title: Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders.
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 (alpha = 0.79-0.91); test-retest reliability was acceptable (Intraclass correlation coefficients alpha=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.
authors.affiliation: MEDTAP International, Inc, Sindelfingen, Germany. rentz@medtap.com
authors.forename: A M
authors.initials: AM
authors.lastname: Rentz
authors.forename: P
authors.initials: P
authors.lastname: Kahrilas
authors.forename: V
authors.initials: V
authors.lastname: Stanghellini
authors.forename: J
authors.initials: J
authors.lastname: Tack
authors.forename: N J
authors.initials: NJ
authors.lastname: Talley
authors.forename: C
authors.initials: C
authors.lastname: de la Loge
authors.forename: E
authors.initials: E
authors.lastname: Trudeau
authors.forename: D
authors.initials: D
authors.lastname: Dubois
authors.forename: D A
authors.initials: DA
authors.lastname: Revicki
mesh_terms: D000704:Analysis of Variance; D004415:Dyspepsia / Q000145:classification*; D005060:Europe; D005260:Female; D005764:Gastroesophageal Reflux / Q000145:classification*; D018589:Gastroparesis / Q000145:classification*; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D011788:Quality of Life; D012650:Self Disclosure; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires