Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) and Questionnaire (HSSQ): Psychometric Validation and Interpretation Threshold Derivation Using Phase 3 Study Data.

IF 3.5 3区 医学 Q1 DERMATOLOGY
John R Ingram, Jérémy Lambert, Valerie Ciaravino, Robert Rolleri, Ingrid Pansar, Luke Peterson, Christopher G Pelligra, Linnea Thorlacius
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引用次数: 0

Abstract

Introduction: Hidradenitis suppurativa (HS) is a chronic inflammatory disease characterised by painful skin lesions which negatively impact patients' physical and mental wellbeing. The HS Symptom Daily Diary (HSSDD) and HS Symptom Questionnaire (HSSQ) are patient-reported outcome (PRO) tools capturing patient-perceived severity of HS symptoms. Here, we report the psychometric properties of HSSDD and HSSQ along with score interpretation thresholds.

Methods: Pooled data from patients with moderate to severe HS in two phase 3 studies (BE HEARD I II) were analysed. Test-retest reliability was evaluated using intraclass correlation coefficients (ICCs). Convergent validity was assessed between the HSSDD (N = 934) and HSSQ (N = 1007) compared with relevant PROs and clinician-reported outcomes (ClinROs) at baseline and Week (Wk)16. Known-groups validity was assessed, comparing HSSDD and HSSQ scores between participant subgroups pre-defined using PRO/ClinRO measures (Patient Global Impression [PGI] of HS severity, Hurley stage, International HS Severity Score System). Responsiveness was evaluated by correlating changes from baseline to Wk16 in HSSDD and HSSQ scores with changes in PGI scales. Clinically meaningful within-patient improvement thresholds were estimated using anchor- and distribution-based analyses. Symptom/impact severity thresholds were estimated using receiver operating characteristic curve analyses.

Results: At Wk16, HSSDD and HSSQ completion rates were 70.1% and 90.2%, respectively. Test-retest reliability analyses demonstrated good score reproducibility (ICC: HSSDD: 0.80-0.86; HSSQ: 0.73-0.82). Correlations between HSSDD and HSSQ scores and other PROs/ClinROs were generally consistent with predefined hypotheses, indicating good convergent validity. HSSDD and HSSQ scores discriminated between pre-defined subgroups, confirming known-groups validity. Sixteen-wk changes from baseline in HSSDD and HSSQ scores and anchors were moderately to strongly correlated (> 0.30), establishing responsiveness. Interpretation thresholds for both HSSDD and HSSQ were estimated.

Conclusion: HSSDD and HSSQ item scores demonstrated good psychometric performance in participants with moderate to severe HS. The clinically meaningful severity thresholds defined here could be used to assess treatment efficacy.

Clinical trial registration: NCT04242446; NCT04242498.

化脓性汗腺炎症状日记(HSSDD)和问卷调查(HSSQ):使用3期研究数据的心理测量验证和解释阈值推导。
化脓性汗腺炎(HS)是一种慢性炎症性疾病,其特征是疼痛的皮肤病变,对患者的身心健康产生负面影响。HS症状日记(HSSDD)和HS症状问卷(HSSQ)是患者报告的结果(PRO)工具,用于捕获患者感知的HS症状严重程度。在这里,我们报告了HSSDD和HSSQ的心理测量特性以及分数解释阈值。方法:对两项3期研究(BE HEARD I和II)中至重度HS患者的汇总数据进行分析。采用类内相关系数(ICCs)评价重测信度。在基线和第16周,将HSSDD (N = 934)和HSSQ (N = 1007)与相关PROs和临床医生报告的结果(ClinROs)进行比较,评估其趋同效度。评估已知组效度,比较使用PRO/ClinRO测量(HS严重程度、Hurley分期、国际HS严重程度评分系统的患者总体印象[PGI])预先定义的参与者亚组之间的HSSDD和HSSQ评分。通过将HSSDD和HSSQ评分从基线到Wk16的变化与PGI量表的变化相关联来评估反应性。使用基于锚点和分布的分析来估计有临床意义的患者改善阈值。使用受试者工作特征曲线分析估计症状/冲击严重程度阈值。结果:在Wk16时,HSSDD和HSSQ完成率分别为70.1%和90.2%。测试-重测信度分析显示了良好的分数再现性(ICC: HSSDD: 0.80-0.86;HSSQ: 0.73 - -0.82)。HSSDD和HSSQ评分与其他PROs/ClinROs的相关性与预先设定的假设基本一致,具有较好的收敛效度。HSSDD和HSSQ分数在预定义的子组之间进行区分,确认已知组的有效性。从基线开始的16周HSSDD和HSSQ评分和锚点的变化中至强相关(> 0.30),建立了响应性。估计HSSDD和HSSQ的解释阈值。结论:HSSDD和HSSQ项目得分在中重度HS患者中表现出良好的心理测量表现。本文定义的具有临床意义的严重程度阈值可用于评估治疗效果。临床试验注册:NCT04242446;NCT04242498。
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来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
期刊介绍: Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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