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BACPR Response to RAMIT Study
A study has been published at HeartOnline which has caused a great deal of concern among members. The study by West et al.1(abstract below) is of a randomised controlled trial of cardiac rehabilitation (CR) that recruited patients from 14 hospitals from 1997 – 2000. Centres were identified via a survey and had to be willing to randomise patients to receive (or not) a cardiac rehabilitation programme. Consequently in this study of 1813 patients, half were randomised to CR, and half were randomised to usual care without CR. The patients were followed up for up to 9 years. The study found no difference on the vast majority of measures including deaths from any cause, quality of life or psychological well-being. The abstract to the study concludes: “The value of cardiac rehabilitation as practised in the UK is open to question.”
Members have already received comments about this study from cardiologist colleagues and managers, and in these times of members receiving threats of cuts to services, this paper has the potential to be damaging. So what arguments can you give as a response if queried about this study?
1. The study does not reflect the findings of the latest systematic review.
The results of any single trial should always be handled with caution. Systematic reviews are at the very top of the hierarchy of evidence, as they combine the results of similar studies, and are considered stronger evidence than a single randomised controlled trial.2
In the background to their study, West et al. gave the view that the evidence for the effect of CR on mortality is out of date. However, they did not include the systematic review published last year by the Cochrane Heart Group.3
The Cochrane review3 included 47 studies with over 10,000 patients, and the evidence continued to demonstrate that CR reduces death from any cause by 13% and reduces cardiac deaths by 26%. (The West et al. study does not report effect on cardiac deaths).
Because of the large numbers of patients already included in the Review analysis, adding in the results from this study is not likely to have a great effect on the Review findings. The authors of the Cochrane Review are going to reassess their findings including the West et al. study, and will be reporting these for publication in Heart.
2. The study does not give the details that are needed to fully assess the evidence.
The usefulness of any study and its application to practice should always be determined by its quality. The report of the study by West et al. does not include sufficient detail in relation to its methodology which makes it difficult for us to fully assess its worth. They do not adequately describe the programmes, so we have no real idea of the components of the programmes (the programmes are reported to include exercise, education and relaxation but there are insufficient details of the format, frequency or intensity of the exercise, and most did not include stress management). The numbers of people recruited per programme were small. 1813 people may sound a large number, but this was from 14 centres – so only approximately 130 people per hospital, and this was over 32 months, so very small numbers per year, only half of which would receive CR. So we have no real idea of uptake of CR within the hospitals in the study, nor of numbers of people who refused to participate. If large numbers refused then this would mean that the study may not reflect the people who usually attended CR. We also have no idea of how many people in the study completed their full CR programme.
3. The findings don’t reflect current findings from the National Audit.
There are anomalies in the results when compared to the findings of the National Audit for Cardiac Rehabilitation (NACR). In the West et al. study, the people who attended CR were exercising less at 12 months than they had been at the start of the programme, but in the latest results from NACR(which reports on 60% of the CR programmes in Britain), people reported doing significantly more exercise 12 months after being referred to CR.4
4. Is your CR programme more than exercise, education and relaxation?
An intervention is only as good as its design and implementation. The intervention described is a very traditional view of CR (exercise, education and relaxation). This is not how the BACPR defines ‘comprehensive’ CR. It is important to note that there has traditionally been gross under-funding of CR and the lack, until recently, of core standards for provision. The data presented in West et al. is 12-15 years old and precedes the 2007 BACR standards which extended beyond ‘exercise, education and relaxation’ and included smoking cessation, diet and weight management, medical risk factor management, cardioprotective therapies and much more. This report shows absolutely no effect in any of these measures but we know little about the inclusion of these important aspects as part of the ‘comprehensive care’ described. Our 2012 BACPR standards build on the success of the 2007 edition with clear inclusion of comprehensive prevention and rehabilitation interventions.
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. [Epub ahead of print]
2. Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-based medicine: how to practice and teach EBM, 3rd ed. Philadelphia: Elsevier Churchill Livingstone, 2005.
3. Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800.
4. Lewin RJP, Petre C, Dale V, Onion N, Mortzou G. The National Audit of Cardiac Rehabilitation: Annual Statistical Report 2011. London, British Heart Foundation 2011 www.cardiacrehabilitation.org.uk/nacr
ABSTRACT: 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. [Epub ahead of print]
Background:
It is widely believed that cardiac rehabilitation following acute myocardial infarction (MI) reduces mortality by approximately 20%.This belief is based on systematic reviews and meta-analyses of mostly small trials undertaken many years ago. Clinical management has been transformed in the past 30-40 years and the findings of historical trials may have little relevance now.
Objectives:
The principal objective was to determine the effect of cardiac rehabilitation, as currently provided, on mortality, morbidity and health-related quality of life in patients following MI. The secondary objectives included seeking programmes that may be more effective and characteristics of patients who may benefit more.
Design, setting, patients, outcome measures:
A multi-centre randomised controlled trial in representative hospitals in England and Wales compared 1813 patients referred to comprehensive cardiac rehabilitation programmes or discharged to 'usual care' (without referral to rehabilitation). The primary outcome measure was all-cause mortality at 2 years. The secondary measures were morbidity, health service use, health-related quality of life, psychological general well-being and lifestyle cardiovascular risk factors at 1 year. Patient entry ran from 1997 to 2000, follow-up of secondary outcomes to 2001 and of vital status to 2006. A parallel study compared 331 patients in matched 'elective' rehabilitation and 'elective' usual care (withoutrehabilitation) hospitals.
Results:
There were no significant differences between patients referred to rehabilitation and controls in mortality at2 years (RR 0.98, 95% CI 0.74 to 1.30) or after 7-9 years (0.99, 95% CI0.85 to 1.15), cardiac events, seven of eight domains of the health-related quality of life scale ('Short Form 36', SF36) or the psychological general well-being scale. Rehabilitation patients reported slightly less physical activity. No differences between groups were reported in perceived overall quality of cardiac aftercare. Data from the 'elective' hospitals comparison concurred with these findings.
Conclusion:
In this trial, comprehensive rehabilitation following MI had no important effect on mortality, cardiac or psychological morbidity, risk factors, health-related quality of life or activity.This finding is consistent with systematic reviews of all trials reported since 1983. The value of cardiac rehabilitation as practised in the UK is open to question.
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