Abstract
Background
Current instruments used to measure disease activity and health-related quality of life in patients with Crohn’s disease (CD) and ulcerative colitis (UC) are often cumbersome, time-consuming, and expensive; although used in clinical trials, they are not convenient for clinical practice. A numeric rating scale (NRS) is a quick, inexpensive, and convenient patient-reported outcome that can capture the patient’s overall perception of health.
Aims
The aim of this study was to assess the validity, reliability, and responsiveness of an NRS and evaluate its use in clinical practice in patients with CD and UC.
Methods
We prospectively evaluated patient-reported NRS scores and measured correlations between NRS and a range of severity measures, including physician-reported NRS, Crohn’s disease activity index (CDAI), Harvey-Bradshaw index (HBI), inflammatory bowel disease questionnaire (IBDQ), and C-reactive protein (CRP) in patients with CD. Subsequently, we evaluated the correlation between the NRS and standard measures of health status (HBI or simple colitis clinical activity index [SCCAI]) and laboratory tests (sedimentation rate [ESR], CRP, and fecal calprotectin) in patients with CD and UC.
Results
The patient-reported NRS showed excellent correlation with CDAI (R 2 = 0.59, p < 0.0001), IBDQ (R 2 = 0.66, p < 0.0001), and HBI (R 2 = 0.32, p < 0.0001) in patients with CD. The NRS showed poor, but statistically significant correlation with SCCAI (R 2 = 0.25, p < 0.0001) in patients with UC. The NRS did not correlate with CRP, ESR, or calprotectin. The NRS was reliable and responsive to change.
Conclusions
The NRS is a valid, reliable, and responsive measure that may be useful to evaluate patients with CD and possibly UC.
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Acknowledgments
This study was funded in part by an unrestricted Investigator-Initiated grant from Centocor, Inc. The authors gratefully acknowledge Dr Fasiha Kanwal and Dr Ron Hays (UCLA) for methodologic input and Dr Patricio Ibanez (Cedars-Sinai) for assistance with patient recruitment. IBD Research at Cedars-Sinai that contributed to this study is supported by USPHS grant PO1DK046763, DK062413 and the Cedars-Sinai F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute Research Funds. Project investigators are support by The Helmsley Foundation, The European Union and the Crohn's and Colitis Foundation of America (D.P.B.M.), The Feintech Family Chair in IBD (S.R.T.), The Joshua L. and Lisa Z. Greer Chair in IBD Genetics (D.P.B.M.).
Conflict of interest
G.Y.M: Consultant (Amgen, Celgene, Janssen (formerly Centrocor), Given Imaging), non-CME speaker (Prometheus, Abbott), research support (Centocor).
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Surti, B., Spiegel, B., Ippoliti, A. et al. Assessing Health Status in Inflammatory Bowel Disease Using a Novel Single-Item Numeric Rating Scale. Dig Dis Sci 58, 1313–1321 (2013). https://doi.org/10.1007/s10620-012-2500-1
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DOI: https://doi.org/10.1007/s10620-012-2500-1