Kimball A B, Ganguli A, Fleischer A
Department of Dermatology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Analysis Group Inc, Boston, MA, USA.
J Eur Acad Dermatol Venereol. 2018 Dec;32(12):2254-2256. doi: 10.1111/jdv.15163. Epub 2018 Jul 17.
Hidradenitis suppurativa clinical response (HiSCR) is a validated clinical end point for measuring response to treatment in patients with hidradenitis suppurativa (HS). Previous studies have reported on the validity, responsiveness and meaningfulness of the HiSCR.
To evaluate the HiSCR for inter- and intrarater reliability characteristics.
A stand-alone, two-site, prospective, non-interventional observational study consisted of 22 patients, with self-reported severity between mild, moderate and severe HS. The Patient Global Impression of Change (PGI-C) scale was completed by patients at Timepoint 2. Descriptive statistics of Hurley Stage, total abscesses, total draining fistulas, total inflammatory nodules and total AN count (sum of inflammatory nodules and lesions) were reported at two timepoints. Inter-rater reliability and intrarater reliability for the HS lesion count tool were evaluated at two timepoints (baseline and Day 7) using the HS lesion count tool. Intraclass correlation (ICC) coefficients of lesion counts were calculated to evaluate inter- and intrarater reliability of lesion counts between pairs of dermatologists.
The majority of patients demonstrated either no change or minimally worse PGI-C in HS scores. Descriptive statistics were similar between rater groups and timepoints assessed. Inter-rater ICC coefficients for abscess count at Timepoints 1 and 2 were 0.38 and 0.67. The ICC coefficients for draining fistula and AN count were ≥0.61 at both timepoints. In an exploratory model, ICC coefficients were ≥0.68 for all evaluated lesion counts. The test-retest reliability using ICC coefficients was ≥0.70 for total abscess, draining fistula, inflammatory nodule and AN count.
The HS lesion count tool had an acceptable inter- and intrarater reliability, indicating that HiSCR has a strong degree of reproducibility and consistency in the evaluation of patients with HS.
化脓性汗腺炎临床反应（HiSCR）是衡量化脓性汗腺炎（HS）患者治疗反应的有效临床终点。既往研究报道了HiSCR的有效性、反应性和意义。
评估HiSCR的评分者间和评分者内信度特征。
一项独立的、双中心、前瞻性、非干预性观察性研究纳入了22例患者，其自我报告的HS严重程度为轻度、中度和重度。患者在时间点2完成了患者整体变化印象（PGI-C）量表。报告了两个时间点的Hurley分期、总脓肿数、总引流瘘管数、总炎性结节数和总AN计数（炎性结节和病变总数）的描述性统计数据。使用HS病变计数工具在两个时间点（基线和第7天）评估HS病变计数工具的评分者间信度和评分者内信度。计算病变计数的组内相关系数（ICC），以评估皮肤科医生对之间病变计数的评分者间和评分者内信度。
大多数患者的HS评分无变化或稍有恶化。评估的评分者组和时间点之间的描述性统计数据相似。时间点1和2脓肿计数的评分者间ICC系数分别为0.38和0.67。两个时间点引流瘘管和AN计数的ICC系数均≥0.61。在一个探索性模型中，所有评估的病变计数的ICC系数均≥0.68。使用ICC系数的重测信度对于总脓肿、引流瘘管、炎性结节和AN计数≥0.70。
HS病变计数工具具有可接受的评分者间和评分者内信度，表明HiSCR在评估HS患者时有很强的可重复性和一致性。
