。验证基于对定义的表面有效性和轮次之间的稳定性进行评估。
共有 31 名专家参与。通过 Delphi 第 3 轮，所有 8 种 HS 原发性病变的定义都达到了超过 70%的共识。丘疹、脓疱和脓肿的稳定性达到了要求。Gwet 一致性系数从第 1 轮的 0.49（95%CI，0.26-0.71）增加到第 3 轮的 0.78（95%CI，0.64-0.92）。表面有效性通过专家在调查回复中保留术语的支持得到证明。在临床医生对隧道的定义中发现了以前未测量的差异，并达成了共识。
一组国际专家就 HS 临床试验中经常包含的 HS 病变形态特征的定义达成一致。这些国际共识术语和定义是支持临床试验中病变识别和量化一致性所必需的。
