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? |
|
Steroid |
Placebo |
Unclear |
|
Steroid |
Placebo |
|
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 |