Carson 2011.
Methods | Randomised, unblinded, parallel, 2‐group, multicentre trial | |
Participants | Participants aged 50 years or older, who were undergoing surgical repair of a hip fracture, with Hb concentrations below 10.0 g/dL within 3 days after surgery and who had clinical evidence of cardiovascular disease or cardiovascular risk factors Sample size = 2016 |
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Interventions |
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Outcomes | The primary outcome was inability to walk 10 feet (or across a room) without human assistance or death prior to closure of the window for 60‐day mortality. Other outcomes were Hb concentration, acute coronary syndrome (ACS), in‐hospital myocardial infarction, unstable angina or death, disposition on discharge, survival, functional measures, fatigue/energy, readmission to hospital, pneumonia, wound infection, thromboembolism, stroke or transient ischaemic attack, cognition (Gruber‐Baldini), mortality at 30 days, and long‐term mortality (Carson 2014). | |
Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Data co‐ordinating centre staff prepared randomisation schedules for each site using randomly ordered block sizes of 2, 4, 6, or 8. |
Allocation concealment (selection bias) | Low risk | The trial used an automated telephone randomisation system. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | After random allocation, clinical site staff, clinicians, and participants were not blinded to treatment assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The primary and secondary outcomes were assessed blinded to treatment assignment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There was nearly complete reporting data for primary outcomes and most secondary outcomes. |
Selective reporting (reporting bias) | Low risk | There was complete reporting. |
Other bias | Low risk | No other biases identified. |