Programme : Ethical review boards: are they important ethical safeguards or over-burdensome and unnecessary bureaucracy? : Abstract of presentation
Demanding informed consent from critically ill patients may result in discrimination: A case report from a study on patients with ruptured aortic aneurysm
Martin Björck
Uppsala University, Dep of Surgical Sciences, Uppsala, Sweden
Background: Ruptured abdominal aortic aneurysm (rAAA) is one the most common causes of preventable death, 700-1.000 fatalities/year in Sweden. Most patients lack symptoms before rupture. Many do not arrive alive to hospital, and mortality among those operated on is high.
Methods: The classical method to operate is with open surgery, but a new method was developed using stentgrafts deployed through a puncture of the femoral arteries. This method, EVAR, EndoVascular Aneurysm Repair, is today used in a half the elective operations in Sweden. It is more problematic to use EVAR in an emergent setting, however, since patients need to be examined first with CT. In 20-30% EVAR is not possible to deploy due to technical problems. Patients treated for rAAA with EVAR do better in non-randomized studies, but the patient groups are different. Patients treated with EVAR have less hostile anatomy, and are more circulatory stable. Patients among whom the operation is delayed by a CT, and are found not suitable for EVAR, have worst outcome. The only way to answer the question which primary strategy is the best is a randomized control trial.
Results: The IMPROVE trial (Immediate Management of Patient with Ruptured aneurysm: Open Versus Endovascular repair) was initiated in the UK. Four Swedish hospitals were invited to participate. Patients with rAAA often suffer severe pain, hypotension and loss of conscience. If they are admitted in company with a relative, he/she is often frightened by the life-threatening situation. Time is short. When we applied for ethical approval of the study we therefore applied with the prerequisite to be able to randomize the patients without prior informed consent in such situations, and to inform afterwards. The application was not granted and the study could not be conducted in Sweden, only in the UK.
Conclusion: We consider this ruling unethical, a discrimination of the sickest patients, who will continue to be treated without evidence base.
Email: martin@bjorck.pp.se
This conference is arranged by Cesagen at the universities of Lancaster and Cardiff and the Centre for Research Ethics & Bioethics at Uppsala University.