Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Patients consenting to enrolment were stratified by surgeon. Within strata, treatment regimens were assigned according to a randomization scheme containing variably sized, balanced blocks of treatment assignments |
Allocation concealment (selection bias) |
Low risk |
The evening before surgery, the JHH Investigational Pharmacy determined the participant's treatment assignment and prepared the masked study medications |
Blinding of participants and personnel (performance bias) |
Low risk |
Masked study medication delivered by the pharmacy |
Blinding of outcome assessment (detection bias) |
Low risk |
Masked study medication delivered by the pharmacy |
Incomplete outcome data (attrition bias) |
High risk |
Eight participants (two in each group) enrolled in the pilot study; their data have been added for mortality. For MI and pneumonia, the trial authors provided the data for participants who survived until hospital discharge |
Selective reporting (reporting bias) |
High risk |
MI and pneumonia among participants who did not survive until hospital discharge not provided. Presence/absence of complications related to the anaesthetic techniques not reported |
Other bias |
High risk |
Half the participants in the GA group (as remodelled for this overview) received postoperative epidural analgesia |