Development and psychometric validation of the Chronic Rhinosinusitis Control Test

Area of Science:

• Otolaryngology
• Clinical Outcomes Research
• Patient-Reported Outcome Measures

Background:

• Assessing disease control in chronic rhinosinusitis (CRS) presents significant challenges.
• A validated patient-reported outcome measure is needed for accurate CRS control assessment.

Purpose of the Study:

• To develop and psychometrically validate the Chronic Rhinosinusitis Control Test (CRCT) for assessing CRS control.
• To establish the validity, reliability, and responsiveness of the CRCT.

Main Methods:

• The CRCT was developed incorporating stakeholder input and guidance from the COSMIN initiative and FDA.
• Psychometric validation involved 545 CRS patients and 23 expert rhinologists, assessing validity, reliability, and responsiveness.
• Factor analysis identified two subdomains: sinonasal and impairment, plus an item on oral corticosteroid use.

Main Results:

• The CRCT demonstrated excellent face, content, concurrent validity, internal consistency, test-retest reliability, and responsiveness.
• A minimal clinically important difference (MCID) of 4 points was established using distribution-based and anchor-based methods.
• Expert rhinologists defined scoring criteria: ≤7 for controlled CRS, 8-15 for partly controlled, and ≥16 for uncontrolled CRS.

Conclusions:

• The Chronic Rhinosinusitis Control Test (CRCT) is a psychometrically validated tool for assessing CRS control.
• The CRCT provides clear thresholds for classifying CRS as controlled (≤7), partly controlled (8-15), or uncontrolled (≥16).
• The MCID for both improvement and worsening of CRS is 4 points on the CRCT.