Bertie 1992.
Methods |
Study design: parallel RCT Recruitment: patients who were admitted to a single centre after AMI Allocation: not reported Blinding: not reported Randomisation: no information provided Follow‐up(s): after rehabilitation, 4 months, 1‐2 years Description: combined rehabilitation programme |
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Participants |
Baseline characteristics Intervention group
Control group
Inclusion criteria: ‐ Exclusion criteria
Baseline imbalances: ‐ Physically demanding work (i.e. white‐ vs blue‐collar): unknown Severity of CHD: less severe (patients with uncontrolled heart failure excluded) |
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Interventions |
Intervention characteristics
Control group
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Outcomes | Proportion at work at < 6 months (short term): 4 months Proportion at work at > 12 months to < 5 years (long term): 1‐2 years Well‐being and anxiety about health Adverse events (mortality, MI) |
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Identification |
Sponsorship source: The British Heart Foundation and the Chest, Heart and Stroke Association Country: UK Setting: single centre: the Plymouth cardiac care unit Possible conflicts of interest: no information provided Ethics committee approval: no information provided |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “On their final hospital day, 110 patients who had suffered acute myocardial infarction and had been admitted to the Plymouth coronary care unit were randomised into two groups…”. No further information provided |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to the nature of the study, blinding of participants was not possible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | None reported. Employment status was assessed with a questionnaire filled out by the study participants (with help from a physiotherapist if necessary). Study participants were aware of their group allocation, which could have affected reporting. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: “Patients were withdrawn from the study because of death, increasing angina, coronary artery surgery, reinfarction at their own request, and failure to complete assessments 2 or 4.” No ITT analysis was conducted; however, attrition: 28% of controls and 25% of exercise group was similar. |
Selective reporting (reporting bias) | Unclear risk | Unable to determine, no study protocol was available |
Other bias | Unclear risk | None identified |