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

Abstract

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.

Key words::

• Bowel Function Index
• Constipation
• Opioid-induced constipation
• Validation study

Transparency

Declaration of funding

Funding for this project was provided by Mundipharma SAS, France.

Declaration of financial/other relationships

P.D. has provided scientific advice and received fees from Mundipharma SAS. C.C. is medical director of Mundipharma SAS.

The peer reviewers on this manuscript have disclosed any relevant financial relationships.

Acknowledgments

The authors thank David P. Figgitt PhD (Content Ed Net), for providing editorial assistance. This editorial assistance was funded by Mundipharma SAS, France.

Notes

*Copyright for the BFI is owned by Mundipharma Research, 2002. The BFI is the subject of European Patent Application Publication No. EP 1 860 988 and corresponding patents and applications in other countries.