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.