Background: Validated instruments for assessing DA are available for different connective tissue disorders, but not for SjS. Objectives: Aim of the present study was to construct a scoring system able to measure DA in patients with SjS, and assess its validity when used as steady state and transition index. Methods: Clinical and serological data from patients with primary SjS were collected, using a standardized clinical chart, and recorded in a centralized database at the time of the patient enrolment (T0), and 3 months later (T1) in those patients judged to be active at T0. The assessment on DA was initially done by the observers (Obs) who scored patients (from 0 to 10 points) on the basis of their expertise. Univariate and multivariate statistical procedures were applied to select the clinical and serological variables which were the best predictors of DA at T0. Correlation coefficients in multivariate models were used as indicative of the weight of each variable. The selected variables and their relative weights were used to build a multi-item scale able to assess the degree of DA in patients with SjS (SjSDAM). Scores obtained with SjSDAM at T0 and T1 were compared to those given by Obs at the same times. The variation from T0 to T1 (Δ) of scores calculated by SjSDAM scale was also compared to the Δ of scores given by the Obs. Results: Data from 155 patients with primary SjS (4 men, mean age 54.1 yrs., ranging from 18 to 84 yrs.; mean disease duration 8.74 yrs., ranging from 1 to 43 yrs.), provided by 11 centres, were analysed. Analysis of data from 90 patients observed at T1 was also performed. The variables which appeared to be related to the scores given by Obs on DA were the followings: constitutional symptoms (fever, fatigue), active articular, pulmonary and renal involvement, new appearance or worsening of salivary gland swelling and vasculitis, lymph node/spleen enlargement, leuko/lymphopenia, and peripheral neuropathy. The scores obtained by SjSDAM were closely correlated with the scores given by Obs both at T0 (r 0.835, p<0.0001) and T1 (r 0.824, p<0.0001). The Δ of SjSDAM scores was also correlated with the Δ of the Obs scores (r 0.704, p<0.0001). Conclusion: The SjSDAM seems to be a valid method to measure DA in patients with primary SjS, when used as steady state index. This scale appears also sensitive in appreciating changes of DA along the time.

MEASUREMENT (M) OF DISEASE ACTIVITY (DA) IN SJØGREN'S SYNDROME (SJS) BY MEANS OF A NEW SCALE (SJSDAM) DEVELOPED BY THE ANALYSIS OF A COHORT OF PATIENTS COLLECTED BY THE STUDY GROUP FOR SJS OF THE ITALIAN SOCIETY OF RHEUMATOLOGY

GOVONI, Marcello;
2006

Abstract

Background: Validated instruments for assessing DA are available for different connective tissue disorders, but not for SjS. Objectives: Aim of the present study was to construct a scoring system able to measure DA in patients with SjS, and assess its validity when used as steady state and transition index. Methods: Clinical and serological data from patients with primary SjS were collected, using a standardized clinical chart, and recorded in a centralized database at the time of the patient enrolment (T0), and 3 months later (T1) in those patients judged to be active at T0. The assessment on DA was initially done by the observers (Obs) who scored patients (from 0 to 10 points) on the basis of their expertise. Univariate and multivariate statistical procedures were applied to select the clinical and serological variables which were the best predictors of DA at T0. Correlation coefficients in multivariate models were used as indicative of the weight of each variable. The selected variables and their relative weights were used to build a multi-item scale able to assess the degree of DA in patients with SjS (SjSDAM). Scores obtained with SjSDAM at T0 and T1 were compared to those given by Obs at the same times. The variation from T0 to T1 (Δ) of scores calculated by SjSDAM scale was also compared to the Δ of scores given by the Obs. Results: Data from 155 patients with primary SjS (4 men, mean age 54.1 yrs., ranging from 18 to 84 yrs.; mean disease duration 8.74 yrs., ranging from 1 to 43 yrs.), provided by 11 centres, were analysed. Analysis of data from 90 patients observed at T1 was also performed. The variables which appeared to be related to the scores given by Obs on DA were the followings: constitutional symptoms (fever, fatigue), active articular, pulmonary and renal involvement, new appearance or worsening of salivary gland swelling and vasculitis, lymph node/spleen enlargement, leuko/lymphopenia, and peripheral neuropathy. The scores obtained by SjSDAM were closely correlated with the scores given by Obs both at T0 (r 0.835, p<0.0001) and T1 (r 0.824, p<0.0001). The Δ of SjSDAM scores was also correlated with the Δ of the Obs scores (r 0.704, p<0.0001). Conclusion: The SjSDAM seems to be a valid method to measure DA in patients with primary SjS, when used as steady state index. This scale appears also sensitive in appreciating changes of DA along the time.
2006
Health service and outcome research
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11392/518980
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