Oldridge 1991.
Methods |
Study design: parallel RCT Recruitment: all patients admitted with a diagnosis of AMI to any 1 of 6 local hospitals Allocation: not reported Blinding: investigators were not blinded to allocation; blinding of participants it is not described Randomisation: not described Follow‐up(s): 2, 4, 8 and 12 months Description: combined outpatient rehabilitation programme |
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Participants |
Baseline characteristics Intervention group
Control group
Inclusion criteria AMI patient Exclusion criteria
Baseline imbalances: ‐ Physically demanding work: unknown Severity of CHD: less severe |
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Interventions |
Intervention characteristics
Control group
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Outcomes | Proportion at work at 6–12 months (medium term): 12 months QoL after AMI questionnaire (self‐developed), quality of well‐being questionnaire Adverse events (mortality) |
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Identification |
Sponsorship source: Grant 6606‐2724‐44 from the National Health Research and Development Programme, Health and Welfare, Canada Country: USA Setting: single‐centre: the Health Sciences Centre; the intervention sessions were held in a hospital gymnasium; outpatient Possible conflicts of interest: no information provided Ethics committee approval: ethics committees of the University and each hospital |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | It is not clear how the allocation sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | The study authors report that participants received the next available study number with the associated group allocation. It is unclear if this method is sufficient to prevent bias. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to the nature of the intervention (supervised exercise, cognitive behavioral intervention), blinding of participants would not have been possible. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Another possible limitation to the present study is that the investigators were not blinded to allocation, although such bias would be expected to favour the rehabilitation group." Quote: "Mortality and work status were monitored throughout the study." ‐ unclear how this was done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | A low number of study participants were lost to follow‐up. The number of study participants who died during the follow‐up period was also similar in both study arms (intervention n = 3, control group n = 4). |
Selective reporting (reporting bias) | Unclear risk | Unable to determine, no study protocol was available |
Other bias | Unclear risk | None identified |