Unruptured aneurysms: Why observational studies fall short no matter how “Big” the Data - 31/05/21
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Highlights |
• | We are still and increasingly being proposed that systematic, large prospective registries replace RCTs. |
• | The Big Data approach uses patients and clinicians as passive research subjects in studies planned by outsiders. |
• | Clinicians should participate in proper RCTs. |
Abstract |
Background |
The best management of unruptured intracranial aneurysms (UIAs) remains unknown, despite multiple observational studies. A randomized trial (RCT) is in order. Yet, a National Institute Neurological Disorders and Stroke workshop has once again proposed to use prospective observational studies (POS) of large databases to address such problems.
Methods |
We review the historical misconceptions that have been associated with observations of UIAs and their treatments. We critically examine some recent methods that have been proposed to address shortcomings of observational studies. We finally review the ethical principles underlying the use of trial methods in the care of patients.
Results |
Replacing RCTs with POS submits patients to management options that have never been proven beneficial, while making them involuntary research subjects of studies that are inevitably biased. A science of practice cannot be an outsider's examination of the behavior of clinicians incapable of questioning their practice. The thesis we propose is that a science of practice must not only eventually determine what best practice will be; It must engage agents involved in medical practice to transparently reveal the uncertainty that calls for management options to be offered under the guidance of declared and controlled care research, to optimize patient outcomes in spite of the uncertainty.
Conclusion |
To use POS rather than RCTs in medical practice is to renege on scientific and ethical principles that characterize modern medicine. Instead, we must learn to integrate care research into our practice to provide optimal medical care in real time.
Le texte complet de cet article est disponible en PDF.Keywords : Unruptured aneurysms, Decision making, Observational studies, Randomized trials
Plan
Vol 67 - N° 4
P. 330-335 - juillet 2021 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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