Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants

Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epub 2010 Feb 27.


Background and aims: Valid instruments are needed to assess important patient-reported outcomes (PROs) in erosive esophagitis (EE).

Methods: Data from 4,092 patients in clinical trials to determine efficacy of dexlansoprazole MR to heal EE and maintain healed EE were used to assess the psychometric properties of the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) and the PAGI-Symptoms Severity Index (PAGI-SYM). A daily diary, gastroesophageal reflux disease (GERD) Symptoms Investigator Assessment and endoscopy results were also used in this study.

Results: PAGI-QOL and PAGI-SYM subscales and total score internal consistency reliability estimates for both studies were acceptable (Cronbach's alpha coefficient = 0.81-0.97). Most subscale and total scores yielded moderate-to-strong correlations with other measures reflecting signs and symptoms of EE. Some subscales were able to detect differences >1 standard error of measurement (SEM) in change scores among patients with improved heartburn frequency compared to those with stable/worsening heartburn frequency in the healing study. Those with relapsed EE demonstrated differences >1 SEM in some PAGI-QOL and PAGI-SYM subscale or total scores compared to patients who maintained their healing status.

Conclusion: The findings of this study support the consideration of the PAGI-QOL and PAGI-SYM in future clinical trials and in the general EE population.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles / pharmacology
  • 2-Pyridinylmethylsulfinylbenzimidazoles / therapeutic use*
  • Adaptation, Psychological
  • Analysis of Variance
  • Anti-Ulcer Agents / pharmacology
  • Anti-Ulcer Agents / therapeutic use*
  • Dexlansoprazole
  • Diet Records
  • Esophagitis, Peptic / drug therapy*
  • Female
  • Health Status
  • Humans
  • Lansoprazole
  • Male
  • Medical Records
  • Middle Aged
  • Proton Pump Inhibitors / pharmacology
  • Proton Pump Inhibitors / therapeutic use*
  • Psychometrics
  • Quality of Life*
  • Reproducibility of Results
  • Severity of Illness Index
  • Statistics as Topic
  • Statistics, Nonparametric
  • Surveys and Questionnaires


  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Ulcer Agents
  • Proton Pump Inhibitors
  • Lansoprazole
  • Dexlansoprazole