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

Summary 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 ...

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Veröffentlicht in:Alimentary pharmacology & therapeutics 2009-12, Vol.30 (11‐12), p.1159-1170
Hauptverfasser: SPIEGEL, B., BOLUS, R., HARRIS, L. A., LUCAK, S., NALIBOFF, B., ESRAILIAN, E., CHEY, W. D., LEMBO, A., KARSAN, H., TILLISCH, K., TALLEY, J., MAYER, E., CHANG, L.
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Sprache:eng
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Zusammenfassung:Summary 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 
ISSN:0269-2813
1365-2036
DOI:10.1111/j.1365-2036.2009.04144.x