Observational, nonintervention, multicenter study for validation of the Bowel Function Index for constipation in...

Area of Science:

• Pain Management
• Gastroenterology
• Psychometrics

Background:

• Opioid analgesics are frequently prescribed for chronic non-malignant pain.
• Constipation is a prevalent adverse effect of opioid therapy, significantly impacting patient quality of life.
• Validated instruments are needed to accurately assess constipation in this patient population.

Purpose of the Study:

• To evaluate the psychometric properties of the Bowel Function Index (BFI).
• To assess the reliability and validity of the BFI in European patients experiencing constipation due to opioid treatment for chronic non-malignant pain.

Main Methods:

• A multinational study involving 131 patients across 15 clinical sites in the Czech Republic, Germany, Italy, and the UK.
• Participants completed the BFI, Patient Assessment of Constipation - Symptoms (PAC-SYM), a global frequency item, and socio-demographic/clinical forms.
• Psychometric properties, including internal consistency and correlations with other measures, were analyzed.

Main Results:

• The BFI demonstrated strong internal consistency (Cronbach's alpha = 0.86).
• Significant moderate to high correlations were found between BFI scores and a global constipation item (r = 0.59 to 0.69; p < 0.0001).
• Moderate, statistically significant correlations were observed between the BFI and the PAC-SYM (p < 0.01 to 0.0001).

Conclusions:

• The Bowel Function Index (BFI) is a reliable and valid measure for assessing constipation-related symptoms in chronic pain patients.
• The BFI can serve as a valuable tool in clinical trials evaluating opioid treatment for chronic pain.
• Further validation supports the BFI's utility in capturing patient-reported outcomes for opioid-induced constipation.