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24-06-2016 | Uitgave 12/2016 Open Access

Quality of Life Research 12/2016

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

Tijdschrift:
Quality of Life Research > Uitgave 12/2016
Auteurs:
Kathleen Rosa, Leticia Delgado-Herrera, Bernie Zeiher, Benjamin Banderas, Rob Arbuckle, Glen Spears, Stacie Hudgens
Belangrijke opmerkingen
Kathleen Rosa and Stacie Hudgens were affiliated with Adelphi Values during the time the research was conducted.
Glen Spears was affiliated with Astellas during the time the research was conducted.

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.

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