Validation of an Allergic Rhinitis Instrument That Synergizes With the Sino-Nasal Outcome Test

Area of Science:

• Otolaryngology and Allergy Research
• Clinical Outcome Measurement
• Patient-Reported Outcomes

Background:

• Allergic rhinitis (AR) and chronic rhinosinusitis (CRS) often coexist, presenting similar symptoms.
• Existing assessment tools can be lengthy and repetitive, increasing patient burden.
• A need exists for a concise, validated instrument to evaluate AR and CRS concurrently yet distinctly.

Purpose of the Study:

• To assess the validity of a novel AR-specific instrument designed for synergistic use with the Sino-Nasal Outcome Test (SNOT) for CRS.
• To determine if the new instrument can efficiently evaluate AR and CRS concurrently and discretely.
• To reduce redundancy and patient response burden in clinical assessments.

Main Methods:

• Prospective data collection from patients completing the AR-specific instrument, SNOT variations, Mini-Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ), and general health assessment.
• Factor analysis of 3566 responses to evaluate instrument structure.
• Assessment of discriminant validity using allergy testing results.
• Evaluation of convergent validity with MiniRQLQ and general health scores.
• Quantification of intra-rater reliability and responsiveness to change.

Main Results:

• The AR instrument, with 26 questions, allows concurrent yet discrete evaluation of AR and CRS, reducing the total question count compared to existing methods.
• The instrument demonstrated discriminant validity, differentiating between patients with positive and negative allergy tests (mean difference 1.22).
• Convergent validity was observed with MiniRQLQ (rho: 0.346-0.736) and PROMIS (rho: -0.118 to -0.264).
• Strong intra-rater reliability (kappa: 0.802-0.829; rho: 0.918-0.935) and responsiveness to change (mean difference -0.28) were confirmed.

Conclusions:

• The developed AR instrument provides a novel, concise, and validated method for assessing AR and CRS concurrently and discretely.
• This synergistic approach with the SNOT reduces redundancy and patient burden.
• The instrument exhibits strong psychometric properties, including validity, reliability, and responsiveness, making it suitable for research and clinical practice.