Petrie 2002.
Methods |
Study design: parallel RCT Recruitment: consecutive first‐time MI patients admitted to Auckland Hospital over 12‐month period (time period not given) Allocation: not reported Blinding: not reported Randomisation: computer‐generated Follow‐up(s): 3 months Description: individualised education to change illness perception |
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Participants |
Baseline characteristics Intervention
Usual care
Inclusion criteria ≤ 65 years of age at the time of the MI Exclusion criteria: none Baseline imbalances: time in hospital (days): intervention group: 7.7 (4.0); control group: 9.3 (6.2); number working at baseline: intervention group: 80.7%; control group; 58.9% Physically demanding work: unknown Severity of CHD: severe |
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Interventions |
Intervention In‐hospital individualised illness perception counselling
Control group
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Outcomes | Proportion at work at < 6 months (short term): 3 months Illness perception questionnaire |
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Identification |
Sponsorship source: Heart Foundation of New Zealand Country: New Zealand Setting: inpatient Possible conflicts of interest: no information provided Ethics committee approval: study authors report obtaining consent and ethics committee approval |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “...patients were randomly assigned into either an intervention or control group using a computer‐generated allocation code.” |
Allocation concealment (selection bias) | Unclear risk | No method of allocation concealment was reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Due to the nature of the study, blinding of participants was not possible. However, it is unclear if the participants in the intervention group would have realised they were in the intervention group, since the intervention was integrated into the inpatient hospital care. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No outcome assessor blinding was reported, time until returning to work was assessed with a questionnaire at 3 months. It is unclear if a validated questionnaire item was used to determine the time point of the participants’ RTW |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: “[The 12‐week follow‐up] questionnaire was returned by 56 patients (86%), and non‐respondents did not differ significantly from respondents on any baseline variables.” It is unclear if group assignment (intervention vs control) is considered to be one of the baseline variables. |
Selective reporting (reporting bias) | Unclear risk | Unable to determine, no study protocol available |
Other bias | Unclear risk | None identified |