Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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NICE guidelines, the National Stroke Strategy and ABCD2 score
- Dr Daniel Robert Harman, Dr Ahmed Abdul-Hamid (Consultant Stroke Physician) (30 July 2008)
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Initial management of acute stroke: rehabilitation starts on day one
- Andrew O. Frank (4 August 2008)
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Are NICE Stroke Guidelines scientific or political?
- David Barer (7 August 2008)
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Re: Are NICE Stroke Guidelines scientific or political?
- Nigel Dudley (11 August 2008)
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Define a Stroke Unit
- Howard B Abrams (23 August 2008)
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Lack of good evidence in NICE Guidelines for Acute Stroke
- Joseph Kwan (19 September 2008)
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Re: Lack of good evidence in NICE Guidelines for Acute Stroke
- Raymond G Holder (21 September 2008)
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Dr Daniel Robert Harman, Specialist Registrar Geriatric & General Medicine Hull Royal Infirmary, HU3 2JZ, Dr Ahmed Abdul-Hamid (Consultant Stroke Physician)
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The National Stroke Strategy1 was an excellent and ambitious move from the Department of Health for acute and long term management of stroke patients. The recent NICE guidelines2 for the diagnosis and initial management of acute stroke and transient ischaemic attack (TIA) will help implement the National Stroke Strategy. There is no doubt that TIA patients benefit from rapid assessment and immediate anti-platelet treatment to prevent strokes3. We do however have concerns regarding the evidence for the identification and management of high risk TIAs according to ABCD2 score, especially for patients with severe carotid stenosis or atrial fibrillation. ABCD2 and carotid stenosis The NICE guidelines state that all patients with a TIA who are considered as candidates for carotid endarterectomy should have carotid imaging within one week of onset of symptoms. In QM 5 of the National Stroke Strategy it is suggested that all higher- risk patients (e.g. ABCD2 score > 4) should have ‘Carotid Imaging’ within 24hrs of the initial assessment to identify severe carotid artery stenosis that may be amenable to surgery. However in publishing the ABCD2 criteria4, the authors did not disclose the proportion of patients with ABCD2 scores > 4 who did indeed have severe carotid stenosis. In fact only one such study has looked at the relationship between ABCD2 score and carotid stenosis5. This study did not identify a clear relationship between score and the prevalence of > 50% carotid stenosis. Therefore using the ABCD2 score to identify patients for urgent carotid imaging and surgery is not evidenced based and requires further research before it is implemented in the stroke strategy. It may therefore be more pragmatic to adopt the approach as suggested by the NICE guidelines, and not use the ABCD2 score to help decide who to perform carotid imaging on. ABCD2 and recurrent TIAs Of further concern is that the ABCD2 criteria will not identify patients who have recurrent TIAs in the same carotid territory (referred to in the NICE guidelines as ‘Crescendo TIAs’). We welcome the suggestion in the NICE guidance that patients with crescendo TIAs should be seen as high risk of subsequent stroke, and therefore managed the same as those patients with an ABCD2 score >4. However, we would question the evidence base for defining crescendo TIAs as >2 TIAs in 1 week, as 1 week seems a very short duration to include recurrent TIAs in the same carotid territory. Patients who have had recurrent TIAs in the same carotid territory may have an ABCD2 score <4, but the patient is likely to have severe carotid stenosis 6. If QM 5 of the stroke strategy is implemented, such patients will not have ‘carotid imaging’ within 24 hours and yet are more likely to have symptomatic carotid artery stenosis. In addition, if the NICE guidelines are followed, these patients will receive carotid imaging no quicker than other lower risk patients. Conclusion The NICE guidelines and the National Stroke Strategy both provide help when trying to decide who to admit and investigate urgently. We conclude that after commencing urgent anti-platelets therapy in primary care, the practical benefit of admitting TIA patients urgently will depend on either the need for carotid surgery in symptomatic severe carotid stenosis, or anticoagulation in atrial fibrillation. We have no evidence that ABCD2 will identify these two groups of patients5. In addition, whilst there is evidence to support carotid surgery performed within 2 weeks of a TIA7 (as suggested by NICE guidelines), there is no such evidence available to support the National Stroke Strategy recommendation that carotid surgery should be performed within 48 hours of a TIA or minor stroke. Before we implement resources on admitting high risk TIA patient on ABCD2 criteria alone, further research is needed into the relationship between ABCD2 score and severity of carotid stenosis, the risk of stroke in recurrent TIAs in the same vascular territory, and how quickly to anticoagulate a TIA patient with atrial fibrillation. Yours sincerely Dr Daniel Harman (SpR Geriatric Medicine), Dr Ahmed Abdul-Hamid (Consultant Stroke Physician), References 1. Department of Health/Vascular Programme/Stroke. National Stroke Strategy. Available at www.dh.gov.uk. Gateway ref 9025. 5th Dec 2007. 2. National Institute fro Health and Clinical Excellence. Stroke: the diagnosis and initial management of acute stroke and transient ischaemic attack. 2008 (Clinical guideline 68.) 3. Rothwell PM, Giles MF, Chandratheva A, Marquardt L, Geraghty O, Redgrave JNE, Lovelock CE, Binney, LE, Bull LM, Cuthbertson FC, Welch SJV, Bosch S, Carasco-Alexander F, Silver LE, Gutnikov SA, Mehta Z. Effect of urgent treatment of transient ischaemic attack and minor stroke on early recurrent stroke (EXPRESS study): a prospective population-based sequential comparison. Lancet 2007; 370: 1432-42. 4. Claiborne Johnston S, Rothwell PM, Nguyen-Huynh MN, Giles MF, Elkins JS, Bernstein AL, Sidney S. Validation and refinement of scores to predict very early stroke risk after transient ischaemic attack. Lancet 2007; 369: 283-92. 5. Rothwell PM, Koton S. Performance of the ABCD and ABCD2 scores in TIA patients with carotid stenosis and atrial fibrillation. Cerebrovascular Diseases 2007; 24 (2-3): 231-5. 6. Kim SH, Han SW, Heo JH. Predictive implications of recurrent transient ischemic attacks in large-artery atherosclerosis. Cerebrovascular Diseases 2006; 22: 240-44. 7. Rothwell PM, Eliasziw M, Gutnikov SA, Warlow CP, Barnett HJM. Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery. Lancet 2004; 363:915-24. Competing interests: None declared |
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Andrew O. Frank, Consultant in Rehabilitation Medicine Northwick Park Hospital, HA1 3UJ
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Whilst recognising that the Department of Health instruction to NICE may have been restrictive [1], nevertheless appropriate initial stroke management includes psychosocial and environmental management in addition to the medical, physical and surgical options listed by NICE [2]. Rehabilitation should start at the beginning of a clinical episode – not as a bolt-on [3]. Two areas of practice should be routine when admitting an acute stroke to hospital. Firstly, family and friends (who may shortly have their lives transformed into ‘carers’) need reassurance, not only of high quality hospital care, but also of high quality community support after discharge – preferably through a co-ordinated stroke pathway. Ideally they should meet early in their hospital stay an individual who will be in a position to provide support both in and out of hospital. Although such support given by care assistants has been proven cost-effective in a cohort of elderly people on discharge from hospital (although not necessarily having had a stroke) [4], the modern approach would be to use a professionally qualified case manager to cross the hospital-community divide. Secondly, patients and their families need to be advised not to precipitately make decisions about an (in)ability to return to work. As individuals work later in life, so the proportion of stroke patients having stroke within their working lives will increase. Patients/families should be advised to contact their employers early to inform them of the situation and to suggest that decisions about a potential return to work are best made later during the rehabilitation period. It is to be hoped that NICE will address these issues in more depth in future work – which should address all stages of the rehabilitation process from the post-acute hospital rehabilitation, discharge planning, early community rehabilitation and the later stages of community support. This is required to ensure individuals who have experienced a severe stroke are supported through dependency and depression to be re-integrated into their community in terms of ‘contributing’ through work or other worthwhile activities. Reference List (1) Rodgers H, Sudlow M. Commentary: controversies in NICE guidance on acute stroke and transient ischaemic attack. BMJ 2008; 337(2 August):294. (2) Swain S, Turner C, Tyrrell P, Rudd A, Guideline Development Group. Guidelines. Diagnosis and initial management of acute stroke and transient ischaemic attack: summary of NICE guidance. BMJ 2008; 337(2 August):291-293. (3) Frank AO, Chamberlain MA. Rehabilitation: an integral part of modern medical practice. Occupational Medicine (Oxford) 2006; 56(5):289- 291. (4) Townsend J, Piper M, Frank AO, Dyer S, North W, Meade TW. Reduction of hospital readmission stay of elderly patients by a community- based hospital discharge scheme: a randomised controlled trial. BMJ 1988; 297:544-547. Competing interests: Andrew Frank is Chair of the Vocational Rehabilitation Special Interest Group of the British Society of Rehabilitation Medicine, Vice Chair of the Vocational Rehabilitation Association and Medical Director of Kynixa Ltd, a rehabilitation company |
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David Barer, Consultant / Professor in Stroke Medicine Queen Elizabeth Hospital, Gateshead NE9 6SX
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After years of shameful neglect, the National Health Service is at last starting to take stroke care seriously. There is no doubting the commitment behind the English National Stroke Strategy [1], and the NICE guidelines [2], summarised by Sharon Swain and colleagues (BMJ 2008;337:a786, 24 July ), should have provided the detailed evidence to underpin the necessary reforms. Yet the enthusiasm of those of us who have worked in the specialty during the lean years will be mixed with dismay at the opportunities wasted and old mistakes repeated. After first declaring an intention not to impose arbitrary targets, which might distort incentives and drive the reform process off course, the DoH has done just that with its ‘Stroke Vital Signs’. These targets, which stipulate that all stroke patients should spend at least 90% of their inpatient stay on stroke units and that ‘high risk TIAs’ should be assessed, scanned and ‘treated’ within 24 hours of referral, are so vaguely defined as to make valid data collection impossible. Thus, as Rodgers and Sudlow point out (BMJ 2008;337:a833 ), there will be a strong temptation to move patients around just to fit the targets (as I found out as Physician on-take on the weekend after the guidelines were published) or simply to fiddle the figures. Unfortunately the NICE Guideline Development Group (GDG) has added to the confusion by recommending different time limits for carotid scanning and intervention. They also recommend that high risk TIA patients should have diffusion-weighted MRI scans within 24 hours of referral ‘where the vascular territory or pathology is uncertain’. Clinicians may be used to uncertainty, but it is naďve to expect managers and coding systems to cope with it. Only stroke specialists can sort out the mess and prevent wholesale misdirection of resources, and the prospect of endless meetings to discuss detailed business cases for extra scanning slots is daunting. The evidence cited for the above recommendations by the NICE group is ‘good quality observational studies and the GDG’s opinion’. Of 30 recommendations in the summary report, only 4 (concerning the use of antithrombotic drugs and carotid imaging) are said to be independent of the group’s opinion, while 17 are based on opinion alone. This is a subtlety likely to be overlooked by managers and auditors as they enforce compliance with guidelines backed by the scientific authority of NICE. I do not underestimate the difficulty in applying rigorous science to something as complex and multifaceted as stroke care, but the boundary between evidence and opinion should be made clear. Thus the four stroke physicians on the GDG are taking a great responsibility in imposing their views on the rest of us. Their recommendations will not only require a huge increase in provision of urgent MRI scans, but will force several other changes in practice, some of which are controversial: • the use of a 300mg daily dose of aspirin for 2 weeks after ischaemic stroke. • the need for ‘specialist assessment’ of swallowing within 72 hours in patients with dysphagia, and instrumental investigation after 3 days of tube feeding. and some which appear to be simple misinterpretations of evidence: • the recommendation to use nasogastric feeding tubes within 24 hours of stroke onset in patients with dysphagia. This is based on the GDG’s opinion, ‘supported’ by a large randomised trial [3], which was clearly neutral according to its pre-specified outcome (showing a reduction in mortality, balanced by an increase in severe disability). Blurring the lines between evidence and opinion like this damages the scientific integrity of NICE and raises fears that its authority could be used to serve a political agenda: concentration of acute stroke care into large regional centres with the resources to meet the GDG recommendations and provide a ‘24/7’ service. Such a policy is likely to do serious damage to stroke services in medium sized hospitals and to compromise care for at least 90% of stroke patients, who are unsuitable for hyperacute treatments such as thrombolysis. Yours faithfully David Barer
1. Department of Health/Vascular Programme/Stroke. National Stroke Strategy. Available at www.dh.gov.uk. Gateway ref 9025. 5th Dec 2007. 2. National Institute for Health and Clinical Excellence. Stroke: the diagnosis and initial management of acute stroke and transient ischaemic attack. 2008 (Clinical guideline 68.) www.nice.org.uk/CG68 3. Dennis M, for FOOD Trial Collaboration. Effect of timing and method of enteral tube feeding for dysphagic stroke patients (FOOD): a multicentre randomised controlled trial. Lancet 2005; 365: 764-72 Competing interests: None declared |
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Nigel Dudley, Consultant in Elderly / Stroke Medicine St James's University Hospital, LEEDS. LS9 7TF
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David Barer is right to point out that "Blurring the lines between evidence and opinion like this damages the scientific integrity of NICE and raises fears that its authority could be used to serve a political agenda:..". By extension, this statement could also be seen to apply to the Royal College of Physicians (RCP) that incorporated the NICE guidlines into the wider stroke guidelines. This concern about the blurring of evidence and potential impact on scientifc integrity of bodies such as NICE / RCP and use of their authority to promote a certain political preference for stroke service development on the basis of opinion appears to be reflected in the "extra points" in information provided to journalists after the conference at which the joint RCP/NICE press statement on their stroke guidelines was released. The BBC and other media organisations were provided with additional information from the press conference the first line of which was, "Approx 4,500 people could be prevented from being disabled through stroke if they were thrombolysed." This 4,500 figure is frankly unbelievable given the Department of Health's own estimate of a 13.1% absolute benefit of recovery to independence (131 per 1000 treated) as it means that some 34,351 patients would have to be given thrombolysis. Similarly, the figure is at odds with those given in the Department of Health's own December 2007 Impact Assessment that indicated 549 would recover to independene with a range of 307 to 792. Who gave this figure of 4,500 to the media? Where did it come from? What purpose was served by it being released in addition to the formal joint RCP/NICE press statement? The "extra points" from the conference continued a little later with, "Further thousands of lives could be saved if all patients were admitted directly to an acute stroke unit (but we do not have a specific figure as not all the variables are known)". What exactly is the evidence basis for this claim made for "an acute stroke unit"? It is also very convenient not to quantify the "futher thousands" figure especially when the Impact Assessment document makes it clear what the public and PCTs can expect from organised stroke care. The claim "acute unit" refers to the type of hyperacute unit where patients can be assessed and given thrombolysis if needs be; as David Barer pointed out, 90% of stroke patients - or more - are not going to be eligible for the treatment; they need good medical and rehabilitation care pathways for their particular needs. The final claim in the "extra points" that "We do not need any more resources to fulfil the recommendations, just better organisation of what we have already" would frankly leave reasonable and informed members of the public, PCTs and politicians rubbing their eyes in disbelief. The Department of Health's Impact Assessment document and the Costing Report that accompanied the NICE stroke guidelines make it very clear that more resources are required in the NHS to deliver the recommendations. Such claims made to the reputable journalists, such as those at the BBC, that then escape into the public domain via newspaper reports and online publications need justification and clarification. The evidence base for such seemingly important claims needs to be fully and clearly disclosed so as to maintain credibility of the authority of the guidelines. Competing interests: None declared |
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Howard B Abrams, Division Head, Internal Medicine, UHN/MSH Toronto Toronto General Hospital, EN 14-216, 200 Elizabeth St., Toronto, ON Canada, M5G 2C4
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What is the specific definition and constituent parts of a "Stroke Unit" as cited by the NICE guidelines? Lack of clarity on this continues to produce a variety of arrangements, some of which may not be capable of producing the desired/predicted outcomes.
Competing interests: None declared |
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Joseph Kwan, Consultant in Stroke Medicine Royal Bournemouth Hospital
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I too have grave concerns over the ways that DoH and NICE have produced their latest guidelines for acute stroke. I agree with David Barer's and Nigel Dudley's comments that a significant proportion of recommendations are based on "GDG's opinion". This is totally contrary to the ethos of NICE, which prides itself in being highly evidece-based and unbiased. Very controversial recommendations are too many to mention, but examples include 1) routine use of aspirin 300mg for 2 weeks, 2) treating patients with stroke secondary to antiphospolipid syndrome in the same way as those without the syndrome, 3) avoidance of statins in the first two days of stroke, and 4) using aspirin rather than warfarin in stroke patients with prosthetic heart valves. The total confusion regarding timing of carotid imaging and surgery, as well as post-TIA neuroimaging, are just the presenting symptom of the disjointed working between "experts" and GDGs. It is better to simply admit that high quality evidence is unavailable for certain aspects of stroke care, and we physicians can use our clinical judgements in deciding what is the best for our own patients. Controversial recommendations which are not based on good evidence are unhelpful, possible harmful, and divert attention and resources to unproven clinical practice. Competing interests: None declared |
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Raymond G Holder, Long retirwed engineer Home BH9 3NF
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Joseph Kwan mentioned (seemingly disparagingly)the guideline relating to refraining from statin use within 3 days of stroke onset. I have a personal take on this matter, having been admitted to the Bournemouth stroke unit some 3 years ago, and having been dependant on Coenzyme Q10 supplementation after statin damage at the time. I had been aware that work on rapid treatment with Q10 after stroke had been found of great benefit in USA trials, but thought I would let the experienced medical staff do their best for me. I had left my Q10 at home, but the consultant, not Dr Kwan, said I should start taking a statin. In view of my previous damage from a statin, I said I would only take it if I could also take my Q10 (and carnitine, as my CK was elevated). Soon after, the statin caused me problems, and I stopped taking it. There seemed little point in taking fairly expensive (at that time) Q10 and taking a statin which only reduced my own manufacture of it, and problems were again becoming evident. My point is, that Q10 seems to prevent some stroke damage if taken soon after the stroke, but a statin given at that time will reduce normal Q10 production, and thus will be counter effective in this respect. The PROSPER trial of statins in elderly people found no benefit at all with respect to stroke, so their use is more theoretical than real, and there are the side effects so little recognised by biassed NICE GDL writers. I now wish that I had insisted on continuing taking my Q10 from the moment I entered the stroke ward, instead of waiting for authority to sanction its use, I might have been spared some of the disability which followed. I feel strongly that my stroke was not the result of my TC figure of 8, but due more to the stress of looking after my late wife, who had Altzheimer's, virtually without assistance, 24/7, in my weakened statin damaged state. There are many simple treatments for the ills of today, without involving drugs whose benefit is mainly to the drug manufacturers' financial advantage, and have endless side effects. Research appears to be directed more to continue that benefit, rather than to explore those of unpatentable life necessities at more reasonable cost and without such unwanted detrimental effects. Competing interests: Statin and stroke damaged patient |
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