Development and Validation of a Patient-Reported Outcome Measurement for Symptom Assessment in Cirrhotic Ascites

Myrte Neijenhuis, Tom J.G. Gevers, Thomas D. Atwell, Tim J. Gunneson, Amanda C. Schimek, Wietske Kievit, Joost P.H. Drenth, Patrick Sequeira Kamath

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Abstract

Objectives: As current treatments of cirrhotic ascites are not associated with survival benefit, symptom relief is the major therapeutic end point. We developed a questionnaire (Ascites-Q; modified polycystic liver disease questionnaire) and assessed validity and responsiveness for symptom assessment in cirrhotic ascites. Methods: Ascites-Q was compared with Functional Assessment of Chronic Illness Therapy-Ascites Index (FACIT-AI; developed for malignant ascites) and Japanese Ascites Symptom Inventory-7 (ASI-7) in cirrhotics undergoing large-volume paracentesis. Convergent validity was defined as correlation >0.4 between ascites questionnaires and quality of life (QoL) visual analog scale. Responsiveness was assessed by comparing scores at baseline and 7 days after large-volume paracentesis. To test discriminative ability, we compared scores of patients with cirrhotic controls without ascites (n=24) and diuretic-sensitive ascites (n=46). Results: We included 90 patients with refractory cirrhotic ascites (61% male, mean age 59 years, Model of End-Stage Liver Disease (MELD) score 16, median paracentesis volume 4,100 ml). Higher symptoms scores were correlated with lower QoL (Ascites-Q: r=0.479, P<0.001, FACIT-AI: r=0.313, P=0.007; ASI-7: r=0.340, P=0.004), but only Ascites-Q showed convergent validity (r>0.4). Symptoms decreased after paracentesis (Ascites-Q: 57 to 34, FACIT-AI: 44 to 33, and ASI-7: 57 to 25, all P<0.001). Ascites-Q and ASI-7 discriminated between controls without ascites, diuretic-sensitive, and refractory ascites (Ascites-Q: 16 vs. 35 vs. 56 points, ASI-7: 2 vs. 25 vs. 61 points, all P<0.05), whereas FACIT-AI (39 vs. 40 vs. 52 points) could not (P=0.314). Ascites-Q was validated at 3 months in an independent cohort with ascites controlled with a pump. Conclusions: The Ascites-Q is the best ascites-specific outcome to evaluate symptom relief in cirrhotic ascites.

Original languageEnglish (US)
Pages (from-to)567-575
Number of pages9
JournalAmerican Journal of Gastroenterology
Volume113
Issue number4
DOIs
StatePublished - Apr 1 2018

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Symptom Assessment
Ascites
Paracentesis
Patient Reported Outcome Measures
Equipment and Supplies
Diuretics

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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Development and Validation of a Patient-Reported Outcome Measurement for Symptom Assessment in Cirrhotic Ascites. / Neijenhuis, Myrte; Gevers, Tom J.G.; Atwell, Thomas D.; Gunneson, Tim J.; Schimek, Amanda C.; Kievit, Wietske; Drenth, Joost P.H.; Kamath, Patrick Sequeira.

In: American Journal of Gastroenterology, Vol. 113, No. 4, 01.04.2018, p. 567-575.

Research output: Contribution to journalArticle

Neijenhuis, M, Gevers, TJG, Atwell, TD, Gunneson, TJ, Schimek, AC, Kievit, W, Drenth, JPH & Kamath, PS 2018, 'Development and Validation of a Patient-Reported Outcome Measurement for Symptom Assessment in Cirrhotic Ascites', American Journal of Gastroenterology, vol. 113, no. 4, pp. 567-575. https://doi.org/10.1038/ajg.2018.18
Neijenhuis, Myrte ; Gevers, Tom J.G. ; Atwell, Thomas D. ; Gunneson, Tim J. ; Schimek, Amanda C. ; Kievit, Wietske ; Drenth, Joost P.H. ; Kamath, Patrick Sequeira. / Development and Validation of a Patient-Reported Outcome Measurement for Symptom Assessment in Cirrhotic Ascites. In: American Journal of Gastroenterology. 2018 ; Vol. 113, No. 4. pp. 567-575.
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abstract = "Objectives: As current treatments of cirrhotic ascites are not associated with survival benefit, symptom relief is the major therapeutic end point. We developed a questionnaire (Ascites-Q; modified polycystic liver disease questionnaire) and assessed validity and responsiveness for symptom assessment in cirrhotic ascites. Methods: Ascites-Q was compared with Functional Assessment of Chronic Illness Therapy-Ascites Index (FACIT-AI; developed for malignant ascites) and Japanese Ascites Symptom Inventory-7 (ASI-7) in cirrhotics undergoing large-volume paracentesis. Convergent validity was defined as correlation >0.4 between ascites questionnaires and quality of life (QoL) visual analog scale. Responsiveness was assessed by comparing scores at baseline and 7 days after large-volume paracentesis. To test discriminative ability, we compared scores of patients with cirrhotic controls without ascites (n=24) and diuretic-sensitive ascites (n=46). Results: We included 90 patients with refractory cirrhotic ascites (61{\%} male, mean age 59 years, Model of End-Stage Liver Disease (MELD) score 16, median paracentesis volume 4,100 ml). Higher symptoms scores were correlated with lower QoL (Ascites-Q: r=0.479, P<0.001, FACIT-AI: r=0.313, P=0.007; ASI-7: r=0.340, P=0.004), but only Ascites-Q showed convergent validity (r>0.4). Symptoms decreased after paracentesis (Ascites-Q: 57 to 34, FACIT-AI: 44 to 33, and ASI-7: 57 to 25, all P<0.001). Ascites-Q and ASI-7 discriminated between controls without ascites, diuretic-sensitive, and refractory ascites (Ascites-Q: 16 vs. 35 vs. 56 points, ASI-7: 2 vs. 25 vs. 61 points, all P<0.05), whereas FACIT-AI (39 vs. 40 vs. 52 points) could not (P=0.314). Ascites-Q was validated at 3 months in an independent cohort with ascites controlled with a pump. Conclusions: The Ascites-Q is the best ascites-specific outcome to evaluate symptom relief in cirrhotic ascites.",
author = "Myrte Neijenhuis and Gevers, {Tom J.G.} and Atwell, {Thomas D.} and Gunneson, {Tim J.} and Schimek, {Amanda C.} and Wietske Kievit and Drenth, {Joost P.H.} and Kamath, {Patrick Sequeira}",
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AU - Neijenhuis, Myrte

AU - Gevers, Tom J.G.

AU - Atwell, Thomas D.

AU - Gunneson, Tim J.

AU - Schimek, Amanda C.

AU - Kievit, Wietske

AU - Drenth, Joost P.H.

AU - Kamath, Patrick Sequeira

PY - 2018/4/1

Y1 - 2018/4/1

N2 - Objectives: As current treatments of cirrhotic ascites are not associated with survival benefit, symptom relief is the major therapeutic end point. We developed a questionnaire (Ascites-Q; modified polycystic liver disease questionnaire) and assessed validity and responsiveness for symptom assessment in cirrhotic ascites. Methods: Ascites-Q was compared with Functional Assessment of Chronic Illness Therapy-Ascites Index (FACIT-AI; developed for malignant ascites) and Japanese Ascites Symptom Inventory-7 (ASI-7) in cirrhotics undergoing large-volume paracentesis. Convergent validity was defined as correlation >0.4 between ascites questionnaires and quality of life (QoL) visual analog scale. Responsiveness was assessed by comparing scores at baseline and 7 days after large-volume paracentesis. To test discriminative ability, we compared scores of patients with cirrhotic controls without ascites (n=24) and diuretic-sensitive ascites (n=46). Results: We included 90 patients with refractory cirrhotic ascites (61% male, mean age 59 years, Model of End-Stage Liver Disease (MELD) score 16, median paracentesis volume 4,100 ml). Higher symptoms scores were correlated with lower QoL (Ascites-Q: r=0.479, P<0.001, FACIT-AI: r=0.313, P=0.007; ASI-7: r=0.340, P=0.004), but only Ascites-Q showed convergent validity (r>0.4). Symptoms decreased after paracentesis (Ascites-Q: 57 to 34, FACIT-AI: 44 to 33, and ASI-7: 57 to 25, all P<0.001). Ascites-Q and ASI-7 discriminated between controls without ascites, diuretic-sensitive, and refractory ascites (Ascites-Q: 16 vs. 35 vs. 56 points, ASI-7: 2 vs. 25 vs. 61 points, all P<0.05), whereas FACIT-AI (39 vs. 40 vs. 52 points) could not (P=0.314). Ascites-Q was validated at 3 months in an independent cohort with ascites controlled with a pump. Conclusions: The Ascites-Q is the best ascites-specific outcome to evaluate symptom relief in cirrhotic ascites.

AB - Objectives: As current treatments of cirrhotic ascites are not associated with survival benefit, symptom relief is the major therapeutic end point. We developed a questionnaire (Ascites-Q; modified polycystic liver disease questionnaire) and assessed validity and responsiveness for symptom assessment in cirrhotic ascites. Methods: Ascites-Q was compared with Functional Assessment of Chronic Illness Therapy-Ascites Index (FACIT-AI; developed for malignant ascites) and Japanese Ascites Symptom Inventory-7 (ASI-7) in cirrhotics undergoing large-volume paracentesis. Convergent validity was defined as correlation >0.4 between ascites questionnaires and quality of life (QoL) visual analog scale. Responsiveness was assessed by comparing scores at baseline and 7 days after large-volume paracentesis. To test discriminative ability, we compared scores of patients with cirrhotic controls without ascites (n=24) and diuretic-sensitive ascites (n=46). Results: We included 90 patients with refractory cirrhotic ascites (61% male, mean age 59 years, Model of End-Stage Liver Disease (MELD) score 16, median paracentesis volume 4,100 ml). Higher symptoms scores were correlated with lower QoL (Ascites-Q: r=0.479, P<0.001, FACIT-AI: r=0.313, P=0.007; ASI-7: r=0.340, P=0.004), but only Ascites-Q showed convergent validity (r>0.4). Symptoms decreased after paracentesis (Ascites-Q: 57 to 34, FACIT-AI: 44 to 33, and ASI-7: 57 to 25, all P<0.001). Ascites-Q and ASI-7 discriminated between controls without ascites, diuretic-sensitive, and refractory ascites (Ascites-Q: 16 vs. 35 vs. 56 points, ASI-7: 2 vs. 25 vs. 61 points, all P<0.05), whereas FACIT-AI (39 vs. 40 vs. 52 points) could not (P=0.314). Ascites-Q was validated at 3 months in an independent cohort with ascites controlled with a pump. Conclusions: The Ascites-Q is the best ascites-specific outcome to evaluate symptom relief in cirrhotic ascites.

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