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.
Similar content being viewed by others
Change history
References
Everhart JE, Renault PF. Irritable bowel syndrome in office-based practice in the United States. Gastroenterology. 1991;100:998–1005.
Foundation R, Guidelines-Rome III. Diagnostic criteria for functional gastrointestinal disorders. J Gastrointest Liver Dis. 2006;15:307–312.
Rasmussen S, Jensen TH, Henriksen SL, et al. Overlap of symptoms of gastroesophageal reflux disease, dyspepsia and irritable bowel syndrome in the general population. Scand J Gastroenterol. 2015;50:162–169.
Lembo TJ, Fink RN. Clinical assessment of irritable bowel syndrome. J Clin Gastroenterol. 2002;35:S31–S36.
Hajjaj FM, Salek MS, Basra MK, et al. Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice. J R Soc Med. 2010;103:178–187.
Little P, Slocock L, Griffin S, et al. Who is targeted for lifestyle advice? A cross-sectional survey in two general practices. Br J Gen Pract. 1999;49:806–810.
Verbrugge LM, Steiner RP. Physician treatment of men and women patients: sex bias or appropriate care? Med Care. 1981;19:609–632.
Steinmetz D, Tabenkin H. The ‘difficult patient’ as perceived by family physicians. Fam Pract. 2001;18:495–500.
Jerant A, Bertakis KD, Fenton JJ, et al. Patient-provider sex and race/ethnicity concordance: a national study of healthcare and outcomes. Med Care. 2011;49:1012–1020.
Chapman KR, Tashkin DP, Pye DJ. Gender bias in the diagnosis of COPD. Chest. 2001;119:1691–1695.
McKinlay JB, Potter DA, Feldman HA. Non-medical influences on medical decision-making. Soc Sci Med. 1996;42:769–776.
Nelson EC, Eftimovska E, Lind C, et al. Patient reported outcome measures in practice. BMJ. 2015;350:g7818.
Santana MJ, Feeny D. Framework to assess the effects of using patient-reported outcome measures in chronic care management. Qual Life Res. 2014;23:1505–1513.
Spiegel BM, Bolus R, Agarwal N, et al. Measuring symptoms in the irritable bowel syndrome: development of a framework for clinical trials. Aliment Pharmacol Ther. 2010;32:1275–1291.
Talley NJ, Phillips SF, Wiltgen CM, et al. Assessment of functional gastrointestinal disease: the bowel disease questionnaire. Mayo Clin Proc. 1990;65:1456–1479.
Whitehead WE. Validation working team in association with the Rome Questionnaire Committee. Development and validation of the Rome III diagnostic questionnaire. McLean: Degnon Associates Inc; 2006.
Chassany O, Holtmann G, Malagelada J, et al. Systematic review: health-related quality of life (HRQOL) questionnaires in gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2008;27:1053–1070.
Holtmann G, Chassany O, Devault KR, et al. International validation of a health-related quality of life questionnaire in patients with erosive gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2009;29:615–625.
Adam B, Liebregts T, Saadat-Gilani K, Vinson B, Holtmann G. Validation of the gastrointestinal symptom score for the assessment of symptoms in patients with functional dyspepsia. Aliment Pharmacol Ther. 2005;22:357–363.
Talley NJ, Haque M, Wyeth JW, et al. Development of a new dyspepsia impact scale: the Nepean Dyspepsia Index. Aliment Pharmacol Ther. 1999;13:225–235.
Rey E, Locke GR 3rd, Jung HK, et al. Measurement of abdominal symptoms by validated questionnaire: a 3-month recall timeframe as recommended by Rome III is not superior to a 1-year recall timeframe. Aliment Pharmacol Ther. 2010;31:1237–1247.
Alrubaiy L, Hutchings HA, Dodds P, Watkins A, Russell IT, Williams JG. Development and validation of a New Disease Severity Index: the inflammatory bowel disease index (IBDEX). Frontline Gastroenterol. doi:10.1136/flgastro-2014-100530.
Alrubiay L, Rikaby I, Mohamed S, Hutchings HA, Williams JG. Systematic review of the clinical disease severity indices for inflammatory bowel disease. Inflamm Bowel Dis. 2015;21:2460–2466.
Smith RC. Patient-Centered Interviewing: An Evidence-Based Method. Philadelphia: Lippincott Williams & Wilkins; 2002.
Schermelleh-Engel K, Kerwer M, Klein AG. Evaluation of model fit in nonlinear multilevel structural equation modeling. Front Psychol. 2014;5:181.
Kline RB. Principles and practice of structural equation modeling. New York: Guilford Press; 2010.
Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997;11:395–402.
Attanasio V, Andrasik F, Blanchard EB, et al. Psychometric properties of the SUNYA revision of the psychosomatic symptom checklist. J Behav Med. 1984;7:247–257.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370.
Moss S, Prosser H, Costello H, et al. Reliability and validity of the PAS-ADD Checklist for detecting psychiatric disorders in adults with intellectual disability. J Intellect Disabil Res JIDR. 1998;42:173–183.
Ballantyne JC, Sullivan MD. Intensity of chronic pain-the wrong metric? N Engl J Med. 2015;373:2098–2099.
Meyer RRM, Campbell JN, Raja SN. Peripheral mechanisms of cutaneous nociception. In: McMahon SBKM, ed. Textbook of pain. London: Elsevier; 2006.
Gururatsakul M, Holloway RH, Bellon M, et al. Complicated and uncomplicated peptic ulcer disease: altered symptom response to a nutrient challenge linked to gastric motor dysfunction. Digestion. 2014;89:239–246.
Hashmi JA, Baliki MN, Huang L, et al. Shape shifting pain: chronification of back pain shifts brain representation from nociceptive to emotional circuits. Brain. 2013;136:2751–2768.
Stroud MW, Thorn BE, Jensen MP, et al. The relation between pain beliefs, negative thoughts, and psychosocial functioning in chronic pain patients. Pain. 2000;84:347–352.
Chang JY, Locke GR 3rd, McNally MA, et al. Impact of functional gastrointestinal disorders on survival in the community. Am J Gastroenterol. 2010;105:822–832.
Agreus L, Svardsudd K, Talley NJ, et al. Natural history of gastroesophageal reflux disease and functional abdominal disorders: a population-based study. Am J Gastroenterol. 2001;96:2905–2914.
Koloski NA, Jones M, Kalantar J, et al. The brain–gut pathway in functional gastrointestinal disorders is bidirectional: a 12-year prospective population-based study. Gut. 2012;61:1284–1290.
Bouchoucha M, Hejnar M, Devroede G, Babba T, Bon C, Benamouzig R. Anxiety and depression as markers of multiplicity of sites of functional gastrointestinal disorders: a gender issue? Clin Res Hepatol Gastroenterol. 2013;37:422–430.
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.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
The authors declare that they have no conflict of interest.
Additional information
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.
Electronic supplementary material
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
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
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10620-017-4599-6