title: The NAtional randomised controlled Trial of Tonsillectomy IN Adults (NATTINA): a clinical and cost-effectiveness study: study protocol for a randomised control trial.
abstract: BACKGROUND
  The role of tonsillectomy in the management of adult tonsillitis remains uncertain and UK regional variation in tonsillectomy rates persists. Patients, doctors and health policy makers wish to know the costs and benefits of tonsillectomy against conservative management and whether therapy can be better targeted to maximise benefits and minimise risks of surgery, hence maximising cost-effective use of resources. NATTINA incorporates the first attempt to map current NHS referral criteria against other metrics of tonsil disease severity.
  
  
  METHODS
  A UK multi-centre, randomised, controlled trial for adults with recurrent tonsillitis to compare the clinical and cost-effectiveness of tonsillectomy versus conservative management. An initial feasibility study comprises qualitative interviews to investigate the practicality of the protocol, including willingness to randomise and be randomised. Approximately 20 otolaryngology staff, 10 GPs and 15 ENT patients will be recruited over 5 months in all 9 proposed main trial participating sites. A 6-month internal pilot will then recruit 72 patients across 6 of the 9 sites. Participants will be adults with recurrent acute tonsillitis referred by a GP to secondary care. Randomisation between tonsillectomy and conservative management will be according to a blocked allocation method in a 1:1 ratio stratified by centre and baseline disease severity. If the pilot is successful, the main trial will recruit a further 528 patients over 18 months in all 9 participating sites. All participants will be followed up for a total of 24 months, throughout which both primary and secondary outcome data will be collected. The primary outcome is the number of sore throat days experienced over the 24-month follow-up. The pilot and main trials include an embedded qualitative process evaluation.
  
  
  CONCLUSIONS
  NATTINA is designed to evaluate the relative effectiveness and efficiency of tonsillectomy versus conservative management in patients with recurrent sore throat who are eligible for surgery. Most adult tonsil disease and surgery has an impact on economically active age groups, with individual and societal costs through loss of earnings and productivity. Avoidance of unnecessary operations and prioritisation of those individuals likely to gain most from tonsillectomy would reduce costs to the NHS and society.
  
  
  BACKGROUND
  ISRCTN55284102, Date of Registration: 4 August 2014.
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK. isabel.rubie@newcastle.ac.uk.
authors.forename: Isabel
authors.initials: I
authors.lastname: Rubie
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK. Katie.haighton@ncl.ac.uk.
authors.forename: Catherine
authors.initials: C
authors.lastname: Haighton
authors.affiliation: ENT Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, NE7 7DN, UK. James.Ohara@nuth.nhs.uk.
authors.forename: James
authors.initials: J
authors.lastname: O'Hara
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK. nikki.rousseau@newcastle.ac.uk.
authors.forename: Nikki
authors.initials: N
authors.lastname: Rousseau
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK. nick.steen@newcastle.ac.uk.
authors.forename: Nick
authors.initials: N
authors.lastname: Steen
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK. deborah.stocken@newcastle.ac.uk.
authors.forename: Deborah D
authors.initials: DD
authors.lastname: Stocken
authors.affiliation: Department of Community and Family Medicine, University of Toronto, Toronto, ON, M5G 1V7, Canada. Frank.Sullivan@nygh.on.ca.
authors.forename: Frank
authors.initials: F
authors.lastname: Sullivan
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK. Luke.Vale@newcastle.ac.uk.
authors.forename: Luke
authors.initials: L
authors.lastname: Vale
authors.affiliation: Department of Pharmacy, Health and Wellbeing, University of Sunderland, Sunderland, SR1 3SD, UK. Scott.Wilkes@sunderland.ac.uk.
authors.forename: Scott
authors.initials: S
authors.lastname: Wilkes
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK. janet.wilson@newcastle.ac.uk.|ENT Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, NE7 7DN, UK. janet.wilson@newcastle.ac.uk.
authors.forename: Janet
authors.initials: J
authors.lastname: Wilson
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D005240:Feasibility Studies; D005260:Female; D017721:Hospital Costs; D006801:Humans; D008297:Male; D010865:Pilot Projects; D012008:Recurrence; D012107:Research Design; D013997:Time Factors; D014068:Tonsillectomy / Q000009:adverse effects / Q000191:economics*; D014069:Tonsillitis / Q000175:diagnosis / Q000191:economics* / Q000601:surgery*; D016896:Treatment Outcome; D006113:United Kingdom