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Development and Validation of a Patient-Reported Outcome Measure to Assess Disease Control in Chronic Prurigo
Martin Metz1,2, Claudia Zeidler3, Tomasz Hawro4
1Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
JAMA Dermatology
|January 17, 2024
Summary
The Prurigo Control Test (PCT) effectively assesses chronic prurigo (CPG) control in patients. This validated 5-item tool aids in treatment decisions for CPG management.
Area of Science:
- Dermatology
- Clinical Trials
- Patient-Reported Outcomes
Background:
- Chronic prurigo (CPG) significantly impacts patient quality of life and presents treatment challenges.
- Effective management of CPG requires tools to assess disease control.
- Prurigo nodularis is a common form of CPG requiring validated assessment measures.
Purpose of the Study:
- To develop and validate the Prurigo Control Test (PCT) for assessing CPG control.
- To establish a cutoff value for the PCT to differentiate between controlled and poorly controlled CPG.
- To provide a reliable tool for clinical practice and research in CPG.
Main Methods:
- A qualitative study followed patient-reported outcome measure development guidelines.
- Item generation, reduction, and selection resulted in a 5-item PCT.
- Validation included internal consistency, test-retest reliability, convergent validity, known-group validity, and screening accuracy in 95 CPG patients across two German expert centers.
Main Results:
- The 5-item PCT demonstrated good internal consistency (Cronbach α = 0.86) and excellent test-retest reliability (ICC = 0.94).
- The PCT showed high convergent and known-group validity, effectively discriminating between patients with different levels of prurigo control.
- A PCT cutoff score of 10 or higher was identified for distinguishing well-controlled from poorly controlled CPG.
Conclusions:
- The Prurigo Control Test (PCT) is a validated, reliable, and brief tool for assessing disease control in chronic prurigo (CPG).
- The PCT's simple scoring and retrospective approach make it suitable for clinical practice and clinical trials.
- The identified cutoff value aids in treatment decisions for CPG management.
