Johnson 1992.
Study characteristics | ||
Methods |
Design: RCT, parallel 2‐arm, single‐centre trial Setting: university teaching hospital, Boston (USA) Recruitment: not specified Maximum follow‐up: in‐hospital stay |
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Participants | 39 autologous blood donors undergoing elective myocardial revascularisation were randomised to 1 of 2 groups:
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Interventions |
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Outcomes | Cardiac events, complications, postoperative blood loss, blood use (total units), allogeneic blood use (units), autologous blood use (units), all product blood use (units), number of participants receiving transfusions, mean cardiac index, mean systemic resistance, exercise capacity, Hct levels, length of ICU stay, length of hospital stay 5 days after surgery, all participants were asked to complete an exercise treadmill test. A second test was performed the following day |
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Notes | Funding not stated Trial registration: none ascertainable Trial funding: none specified for the trial, but 1 investigator was supported in part by Transfusion Medicine Academic Award K07HL02033 from the National Institutes of Health (Johnson 1992 p 307) COI statement by investigators: none appears in the publication |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "All patients giving informed consent were randomized (with the aid of a table of random numbers and an odd‐even [conservative strategy‐liberal strategy] designation) to one of two postoperative transfusion strategies" (Johnson 1992 p 308) |
Allocation concealment (selection bias) | Unclear risk | It is unclear if assignment was concealed before randomisation |
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' Surgeons and anaesthesiologists were said to be blinded to the group of randomisation until the participant reached the ICU |
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 (detection bias) Subjective measures | High risk | No data from subjective outcomes (e.g. function). Exercise tolerance was assessed and reported, and risk of bias is considered unclear without more information on the assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Data were complete for 38/39 participants (18/18 in the liberal group; 20/21 in the restrictive group)" |
Selective reporting (reporting bias) | Unclear 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 biases were apparent |