Vermeulen 1988.
Methods |
Study design: parallel RCT Recruitment: hospitalised for AMI during the period January 1971‐May 1975 Allocation: not reported Blinding: not reported Randomisation: no method described Follow‐up(s): 12 months Description: combined outpatient rehabilitation programme |
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Participants |
Baseline characteristics Intervention group
Control group
Inclusion criteria
Exclusion criteria
Baseline imbalances: ‐ Physically demanding work: blue‐collar Severity of CHD: less severe |
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Interventions |
Intervention characteristics Rehabilitation interventions consisted of physical training, social counselling, group meetings and, when necessary, individual psychological advice
Control group
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Outcomes | Proportion at work at 6– 12 months (medium term): 12 months Adverse events (mortality, reinfarction) |
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Identification |
Sponsorship source: no information provided Country: The Netherlands Setting: single‐centred, outpatient: Revalidatie Instituut Muiderpoort Possible conflicts of interest: no information provided Ethics committee approval: not reported |
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Notes | The proportion of blue‐collar workers returning to work was lower but the difference was not statistically significant. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...the patients were randomly assigned to either a control group (N = 47) or a rehabilitation group (N = 51)." No further information given |
Allocation concealment (selection bias) | Unclear risk | None described |
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 | Not reported, and unclear how RTW was assessed (questionnaire or register) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss‐to‐follow‐up reported. RTW results at 1‐year follow‐up describe 85 participants. Examination of exercise tolerance at 5‐year follow‐up according to working status describes 89 participants |
Selective reporting (reporting bias) | Low risk | No study protocol was available. However, the results were not statistically significant, and little differences were observed regarding RTW between the intervention and control group |
Other bias | Unclear risk | None identified |