D'Eredita 2006.

Study characteristics
Methods	2‐arm, parallel group, non‐blinded, single‐centre, non‐blinded RCT with 12 months follow‐up Randomised by child
Participants	Location: Italy, single centre Setting of recruitment and treatment: Division of Paediatric Otolaryngology, in a tertiary paediatric care institution Study dates: January 2001 to January 2003 Sample size: Number randomised: 30 (15 in VT group, 15 in laser myringotomy group) Number completed: 30 (15 in VT group, 15 in laser myringotomy group) Participant (baseline) characteristics: Age (years): Ventilation tubes (VT): 3.6 (range 2 to 6) Laser myringotomy (LM): 3.8 (range 2 to 6) Gender: VT males 8/15 (53%), females 7/15 (47%) LM males 8/15 (53%), females 7/15 (47%) Inclusion criteria: OME for at least 3 months duration Exclusion criteria: A history of prior middle ear surgery or pressure equalising tube insertion Down or other syndrome involving the head and neck Cleft palate or previous pharyngeal surgery Mental retardation or other known cognitive or psychiatric disorder
Interventions	VT group: cold myringotomy, middle ear secretions were suctioned and a Teflon Shah tube inserted Laser myringotomy: laser myringotomy using diode laser, then middle ear secretions suctioned. Laser settings were 2 W power, 0.5 second pulse duration, with 5 pulses in the contact mode used with 600 mm thick fibre, which tapers to a 300 mm tip. Use of additional interventions: Following VT or LM, "middle ear secretions were suctioned. Ofloxacin 0.3% otic solution (Floxin otic1, Daiichi Pharmaceutical Corp., Montvale, NJ) was then instilled in each ear, and was prescribed for use at home thrice daily for 5 days."
Outcomes	Hearing returned to normal No definition of normal hearing was provided Persistent perforation Otorrhoea
Funding sources	Not reported
Declarations of interest	Not reported
Notes	Research integrity checklist: No retraction notices identified Prospective registration not applicable (published before 2010) Baseline characteristics show identical numbers of males/females No loss to follow‐up was reported Hearing was assessed as normal in all children at follow‐up, which may be implausible The number randomised to each group was identical, and no information on how randomisation was performed
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Thirty children ... with OME for at least 3 months duration were randomized into study (CDLM) and control (M&T) groups." No details provided.
Allocation concealment (selection bias)	Unclear risk	No details provided.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of participants and personnel is not reported. There is a strong possibility that participants and personnel could identify which treatment a participant received and hence change their behaviour as a result.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details provided.
Incomplete outcome data (attrition bias) All outcomes	Low risk	The only missing data seems to be one of 60 parent‐completed questionnaires. No children were lost to follow‐up.
Selective reporting (reporting bias)	High risk	"Patients were scheduled for post‐operative office evaluation at day 10, 20, 30, 40, 60 and 80, and then at month 3, 4, 5, 6, 8, and 12. During each visit, myringotomy patency and tube status were assessed ….. All patients underwent a post‐operative age‐appropriate audiometric evaluation with tympanometry at month 6, and then again at 1‐year follow‐up." No protocol is available. The main outcome of middle ear ventilation is presented graphically. However, data presented in the text are sparse. Few outcome data are presented for tympanometry and audiometric testing at 6 and 12 months.
Other bias	Unclear risk	No details given as to how potential participants were identified for the study. The instructions given to parents on completing the questionnaire, the validity of the questionnaire and the reliability of outcome assessments were not reported. The risk of detection bias is therefore unclear.