Li 2013.
Study characteristics | ||
Methods | Non‐blinded, parallel‐group randomised controlled surgical trial with 6‐month duration of follow‐up | |
Participants |
Setting: Center Hospital Dalian, China Sample size:
Participant (baseline) characteristics:
Inclusion criteria: diagnosis of OSAHS according to the Urumqi 2007 criteria produced by the Chinese Otolaryngology Research Team Exclusion criteria: not stated |
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Interventions |
Intervention group: tonsillectomy (TE) using coblation (n = 80) Comparator group: tonsillotomy (TT) using coblation (n = 80) Use of additional interventions: concurrent adenoidectomy in all participants |
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Outcomes |
Short‐term outcomes (1 week and 3 months): sleep monitoring results (looking at snoring/apnoea, lowest oxygen saturation and mean oxygen saturation), postoperative pain according to VAS and therapeutic effects (e.g. postoperative bleeding) Medium‐term outcomes (6 months): recurrence of oSDB symptoms |
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Notes | Participants lost to medium‐term follow‐up (6 months) total: 8% (10% TE, 6% TT) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described |
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 | 8% patients lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | No protocol available; insufficient information to permit a judgement of low or high risk |
Other bias | Unclear risk | Participant base characteristics: balanced Formal sample size calculations: not performed ITT analysis: unclear Use of co‐interventions: similar across groups (concurrent adenoidectomy performed in 100% TE, 100% TT) |