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Aliment Pharmacol Ther. 2009 Dec 1;30(11-12):1159-70. doi: 10.1111/j.1365-2036.2009.04144.x. Epub 2009 Sep 12.

Measuring irritable bowel syndrome patient-reported outcomes with an abdominal pain numeric rating scale.

Author information

  • 1VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA. bspiegel@mednet.ucla.edu

Abstract

BACKGROUND:

Controversy exists on how to measure patient-reported outcomes in irritable bowel syndrome (IBS) clinical trials effectively. Pain numeric rating scales (NRS) are widely used in the non-IBS pain literature. The Food and Drug Administration has proposed using the NRS in IBS.

AIM:

To test the psychometrics of an abdominal pain NRS in IBS. Methods We analysed data from a longitudinal cohort of Rome III IBS subjects. At entry, subjects completed a 10-point NRS, bowel symptoms, IBS severity measurements (IBS-SSS, FBDSI), health-related quality of life indices (IBS-QOL, EQ5D), and the Worker Productivity Activity Index (WPAI). We repeated assessments at 3 months along with a response scale to calculate the minimal clinically important difference.

RESULTS:

There were 277 subjects (82% women; age = 42 +/- 15) at baseline and 90 at 3 months. The NRS correlated cross-sectionally with IBS-SSS (r = 0.60; P < 0.0011), FBDSI (r = 0.49; P < 0.0001), IBS-QOL (r = 0.43; P < 0.0001), EQ5D (r = 0.48; P < 0.0001), presenteeism (r = 0.39; P < 0.0001), absenteeism (r = 0.17; P = 0.04) and distension (r = 0.46; P < 0.0001), but not stool frequency or form. The minimal clinically important difference was 2.2 points, correlating with a 29.5% reduction over time.

CONCLUSIONS:

An abdominal pain NRS exhibits excellent validity and can be readily interpreted with a minimal clinically important difference in patients with IBS. These data support the use of the NRS in IBS clinical trials.

PMID:
19751360
[PubMed - indexed for MEDLINE]
PMCID:
PMC2793273
Free PMC Article
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