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. 2020 Apr 29;2020(4):CD011365. doi: 10.1002/14651858.CD011365.pub2

Borgstrom 2017.

Study characteristics
Methods Double‐blinded, parallel‐group randomised controlled non‐inferiority surgical trial with 1‐year duration of follow‐up
Participants Setting: Karolinska University Hospital, Stockholm, Sweden
Sample size:
  • Number randomised: 79 children

  • Number completed: 74 children


Participant (baseline) characteristics:
  • Age: 2 to 6 years

  • Gender: 67% boys, 23% girls


Inclusion criteria: age 2 to 6 years, history or symptoms of OSA, tonsil hypertrophy 3 or 4 (scale 1 to 4 according to Brodsky 11), Apnea Hypopnea Index (AHI) of ≥ 5 and ≤ 30 events/hour sleep
Exclusion criteria: craniofacial abnormality, neuromuscular disease, chromosomal abnormality, obesity (BMI z score > 1.67), previous adenotonsillar surgery, bleeding disorder, cardiopulmonary disease, history of recurrent tonsillitis and parents with insufficient knowledge of the Swedish language
Interventions Intervention group: tonsillectomy by cold steel dissection (TE) (n = 40)
Comparator group: intracapsular tonsillotomy by coblation (TT) (n = 39)
Use of additional interventions: concurrent adenoidectomy in all children
Outcomes Long‐term outcomes (1 year): postoperative complications, respiratory events during sleep (polysomnography), disease‐specific quality of life, general quality of life, reoperation rates
Notes Participants lost to follow‐up total: 6%
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Before study start, 90 sealed envelopes were randomly mixed, 45 for ATE and 45 for ATT, giving a 1:1 allocation ratio"
Allocation concealment (selection bias) Low risk Quote: "The envelopes were placed at the operating room and opened by the surgeon"
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "Only the surgeon and the staff in the operating room knew which surgical method was performed. The surgeon did not meet the patients or parents after surgery; they were discharged by another doctor the day after surgery."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "patients and care providers were blinded to intervention method, as was the technologist interpreting the PSGs"
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 6% (5/79) not included in the analysis
Selective reporting (reporting bias) Low risk Clinical Trial Registration #NCT01676181
Other bias Low risk Baseline characteristics: balanced
ITT analysis: performed
Formal sample size calculations: performed
Use of co‐interventions: balanced, all children received concurrent adenoidectomy