Original articlesResponsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders
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
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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].