Fielding 1980.
Methods |
Study design: parallel RCT Recruitment: participants were recruited at discharge from the CCU Allocation: not reported Blinding: not blinded Randomisation: not reported Follow‐up(s): 6 months Description: weekly group meetings with a psychologist with relaxation training |
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Participants |
Baseline characteristics Intervention group "Heart Club"
Control group
Inclusion criteria
Exclusion criteria
Baseline imbalances: ‐ Physically demanding work (i.e. white vs. blue collar): unknown Severity of CHD: unknown |
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Interventions |
Intervention "Heart Club"
Control group
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Outcomes | Proportion at work at 6 months–12 months (medium term): 6 months Mean length of illness (sick leave) in days Anxiety with the Catell Self‐Analysis Form; 9‐point rating scale Adverse events (reinfarctions) |
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Identification |
Sponsorship source: no information Country: UK Setting: single setting, outpatient Possible conflicts of interest: none reported Ethics committee approval: |
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Notes | Personal communication: information regarding occupational status of the study participants provided by the study author | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | A randomisation method was not described. Quote: "Ten patients were assessed and randomly allocated to experimental or control groups." |
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. Control participants were placed on a ‘waiting list’, which might have influenced their decisions of when to return to work |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | There is no mention of blinding and information regarding the assessment of working status and illness duration is insufficient to determine if these were prone to detection bias. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No dropouts reported; no percentage of 'number working' reported, unclear how many participants remained in each group |
Selective reporting (reporting bias) | Unclear risk | Unable to determine, no study protocol was available |
Other bias | Unclear risk | None identified |