Tao 2020.
Study characteristics | ||
Methods | 2‐arm, randomised, parallel‐group, open, controlled trial with 12 months of follow‐up Randomised by child |
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Participants |
Location: China, single centre Setting of recruitment and treatment: ENT Department, Guangzhou Women and Children's Medical Center Study dates: January 2016 to June 2018 Sample size:
Participant (baseline) characteristics: Age (years): VT plus adenoidectomy mean 7.0 (SD 1.9) years; LM plus adenoidectomy mean 7.2 (SD 2.4) years Gender: VT males 42/87 (48%), females 45/87 (52%); LM males 42/82 (51%), females 40/82 (49%) Inclusion criteria:
Exclusion criteria:
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Interventions |
Ventilation tube:
Myringotomy:
Interventions administered to both groups:
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Outcomes | Persistent perforation Persistence of OME ‐ these data were not used in the review, as data were only reported for one group at 3 months follow‐up, and data from later time points will be affected by the use of different additional treatments in each arm. Adverse events |
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Funding sources | Not reported | |
Declarations of interest | — | |
Notes |
Research integrity checklist: No retraction notices or expressions of concern were noted No prospective trial registration was identified Baseline characteristics were not excessively similar between the two groups Plausible loss to follow‐up was reported No implausible results were found Different numbers of participants were allocated to each group |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “All patients were randomly divided into two groups, namely Group A and B, according to the sequence generated by a computer program when they were admitted to the hospital.” |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to assess. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | There was no report of blinding. Blinding of patients and personnel may not have been feasible for operative interventions. However, lack of blinding could influence outcomes. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | There was no report of blinding. Blinding of patients and personnel may not have been feasible for operative interventions. However, lack of blinding could influence outcome interpretation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low attrition rate. |
Selective reporting (reporting bias) | Unclear risk | No protocol was available to assess. |
Other bias | Unclear risk | Insufficient detail in the report to assess whether an important risk of bias exists. |