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dc.contributor.authorRubie, Isabel
dc.contributor.authorHaighton, Catherine
dc.contributor.authorO'Hara, James
dc.contributor.authorRousseau, Nikki
dc.contributor.authorSteen, Nick
dc.contributor.authorStocken, Deborah D
dc.contributor.authorSullivan, Frank
dc.contributor.authorVale, Luke
dc.contributor.authorWilkes, Scott
dc.contributor.authorWilson, Janet
dc.identifier.citationRubie , I , Haighton , C , O'Hara , J , Rousseau , N , Steen , N , Stocken , D D , Sullivan , F , Vale , L , Wilkes , S & Wilson , J 2015 , ' The NAtional randomised controlled Trial of Tonsillectomy IN Adults (NATTINA) : a clinical and cost-effectiveness study: study protocol for a randomised control trial ' , Trials , vol. 16 , 263 .
dc.identifier.otherPURE: 249969664
dc.identifier.otherPURE UUID: e6b2b761-bfa2-47a6-9e79-44b87db49bec
dc.identifier.otherPubMed: 26047934
dc.identifier.otherPubMedCentral: PMC4467045
dc.identifier.otherScopus: 84931268250
dc.identifier.otherORCID: /0000-0002-6623-4964/work/33508495
dc.descriptionThis project is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (project number 12/146/06).en
dc.description.abstractBACKGROUND: 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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ISRCTN55284102, Date of Registration: 4 August 2014.
dc.rights© Rubie et al. 2015. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.en
dc.subjectSore throaten
dc.subjectRandomised controlled trialen
dc.subjectRA0421 Public health. Hygiene. Preventive Medicineen
dc.subjectRD Surgeryen
dc.subjectSDG 3 - Good Health and Well-beingen
dc.titleThe NAtional randomised controlled Trial of Tonsillectomy IN Adults (NATTINA) : a clinical and cost-effectiveness study: study protocol for a randomised control trialen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews. School of Medicineen
dc.description.statusPeer revieweden

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