Translation and validation of the Serbian primary biliary cholangitis-40 questionnaire

Abstract

Background and aimsTo translate into Serbian and validate the Primary Biliary Cholangitis–40 (PBC-40) and PBC-27 questionnaires.Materials and methodsNinety-four consecutive outpatients with the diagnosis of PBC from three departments across two tertiary care institutions in Belgrade were enrolled from February to October 2016. Standard methodology for cultural adaption of healthcare related quality of life questionnaires was used, and included: a forward translation, backward translation and a pilot test of the Serbian PBC-40 on five patients who gave suggestions and comments. For evaluation of the questionnaires, acceptance was shown by the proportion of missing items and the internal consistency was assessed using Cronbach’s α coefficient. The PBC-40 was self-administered under the supervision of an experienced hepatologist. The PBC-27 is a shorter version of the PBC-40.ResultsA total of 92 (97.9%) of the patients were females. The mean age was 59.26 ± 1.05 years and the average length of disease was 60.45 ± 48.314 months. The average PBC-40 score was 85.62 ± 30.46. The total time needed to complete the questionnaire ranged from 7 to 16 minutes. The proportion of missing items was 5.45% (205/3760). Cronbach’s α for the entire scale was 0.93. Reliability for all of the domains of the PBC-40 was above 0.70, except for the domain “Symptoms” (α = 0.52). Overall reliability of the PBC-27 was α = 0.90. Domains “Dryness”, “Symptoms” and “Fatigue” demonstrated reliability below α = 0.70.ConclusionsThe Serbian PBC-40 is a valid and reasonably adequate for use in Serbian PBC patients. The PBC-40 is preferred over the PBC-27.

Quality of Life in Patients with Primary Biliary Cholangitis: A Single-Center Experience in Serbia

“…This study included patients with diagnosed PBC who were treated for at least 6 months in order to allow adequate time for the initial burden of symptoms to subside. Some of the patients in this cohort were included in a previous validation study of the Serbian version of the PBC-40 questionnaire, for which the methodology has been published [12]. The PBC diagnosis was established based on the European Association for the Study of the Liver guidelines [13], requiring the presence of any 2 of the following 3 features: biochemical parameters of cholestasis on 2 occasions, at least 6 months apart; presence of anti-mitochondrial antibodies at titers ≥1:40; and histopathological findings consistent with PBC obtained by percutaneous liver biopsy [12,13].…”

“…Liver biopsy confirmed the diagnosis of PBC in all patients with negative anti-mitochondrial antibodies or HEp-2 antinuclear antibodies. Each biopsy specimen was staged in accordance with the histological staging system proposed by Ludwig et al [12,14]. Other inclusion criteria were fluency in spoken and written Serbian language, and age >18 years.…”

“…Patients with the following criteria were excluded: illiteracy in the Serbian language; length of disease <6 months; presence of dementia or psychosis; comorbid CLD, including viral hepatitis, as well as alcoholic, metabolic, and autoimmune liver disease; acute decompensation of CLD; and prior liver transplantation [12]. All patients in the study were outpatients coming for regular checkups, and the demographic, clinical, and laboratory data were collected.…”

“…We used the PBC-40 validated in the Serbian language [12], initially developed by Jacoby et al [2] to assess HRQoL [2]. The PBC-40 is "a patient-reported 40-item HRQoL scale," consisting of QoL statements divided into 6 domains: "Fatigue," "Emotional," "Social," "Cognitive," "Itch," and "Symptoms" [12]. The domains Symptoms, Itch, Fatigue, and Cognition refer to the last 4 weeks, on a 1-to 5-point scale, with 1 representing the minimum "Never" and 5 indicating the maximum "Always."…”

Symptoms and health-related quality of life in Japanese patients with primary biliary cholangitis

“…To measure the HRQOL of patients with PBC in an objective and reproducible manner, the PBC-40, a disease-specific measure of symptoms and HRQOL was developed 9 and are widely used in clinical studies 10 – 19 and clinical trials 20 , 21 in Europe and the United States, and especially in the United Kingdom (UK). In addition, the PBC-40, originally developed in English, has been translated into other languages and validated in other European countries 22 – 24 . However, to date, the measure and characterization of HRQOL in patients with PBC have not been reported in Asian countries.…”