WHO 1983.
Methods |
Study design: multi‐centre, RCT Recruitment: 24 centres; hospitalised AMI patients from June 1973‐October 1975 Allocation: not reported Blinding: not reported Randomisation: random numbers table (some centres applied cluster‐randomisation or a non‐randomised control group) Follow‐up(s): 3, 6, 12 months, 2 and 3 years Description: combined rehabilitation programme |
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Participants |
Baseline characteristics Intervention group (rehabilitation)
Control group
Inclusion criteria
Exclusion criteria ‐ Baseline imbalances: ‐ Physically demanding work: unknown Severity of CHD: severe |
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Interventions |
Intervention characteristics
Control group
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Outcomes | Proportion at work at < 6 months (short term): 3 months Proportion at work at 6–12 months (medium term): 12 months Proportion at work at > 12 months to < 5 years (long term): 3 years Adverse events (mortality, reinfarctions, non‐fatal reinfarctions) |
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Identification |
Sponsorship source: WHO Country: international Setting: ‐ Possible conflicts of interest: no information provided Ethics committee approval: not reported |
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Notes | The results of the individual centres were often published separately and the number of people included in the RTW results were not reported, therefore this study is not included in the meta‐analyses. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Although the study protocol called for the randomisation of participants according to random number tables, some study centres applied cluster‐randomisation or a selected a non‐randomised control group (i.e. control hospital). Also the study authors write, "Only 12 centres out of the 24 seemed to have achieved proper randomisation in their groups of R and C patients". |
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 | None described |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "By 1 April 1970 data on follow‐up over a three‐year period were available for about 78% of all patients initially enrolled in the study." Overall 22% loss to follow‐up |
Selective reporting (reporting bias) | Low risk | All of the results' proposed analyses seem to have been reported. |
Other bias | Unclear risk | None identified |