Geissler 1979.
Methods |
Study design: parallel RCT Recruitment: MI patients surviving the first phase of rehabilitation (in‐hospital treatment) in one East German district; June 1973‐June 1975 Allocation: not reported Blinding: not reported Randomisation: cluster‐randomisation according to hospital region Follow‐up(s): 6 months, 12 months, 2 years Description: combined rehabilitation with an inpatient and outpatient phase |
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Participants |
Baseline characteristics Intervention group
Control group
Inclusion criteria < 70 years of age at the time of the MI Exclusion criteria ‐ Baseline imbalances: ‐ Physically demanding work (i.e. white vs. blue collar): unknown Severity of CHD: unknown |
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Interventions |
Intervention characteristics Inpatient (Phase II) and outpatient (Phase III) rehabilitation:
Control group
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Outcomes | Proportion at work at 6 months–12 months (medium term): 12 months Proportion at work at > 12 months to < 5 years (long term): 2 years Adverse events (cardiac deaths, reinfarctions) |
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Identification |
Sponsorship source: no information provided Country: Former East Germany (GDR) Setting: inpatient and outpatient Possible conflicts of interest: not reported Ethics committee approval: not reported |
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Notes | The number of people working before MI is not explicitly reported, but RTW is reported for all men aged < 65 years. Due to the sociopolitical policies in place at the time of this study, presumed that all of the participants presented in the RTW table were working prior to their heart attack. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | The study authors write that "regional cluster randomisation" was used. No further description of the randomisation method was reported. |
Allocation concealment (selection bias) | Unclear risk | No method of 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 | No outcome assessor blinding was reported, nor is it reported how RTW was assessed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 2 participants from the control group refused the 2‐year follow‐up and the participants' 2‐year survival was similar in both groups. |
Selective reporting (reporting bias) | Unclear risk | Unable to determine, no study protocol available |
Other bias | Unclear risk | Additional sources of bias from cluster‐RCT:
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