The Bile Acid Sequestrant Acceptability scale validation study.

Area of Science:

• Gastroenterology and Hepatology
• Clinical Pharmacology
• Patient-Reported Outcomes

Background:

• Bile acid sequestrants (BAS) are crucial in managing hyperlipidemia and cholestatic pruritus.
• Assessing patient acceptability and tolerability of BAS formulations is vital for adherence.
• Existing measures may not fully capture the nuances of beverage-based BAS preparations.

Purpose of the Study:

• To validate a novel Bile Acid Sequestrant Acceptability (BASA) Scale for assessing BAS beverage preparations.
• To evaluate the utility of subjective clinical importance weightings for BASA scale components and composite scores.

Main Methods:

• A randomized, single-blind, controlled study involving oral administration of 4g and 12g orange-flavored cholestyramine powders versus a control drink.
• The BASA scale assessed taste, texture, appearance, and mixability, with scores ranging from 4-20 (higher indicating better acceptability).
• Statistical analysis compared BASA scores between treatments and evaluated the impact of component weightings.

Main Results:

• The study included 42 participants (26 men, 16 women; mean age 51.4 years).
• Composite BASA scores were significantly lower for both 4g (10.3) and 12g (9.4) cholestyramine compared to the control (16.7) (p < 0.001).
• No significant difference in BASA scores was observed between the 4g and 12g cholestyramine doses (p = 0.215); component weightings did not alter findings.

Conclusions:

• The BASA scale demonstrated effectiveness in differentiating between bile acid sequestrant powders and a control beverage.
• The scale provides a valuable tool for assessing the acceptability and tolerability of oral BAS formulations.
• Weighting individual components did not significantly impact the overall assessment of acceptability.