TY - JOUR
T1 - Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders
AU - Rentz, A. M.
AU - Kahrilas, P.
AU - Stanghellini, V.
AU - Tack, J.
AU - Talley, N. J.
AU - De La Loge, C.
AU - Trudeau, E.
AU - Dubois, D.
AU - Revicki, D. A.
N1 - Funding Information:
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.
PY - 2004/12
Y1 - 2004/12
N2 - 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.
AB - 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.
KW - Patient-reported outcomes
KW - Psychometric evaluation
KW - Reliability
KW - Symptoms
KW - Validity
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U2 - 10.1007/s11136-004-9567-x
DO - 10.1007/s11136-004-9567-x
M3 - Article
C2 - 15651544
AN - SCOPUS:13844299543
SN - 0962-9343
VL - 13
SP - 1737
EP - 1749
JO - Quality of Life Research
JF - Quality of Life Research
IS - 10
ER -