Goals and benefits in topical treatment for psoriasis: Development and pilot validation of a patient-reported outcomes tool (PBI-TOP).

BACKGROUND:Topical agents are an essential component of psoriasis therapy. OBJECTIVES:To develop a new version of the patient-reported Patient Benefit Index assessing the importance and achievement of treatment goals in topical psoriasis therapy in adult patients (PBI-TOP). METHODS:In semi-structured interviews, focus groups, and free-text questionnaires, patients reported their needs in topical treatment. Based on qualitative content analysis, items were developed by a consensus group and were refined in cognitive debriefing interviews. A pilot validation assessed the PBI-TOP and convergent criteria (Dermatology Life Quality Index, DLQI; Psoriasis Area and Severity Index, PASI; affected Body Surface Area, BSA). RESULTS:Thirty patients (26-72 years, mean 47, 60% male) reported various treatment goals relating to the themes 'effectiveness' and 'characteristics of the preparation'. Twenty patients took part in cognitive debriefings (22-84 years, mean 50.6, 50% male). N = 154 patients participated in the pilot validation (18-85 years, mean 46.9, 63.6% male). An importance-weighted total score on overall effectiveness and three subscales based on exploratory factor analysis were defined: effectiveness on symptoms; effectiveness on quality of life; characteristics of the preparation. All scores showed excellent internal consistency (alpha > 0.9). The global effectiveness score correlated significantly with DLQI (r = -0.41), PASI (r = -0.32), and BSA (r = -0.22). The effectiveness subscales correlated significantly with DLQI (r = -0.41; -0.32) and PASI (r = -0.27; -0.33). The score on characteristics of the preparation correlated significantly with the DLQI (r = -0.34). CONCLUSION:The PBI-TOP showed good feasibility and favourable psychometric characteristics in this pilot validation.