The Clostridium difficile Infection – Daily Symptoms (CDI-DaySymsTM) Patient-Reported Outcome (PRO) Questionnaire: Final Validation and Responder Thresholds

ABSTRACT: Abstract

Background

Patient perspectives on their disease are undoubtedly important in clinical trials and in practice. To date, no patient-reported outcome (PRO) questionnaire assessing symptoms of Clostridium difficile infection (CDI) has been developed following FDA guidance. The CDI-DaySyms™ is a new comprehensive measure of a broad range of local and systemic CDI symptoms (not only diarrhea) that patients report as meaningful. Objectives were to: finalize the CDI-DaySyms™ items (questions); assign them to domains (concepts); evaluate the questionnaire’s measurement properties; and define responder thresholds.

Methods

Blinded data from a sub-study of two Phase III trials (NCT01987895 and NCT01983683) in CDI patients were analyzed following FDA guidance for validating

SUBMITTER: Talbot G 

PROVIDER: S-EPMC5630859 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature