The validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for evaluating symptoms in the clinical setting

N. A. Koloski, M. Jones, J. Hammer, M. von Wulffen, A. Shah, H. Hoelz, M. Kutuyla, D. Burger, N. Martin, S. R. Gurusamy, N. J. Talley, G. Holtmann*

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    42 Citations (Scopus)


    Background: The clinical assessments of patients with gastrointestinal symptoms can be time-consuming, and the symptoms captured during the consultation may be influenced by a variety of patient and non-patient factors. To facilitate standardized symptom assessment in the routine clinical setting, we developed the Structured Assessment of Gastrointestinal Symptom (SAGIS) instrument to precisely characterize symptoms in a routine clinical setting. Aims: We aimed to validate SAGIS including its reliability, construct and discriminant validity, and utility in the clinical setting. Methods: Development of the SAGIS consisted of initial interviews with patients referred for the diagnostic work-up of digestive symptoms and relevant complaints identified. The final instrument consisted of 22 items as well as questions on extra intestinal symptoms and was given to 1120 consecutive patients attending a gastroenterology clinic randomly split into derivation (n = 596) and validation datasets (n = 551). Discriminant validity along with test–retest reliability was assessed. The time taken to perform a clinical assessment with and without the SAGIS was recorded along with doctor satisfaction with this tool. Results: Exploratory factor analysis conducted on the derivation sample suggested five symptom constructs labeled as abdominal pain/discomfort (seven items), gastroesophageal reflux disease/regurgitation symptoms (four items), nausea/vomiting (three items), diarrhea/incontinence (five items), and difficult defecation and constipation (2 items). Confirmatory factor analysis conducted on the validation sample supported the initially developed five-factor measurement model ((Formula presented.), p < 0.0001, χ2/df = 4.6, CFI = 0.90, TLI = 0.88, RMSEA = 0.08). All symptom groups demonstrated differentiation between disease groups. The SAGIS was shown to be reliable over time and resulted in a 38% reduction of the time required for clinical assessment. Conclusions: The SAGIS instrument has excellent psychometric properties and supports the clinical assessment of and symptom-based categorization of patients with a wide spectrum of gastrointestinal symptoms.

    Original languageEnglish
    Pages (from-to)1913–1922
    Number of pages10
    JournalDigestive Diseases and Sciences
    Issue number8
    Publication statusPublished - Aug 2017


    • questionnaire development
    • validation
    • irritable bowel syndrome
    • quality of life
    • gastrointestinal symptoms


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