Bell 1998.
Methods |
Study design: Multicentre RCT (5 sites), participants randomised 4 to 6 days post‐event. Two independent 2‐way evaluations: conventional CR versus the Heart Manual (HM) and HM versus usual care. Country: UK Dates patients recruited: NR Maximum follow up: 1 year |
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Participants |
Inclusion criteria: Post MI < 65 years Exclusion criteria: NR N Randomised: total: 353; intervention: 251; comparator: 102 Diagnosis (% of pts): MI: 100% Age (mean ±SD): for women: 60.7 ± 7.2 to 64.3 ± 7.3; for men:57.8 ± 8.9 to 59.4 ± 9.4 Percentage male: 78% Ethnicity: NR |
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Interventions |
Intervention: Heart Manual Group: The Heart Manual is a comprehensive home‐based programme which includes 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. Components: exercise, education and psychological. Setting: home Aerobic exercise: Modality: walking Length of session: NR Frequency: NR Intensity: NR Resistance training included? NR Total duration: up to 6 weeks Co‐interventions: Relaxation and stress management techniques, specific self‐help treatments for psychological problems commonly experienced by MI patients and advice on coronary risk‐related behaviours. Conventional CR Group: 1 to 2 group classes per week, walking etc other days for 8‐12 weeks with multidisciplinary team. Comparator: usual care. Co‐interventions: none described. |
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Outcomes | Total mortality, health‐related quality of life: Nottingham Health Profile. | |
Source of funding | NR | |
Conflicts of interest | NR | |
Notes | Hospital readmissions significantly reduced in Heart Manual group compared with conventional CR and control in initial six‐month period. | |
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 of randomisation 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 of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described |
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) | Low risk | All outcomes were reported at all time points. |
Groups balanced at baseline | Unclear risk | Full text no longer available. |
Intention‐to‐treat analysis conducted | Unclear risk | Full text no longer available. |
Groups received same treatment (apart from the intervention) | Unclear risk | Full text no longer available. |