The Development of a Patient-Reported Outcome Measure for Assessment of Genital Psoriasis Symptoms: The Genital Psoriasis Symptoms Scale (GPSS)
The Development of a Patient-Reported Outcome Measure for Assessment of Genital Psoriasis Symptoms: The Genital Psoriasis Symptoms Scale (GPSS)
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DOI：
10.1007/s13555-017-0213-2
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发表时间：
2018-03-01
影响因子：
3.4
通讯作者：
Yosipovitch, Gil
中科院分区：
文献类型：
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作者：
Gottlieb, Alice B.;Kirby, Brian;Yosipovitch, Gil
简介：生殖器银屑病（GenPs）的具体患者报告的结果措施（PRO）没有被描述。方法：在这个横断面，定性研究中，中度至重度GenPs患者，我们试图开发一个PRO GenPs症状评估有用。进行了文献综述，以确定相关的银屑病或GenPs症状和现有的PRO，这可能有助于评价GenPs患者的症状严重程度。文献综述的结果进行了讨论，与临床医生，然后患者与GenPs.Results：相关银屑病或GenPs的症状，从文献综述包括瘙痒，疼痛，鳞屑，发红/红斑，刺痛/燃烧。临床专家证实了GenP和潜在相关PRO的这些症状的有效性。经差距分析后，由数字评定量表（NRS）项目组成的症状量表草案。然后，我们与GenPs患者（n = 20）进行了访谈，以支持内容效度和在常规实践和临床试验中使用症状NRS项目草案。参与者识别并确认相关症状，并评估PRO草案的实用性。一种新的PRO被开发出来：生殖器银屑病症状量表（GPSS）。第二组患者的认知述职和文化适应/翻译访谈证实了文化的适当性GPSS.Conclusion：GPSS可能是有用的，用于评估症状之前，期间和治疗后，在常规的临床实践和临床试验中，涉及GenPs患者。
Introduction: Patient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described.Methods: In this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs.Results: Relevant psoriasis or GenPs symptoms from the literature review included itch, pain, scaling, redness/erythema, and stinging/burning. The validity of these symptoms for GenPs and potentially relevant PROs was corroborated by clinical experts. After gap analysis, a draft symptom scale consisting of Numeric Rating Scale (NRS) items was constructed. We then conducted interviews with GenPs patients (n = 20) to support content validity and use of the draft symptom NRS items in routine practice and in clinical trials. Participants identified and confirmed relevant symptoms and evaluated the utility of the draft PRO. A new PRO was developed: the Genital Psoriasis Symptoms Scale (GPSS). Cognitive debriefing and cultural adaptation/translation interviews with a second group of patients confirmed cultural appropriateness of the GPSS.Conclusion: The GPSS may be useful for assessing symptoms before, during, and after treatment in routine clinical practice and in clinical trials involving patients with GenPs.