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Critically appraising noninferiority randomized controlled trials: a primer for emergency physicians

Published online by Cambridge University Press:  02 June 2015

Mohammad Al Deeb ,
Aftab Azad  and
David Barbic
Mohammad Al Deeb
Affiliation:
Department of Emergency Medicine, McGill University Health Centre, Montreal, QC Department of Emergency Medicine, King Abdulaziz Medical City, Riyadh, Saudi Arabia
Aftab Azad
Affiliation:
Department of Emergency Medicine, McGill University Health Centre, Montreal, QC Department of Emergency Medicine, Hamad Medical Corporation, Doha, Qatar
David Barbic*
Affiliation:
Department of Emergency Medicine, Sunnybrook Health Sciences Centre, Toronto, ON
*
Correspondence to: Dr. David Barbic, Department of Emergency Medicine, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto,ON M4N 3N5; david.barbic@gmail.com

Abstract

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Noninferiority (NI) trials aim to show that a new treatment or drug is not inferior to a standard, accepted treatment. The rapid proliferation of NI trials within the literature makes it imperative for emergency physicians to be able to read, interpret, and appraise critically this type of research study. Using several emergency medicine examples from the recent literature, this article outlines the key differences between traditional, superiority randomized controlled trials and NI trials. We summarize four important points that an emergency physician should consider when critically appraising an NI trial: 1) Does the new treatment have tangible benefits over the standard treatment? 2) Was the choice of the NI margin appropriate? 3) Was the effect of the standard treatment preserved? Does the trial have assay sensitivity? and 4) What type of analysis strategy was employed: intention-to-treat (ITT) or per protocol (PP)?

Résumé

Les essais de non-infériorité (ENI) visent à démontrer qu’un nouveau traitement ou un nouveau médicament n’est pas inférieur au traitement de référence, reconnu. La prolifération des ENI dans la documentation rend impérative la capacité des urgentologues à comprendre, à interpréter et à évaluer d’un oeil critique ce type de recherche. Ainsi, l’article fera ressortir, à l’aide de plusieurs exemples tirés de la documentation récente en médecine d’urgence, les principales différences qui existent entre le modèle classique d’essai comparatif, hasardisé , de supériorité , et le modèle d’ENI. Seront résumés quatre points importants qu’un urgentologue devrait envisager lorsqu’il évalue de façon critique un ENI: 1) Le nouveau traitement offre-t-il des avantages tangibles comparativement au traitement habituel? 2) Le choix de l’intervalle de non-infé riorité est-il pertinent? 3) L’effet du traitement de référence est-il conservé ? L’essai est-il sensible? 4) Quel type de straté gie d’analyse a été employé : selon l’intention de traiter ou selon le protocole?

Type
Editorial/Commentary
Information
Canadian Journal of Emergency Medicine , Volume 17 , Issue 3 , May 2015 , pp. 231 - 236
Copyright
Copyright © Canadian Association of Emergency Physicians 2015 

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