Literature DB >> 33658182

Integrating Patient Perspectives into Medical Device Regulatory Decision Making to Advance Innovation in Kidney Disease.

Michelle E Tarver1, Carolyn Neuland2.   

Abstract

Entities:  

Keywords:  Food and Drug Administration; decision making; end stage kidney disease; patient engagement; patient preference; patient-reported outcomes; regulatory

Mesh：

Year:  2021        PMID： 33658182      PMCID： PMC8092069          DOI： 10.2215/CJN.11510720

Source DB:  PubMed          Journal:  Clin J Am Soc Nephrol        ISSN： 1555-9041            Impact factor:   8.237


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  5 in total

1.  Engaging Patients Across the Spectrum of Medical Product Development: View From the US Food and Drug Administration.

Authors:  Nina L Hunter; Kathryn M O'Callaghan; Robert M Califf
Journal:  JAMA       Date:  2015-12-15       Impact factor: 56.272

2.  Advancing the Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation: A Summary Report of the Patient Preference Workshop.

Authors:  Heather L Benz; Ting-Hsuan Joyce Lee; Jui-Hua Tsai; John F P Bridges; Sara Eggers; Megan Moncur; Fadia T Shaya; Ira Shoulson; Erica S Spatz; Leslie Wilson; Anindita Saha
Journal:  Patient       Date:  2019-12       Impact factor: 3.883

3.  Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop.

Authors:  Frank P Hurst; Dolph Chianchiano; Linda Upchurch; Benjamin R Fisher; Jennifer E Flythe; Celeste Castillo Lee; Terri Hill; Carolyn Y Neuland
Journal:  Am J Kidney Dis       Date:  2017-04-27       Impact factor: 8.860

4.  Integrating the Voice of the Patient Into the Medical Device Regulatory Process Using Patient Preference Information.

Authors:  Heather L Benz; Anindita Saha; Michelle E Tarver
Journal:  Value Health       Date:  2020-02-29       Impact factor: 5.725

5.  Implementing core outcomes in kidney disease: report of the Standardized Outcomes in Nephrology (SONG) implementation workshop.

Authors:  Allison Tong; Braden Manns; Angela Yee Moon Wang; Brenda Hemmelgarn; David C Wheeler; John Gill; Peter Tugwell; Robert Pecoits-Filho; Sally Crowe; Tess Harris; Wim Van Biesen; Wolfgang C Winkelmayer; Adeera Levin; Aliza Thompson; Vlado Perkovic; Angela Ju; Talia Gutman; Amelie Bernier-Jean; Andrea K Viecelli; Emma O'Lone; Jenny Shen; Michelle A Josephson; Yeoungjee Cho; David W Johnson; Bénédicte Sautenet; Marcello Tonelli; Jonathan C Craig
Journal:  Kidney Int       Date:  2018-10-22       Impact factor: 10.612
  5 in total
  3 in total

1.  Overview of Various Components of the Science of Patient Input: Advancing the Use of Patient-Reported, Real-World Evidence for Medical Device Evaluation of Innovative Products for the Treatment of Kidney Failure Using Strategically Coordinated Registry Networks.

Authors:  Murray Sheldon
Journal:  Clin J Am Soc Nephrol       Date:  2021-03-03       Impact factor: 8.237

2.  Legitimization and Incorporation of Patient Preferences: The Arrow that Hit the Achilles Heel of Status Quo Kidney Care.

Authors:  Paul T Conway; Richard Knight
Journal:  Clin J Am Soc Nephrol       Date:  2021-03-03       Impact factor: 8.237

3.  Using Patient Preference Information to Inform Regulatory Decision Making: An Opportunity to Spur Patient-Centered Innovation in Kidney Replacement Therapy Devices.

Authors:  Jennifer E Flythe; Melissa West
Journal:  Clin J Am Soc Nephrol       Date:  2021-03-03       Impact factor: 8.237
  3 in total

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