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Nigel Dudley, Consultant in Elderly / Stroke Medicine St James's UNiversity Hospital, LEEDS LS9 7TF
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Rather than acknowledge that the claim “Approx 4,500 people could be prevented from being disabled through stroke if they were thrombolysed” was simply wrong and was contradicted by the published evidence from Cologne’s “hub and spoke” model of thrombolysis delivery, the Department of Health’s own December 2007 Impact Assessment document and Boehringer- Ingelheim’s evidence to NICE in relation to the Alteplase appraisal, the NICE / RCP stroke guidelines groups, through their chairman, claimed that there had been a misunderstanding of “where this figure comes from”.[1-5] The claim was revised to one indicating that there would be “about 2550 patients who would be less disabled each year if thrombolysis alone was used appropriately” and “a further 2080 patients would be saved from death or disability” if admitted directly to a stroke unit. The claim was that “If these two figures are added together then the number achieved is 4630 which is fairly close to the 4,500 patients quoted in the press.” The correction circulated to the media on behalf of the NICE / RCP stroke guidelines groups on 14 August read: “Approx 4,500 people could be prevented from being disabled through stroke if they were thrombolysed”, should have made it clear that this figure also included the impact of admitting all acute patients directly to a stroke unit. The 4,500 figure is calculated from the joint effect of these two activities, not thrombolysis alone.” NICE and its independent statisticians has been asked to examine these claims made by the NICE / RCP stroke guidelines groups to see if they fairly and accurately reflect the evidence and are supported by the evidence. There must be concerns here about real or apparent bias when members of the stroke guidelines group are also members of the group leading the National Stroke Strategy that is promoting specialist, centralised stroke services over other possible models of stroke care. The latest Cochrane review on organised stroke care in section 3 on page 6 shows that there is no additional benefit to a monitoring acute stroke unit of the type that will be found in a specialist stroke centre over and above the normal acute stroke unit found in most district general hospitals.[6] In addition, as Helen Rodgers and Mark Sudlow pointed out in their commentary on the NICE guidelines, NICE has gone beyond the evidence. This is not a good basis for the world class commissioning of services in the NHS that requires decisions and choices to be made on sound evidence not biased optimism. There now have to be explanations provided by NICE as to why certain claims are being made by the NICE / RCP guidelines group about stroke outcomes that appear to disregard the published evidence; lessons can and should be learned for future NICE guideline production.[7] [1] Tyrrell P. Thrombolysis: How the NHS can learn from the European experience. Geriatric Medicine, May 2000: 10-12 [2] Grond M, Stenzel C, Schmulling S et al. Early intravenous thrombolysis for acute ischaemic stroke in a community-based approach. Stroke 1998:1544-1549 [3] Sobesky J, Frackowiak M, Weber OZ et al. The Cologne Stroke Experience: Safet and Outcome in 450 patients treated with intravenous thrombolysis. Cerebrovasc Dis 2007;24:56-65 [4] Department of Health (2007). Impact Assessment. A new ambition for stroke. Department of Health [5] Manufacturer Submission. www.nice.org.uk/nicemedia/pdf/StokeAteplFADMS.pdf (accessed 16/06/2008) [6] Stroke Unit Trialists’ Collaboration. Organised inpatient (stroke unit) care for stroke. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No: CD000197.DOI:10.1002/14651858.CD000197.pub2. [7] Rodgers H, Sudlow M. Commentary: Controversies in NICE guidance on acute stroke and transient ischaemic attack. BMJ 2008;337:a833 Competing interests: None declared |
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