Standard liver biochemistry selleckchem (alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyltranspeptidase, and alkaline phosphatase [ALP]) along with other standard laboratory investigations (creatinine, hemoglobin, and thyroid-stimulating hormone levels) were retrieved. Serum immunoglobulin G, immunoglobulin M, and titer of serum AMA (routine immunofluorescence) or AMA-M2 (Pharmacia Diagnostics, Dorval, Quebec) were recorded. Serum biochemical data were available for all subjects at the time of questionnaire and from within the year immediately before symptom assessment. Data from liver biopsy, abdominal ultrasound, as well as upper endoscopy,
were also collected. PBC-40 is a 40-item scale measuring health-related quality of life in PBC, readily applicable to routine clinic practice, as a way of patients evaluating their symptoms.26 It consists of specific symptom domains (Cognition,
Itch, Fatigue, Social, Emotional, and Symptoms) and is designed for self-completion. Participants Selleck AG-14699 rate items on a five-point scale (1 = ‘never’ to 5 = ‘always’), with high scores denoting greater symptoms impact and poorer quality of life. A previous study defined ranges of severity for the symptom domains contained in the PBC-40.21 By using these clinically meaningful cutoff values applied to the scores from the PBC-40 Fatigue domain, no fatigue was a score of 11 or less, mild was a score of MCE 12 to 28, moderate was a score of 29 to 39, and severe was a score of 40 or greater. To test the reliability of the questionnaire in our PBC patient population, the PBC-40 questionnaire was applied twice, at a 1-year interval, to a random sample of 196 patients. Data were analyzed using SAS. Results are reported as mean ± standard deviation. Categorical variables were analyzed using a series of t tests and chi-squared test (or Fisher’s exact test where appropriate). Pearson correlation coefficient (or analysis of variance where appropriate) was performed to analyze correlations between fatigue scores and various biological, demographic,
and clinical variables. Finally, variables that were found to be statistically significant were further analyzed with multivariate analysis using a backward selection procedure to determine predictive factors for fatigue. A P value < 0.05 was considered significant. ALP, alkaline phosphatase; AMA, antimitochondrial antibody; BMI, body mass index; PBC, primary biliary cirrhosis; QOL, quality of life; UDCA, ursodeoxycholic acid. Three hundred twenty-seven unselected patients with PBC were included in the review. Clinical, biochemical, and histological stage of disease in the participants are summarized in Table 1. At the time of questionnaire, 94% of the participating cohort were women, and the mean age was 57.3 ± 11.5 (range, 24-90).