Gottlieb Alice B, Kirby Brian, Ryan Caitriona, Naegeli April N, Burge Russel, Potts Bleakman Alison, Anatchkova Milena D, Cather Jennifer
New York Medical College, Metropolitan Hospital, New York, NY, USA.
St Vincent's University Hospital, Dublin, Ireland.
Dermatol Ther (Heidelb). 2018 Mar;8(1):33-44. doi: 10.1007/s13555-017-0212-3. Epub 2017 Dec 4.
Patient-reported outcome measures (PROs) exist for psoriasis but not genital psoriasis (GenPs).
This cross-sectional, qualitative study in patients with moderate-to-severe GenPs was conducted to support development of a PRO for measuring the impact of GenPs on sexual activity and to establish content validity. The impacts of GenPs were identified in a literature review. Findings from the literature review were discussed with clinicians, and then patients with GenPs were interviewed.
From the literature review, 52 articles, 44 abstracts, and 41 clinical trials met predefined search criteria. Of these, 11 concepts emerged as having theoretical support for use as measurable impacts of psoriasis symptoms on patients; these concepts included sexual functioning and general health-related quality of life (HRQoL). These concepts were confirmed and expanded upon by two clinicians who routinely care for patients with GenPs. Interviews were then conducted with GenPs patients (n = 20) to discuss the impact of GenPs on their HRQoL. Eighty percent of patients reported that GenPs impacted sexual frequency. The two-item GenPs Sexual Frequency Questionnaire (GenPs-SFQ) was developed to assess limitations on sexual activity frequency because of GenPs. Cognitive debriefing with an additional 50 patients with GenPs confirmed the utility and understandability of the GenPs-SFQ.
The GenPs-SFQ may have utility in clinical trials involving GenPs patients and in routine clinical practice.
Eli Lilly and Company. Plain language summary available for this article.
银屑病有患者报告结局量表(PRO),但生殖器银屑病(GenPs)尚无此类量表。
开展了这项针对中重度GenPs患者的横断面定性研究,以支持开发一种用于衡量GenPs对性活动影响的PRO,并确立内容效度。通过文献综述确定GenPs的影响。与临床医生讨论文献综述结果,然后对GenPs患者进行访谈。
通过文献综述,52篇文章、44篇摘要和41项临床试验符合预定义的搜索标准。其中,有11个概念被认为在理论上可作为银屑病症状对患者的可测量影响;这些概念包括性功能和一般健康相关生活质量(HRQoL)。两名经常诊治GenPs患者的临床医生证实并扩展了这些概念。随后对GenPs患者(n = 20)进行访谈,讨论GenPs对其HRQoL的影响。80%的患者报告GenPs影响性频率。开发了两项GenPs性频率问卷(GenPs-SFQ),以评估GenPs对性活动频率的限制。对另外50名GenPs患者进行认知反馈,证实了GenPs-SFQ的实用性和可理解性。
GenPs-SFQ可能在涉及GenPs患者的临床试验和常规临床实践中有用。
礼来公司。本文提供了通俗易懂的总结。