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Validation of a bowel function diary for assessing opioid-induced constipation.

Michael Camilleri¹, Margaret Rothman, Kai Fai Ho

¹Department of Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota 55905, USA. camilleri.michael@mayo.edu

The American Journal of Gastroenterology

|November 11, 2010

Summary

Validated tools for opioid-induced constipation (OIC) are essential. The Bowel Function Diary (BF-Diary) demonstrates reliability and validity in assessing OIC symptoms and patient-reported outcomes.

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Area of Science:

Gastroenterology
Clinical pharmacology
Patient-reported outcomes research

Background:

Opioid-induced constipation (OIC) is a common and distressing side effect of opioid therapy.
Validated tools are needed to accurately assess OIC and its impact on patients.
Patient-reported outcomes (PROs) are crucial for understanding the patient experience of OIC.

Purpose of the Study:

To validate the Bowel Function Diary (BF-Diary) as a reliable and valid tool for assessing OIC.
To evaluate the BF-Diary's ability to capture patient-reported outcomes related to OIC.
To confirm the utility of the BF-Diary in clinical research settings for OIC.

Main Methods:

A multicenter, observational study involving 238 adults with chronic pain using oral opioids.
Daily electronic diary completion for 2 weeks to assess bowel function and OIC-related PROs.
Evaluation of test-retest reliability and validity, including spontaneous bowel movements (SBM) and complete SBMs (SCBM).

Main Results:

63% of patients reported constipation; the BF-Diary showed good reliability (intraclass correlation coefficient ≥ 0.71) for most items.
The number of SBM per week was significantly lower in patients with constipation compared to those without.
Individual BF-Diary items demonstrated validity, with strong statistical significance (P<0.05 for stool consistency, P<0.0001 for others).

Conclusions:

The BF-Diary is a generally reliable and valid instrument for OIC research.
The number of spontaneous bowel movements (SBM) is a valid measure to distinguish between opioid-treated patients with and without constipation.
The BF-Diary effectively captures key PROs relevant to OIC assessment.