Objective: To validate the French version of the Empty Nose Syndrome Index (Fr-ENSI).
Methods: Patients with ENS, chronic rhinitis/rhinosinusitis, and asymptomatic individuals were recruited from April to August 2024. The internal consistency was evaluated with Cronbach-alpha. The test-retest reliability was assessed with the intraclass correlation coefficient (ICC). The external validity was assessed with a correlation study between the Fr-ENSI and the Sinonasal Outcome Tool-22 (Fr-SNOT-22), and Nasal Obstruction Symptom Evaluation (Fr-NOSE). The Fr-ENSI threshold for suspecting the ENS diagnosis was determined with the receiver operating characteristic (ROC) curve.
Results: Ninety-three subjects completed the evaluations. There were 36 ENS patients, 23 patients with chronic rhinosinusitis/rhinitis, and 34 healthy individuals. The mean age was 44.8±14.7 years. Patients with ENS reported significantly higher Fr-ENSI scores compared to others, indicating high internal validity. The Cronbach-alpha of Fr-ENSI was 0.891, which indicates an adequate internal consistency. The test-retest reliability was high. Depression and anxiety scores were associated with sleep disturbances. The Fr-ENSI was significantly correlated with Fr-SNOT-22, which supports a high external validity. The threshold of Fr-ENSI associated with the highest sensitivity and specificity was >23/60.
Conclusions: The Fr-ENSI is a valid and reliable questionnaire for documenting 12 prevalent symptoms of ENS. The consideration of sleep disorders in ENSI is important regarding its association with depression and anxiety.