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:
Participant (baseline) characteristics:
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 |
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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 |
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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 |