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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
Article

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.

Keywords

Patient-reported outcomes Psychometric evaluation Reliability Symptoms Validity 

Abbreviations

ANCOVA

analysis of covariance

GERD

gastroesophageal reflux disease

GCSI

gastroparesis cardinal symptom index

GI

gastrointestinal

HRQL

health-related quality of life

ICCs

intraclass correlation coefficients

IRT

item response theory

MCS

mental component summary

OTE

overall treatment effect

PAGI-QOL

patient assessment of upper gastrointestinal disorders-quality of life index

PAGI-SYM

patient assessment of upper gastrointestinal disorders-symptom severity Index

PRO

patient reported outcomes

PCS

physical component summary

SD

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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