The PAC-SYM questionnaire for chronic constipation: defining the minimal important difference.

ABSTRACT:

Background

The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire is frequently used in clinical trials of constipation. However, the threshold for reduction in total PAC-SYM score used to define a clinical response on this 0-4 point scale has not undergone formal appraisal, and its relationship with clinical benefit as perceived by patients has not been defined.

Aim

To determine the minimal important difference in PAC-SYM score, and the optimum cut-off value for defining responders.

Methods

The minimal important difference was estimated using data from six international phase 3/4, double-blind, randomised controlled trials of prucalopride in patients with chronic constipation (NCT01147926, NCT01424228, NCT01116206, NCT00485940, NCT00483886, NCT004881

SUBMITTER: Yiannakou Y 

PROVIDER: S-EPMC5698746 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature