The NAtional randomised controlled Trial of Tonsillectomy IN Adults (NATTINA): a clinical and cost-effectiveness study: study protocol for a randomised control trial

Abstract

BackgroundThe 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/designA 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.DiscussionNATTINA 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 registrationISRCTN55284102, Date of Registration: 4 August 2014

Stakeholders’ views of recurrent sore throat, tonsillitis and their management: a qualitative interview study for the NAtional Trial of Tonsillectomy IN Adults (NATTINA Part 1)

“…Patients: ENT staff provided patients, attending referral visits, who met the proposed NATTINA eligibility criteria, a participant information sheet (PIS), considered to be the most efficient form of recruitment. One of the authors (LM) contacted patients who expressed interest and arranged interviews at a time and location convenient for them.…”

“…However, there is a paucity of qualitative research examining key stakeholders’ experience and management of recurrent sore throat. This study provides a unique opportunity to triangulate the perspectives of patients, GPs and ENT staff during a feasibility study for the NAtional Trial of Tonsillectomy IN Adults (NATTINA) . The specific objectives of the NATTINA feasibility study (Reference the linked NATTINA part 2 paper submitted separately) were to establish the following: standard NHS ENT staff's willingness to randomise patients to the treatment arms; feasibility of patient identification and eligibility criteria; GPs’ willingness to refer patients to standard NHS NATTINA centres; patients’ willingness to be randomised; and views on the proposed data collection methods.…”

The effect of tonsillectomy on the morbidity from recurrent tonsillitis

“…The two additional questions were originally in the first phase of validation for the TOI 14 questionnaire. The TOI14 is being used to assess throat‐related quality of life in adults in NATTINA . The 16 items offer categorical response options graded 0 to 5 (5=most severe; 0=no problem), reflecting patients’ experience of symptoms over the previous 6 months.…”

“…Our team is contributing to the UK NAtional Trial of Tonsillectomy IN Adults (NATTINA), a nationally funded trial aiming to provide level one evidence for tonsillectomy. The randomised controlled trial in adults examining tonsillectomy vs medical treatment is currently recruiting patients in the UK, but results will not be available for some years …”

Is tonsillectomy recommended in adults with recurrent tonsillitis?

“…We found one multicentre randomised controlled trial that is currently recruiting patients and is expected to complete in 2019. The National Trial of Tonsillectomy In Adults in the UK (UKCRN ID 17530, www.NATTINA.com) 12 aims to assess the clinical and cost effectiveness of tonsillectomy compared with conservative management (deferred surgery) in 510 adult participants with recurrent tonsillitis. The primary outcome measure is the number of sore throat days over a 24 month period.…”