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Measuring psoriatic arthritis symptoms: A core domain in psoriasis clinical trials.
Journal of the American Academy of Dermatology ( IF 13.8 ) Pub Date : 2019-06-01 , DOI: 10.1016/j.jaad.2019.05.075
Lourdes Maria Perez-Chada 1 , Alice Bendix Gottlieb 2 , Jeffrey Cohen 3 , Philip Mease 4 , Kristina Callis Duffin 5 , Amit Garg 6 , John Latella 7 , April Wang Armstrong 8 , Alexis Ogdie 9 , Joseph Frank Merola 10
Affiliation  

BACKGROUND The International Dermatology Outcome Measures established a set of core domains to be measured in all psoriasis trials. This set requires that symptoms of psoriatic arthritis (PsA) be measured in all psoriasis studies. OBJECTIVE To identify the approach to PsA screening and the most appropriate outcome measure for capturing PsA symptoms. METHODS Following guidelines (ie, the COnsensus-based Standards for the selection of health Measurement INstruments, Core Outcome Measures in Effectiveness Trials Initiative, and Outcome Measures in Rheumatology Handbook), we conducted a consensus-building study that included patients, physicians, industry partners, and patient association representatives. The process consisted of a literature review and quality appraisal of measures for PsA symptoms, a pre-Delphi exercise, a Delphi survey, and a consensus meeting. RESULTS Among the 297 expert participants in the Delphi survey, 87.5% agreed that all patients in a psoriasis trial should be screened for PsA with a validated screening tool. Regarding the measurement of PsA symptoms, the preferred instrument was the Psoriatic Arthritis Impact of Disease-9 (PsAID9), with the Routine Assessment Patient Index Data-3 (RAPID3) representing an acceptable alternative. LIMITATIONS Only International Dermatology Outcome Measures members participated in the consensus meeting. CONCLUSION The overwhelming majority of expert stakeholders agreed that all psoriasis trial participants should be screened for PsA, with PsA symptoms measured by using PsAID9 (or alternatively with RAPID3).

中文翻译:

测量牛皮癣关节炎症状:牛皮癣临床试验中的核心领域。

背景技术《国际皮肤病学成果计量标准》建立了一套在所有牛皮癣试验中都需要测量的核心领域。此设置要求在所有牛皮癣研究中都应测量牛皮癣关节炎(PsA)的症状。目的确定PsA筛查的方法和捕获PsA症状的最合适结果指标。方法按照指导原则(即基于健康咨询工具的基于COnsensus的标准,有效性试验计划中的核心成果措施以及《风湿病手册》中的成果措施),我们进行了建立共识研究,其中包括患者,医生,行业合作伙伴以及患者协会代表。该过程包括对PsA症状的文献综述和质量评估,德尔福运动前的锻炼,德尔菲调查,和共识会议。结果在Delphi调查的297名专家参与者中,有87.5%的人同意,应使用经过验证的筛查工具筛查牛皮癣试验中的所有患者的PsA。关于PsA症状的测量,首选仪器是9型牛皮癣关节炎影响(PsAID9),常规评估患者指数数据3(RAPID3)是可以接受的选择。局限性只有国际皮肤病学成果措施成员参加了共识会议。结论绝大多数专家利益相关者同意,应筛选所有银屑病试验参与者的PsA,并通过使用PsAID9(或使用RAPID3)来测量PsA症状。5%的患者同意在银屑病试验中所有患者均应使用经过验证的筛查工具筛查PsA。关于PsA症状的测量,首选仪器是9型牛皮癣关节炎影响(PsAID9),常规评估患者指数数据3(RAPID3)是可以接受的选择。局限性只有国际皮肤病学成果措施成员参加了共识会议。结论绝大多数专家利益相关者同意,应筛选所有银屑病试验参与者的PsA,并通过使用PsAID9(或使用RAPID3)来测量PsA症状。5%的患者同意在银屑病试验中所有患者均应使用经过验证的筛查工具筛查PsA。关于PsA症状的测量,首选仪器是9型牛皮癣关节炎影响(PsAID9),常规评估患者指数数据3(RAPID3)是可以接受的选择。局限性只有国际皮肤病学成果措施成员参加了共识会议。结论绝大多数专家利益相关者同意,应筛选所有银屑病试验参与者的PsA,并通过使用PsAID9(或使用RAPID3)来测量PsA症状。常规评估患者指数数据3(RAPID3)代表了可以接受的选择。局限性只有国际皮肤病学成果措施成员参加了共识会议。结论绝大多数专家利益相关者同意,应筛选所有银屑病试验参与者的PsA,并通过使用PsAID9(或使用RAPID3)来测量PsA症状。常规评估患者指数数据3(RAPID3)代表了可以接受的选择。局限性只有国际皮肤病学成果措施成员参加了共识会议。结论绝大多数专家利益相关者同意,应筛选所有银屑病试验参与者的PsA,并通过使用PsAID9(或使用RAPID3)来测量PsA症状。
更新日期:2019-12-17
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