Horlick 1984.
Methods |
Study design: parallel RCT Recruitment: consecutive post‐MI patients Allocation: not reported Blinding: not reported Randomisation: no method described Follow‐up(s): 6 months Description: educational‐group discussion programme |
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Participants |
Baseline characteristics Intervention group
Control group
Inclusion criteria
Exclusion criteria: none Baseline imbalances: ‐ Physically demanding work: white‐collar Severity of CHD: unknown |
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Interventions |
Intervention
Control group
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Outcomes | Proportion at work at < 6 months (short term): 3 months Proportion at work at 6 months–12 months (medium term): 6 months Self‐developed personal adjustment questionnaires |
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Identification |
Sponsorship source: grant from the Saskatchewan Heart Foundation Country: Canada Setting: multi‐centred: three Saskatoon hospitals; in‐ and outpatient Possible conflicts of interest: no information provided Ethics committee approval: not reported |
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Notes | Number of participants returning to work calculated from percents given in text and number of study participants followed at 3 and 6 months. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Only the ratios of distribution to treatment versus control group over time are described, i.e. 3:1 and later 2.5:1. The method of sequence generation is not described. |
Allocation concealment (selection bias) | Unclear risk | No method of allocation concealment is described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to the nature of the intervention (outpatient educational group discussions), blinding of participants would not have been possible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No concealment of outcome assessors is described, and assessment of "intention to return to work or retire" was described as self‐reported. Information regarding RTW was also obtained from a physician's report, but it is unclear if the physicians were aware of their participant's group allocation. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The proportion of study participants lost to follow‐up was 12% in the control group and 22% in the Intervention group. |
Selective reporting (reporting bias) | Unclear risk | Unable to determine, no study protocol was available |
Other bias | Unclear risk | None identified |