Bush 1997.
Study characteristics | ||
Methods |
Design: RCT, parallel 2‐arm, single‐site trial Setting: university teaching hospital, Sacramento CA, USA Recruitment: August 1995 to November 1996 Maximum follow‐up: in‐hospital stay |
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Participants | 99 participants undergoing elective aortic or infrainguinal arterial reconstruction were randomised to 1 of 2 groups:
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Interventions |
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Outcomes |
Primary endpoints: myocardial ischaemia, myocardial infarction, death during hospitalisation Secondary endpoints: length of ICU stay, hospital stay, graft patency |
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Notes |
Trial registration: none confirmed Trial funding: not reported COI statement by investigators: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Sealed envelopes were chosen at random for participant assignment" (Bush 1997 p 144) |
Allocation concealment (selection bias) | Low risk | Sealed envelopes were chosen at random for participant assignment |
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 have graded risk of bias as 'low' |
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 | Low risk | No data on subjective outcomes (e.g. function) Review authors' judgement: low risk of bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data appeared to be complete |
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 identified |