Methods | Post MI Randomised 4-6 days post event. |
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Participants | 311 men / 89 women < 65 yrs. Mean ages for women 60.7 (+/− 7.2) to 64.3 (+/−7.3), for men 57.8(+/− 8.9) to 59.4 (+/− 9.4). 2 comparisons conventional CR v: the Heart Manual (HM) and HM v: control |
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Interventions | Conventional CR - 1 to 2 group classes per week, walking etc other days for 8-12 weeks with multidisciplinary team HM - individual - walking programme up to 6 weeks post MI, facilitator and written text. F/U - 1 year. |
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Outcomes | Total mortality, health-related quality of life: Nottingham Health Profile | |
Notes | “Heart Manual is a comprehensive home based programme which included an exercise regimen, relaxation and stress management techniques, specific self-help treatments for psychological problems commonly experienced by MI patients and advice on coronary risk-related behaviours.” Hospital readmissions significantly reduced in Heart Manual group compared with conventional CR and control in initial 6 month period |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Randomisation was achieved by providing each hospital with a series of sealed envelopes containing cards evenly distributed between conditions. The envelopes were taken sequentially and, before opening the envelope, the patient’s surname was written diagonally across the sealed flap, in such a way that when the envelope was opened the name was ‘torn in two’. Opened envelopes were retained and returned to the trial coordinator. The importance of remaining neutral when advising the patients of the outcome of randomisation was emphasised in the written protocol and was reinforced during the sessions which were held to familiarise facilitators with the protocol.”” |
Allocation concealment (selection bias) | Low risk | “Randomisation was achieved by providing each hospital with a series of sealed envelopes containing cards evenly distributed between conditions. The envelopes were taken sequentially and, before opening the envelope, the patient’s surname was written diagonally across the sealed flap, in such a way that when the envelope was opened the name was ‘torn in two’. Opened envelopes were retained and returned to the trial coordinator. The importance of remaining neutral when advising the patients of the outcome ofrandomisation was emphasised in the written protocol and was reinforced during the sessions which were held to familiarise facilitators with the protocol.” Comment: Patients were informed of outcome of randomisation. |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | Unclear in terms of assessment of outcomes. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | 1.5% lost to follow up and reported description of withdrawals and/or dropouts |
Selective reporting (reporting bias) | Unclear risk | No information reported. |