Quality of Life Research

, Volume 13, Issue 10, pp 1737–1749 | Cite as

Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders

  • A.M. RentzEmail author
  • P. Kahrilas
  • V. Stanghellini
  • J. Tack
  • N.J. Talley
  • C. De la loge
  • E. Trudeau
  • D. Dubois
  • D.A. Revicki


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.


Patient-reported outcomes Psychometric evaluation Reliability Symptoms Validity 



analysis of covariance


gastroesophageal reflux disease


gastroparesis cardinal symptom index




health-related quality of life


intraclass correlation coefficients


item response theory


mental component summary


overall treatment effect


patient assessment of upper gastrointestinal disorders-quality of life index


patient assessment of upper gastrointestinal disorders-symptom severity Index


patient reported outcomes


physical component summary


standard deviation


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Copyright information

© Kluwer Academic Publishers 2004

Authors and Affiliations

  • A.M. Rentz
    • 1
    • 9
    Email author
  • P. Kahrilas
    • 2
  • V. Stanghellini
    • 3
  • J. Tack
    • 4
  • N.J. Talley
    • 5
  • C. De la loge
    • 6
  • E. Trudeau
    • 6
  • D. Dubois
    • 7
  • D.A. Revicki
    • 8
  1. 1.MEDTAP International, Inc.SindelfingenGermany
  2. 2.Division of GastroenterologyNorthwestern UniversityChicagoUSA
  3. 3.Department of Internal Medicine and GastroenterologyUniversity of BolognaBologna Italy
  4. 4.Department of GastroenterologyUniversity of LeuvenLeuvenBelgium
  5. 5.Department of MedicineUniversity of SydneySydneyAustralia
  6. 6.Mapi ValuesLyonFrance
  7. 7.Johnson & Johnson Pharmaceutical ServicesBeerseBelgium
  8. 8.MEDTAP International, Inc.BethesdaUSA
  9. 9.Center for Health Outcomes ResearchMEDTAP International, Inc.SindelfingenGermany

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