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Published in: Quality of Life Research 12/2016

Open Access 01-12-2016

Psychometric assessment of the IBS-D Daily Symptom Diary and Symptom Event Log

Authors: Kathleen Rosa, Leticia Delgado-Herrera, Bernie Zeiher, Benjamin Banderas, Rob Arbuckle, Glen Spears, Stacie Hudgens

Published in: Quality of Life Research | Issue 12/2016

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Abstract

Purpose

Diarrhea-predominant irritable bowel syndrome (IBS-D) can considerably impact patients’ lives. Patient-reported symptoms are crucial in understanding the diagnosis and progression of IBS-D. This study psychometrically evaluates the newly developed IBS-D Daily Symptom Diary and Symptom Event Log (hereafter, “Event Log”) according to US regulatory recommendations.

Methods

A US-based observational field study was conducted to understand cross-sectional psychometric properties of the IBS-D Daily Symptom Diary and Event Log. Analyses included item descriptive statistics, item-to-item correlations, reliability, and construct validity.

Results

The IBS-D Daily Symptom Diary and Event Log had no items with excessive missing data. With the exception of two items (“frequency of gas” and “accidents”), moderate to high inter-item correlations were observed among all items of the IBS-D Daily Symptom Diary and Event Log (day 1 range 0.67–0.90). Item scores demonstrated reliability, with the exception of the “frequency of gas” and “accidents” items of the Diary and “incomplete evacuation” item of the Event Log. The pattern of correlations of the IBS-D Daily Symptom Diary and Event Log item scores with generic and disease-specific measures was as expected, moderate for similar constructs and low for dissimilar constructs, supporting construct validity. Known-groups methods showed statistically significant differences and monotonic trends in each of the IBS-D Daily Symptom Diary item scores among groups defined by patients’ IBS-D severity ratings (“none”/“mild,” “moderate,” or “severe”/“very severe”), supporting construct validity.

Conclusions

Initial psychometric results support the reliability and validity of the items of the IBS-D Daily Symptom Diary and Event Log.
Literature
1.
go back to reference Longstreth, G. F., Thompson, W. G., Chey, W. D., Houghton, L. A., Mearin, F., & Spiller, R. C. (2006). Functional bowel disorders. Gastroenterology, 130(5), 1480–1491.CrossRefPubMed Longstreth, G. F., Thompson, W. G., Chey, W. D., Houghton, L. A., Mearin, F., & Spiller, R. C. (2006). Functional bowel disorders. Gastroenterology, 130(5), 1480–1491.CrossRefPubMed
2.
go back to reference Yacavone, R. F., Locke, G. R. I., Provenzale, D. T., & Eisen, G. M. (2001). Quality of life measurement in gastroenterology: what is available? American Journal of Gastroenterology, 96(2), 285–297.CrossRefPubMed Yacavone, R. F., Locke, G. R. I., Provenzale, D. T., & Eisen, G. M. (2001). Quality of life measurement in gastroenterology: what is available? American Journal of Gastroenterology, 96(2), 285–297.CrossRefPubMed
3.
go back to reference Sandler, R. S., Everhart, J. E., Donowitz, M., Adams, E., Cronin, K., Goodman, C., et al. (2002). The burden of selected digestive diseases in the United States. Gastroenterology, 122(5), 1500–1511.CrossRefPubMed Sandler, R. S., Everhart, J. E., Donowitz, M., Adams, E., Cronin, K., Goodman, C., et al. (2002). The burden of selected digestive diseases in the United States. Gastroenterology, 122(5), 1500–1511.CrossRefPubMed
5.
go back to reference Whitehead, W. E., Palsson, O. S., Levy, R. L., Feld, A. D., VonKorff, M., & Turner, M. (2006). Reports of “satisfactory relief” by IBS patients receiving usual medical care are confounded by baseline symptom severity and do not accurately reflect symptom improvement. American Journal of Gastroenterology, 101, 1057–1065.CrossRefPubMed Whitehead, W. E., Palsson, O. S., Levy, R. L., Feld, A. D., VonKorff, M., & Turner, M. (2006). Reports of “satisfactory relief” by IBS patients receiving usual medical care are confounded by baseline symptom severity and do not accurately reflect symptom improvement. American Journal of Gastroenterology, 101, 1057–1065.CrossRefPubMed
6.
go back to reference Camilleri, M., Mangel, A. W., Fehnel, S. E., Drossman, D. A., Mayer, E. A., & Talley, N. J. (2007). Primary endpoints for irritable bowel syndrome trials: a review of performance of endpoints. Clinics and Research In Hepatology and Gastroenterology, 5(5), 534–540.CrossRef Camilleri, M., Mangel, A. W., Fehnel, S. E., Drossman, D. A., Mayer, E. A., & Talley, N. J. (2007). Primary endpoints for irritable bowel syndrome trials: a review of performance of endpoints. Clinics and Research In Hepatology and Gastroenterology, 5(5), 534–540.CrossRef
7.
go back to reference Trentacosti, A. M., He, R., Burke, L. B., Griebel, D., & Kennedy, D. L. (2010). Evolution of clinical trials for irritable bowel syndrome: issues in end points and study design. American Journal of Gastroenterology, 105(4), 731–735.CrossRefPubMed Trentacosti, A. M., He, R., Burke, L. B., Griebel, D., & Kennedy, D. L. (2010). Evolution of clinical trials for irritable bowel syndrome: issues in end points and study design. American Journal of Gastroenterology, 105(4), 731–735.CrossRefPubMed
8.
go back to reference Drossman, D. A., Morris, C. B., Schneck, S., Hu, Y. J., Norton, N. J., Norton, W. F., et al. (2009). International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit. Journal of Clinical Gastroenterology, 43(6), 541–550.CrossRefPubMedPubMedCentral Drossman, D. A., Morris, C. B., Schneck, S., Hu, Y. J., Norton, N. J., Norton, W. F., et al. (2009). International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit. Journal of Clinical Gastroenterology, 43(6), 541–550.CrossRefPubMedPubMedCentral
12.
go back to reference Francis, C. Y., Morris, J., & Whorwell, P. J. (1997). The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Alimentary Pharmacology and Therapeutics, 11(2), 395–402.CrossRefPubMed Francis, C. Y., Morris, J., & Whorwell, P. J. (1997). The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Alimentary Pharmacology and Therapeutics, 11(2), 395–402.CrossRefPubMed
13.
go back to reference Drossman, D. A., Patrick, D. L., Whitehead, W. E., Toner, B. B., Diamant, N. E., & Hu, Y. (2000). Further validation of the IBS-QOL: a disease-specific quality-of-life questionnaire. American Journal of Gastroenterology, 95(4), 999–1007.CrossRefPubMed Drossman, D. A., Patrick, D. L., Whitehead, W. E., Toner, B. B., Diamant, N. E., & Hu, Y. (2000). Further validation of the IBS-QOL: a disease-specific quality-of-life questionnaire. American Journal of Gastroenterology, 95(4), 999–1007.CrossRefPubMed
14.
go back to reference El Serag, H. B. (2003). Impact of irritable bowel syndrome: prevalence and effect on health-related quality of life. Reviews in Gastroenterological Disorders, 3(Suppl. 2), S3–11.PubMed El Serag, H. B. (2003). Impact of irritable bowel syndrome: prevalence and effect on health-related quality of life. Reviews in Gastroenterological Disorders, 3(Suppl. 2), S3–11.PubMed
15.
go back to reference Marquis, P., Lasch, K. E., Delgado-Herrera, L., Kothari, S., Lembo, A., Lademacher, C., et al. (2014). Qualitative development of a patient-reported outcome symptom measure in diarrhea-predominant irritable bowel syndrome. Clinical and Translational Gastroenterology, 5, 59.CrossRef Marquis, P., Lasch, K. E., Delgado-Herrera, L., Kothari, S., Lembo, A., Lademacher, C., et al. (2014). Qualitative development of a patient-reported outcome symptom measure in diarrhea-predominant irritable bowel syndrome. Clinical and Translational Gastroenterology, 5, 59.CrossRef
16.
go back to reference World Medical Association Declaration of Helsinki. (2002). Ethical principles for medical research involving human subjects. Nursing Ethics, 9(1), 105–109.CrossRef World Medical Association Declaration of Helsinki. (2002). Ethical principles for medical research involving human subjects. Nursing Ethics, 9(1), 105–109.CrossRef
17.
go back to reference Ware, J. E, Jr., Kosinski, M., & Keller, S. D. (1996). A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Medical Care, 34(3), 220–233.CrossRefPubMed Ware, J. E, Jr., Kosinski, M., & Keller, S. D. (1996). A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Medical Care, 34(3), 220–233.CrossRefPubMed
18.
go back to reference Guy, W. (1976). ECDEU assessment manual for psychopharmacology. Washington, DC: Department of Health, Education, and Welfare. Guy, W. (1976). ECDEU assessment manual for psychopharmacology. Washington, DC: Department of Health, Education, and Welfare.
19.
go back to reference Campbell, D. T., & Fiske, D. W. (1959). Convergent and discriminant validation by the multitrait-multimethod matrix. Psychological Bulletin, 56(2), 81–105.CrossRefPubMed Campbell, D. T., & Fiske, D. W. (1959). Convergent and discriminant validation by the multitrait-multimethod matrix. Psychological Bulletin, 56(2), 81–105.CrossRefPubMed
20.
go back to reference Fitzpatrick, R., Davey, C., Buxton, M. J., & Jones, D. R. (1998). Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess, 2(14), i-74. Fitzpatrick, R., Davey, C., Buxton, M. J., & Jones, D. R. (1998). Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess, 2(14), i-74.
21.
go back to reference Hinkle, D. E., Jurs, S. G., & Wiersma, W. (1988). Applied statistics for the behavioral sciences. Boston: Houghton Mifflin. Hinkle, D. E., Jurs, S. G., & Wiersma, W. (1988). Applied statistics for the behavioral sciences. Boston: Houghton Mifflin.
22.
go back to reference Kerlinger, F. N., & Lee, H. B. (2000). Foundations of behavioral research. Fort Worth: Harcourt College Publishers. Kerlinger, F. N., & Lee, H. B. (2000). Foundations of behavioral research. Fort Worth: Harcourt College Publishers.
Metadata
Title
Psychometric assessment of the IBS-D Daily Symptom Diary and Symptom Event Log
Authors
Kathleen Rosa
Leticia Delgado-Herrera
Bernie Zeiher
Benjamin Banderas
Rob Arbuckle
Glen Spears
Stacie Hudgens
Publication date
01-12-2016
Publisher
Springer International Publishing
Published in
Quality of Life Research / Issue 12/2016
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-016-1335-1

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