医学
便秘
组内相关
功能性便秘
类阿片
观察研究
物理疗法
内科学
慢性便秘
肠功能
排便
心理测量学
临床心理学
受体
作者
Michael Camilleri,Margaret Rothman,Kai Fai Ho,Mila Etropolski
摘要
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.
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