Literature DB >> 27637816

Trials without tribulations: Minimizing the burden of pragmatic research on healthcare systems.

Eric B Larson1, Chris Tachibana1, Ella Thompson1, Gloria D Coronado2, Lynn DeBar2, Laura M Dember3, Stacey Honda4, Susan S Huang5, Jeffrey G Jarvik6, Christine Nelson7, Edward Septimus8, Greg Simon1, Karin E Johnson9.   

Abstract

Pragmatic clinical trials are increasingly common because they have the potential to yield findings that are directly translatable to real-world healthcare settings. Pragmatic clinical trials need to integrate research into clinical workflow without placing an undue burden on the delivery system. This requires a research partnership between investigators and healthcare system representatives. This paper, organized as a series of case studies drawn from our experience in the NIH Health Care Systems Research Collaboratory, presents guidance from informational interviews of physician-scientists, health services researchers, and delivery system leaders who recently launched pragmatic clinical trials.
Copyright © 2015 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Pragmatic trials

Mesh:

Year:  2015        PMID: 27637816      PMCID: PMC5027068          DOI: 10.1016/j.hjdsi.2015.07.005

Source DB:  PubMed          Journal:  Healthc (Amst)        ISSN: 2213-0764


  5 in total

1.  Medical research. Clinical trials get practical.

Authors:  Jennifer Couzin-Frankel
Journal:  Science       Date:  2015-04-24       Impact factor: 47.728

2.  PCORI at 3 years--progress, lessons, and plans.

Authors:  Joseph V Selby; Steven H Lipstein
Journal:  N Engl J Med       Date:  2014-02-13       Impact factor: 91.245

3.  Explanatory and pragmatic attitudes in therapeutical trials.

Authors:  D Schwartz; J Lellouch
Journal:  J Chronic Dis       Date:  1967-08

4.  What does it mean to be pragmatic? Pragmatic methods, measures, and models to facilitate research translation.

Authors:  Russell E Glasgow
Journal:  Health Educ Behav       Date:  2013-06

5.  A guide to research partnerships for pragmatic clinical trials.

Authors:  Karin E Johnson; Chris Tachibana; Gloria D Coronado; Laura M Dember; Russell E Glasgow; Susan S Huang; Paul J Martin; Julie Richards; Gary Rosenthal; Ed Septimus; Gregory E Simon; Leif Solberg; Jerry Suls; Ella Thompson; Eric B Larson
Journal:  BMJ       Date:  2014-12-01
  5 in total
  6 in total

Review 1.  Sustainable Financing of Innovative Therapies: A Review of Approaches.

Authors:  Aidan Hollis
Journal:  Pharmacoeconomics       Date:  2016-10       Impact factor: 4.981

2.  Responding to signals of mental and behavioral health risk in pragmatic clinical trials: Ethical obligations in a healthcare ecosystem.

Authors:  Joseph Ali; Stephanie R Morain; P Pearl O'Rourke; Benjamin Wilfond; Emily C O'Brien; Christina K Zigler; Karen L Staman; Kevin P Weinfurt; Jeremy Sugarman
Journal:  Contemp Clin Trials       Date:  2022-01-05       Impact factor: 2.226

3.  Think Pragmatically: Investigators' Obligations to Patient-Subjects When Research is Embedded in Care.

Authors:  Stephanie Morain; Emily Largent
Journal:  Am J Bioeth       Date:  2022-04-18       Impact factor: 14.676

4.  Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.

Authors:  Kevin P Weinfurt; Adrian F Hernandez; Gloria D Coronado; Lynn L DeBar; Laura M Dember; Beverly B Green; Patrick J Heagerty; Susan S Huang; Kathryn T James; Jeffrey G Jarvik; Eric B Larson; Vincent Mor; Richard Platt; Gary E Rosenthal; Edward J Septimus; Gregory E Simon; Karen L Staman; Jeremy Sugarman; Miguel Vazquez; Douglas Zatzick; Lesley H Curtis
Journal:  BMC Med Res Methodol       Date:  2017-09-18       Impact factor: 4.615

5.  Promoting early autism detection and intervention in underserved communities: study protocol for a pragmatic trial using a stepped-wedge design.

Authors:  Lisa V Ibañez; Ann Vander Stoep; Kathleen Myers; Chuan Zhou; Shannon Dorsey; Kyle J Steinman; Wendy L Stone
Journal:  BMC Psychiatry       Date:  2019-06-07       Impact factor: 3.630

6.  The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care.

Authors:  Dan Kabonge Kaye
Journal:  BMC Pediatr       Date:  2019-07-02       Impact factor: 2.125

  6 in total

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