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Validation of a bowel function diary for assessing opioid-induced constipation.
MedLine Citation:
PMID:  21063394     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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.
Authors:
Michael Camilleri; Margaret Rothman; Kai Fai Ho; Mila Etropolski
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Publication Detail:
Type:  Journal Article     Date:  2010-11-09
Journal Detail:
Title:  The American journal of gastroenterology     Volume:  106     ISSN:  1572-0241     ISO Abbreviation:  Am. J. Gastroenterol.     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-03-07     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0421030     Medline TA:  Am J Gastroenterol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  497-506     Citation Subset:  IM    
Affiliation:
Department of Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota, USA.
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