Discussion
ear/facial pain, nasal obstruction, nasal airflow, nasal or sinus disease, inferior turbinate reduction
SECONDARY
Septoplasty results in significantly greater improvement in patient reported SNOT-22 scores at six months compared with a regimen of nasal steroid and saline sprays, and this improvement is sustained to 12 months. We therefore recommend that adults presenting with nasal obstruction associated with a deviated nasal septum, in the absence of coexistent nasal or sinus disease and with a baseline NOSE score >30, can reliably be offered surgery. The per protocol and per treatment analyses corroborated the ITT results, confirming the greater improvement in patient reported outcomes of those participants who received surgery compared with those treated medically.The STEPP analysis provided evidence of the increasing improvement in SNOT-22 scores as baseline NOSE score severity increased. This effect was observed in both male and female participants. This analysis can enable clinicians to quantify expected improvements in outcomes of patients considering septoplasty, predicated on baseline NOSE score. The STEPP analysis, in parallel with an understanding of the potential risks associated with both medical treatment and surgery, substantially improved the quality of information available to the clinician and patient in the decision making process around septoplasty.In 2014 when the National Institute for Health and Care Research commissioned this trial, no high level evidence existed for surgery compared with medical management for nasal obstruction associated with septal deviation. No specific guidance was available as to who should be referred for consideration of surgery, or the likely outcomes. The intervention was practice based, not evidence based. To our knowledge, in 2019 van Egmond et al reported the first randomised clinical trial assessing septoplasty.We estimated a superiority for septoplasty of 20 points on SNOT-22 at six months compared with 9.7 points at 12 months in the study by van Egmond et al. Their data transformation and variable non-surgical arm treatments make direct comparison with the current study difficult. The two clinical trials report concordant results in showing that septoplasty is clinically effective. The current study substantially enhances understanding of the role of quantitative patient reported data in the selection of patients for surgery by showing that the degree of improvement in symptoms (as measured by SNOT-22) is closely related to baseline severity stratification (as measured by NOSE score). This improvement in SNOT-22 score remained across each of the four SNOT-22 subdomains— nose, sleep, ear/facial pain, psychological. The impact of septal surgery in improving SNOT-22 scores is also found in studies of snoringIn the current study, although a greater and sustained improvement was observed in the surgical arm, we did note a potentially clinically important improvement in SNOT-22 scores in the medical management arm of 9.1 points between six and 12 months. In the ITT analysis, some of the improvement at 12 months in the medical management group may have been affected by 37 participants who were randomised to receive medical management undergoing septoplasty after six months. The primary outcome, SNOT-22 score at six months, did not improve from baseline in these 37 participants, suggesting that these participants undergoing septoplasty had an important impact on the medical management group.The benefits of septoplasty were also seen in the secondary outcome measures, including clinical airflow assessment, patient reported outcome measures, and objective measurements of peak nasal inspiratory flow and rhinospirometry. Absolute subjective double ordinal airway subjective scale, the subjective comparator of the worse versus the better nostril airflow, revealed a substantial treatment related shift from predominantly unilateral nasal airflow to equal airflow through both nostrils, more noticeable in magnitude in the surgical arm than in the medical management arm at both six and 12 months. It may be a useful tool to audit surgical outcomes, or future trials of nasal airway surgery.The results of the current study infer that turbinate surgery added no additional improvement to septoplasty alone. The decision to perform turbinate surgery was, however, pragmatic and left to the discretion of the operating surgeon. The results for inferior turbinate reduction may not be generalisable to other techniques or to bilateral reduction practices. The study by van Egmond et al similarly reported no additional benefit of turbinate surgery.