Abstract
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 (\(\chi_{193}^{2} = 892.2\), p < 0.0001, χ 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 psychometric properties and supports the clinical assessment of and symptom-based categorization of patients with a wide spectrum of gastrointestinal symptoms.
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Acknowledgments
The authors acknowledge the contributions of the clinical staff at the Department of Gastroenterology and Hepatology and our patients during the development and validation stages of the instrument. In particular, we would like to acknowledge Jenny Scott, Pam Yap and Elisabeth Debowski who substantially contributed to this project.
Funding
This project has been in parts funded by the National Health and Medical Research Council and grants from the Princess Alexandra Research Foundation and Brisbane Diamantina Health Partners.
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The authors declare that they have no conflict of interest.
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The original version of this article was revised: To correct the spelling of the coauthor name [M. Kutyla].
An erratum to this article is available at https://doi.org/10.1007/s10620-017-4674-z.
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Koloski, N.A., Jones, M., Hammer, J. et al. The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Evaluating Symptoms in the Clinical Setting. Dig Dis Sci 62, 1913–1922 (2017). https://doi.org/10.1007/s10620-017-4599-6
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DOI: https://doi.org/10.1007/s10620-017-4599-6