ISAT and ISUIA: the impact on informed consent.
The International Subarachnoid Aneurysm Trial (ISAT) was a multicenter randomized trial that compared the safety and efficacy of endovascular coil treatment versus surgical clipping for the treatment of ruptured brain aneurysms. To be eligible for enrollment in the ISAT trial, each patient had to be deemed equally suitable for either coiling or clipping. The investigators used the term "clinical equipoise" to describe this balance. This study more than any other has set the playing field for the future of interventional radiology/endovascular neurosurgery politics.
Murphy
Kieran
K
Department of Radiology and Neurosurgery, Johns Hopkins Medical Institution, Baltimore, MD 21287, USA. kmurphy@jhmi.edu
D017542:Aneurysm, Ruptured / Q000145:classification / Q000601:surgery / Q000628:therapy*; D004621:Embolization, Therapeutic; D006801:Humans; D007258:Informed Consent; D002532:Intracranial Aneurysm / Q000145:classification / Q000601:surgery / Q000628:therapy*; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D019635:Neurosurgical Procedures; D010353:Patient Education as Topic; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment