Secondary outcomes
inferior turbinate reduction, Nasal Obstruction
SECONDARY
The improvement in SNOT-22 scores in the septoplasty group remained at 12 months but was less noticeable compared with those in the medical management group (Box plots showing summary statistics for SNOT-22 scores in intention-to-treat groups. Box represents middle 50% of data (lower quartile to upper quartile), horizontal line in box shows median (50th centile), whiskers show data that fall within 1.5× interquartile range, and points show data that fall outside these limits. SNOT-22=Sino-Nasal Outcome Test-22Supplementary table S3 shows that the secondary outcomes measured at six months improved more in the septoplasty group than in the medical management group, including the objective flow measures. A noticeable improvement in SNOT-22 scores was observed between six and 12 months for 29 of the 37 participants randomised to receive medical management and who chose to undergo septoplasty after six months, restricted to those who provided 12 months’ data. The SNOT-22 scores for these 37 participants had not improved between baseline and six months (see supplementary figure S5). The analysis between the groups in the 12 month objective assessments was affected by lack of face-to-face assessments during the covid-19 pandemic.For the ITT population (n=307) mean scores on the SF-36 physical component summary and mental component summary at six months were 2.74 (95% confidence interval 1.23 to 4.25) and 4.39 (2.43 to 6.36) units higher, respectively (better health), in the septoplasty group than in the medical management group (adjusted for baseline severity and stratification variables, P<0.001; see supplementary tables S5-S8 for full details).The STEPP analysis shows that for the 18 participants with moderate NOSE scores at baseline the average improvement in SNOT-22 score was around 5 units compared with medical management (Outcome data using subpopulation treatment effect pattern plot to assess individual changes in SNOT-22 scores from baseline to six months. Purple line shows average effect of being randomised to septoplasty for those with specific NOSE scores at baseline and shading represents 95% confidence intervals. Minimal clinically important difference is 9 points on SNOT-22. NOSE=Nasal Obstruction and Symptom Evaluation; SNOT-22=Sino-Nasal Outcome Test-22For the 148 participants who underwent septoplasty and had SNOT-22 scores at both baseline and six months, there was no difference in primary outcome scores between those chosen to receive inferior turbinate reduction and those chosen not to receive inferior turbinate reduction: 2.8 points difference (95% confidence interval −2.78 to 8.35 points difference; P=0.33).No other clinically relevant factors showed a statistically significant association with the primary outcome of patient reported SNOT-22 score at six months (see supplementary tables S1 and S2). The primary outcome SNOT-22 scores were not altered appreciably by the reported adherence rates in participants treated with medical management (see supplementary figure S6).