Maeder 1977.
Methods |
Study design: parallel RCT Recruitment: participants hospitalised for AMI October 1971‐ December 1972 Allocation: not reported Blinding: not reported Randomisation: random numbers table Follow‐up(s): 12 months, 4 years Description: participants in the intervention group encouraged to move and walk more in the weeks post‐MI |
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Participants |
Baseline characteristics Intervention group
Control group
Inclusion criteria
Exclusion criteria
Baseline imbalances: higher frequency of anamnestic angina in the early mobilisation group Recruitment methods: all participants < 70 years hospitalised for AMI were included in the study. Physically demanding work: blue‐collar Severity of CHD: less severe |
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Interventions |
Intervention characteristics Early mobilisation group
Control group
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Outcomes | Proportion at work (part‐/full‐time) at 6 months–12 months (medium term): 12 months Proportion at work at > 12 months to < 5 years (long term): 4 years Mean sick leave duration in months Depression‐ transient and prolonged (clinical information from attending physician) Adverse events (mortality, non‐fatal reinfarctions) |
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Identification |
Sponsorship source: not reported Country: Switzerland Setting: single centre: the Cantonal Hospital of Geneva; inpatient Possible conflicts of interest: no information provided Ethics committee approval: not reported |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using “random number tables in serial subgroups of six” |
Allocation concealment (selection bias) | Unclear risk | No allocation method was reported. |
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, and it is unclear how RTW was assessed. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | An ITT analysis was not conducted, and the study authors do not report if the attrition of study participants was evenly distributed across groups. Quantities of dropout cases (also in combination of the 2 studies) did not match with the combined numbers provided in the text. |
Selective reporting (reporting bias) | Unclear risk | Unable to determine, no study protocol was available |
Other bias | Unclear risk | None identified |