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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.).
Valid instruments are needed to assess important patient-reported outcomes (PROs) in erosive esophagitis (EE).
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.
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.
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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Camilleri, M., Dubois, D., Coulie, B., Jones, M., Kahrilas, P. J., Rentz, A. M., et al. (2005). Prevalence and socioeconomic impact of upper gastrointestinal disorders in the United States: Results of the US Upper Gastrointestinal Study. Clinical Gastroenterology and Hepatology, 3(6), 543–552. CrossRefPubMed
Vakil, N. (2004). Treatment of gastroesophageal reflux disease: Defining endpoints that are important to patients. Reviews in gastroenterological disorders, 4(Suppl 4), S3–S7. PubMed
Food and Drug Administration. (2006). Draft guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims. Federal Register, 71(23), 5862–5863.
de la Loge, C., Trudeau, E., Marquis, P., Kahrilas, P., Stanghellini, V., Talley, N. J., et al. (2004). Cross-cultural development and validation of a patient self-administered questionnaire to assess quality of life in upper gastrointestinal disorders: The PAGI-QOL. Quality of Life Research, 13(10), 1751–1762. CrossRefPubMed
de la Loge, C., Trudeau, E., Marquis, P., Revicki, D. A., Rentz, A. M., Stanghellini, V., et al. (2004). Responsiveness and interpretation of a quality of life questionnaire specific to upper gastrointestinal disorders. Clinical Gastroenterology and Hepatology, 2(9), 778–786. CrossRef
Rentz, A. M., Kahrilas, P., Stanghellini, V., Tack, J., Talley, N. J., de la Loge, C., et al. (2004). Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders. Quality of Life Research, 13(10), 1737–1749. CrossRefPubMed
Cronbach, L. J. (1951). Coefficient alpha and the internal structure of tests. Psychometrika, 16, 297–334. CrossRef
Hays, R., & Revicki, D. A. (2005). Reliability and validity (including responsiveness). In R. Hays & D. A. Revicki (Eds.), Assessing quality of life in clinical trials (2nd ed., pp. 25–39). New York: Oxford University Press.
Hinkle, D. E., Jurs, S. G., & Wiersma, W. (1988). Applied statistics for the behavioral sciences. Boston: Houghton Mifflin.
Fass, R., Shapiro, M., Dekel, R., & Sewell, J. (2005). Systematic review: Proton-pump inhibitor failure in gastro-oesophageal reflux disease—Where next? Alimentary Pharmacology & Therapeutics, 22(2), 79–94. CrossRef
Kovacs, Z., & Kerekgyarto, O. (2007). Psychological factors, quality of life, and gastrointestinal symptoms in patients with erosive and non-erosive reflux disorder. The International Journal of Psychiatry in Medicine, 37(2), 139–150. CrossRef
- Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants
Kathleen W. Wyrwich
Lois M. Larsen
Dennis A. Revicki
- Springer Netherlands