Rahe 1979.
Methods |
Study design: parallel RCT Recruitment: October 1971‐June 1972 (January‐July1973 17 additional post‐MI patients were referred for treatment) Allocation: not reported Blinding: not reported Randomisation: no method described Follow‐up(s): 18 months, 3‐4 years Description: a randomised treatment group and a non‐randomised group of volunteers (not included in the meta‐analysis) received group therapy |
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Participants |
Baseline characteristics Intervention group 1 (randomised)
Intervention group 2 (non‐randomised volunteers, not included in the analysis)
Control group (CG)
Inclusion criteria
Exclusion criteria: not reported Baseline imbalances: average age: intervention group 1 50.9 years; control group 55.2 years 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): 6, 12 months Participants working full‐time after > 12 months to < 5 years: 4 years Clinical anxiety (general and cardiac‐specific) Adverse events (mortality, reinfarction, bypass) |
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Identification |
Sponsorship source: by the Naval Medical Research and Development Command, Department of the Navy, under Research Work Unit ZF 51.524.002.‐5020 Country: USA Setting: Naval Regional Medical Centre/US Naval Hospital 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) | Unclear risk | Quote: "Twenty‐two patients were randomly assigned to the treatment group and 22 to the control group." No further information provided |
Allocation concealment (selection bias) | High risk | No allocation concealment was described, and the study authors report that, "17 additional post‐MI patients who met the research criteria were referred for treatment." Although these participants should have been randomly allocated to the study arms, the study authors explain that these participants joined the study expecting the intervention (and examined as a separate treatment group). The results of these non‐randomised people are nevertheless excluded from the quantitative synthesis of results. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to the nature of the intervention (group therapy), blinding of participants and personnel would not have been possible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding of outcome assessors is described, and it is unclear how exactly RTW was assessed. The study authors state that standardised interviews and research questionnaires were used at the follow‐ups. However, no validated questionnaire or validation with independent (unbiased) occupational records is described. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Loss to follow‐up was low across all groups. Three people died before the 3‐4‐year follow‐up, but the study authors do not describe to which of the three study groups these participants were allocated. |
Selective reporting (reporting bias) | Unclear risk | Although the study authors do mention a study protocol, it does not appear to have been published. |
Other bias | Unclear risk | None identified |