The Bowel Function Index: a new validated scale for assessing opioid-induced constipation.

BACKGROUND

The management of opioid-induced constipation (OIC) is often complicated by the fact that clinical measures of constipation do not always correlate with patient perception. As the discomfort associated with OIC can lead to poor compliance with the opioid treatment, a shift in focus towards patient assessment is often advocated.

SCOPE

The Bowel Function Index * (BFI) is a new patient-assessment scale that has been developed and validated specifically for OIC. It is a physician-administered, easy-to-use scale made up of three items (ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation). An extensive analysis has been performed in order to validate the BFI as reliable, stable, clinically valid, and responsive to change in patients with OIC, with a 12-point change in score constituting a clinically relevant change in constipation.

FINDINGS

The results of the validation analysis were based on major clinical trials and have been further supported by data from a large open-label study and a pharmaco-epidemiological study, in which the BFI was used effectively to assess OIC in a large population of patients treated with opioids. Although other patient self-report scales exist, the BFI offers several unique advantages. First, by being physician-administered, the BFI minimizes reading and comprehension difficulties; second, by offering general and open-ended questions which capture patient perspective, the BFI is likely to detect most patients suffering from OIC; third, by being short and easy-to-use, it places little burden on the patient, thereby increasing the likelihood of gathering accurate information.

CONCLUSION

Altogether, the available data suggest that the BFI will be useful in clinical trials and in daily practice.