Evaluating symptom outcomes in gastroparesis clinical trials: Validity and responsiveness of the Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD)

D. A. Revicki, M. Camilleri, B. Kuo, L. A. Szarka, J. McCormack, H. P. Parkman

Research output: Contribution to journalArticlepeer-review

66 Scopus citations

Abstract

Background Patient-reported symptom scales are needed to evaluate treatments for gastroparesis. The Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) was developed to assess daily symptoms of gastroparesis. This study evaluated the validity and responsiveness of the GCSI-DD in patients with gastroparesis. Methods Symptomatic patients were started with a new treatment for gastroparesis. Patients completed the GCSI-DD each evening during a baseline week and for 8weeks of treatment. Responders were defined based on patient and clinician global rating of change. Minimal important differences (MID) were estimated based on baseline to 4week changes in symptoms scores for small improvements. Key Results Of 69 patients participating, 46 had idiopathic, 19 diabetic, and four postfundoplication gastroparesis. Excellent test-retest reliability was seen for GCSI-DD scores, and there were significant correlations between GCSI-DD scores and clinician ratings of symptom severity. Responders to treatment reported improvements in nausea [effect size (ES)= 0.42, P<0.001], postprandial fullness, ES=0.83, P<0.001), bloating (ES=0.34, P<0.001), early satiety (ES=0.53, P<0.001), but lower responses for upper abdominal pain (ES=0.29), and vomiting (ES=0.22; P=0.119). MIDs were 0.55 for nausea, 0.97 for excessive fullness, 0.63 for bloating, 0.77 for postprandial fullness, and 0.30 for abdominal pain. A composite score of four symptoms (Composite-1; nausea, bloating, excessive fullness, postprandial fullness) had ES of 0.61 and MID of 0.73. Composite-2 score (nausea, early satiety, bloating, abdominal pain) had a lower ES of 0.47. Conclusions & Inferences Symptoms of early satiety, nausea, postprandial fullness, and bloating were responsive to treatment for gastroparesis. A composite of these symptoms also demonstrates validity and responsiveness to treatment for gastroparesis, and may represent an acceptable endpoint for evaluating the effectiveness of medical treatments in clinical trials for gastroparesis.

Original languageEnglish (US)
Pages (from-to)456-463
Number of pages8
JournalNeurogastroenterology and Motility
Volume24
Issue number5
DOIs
StatePublished - May 1 2012

Keywords

  • Clinical endpoints
  • Clinical significance
  • Daily diary
  • Gastroparesis
  • Gastroparesis Cardinal Symptom Scale
  • Patient-reported outcome
  • Responsiveness
  • Validity

ASJC Scopus subject areas

  • Physiology
  • Endocrine and Autonomic Systems
  • Gastroenterology

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