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Updated: Feb 11, 2026
09:13
Development of a Larval Zebrafish Infection Model for Clostridioides difficile
Published on: February 14, 2020
6.9K
The CDI-DaySyms: Content Development of a New Patient-Reported Outcome Questionnaire for Symptoms of Clostridium
Leah Kleinman1, George H Talbot2, Elke Hunsche3
1Evidera, Bethesda, MD, USA.
Summary
A new patient-reported outcome (PRO) questionnaire, Clostridium difficile infection Daily Symptoms (CDI-DaySyms), was developed to capture patient experiences with CDI symptoms. This tool shows initial content validity for assessing patient-reported outcomes in Clostridium difficile infection.
Area of Science:
- Medical Informatics
- Patient-Reported Outcomes
- Infectious Diseases
Background:
- Clostridium difficile infection (CDI) significantly impacts patient well-being.
- Standardized tools are needed to effectively measure patient-reported symptoms of CDI.
Purpose of the Study:
- To develop and validate a patient-reported outcome (PRO) questionnaire for Clostridium difficile infection (CDI) symptoms.
- To align with US Food and Drug Administration PRO guidelines for questionnaire development.
Main Methods:
- Elicited patient experiences through open-ended interviews with patients and nurses across five US sites.
- Developed a draft PRO measure, followed by two rounds of cognitive interviews with patients for refinement.
- Involved a panel of CDI experts and conducted interviews with 34 patients and 6 nurses.
Main Results:
- A 13-item draft daily diary, CDI-DaySyms, was created, organized into five hypothesized domains: diarrhea, abdominal discomfort, tiredness, lightheadedness, and other symptoms.
- Stage 2 cognitive interviews demonstrated initial content validity, with patients finding the questions clear, relevant, and comprehensive.
- Patients confirmed the usability of instructions and appropriateness of the 24-hour recall period.
Conclusions:
- The CDI-DaySyms questionnaire effectively captures patient-reported symptoms of Clostridium difficile infection.
- The developed tool demonstrates initial content validity for assessing patient experiences with CDI.
- Further evaluation of final content and psychometric validity is ongoing in international clinical trials.
Keywords:
CDAD-DaySyms(®)Clostridium difficile infectionClostridium difficile–associated diarrheahealth-related quality of lifepatient-reported outcomessymptomsMore Related Videos
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