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

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Abstract

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.

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Abbreviations

ANOVA:

Analysis of variance

EE:

Erosive esophagitis

GERD:

Gastroesophageal reflux disease

H2:

Histamine

H2RA:

Histamine (H2) receptor antagonist

HRQL:

Health-related quality of life

MID:

Minimally important difference

MR:

Modified release

NSAID:

Non-steroidal anti-inflammatory drug

PAGI-QOL:

Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life

PAGI-SYM:

Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index

PPIs:

Proton pump inhibitor

PRO:

Patient-reported outcome

SEM:

Standard error of measurement

US:

United States

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Acknowledgments

This study was sponsored by Takeda Pharmaceuticals North America, Inc., Deerfield, IL, USA. (TAP Pharmaceutical Products Inc., Lake Forest, IL, USA, is now part of Takeda Pharmaceuticals North America, Inc.) The authors wrote the manuscript.

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Authors and Affiliations

  1. United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD, 20814, USA

    Kathleen W. Wyrwich, Neesha Harnam & Dennis A. Revicki

  2. Takeda Pharmaceuticals North America, Inc., Deerfield, IL, USA

    Reema Mody

  3. TAP Pharmaceutical Products Inc., Deerfield, IL, USA

    Lois M. Larsen & Misun Lee

Authors
  1. Kathleen W. Wyrwich
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  2. Reema Mody
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  3. Lois M. Larsen
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  4. Misun Lee
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  5. Neesha Harnam
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  6. Dennis A. Revicki
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Corresponding author

Correspondence to Kathleen W. Wyrwich.

Additional information

TAP Pharmaceutical Products Inc., Lake Forest, IL, USA, is now a part of Takeda Pharmaceuticals North America, Inc.

Lois M. Larsen, Misun Lee—TAP Pharmaceutical Products Inc. at the time of study conduct and analysis (now a part of Takeda Pharmaceuticals North America, Inc.).

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Wyrwich, K.W., Mody, R., Larsen, L.M. et al. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res 19, 551–564 (2010). https://doi.org/10.1007/s11136-010-9620-x

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  • DOI: https://doi.org/10.1007/s11136-010-9620-x

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