Development and validation of the Functional Rhinoplasty Outcome Inventory 17 (FROI-17).

[STATEMENT OF PROBLEM] Quality of life aspects become more and more important in all fields of medicine. There is a lack of such instruments for septorhinoplasty that cover sufficiently both functional and aesthetic aspects.

[METHODOLOGY] In Phase 1, a group of experts identified 22 questions that represent the symptoms of patients with nasal deformities, which undergo a functional and aesthetic nasal surgery. Forty-one patients filled out the questionnaires before septorhinoplasty. The item assessment and item reduction was performed by a sequential statistical analysis, which included a single item analysis, an assessment of internal consistency, construct validity, the divergence validity and a factor analysis. The resulting 17-item questionnaire was used in a prospective validation study (Phase 2) in which 103 patients were enrolled. Statistical analysis included testing of validity, reliability and responsiveness.

[RESULTS] In Phase 2 data analysis revealed a good internal consistency and significant test-retest reliability. A literature survey confirmed that the relevant items were included in the questionnaire. We found significant item-score-correlations. Furthermore, the existence of concurrent validity was confirmed. Standardized Response Mean (SRM) as a measure for sensitivity to change indicated moderate to large effects.

[CONCLUSION] FROI-17 is a valid quality of life instrument for use in septorhinoplasty patients. The instrument is now available for prospective data collection in future septorhinoplasty outcome studies.