Fan 2014.
Study characteristics | ||
Methods | Design: RCT Date of study: October 2011 to May 2013 Power calculation: no Inclusion criteria: patients older than 65 years undergoing elective unilateral total hip replacement surgery with spinal anaesthetic Exclusion criteria: ASA physical status 3 IV; preoperative delirium; unwilling to comply with the procedures; inability to understand the language (Mandarin Chinese); hearing loss, or a failure in spinal anaesthesia |
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Participants | Sample size:192 Country: China Setting: hospital inpatient – elective orthopaedics Age: mean age 73 (+/‐ 7) in the intervention group, 75 (+/‐ 6) in the control group Sex: male, 30, (31.9%) in the Intervention group, male, 32, (35.9%) in the control group Co‐morbidity: no baseline between‐group differences in CVD, IHD, CHF, hypertension, pulmonary disease, renal insufficiency, PVD, diabetes mellitus, liver disease. Dementia: not mentioned explicitly but cognitive assessment undertaken using MMSE Frailty: not reported |
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Interventions | Intervention: patients older than 65 years undergoing elective unilateral total hip replacement surgery with spinal anaesthetic. Control: ASA physical status 3 IV; preoperative delirium; unwilling to comply with the procedures; inability to understand the language (Mandarin Chinese); hearing loss, or a failure in spinal anaesthesia |
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Outcomes | Outcomes reported ‐ Incident delirium using the Confusion Assessment Method for the intensive care unit (CAM‐ICU) ‐ Length of stay ‐ Withdrawal Outcomes from study not reported: none Frequency of outcomes assessment: Delirium was assessed by the same attending anaesthesiologist between 8 a.m. and 9 a.m. preoperatively, and 1, 2, 3 days after surgery. |
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Notes | Funding source: this work was supported by the grants from the National Natural Science Foundation of China (No. 81300946) and the Natural Science Foundation of Jiangsu Province (BK2012778). Declarations of interest: no conflict of interest stated by authors Delirium excluded at enrolment using the (CAM‐ ICU) criteria (Chinese version) Imbalance between groups om other substances transfused – restrictive group received more Ringer’s lactate and hydroxyethyl starch |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly assigned to restrictive or liberal group using a random number table |
Allocation concealment (selection bias) | Unclear risk | The method used to was sealed envelope technique, however, there is insufficient detail as to whether these were opaque. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants or personnel described |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessments described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Clear accounting for all participants at follow‐up. Loss of 2 from restrictive and 4 from liberal transfusion groups at follow‐up due to declined consent for transfusion. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to assess as no published protocol |
Other bias | Low risk | No evidence of other bias |