Skip to main content
Top
Published in: Digestive Diseases and Sciences 8/2017

01-08-2017 | Original Article

The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Evaluating Symptoms in the Clinical Setting

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

Published in: Digestive Diseases and Sciences | Issue 8/2017

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
go back to reference Everhart JE, Renault PF. Irritable bowel syndrome in office-based practice in the United States. Gastroenterology. 1991;100:998–1005.CrossRefPubMed Everhart JE, Renault PF. Irritable bowel syndrome in office-based practice in the United States. Gastroenterology. 1991;100:998–1005.CrossRefPubMed
2.
go back to reference Foundation R, Guidelines-Rome III. Diagnostic criteria for functional gastrointestinal disorders. J Gastrointest Liver Dis. 2006;15:307–312. Foundation R, Guidelines-Rome III. Diagnostic criteria for functional gastrointestinal disorders. J Gastrointest Liver Dis. 2006;15:307–312.
3.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
4.
go back to reference Lembo TJ, Fink RN. Clinical assessment of irritable bowel syndrome. J Clin Gastroenterol. 2002;35:S31–S36.CrossRefPubMed Lembo TJ, Fink RN. Clinical assessment of irritable bowel syndrome. J Clin Gastroenterol. 2002;35:S31–S36.CrossRefPubMed
5.
go back to reference 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.CrossRefPubMedPubMedCentral 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.CrossRefPubMedPubMedCentral
6.
go back to reference 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.PubMedPubMedCentral 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.PubMedPubMedCentral
7.
go back to reference Verbrugge LM, Steiner RP. Physician treatment of men and women patients: sex bias or appropriate care? Med Care. 1981;19:609–632.CrossRefPubMed Verbrugge LM, Steiner RP. Physician treatment of men and women patients: sex bias or appropriate care? Med Care. 1981;19:609–632.CrossRefPubMed
8.
go back to reference Steinmetz D, Tabenkin H. The ‘difficult patient’ as perceived by family physicians. Fam Pract. 2001;18:495–500.CrossRefPubMed Steinmetz D, Tabenkin H. The ‘difficult patient’ as perceived by family physicians. Fam Pract. 2001;18:495–500.CrossRefPubMed
9.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
10.
11.
go back to reference McKinlay JB, Potter DA, Feldman HA. Non-medical influences on medical decision-making. Soc Sci Med. 1996;42:769–776.CrossRefPubMed McKinlay JB, Potter DA, Feldman HA. Non-medical influences on medical decision-making. Soc Sci Med. 1996;42:769–776.CrossRefPubMed
12.
go back to reference Nelson EC, Eftimovska E, Lind C, et al. Patient reported outcome measures in practice. BMJ. 2015;350:g7818.CrossRefPubMed Nelson EC, Eftimovska E, Lind C, et al. Patient reported outcome measures in practice. BMJ. 2015;350:g7818.CrossRefPubMed
13.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
14.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
15.
go back to reference Talley NJ, Phillips SF, Wiltgen CM, et al. Assessment of functional gastrointestinal disease: the bowel disease questionnaire. Mayo Clin Proc. 1990;65:1456–1479.CrossRefPubMed Talley NJ, Phillips SF, Wiltgen CM, et al. Assessment of functional gastrointestinal disease: the bowel disease questionnaire. Mayo Clin Proc. 1990;65:1456–1479.CrossRefPubMed
16.
go back to reference 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. 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.
17.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
18.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
19.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
20.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
21.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
22.
go back to reference 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. 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.
23.
go back to reference 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. 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.
24.
go back to reference Smith RC. Patient-Centered Interviewing: An Evidence-Based Method. Philadelphia: Lippincott Williams & Wilkins; 2002. Smith RC. Patient-Centered Interviewing: An Evidence-Based Method. Philadelphia: Lippincott Williams & Wilkins; 2002.
25.
26.
go back to reference Kline RB. Principles and practice of structural equation modeling. New York: Guilford Press; 2010. Kline RB. Principles and practice of structural equation modeling. New York: Guilford Press; 2010.
27.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
28.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
29.
go back to reference Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370.CrossRefPubMed Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370.CrossRefPubMed
30.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
31.
go back to reference Ballantyne JC, Sullivan MD. Intensity of chronic pain-the wrong metric? N Engl J Med. 2015;373:2098–2099.CrossRefPubMed Ballantyne JC, Sullivan MD. Intensity of chronic pain-the wrong metric? N Engl J Med. 2015;373:2098–2099.CrossRefPubMed
32.
go back to reference Meyer RRM, Campbell JN, Raja SN. Peripheral mechanisms of cutaneous nociception. In: McMahon SBKM, ed. Textbook of pain. London: Elsevier; 2006. Meyer RRM, Campbell JN, Raja SN. Peripheral mechanisms of cutaneous nociception. In: McMahon SBKM, ed. Textbook of pain. London: Elsevier; 2006.
33.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
34.
go back to reference 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.CrossRefPubMedPubMedCentral 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.CrossRefPubMedPubMedCentral
35.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
36.
go back to reference 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.CrossRefPubMedPubMedCentral 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.CrossRefPubMedPubMedCentral
37.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
38.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
39.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
Metadata
Title
The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Evaluating Symptoms in the Clinical Setting
Authors
N. A. Koloski
M. Jones
J. Hammer
M. von Wulffen
A. Shah
H. Hoelz
M. Kutyla
D. Burger
N. Martin
S. R. Gurusamy
N. J. Talley
G. Holtmann
Publication date
01-08-2017
Publisher
Springer US
Published in
Digestive Diseases and Sciences / Issue 8/2017
Print ISSN: 0163-2116
Electronic ISSN: 1573-2568
DOI
https://doi.org/10.1007/s10620-017-4599-6

Other articles of this Issue 8/2017

Digestive Diseases and Sciences 8/2017 Go to the issue
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discuss last year's major advances in heart failure and cardiomyopathies.