Boshkov 2006.
Methods | Design: Parallel group RCT Country: USA Multicentre study: Yes (three centre trial) Setting: Hospital Follow‐up: 2 to 12 months Unit of allocation: Patients Unit of analysis: Patients |
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Participants | Inclusion criteria:
Exclusion criteria: Not reported in the abstract
Prestorage leukoreduced RBC (LR‐RBCs): The number of patients is not clearly reported in the abstract. Standard RBCs (S‐RBCs): The number of patients is not clearly reported in the abstract.
Main characteristics of patients: "Groups were statistically equivalent demographically and by all Society of Thoracic Surgery risk criteria". |
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Interventions |
Co‐intervention: not reported in the abstract |
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Outcomes | Primary:
Secondary: Not reported in the abstract. |
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Notes | Trial registration: Not reported in the abstract Funding: Not reported in the abstract Role of sponsor: Not reported in the abstract A priori sample size estimation: Not reported in the abstract Conducted: Not reported in the abstract Declared conflicts of interest: "No relevant conflicts of interest to declare" (reported in the abstract) Other relevant information: All study characteristics were obtained from the abstract. We tried to contact two trial authors by email, but no response has not yet been obtained |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients (undergoing coronary artery bypass grafting, cardiac valve replacement, or a combination of the two) were pre‐operatively randomised to receive either LR‐ or S‐RBCs (Abstract). Insufficient information to permit judgement of ‘low risk’ or ‘high risk’. |
Allocation concealment (selection bias) | Unclear risk | Comment: Insufficient information to permit judgement of ‘low risk’ or ‘high risk’. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "Patients and clinicians were blinded as to product type" (Abstract). The blinding methods are not clearly reported. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Patients and clinicians were blinded as to product type" (Abstract). Comments: No blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "562 patients (45.8%) were transfused: 304 received LR‐RBCs and 258 S‐RBCs" (Abstract) Loss after transfusion: Not reported in the abstract Loss after transfusion LR group: Not reported in the abstract Loss after transfusion Control group: Not reported in the abstract Loss after transfusion. Imbalance between comparison groups: Not reported in the abstract. Comment: Insufficient reporting of attrition/exclusions to permit judgement of ‘low risk’ or ‘high risk’ (e.g. number randomised not stated, no reasons for missing data provided). |
Selective reporting (reporting bias) | Unclear risk | Comment: Insufficient information to permit judgement of ‘low risk’ or ‘high risk’ (Abstract data). |
Other bias | High risk | Design bias: 1226 patients randomised; only 562 (45.8) were transfused. |