NAIL ASSESSMENT IN PSORIASIS AND PSORIATIC ARTHRITIS (NAPPA)- AN INTEGRATED APPROACH OF OUTCOMES MEASUREMENT IN NAIL PSORIASIS
Author(s)
Augustin M1, Blome C2, Costanzo A3, Dauden E4, Ferrandiz C5, Girolomoni G6, Gniadecki R7, Iversen L8, Menter A9, Michaelis-Wittern K10, Morita A11, Nakagawa H12, Reich K131University Clinics of Hamburg, Hamburg, Germany, 2University Medical Center Hamburg, Hamburg, Germany, 3University of Rome, Roma, Italy, 4Hospital Universitario La Princesa, Madrid, Spain, 5Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Barcelona, Spain, 6University of Verona, Verona, Italy, 7University of Copenhagen, Copenhagen, Denmark, 8Department of Dermatology, Aarhus, Denmark, 9Baylor Research Institute, Dallas, TX, USA, 10SCIderm GmbH, Hamburg, Germany, 11Nagoya City University, Graduate School of Medical Sciences, Nagoya, Japan, 12The Jikei University, School of Medicine, Tokyo, Japan, 13Dermatologikum Hamburg, Hamburg, Germany
OBJECTIVES: Although there are a range of established outcomes measures for psoriasis in general, there has been a lack of valid instruments for nail psoriasis (NPso). Therefore, we developed and validated the three-component tool “Nail Assessment in Psoriasis and Psoriatic Arthritis” (NAPPA) including health-related quality of life (NAPPA-QoL), patient-relevant treatment benefit (NAPPA-PBI) and clinical severity (NAPPA-CLIN). METHODS: The NAPPA tool was developed by a multinational expert group involving dermatologists, psychologists, statisticians, and patients. Development included the following steps: 1) Open item collection on patient-relevant impairments and needs in n=120 patients in 2 countries (D, USA); 2) item development by an expert panel including patients; 3) double forward and backward translations with subsequent translators' and developers’ conferences; 4) feasibility testing of the pilot questionnaire in n=55 patients in 4 countries (D, USA, Canada, UK) with subsequent questionnaire refinement; 5) longitudinal feasibility and validation study in n=203 patients from 6 countries (Germany, USA, Denmark, Japan, Italy, Spain). RESULTS: Open item collection generated 692 single items with redundant content which could be condensed to 20 items for the NAPPA-QoL and 24 items for the NAPPA-PBI. Most patients rated the final questionnaires as feasible, i.e. the purpose was clear to them (95.0%), instructions and questions were comprehensible (83.6% / 89.1%), and all relevant areas were covered (87.1%). NAPPA-QoL and -PBI correlated moderately with clinical outcomes (PASI, NAPSI) but markedly with other QoL questionnaires (EQ-5D, DLQI). Sensitivity to change and internal consistency were good. Clinical severity (NAPPA-CLIN) was measured with a two-digit solution which correlated highly (r>0.9) with NAPSI but which can be assessed much more time-efficiently. CONCLUSIONS: With the modular NAPPA outcomes tool, clinical and patient-reported outcomes in nail psoriasis can be measured validly and reliably. Thus, it can be recommended for usage in international clinical studies and daily practice.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PSS26
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Sensory System Disorders
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