Evidence map›Paper›PMID 38738764›Full record

ArticleClinical and translational gastroenterology2024

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

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

Abstract readValidation Study
In one paragraph

Article in Clinical and translational gastroenterology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Assessment of PBC Pruritus From the ITCH-E Study: Quality of Life, Productivity, and Treatment Experiences.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Zobair M YounossiBetty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia, USA.ORCID 0000-0001-9313-577
Maria StepanovaCenter for Outcomes Research in Liver Disease, Washington, District of Columbia, USA.
Issah YounossiCenter for Outcomes Research in Liver Disease, Washington, District of Columbia, USA.
Andrei RacilaCenter for Outcomes Research in Liver Disease, Washington, District of Columbia, USA.

Funding

The Study was supported by funding from Center for Outcomes Research in Liver Disease. CLDQ and CLDQ-PBC were used in the study under permission granted by copyright holder of these instruments (LPRO LLC). NA
6 · The paper itself

Abstract

introductionPrimary 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.

methodsFrom 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.

resultsData 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.

Indexed as

FatigueLiver Cirrhosis, BiliaryQuality of LifeAgedChronic DiseaseFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresPruritusPsychometricsReproducibility of ResultsSurveys and Questionnaires

Identifiers

PMID38738764
PMCPMC11421712

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.