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. Author manuscript; available in PMC: 2014 Nov 13.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2
Methods Post MI
Randomised 4-6 days post event.
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
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.
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
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.