Validation of a Primary Biliary Cholangitis-Specific Version of Chronic Liver Disease Questionnaire: CLDQ-PBC.

IF 3 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Clinical and Translational Gastroenterology Pub Date : 2024-09-01 DOI:10.14309/ctg.0000000000000709

Zobair M Younossi, Maria Stepanova, Issah Younossi, Andrei Racila

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Abstract

Introduction: Primary biliary cholangitis (PBC) is a chronic liver disease, leading to cirrhosis and impairment of patient-reported outcomes. We aimed to develop a PBC-specific version of the Chronic Liver Disease Questionnaire (CLDQ) instrument to assess health-related quality of life of patients with PBC.

Methods: From our Liver Database, we included patients with PBC who had CLDQ, clinicolaboratory data, and completed Short Form-36 and The Functional Assessment of Chronic Illness Therapy-Fatigue. The 29 items of CLDQ were subjected to item reduction, exploratory factor analysis, and fed into a standard instrument validation pipeline.

Results: Data were available for 108 patients with PBC: 57 ± 11 years, 7% male, 58% cirrhosis, and 24% decompensated cirrhosis (Child B and C). Of 29 CLDQ items, none met the exclusion criteria. Exploratory factor analysis (95% of variance) returned 7 factors. Based on evaluation of factor loadings and face validity, those factors yielded 7 domains (Diet, Emotion, Fatigue, Itch, Symptoms, Sleep, and Worry). Good to excellent internal consistency (Cronbach's α 0.85-0.93) was observed for 5/7 domains. For the remaining 2 domains (Diet and Itch), additional items obtained from patients, experts, and review of the literature were included. For 5 domains, known-group validity tests discriminated between patients with PBC with and without cirrhosis, advanced cirrhosis, and depression ( P < 0.05 for 3-5 domains). The CLDQ-PBC domains were correlated with relevant domains of Short Form-36, CLDQ-PBC Fatigue correlated with Fatigue Scale of Functional Assessment of Chronic Illness Therapy-Fatigue (rho = +0.85), and CLDQ-PBC Worry domain negatively correlated with alkaline phosphatase (rho = -0.38, P = 0.0082).

Discussion: The CLDQ-PBC has been developed based on the original CLDQ. The new instrument has evidence for internal consistency and validity and is being fully validated using an external cohort.

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开发原发性胆管炎专用版慢性肝病问卷：CLDQ-PBC。

背景和目的：原发性胆汁性胆管炎（PBC）是一种导致肝硬化和患者报告结果（PROs）受损的慢性肝病。我们的目的是开发一个 PBC 专用版的慢性肝病问卷（CLDQ）工具，以评估 PBC 患者与健康相关的生活质量：从我们的肝脏数据库中，我们纳入了拥有 CLDQ、临床实验室数据并完成了简表-36（SF-36）和慢性疾病治疗功能评估-疲劳（FACIT-F）的 PBC 患者。对CLDQ的29个项目进行了项目缩减和探索性因子分析，并将其纳入标准工具验证流程：108名PBC患者的数据：57±11岁，7%为男性，58%为肝硬化，24%为失代偿期肝硬化（Child's B和C）。在 29 个 CLDQ 项目中，没有一个符合排除标准。探索性因子分析（方差的 95%）得出 7 个因子。根据因子载荷和表面效度评估，这些因子产生了 7 个领域（饮食、情绪、疲劳、瘙痒、症状、睡眠、担忧）。5/7个领域的内部一致性良好至极佳（克朗巴赫α0.85-0.93）。在其余两个领域（饮食、瘙痒）中，纳入了从患者、专家和文献综述中获得的附加项目。在 5 个领域中，已知组有效性测试可区分有肝硬化和无肝硬化的 PBC 患者、肝硬化晚期患者、抑郁症患者（pConclusion）：CLDQ-PBC是在原CLDQ的基础上开发的。新工具具有内部一致性和有效性，目前正在通过外部队列进行全面验证。

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来源期刊

Clinical and Translational Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

7.00

自引率

0.00%

发文量

114

审稿时长

16 weeks

期刊介绍： Clinical and Translational Gastroenterology (CTG), published on behalf of the American College of Gastroenterology (ACG), is a peer-reviewed open access online journal dedicated to innovative clinical work in the field of gastroenterology and hepatology. CTG hopes to fulfill an unmet need for clinicians and scientists by welcoming novel cohort studies, early-phase clinical trials, qualitative and quantitative epidemiologic research, hypothesis-generating research, studies of novel mechanisms and methodologies including public health interventions, and integration of approaches across organs and disciplines. CTG also welcomes hypothesis-generating small studies, methods papers, and translational research with clear applications to human physiology or disease. Colon and small bowel Endoscopy and novel diagnostics Esophagus Functional GI disorders Immunology of the GI tract Microbiology of the GI tract Inflammatory bowel disease Pancreas and biliary tract Liver Pathology Pediatrics Preventative medicine Nutrition/obesity Stomach.