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RAMIT: BACPR summary of the editorials and letters
The discussion around RAMIT: summary of the editorials and letters in response to West et al.1
Prepared by: Gail Sheppard and Gill Furze, June 2012.
To download the below as an extract: Click here To also see or download the BACPR response to the 'Letter from the Authors': Click here The RAMIT trial by West et al1, published in 2011, is a randomized controlled trial (RCT) of cardiac rehabilitation (CR) in patients following acute myocardial infarction that was undertaken between 1997 and 2000, with follow-up of secondary outcomes to 2001 and for mortality to 2006. The trial compared cardiac rehabilitation as an intervention with that of usual care, and the authors conclude that they found ‘no effect on mortality at 1 year, 2 years or after 7-9 years and little evidence of any beneficial effect on morbidity, cardiac medication, risk factors, lifestyle or patients’ appreciation of total aftercare’. They concluded that “The value of cardiac rehabilitation as practised in the UK is open to question” (page 1).At a time when NHS secondary prevention services are required to justify the efficacy of their interventions, unsurprisingly, the RAMIT study instigated much academic and professional discussion of cardiac rehabilitation both in the United Kingdom and around the world. In order to reduce the potential damaging effects that this study could have on CR services, the BACPR released an initial response to the study (click here to view the BACPR's initial response to its members) which offered members suggested responses to those questioning the worth of CR as an effective prevention treatment. The BACPR also submitted a letter to the Editor of Heart which was published (to read this letter click here).
What follows is a summary of the responses prompted by the publication of the RAMIT trial. We encourage members to consider these when evaluating the findings of this study. The main themes that emerged from the responses were;
RAMIT findings in context of the 2011 Cochrane review.
The RAMIT trial was submitted for publication before the release of the recent Cochrane Collaboration Systematic Review and meta-analysis2 of 47 RCTs and the authors therefore did not consider this in their discussion. However, when the RAMIT trial findings are pooled with those of the Cochrane review, additional analysis by Taylor3 concludes that with CR there still remains an average reduction in all-cause mortality of 11% compared to that of usual care. Additionally, Taylor3 suggests that the RAMIT trial provides further data that supports reduced hospitalisation following CR.
Study design.
The RAMIT study required an 8000 sample size (from power calculations) in order to illustrate their primary endpoint of 2 year all-cause mortality, but due to funding cuts were unable to recruit to this level. Several respondents (Rashid & Wood4 , Redfern and Clark5, Wood6 and Berger et al7), point out that the final sample size of 1817 patients does not meet this criteria, thus meaning that the sample size was not strong enough to assess the primary endpoint. Rashid & Wood4 further state that the inclusion of ‘elective hospitals’ is ‘inappropriate’ as a method to increase the sample size, and Wood6 adds that this merely serves as a ‘distraction’. Redfern & Clark5 add that over 20% of the intervention group dropped out, therefore not completing the rehabilitation programme and further add that ‘any contamination among controls is unclear’.
Doherty and Lewin8 reiterate the point made by BACPR9 that the RAMIT study did not report CONSORT data (quantifying recruitment and subsequent losses) although subsequently data is produced within a response from the authors of the RAMIT trial, West and Jones10.
Heterogeneity of programmes.
Following extensive audit of 348 cardiac rehabilitation programmes in England, Wales and Northern Ireland over the past 5 years, the National Audit of Cardiac Rehabilitation (NACR) has documented a substantial reduction in patients who were previously sedentary (49% pre CR, 29% at 12 months) and also an increase of 15% in those achieving the recommended guidelines for physical activity, again at 12 months11. As Wood6 points out, the NACR results are consistent with those of a European audit of 12 month outcomes from 22 countries in 200812. The findings of the RAMIT study are not consistent with these results. – one possible explanation is that the RAMIT study was conducted a decade previous to the recent NACR audit and although the RAMIT trial was conducted well, ‘by comparison with the BACR standards of the time these programmes were not fit for purpose’ (Wood6). One of the reasons that NACR was initiated was that it was recognised at the time that not all CR programmes were delivering effective interventions (lack of staffing, resources etc,) and that it was necessary to audit activity and to be able to provide a realistic picture of CR practice in the UK.
Williams and Austin13 make reference to the subject characteristics in the RAMIT trial – they averaged around 64 years of age (not old for this population) and there was no evidence of them being at risk or experiencing anxiety and depression. They also point out that the study provided no evidence of short-term analysis – no assessment immediately post intervention. Results from a study conducted by Williams et al14 with heart failure patients, show that at five years following CR, 71% were still exercising, compared with 51% of those who had no intervention – and the authors further highlight a recent review showing reduced hospital admissions and improved quality of life following hospital based CR15. Again these findings are not consistent with those of the RAMIT trial.
The quality and comprehensiveness of any intervention will determine the outcome of the study. The initial response from the BACPR9 points out that the RAMIT trial took place previous to the original BACR (2007) standards – and although RAMIT claims to evaluate ‘comprehensive cardiac rehabilitation’, encompassing the traditional CR remit of exercise, education and relaxation, the 2007 standards surpassed this, with the addition of cardio-protective therapies, smoking cessation, medical risk factor management amongst many others. The 2012 BACPR Standards and Core Components16 offer an advanced interventional model of comprehensive prevention and rehabilitation.
Wood6 offers the EUROACTION trial as an example of a comprehensive multidisciplinary programme that documented substantial positive lifestyle changes such as reduced consumption of saturated fat, increased intake of fruit and vegetables, decreased smoking relapse and more notably, a difference (34%) between physical activity uptake in those receiving the intervention compared to usual care17. The EUROACTION trial also saw significant improvement in blood pressure control between the intervention and usual care as a result of changing behaviour – something, as noted by Wood6 that was not reported on by the RAMIT authors, despite their focus on secondary prevention.
Exercise component.
Berger and colleagues7 point out that intervention subjects in the RAMIT trial received around ten hours of exercise training within six to eight weeks as compared with recommended guidelines18. They suggest that as the intensity of exercise will determine the success of the intervention, this may be why the RAMIT trial did not produce positive results. They further note that lack of detailed information on the exercise component in the RAMIT trial makes it impossible to generalise the findings of the study, a view already expressed by the BACPR9 and echoed by Conraads et al19 in their response to the RAMIT trial. Conraads and colleagues19 further comment that there is no evidence of pre and post exercise testing, something that could have enhanced our understanding of the results. Doherty and Lewin8 bring our attention to recent observational studies20-23 that suggest that any proven benefit is determined by the dose and mode of intervention and also highlight a review of trials and observational studies that provide evidence of effectiveness of CR24. Taylor3 points out that in the recent Cochrane review2, the CR interventions were heterogeneous in character, including the exercise component. The lack of detail on the intervention in the RAMIT trial makes it difficult to consider this study within the context of current practice.
Optimisation of medication (secondary prevention) in RAMIT trial.
Two respondents to the RAMIT trial point to the sub-optimisation of medication for secondary prevention6,19 that is apparent in the study, with only 65% of both intervention and control patients taking a statin, 43% an ACE inhibitor and 61% a beta-blocker at 12 month follow-up. Berger and colleagues7 suggest that this sub-optimisation may explain to some extent the rather high mortality rate amongst RAMIT trial intervention group (6%) and control group (5.2%) when compared to other studies of 2.2%20 and2.6%25.
References
1. West RR, Jones DA, Henderson, AH. Rehabilitation after myocardial infarction trial (RAMIT): multi-centre randomised controlled trial of comprehensive cardiac rehabilitation in patients following acute myocardial infarction. Heart. 2011 Dec 22. Early view online. (http://heart.bmj.com/content/early/2011/12/21/heartjnl-2011-300302.abstract)
2. Heran BS, Chen JM, Ebrahim S, et al. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Systematic Review 2011;(7):CD001800.
3. Rod S Taylor. The RAMIT trial: its results in the context of 2012 Cochrane review. http://heart.bmj.com/content/98/8/672.2.extract
4. Mohammed A Rashid and David A Wood. The future of Cardiac Rehabilitation in the UK. http://heart.bmj.com/content/98/8/675.1.extract
5. Julie Redfern, Alexander Clark, Lis Neubeck and Tom Briffa. RAMIT: Making sense of its findings and flaws. http://heart.bmj.com/content/early/2011/12/21/heartjnl-2011-300302.short/reply
6. David Wood. Is cardiac rehabilitation fit for purpose in the NHS: maybe not. http://heart.bmj.com/content/98/8/607.extract
7. Thomas Berger, Christian Brenneis and Hannes Alber. Is RAMIT reflecting the real world? http://heart.bmj.com/content/early/2012/05/22/heartjnl-2012-301983.extract
8. Patrick Doherty and Robert Lewin. The RAMIT trial, a pragmatic RCT of cardiac rehabilitation versus usual care: what does it tell us?http://heart.bmj.com/content/98/8/605.extract
9. BACPR Elected Council Members: RAMIT presents an outdated version of cardiac rehabilitation. http://heart.bmj.com/content/98/8/672.1.extract
10. West R, Jones, D. The Authors Reply. Heart 2012;98:673-674. http://heart.bmj.com/content/98/8/673.2.extract
11. National Audit of Cardiac Rehabilitation (NACR). Annual Statistical Report. Vol 5. British Heart Foundation, 2011:6-11.
12. Kotseva K, Wood D, De Backer G, et al: on behalf of EUROASPIRE study group. Use and effects of cardiac rehabilitation in patients with coronary heart disease: results from the EUROASPIRE III survey. European Journal of Preventive Cardiology. In press.
13. Robert Williams and Jackie Austin. Cardiac rehabilitation supports a heterogeneous population of patients. http://heart.bmj.com/content/98/8/673.1.extract
14. Austin J, Williams WR, Hutchinson S. Exercise profile as a 5 year determinant of physical health and well-being in a cohort of heart failure patients. Cardiovascular Continuum 2011;2:1-5.
15. Davies EJ, Moxham T, Rees K et al. Exercise based rehabilitation for heart failure. Cochrane Database Systematic Review 2010;(4):CD003331.
16. BACPR Standards and Core Components for Cardiovascular Disease Prevention and Rehabilitation 2nd Ed. 2012.
17. Wood DA, Kotseva K, Connolly S et al, EUROACTION Study Group. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet 2008;371:1999-2012.
18. Smith SC, Jr., Benjamin EJ, Bonow RO, Braun LT, Creager MA, Franklin BA, et al. AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and other Atherosclerotic Vascular Disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation. Circulation 2011;124(22):2458-73.
19. Conraads VM, Denoliet J, De Maeyer C, Van Craenenbroeck E, Verheyen J, Beckers P. Exercise training as an essential component of cardiac rehabilitation. http://heart.bmj.com/content/98/8/674.extract
20. Hammill BG, Curtis LH, Schulman KA, et al. Relationship between cardiac rehabilitation and long-term risks of death and myocardial infarction among elderly medicare beneficiaries. Circulation 2010;121:63-70.
21. Junger C, Rauch B, Schneider S, et al. Effect of early short-term cardiac rehabilitation after acute ST-elevation and non-ST-elevation myocardial infarction on 1-year mortality. Current Medical Research Opinion 2010;26:803-11.
22. Goel K, Lennon RJ, Tilbury RT, et al. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation 2011;123:2344-52.
23. Suaya JA, Stason WB, Ades PA, et al. Cardiac rehabilitation and survival in older coronary patients. Journal of the American College of Cardiology 2009;54:25-33.
24. Dobson LE, Lewin RJ, Doherty P, et al. Is cardiac rehabilitation still relevant in the new millennium. Journal of Cardiovascular Medicine 2012;13:32-7.
25. Myers J, Prakash M, Froelicher V, Do D, Partington S, Atwood JE. Exercise capacity and mortality among men referred for exercise testing. The New England Journal of Medicine 2002;346(11):793-801.
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