Jamalullah 2016.

Methods	Two‐arm, non‐blinded, parallel‐group, quasi‐randomised controlled trial, with 2‐week duration of treatment and follow‐up
Participants	Location: Pakistan, 1 site Setting of recruitment and treatment: Department of Otolaryngology, Pakistan Institute of Medical Sciences, Islamabad, September 2009 to March 2010 Sample size: 80 Number randomised: 40 in gentamycin, 40 in ofloxacin Number completed: 40 in gentamycin, 40 in ofloxacin Participant (baseline) characteristics: Age: 28.1 years (averages with SD given for males and females in each treatment group) Gender (F/M): 35 (43.8%)/45 (56.2%) Main diagnosis: tubotympanic type of CSOM High‐risk population: unclear Cleft palate (or other craniofacial malformation): not reported Down syndrome: not reported Indigenous groups (Australian Aboriginals/Greenland natives): not reported Immunocompromised: not reported Diagnosis method: Confirmation of perforated tympanic membrane: yes (otoscopic/microscopic examination) Presence of mucopurulent discharge: 100% At baseline Profuse otorrhoea: gentamycin: 67.5%, ofloxacin: 75% Moderate otorrhoea: gentamycin 32.5%, ofloxacin: 25% Duration of symptoms (discharge): more than 3 months Other important effect modifiers: Alternative diagnosis of ear discharge: polypoidal middle ear mucosa (gentamycin: 10%; ofloxacin: 27.5%) Number who have previously had grommets inserted: not reported Number who have had previous ear surgery: not reported Number who had previous antibiotic treatment for CSOM: not reported Inclusion criteria: Adult patients having central perforation of tympanic membrane and symptoms of ear discharge for more than 3 months and/or polypoidal/erythematous middle ear mucosa and they were not on any topical or systemic antibiotics one week prior to 1st visit Exclusion criteria: Features of atticoantral disease including attic perforation, cholesteatoma, polyps, having previous mastoid exploration, lactating mothers, diabetes mellitus and sensitivity to aminoglycosides or quinolones
Interventions	Intervention (n = 40): ofloxacin 0.6%, ear drops, 4 drops 3 times daily. Duration of treatment = 2 weeks. Comparator group (n = 40): gentamycin 0.3%, ear drops, 4 drops 3 times daily. Duration of treatment = 2 weeks. Concurrent treatment: aural toileting: "aural toilets or all the patients were done before initiating any therapy." No other information about additional treatments was given.
Outcomes	Outcomes of interest in the review: Primary outcomes: Resolution of ear discharge ("dry ear"), measured at between 2 to 4 weeks (2 weeks). Otoscopically confirmed. Secondary outcomes: Not reported
Funding sources	No information provided
Declarations of interest	No information provided
Notes	Unit of randomisation: person Methods for including patients with bilateral disease: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "This randomized controlled trial ..." Comment: no methods of sequence generation were described
Allocation concealment (selection bias)	Unclear risk	Comment: methods of allocation concealment were not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: no blinding of participants was attempted despite blinding being a possibility as both of the treatments were topical ear drops and the regimens were the same
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: the paper does not mention any attempts to blind the outcome assessors, despite this being feasible because the outcomes were the presence or absence of ear discharge
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: it appears that all of the patients who started the trial were included in the analysis. There was no mention of any participants being lost to follow‐up.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol for the paper was found on the WHO clinical trial database (ICTRP). The paper does not mention a protocol. The outcomes listed in the methods section are reported in the results section although there is a greater emphasis on subgroups relating to the severity of initial otorrhoea and type of mucosa (polypoidal or erythematous) in the results. It is unclear if these were pre‐determined subgroups or whether the results were analysed in this way post‐hoc.