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A Protocol to Characterize the Morphological Changes of Clostridium difficile in Response to Antibiotic Treatment
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Clostridium difficile Infection-Daily Symptoms (CDI-DaySyms™) questionnaire: psychometric characteristics and
George H Talbot1, Leah Kleinman2, Evan Davies3
1Talbot Advisors LLC, PO Box 2121, Anna Maria, FL, 34217, USA. ghtalbot@gmail.com.
Health and Quality of Life Outcomes
|May 5, 2019
Summary
The Clostridium difficile infection (CDI)-Daily Symptoms (CDI-DaySyms™) questionnaire is a validated tool for measuring patient-reported symptoms. It demonstrates good psychometric properties and can be used as a clinical endpoint.
Area of Science:
- Medical research
- Clinical outcomes assessment
- Patient-reported outcomes
Background:
- Clostridium difficile infection (CDI) significantly impacts patient well-being.
- Accurate measurement of CDI symptoms is crucial for evaluating treatment efficacy.
- Patient-reported outcome (PRO) measures are essential for capturing the patient experience.
Purpose of the Study:
- To validate the Clostridium difficile infection (CDI)-Daily Symptoms (CDI-DaySyms™) patient-reported outcome (PRO) questionnaire.
- To assess its psychometric characteristics, including reliability and validity.
- To determine clinically meaningful improvement and responder thresholds for CDI symptoms.
Main Methods:
- Validation study integrated into two Phase III clinical trials (NCT01987895, NCT01983683).
- Evaluation in three stages: PRO content validation, psychometric assessment (reliability, construct validity), and determination of clinically meaningful improvement and responder thresholds.
- Utilized distribution-based methods for threshold determination.
Main Results:
- The CDI-DaySyms™ questionnaire includes 10 items across three domains: Diarrhea Symptoms, Abdominal Symptoms, and Systemic/Other Symptoms.
- Domain scores showed acceptable internal consistency and test-retest reliability.
- Responder thresholds were established for each domain, indicating meaningful change in CDI symptoms.
Conclusions:
- The CDI-DaySyms™ is a valid and reliable PRO measure for CDI symptoms.
- Its established measurement properties support its use as a clinical trial endpoint.
- Further research using anchor-based methods is recommended to confirm responder thresholds.
Keywords:
Clostridium difficile infectionClostridium difficile–associated diarrheaPatient-reported outcomesPsychometric validationSymptomsMore Related Videos
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