Functional nasal airway surgery includes septoplasty, inferior turbinate surgery, nasal valve surgery and functional septorhinoplasty undertaken to improve nasal breathing. The scoping review identified substantial variation in outcomes, instruments, objective-test protocols and follow-up intervals, limiting comparison and evidence synthesis.
Patient-reported and objective measures assess related but non-interchangeable aspects of nasal function. The review identified five candidate outcome domains and six commonly used instruments suitable for formal consideration.
A Core Outcome Set (COS) defines the minimum outcomes that should be measured and reported. This study will first agree what must be measured and then a small, implementable measurement standard. It follows recognised COS guidance while avoiding unnecessary rounds, duplicated evidence review and overly detailed technical voting.
Primary aim: To develop an international consensus statement defining a minimum, standardised and feasible outcome-measurement framework for adult functional nasal airway surgery studies.
Objectives: To agree core domains; select suitable instruments or methods; define minimum assessment time points and essential operating and reporting requirements; identify supplementary measures; and record research priorities where evidence is insufficient.
Scope: Element Defined scope Context Clinical trials and prospective clinical studies. The statement may inform audit and registries but is not a treatment guideline.
Condition: Persistent nasal airway obstruction attributable wholly or partly to structural or functional narrowing of the nasal airway.
Population: Adults aged 18 years or older undergoing, or eligible for, functional nasal airway surgery.
Interventions Septoplasty; inferior turbinate surgery; nasal valve surgery; functional septorhinoplasty; and combinations.
Setting: International, across healthcare systems.
Exclusions: Cosmetic-only rhinoplasty; paediatric surgery; and surgery undertaken principally for inflammatory sinonasal disease, including FESS.
Outputs: Core domains; instruments or methods; minimum time points; essential procedures; interpretation principles; and minimum reporting items.
Out of scope: Patient selection, indications, operative technique and comparative treatment effectiveness.
Principal Investigators: Guled M. Jama, Filippo Cainelli
Steering Committee: Alfonso Luca Pendolino, Giancarlo Ottaviano, Peter J. Andrews, Carl M. Philpott, Hesham Saleh
International Panel:
Name Department and institution
Guled M. Jama Chelsea and Westminster Hospital NHS Foundation Trust, London,
United Kingdom.
Alfonso Luca Pendolino, Imperial College Healthcare NHS Trust, London, United Kingdom.
Filippo Cainelli, Frimley Health NHS Trust,
Dean M. Toriumi Rush University Medical School, Chicago, United States.
Richard J. Harvey University of New South Wales, Sydney, Australia.
Sam P. Most Stanford University School of Medicine, Palo Alto, United States.
Michael G. Stewart Weill Cornell Medical College, New York, United States.
Peter W. Hellings Catholic University of Leuven, Leuven, Belgium.
Yong Ju Jang University of Ulsan College of Medicine, Seoul, South Korea.
Robin W. Lindsay Harvard Medical School, Massachusetts Eye and Ear Infirmary,
Boston, United States.
Isam Alobid Hospital Clinic, University of Barcelona, Barcelona, Spain.
Anna K. Hernandez Carl Gustav Carus Faculty of Medicine, Technical University Dresden, Dresden, Germany;
Giancarlo Ottaviano University of Padova, Padova, Italy.
Matt Lechner University College London, London, United Kingdom.
Vikas Acharya University College London Hospitals NHS Foundation Trust, London,
United Kingdom.
Sean Carrie Newcastle Upon Tyne NHS Foundation Trust, Newcastle upon Tyne,
United Kingdom.
Claire Hopkins Guy’s and St Thomas’ NHS Foundation Trust, London, United
Kingdom.
Valerie J. Lund University College London Hospitals NHS Foundation Trust, London, United Kingdom.
Peter J. Andrews University College London Hospitals NHS Foundation Trust, London, United Kingdom.
Carl M. Philpott James Paget University Hospital NHS Foundation Trust, Great
Yarmouth, United Kingdom.
Hesham Saleh Imperial College Healthcare NHS Trust, London, United Kingdom.
Disease Category: Ear, nose, & throat
Disease Name: Persistent nasal airway obstruction
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Surgery
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Semi structured discussion
Study design
Stage 1 is a two-round e-Delphi to agree core outcome domains. Stage 2 is one focused survey of evidence-based measurement proposals for domains retained after Round 2. Stage 3 is an online consensus meeting followed, where required, by a brief anonymous final vote. This sequence is consistent with the participant-facing Round 1 survey and preserves the distinction between deciding what to measure and how to measure it.
Stage Purpose Method
Preparation Confirm governance, registration, panel and materials.
Use the scoping review; pilot Round 1; pre-book all dates.
Stage 1: domains
Agree what should be measured.
Two e-Delphi rounds with controlled feedback.
Stage 2: measurement
Agree how and when retained domains should be measured.
One short survey of specific evidence-based proposals.
Stage 3: finalisation
Resolve selected outstanding items and approve the set.
A 90-minute meeting, final vote, drafting and ratification.
A third domain round is not routine. It may be used only if a new domain introduced in Round 2 requires a second anonymous rating and cannot reasonably be resolved in the final consensus process. The protocol, item rules and analysis plan will be locked before Round 1; amendments will be dated and justified.