Fokkema 2009.
Methods | Date of publication: 2009 Design: not reported Allocation: randomised Country: Netherlands | |
Participants | Diagnosis: acute STEMI for PPCI Number: 448 (adenosine 226; control 222) Age, years: adenosine (mean 62.4 ± 12.2); control (mean 62.5 ± 13.0) Sex: 75% men Inclusion: chest pain suggestive of myocardial ischaemia for at least 30 minutes; time from onset of symptoms of 12 hours before hospital admission; and ECG showing ST‐segment elevation of 0.1 mV in 2 or more leads Exclusion: cardiogenic shock; presence of a life‐threatening disease with a life expectancy of 6 months; receiving pharmacotherapy for chronic obstructive pulmonary disease; no informed consent Withdrawals or losses to follow‐up: not reported |
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Interventions | Adenosine
Control
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Outcomes |
Follow‐up: 30 days (collected from hospital records, written questionnaires and telephone interviews) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, no further description |
Allocation concealment (selection bias) | High risk | "a single‐center, prospective randomized open trial with blinded evaluation of end points" |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Coronary angiograms were reviewed by 2 observers blinded for treatment allocation and clinical data" "QuBE was measured blinded to clinical data and treatment allocation by 2 observers" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No withdrawals or drop‐outs were reported, but for some outcomes not all participant data were addressed, with no reason given. Missing outcome data were balanced across groups |
Selective reporting (reporting bias) | Low risk | All outcomes stated in Methods are reported in Results |
Other bias | Low risk | Not obvious |