Literature DB >> 30786939

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

Jean Raymond1, Robert Fahed2, Daniel Roy1, Tim E Darsaut3.   

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.

Entities:  

Keywords:  Randomized trials; Research ethics; Stroke; Thrombectomy

Mesh:

Year:  2019        PMID: 30786939     DOI: 10.1017/cjn.2018.391

Source DB:  PubMed          Journal:  Can J Neurol Sci        ISSN: 0317-1671            Impact factor:   2.104


  6 in total

1.  The RISE trial: A Randomized Trial on Intra-Saccular Endobridge devices.

Authors:  Jean Raymond; Anne-Christine Januel; Daniela Iancu; Daniel Roy; Alain Weill; Andrew Carlson; Tim E Darsaut
Journal:  Interv Neuroradiol       Date:  2019-11-05       Impact factor: 1.610

2.  Flow Diversion in the Treatment of Intracranial Aneurysms: A Pragmatic Randomized Care Trial.

Authors:  J Raymond; D Iancu; W Boisseau; J D B Diestro; R Klink; M Chagnon; J Zehr; B Drake; H Lesiuk; A Weill; D Roy; M W Bojanowski; C Chaalala; J L Rempel; C O'Kelly; M M Chow; S Bracard; T E Darsaut
Journal:  AJNR Am J Neuroradiol       Date:  2022-08-04       Impact factor: 4.966

3.  Ethical care requires pragmatic care research to guide medical practice under uncertainty.

Authors:  Tim E Darsaut; Jean Raymond
Journal:  Trials       Date:  2021-02-15       Impact factor: 2.279

4.  Measuring clinical uncertainty and equipoise by applying the agreement study methodology to patient management decisions.

Authors:  Robert Fahed; Tim E Darsaut; Behzad Farzin; Miguel Chagnon; Jean Raymond
Journal:  BMC Med Res Methodol       Date:  2020-08-25       Impact factor: 4.615

5.  Practicing outcome-based medical care using pragmatic care trials.

Authors:  Tim E Darsaut; Jean Raymond
Journal:  Trials       Date:  2020-10-29       Impact factor: 2.279

6.  Retreatments must be included in the evaluation of device performance.

Authors:  René Chapot; Pascal J Mosimann; Tim E Darsaut; Jean Raymond
Journal:  J Neurointerv Surg       Date:  2020-09-14       Impact factor: 5.836

  6 in total

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