Topic: Ear, nose and throat
Conditions
Interventions
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
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed