ORIGINAL ARTICLE The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Evaluating Symptoms in the Clinical Setting N. A. Koloski 1,2,3 • M. Jones 4 • J. Hammer 1,2 • M. von Wulffen 1,2 • A. Shah 1,2 • H. Hoelz 1 • M. Kutuyla 1 • D. Burger 1 • N. Martin 1 • S. R. Gurusamy 1 • N. J. Talley 3 • G. Holtmann 1,2,5 Received: 8 December 2016 / Accepted: 29 April 2017 Ó Springer Science+Business Media New York 2017 Abstract Background The clinical assessments of patients with gastrointestinal symptoms can be time-consuming, and the symptoms captured during the consultation may be influ- enced 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 clin- ical 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 vali- dation datasets (n = 551). Discriminant validity along with test–retest reliability was assessed. The time taken to per- form 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). Confirma- tory factor analysis conducted on the validation sample sup- ported the initially developed five-factor measurement model (v 2 193 ¼ 892:2, p \ 0.0001, v 2 /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 psy- chometric properties and supports the clinical assessment of and symptom-based categorization of patients with a wide spectrum of gastrointestinal symptoms. Keywords Questionnaire development Á Validation Á Irritable bowel syndrome Á Quality of life Á Gastrointestinal symptoms Introduction Patients with gastrointestinal disorders often present with a multitude of symptoms ranging from heartburn and early satiety to abdominal pain, constipation, and diarrhea which Electronic supplementary material The online version of this article (doi:10.1007/s10620-017-4599-6) contains supplementary material, which is available to authorized users. & G. Holtmann G.holtmann@uq.edu.au 1 Department of Gastroenterology and Hepatology, Princess Alexandra Hospital and Translational Research Institute (TRI), Ipswich Rd, Woolloongabba, Brisbane, QLD 4102, Australia 2 Faculty of Medicine, University of Queensland, Brisbane, QLD 4072, Australia 3 Faculty of Health and Medicine, University of Newcastle, Newcastle, NSW 2308, Australia 4 Department of Psychology, Macquarie University, North Ryde, NSW 2109, Australia 5 Faculty of Health and Behavioural Sciences, University of Queensland, St Lucia, QLD 4067, Australia 123 Dig Dis Sci DOI 10.1007/s10620-017-4599-6