Abstract
Objective: Describe the development and evaluation of a new self-report instrument, the patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) in subjects with gastroesophageal reflux disease (GERD), dyspepsia, or gastroparesis. Methods: Recruited subjects with GERD (n=810), dyspepsia (n=767), or gastroparesis (n=169) from the US, France, Germany, Italy, the Netherlands, and Poland. Subjects completed the PAGI-SYM, SF-36, a disease-specific HRQL measure (PAGI-QOL), and disability day questions. Two-week reproducibility was evaluated in 277 stable subjects. We evaluated construct validity by correlating subscale scores with SF-36, PAGI-QOL, disability days, and global symptom severity scores. Results: The final 20-item PAGI-SYM has six subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Internal consistency reliability was good (α ≡ 0.79 0.91); test-retest reliability was acceptable (Intraclass correlation coefficients α ≡ 0.60 0.82). PAGI-SYM subscale scores correlated significantly with SF-36 scores (all p < 0.0001), PAGI-QOL scores (all p < 0.0001), disability days (p< 0.0001), and global symptom severity (p < 0.0001). Mean PAGI-SYM scores varied significantly in groups defined by disability days (all p < 0.0001), where greater symptom severity was associated with more disability days. Conclusions: Results suggest the PAGI-SYM, a brief symptom severity instrument, has good reliability and evidence supporting construct validity in subjects with GERD, dyspepsia, or gastroparesis.
Original language | English (US) |
---|---|
Pages (from-to) | 1737-1749 |
Number of pages | 13 |
Journal | Quality of Life Research |
Volume | 13 |
Issue number | 10 |
DOIs | |
State | Published - Dec 2004 |
Funding
The authors would like to thank all participating investigators, study coordinators, and patients for their participation. We would also like to thank Robert Jones for his tireless effort on behalf of the study, Christine Thompson for her programming assistance, and Jodi Shorr for her assistance in preparation of this manuscript. Funding for this study was provided by Janssen Pharmaceutica, N.V.
Keywords
- Patient-reported outcomes
- Psychometric evaluation
- Reliability
- Symptoms
- Validity
ASJC Scopus subject areas
- Public Health, Environmental and Occupational Health