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. 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

B Spiegel  1 , R Bolus, L A Harris, S Lucak, B Naliboff, E Esrailian, W D Chey, A Lembo, H Karsan, K Tillisch, J Talley, E Mayer, L Chang
Affiliations

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

B Spiegel et al. Aliment Pharmacol Ther. .

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.

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Conflict of interest statement

Conflicts of interest statements

Brennan Spiegel is the guarantor of this manuscript. Drs. Spiegel and Chang formulated the hypotheses and aims of the study, wrote the study protocol, and prepared the manuscript. Dr. Spiegel performed the analyses in concert with Drs. Chang and Bolus. Drs. Chang, Chey, Derezin, Dulai, Esrailian, Harris, Karsan, Lembo, Lucak, Strickland, and Tillisch assisted with patient recruitment and review of the manuscript. Drs. Naliboff and Mayer provided intellectual input to the manuscript. Partial support was provided from the UCLA Center for Neurobiology of Stress (NIH P50 DK64539 and 1 R24 AT002681-NCCAM). This study is also supported by an investigator initiated research grant from Takeda Pharmaceuticals.

Figures

Figure 1
Figure 1
Proportion of Patients Achieving a Minimal Clinically Important Difference (MCID) for Key Variables Stratified by Pain Numeric Rating Scale (NRS) Responder Status. Each set of bars depicts the results of an individual longitudinal 2×2 table, and demonstrates the difference in MCID achievement between NRS responders vs. non-responders over the 3-month study period. For example, 46% of NRS responders achieved an MCID in distension, whereas only 15% of NRS non-responders achieved an MCID in distension (31% difference in response; p=0.002). The differences were statistically significant across all comparisons except IBS-QOL, where there was a trend towards significance. The data indicate that the pain NRS was able to discriminate between clinically relevant responses for each of the concurrent indices tested.
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