补腺炎症状日记 (HSSDD) 和问卷 (HSSQ):用第三阶段研究数据进行心理测定验证和解释值推导
John R Ingram1,2, Jérémy Lambert3, Valerie Ciaravino3
1Division of Infection and Immunity, Department of Dermatology & Academic Wound Healing, Cardiff University, Cardiff, UK. ingramjr@cardiff.ac.uk.
Dermatology and therapy
|March 28, 2025
概括
HS症状日记 (HSSDD) 和HS症状问卷 (HSSQ) 显示出良好的心理测量特性,用于评估腹炎 (HS) 症状严重程度. 定义的值可以帮助评估HS患者的治疗有效性.
科学领域:
- 皮肤病学 皮肤病学
- 临床试验 临床试验
- 心理测量 心理测量 心理测量
背景情况:
- 补腺炎 (HS) 是一种慢性炎症性皮肤疾病,影响患者的福祉.
- 患者报告的结果 (PRO) 工具,如HS症状日记 (HSSDD) 和HS症状问卷 (HSSQ),衡量HS症状的严重程度.
- 验证这些PRO对于临床试验评估和患者护理至关重要.
研究的目的:
- 评估中度至重度HS的患者中HSSDD和HSSQ的心理特征.
- 建立HSSDD和HSSQ的分数解释值,以评估临床上有意义的改善.
- 验证这些仪器用于临床研究和实践.
主要方法:
- 分析了两项3期HS试验 (BE HEARD I & II) 的数据.
- 评估了包括测试重试可靠性,收有效性,已知组有效性和响应能力在内的心理测量属性.
- 通过基于和分布的分析估计了临床上有意义的改善值.
主要成果:
- HSSDD和HSSQ显示出良好的测试重试可靠性 (ICC:0.73-0.86) 和收的有效性.
- 这些仪器有效地区分了患者子组,证实了已知组的有效性.
- 通过与尺度的相关性来确定响应性,并定义了解释值.
结论:
- HSSDD和HSSQ在评估HS症状严重程度方面表现出强大的心理测量性能.
- 已建立的解释值为评估中度至重症HS治疗疗效提供了基础.
- 这些经过验证的PRO工具可以在临床试验和实践中帮助评估HS患者.
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