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A clinical and laboratory investigation of 141 patients fulfilling the American-European consensus criteria of pSS was undertaken in the period May 2004 to April 2005. Median time since diagnosis was 5.5 years. Examinations included the fatigue questionnaires: fatigue severity scale (FSS), fatigue visual analogue scale (VAS), functional assessment of chronic illness therapy - fatigue (FACIT-F) and medical outcome study short form-36 (SF-36) vitality, which were repeated in a follow-up investigation in January and February 2010.

Standard haematological and immunological tests were carried out, including antinuclear antibodies (ANA), anti-SSA and anti-Sjögren's syndrome B antigen (anti-SSB) and IgG. These laboratory tests were performed in the routine hospital laboratory. ANA, anti-SSA and anti-SSB were analysed by ELISA. Anti-SSA and -SSB statuses were classified dichotomously; other serum and blood laboratory values had continuous values. Lip biopsy focus score was recorded from the medical files. Serum cytokines were previously analysed at our laboratory [18]. The assay comprises analyses of 25 cytokines:

Among fatigue instruments used in rheumatic disease studies, including pSS, is the Fatigue Severity Scale (FSS), Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) and different VAS variants. FSS assesses functional issues during the preceding two weeks [19]. FACIT-F is a general fatigue measure with emphasis on daily life function [20]. SF-36 assesses different health aspects during the preceding four weeks [21]. The vitality domain of SF-36 has been used as a proxy measure of fatigue in several conditions. FSS and fatigue VAS are positive scales in that higher values mean higher fatigue levels, while FACIT-F and vitality have the opposite direction. In the present study, Norwegian versions of FSS, fatigue VAS, FACIT-F and SF-36 vitality were used. The SF-36 mental health domain was also recorded and included in the analyses to account for possible depression bias. Regarding fatigue VAS, patients were asked: "How have you experienced fatigue (tretthet; that is, "tiredness") during last week", and the anchors were 0 mm = tiredness is no problem, and 100 mm = tiredness is a big problem. The questionnaires were initially completed face-to-face in connection with the clinical investigation in 2004 to 2005. At follow-up, postal questionnaires were sent to the trial participants in January and February 2010. Three patients were deceased and one had emigrated to an unknown location, thus 137 patients were sent questionnaires at this time. Patients not responding also received a postal reminder and new questionnaires. The study was approved by the Regional Committee for Medical and Health Research Ethics, and informed consent was obtained from all participants.

The difference in fatigue measures between follow-up and baseline was computed. To assess whether or not fatigue changed over time, paired t-tests were applied. Fatigue was compared with the following clinical and laboratory variables: serum cytokine concentrations, CRP, serum IgG, ANA, anti-SSA, anti-SSB, blood sedimentation rate, and Schirmer's test, UWS, focus score, VAS assessments of eye and mouth dryness, and pain. Comparisons with baseline fatigue were performed using Spearman's rank coefficient (rho). Regarding change in fatigue over time, these variables were compared with continuous fatigue differences (using Spearman's rho), and dichotomised differences (increased fatigue or not, using the Mann-Whitney U test). Associations between dichotomous variables were calculated using Fisher's exact test or McNemar's test. Hierarchical multiple linear regression was used to assess the ability of clinical and laboratory control measures to predict fatigue change over time, over and above


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