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Editorial
Cochrane corner: cardiac rehabilitation for people with heart disease Rod S Taylor,1 Lindsey J Anderson2 Cardiac rehabilitation has been defined as:
(CR)
‘the coordinated sum of activities required to influence favourably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions, so that the patients may, by their own efforts, preserve or resume optimal functioning in their community and through improved health behaviour, slow or reverse progression of disease’.1
While exercise training is a cornerstone of CR, it is recommended that ‘comprehensive’ programmes also include education (eg, provision of information about a healthy lifestyle) and psychological intervention (eg, counselling to reduce stress). The first systematic reviews and meta-analyses of CR were published more than 20 years ago, and reported a 20%– 25% reduction in all-cause and cardiovascular mortality, pooling data from up to 22 randomised trials, comparing exercisebased CR and no-exercise control in over 4300 patients with postmyocardial infarction. In 2001, Jolliffe et al2 published the first Cochrane review of exercise-based CR, including 32 randomised controlled trials (RCTs) in 8440 patients with postmyocardial infarction and revascularisation. Since then, a further five Cochrane reviews of CR have been published— exercise-based rehabilitation for heart failure, home-based versus centre-based CR, psychological interventions for coronary heart disease, patient education in the management of coronary heart disease and promoting patient uptake and adherence in CR. The portfolio of Cochrane CR review remains dynamic with the publication of regular review updates. The development of this portfolio of Cochrane reviews reflects many of the key areas of evolution in the model provision of CR, and how this model can vary across 1
Institute of Health Research, University of Exeter Medical School, Exeter, UK; 2Evidence Synthesis & Modelling for Health Improvement (ESMI), Institute of Health Services Research, University of Exeter Medical School, Exeter, UK Correspondence to Professor Rod Taylor, Institute of Health Research, University of Exeter Medical School, South Cloisters, St Lukes Campus, Heavitree Road, Exeter EX1 2LU, UK; [email protected]
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international healthcare jurisdictions. These include the shift from exercise training alone to comprehensive secondary prevention, including risk factor and dietary education and management of psychological factors; the broadening of the population of patients receiving CR services, including those with heart failure; and the development of alternative settings of CR delivery, including home provision alongside to the traditional supervised hospital-based or centre-based programmes and the need to focus the outcomes of CR to inform the needs of healthcare policy-makers (eg, rates of hospital admission, health-related quality of life and economic considerations). Overviews are a relatively new approach to summarising evidence and synthesising results from multiple systematic reviews into a single document. By providing a single synthesis of all relevant evidence in a particular area, overviews are particularly useful for clinical and policy decisionmaking, providing a comprehensive ‘friendly front end’ to the evidence. Overviews can also help inform the strategic direction of conduct and structuring of future systematic reviews and also provide an opportunity to identify potential ‘evidence gaps’ informing areas in which new Cochrane reviews should be prioritised. An overview was undertaken to provide a contemporary review of the evidence for
Table 1
STUDY LIMITATIONS The first limitation of this overview was that due to the heterogeneity of populations, interventions and outcomes in the included Cochrane reviews, it was not considered appropriate to undertake a network meta-analysis. In other words, to use the randomised trials identified by this overview in order to make indirect
PICO summary
Type of evidence Population Intervention Control group
Outcomes
CR3 (see table 1). The overview included six Cochrane reviews across 148 RCTs in 97 486 participants. Based on assessment using the R-AMSTAR tool, the six systematic reviews scored 35–41 (maximum score 44), and were, therefore, deemed of high methodological quality. The findings of the overview are summarised in table 2 in the format of GRADE summary of evidence table for each of the reviews. In brief, the overview findings are summarised as follows: compared with usual care alone (no exercise intervention), exercise-based CR reduces hospital admissions and improves participant health-related quality of life in those with low-to-moderate risk heart failure and coronary heart disease. At 12 months’ or more follow-up, there was evidence of some reduction in mortality in people with coronary heart disease; psychological-based and education-based interventions appear to have little impact on mortality or morbidity, but may improve health-related quality of life of those with coronary heart disease; home-based and centre-based programmes are equally effective in improving quality of life and have similar costs; and selected interventions can increase the uptake of CR programmes, but evidence to support interventions that improve adherence is weak.
Cochrane reviews (of RCTs) currently published in The Cochrane Library that examined the impact of CR. Non-Cochrane systematic reviews were excluded Adults aged 18 or over, with heart disease, regardless of aetiology CR defined as exercise with or without education, with or without psychological intervention, delivered to people with heart disease in a hospital community or a home-based setting Various depending on Cochrane review question. Included: ▸ No-exercise training control ▸ No-psychological-intervention control ▸ No-education intervention-control, CR programmes delivered in a centre-based setting, and ▸ CR programmes without intervention to promote uptake or adherence Patient-related outcomes ▸ Mortality: cardiovascular and non-cardiovascular ▸ Morbidity: total, fatal and non-fatal myocardial infarction, total revascularisations, coronary artery bypass graft, percutaneous transluminal coronary angioplasty and restenting; hospitalisations total, cardiovascular and other ▸ Health-related quality of life: assessed using validated instruments Process-related outcomes ▸ Measure of uptake of, or adherence to, CR ▸ Costs and cost-effectiveness
CR, cardiac rehabilitation; RCT, randomised controlled trial.
Taylor RS, Anderson LJ. Heart August 2015 Vol 101 No 16
Anderson and Taylor Cochrane CR overview3—GRADE summary of evidence
Short title and author
Exercise for CHD Heran 2011
Exercise for HF Taylor 2014a
Psychological for CHD Whalley 2011
Education for CHD Brown 2011
Home vs centre Taylor 2014
Uptake and adherence Karmali 2014
Total mortality
Follow-up 12 months N=16 RCTs (5790 patients) RR=0.87 (0.75 to 0.99) ⊕⊕⊕⊝ moderate* Follow-up 12 months N=12 RCTs (4757) RR=0.74 (0.63 to 0.87) I2= 0.0% ⊕⊕⊕⊝ moderate* Follow-up 12 months N=7 RCTs (2009 patients) RR=0.98 (0.87 to 1.11) ⊕⊕⊝⊝ low*‡ NR
Follow-up 12 months N=6 RCTs (2845 patients) RR=0.88 (0.75 to 1.02) ⊕⊕⊝⊝ low*† ‘Studies did not consistently report deaths due to heart failure or sudden death’
N=17 RCTs (6852 patients) RR=0.89 (0.75 to 1.05) ⊕⊕⊝⊝ low*†
N=6 RCTs (2330 patients) RR=0.79 (0.55 to 1.13) ⊕⊕⊕⊝ moderate†
Follow-up 12 months N=1 (525 patients) RR=1.99 (0.50 to 7.88)
N=3 RCTs (211 patients) 0/3 RCTs reported a significant difference between intervention and control groups (no pooling of data)
N=5 RCTs (3893 patients) RR=0.80 (0.6 to 1.00) ⊕⊕⊝⊝ low*†
NR
NR
NR
NR
At end of follow-up period N=4 RCTs (12 905 patients) RR=0.83 (0.65 to 1.07) ⊕⊕⊕⊝ moderate†
N=1 RCT No difference between home-based and centre-based CR
N=3 RCTs (numbers not provided) No significant difference between intervention and control groups (no pooling of data)
NR
N=1 RCT Patients in the intervention group had 41% fewer heart-related admissions (p=0.05) and 61% fewer heart-related inpatient days (p=0.02) than in the control group MI at the end of the follow-up period N=2 RCTs (209 patients) RR=0.63 (0.26 to 1.48) ⊕⊝⊝⊝ very low¶
NR
NR
N=2 RCTs No difference between home-based and centre-based CR (no pooling of data performed)
CHD event rates N=3 RCTs (414 patients) 2/3 RCTs reported no difference between intervention and control groups N=1 (228 patients) RR=1.66, p12 months N=12 RCTs (1036 patients) RR=0.61 (0.46 to 0.80) I²=34% ⊕⊕⊕⊝ moderate*† NR
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Taylor RS, Anderson LJ. Heart August 2015 Vol 101 No 16
Table 2
Continued Exercise for CHD Heran 2011
Exercise for HF Taylor 2014a
Psychological for CHD Whalley 2011
Education for CHD Brown 2011
Home vs centre Taylor 2014
CABG
Follow-up 12 months N=9 RCTs (2189 patients) RR=0.93 (0.68 to 1.27) I2=0% ⊕⊕⊝⊝ low*† Follow-up 12 months N=6 RCTs (1322 patients) RR=0.89 (0.66 to 1.19) ⊕⊕⊝⊝ low*† N=10 7/10 RCTs reported evidence of a significantly higher level of HRQL with intervention at follow-up
NR
Revascularisation (CABG and PTCA combined) N=12 RCTs (6670 patients) RR=0.95 (0.80 to 1.13) ⊕⊕⊕⊝ moderate*
At end of follow-up period N=2 RCTs (209 patients) RR=0.58 (0.19 to 1.71) ⊕⊕⊝⊝ low¶
Not reported by RCTs
NR
See above
Not reported by RCTs
Not reported by RCTs
N=20 MLWHF score Follow-up 12 months N=3 RCTs (329 patients) WMD=−9.5 (−17.54 to −1.5) All HRQL measures pooled N=20 RCTs (3240 patients) SMD=−0.5 (−0.7 to −0.3) N=3 Two studies undertook a cost-effectiveness analysis and one reported costs There was no evidence of significantly different costs or outcomes
N=7 1/7 RCTs reported evidence of a significantly higher level of HRQL with intervention at follow-up
Across 11 RCTs, 81 HRQL outcome scores/subscores reported: ▸ 14/81 in favour of intervention compared with control ▸ 67/81 no significant difference between intervention and control 5/11 RCTs reported evidence of a significantly higher level of some HRQL domains with intervention at follow-up No consistent difference in HRQL total or domain score at follow-up between intervention and control N=5 RCTs reported healthcare usage costs 2/5 RCTs reported an overall average net saving of US$965 per patient at 6 months’ follow-up and US$1420 per patient at 24 months’ follow-up 1/5 reported an increase in average net costs of US$52 per patient 2/5 reported no difference between groups No RCTs reported cost-effectiveness
N=10 8/10 studies reported improvements in HRQL at follow-up with both home-based and centre-based CR compared with baseline No strong evidence of difference in overall HRQL outcomes or domain score at follow-up between home-based and centre-based CR
N=2 1/2 studies reported improvement in HRQL with intervention (ns) 1/2 studies reported improvement in both groups, but no significant difference between intervention and control
3/4 RCTs reported healthcare costs associated with CR were lower for the home-based than centre-based programmes 1/4 reported that home-based CR was more costly than centre-based CR, but costs would be the same if patient costs were included Eight studies reported different aspects of consumption of healthcare resources No significant between-group differences were seen At follow-up N=18 (1894 patients) RR=1.04 (1.00 to 1.08)
NR
PTCA
HRQL
Taylor RS, Anderson LJ. Heart August 2015 Vol 101 No 16
Economics Costs Cost-effectiveness
Costs 2/3 studies reported total healthcare costs were not statistically significantly different between groups Cost-effectiveness N=1 Authors concluded that rehabilitation was an efficient use of healthcare resources and may be economically justified
All cause withdrawal/ dropout at follow-up
NR
NR
NR
NR
At follow-up N=8 RCTs (2862 patients) RR=1.03 (0.83 to 1.27)
Uptake and adherence Karmali 2014
NR
Continued
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Table 2
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Taylor RS, Anderson LJ. Heart August 2015 Vol 101 No 16
Table 2
Continued
Short title and author
Exercise for CHD Heran 2011
Exercise for HF Taylor 2014a
Psychological for CHD Whalley 2011
Education for CHD Brown 2011
Home vs centre Taylor 2014 ⊕⊕⊕⊝ moderate* NR
N=14 3/14 studies reported adherence was significantly higher in home-based CR
Uptake
NR
NR
NR
⊕⊕⊕⊝ moderate† NR
Adherence
NR
NR
NR
NR
Uptake and adherence Karmali 2014
N=10 (1338 patients) 8/10 studies reported uptake was significantly higher in intervention group N=8 (1150 patients) 3/8 studies reported adherence was significantly higher in intervention group
GRADE Working Group grades of evidence. ⊕⊕⊕⊝ Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. ⊕⊕⊝⊝ Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. ⊕⊝⊝⊝ Very low quality: we are very uncertain about the estimate. *Random sequence generation and allocation concealment were poorly described; bias likely. †The 95% CIs includes both no effect and appreciable benefit or harm (ie, RR 1.25). ‡Moderate heterogeneity (I2 greater than 50%). §Funnel plots and/or Egger test suggest evidence of asymmetry. ¶The 95% CIs includes both no effect and substantial benefit or harm (ie, RR 1.50). CABG, coronary artery bypass graft; CHD, coronary heart disease; CR, cardiac rehabilitation; HRQL, health-related quality of life; HF, heart failure; MLWHF, Minnesota Living with Heart Failure questionnaire; MI, myocardial infarction; NR, not reported; PICO, population, intervention, Control or comparator, outcomes; PTCA, percutaneous transluminal coronary angioplasty; RCT, randomised controlled trial; RR, relative risk; SMD, standardised mean differences; WMD, weighted mean difference.
Editorial
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Editorial comparisons either across systematic reviews interventions (eg, to assess the relative effectiveness of exercise-training vs education interventions) or across systematic review populations (eg, to assess the relative effectiveness of exercise-based CR in patients with postmyocardial infarction and revascularisation vs patients with heart failure). The second limitation was that the quality of the primary trials in the included systematic reviews was variable. The main sources of bias were inadequate reporting of allocation concealment and randomisation methods and lack of outcome blinding. Another potential source of inconsistency was differential use of outcome data by the trials, that is, some reported only postinterventional data, while others reported pre–post change. Finally, this overview included randomised trials conducted over a wide period of time (1974–2013). During this time, there have been major advances in medical management, such as the increased use of statins since the mid-1990s. Indeed, it has been hypothesised that major advances in post-MI medical management since the mid-2000s have led to a reduction in the incremental effect on mortality of CR compared with usual care alone.4
IMPLICATIONS The evidence compiled by this overview supports current international clinical guidelines that state that the addition of CR to medical management is effective (improving health-related quality of life and reducing the risk of future hospitalisations) and safe (with no increase in short-term mortality), compared with a no-exercise training control for clinically stable participants following myocardial infarction or percutaneous coronary intervention or who have heart failure.
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This overview also highlights several potential areas for consideration in future research—systematic reviews and randomised trials. CR is a complex intervention with heterogeneity in interventions (content and methods of delivery) and the population of people who receive it. Future reviews of CR need to explore this complexity using approaches that include stratification (‘splitting’) of outcome results by patient indication (eg, postmyocardial infarction vs post-percutaneous coronary intervention) or intervention type (ie, exercise training only vs comprehensive CR interventions), reporting within trial subgroup analyses and use of meta-regression to explore the association between intervention characteristics and outcomes across trials. Consideration should also be given to the appropriate use of indirect comparison/mixed treatment methods in reviews or broadening the inclusion criteria of reviews to include active comparator arms of trials that would allow assessment of the comparative effectiveness of different CR interventions (or both). Theory-based approaches to systematic reviews of CR are also needed.5 Future trials of CR need to include patients at higher risk who are older, female and from a broader range of ethnicities and socioeconomic groups. Reporting of trial methods should be improved (eg, details of the process of randomisation and outcome blinding), and consistency is needed in the collection and reporting of outcome measures, including the use of validated quality-of-life measures, cardiac-related events, readmissions and costs. Finally, future trials need to better ‘open the black box’ of CR.5 In other words, to determine the incremental benefits of the various components of CR, future trials to provide more precise descriptions of their CR interventions are required, so that these comparisons can be
more explicitly and reliably undertaken in future systematic reviews. This would also be aided by ‘head-to-head’ trials of different combinations of CR interventions (eg, an ‘exercise only’ CR intervention vs ‘exercise plus’ CR intervention). Contributors RST drafted the manuscript. LJA revised the manuscript for its intellectual content. Both authors contributed substantially to this manuscript and have approved its final version. Competing interests RST was a coauthor on five of the six Cochrane reviews included in the overview and is the Chief Investigator on an ongoing National Institute of Health Research Programme Grants for Applied Research (RP-PG-1210-12004): Rehabilitation Enablement in Chronic Heart Failure (REACH-HF). Provenance and peer review Commissioned; internally peer reviewed.
To cite Taylor RS, Anderson LJ. Heart 2015;101:1256–1260. Published Online First 29 May 2015 Heart 2015;101:1256–1260. doi:10.1136/heartjnl-2015-307778
REFERENCES 1
2
3
4
5
British Association for Cardiovascular Prevention and Rehabilitation. The BACPR standards and core components for cardiovascular disease prevention and rehabilitation. 2nd edn. 2012. http://www.bacpr.com/ resources/46C_BACPR_Standards_and_Core_ Components_2012.pdf (accessed 24 Apr 2015). Jolliffe JA, Rees K, Taylor RS, et al. Exercise-based rehabilitation for coronary heart disease. Cochrane Database Syst Rev 2001;(1):CD001800. Anderson L, Taylor RS. Cardiac rehabilitation for people with heart disease: an overview of Cochrane systematic reviews. Cochrane Database Syst Rev 2014;12:CD011273. Taylor RS, Cochrane Review Authors. The RAMIT trial: its results in the context of 2012 Cochrane review. Heart 2012;98:672–3. Clark AM. What are the components of complex interventions in healthcare? Theorizing approaches to parts, powers and the whole intervention. Soc Sci Med 2013;93:185–93.
Taylor RS, Anderson LJ. Heart August 2015 Vol 101 No 16
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Cochrane corner: cardiac rehabilitation for people with heart disease Rod S Taylor and Lindsey J Anderson Heart 2015 101: 1256-1260 originally published online May 29, 2015
doi: 10.1136/heartjnl-2015-307778 Updated information and services can be found at: http://heart.bmj.com/content/101/16/1256
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Editorial
Cochrane corner: cardiac rehabilitation for people with heart disease Rod S Taylor,1 Lindsey J Anderson2 Cardiac rehabilitation has been defined as:
(CR)
‘the coordinated sum of activities required to influence favourably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions, so that the patients may, by their own efforts, preserve or resume optimal functioning in their community and through improved health behaviour, slow or reverse progression of disease’.1
While exercise training is a cornerstone of CR, it is recommended that ‘comprehensive’ programmes also include education (eg, provision of information about a healthy lifestyle) and psychological intervention (eg, counselling to reduce stress). The first systematic reviews and meta-analyses of CR were published more than 20 years ago, and reported a 20%– 25% reduction in all-cause and cardiovascular mortality, pooling data from up to 22 randomised trials, comparing exercisebased CR and no-exercise control in over 4300 patients with postmyocardial infarction. In 2001, Jolliffe et al2 published the first Cochrane review of exercise-based CR, including 32 randomised controlled trials (RCTs) in 8440 patients with postmyocardial infarction and revascularisation. Since then, a further five Cochrane reviews of CR have been published— exercise-based rehabilitation for heart failure, home-based versus centre-based CR, psychological interventions for coronary heart disease, patient education in the management of coronary heart disease and promoting patient uptake and adherence in CR. The portfolio of Cochrane CR review remains dynamic with the publication of regular review updates. The development of this portfolio of Cochrane reviews reflects many of the key areas of evolution in the model provision of CR, and how this model can vary across 1
Institute of Health Research, University of Exeter Medical School, Exeter, UK; 2Evidence Synthesis & Modelling for Health Improvement (ESMI), Institute of Health Services Research, University of Exeter Medical School, Exeter, UK Correspondence to Professor Rod Taylor, Institute of Health Research, University of Exeter Medical School, South Cloisters, St Lukes Campus, Heavitree Road, Exeter EX1 2LU, UK; [email protected]
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international healthcare jurisdictions. These include the shift from exercise training alone to comprehensive secondary prevention, including risk factor and dietary education and management of psychological factors; the broadening of the population of patients receiving CR services, including those with heart failure; and the development of alternative settings of CR delivery, including home provision alongside to the traditional supervised hospital-based or centre-based programmes and the need to focus the outcomes of CR to inform the needs of healthcare policy-makers (eg, rates of hospital admission, health-related quality of life and economic considerations). Overviews are a relatively new approach to summarising evidence and synthesising results from multiple systematic reviews into a single document. By providing a single synthesis of all relevant evidence in a particular area, overviews are particularly useful for clinical and policy decisionmaking, providing a comprehensive ‘friendly front end’ to the evidence. Overviews can also help inform the strategic direction of conduct and structuring of future systematic reviews and also provide an opportunity to identify potential ‘evidence gaps’ informing areas in which new Cochrane reviews should be prioritised. An overview was undertaken to provide a contemporary review of the evidence for
Table 1
STUDY LIMITATIONS The first limitation of this overview was that due to the heterogeneity of populations, interventions and outcomes in the included Cochrane reviews, it was not considered appropriate to undertake a network meta-analysis. In other words, to use the randomised trials identified by this overview in order to make indirect
PICO summary
Type of evidence Population Intervention Control group
Outcomes
CR3 (see table 1). The overview included six Cochrane reviews across 148 RCTs in 97 486 participants. Based on assessment using the R-AMSTAR tool, the six systematic reviews scored 35–41 (maximum score 44), and were, therefore, deemed of high methodological quality. The findings of the overview are summarised in table 2 in the format of GRADE summary of evidence table for each of the reviews. In brief, the overview findings are summarised as follows: compared with usual care alone (no exercise intervention), exercise-based CR reduces hospital admissions and improves participant health-related quality of life in those with low-to-moderate risk heart failure and coronary heart disease. At 12 months’ or more follow-up, there was evidence of some reduction in mortality in people with coronary heart disease; psychological-based and education-based interventions appear to have little impact on mortality or morbidity, but may improve health-related quality of life of those with coronary heart disease; home-based and centre-based programmes are equally effective in improving quality of life and have similar costs; and selected interventions can increase the uptake of CR programmes, but evidence to support interventions that improve adherence is weak.
Cochrane reviews (of RCTs) currently published in The Cochrane Library that examined the impact of CR. Non-Cochrane systematic reviews were excluded Adults aged 18 or over, with heart disease, regardless of aetiology CR defined as exercise with or without education, with or without psychological intervention, delivered to people with heart disease in a hospital community or a home-based setting Various depending on Cochrane review question. Included: ▸ No-exercise training control ▸ No-psychological-intervention control ▸ No-education intervention-control, CR programmes delivered in a centre-based setting, and ▸ CR programmes without intervention to promote uptake or adherence Patient-related outcomes ▸ Mortality: cardiovascular and non-cardiovascular ▸ Morbidity: total, fatal and non-fatal myocardial infarction, total revascularisations, coronary artery bypass graft, percutaneous transluminal coronary angioplasty and restenting; hospitalisations total, cardiovascular and other ▸ Health-related quality of life: assessed using validated instruments Process-related outcomes ▸ Measure of uptake of, or adherence to, CR ▸ Costs and cost-effectiveness
CR, cardiac rehabilitation; RCT, randomised controlled trial.
Taylor RS, Anderson LJ. Heart August 2015 Vol 101 No 16
Anderson and Taylor Cochrane CR overview3—GRADE summary of evidence
Short title and author
Exercise for CHD Heran 2011
Exercise for HF Taylor 2014a
Psychological for CHD Whalley 2011
Education for CHD Brown 2011
Home vs centre Taylor 2014
Uptake and adherence Karmali 2014
Total mortality
Follow-up 12 months N=16 RCTs (5790 patients) RR=0.87 (0.75 to 0.99) ⊕⊕⊕⊝ moderate* Follow-up 12 months N=12 RCTs (4757) RR=0.74 (0.63 to 0.87) I2= 0.0% ⊕⊕⊕⊝ moderate* Follow-up 12 months N=7 RCTs (2009 patients) RR=0.98 (0.87 to 1.11) ⊕⊕⊝⊝ low*‡ NR
Follow-up 12 months N=6 RCTs (2845 patients) RR=0.88 (0.75 to 1.02) ⊕⊕⊝⊝ low*† ‘Studies did not consistently report deaths due to heart failure or sudden death’
N=17 RCTs (6852 patients) RR=0.89 (0.75 to 1.05) ⊕⊕⊝⊝ low*†
N=6 RCTs (2330 patients) RR=0.79 (0.55 to 1.13) ⊕⊕⊕⊝ moderate†
Follow-up 12 months N=1 (525 patients) RR=1.99 (0.50 to 7.88)
N=3 RCTs (211 patients) 0/3 RCTs reported a significant difference between intervention and control groups (no pooling of data)
N=5 RCTs (3893 patients) RR=0.80 (0.6 to 1.00) ⊕⊕⊝⊝ low*†
NR
NR
NR
NR
At end of follow-up period N=4 RCTs (12 905 patients) RR=0.83 (0.65 to 1.07) ⊕⊕⊕⊝ moderate†
N=1 RCT No difference between home-based and centre-based CR
N=3 RCTs (numbers not provided) No significant difference between intervention and control groups (no pooling of data)
NR
N=1 RCT Patients in the intervention group had 41% fewer heart-related admissions (p=0.05) and 61% fewer heart-related inpatient days (p=0.02) than in the control group MI at the end of the follow-up period N=2 RCTs (209 patients) RR=0.63 (0.26 to 1.48) ⊕⊝⊝⊝ very low¶
NR
NR
N=2 RCTs No difference between home-based and centre-based CR (no pooling of data performed)
CHD event rates N=3 RCTs (414 patients) 2/3 RCTs reported no difference between intervention and control groups N=1 (228 patients) RR=1.66, p12 months N=12 RCTs (1036 patients) RR=0.61 (0.46 to 0.80) I²=34% ⊕⊕⊕⊝ moderate*† NR
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Taylor RS, Anderson LJ. Heart August 2015 Vol 101 No 16
Table 2
Continued Exercise for CHD Heran 2011
Exercise for HF Taylor 2014a
Psychological for CHD Whalley 2011
Education for CHD Brown 2011
Home vs centre Taylor 2014
CABG
Follow-up 12 months N=9 RCTs (2189 patients) RR=0.93 (0.68 to 1.27) I2=0% ⊕⊕⊝⊝ low*† Follow-up 12 months N=6 RCTs (1322 patients) RR=0.89 (0.66 to 1.19) ⊕⊕⊝⊝ low*† N=10 7/10 RCTs reported evidence of a significantly higher level of HRQL with intervention at follow-up
NR
Revascularisation (CABG and PTCA combined) N=12 RCTs (6670 patients) RR=0.95 (0.80 to 1.13) ⊕⊕⊕⊝ moderate*
At end of follow-up period N=2 RCTs (209 patients) RR=0.58 (0.19 to 1.71) ⊕⊕⊝⊝ low¶
Not reported by RCTs
NR
See above
Not reported by RCTs
Not reported by RCTs
N=20 MLWHF score Follow-up 12 months N=3 RCTs (329 patients) WMD=−9.5 (−17.54 to −1.5) All HRQL measures pooled N=20 RCTs (3240 patients) SMD=−0.5 (−0.7 to −0.3) N=3 Two studies undertook a cost-effectiveness analysis and one reported costs There was no evidence of significantly different costs or outcomes
N=7 1/7 RCTs reported evidence of a significantly higher level of HRQL with intervention at follow-up
Across 11 RCTs, 81 HRQL outcome scores/subscores reported: ▸ 14/81 in favour of intervention compared with control ▸ 67/81 no significant difference between intervention and control 5/11 RCTs reported evidence of a significantly higher level of some HRQL domains with intervention at follow-up No consistent difference in HRQL total or domain score at follow-up between intervention and control N=5 RCTs reported healthcare usage costs 2/5 RCTs reported an overall average net saving of US$965 per patient at 6 months’ follow-up and US$1420 per patient at 24 months’ follow-up 1/5 reported an increase in average net costs of US$52 per patient 2/5 reported no difference between groups No RCTs reported cost-effectiveness
N=10 8/10 studies reported improvements in HRQL at follow-up with both home-based and centre-based CR compared with baseline No strong evidence of difference in overall HRQL outcomes or domain score at follow-up between home-based and centre-based CR
N=2 1/2 studies reported improvement in HRQL with intervention (ns) 1/2 studies reported improvement in both groups, but no significant difference between intervention and control
3/4 RCTs reported healthcare costs associated with CR were lower for the home-based than centre-based programmes 1/4 reported that home-based CR was more costly than centre-based CR, but costs would be the same if patient costs were included Eight studies reported different aspects of consumption of healthcare resources No significant between-group differences were seen At follow-up N=18 (1894 patients) RR=1.04 (1.00 to 1.08)
NR
PTCA
HRQL
Taylor RS, Anderson LJ. Heart August 2015 Vol 101 No 16
Economics Costs Cost-effectiveness
Costs 2/3 studies reported total healthcare costs were not statistically significantly different between groups Cost-effectiveness N=1 Authors concluded that rehabilitation was an efficient use of healthcare resources and may be economically justified
All cause withdrawal/ dropout at follow-up
NR
NR
NR
NR
At follow-up N=8 RCTs (2862 patients) RR=1.03 (0.83 to 1.27)
Uptake and adherence Karmali 2014
NR
Continued
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Table 2
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Taylor RS, Anderson LJ. Heart August 2015 Vol 101 No 16
Table 2
Continued
Short title and author
Exercise for CHD Heran 2011
Exercise for HF Taylor 2014a
Psychological for CHD Whalley 2011
Education for CHD Brown 2011
Home vs centre Taylor 2014 ⊕⊕⊕⊝ moderate* NR
N=14 3/14 studies reported adherence was significantly higher in home-based CR
Uptake
NR
NR
NR
⊕⊕⊕⊝ moderate† NR
Adherence
NR
NR
NR
NR
Uptake and adherence Karmali 2014
N=10 (1338 patients) 8/10 studies reported uptake was significantly higher in intervention group N=8 (1150 patients) 3/8 studies reported adherence was significantly higher in intervention group
GRADE Working Group grades of evidence. ⊕⊕⊕⊝ Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. ⊕⊕⊝⊝ Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. ⊕⊝⊝⊝ Very low quality: we are very uncertain about the estimate. *Random sequence generation and allocation concealment were poorly described; bias likely. †The 95% CIs includes both no effect and appreciable benefit or harm (ie, RR 1.25). ‡Moderate heterogeneity (I2 greater than 50%). §Funnel plots and/or Egger test suggest evidence of asymmetry. ¶The 95% CIs includes both no effect and substantial benefit or harm (ie, RR 1.50). CABG, coronary artery bypass graft; CHD, coronary heart disease; CR, cardiac rehabilitation; HRQL, health-related quality of life; HF, heart failure; MLWHF, Minnesota Living with Heart Failure questionnaire; MI, myocardial infarction; NR, not reported; PICO, population, intervention, Control or comparator, outcomes; PTCA, percutaneous transluminal coronary angioplasty; RCT, randomised controlled trial; RR, relative risk; SMD, standardised mean differences; WMD, weighted mean difference.
Editorial
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Editorial comparisons either across systematic reviews interventions (eg, to assess the relative effectiveness of exercise-training vs education interventions) or across systematic review populations (eg, to assess the relative effectiveness of exercise-based CR in patients with postmyocardial infarction and revascularisation vs patients with heart failure). The second limitation was that the quality of the primary trials in the included systematic reviews was variable. The main sources of bias were inadequate reporting of allocation concealment and randomisation methods and lack of outcome blinding. Another potential source of inconsistency was differential use of outcome data by the trials, that is, some reported only postinterventional data, while others reported pre–post change. Finally, this overview included randomised trials conducted over a wide period of time (1974–2013). During this time, there have been major advances in medical management, such as the increased use of statins since the mid-1990s. Indeed, it has been hypothesised that major advances in post-MI medical management since the mid-2000s have led to a reduction in the incremental effect on mortality of CR compared with usual care alone.4
IMPLICATIONS The evidence compiled by this overview supports current international clinical guidelines that state that the addition of CR to medical management is effective (improving health-related quality of life and reducing the risk of future hospitalisations) and safe (with no increase in short-term mortality), compared with a no-exercise training control for clinically stable participants following myocardial infarction or percutaneous coronary intervention or who have heart failure.
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This overview also highlights several potential areas for consideration in future research—systematic reviews and randomised trials. CR is a complex intervention with heterogeneity in interventions (content and methods of delivery) and the population of people who receive it. Future reviews of CR need to explore this complexity using approaches that include stratification (‘splitting’) of outcome results by patient indication (eg, postmyocardial infarction vs post-percutaneous coronary intervention) or intervention type (ie, exercise training only vs comprehensive CR interventions), reporting within trial subgroup analyses and use of meta-regression to explore the association between intervention characteristics and outcomes across trials. Consideration should also be given to the appropriate use of indirect comparison/mixed treatment methods in reviews or broadening the inclusion criteria of reviews to include active comparator arms of trials that would allow assessment of the comparative effectiveness of different CR interventions (or both). Theory-based approaches to systematic reviews of CR are also needed.5 Future trials of CR need to include patients at higher risk who are older, female and from a broader range of ethnicities and socioeconomic groups. Reporting of trial methods should be improved (eg, details of the process of randomisation and outcome blinding), and consistency is needed in the collection and reporting of outcome measures, including the use of validated quality-of-life measures, cardiac-related events, readmissions and costs. Finally, future trials need to better ‘open the black box’ of CR.5 In other words, to determine the incremental benefits of the various components of CR, future trials to provide more precise descriptions of their CR interventions are required, so that these comparisons can be
more explicitly and reliably undertaken in future systematic reviews. This would also be aided by ‘head-to-head’ trials of different combinations of CR interventions (eg, an ‘exercise only’ CR intervention vs ‘exercise plus’ CR intervention). Contributors RST drafted the manuscript. LJA revised the manuscript for its intellectual content. Both authors contributed substantially to this manuscript and have approved its final version. Competing interests RST was a coauthor on five of the six Cochrane reviews included in the overview and is the Chief Investigator on an ongoing National Institute of Health Research Programme Grants for Applied Research (RP-PG-1210-12004): Rehabilitation Enablement in Chronic Heart Failure (REACH-HF). Provenance and peer review Commissioned; internally peer reviewed.
To cite Taylor RS, Anderson LJ. Heart 2015;101:1256–1260. Published Online First 29 May 2015 Heart 2015;101:1256–1260. doi:10.1136/heartjnl-2015-307778
REFERENCES 1
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5
British Association for Cardiovascular Prevention and Rehabilitation. The BACPR standards and core components for cardiovascular disease prevention and rehabilitation. 2nd edn. 2012. http://www.bacpr.com/ resources/46C_BACPR_Standards_and_Core_ Components_2012.pdf (accessed 24 Apr 2015). Jolliffe JA, Rees K, Taylor RS, et al. Exercise-based rehabilitation for coronary heart disease. Cochrane Database Syst Rev 2001;(1):CD001800. Anderson L, Taylor RS. Cardiac rehabilitation for people with heart disease: an overview of Cochrane systematic reviews. Cochrane Database Syst Rev 2014;12:CD011273. Taylor RS, Cochrane Review Authors. The RAMIT trial: its results in the context of 2012 Cochrane review. Heart 2012;98:672–3. Clark AM. What are the components of complex interventions in healthcare? Theorizing approaches to parts, powers and the whole intervention. Soc Sci Med 2013;93:185–93.
Taylor RS, Anderson LJ. Heart August 2015 Vol 101 No 16
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Cochrane corner: cardiac rehabilitation for people with heart disease Rod S Taylor and Lindsey J Anderson Heart 2015 101: 1256-1260 originally published online May 29, 2015
doi: 10.1136/heartjnl-2015-307778 Updated information and services can be found at: http://heart.bmj.com/content/101/16/1256
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