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The 2018 ter Brugge Lecture: Problems with the Introduction of Innovations in Neurovascular Care

  • Jean Raymond (a1), Robert Fahed (a2), Daniel Roy (a1) and Tim E. Darsaut (a3)

Abstract:

Most endovascular innovations have been introduced into clinical care by showing good outcomes in small enthusiastic case series of selected patients. Randomized clinical trials (RCTs) have rarely been performed, except for acute ischemic stroke, but even then most trial designs were too explanatory to inform clinical decisions. In this article, we review 2 × 2 tables and forest plots that summarize RCT results to examine methodological issues in the design and interpretation of clinical studies. Research results can apply in practice when RCTs are all-inclusive, pragmatic trials. Common problems include the following: (i) using restrictive eligibility criteria in explanatory trials, instead of including the diversity of patients in need of care, which hampers future generalizability of results; (ii) ignoring an entire line of the 2 × 2 table and excluding patients who do not meet the proposed criteria of a diagnostic test in its evaluation (perfusion studies) which renders clinical inferences misleading; (iii) ignoring an entire column of the 2 × 2 table and comparing different patients treated using the same treatment instead of different treatments in the same patients (the “wrong axis” comparisons of prognostic studies and clinical experience) which leads to unjustified treatment decisions and actions; or (iv) combining all aforementioned problems (case series and epidemiological studies). The most efficient and reliable way to improve patient outcomes, after as well as long before research results are available, is to change the way we practice: to use care trials to guide care in the presence of uncertainty.

La conférence Karel ter Brugge 2018: Les problèmes liés à l’introduction des innovations endovasculaires en matière de soins neurologiques. La plupart des innovations endovasculaires ont été adoptées en pratique clinique parce que de petites séries de cas enthousiastes avaient montré de bons résultats. Des essais cliniques randomisés (ECRs) ont rarement été effectués, à l’exception des accidents ischémiques cérébraux (AIC) aigus, mais même dans ce cas la plupart des études étaient trop explicatives pour guider la prise de décisions cliniques. Dans cet article, nous passons en revue les tableaux 2 × 2 et les graphiques en forêt qui résument les résultats des ECRs. Notre objectif est d’examiner les problèmes méthodologiques liés à la conception et à l’interprétation des ECRs. Des résultats de recherche peuvent être appliqués en pratique lorsque les études sont inclusives et pragmatiques. Parmi les problèmes les plus fréquemment observés mentionnons: i) l’utilisation dans le cadre d’essais explicatifs de critères restreignant l’admissibilité à l’étude au lieu d’inclure toute la diversité des patients nécessitant des soins, ce qui nuit à la généralisabilité future des résultats; ii) le fait d’ignorer une ligne du tableau 2 × 2 et d’exclure les patients qui ne satisfont pas aux critères d’un test diagnostic qu’on cherche à évaluer (les études de perfusion cérébrale), ce qui induit en erreur les décisions cliniques; iii) le fait d’ignorer une colonne entière du tableau 2 × 2 et de comparer entre eux divers patients soignés au moyen du même traitement au lieu de comparer les résultats de divers traitements chez les mêmes patients (la comparaison fallacieuse des études pronostiques et de l’expérience clinique), ce qui conduit à des décisions cliniques et des mesures thérapeutiques injustifiées; iv) la conjugaison des erreurs ci-haut mentionnées dans les séries de cas ou les études épidémiologiques. La façon la plus efficace et la plus fiable d’améliorer le sort des patients, que ce soit après ou avant que les résultats de la recherche soient disponibles, est de modifier nos pratiques en utilisant des ‘études de soins’ pour guider nos interventions cliniques en contexte d’incertitude.

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Corresponding author

Correspondence to: Jean Raymond, Service of Neuroradiology, Department of Radiology, Centre Hospitalier Universitaire de Montréal – CHUM, Room D03-5462B, 1000 Saint-Denis Street, Montreal, QC, Canada H2X 0C1. Email: jean.raymond@umontreal.ca.

Footnotes

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The present manuscript is a transcription of the Karel ter Brugge lecture given at the Canadian Neurological Sciences Federation 53rd meeting in Halifax on Monday June 25th 2018.

Footnotes

References

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