Bengtsson 1983.
Methods |
Study design: parallel RCT Recruitment: October 1973‐January 1975 Allocation: no information provided Blinding: not reported Randomisation: “…allocated at random"; no further information provided Follow‐up(s): 8‐19 months (average 14 months) Description: combined rehabilitation programme with recommendations for work modifications |
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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: severe (severe cardiac failure excluded, angina not excluded) |
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Interventions |
Intervention characteristics Rehabilitation programme
Control group
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Outcomes | Proportion at work at > 12 months to < 5 years (long term): about 13.5 months Working status ascertained at follow‐up examination between 8 and 19 months Mean sick leave (days) Minnesotal Multiphasic Personality Inventory Adverse events (mortality, reinfarction) |
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Identification |
Sponsorship source: none reported Country: Sweden Setting: single‐centre; outpatient Possible conflicts of interest: no information provided Ethics committee approval: no information provided regarding patient consent or ethics committee approval |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “…allocated at random to either the rehabilitation (81) or the control (90) group…” No further information provided |
Allocation concealment (selection bias) | Unclear risk | No information regarding allocation concealment 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 | Neither blinding of outcome assessors, nor how work status was assessed was reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The study authors attempted an intention‐to‐treat analysis. Quote: “Seven who were invited to take part [in the treatment programme] declined; 6 of these were seen at follow‐up examination, and were included in the rehabilitation group because the control group probably also comprised a comparable number of patients who would no doubt also have declined further treatment.” However the impact of adverse effects was not assessed. Quote: “Those patients who developed a new infarction during the investigation period were excluded, because the follow‐up interview was focused on experiences of MI at time of entry to the study.” |
Selective reporting (reporting bias) | Unclear risk | Unable to determine, no study protocol available |
Other bias | Unclear risk | None identified |