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Justification of a therapy rests on the criteria of safety,efficacy(net benefit under ideal conditions),effectiveness(net benefit under routine conditions),efficiency(cost-effectiveness or cost benefit),and outcome (proportionality and informed consent).The ethical principal of proportionality states that positive outcomes must be proportional to negative outcomes;only the NINDS trial sets equipoise between risk and benefit.The relative risk to benefit ratio and cost-effectiveness of thrombolysis will likely vary among treating physicians and patient subgroups.Although some potential selection factors such as early CT changes,Nation Institutes of Health Stroke Scale score>22,age>77 hears have been identified,it is not yet possible to predict response to treatment in individual patients.The effectiveness of thrombolysis outside of a clinical trial has not yet been demonstrated,and it is not clear that thrombolysis is cost-effective for all potential patient subgroups.No stroke thrombolysis regimen has met all five justification criteria. Proportional outcome standards take into account patient preferences must be established.The risk to benefit ratio of thrombolysis in patient subgroups requires clarification and should incorporate cost-efficiency analyses.These issues should be kept in mind when considering thrombolysis therapy in patients with acute ischemic stroke and when designing clinical trials. |
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