Trial selection criteria should not be used for clinical decisions and recommendations: the thrombectomy trials example - 14/09/24
, William Boisseau a, b, Thanh N. Nguyen c, Tim E. Darsaut dHighlights |
• | Legitimate reasons for restricting trial eligibility are reviewed. |
• | Most thrombectomy trials have been too restrictive, leading to countless acute stroke patients being denied effective, life-saving treatment. |
• | Trial eligibility criteria cannot be used to make recommendations unless they have been shown to reliably categorize patients according to treatment effect. |
Abstract |
Background |
Despite multiple calls for more inclusive studies, most clinical trial eligibility criteria remain too restrictive. Thrombectomy trials have been no exception.
Methods |
We review the landmark trials that have shown the benefits of thrombectomy, their eligibility criteria, and consequences on clinical practice. We discuss the rationale behind various reasons for exclusions. We also examine the logical problem involved in using eligibility criteria as indications for treatment.
Results |
Most thrombectomy trials have been too restrictive. This has been shown by a plethora of follow-up studies that have refuted most of the previously recommended trial eligibility restrictions. Meanwhile, the effect of clinical recommendations based on restrictive eligibility criteria is that treatment has been denied to the majority of patients who could have benefitted. Trial eligibility criteria cannot be used to make clinical decisions or recommendations unless, like any other medical diagnosis, they have been shown capable of reliably differentiating patients into those that will, and those that will not benefit from treatment. This goal can only be achieved with all-inclusive pragmatic trials.
Conclusion |
Restrictive eligibility criteria render clinical trials incapable of guiding medical decisions or recommendations.
Le texte complet de cet article est disponible en PDF.Keywords : Mechanical thrombectomy, Acute stroke, Randomized trials, Selection criteria, Iatrogenic morbidity, Trial methodology
Plan
Vol 70 - N° 6
Article 101587- novembre 2024 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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