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:
Participant (baseline) characteristics:
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 |
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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 |
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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 |