Type of bias | Criteria | WISP | O'Brien et al | COPE | COSMIC | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Selection | Method used to generate randomisation sequence? | 'Patients were allocated with minimisation to intervention using the programme MINIM v1.3' | 'Randomisation was performed by the clinical pharmacist who randomised an odd number dice roll to placebo and an even number dice roll to drug' | 'Randomisation was performed in blocks of six by computer generated allocation' | 'A randomisation schedule generated by the patient allocation for clinical trials (PACT) program' | ||||||
 | Method used to generate allocation concealment? | 'Inhalers were given an alphanumeric code to conceal allocation' | Inadequate | Unclear | Unclear | ||||||
Performance | Double-blinding? | 'Study nurses and regular clinicians were blind to allocation throughout the study' | 'The subject and pulmonary physician were blinded to the treatment regimen. Placebo and drug MDI canisters were identical, and the placebo mist was flavoured to make the treatments indistinguishable' | 'This study was a randomised, double-blind parallel-group single centre study...' | 'the study medication was packed in identical inhaler devices to ensure both the patient and investigator were unaware of the allocated treatment' | ||||||
Attrition | Loss of patients accounted for? | Â | Steroid | Placebo | Unclear | Â | Steroid | Placebo | Â | Steroid | Placebo |
 |  | Number randomised | 128 | 132 |  | Number randomised | 123 | 121 | Number randomised | 189 | 184 |
 |  | Number analysed | 128 | 132 |  | Number analysed | 122(1 died) | 120(1 died) | Number analysed | unclear | unclear |
Detection | Outcome assessor blind | Unclear | Unclear | Unclear | Unclear | ||||||
Reporting | Any evidence of reporting bias? | No | No | No | No |