DEVELOPMENT AND INITIAL PSYCHOMETRIC VALIDATION OF THE PATIENT ASSESSMENT OF UPPER GASTROINTESTINAL DISORDERS-QUALITY OF LIFE INSTRUMENT (PAGI-QOL) IN GI PATIENTS
Author(s)
de la Loge C1, Rentz A2, Dubois D3, Jones R4, Peeters K3, Marquis P1, 1MAPI VALUES, Lyon, France; 2Center for Health Outcomes Research, MEDTAP International, Bethesda, MD, USA; 3Health Economics, Johnson & Johnson, Beerse, Belgium; 4Health Economics, Johnson & Johnson, Titusville, NJ, USA
BACKGROUND: A multi-language Patient Assessment in upper Gastrointestinal disorders, the PAGI, has been developed for use in international trials in patients with Gastroesophagial Reflux Disease (GERD), Dyspepsia and Gastroparesis. This comprehensive assessment is made of 2 complementary parts: a symptom questionnaire (PAGI-SYM), and a Health related Quality of Life questionnaire (PAGI-QOL). OBJECTIVE: To assess the preliminary psychometric properties of the PAGI-QOL in a US sample of GERD patients. METHODS: 249 patients selected from a previous epidemiological survey filled in the PAGI questionnaire via phone interviews. Psychometric testing included test of scaling assumptions, internal consistency, test-retest reliability and clinical validity. RESULTS: The 7 hypothesized subscales of the 43-item PAGI-QOL was confirmed by the item convergent validity (item-scale correlation>0.40) for all but one item (0.39), and by the item discriminant validity (scaling success from 94 to 100%) for all but one scale (67%). Excellent internal consistency was observed with Cronbach’s alpha coefficient ranging from 0.76 to 0.95. Test-retest reliability in subjects who were clinically stable over two weeks was also excellent (intraclass correlation coefficient from 0.76 to 0.94). The PAGI-QOL significantly discriminated patients with different levels of symptom frequency and symptom intensity, indicating its clinical validity. CONCLUSIONS: Preliminary psychometric results support the reliability and the validity of the PAGI-QOL. An international validation study is on going to establish the structural cultural equivalence of the PAGI-QOL across countries and its responsiveness.
Conference/Value in Health Info
2000-11, ISPOR Europe 2000, Antwerp, Belgium
Value in Health, Vol. 3, No. 5 (September/October 2000)
Code
PGU6
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Gastrointestinal Disorders