Methods

This manuscript has been prepared with reference to the STROBE checklist for observational studies.(11)
Ethical approval was obtained from the Southern Adelaide Clinical Human Research Ethics Committee (Project number 123.17, HREC reference: HREC/17/SAC/206, approved 31 July 2017). Participants were recruited consecutively from August 2017 to August 2018 during preadmission clinic or on the day of surgery. Parents provided written, informed consent.
An observational study was undertaken in paediatric patients placed on the elective surgical waiting list for a tonsillectomy in a public tertiary hospital in South Australia. Inclusion criteria included: age 2 – 16 years; undergoing a tonsillectomy with or without an adenoidectomy and/or grommet insertion as an elective procedure for sleep disordered breathing and/or recurrent tonsillitis.(12) Exclusion criteria comprised of: non-English speaking parents; undergoing an emergency procedure; undergoing tonsillectomy combined with additional procedure (excluding adenoidectomy/grommet insertion); cranio-facial anomalies – congenital or acquired; diagnosed with a neuromuscular disorder, a recognised congenital syndrome, a coagulation/bleeding disorder, and/or severe laryngomalacia; malignancy; tracheostomy in situ .
The T-14 Paediatric Throat Disorders Outcome Test was utilised to measure the patient’s symptoms and health-related QoL via parental reports.(13) This validated, sensitive tool was developed by Hopkins et al. in 2010 for use in the UK population and was adapted for use in the Australian population (Supplementary Material).(14) It is comprised of fourteen Likert-scale questions, with a total score calculated (range 0 – 70), where a higher score signifies greater burden of symptoms and lower health-related QoL (mean score of healthy controls is 0.78 [range 0 – 11]).(13) The T-14 also comprises of two sub-scores, with questions 1-6 totalling for an ‘obstruction’ symptom sub-score and questions 7-14 totalling for an ‘infection’ symptom sub-score.
Administration of the T-14 questionnaire to parents is part of the standard clinical process during the initial consultation clinic and responses were extracted from the patients’ medical chart. Whilst awaiting surgery, all patients received ongoing medical management from their primary care physician. The T-14 questionnaire was also administered on day of surgery, at 6 weeks post-operative (the standard timeframe for post-operative review at this institution as surgical recovery is assessed as completed), and at 6 months. T-14 questionnaires were administered either in person or via telephone call from an ENT doctor or member of the research team.
Data collected included: age; gender (male, female); surgical indication (SDB, RT, both); date of initial consultation, surgery, post-operative review, and 6-months follow-up; Brodsky Tonsil Grade (1 - 4, a scale to describe tonsil size)(15); surgical procedure (tonsillectomy, adenotonsillectomy, tonsillectomy & grommets, adenotonsillectomy & grommets); and T-14 scores (at initial consultation, at surgery, 6-weeks post-operatively, and 6-months post-operatively). T-14 total scores and sub-scores were calculated for each time point.