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©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
Development and predictive validity of the cirrhosis-associated ascites symptom scale: A cohort study of 103 patients
Agnete Nordheim Riedel, Nina Kimer, Anne-Sofie Houlberg Jensen, Emilie Kristine Dahl, Mads Israelsen, Luise Aamann, Lise Lotte Gluud
Agnete Nordheim Riedel, Nina Kimer, Anne-Sofie Houlberg Jensen, Emilie Kristine Dahl, Lise Lotte Gluud, Gastro Unit, Medical Davison, Copenhagen University Hospital Hvidovre, Hvidovre 2650, Denmark
Nina Kimer, Abdominal Center K, Medical Section, Copenhagen University Hospital Bispebjerg, København 2400, Denmark
Anne-Sofie Houlberg Jensen, Department of Gastroenterology and Hepatology, University Hospital Zealand Slagelse, Slagelse 4200, Denmark
Mads Israelsen, Department of Gastroenterology and Hepatology, Odense University Hospital, Odense C 5000, Denmark
Luise Aamann, Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus C 8000, Denmark
Author contributions: Gluud LL designed the study and drafted the protocol; Gluud LL, Jensen AS and Dahl EK collected questionnaires and conducted interviews for the pilot-testing of the cirrhosis-associated ascites symptom (CAS); Riedel AN, Jensen AS, Dahl EK, Gluud LL, Aamann L, Israelsen M and Kimer N collected questionnaires for the validation of CAS; Riedel AN and Gluud LL performed the analyses; Kimer N, Riedel AN and Gluud LL drafted the first version of the manuscript. All authors critically revised and approved of the final version of the manuscript.
Institutional review board statement: The study was approved by the Danish Data protection Agency, journal no: 04054, ID: AHH-2015-075.
Informed consent statement: All participants signed an informed consent.
Conflict-of-interest statement: The authors declare no conflicts of interest.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Lise Lotte Gluud, DSc, MD, Associate Professor, Chief Doctor, Research Fellow, Gastro Unit, Medical Division, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, Hvidovre 2650, Denmark. lise.lotte.gluud.01@regionh.dk
Telephone: +45-31-353212
Received: November 28, 2017
Peer-review started: November 29, 2017
First decision: December 13, 2017
Revised: December 20, 2017
Accepted: January 18, 2018
Article in press: January 18, 2018
Published online: April 21, 2018
Processing time: 141 Days and 22.3 Hours
AIM
To develop a scale of domains associated with the health-related quality-of-life (HRQOL) in patients with cirrhosis-related ascites.
METHODS
We initially undertook literature searches and a qualitative study in order to design a cirrhosis-associated ascites symptom (CAS) scale describing symptoms with a potential detrimental impact on health related quality of life (HRQL) (the higher the score, the worse the symptoms). Discriminatory validity was assessed in a validation cohort including cirrhotic patients with (1) tense/severe; (2) moderate/mild; or (3) no ascites (controls). Patients also completed chronic liver disease questionnaire (CLDQ) and the EuroQoL 5-Dimensions 5-Level (EQ-5D-5L) questionnaire evaluating HRQL. The relation between scale scores was analysed using Spearman correlations.
RESULTS
The final CAS scale included 14 items. The equivalent reliability was high (Chronbach’s alpha 0.88). The validation cohort included 103 patients (72% men, mean age 62.4 years). The mean scores for each question in the CAS scale were higher for patients with severe/tense ascites than for mild/moderate ascites and controls. Compared with controls (mean = 9.9 points), the total CAS scale score was higher for severe/tense ascites (mean = 23.8 points) as well as moderate/mild ascites (mean = 18.6 points) (P < 0.001 both groups). We found a strong correlation between the total CAS and CLDQ score (rho = 0.82, P < 0.001) and a moderate correlation between the CAS and the EQ-5D-5L score (0.67, P < 0.001).
CONCLUSION
The CAS is a valid tool, which reflects HRQOL in patients with ascites.
Core tip: This paper presents a newly generated cirrhosis-associated ascites symptom scale consisting of 14 items. The questionnaire addresses relevant questions of symptom burden of cirrhosis-associated ascites, takes only five minutes to complete and correlates strongly with chronic liver disease questionnaire score in patients with cirrhosis and ascites.
