Clostridium difficile Infection-Daily Symptoms (CDI-DaySyms™) questionnaire: psychometric characteristics and responder thresholds.

ABSTRACT:

Background

The purpose of the current study was to determine the final content validation, psychometric characteristics, clinically meaningful improvement, and responder thresholds of the Clostridium difficile infection (CDI)-Daily Symptoms (CDI-DaySyms™) patient-reported outcome (PRO) questionnaire.

Methods

This validation study was part of two phase III studies (NCT01987895 and NCT01983683) conducted in patients with mild-to-moderate or severe CDI who completed the CDI-DaySyms™ daily throughout the treatment period. The questionnaire was evaluated in three stages: final PRO item content validation (Stage I); psychometric evaluation of reliability and construct validity (Stage II); and determination of clinically meaningful improvement and responder thresholds using distrib

SUBMITTER: Talbot GH 

PROVIDER: S-EPMC6499966 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature