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

Dai 2014.

Study characteristics
Methods Non‐blinded, parallel‐group randomised controlled surgical trial with 3‐month duration of follow‐up
Participants Setting: general hospital, China
Sample size:
  • Number randomised: 57 children

  • Number completed: 57 children


Participant (baseline) characteristics:
  • Age: 2 to 12 years

  • Gender: 67% males, 33% females


Inclusion criteria: positive polysomnography for OSAHS (AHI > 5/hour and/or AI >1/hour, lowest oxygen saturation < 92%), adenoid hypertrophy (A/N ratio ≥ 0.71 on nasopharyngeal lateral radiographs), tonsil hypertrophy on physical exam (bilateral tonsils beyond velopharyngeal bow – Grade III), absence of CRS (paranasal sinus computed tomography)
Exclusion criteria: chronic sinusitis, allergic rhinitis, recurrent acute tonsillitis, chronic respiratory disease, nephritis, systemic allergic disease and URTI in 2 weeks prior to surgery
Interventions Intervention group: tonsillectomy (TE) by low‐temperature plasma radiofrequency ablation (n = 20)
Comparator group: tonsillotomy (TT) by low‐temperature plasma radiofrequency ablation (n = 37)
Use of additional interventions: not stated
Outcomes Short‐term outcomes (1 and 3 months): humoral immunity (serum levels of immunoglobulins A, G and M), cellular immunity (serum levels of T cells CD3+/CD4+/CD8+)
Notes Participants analysed: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly divided" – no method given
Allocation concealment (selection bias) Unclear risk Method not described
Blinding of participants and personnel (performance bias)
All outcomes High risk Not blinded
Blinding of outcome assessment (detection bias)
All outcomes High risk Not blinded
Incomplete outcome data (attrition bias)
All outcomes High risk Not clear if there was any loss of data due to no statement of data numbers analysed
Selective reporting (reporting bias) Unclear risk No protocol available; insufficient information to permit a judgement of low or high risk
Other bias High risk Baseline characteristics: not balanced for gender (M 67%:F 33%) or group size (35% TE:64% TT)
ITT analysis: performed
Formal sample size calculations: not performed
Use of co‐interventions: not stated across groups