Benefit Evaluation in Vitiligo Treatment: Development and Validation of a Patient-Defined Outcome Questionnaire

Abstract

Background: In addition to clinical efficacy, patient-defined benefit assessment has become an important outcome parameter. Thus far, no such instrument has been developed for vitiligo. Objectives: Development and validation of a patient-defined benefit questionnaire in the therapy of vitiligo. Methods: Open questioning of 50 vitiligo patients generated 110 benefit items, which were converted into a 26-item questionnaire by a panel of dermatologists, psychologists and patients. This was used to record patient-defined needs prior to therapy and to evaluate patient benefit attained after therapy. A ‘patient benefit index’ (PBI) was formed on the basis of both. Validation was based on data of n = 1,023 vitiligo patients. Results: The questionnaires were feasible in clinical practice, Cronbach’s α (patient need questionnaire) was 0.94. The PBI showed convergent and discriminant validity with respect to quality of life and patient satisfaction. Conclusion: The PBI for vitiligo is a valid instrument, which is highly accepted in practice for recording patient-reported benefit.

Health Services Research in Psoriasis – The German Approach

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A programme of research to set priorities and reduce uncertainties for the prevention and treatment of skin disease

“…¢ Global improvement in vitiligo: five-point Likert scale (much worse, a bit worse, no change, a bit better and much better) at week 16 visit. ¢ PBI 489 at baseline and week 16 visit. ¢ Colour match of newly repigmented vitiliginous lesions (bad, fair or excellent) at week 16 visit.…”