Asmatullah 2014.
Methods | Two‐arm, non‐blinded, parallel‐group RCT, with 10 days duration of treatment and 2‐week duration of follow‐up | |
Participants |
Location: Pakistan, 1 site Setting of recruitment and treatment: ENT Department, Hayatabad Medical Complex, Peshawar, January to July 2012 Sample size: 134
Participant (baseline) characteristics:
Inclusion criteria:
Exclusion criteria:
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Interventions |
Intervention (n = 67): gentamycin 0.3% ear drops, 4 drops 3 times daily, treatment continued for 10 days Comparator group (n = 67): ofloxacin 0.3% ear drops, 4 drops 3 times daily, treatment continued for 10 days Concurrent treatment: none listed. No aural toileting methods mentioned. |
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Outcomes |
Outcomes of interest in the review: Primary outcomes:
Secondary outcomes:
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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 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "All patients were allocated into two groups by randomization done by lottery method." Comment: not enough information to know whether this method was sufficient to generate a sufficiently randomised sequence |
Allocation concealment (selection bias) | Unclear risk | Comment: no methods regarding allocation concealment were reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: there is no mention of blinding for any of the outcomes despite the ability to blind the trial (same treatment regimen) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: there is no mention of blinding the treatment outcome. There may have been bias when judging the marginal cases such as the boundary between 'mild' and 'no' discharge. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: the description of patient allocation is not clear within the paper. Although the paper does not appear to have lost patients to follow‐up, there is no clear statement of this. It is unclear whether only patients included in the outcome were reported. |
Selective reporting (reporting bias) | High risk | Comment: no trial protocol was mentioned in the paper or found on the clinicaltrials.gov website. The levels of discharge were not well defined in the methods section. In addition, there was no defined measuring or indeed mention of adverse events anywhere within the paper. |