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The Simple Cholestatic Complaints Score is a valid and quick patient-reported outcome measure in primary sclerosing cholangitis.

ABSTRACT: Background: Measuring symptoms and disease burden in patients with primary sclerosing cholangitis (PSC) is increasingly important for daily practice and clinical trials. The Simple Cholestatic Complaints Score (SCCS) is a four-item questionnaire, that measures cholestatic symptoms (pruritus, fatigue, RUQ abdominal pain and fever) in PSC patients. The aim of this study was to evaluate reliability and validity of SCCS in a Dutch population.

Methods: The study population consisted of 212 patients from the Dutch prospective PSC registry. Data were collected via digital surveys. Reliability was evaluated by internal consistency and reproducibility. Construct-, criterion- and discriminant validity were determined. The ability to detect clinical change with SCCS was evaluated in patients who underwent endoscopic intervention. Simple Cholestatic Complaints Score collected by email and by a mobile application were compared.

Results: A total of 153 patients completed the questionnaire. Internal consistency was moderate and increased to 0.71 after removal of the fever item. Test-re-test reproducibility was high (intraclass correlation coefficient = 0.96). Criterion validity was good (all > 0.82). Construct validity was in line with a priori hypothesized correlations in 80%. SCCS was able to differentiate between clinically different groups. There was no difference between inflammatory bowel disease (IBD) and non-IBD patients. Simple Cholestatic Complaints Score was responsive to change after endoscopic intervention in successfully treated patients. Simple Cholestatic Complaints Score measurement by digital questionnaire and a mobile application was comparable.

Conclusion: The SCCS is a valid instrument to measure cholestatic symptoms in PSC patients. Because of its quick and easy to use properties it is suitable for frequent monitoring of symptoms in clinical trials and daily practice.

SUBMITTER: van Munster KN

PROVIDER: S-EPMC7702029 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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The Simple Cholestatic Complaints Score is a valid and quick patient-reported outcome measure in primary sclerosing cholangitis.

van Munster Kim N KN Dijkgraaf Marcel G W MGW van Gennep Sara S Beuers Ulrich U Ponsioen Cyriel Y CY

Liver international : official journal of the International Association for the Study of the Liver 20201101 11

<h4>Background</h4>Measuring symptoms and disease burden in patients with primary sclerosing cholangitis (PSC) is increasingly important for daily practice and clinical trials. The Simple Cholestatic Complaints Score (SCCS) is a four-item questionnaire, that measures cholestatic symptoms (pruritus, fatigue, RUQ abdominal pain and fever) in PSC patients. The aim of this study was to evaluate reliability and validity of SCCS in a Dutch population.<h4>Methods</h4>The study population consisted of 2 ...[more]

PMID: 32841496

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Project description:BackgroundPrimary Sclerosing Cholangitis (PSC) is a rare chronic, cholestatic liver condition in which patients can experience a range of debilitating symptoms. Patient reported outcome measures (PROMs) could provide a valuable insight into the impact of PSC on patient quality of life and symptoms. A previous review has been conducted on the quality of life instruments used in liver transplant recipients. However, there has been no comprehensive review evaluating PROM use or measurement properties in PSC patients' to-date. The aim of the systematic review was to: (a) To identify and categorise which PROMs are currently being used in research involving the PSC population (b) To investigate the measurement properties of PROMs used in PSC.MethodsA systematic review of Medline, EMBASE and CINAHL, from inception to February 2018, was undertaken. The methodological quality of included studies was assessed using the Consensus-based Standards for selection of health Measurement Instruments (COSMIN) checklist.ResultsThirty-seven studies were identified, which included 36 different PROMs. Seven PROMs were generic, 10 disease-specific, 17 symptom-specific measures and 2 measures on dietary intake. The most common PROMs were the Short form-36 (SF-36) (n = 15) and Chronic liver disease questionnaire (CLDQ) (n = 6). Only three studies evaluated measurement properties, two studies evaluated the National Institute of Diabetes Digestive and Kidney Diseases Liver Transplant (NIDDK-QA) and one study evaluated the PSC PRO; however, according to the COSMIN guidelines, methodological quality was poor for the NIDDK-QA studies and fair for the PSC PRO study.ConclusionA wide variety of PROMs have been used to assess health-related quality of life and symptom burden in patients with PSC; however only two measures (NIDDK-QA and PSC PRO) have been formally validated in this population. The newly developed PSC PRO requires further validation in PSC patients with diverse demographics, comorbidities and at different stages of disease; however this is a promising new measure with which to assess the impact of PSC on patient quality of life and symptoms.

Dataset Information

The Simple Cholestatic Complaints Score is a valid and quick patient-reported outcome measure in primary sclerosing cholangitis.

Publications

The Simple Cholestatic Complaints Score is a valid and quick patient-reported outcome measure in primary sclerosing cholangitis.

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