Literature DB >> 30917969

Low risk pragmatic trials do not always require participants' informed consent.

Rafael Dal-Ré1, Cristina Avendaño-Solà2, Brigitte Bloechl-Daum3, Anthonius de Boer4, Stefan Eriksson5, Uwe Fuhr6, Søren Holm7, Stefan K James8, Robert J Mentz9, Emilio Perucca10, Frits R Rosendaal11, Shaun Treweek12.   

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Year:  2019        PMID: 30917969     DOI: 10.1136/bmj.l1092

Source DB:  PubMed          Journal:  BMJ        ISSN: 0959-8138


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  11 in total

1.  Practical steps to identifying the research risk of pragmatic trials.

Authors:  Scott Yh Kim; Jonathan Kimmelman
Journal:  Clin Trials       Date:  2022-03-29       Impact factor: 2.599

2.  Informed consent in pragmatic trials: results from a survey of trials published 2014-2019.

Authors:  Jennifer Zhe Zhang; Stuart G Nicholls; Kelly Carroll; Hayden Peter Nix; Cory E Goldstein; Spencer Phillips Hey; Jamie C Brehaut; Paul C McLean; Charles Weijer; Dean A Fergusson; Monica Taljaard
Journal:  J Med Ethics       Date:  2021-11-15       Impact factor: 5.926

Review 3.  A review of pragmatic trials found a high degree of diversity in design and scope, deficiencies in reporting and trial registry data, and poor indexing.

Authors:  Stuart G Nicholls; Kelly Carroll; Spencer Phillips Hey; Merrick Zwarenstein; Jennifer Zhe Zhang; Hayden P Nix; Jamie C Brehaut; Joanne E McKenzie; Steve McDonald; Charles Weijer; Dean A Fergusson; Monica Taljaard
Journal:  J Clin Epidemiol       Date:  2021-03-28       Impact factor: 6.437

Review 4.  Leveraging Data Science for a Personalized Haemodialysis.

Authors:  Miguel Hueso; Lluís de Haro; Jordi Calabia; Rafael Dal-Ré; Cristian Tebé; Karina Gibert; Josep M Cruzado; Alfredo Vellido
Journal:  Kidney Dis (Basel)       Date:  2020-05-25

5.  The trial to reduce antimicrobial use in nursing home residents with Alzheimer's disease and other dementias: study protocol for a cluster randomized controlled trial.

Authors:  Andrea J Loizeau; Erika M C D'Agata; Michele L Shaffer; Laura C Hanson; Ruth A Anderson; Timothy Tsai; Daniel A Habtemariam; Elaine H Bergman; Ruth P Carroll; Simon M Cohen; Erin M E Scott; Erin Stevens; Jeremy D Whyman; Elizabeth H Bennert; Susan L Mitchell
Journal:  Trials       Date:  2019-10-15       Impact factor: 2.279

6.  Ethical considerations within pragmatic randomized controlled trials in dementia: Results from a literature survey.

Authors:  Stuart G Nicholls; Kelly Carroll; Hayden P Nix; Fan Li; Spencer Phillips Hey; Susan L Mitchell; Charles Weijer; Monica Taljaard
Journal:  Alzheimers Dement (N Y)       Date:  2022-05-02

Review 7.  Role of Real-World Data in Assessing Cardiac Toxicity After Lung Cancer Radiotherapy.

Authors:  Azadeh Abravan; Gareth Price; Kathryn Banfill; Tom Marchant; Matthew Craddock; Joe Wood; Marianne C Aznar; Alan McWilliam; Marcel van Herk; Corinne Faivre-Finn
Journal:  Front Oncol       Date:  2022-07-19       Impact factor: 5.738

8.  Pilot and feasibility studies for pragmatic trials have unique considerations and areas of uncertainty.

Authors:  Claire L Chan; Monica Taljaard; Gillian A Lancaster; Jamie C Brehaut; Sandra M Eldridge
Journal:  J Clin Epidemiol       Date:  2021-07-03       Impact factor: 6.437

9.  Three European Retrospective Real-World Chart Review Studies to Determine the Effectiveness of Flash Glucose Monitoring on HbA1c in Adults with Type 2 Diabetes.

Authors:  Jens Kröger; Peter Fasching; Hélène Hanaire
Journal:  Diabetes Ther       Date:  2019-12-12       Impact factor: 2.945

10.  Patient Partner Perspectives Regarding Ethically and Clinically Important Aspects of Trial Design in Pragmatic Cluster Randomized Trials for Hemodialysis.

Authors:  Stuart G Nicholls; Kelly Carroll; Cory E Goldstein; Jamie C Brehaut; Charles Weijer; Merrick Zwarenstein; Stephanie Dixon; Jeremy M Grimshaw; Amit X Garg; Monica Taljaard
Journal:  Can J Kidney Health Dis       Date:  2021-07-26
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