Fan 2014.
Study characteristics | ||
Methods |
Design: RCT, parallel 2‐arm, single‐site trial Setting: tertiary (university teaching hospital), Nanjing, China Recruitment: October 2011 to May 2013 Maximum follow‐up: in‐hospital stay |
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Participants | 192 randomised 186 participants analysed, 65 years of age or older, undergoing elective unilateral total hip replacement
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Interventions |
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Outcomes | Postoperative delirium, cerebrovascular accident, cardiac failure, myocardial infarction, pulmonary embolism, pneumonia, superficial wound infection, urinary tract infection, acute renal failure | |
Notes |
Trial registration: none ascertainable Trial funding: work was supported by grants from the National Natural Science Foundation of China (No. 81300946) and the Natural Science Foundation of Jiangsu Province (BK2012778) COI statement by investigators: "there is no conflict of interest to be stated" (Fan 2014 p 184) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were randomly assigned to the restrictive or liberal transfusion strategy group using a random number table and a sealed envelope technique" (Fan 2014 p 182) |
Allocation concealment (selection bias) | Low risk | "Patients were randomly assigned to the restrictive or liberal transfusion strategy group using a random number table and a sealed envelope technique" (Fan 2014 p 182) |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Blinding of personnel for this intervention was not feasible, but in our view, for objective outcomes such as mortality (the primary outcome used within this review), we graded risk of bias as 'low' |
Blinding of outcome assessment (detection bias) Objective measures | Low risk | Blinding of outcome assessment was not described. Blinding of mortality (the primary outcome used within this review) is not relevant, and we graded risk of bias as 'low'. We have also considered outcomes such as pneumonia, requiring radiological investigations as a hard outcome |
Blinding of outcome assessment (detection bias) Subjective measures | Low risk | Blinding of outcome assessment was not described for assessments of cognition and delirium. We considered risk of bias as low, given the structured assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 192 participants were randomised. Data were included for 94/96 in the restrictive group (2 excluded as declined transfusion). Data were included for 92/96 in the liberal group (4 excluded as declined transfusion) |
Selective reporting (reporting bias) | Low risk | No reporting bias was apparent, but in the absence of prospective registration or a trial protocol, assessment must remain 'unclear' |
Other bias | Low risk | No other bias was apparent. Study sample size might be considered small for the outcomes |