Pollak 1993.
Methods |
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Participants | Inclusion criteria
Exclusion criteria
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Interventions |
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Outcomes |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Authors report use of computer‐generated assignment schedule |
Allocation concealment (selection bias) | Low risk | Study reported that the only randomisation master code was held by the Bristol‐Myers Company. No investigator had access to randomisation codes until study termination |
Blinding (performance bias and detection bias) All outcomes | Low risk | Study reported double blinding. "No investigator had access to the code until the study was terminated." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information regarding completeness of follow‐up reported, no information regarding the conduct of analyses based on the intention‐to‐treat principle |
Selective reporting (reporting bias) | High risk | Study reported in the methods that routine "serum chemistry, cyclosporine blood levels, and hematology" were collected, however, these were not reported in the results |
Other bias | High risk | Study reported early termination by the monitor citing that it was "unlikely that a benefit would be shown for rh‐SOD by the addition of 84 extra subjects" Bristol‐Myers Squibb Company supported the study and provided the recombinant SOD. Bristol‐Myers Company held the only master code. |