A prospective study comparing patient-reported outcomes in Crohn's disease

Area of Science:

• Gastroenterology
• Clinical Research
• Patient-Reported Outcomes

Background:

• Patient-reported outcomes (PROs) are crucial for evaluating Crohn's disease management.
• Assessing the performance of the Bristol Stool Form Scale (BSFS) and visual analog scale (VAS) for abdominal pain as outcome measures in Crohn's disease is important.

Purpose of the Study:

• To investigate the performance and construct validity of the BSFS and VAS in monitoring patients with Crohn's disease.
• To compare the correlation of BSFS and VAS with clinical activity indices and biomarkers.

Main Methods:

• A prospective cohort study included Crohn's disease patients initiating glucocorticoids or anti-tumor necrosis factor therapy.
• Data collected included clinical activity (Harvey Bradshaw Index, Crohn's-Disease-Activity-Index), C-reactive protein, fecal calprotectin, BSFS, and VAS scores at baseline and 10 weeks.
• Response definitions were based on reductions in clinical indices, C-reactive protein, or fecal calprotectin.

Main Results:

• At baseline, BSFS parameters correlated more strongly with clinical activity than with CRP or fecal calprotectin.
• VAS scores showed weak to moderate correlations with clinical activity and biomarkers.
• Changes in VAS scores demonstrated moderate to strong correlations with changes in clinical activity, while changes in BSFS showed weaker correlations.
• Responsiveness of both VAS and BSFS was moderate to high, influenced by response definitions.

Conclusions:

• The BSFS and VAS are responsive outcome measures for monitoring patients with Crohn's disease.
• Both scales exhibit moderate-to-strong construct validity for assessing disease activity in Crohn's disease patients.