Authors' objectives: The indications for septoplasty are practice-based, rather than evidence-based. In addition, internationally accepted guidelines for the management of nasal obstruction associated with nasal septal deviation are lacking. The objective was to determine the clinical effectiveness and cost-effectiveness of septoplasty, with or without turbinate reduction, compared with medical management, in the management of nasal obstruction associated with a deviated nasal septum. The indications for septoplasty are practice-based, rather than evidence-based. In addition, internationally accepted guidelines for the management of nasal obstruction associated with nasal septal deviation are lacking. The study objectives are split into three different aspects: clinical effectiveness, economic evaluation and mixed-methods process evaluation. Objective 1 was to measure clinical effectiveness according to: subjective self-reported rating of nasal airway obstruction heterogeneity of estimated treatment effect, specifically according to severity of obstruction and gender objective measures of nasal patency number of adverse events (AEs) and additional interventions required technical failure in the surgical arm how well those agreeing to enter the trial reflect those screened for eligibility. Objective 2 was to conduct an economic evaluation from the perspective of the NHS and Personal Social Services. This entailed the following processes: conducting a cost-effectiveness analysis, with outcomes reported as incremental cost per ≥ 9-point improvement in the Sino-nasal Outcome Test-22 items (SNOT-22) scores and number of AEs conducting a cost–utility analysis, with outcomes reported as incremental cost per quality-adjusted life-year (QALY) gained designing a longer-term economic model to assess costs and health consequences beyond the 12-month follow-up period. Objective 3 was to conduct a mixed-methods process evaluation of the trial and interventions, to understand: barriers to optimal recruitment, and potential solutions to address these, through integration of the Qualitative research integrated within Trials (QuinteT) Recruitment Intervention (QRI) participants’ and healthcare professionals’ experiences of trial participation and the interventions, and perceived factors likely to influence wider implementation of trial findings.

Authors' results and conclusions: At the 6-month time point, 307 participants provided primary outcome data (septoplasty, n = 152; medical management, n = 155). An intention-to-treat analysis revealed a greater and more sustained improvement in the primary outcome measure in the surgical arm. The 6-month mean Sino-nasal Outcome Test-22 items scores were −20.0 points lower (better) for participants randomised to septoplasty than for those randomised to medical management [the score for the septoplasty arm was 19.9 and the score for the medical management arm was 39.5 (95% confidence interval −23.6 to −16.4; p < 0.0001)]. This was confirmed by sensitivity analyses and through the analysis of secondary outcomes. Outcomes were statistically significantly related to baseline severity, but not to gender or turbinate reduction. In the surgical and medical management arms, 132 and 95 adverse events occurred, respectively; 14 serious adverse events occurred in the surgical arm and nine in the medical management arm. On average, septoplasty was more costly and more effective in improving Sino-nasal Outcome Test-22 items scores and quality-adjusted life-years than medical management, but incurred a larger number of adverse events. Septoplasty had a 15% probability of being considered cost-effective at 12 months at a £20,000 willingness-to-pay threshold for an additional quality-adjusted life-year. This probability increased to 99% and 100% at 24 and 36 months, respectively. Septoplasty, with or without turbinate reduction, is more effective than medical management with a nasal steroid and saline spray. Baseline severity predicts the degree of improvement in symptoms. Septoplasty has a low probability of cost-effectiveness at 12 months, but may be considered cost-effective at 24 months. Future work should focus on developing a septoplasty patient decision aid. Primary outcomes The ITT analysis found that, at 6 months, participants randomised to the septoplasty arm (n = 152) had SNOT-22 scores that were, on average, 20.0 points lower (i.e. better) than those of participants randomised to medical management (n = 155) [95% confidence interval (CI) −23.6 to −16.4 points; p < 0.0001]. This strong signal was confirmed by both sensitivity analyses and analysis of secondary outcomes. The mean SNOT-22 scores at 6 months were 19.9 points for the septoplasty arm and 39.5 points for the medical management arm. At 12 months, the adjusted mean difference for SNOT-22 scores between the two arms had reduced to −10.1 points (95% CI −14.5 to −5.6 points; p < 0.0001). This diminished effect at 12 months was predominantly due to SNOT-22 scores tending to reduce over time among those randomised to medical management. Overall, the improvement in SNOT-22 score in the surgical arm was both notably faster and greater, and was sustained over the trial period. Increased baseline severity of nasal obstruction was associated with greater improvements in the primary outcome. Gender had no impact on outcome improvement. Approximately 45 out of 190 (24%) participants discontinued allocated medical management treatment and had non-trial surgery, and 22 out of 188 (12%) of those randomised to septoplasty did not receive the surgical intervention. The per-protocol (treatment effect −19.7, 95% CI −23.4 to −16.0) and per-treatment analyses (treatment effect −19.3, 95% CI −23.3 to −15.3) confirmed a statistically significant greater improvement in the surgical arm. Septoplasty, with or without turbinate reduction, is a clinically effective intervention. Participants with a deviated nasal septum with a moderate, severe or extreme baseline severity of nasal obstruction symptoms had an improvement in patient-reported outcomes at 6 and 12 months. This improvement surpassed that of standardised medical management. The results suggest that surgery has a low probability of being cost-effective at 12 months but may be considered cost-effective at 24 months. Impact on health services The NAIROS clearly demonstrates that adults presenting with nasal obstruction associated with a deviated nasal septum, in the absence of clinical evidence of a coexistent nasal/sinus disease and with a baseline NOSE score of > 30, can reliably be offered surgery in the knowledge that improvements in patient-reported outcomes are superior to improvements when treated with a nasal steroid/saline spray combination.

Authors' recommendations: The most important research priority to emerge from the NAIROS is the need to develop a patient decision aid to explore management of a deviated nasal septum. The place of medical treatment in the management of nasal obstruction associated with a deviated nasal septum needs to be explored further. A prospective randomised trial would be required to examine the place of turbinate reduction surgery in nasal obstruction.

Authors' methods: This was a multicentre randomised controlled trial comparing septoplasty, with or without turbinate reduction, with defined medical management; it incorporated a mixed-methods process evaluation and an economic evaluation. The trial was set in 17 NHS secondary care hospitals in the UK. A total of 378 eligible participants aged > 18 years were recruited. Participants were randomised on a 1: 1 basis and stratified by baseline severity and gender to either (1) septoplasty, with or without turbinate surgery (n = 188) or (2) medical management with intranasal steroid spray and saline spray (n = 190). The primary outcome was the Sino-nasal Outcome Test-22 items score at 6 months (patient-reported outcome). The secondary outcomes were as follows: patient-reported outcomes – Nasal Obstruction Symptom Evaluation score at 6 and 12 months, Sino-nasal Outcome Test-22 items subscales at 12 months, Double Ordinal Airway Subjective Scale at 6 and 12 months, the Short Form questionnaire-36 items and costs; objective measurements – peak nasal inspiratory flow and rhinospirometry. The number of adverse events experienced was also recorded. A within-trial economic evaluation from an NHS and Personal Social Services perspective estimated the incremental cost per (1) improvement (of ≥ 9 points) in Sino-nasal Outcome Test-22 items score, (2) adverse event avoided and (3) quality-adjusted life-year gained at 12 months. An economic model estimated the incremental cost per quality-adjusted life-year gained at 24 and 36 months. A mixed-methods process evaluation was undertaken to understand/address recruitment issues and examine the acceptability of trial processes and treatment arms. COVID-19 had an impact on participant-facing data collection from March 2020. The Nasal AIRway Obstruction Study (NAIROS) was a multicentre, non-blinded randomised controlled trial comparing the effectiveness of septoplasty, with or without turbinate surgery, with a standardised medical management package of 6 months of intranasal steroid spray and saline spray. Participants were randomised on a 1 : 1 basis between the septoplasty (within 8 weeks) and medical management arms. The trial included an integrated health economic evaluation and a mixed-methods process evaluation incorporating a QRI. The target sample size of 378 participants allowed for 20% dropout to deliver 90% power for detecting a minimal clinically important difference of 9 points in SNOT-22 scores. This assumed a two-sided type error rate of 5% and a standard deviation of 24 points in SNOT-22 scores at 6 months. Interventions The two interventions being compared were as follows. Septoplasty, with or without inferior turbinate reduction in the contralateral nostril, performed at the discretion of the investigating clinician, preferably performed within 8 weeks of randomisation or, if not, by 12 weeks. Medical management with 6 months of mometasone furoate 50 μg per dose nasal steroid spray, suspension (Nasonex®; Merck Sharp & Dohme Limited, Hoddesdon, UK), and isotonic nasal saline spray. Participants had the option of deferred surgery after 6 or 12 months post randomisation. We recruited 378 patients to the main trial from 17 NHS hospitals in Great Britain. Eligible patients were identified from general ear, nose and throat referrals. Of those recruited, 188 were randomised to septoplasty and 190 were randomised to medical management. Inclusion criteria Adults aged ≥ 18 years. Baseline Nasal Obstruction Symptom Evaluation (NOSE) scale score of ≥ 30. Septal deflection visible via nasoendoscopy. Capacity to provide informed consent/complete trial questionnaires. COVID-19 had a major impact on the study, resulting in the cessation of clinical measurements and objective outcomes from March 2020. From that time, all patient-reported outcomes were collected by post or online, or transcribed over the telephone. The ITT analysis is likely to offer an overestimate of the true impact of medical management in improving outcomes as 22% of participants in that arm received septoplasty before the 12-month outcome point.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/14/226/07

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/MVFR4028

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/MVFR4028

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk