Aitken 1992.
Methods |
|
|
Participants |
|
|
Interventions | Treatment group 1
Treatment group 2
Control group
|
|
Outcomes |
|
|
Notes |
|
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study was described as randomised, method of randomisation was not reported |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Study described as "double‐blind"; insufficient information to permit judgement |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement |
Incomplete outcome data (attrition bias) All outcomes | High risk | 67 patients were randomised, of which 63 patients were included in the patient data table. Six patients were withdrawn from the study after 24 or 48 h of treatment due to equipment failure or on patient's request. No data on randomisation of the withdrawn patients. Of remaining 61 patients there is missing data from 15 patients, probably equally distributed amongst the intervention and placebo groups. |
Selective reporting (reporting bias) | Low risk | Study protocol matches outcomes presented |
Other bias | High risk | A commercial funding source was used for this study |