Zec Simon, Popovic Dusan, Matovic Vera, Nikolic Vladimir, Bojovic Ksenija, Jovic Jasna, Markovic Denic Ljiljana, Milosavljevic Tomica, Alempijevic Tamara
Department of Internal Medicine, School of Medicine, University of Belgrade, Belgrade, Serbia.
Clinic for Gastroenterology and Hepatology, Clinical Center of Serbia, Belgrade, Serbia.
PLoS One. 2017 Apr 13;12(4):e0175697. doi: 10.1371/journal.pone.0175697. eCollection 2017.
To translate into Serbian and validate the Primary Biliary Cholangitis-40 (PBC-40) and PBC-27 questionnaires.
Ninety-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.
A 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.
The Serbian PBC-40 is a valid and reasonably adequate for use in Serbian PBC patients. The PBC-40 is preferred over the PBC-27.
将原发性胆汁性胆管炎-40（PBC-40）问卷和PBC-27问卷翻译成塞尔维亚语并进行验证。
2016年2月至10月，连续纳入了来自贝尔格莱德两家三级医疗机构三个科室的94例诊断为PBC的门诊患者。采用医疗保健相关生活质量问卷文化适应的标准方法，包括：正向翻译、反向翻译以及对5名患者进行塞尔维亚语PBC-40问卷的预测试，这5名患者提出了建议和意见。为评估问卷，用缺失项目的比例表示接受程度，并使用克朗巴赫α系数评估内部一致性。PBC-40问卷在经验丰富的肝病专家监督下由患者自行填写。PBC-27是PBC-40的较短版本。
共有92例（97.9%）患者为女性。平均年龄为59.26±1.05岁，平均病程为60.45±48.314个月。PBC-40问卷平均得分为85.62±30.46。完成问卷所需的总时间为7至16分钟。缺失项目的比例为5.45%（205/3760）。整个量表的克朗巴赫α系数为0.93。PBC-40所有领域的信度均高于0.70，但“症状”领域除外（α=0.52）。PBC-27的总体信度为α=0.90。“干燥”“症状”和“疲劳”领域的信度低于α=0.70。
塞尔维亚语PBC-40问卷在塞尔维亚PBC患者中有效且适用。与PBC-27相比，PBC-40更优。
