Parker 2013.
Study characteristics | ||
Methods |
Design: RCT, parallel 2‐arm, single‐site trial Setting: general hospital, Peterborough, UK Recruitment: not stated in paper; ISRCT states trial ran from 2002 to 2012 Maximum follow‐up: 12 months |
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Participants | 200 participants 60 years of age or older with hip fracture whose postoperative Hb on postoperative day 1 or 2 was 8.0 g/dL to 9.5 g/dL
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Interventions | Participants had postoperative Hb in a prescribed range (8.0 g/dL to 9.5 g/dL)
For the purposes of this review, the trial author's definitions of 'transfusion' group = liberal, and 'no transfusion' or 'symptomatic' = restrictive
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Outcomes | Mobility, mental agility, physical status using American Society of Anesthesiologists grades | |
Notes |
Trial registration (not prospective): ISRCTN61328173 Trial funding: "there was no external funding for this study" (Parker 2013 p 1918) COI statement by investigators: "the author does not have any conflict of interest with this article" (Parker 2013 p 1918) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomisation was undertaken using numbered, sealed, opaque envelopes that were prepared before the start of the study" |
Allocation concealment (selection bias) | Low risk | Trial used opaque numbered envelopes |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Blinding of personnel for this intervention is 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 participants and personnel was not addressed |
Blinding of outcome assessment (detection bias) Objective measures | Low risk | Blinding of mortality (the primary outcome used within this review) is not relevant, and we graded risk of bias as 'low' Blinding of outcome assessment was not addressed |
Blinding of outcome assessment (detection bias) Subjective measures | High risk | Blinding of outcome assessor was not addressed for mobility |
Incomplete outcome data (attrition bias) All outcomes | High risk | Mobility score was missing for 94 of 200 participants |
Selective reporting (reporting bias) | Unclear risk | No reporting bias was apparent; however, trial was retrospectively registered (ISRCTN61328173), and in the absence of a protocol, assessment must remain 'unclear' |
Other bias | Low risk | No other biases were apparent |