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Validation of a Bowel Function Diary for Assessing Opioid-Induced Constipation

Camilleri, Michael MD1; Rothman, Margaret PhD2; Ho, Kai Fai PhD3; Etropolski, Mila MD4

American Journal of Gastroenterology: March 2011 - Volume 106 - Issue 3 - p 497–506
doi: 10.1038/ajg.2010.431

OBJECTIVES: Validated tools to assess opioid-induced constipation (OIC) are needed. The aim of this study was to validate a Bowel Function Diary (BF-Diary) that includes patient-reported outcomes (PROs) associated with OIC.

METHODS: In a multicenter, observational study, opioid-naive or recently untreated (≥14 days) adults with nonmalignant, chronic pain who were prescribed oral opioid and usual care completed an electronic diary daily for 2 weeks. Test–retest reliability was assessed. Validity was evaluated for two composite end points—number of spontaneous bowel movements (SBM) and complete SBMs (SCBM)—and for other relevant PROs.

RESULTS: Of 238 patients (mean age 54 years, 58% women), 63% reported constipation. The intraclass correlation coefficient for numbers of SBM and SCBM, and other BF-Diary PROs was ≥0.71 for all items except stool consistency. Mean (s.d.) number of SBM per week was significantly less in each week for patients with vs. without constipation (5.6±4.3 and 7.3±3.6, respectively over week 1,P=0.0012; similarly,P=0.0096 over week 2). Validity of individual items in the BF-Diary was supported (P<0.05, stool consistency;P<0.0001, all others).

CONCLUSIONS: BF-Diary items are generally reliable and valid assessments for OIC research. Specifically, number of SBM is a valid measure for differentiating opioid-treated patients with and without constipation.

1Department of Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota, USA

2Department of Health Economics, Johnson & Johnson Pharmaceutical Services, Raritan, New Jersey, USA

3Department of Clinical Biostatistics, STAT-TU, Toronto, Ontario, Canada

4Neuroscience Therapeutic Area, Johnson & Johnson Pharmaceutical Research and Development, Raritan, New Jersey, USA

Correspondence: Michael Camilleri, MD, Mayo Clinic College of Medicine, Charlton 8-110, 200 First Street SW, Rochester, Minnesota 55905, USA. E-mail:

published online 9 November 2010

SUPPLEMENTARY MATERIAL accompanies this paper at

Received 11 August 2010; accepted 8 October 2010

© The American College of Gastroenterology 2011. All Rights Reserved.
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