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Quality of Life Research
Gepubliceerd in: Quality of Life Research 4/2010

01-05-2010

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

Auteurs: Kathleen W. Wyrwich, Reema Mody, Lois M. Larsen, Misun Lee, Neesha Harnam, Dennis A. Revicki

Gepubliceerd in: Quality of Life Research | Uitgave 4/2010

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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.
vorige artikel The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study
volgende artikel Responsiveness of the EQ-5D and 8-item Parkinson’s Disease Questionnaire (PDQ-8) in a 4-year follow-up study
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Metagegevens
Titel
Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants
Auteurs
Kathleen W. Wyrwich
Reema Mody
Lois M. Larsen
Misun Lee
Neesha Harnam
Dennis A. Revicki
Publicatiedatum
01-05-2010
Uitgeverij
Springer Netherlands
Gepubliceerd in
Quality of Life Research / Uitgave 4/2010
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-010-9620-x

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