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• W2016056009 abstract "Authors' replySir—We agree with the points made by Wil Hoefnagels. We have argued that the overall results of clinical trials cannot be generalised to all individual patients,1Rothwell PM Generalisability of the results of large randomised clinical trials.J Nephrol. 1997; 10: 1-2Google Scholar and we have shown previously that carotid endarterectomy is likely to be ineffective or harmful in most patients with recently symptomatic 70–99% carotid stenosis.2Rothwell PM Can overall results of clinical trials be applied to all patients?.Lancet. 1995; 345: 1616-1619Summary Full Text PDF PubMed Scopus (253) Google Scholar The difficulty has been in identifying exactly which patients will benefit (ie, predicting in advance which patients have a high risk of stroke on medical treatment and a low operative risk).The simple risk score in our paper goes some way to achieving this. However, we agree that more powerful and more detailed models are required. We did include preliminary versions of such models in our paper (tables 5 and 6), but these need to be validated on independent datasets before they are used in practice. We are in the process of validating these models and developing more definitive models in collaboration with the North American Symptomatic Carotid Endarterectomy Trial (NASCET) group3North American Symptomatic Carotid Endarterectomy Trialists' Collaborative Group.The final result of the NASCET trial.N Engl J Med. 1998; 339: 1415-1425Crossref PubMed Scopus (2991) Google Scholar and the Veterans Administration (VA#309) trial group.4Mayberg MR Wilson E Yatsu F et al.Carotid endarterectomy and prevention of cerebral ischaemia in symptomatic carotid stenosis.JAMA. 1991; 266: 3289-3294Crossref PubMed Scopus (828) Google Scholar Each of the risk factors cited by Hoefnagels will certainly be included in the modelling process.The mean numbers needed to treat and numbers needed to harm that Hoefnagels reports may be a little confusing. First, the risks quoted (stroke and death at 3 years) are derived from patients with 80–99% stenosis and not 70–99% stenosis.5European Carotid Surgery Trialists' Collaborative Group.Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST).Lancet. 1998; 351: 1379-1387Summary Full Text Full Text PDF PubMed Scopus (2935) Google Scholar Second, that the values are identical suggests, at first glance, that endarterectomy is of no overall benefit in patients with recently symptomatic 80–99% stenosis. This is not the case because the immediate risk of surgery (7% major stroke, number needed to harm therefore 100/7=14) is traded against the risk of major stroke in patients with 80–99% stenosis who were randomly assigned medical treatment. This risk was 26·5% at 3 years.There are other numbers that can be derived from studies such as these: the number needed to neglect (the number of patients that it would be necessary not to treat for a stroke to occur on medical treatment only [just under four in this case]); and the number treated pointlessly (the number of patients who are treated who would have done well had they not been treated [100%–26·5% in this case, ie, three of four]). However, the profusion of these various summary statistics often serves more to confuse than to inform, and with the possible exception of number needed to treat, clinicians could probably manage without them. Even numbers needed to treat are somewhat over-simplistic and cannot necessarily be applied to populations other than those in which the trials were done. Authors' reply Sir—We agree with the points made by Wil Hoefnagels. We have argued that the overall results of clinical trials cannot be generalised to all individual patients,1Rothwell PM Generalisability of the results of large randomised clinical trials.J Nephrol. 1997; 10: 1-2Google Scholar and we have shown previously that carotid endarterectomy is likely to be ineffective or harmful in most patients with recently symptomatic 70–99% carotid stenosis.2Rothwell PM Can overall results of clinical trials be applied to all patients?.Lancet. 1995; 345: 1616-1619Summary Full Text PDF PubMed Scopus (253) Google Scholar The difficulty has been in identifying exactly which patients will benefit (ie, predicting in advance which patients have a high risk of stroke on medical treatment and a low operative risk). The simple risk score in our paper goes some way to achieving this. However, we agree that more powerful and more detailed models are required. We did include preliminary versions of such models in our paper (tables 5 and 6), but these need to be validated on independent datasets before they are used in practice. We are in the process of validating these models and developing more definitive models in collaboration with the North American Symptomatic Carotid Endarterectomy Trial (NASCET) group3North American Symptomatic Carotid Endarterectomy Trialists' Collaborative Group.The final result of the NASCET trial.N Engl J Med. 1998; 339: 1415-1425Crossref PubMed Scopus (2991) Google Scholar and the Veterans Administration (VA#309) trial group.4Mayberg MR Wilson E Yatsu F et al.Carotid endarterectomy and prevention of cerebral ischaemia in symptomatic carotid stenosis.JAMA. 1991; 266: 3289-3294Crossref PubMed Scopus (828) Google Scholar Each of the risk factors cited by Hoefnagels will certainly be included in the modelling process. The mean numbers needed to treat and numbers needed to harm that Hoefnagels reports may be a little confusing. First, the risks quoted (stroke and death at 3 years) are derived from patients with 80–99% stenosis and not 70–99% stenosis.5European Carotid Surgery Trialists' Collaborative Group.Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST).Lancet. 1998; 351: 1379-1387Summary Full Text Full Text PDF PubMed Scopus (2935) Google Scholar Second, that the values are identical suggests, at first glance, that endarterectomy is of no overall benefit in patients with recently symptomatic 80–99% stenosis. This is not the case because the immediate risk of surgery (7% major stroke, number needed to harm therefore 100/7=14) is traded against the risk of major stroke in patients with 80–99% stenosis who were randomly assigned medical treatment. This risk was 26·5% at 3 years. There are other numbers that can be derived from studies such as these: the number needed to neglect (the number of patients that it would be necessary not to treat for a stroke to occur on medical treatment only [just under four in this case]); and the number treated pointlessly (the number of patients who are treated who would have done well had they not been treated [100%–26·5% in this case, ie, three of four]). However, the profusion of these various summary statistics often serves more to confuse than to inform, and with the possible exception of number needed to treat, clinicians could probably manage without them. Even numbers needed to treat are somewhat over-simplistic and cannot necessarily be applied to populations other than those in which the trials were done. Carotid surgery can be hazardous for your healthPeter Rothwell and Charles Warlow (June 19, p 2105)1 are right that we need better prediction models of who will benefit from carotid surgery and who will be harmed. Indeed, surgery is of no value in 80% of patients who, despite having severe symptomatic stenosis, will remain stroke-free on medical treatment alone, but that is not how the medical community has interpreted the trials. Carotid surgery is increasing, even for symptomless cases.2 Full-Text PDF" @default.
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• W2016056009 title "Carotid surgery can be hazardous for your health" @default.
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