Original articles
Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders

https://doi.org/10.1016/S1542-3565(04)00348-9Get rights and content

Background & Aims: Determining clinically meaningful change of patient-reported outcome measures is important for evaluating effectiveness of treatments for gastrointestinal (GI) diseases. This study evaluates responsiveness of the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) in gastroesophageal reflux disease (GERD) and dyspepsia. Methods: The PAGI-SYM was based on a review of the published literature and interviews with patients and clinicians. Items were developed to be linguistically and culturally appropriate for multicountry studies. The PAGI-SYM includes 6 subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Subjects with GERD (n = 810) or dyspepsia (n = 767) participated in this multicountry, observational study. All subjects completed the PAGI-SYM, a global symptom relief questionnaire, and a measure of patient-rated change in GI-related symptoms, the Overall Treatment Effect (OTE) scale. Responsiveness was evaluated at 8 weeks by comparing groups by disease, symptom relief, and OTE (improved, stable, and worsened). Results: Subjects reporting symptom relief reported significantly lower (better) PAGI-SYM scores than those reporting no symptom relief (P < 0.0001 to P < 0.0005). Subjects with improvements in overall GI symptoms exhibited significant decreases in PAGI-SYM subscale scores compared with those who remained the same or worsened (all P values < 0.0001). Effect sizes ranged from 0.21–1.28, and standard errors of measurement ranged from 0.29–0.63, depending on subscale and disease sample. Conclusions:The PAGI-SYM is a brief symptom severity instrument that measures common GI symptoms. Results suggest that the PAGI-SYM is responsive and sensitive to change in clinical status in subjects with GERD or dyspepsia.

Section snippets

Study sample

U.S. GERD and dyspepsia subjects were recruited from a national survey of GI disorders,4, 15 whereas the European GERD and dyspepsia subjects were recruited from clinical centers. Eligible subjects provided consent to participate in the study, were able to read and understand their primary language, and were 18 years of age or older. Exclusion criteria included a history of gastric surgery or cancer of the GI tract or psychiatric disorders or cognitive impairments that would interfere with

Study sample

The PAGI-SYM validation study included 810 GERD patients (51.4%) and 767 dyspepsia patients (48.6) for a total of 1577 subjects (Table 1). The mean age of respondents was 48.1 years (standard deviation, 14.9), 60.3% were female, 68% were married or living with partner, and 55.2% were employed either full- or part-time. Twenty-eight percent of the sample was from the U.S., with the remaining subjects from France (16.9%), Germany (13.5%), Italy (12.7%), the Netherlands (13.6%), or Poland (15.0%).

Discussion

The PAGI-SYM was developed to measure the severity of GI symptoms on the basis of patient self-assessments. The PAGI-SYM was developed and psychometrically evaluated in parallel in 6 countries,14 so it can be used in international clinical trials and for monitoring outcomes in clinical practice. Previous research has demonstrated that the PAGI-SYM is reliable and valid in subjects with GERD, dyspepsia, or gastroparesis.13, 14 The findings of this study indicate that the PAGI-SYM varies

References (26)

  • D.A. Drossman

    Do the ROME criteria stand up?

  • N.J. Talley et al.

    Quality of life in patients with endoscopy-negative heartburnreliability and sensitivity of disease-specific instruments

    Am J Gastroenterol

    (2002)
  • D.A. Revicki et al.

    Recommendations on health-related quality of life research to support labeling and promotional claims in the United States

    Qual Life Res

    (2000)
  • Cited by (76)

    • Update in Advancing the Gastrointestinal Frontier in Cystic Fibrosis

      2022, Clinics in Chest Medicine
      Citation Excerpt :

      Various algorithms13,14 have been proposed recently for the diagnostic work-up and management of GER and GERD, and in the absence of data tailored specifically to pwCF, population-wide guidance should be offered by CF-focused clinicians. Reasonable recommendations include1: starting proton pump inhibitors (PPIs) empirically with typical esophageal reflux symptoms such as heartburn and regurgitation2; attempting the discontinuation of PPIs with responsive symptoms3; diagnostic endoscopy in patients not responsive to PPI4; ambulatory reflux testing in patients with typical symptoms; and5 avoidance of using barium swallow as the sole proof of resource. There is greater variability in both pwCF and patients without CF in terms of the application of additional diagnostic testing such as high-resolution esophageal manometry (HRM) and ambulatory reflux monitoring.

    • Controlled long term outcome of pyloromyotomy for pyloric stenosis: No long-term adverse effect

      2022, Journal of Pediatric Surgery
      Citation Excerpt :

      The difference in mean score was however small (0.68 points for post prandial fullness and 0.45 points for heartburn). Clinically valid differences for PAGI-SYM has been suggest to be in the range 0.21–1.28 [22]. Taking this in account combined with the finding that fewer female patients had undergone a gastroscopy and were using less antacid drugs the findings are probably not clinically significant.

    View all citing articles on Scopus

    Dr. Talley is a consultant for Fanizzi Associates, Novartis, Oridion, Solvay, and Yamanouchi Pharma America, Inc. and has received research support from Merck, Forest, AstraZeneca, Novartis, and Solvay. Dr. Revicki and Ms. Rentz have received research support from AstraZeneca, Novartis, and Johnson & Johnson.

    For more information, contact Dennis Revicki, Ph.D., Center for Health Outcomes Research, MEDTAP International, 7101 Wisconsin Avenue, Suite 600, Bethesda, Maryland 20814; telephone: (301) 654-9729; fax: (301) 654-9864; e-mail: [email protected].

    For permission to use the PAGI-SYM instrument, contact Natasha Serrano at [email protected].

    View full text