Plain English Summary
Background and study aims
NATTINA is a clinical trial for adults with recurrent acute tonsillitis (inflammation of the tonsils) and is looking to establish the clinical and cost effectiveness of tonsillectomy (surgery to remove the tonsils) compared with conservative management (delayed surgery), which, through observation and statistical modelling of outcomes, will evaluate the impact of alternative sore throat patient pathways and develop future research. The study is split into 3 phases: feasibility, internal pilot and main trial. The feasibility study will explore patient, clinician and GP decision making of acute recurrent tonsillitis and will assess the practicality of the proposed NATTINA trial.
Who can participate?
Patients aged 16 years and over who have been referred to secondary care with recurrent acute tonsillitis.
What does the study involve?
The feasibility study involves in-depth interviews with tonsillitis patients, ENT staff and GPs which will explore patients’ willingness to be randomised, as well as clinician/GP willingness to randomly allocate or refer patients. Interviews will also investigate acceptability of the conservative management treatment group and collate the views and experiences of sore throat and its treatment. The NATTINA internal pilot and main trial involves the randomisation of participants to either tonsillectomy or conservative management. Participants will be followed up for 24 months, during which the patient submits weekly sore throat information, completes 6 monthly questionnaires and attends 2 clinic visits.
What are the possible benefits and risks of participating?
There may be no direct benefit for the patient but the information revealed from this study will help improve the treatment of people with recurrent acute tonsillitis. There are no risks associated with this study.
Where is the study run from?
Newcastle University (UK)
When is the study starting and how long is it expected to run for?
The feasibility study will start in July 2014, the internal pilot in December 2014 and the main trial commencing in June 2015. The study is expected to last until April 2020.
Who is funding the study?
NIHR Health Technology Assessment (HTA) Programme (UK)
Who is the main contact?
1. Nicola Goudie
nicola.goudie@newcastle.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Ms Nicola Goudie
ORCID ID
Contact details
Newcastle Clinical Trials Unit
1–4 Claremont Terrace
Newcastle University
Newcastle Upon Tyne
NE2 4AE
United Kingdom
0191 2087187
nicola.goudie@newcastle.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16972, HTA 12/146/06
Study information
Scientific title
The NAtional Trial of Tonsillectomy IN Adults: a clinical and cost effectiveness study
Acronym
NATTINA
Study hypothesis
The NATTINA feasibility study will use qualitative and cognitive interviews to assess the practicality of the planned NATTINA internal pilot and full scale randomised controlled trial and will address any key issues raised, as well as evaluate the recruitment process, design and delivery of usual care, the experiences and acceptability of the treatments, acceptibility of the questionnaire design and the outcome measures.
The NATTINA pilot and main trial will estimate treatment effectiveness based on number of sore throat episodes, sore throat severity, quality of life and number of primary/secondary healthcare interactions at baseline and throughout the patient’s 24 month follow-up, which will help to model future patient sore throat pathways and provide more accurate guidelines for tonsillectomy referral. The study will also consider socio-economic aspects and estimate the efficiency to the NHS and patients.
More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16972 and http://www.nets.nihr.ac.uk/projects/hta/1214606
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/123354/PRO-12-146-06.pdf
Ethics approval
Feasibility: 15/LO/1115; First MREC approval date 18/06/2014
NATTINA: 14/NE/1144; First MREC approval date 10/11/2014
Study design
Randomised controlled surgical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Available on the NATTINA website or upon request (contact details below)
Condition
Topic: Ear, nose and throat; Subtopic: Ear (all Subtopics); Disease: Ear, nose & throat
Intervention
Feasibility study:
Qualitative Interviews - participants will have an in-depth interview with a researcher
Follow Up Length: 5 month(s)
Main trial:
1. Conservative Management - usual care as normally treated by the patients themselves or the referring GP, comprising self-administered analgesia, +/- ad hoc primary care prescription of antibiotics. Patients are asked to defer surgery for up to 24 months, and reviewed at 12 months to assess their willingness to remain in conservative management arm
2. Immediate Tonsillectomy - immediate Tonsillectomy within 6-8 weeks of randomisation; Study Entry : Registration and One or More Randomisations
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
The number of sore throat days collected through weekly ‘returns’ from the participants over a period of 24 months will be the primary outcome measure. The data will allow comparison of tonsillectomy versus conservative management to determine the effectiveness in recurrent adult tonsillitis.
Secondary outcome measures
1. Responses on the Tonsil Outcome Inventory 14 and STAR data to measure frequency, severity, health and economic impact of any sore throat episodes experienced.
2. Quality-of-life as recorded by SF-12 at the end of study follow up
3. Quality of life using SF-6D scores derived from the SF-12 responses measured at baseline, throughout the study and during episodes of sore throat experienced
4. The number of adverse events, visits to the GP/walk-in clinic/A&E, prescriptions issued and additional interventions required as collected from GP records and other primary care linkage data.
5. Incremental cost per sore throat day avoided from the perspective of the NHS and patients over 24 months to measure the cost effectiveness
6. The views and experiences of patients and clinicians regarding tonsillectomy and conservative management and how patient experience may shape any future research required
Overall trial start date
08/07/2014
Overall trial end date
30/04/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 16 years and over
2. Recurrent sore throats which fulfil current SIGN guidance for elective tonsillectomy.
3. Subject has provided written informed consent for participation in the study prior to any study specific procedures
ENT staff for the feasibility study interviews must be ENT staff members at a participating site and likely to be involved in the proposed NATTINA trial.
There are no exclusion criteria for GPs for the feasibility study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
There will be 45 participants in the feasibility study, 72 in the internal pilot (over 6 months) and 528 in the main trial (18 month recruitment).
Participant exclusion criteria
1. Under 16 years of age
2. Previous tonsillectomy
3. Listed directly (i.e. added to waiting list without prior elective ENT outpatient appointment) during emergency admission (e.g. due to peritonsillar abscess/quinsy)
4. Primary sleep breathing disorder
5. Suspected malignancy
6. Tonsilloliths
7. Pregnant or breastfeeding
8. Bleeding diathesis
9. Therapeutic anticoagulation
10. Inability to complete self-reported questionnaires and sore throat returns
There are no exclusion criteria for GPs or ENT staff for the feasibility study.
Recruitment start date
08/07/2014
Recruitment end date
30/04/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle Clinical Trials Unit
Institute of Health and Society
Newcastle University
4th Floor William Leech Building
Newcastle Upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
It is planned to publish this study in peer review articles and to present data at national and international meetings. Results of the study will also be reported to the Sponsor and Funder, and will be available on their website.
A lay summary of the study results will be made available to the participants on the NATTINA website at the end of the study.
ITP sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/10/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26047934