GRAPPA Meeting, Oct. 16, 2004 San Antonio, Texas Patient Global Question Alberto Cauli Rheumatology Division University of Cagliari, Italy Director Prof.

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GRAPPA Meeting, Oct. 16, 2004 San Antonio, Texas Patient Global Question Alberto Cauli Rheumatology Division University of Cagliari, Italy Director Prof. A Mathieu B*2709

Proposal for the Assessment of Patients and Physicians perception of Joints & Skin involvement in PsA through VAS DCART (Delphi) ranked highest: JC, x-ray, patient global, pain, function, acute phase res. GRAPPA meeting in Berlin 6 VASs. Are they too many? Is it worth? What exactly do they tell us? The aim of the proposed exercise is to test the information given by the different VASs.

PsA Patients VASs Please place a mark on each line below to indicate your answer to each question relating to the past week (or 3 days?/ or day of assessment?) Global In all the ways in which your PSORIASIS and ARTHRITIS, as a whole, affects you, how would you rate the way you feel at this time? (10 cm line) (from “wellness” to “the worse I can feel”) Joints In all the ways your ARTHRITIS affects you, how would you rate the way you feel at this time? (10 cm line) Skin In all the ways your PSORIASIS affects you, how would you rate the way you feel at this time? (10 cm line)

Physician VAS Global How would you rate GLOBAL skin and joint disease in this patient? (10 cm line) (from quiet to very severe) Joints How would you rate JOINT disease in this PsA patient? (10 cm line) (from no inflammation to very severe) Skin How would you rate PSORIASIS in this PsA patient? (10 cm line) (from “clear” to “very severe”)

RECRUITMENT AND ASSESSMENT Any consecutive PsA patient that comes to the clinic regardless of disease activity or treatment ? The following data will be recorded at time 0, T1 (after 1 week) and T2 (after 3 months): Patient Global, Joint, Skin VAS Doctor Global, Joint, Skin VAS ACR joint count (68)* PASI (Dermatologist Static Global Assessment?) Sex, age, clinical subset, disease duration, job (manual, intellectual, contact with the public) Data analysis and discussion among GRAPPA members * As decided at the GRAPPA meeting in Berlin

Statistical analysis How many patients do we need? No pre-study to evaluate a sample of patients I have assumed that: changes in the score (T1-T2) will range from 0 to 5 cm and  = 1 cm In order to fulfill the primary aim (comparison of VASs only) we need at least 131 patients (recommended 200), to further analyse the data (JC, PASI, clinical subset, sex, age, job, disease duration) we may need more. The results will be statistically analysed as appropriate. The data will be discussed by the partecipating Colleagues and by all GRAPPA members through Big Mind Catalyst. A final vote will decide which VAS to be included in the assessment of PsA patients.