Literature DB >> 25042688

Pragmatic trials can be designed as optimal medical care: principles and methods of care trials.

Jean Raymond1, Tim E Darsaut2, Douglas G Altman3.   

Abstract

OBJECTIVES: The way clinical research and care are currently separated encourages the practice of unverifiable medicine. Some pragmatic trials can be designed (1) to guide proper medical conduct in the presence of uncertainty and (2) to govern the distinction between unvalidated and validated care.
METHODS: Care trials are simple randomized trials integrated into a practice they regulate in the interest of present patients. The fundamental principle guiding the design of a care trial is the protection of the patient being offered medical care that has not yet been validated. Selection criteria are inclusive, to assist most current patients confronted with the problem. The trial entails no extra tests or risks beyond what is proven beneficial. Endpoints are pre-defined, simple, valuable and resistant to bias. Follow-up visits and tests are routine. Data is collected in simple case-report forms.
RESULTS: Care trials protect present patients from both unverifiable medicine and research performed for extraneous interests. They provide prudent care when evidence is lacking. They should not be obstructed by the need for separate funding, or by bureaucracy.
CONCLUSION: Care trials can identify which medical alternative should be standard therapy. In the meantime, they provide optimal care in the presence of uncertainty.
Copyright © 2014 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Clinical practice; Clinical trials; Evidence-based medicine; Methodology; Pragmatic trials; Research ethics

Mesh:

Year:  2014        PMID: 25042688     DOI: 10.1016/j.jclinepi.2014.04.010

Source DB:  PubMed          Journal:  J Clin Epidemiol        ISSN: 0895-4356            Impact factor:   6.437


  15 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.  Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM): Study protocol of a randomised controlled trial.

Authors:  Robert Fahed; Tim E Darsaut; Charbel Mounayer; René Chapot; Michel Piotin; Raphaël Blanc; Vitor Mendes Pereira; Daniel G Abud; Dana Iancu; Alain Weill; Daniel Roy; Lorena Nico; Suzanne Nolet; Guylaine Gevry; Jean Raymond
Journal:  Interv Neuroradiol       Date:  2019-02-04       Impact factor: 1.610

3.  Uncertainty and agreement regarding the role of flow diversion in the management of difficult aneurysms.

Authors:  T E Darsaut; J-C Gentric; C M McDougall; G Gevry; D Roy; A Weill; J Raymond
Journal:  AJNR Am J Neuroradiol       Date:  2015-01-15       Impact factor: 3.825

4.  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

5.  Surgical or Endovascular Treatment of MCA Aneurysms: An Agreement Study.

Authors:  W Boisseau; T E Darsaut; R Fahed; J M Findlay; R Bourcier; G Charbonnier; S Smajda; J Ognard; D Roy; F Gariel; A P Carlson; E Shotar; G Ciccio; G Marnat; P B Sporns; T Gaberel; V Jecko; A Weill; A Biondi; G Boulouis; A L Bras; S Aldea; T Passeri; S Boissonneau; N Bougaci; J C Gentric; J D B Diestro; A T Omar; H M Al-Jehani; G El Hage; D Volders; Z Kaderali; I Tsogkas; E Magro; Q Holay; J Zehr; D Iancu; J Raymond
Journal:  AJNR Am J Neuroradiol       Date:  2022-09-22       Impact factor: 4.966

6.  Better Outcomes through Learning, Data, Engagement, and Research (BOLDER) - a system for improving evidence and clinical practice in low and middle income countries.

Authors: 
Journal:  F1000Res       Date:  2016-04-18

7.  The need for pragmatic clinical trials in low and middle income settings - taking essential neonatal interventions delivered as part of inpatient care as an illustrative example.

Authors:  Mike English; Jamlick Karumbi; Michuki Maina; Jalemba Aluvaala; Archna Gupta; Merrick Zwarenstein; Newton Opiyo
Journal:  BMC Med       Date:  2016-01-18       Impact factor: 8.775

8.  A randomized pragmatic care trial on endovascular acute stroke interventions (EASI): criticisms, responses, and ethics of integrating research and clinical care.

Authors:  Robert Fahed; Stefanos Finitsis; Naim Khoury; Yan Deschaintre; Nicole Daneault; Laura Gioia; Gregory Jacquin; Céline Odier; Alexande Y Poppe; Alain Weill; Daniel Roy; Tim E Darsaut; Thanh N Nguyen; Jean Raymond
Journal:  Trials       Date:  2018-09-19       Impact factor: 2.279

9.  Noninvasive Angiographic Results of Clipped or Coiled Intracranial Aneurysms: An Inter- and Intraobserver Reliability Study.

Authors:  A Benomar; B Farzin; G Gevry; W Boisseau; D Roy; A Weill; D Iancu; F Guilbert; L Létourneau-Guillon; G Jacquin; C Chaalala; M W Bojanowski; M Labidi; R Fahed; D Volders; T N Nguyen; J-C Gentric; E Magro; G Boulouis; G Forestier; J-F Hak; J S Ghostine; Z Kaderali; J J Shankar; M Kotowski; T E Darsaut; J Raymond
Journal:  AJNR Am J Neuroradiol       Date:  2021-07-29       Impact factor: 4.966

10.  Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial.

Authors:  Tim E Darsaut; Elsa Magro; Jean-Christophe Gentric; André Lima Batista; Chiraz Chaalala; David Roberge; Michel W Bojanowski; Alain Weill; Daniel Roy; Jean Raymond
Journal:  Trials       Date:  2015-11-04       Impact factor: 2.279

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