What this study adds
Leigh, Paget, nasal obstruction
LEIGH, RECRUITMENT
Septoplasty is a clinically effective treatment for nasal obstruction associated with septal deviation compared with a defined regimen of nasal steroid and saline spraysParticipants who underwent septoplasty had greater improvement in nasal obstruction and quality of life, as measured using the SNOT-22 questionnaireHowever, people with a deviated nasal septum and at least moderate nasal obstruction do tend to improve over time with medical treatmentWe thank the clinical research staff across the UK at the following centres: Aneurin Bevan University Health Board; Bradford Teaching Hospitals NHS Foundation Trust; County Durham and Darlington NHS Foundation Trust; Guy’s and St Thomas’s NHS Foundation Trust; James Paget University Hospital NHS Foundation Trust; Leeds Teaching Hospitals NHS Trust; Liverpool University Hospitals NHS Foundation Trust; Newcastle Upon Tyne Hospitals NHS Foundation Trust; NHS Grampian; NHS Lanarkshire; NHS Tayside; North Cumbria Integrated Care NHS Foundation Trust; Plymouth Hospitals NHS Trust; Salisbury NHS Foundation Trust; Stockport NHS Foundation Trust; University Hospitals Birmingham NHS Foundation Trust; Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust. The Newcastle Clinical Trials Unit staff, including previous team members: Trial Manager, Ann-Marie Hynes; Clinical Trial Administrators, Eva-Maria Holstein, Wendy Banks; Secretary, Ruby Smith-Whelan; Data Manager, Alaa Abouhajar; Senior Trial Managers, Lesley Hall, Jared Thornton, Sonya Carnell. Maria Allen and Ian Campbell for providing clinical trials pharmacy guidance and review on behalf the sponsor. Joan Mackintosh for qualitative data collection. The patient and public involvement advisors who provided helpful advice and guidance when reviewing the trial and patient facing documents. The members of the NAIROS Trial Steering Committee: Valerie Lund (chair), Natalie Rowland (independent statistician), Helen Mason (independent health economist), Russell Cathcart (independent clinician), Tim Woolford (independent clinician), Andrea Anderson and Irene Soulsby (independent lay members). The members of the NAIROS Data Monitoring Committee; Steff Lewis (chair), Stephen Gerry (independent statistician), and Gerald McGarry (independent clinician). Most importantly, we would like to thank every participant who took part in the NAIROS trial.Extra material supplied by authorsSupplementary information: Inclusion and exclusion criteria, figures S1-S6, and tables S1-S8Contributors: All authors have contributed to writing, reviewing, and revising the manuscript. SC and JOH are joint first authors. SC is the corresponding author and NAIROS chief investigator.TF, DS, and DT performed the trial statistical analysis. TH and LT performed the trial health economic evaluation. NR and KL performed the qualitative research. KR, EC, and AS were the trial management team. NW managed the trial database. LR, JD, and CW performed the qualitative research that guided trial recruitment. AB and MD devised the nasal patency methodology and performed the related data analysis. DH and JW were co-applicants and contributed to the trial design and participant recruitment. YO contributed to the trial methodology design. JM acted as a co-applicant and primary care lead. QG, NK, SK, SL, SM, and PN were clinical co-applicants and contributed to participant recruitment. SC and JOH, as guarantors, accept full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish. The corresponding authors attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.Funding: The study was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (reference 14/226/07). The NIHR commissioned the research trial with some stipulation on the trial design. Thereafter, the funders were independent of the running of the trial, analysis and interpretation, and the decision to publish the results.Competing interests: All authors have completed the ICMJE uniform disclosure form at The lead authors (SC and JOH) affirm that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.Dissemination to participants and related patient and public communities: A lay summary of results will be available on the NAIROS website. Access to the Health Technology Assessment report will also be available through the trial website. Members of the patient and public involvement focus groups will review results and they will be involved in writing lay summaries of results for dissemination to relevant patient groups.Provenance and peer review: Not commissioned; externally peer reviewed.