OBJECTIVE: The Bowel Function Index (BFI) is a clinician-administered, patient-reported, 3-item questionnaire to evaluate opioid-induced constipation in cancer and non-cancer chronic pain patients. The objective of the present analysis was to evaluate the psychometric characteristics of the BFI using data from clinical studies of oral prolonged release (PR) oxycodone/naloxone. METHODS:OXN2401 was a multicenter, controlled, randomized, double-blind, parallel-group study including oral PR oxycodone combined with oral PR naloxone as well as oral PR oxycodone combined with corresponding naloxone placebo. OXN3401 and OXN3001 were 12-week multicenter, controlled, randomized, double-blind, parallel-group studies of a fixed combination of oral PR oxycodone/naloxone versus PR oxycodone. In addition, a placebo group was included in study OXN3401. BFI psychometric characteristics (reliability, reproducibility, convergent/known groups validity, and responsiveness) were evaluated. RESULTS: Demographic data (n=985) were comparable and analyses indicated a high degree of internal consistency (Cronbach's alpha >0.7). Change of less than 5 points in BFI was indicative of high reproducibility. Correlations between BFI item and total scores to stool frequency were statistically significant and in the low-to-moderate range (OXN2401 -0.23 to -0.29, p < 0.001; OXN3401 range -0.26 to -0.40, p < 0.001; OXN3001 -0.14 to -0.15, p < 0.05). Data indicate that a BFI score change of ≥12 points represents a clinically meaningful change in constipation. LIMITATIONS: This publication for validation of BFI only includes data from three clinical trials. However, another publication of an additional specifically designed cross-sectional validation study is in preparation. CONCLUSION: The BFI is a valid and reliable instrument for the assessment of opioid-induced constipation in chronic pain patients. Psychometric analyses from clinical trials support the BFI's psychometric properties.
RCT Entities:
OBJECTIVE: The Bowel Function Index (BFI) is a clinician-administered, patient-reported, 3-item questionnaire to evaluate opioid-induced constipation in cancer and non-cancerchronic painpatients. The objective of the present analysis was to evaluate the psychometric characteristics of the BFI using data from clinical studies of oral prolonged release (PR) oxycodone/naloxone. METHODS: OXN2401 was a multicenter, controlled, randomized, double-blind, parallel-group study including oral PR oxycodone combined with oral PR naloxone as well as oral PR oxycodone combined with corresponding naloxone placebo. OXN3401 and OXN3001 were 12-week multicenter, controlled, randomized, double-blind, parallel-group studies of a fixed combination of oral PR oxycodone/naloxone versus PR oxycodone. In addition, a placebo group was included in study OXN3401. BFI psychometric characteristics (reliability, reproducibility, convergent/known groups validity, and responsiveness) were evaluated. RESULTS: Demographic data (n=985) were comparable and analyses indicated a high degree of internal consistency (Cronbach's alpha >0.7). Change of less than 5 points in BFI was indicative of high reproducibility. Correlations between BFI item and total scores to stool frequency were statistically significant and in the low-to-moderate range (OXN2401 -0.23 to -0.29, p < 0.001; OXN3401 range -0.26 to -0.40, p < 0.001; OXN3001 -0.14 to -0.15, p < 0.05). Data indicate that a BFI score change of ≥12 points represents a clinically meaningful change in constipation. LIMITATIONS: This publication for validation of BFI only includes data from three clinical trials. However, another publication of an additional specifically designed cross-sectional validation study is in preparation. CONCLUSION: The BFI is a valid and reliable instrument for the assessment of opioid-induced constipation in chronic painpatients. Psychometric analyses from clinical trials support the BFI's psychometric properties.
Authors: Adam D Farmer; Asbjørn M Drewes; Giuseppe Chiarioni; Roberto De Giorgio; Tony O'Brien; Bart Morlion; Jan Tack Journal: United European Gastroenterol J Date: 2018-12-14 Impact factor: 4.623
Authors: Oliver Löwenstein; Petra Leyendecker; Eberhard A Lux; Mark Blagden; Karen H Simpson; Michael Hopp; Björn Bosse; Karen Reimer Journal: BMC Clin Pharmacol Date: 2010-09-29
Authors: A Sandner-Kiesling; P Leyendecker; M Hopp; L Tarau; J Lejcko; W Meissner; P Sevcik; M Hakl; R Hrib; R Uhl; H Dürr; K Reimer Journal: Int J Clin Pract Date: 2010-03-29 Impact factor: 2.503
Authors: William C Becker; Liana Fraenkel; E Jennifer Edelman; Stephen R Holt; Janis Glover; Robert D Kerns; David A Fiellin Journal: Pain Date: 2013-03-14 Impact factor: 6.961