Literature DB >> 27417953

Physicians' perspectives regarding pragmatic clinical trials.

Rachel Topazian1, Juli Bollinger1, Kevin P Weinfurt2,3, Rachel Dvoskin1, Debra Mathews1, Kathleen Brelsford2, Matthew DeCamp1,4, Jeremy Sugarman1,4,5.   

Abstract

AIM: Practicing physicians inevitably become involved in pragmatic clinical trials (PCTs), including comparative effectiveness research. We sought to identify physicians' perspectives related to PCTs.
METHODS: In-depth semistructured interviews with 20 physicians in the USA.
RESULTS: Although physicians are generally willing to participate in PCTs, their support is predicated on several factors including expected benefits, minimization of time and workflow burdens and physician engagement. Physicians communicated a desire to respect patients' rights and interests while maintaining a high level of care.
CONCLUSION: Future work is needed to systematically assess the impact of PCTs on clinicians in meeting their ethical obligations to patients and the burdens clinicians are willing to accept in exchange for potential benefits.

Entities:  

Keywords:  comparative effectiveness research; ethics; qualitative research

Mesh:

Year:  2016        PMID: 27417953      PMCID: PMC4975022          DOI: 10.2217/cer-2016-0024

Source DB:  PubMed          Journal:  J Comp Eff Res        ISSN: 2042-6305            Impact factor:   1.744


  14 in total

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Authors:  Donald L Patrick; Laurie B Burke; Chad J Gwaltney; Nancy Kline Leidy; Mona L Martin; Elizabeth Molsen; Lena Ring
Journal:  Value Health       Date:  2011-10-13       Impact factor: 5.725

2.  Physician views on the use of comparative effectiveness research: a national survey.

Authors:  Salomeh Keyhani; Mark Woodward; Alex D Federman
Journal:  Ann Intern Med       Date:  2010-10-19       Impact factor: 25.391

3.  Qualitative data analysis for health services research: developing taxonomy, themes, and theory.

Authors:  Elizabeth H Bradley; Leslie A Curry; Kelly J Devers
Journal:  Health Serv Res       Date:  2007-08       Impact factor: 3.402

4.  Patient and clinician views on comparative effectiveness research and engagement in research.

Authors:  Laura P Forsythe; Lori Frank; Kara Odom Walker; Ayodola Anise; Natalie Wegener; Harlan Weisman; Gail Hunt; Anne Beal
Journal:  J Comp Eff Res       Date:  2015-01       Impact factor: 1.744

5.  Use of altered informed consent in pragmatic clinical research.

Authors:  Ross E McKinney; Laura M Beskow; Daniel E Ford; John D Lantos; Jonathan McCall; Bray Patrick-Lake; Mark J Pletcher; Brian Rath; Hollie Schmidt; Kevin Weinfurt
Journal:  Clin Trials       Date:  2015-09-15       Impact factor: 2.486

6.  Exploring the ethical and regulatory issues in pragmatic clinical trials.

Authors:  Robert M Califf; Jeremy Sugarman
Journal:  Clin Trials       Date:  2015-09-15       Impact factor: 2.486

7.  Gatekeepers for pragmatic clinical trials.

Authors:  Danielle M Whicher; Jennifer E Miller; Kelly M Dunham; Steven Joffe
Journal:  Clin Trials       Date:  2015-09-15       Impact factor: 2.486

8.  Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey.

Authors:  Mildred K Cho; David Magnus; Melissa Constantine; Sandra Soo-Jin Lee; Maureen Kelley; Stephanie Alessi; Diane Korngiebel; Cyan James; Ellen Kuwana; Thomas H Gallagher; Douglas Diekema; Alexander M Capron; Steven Joffe; Benjamin S Wilfond
Journal:  Ann Intern Med       Date:  2015-05-19       Impact factor: 25.391

9.  Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network.

Authors:  Joseph Ali; Robert Califf; Jeremy Sugarman
Journal:  Account Res       Date:  2016       Impact factor: 2.622

10.  Lumbar Imaging With Reporting Of Epidemiology (LIRE)--Protocol for a pragmatic cluster randomized trial.

Authors:  Jeffrey G Jarvik; Bryan A Comstock; Kathryn T James; Andrew L Avins; Brian W Bresnahan; Richard A Deyo; Patrick H Luetmer; Janna L Friedly; Eric N Meier; Daniel C Cherkin; Laura S Gold; Sean D Rundell; Safwan S Halabi; David F Kallmes; Katherine W Tan; Judith A Turner; Larry G Kessler; Danielle C Lavallee; Kari A Stephens; Patrick J Heagerty
Journal:  Contemp Clin Trials       Date:  2015-10-19       Impact factor: 2.226

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  7 in total

1.  Identification and management of pragmatic clinical trial collateral findings: A current understanding and directions for future research.

Authors:  Stephanie R Morain; Debra J H Mathews; Gail Geller; Juli Bollinger; Kevin Weinfurt; Jeffrey G Jarvik; Elizabeth May; Jeremy Sugarman
Journal:  Healthc (Amst)       Date:  2021-09-29

2.  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

3.  Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research.

Authors:  Stephanie R Morain; Ellen Tambor; Rachael Moloney; Nancy E Kass; Sean Tunis; Kristina Hallez; Ruth R Faden
Journal:  Learn Health Syst       Date:  2017-12-05

4.  The ethical challenges raised in the design and conduct of pragmatic trials: an interview study with key stakeholders.

Authors:  Stuart G Nicholls; Kelly Carroll; Merrick Zwarenstein; Jamie C Brehaut; Charles Weijer; Spencer P Hey; Cory E Goldstein; Ian D Graham; Jeremy M Grimshaw; Joanne E McKenzie; Dean A Fergusson; Monica Taljaard
Journal:  Trials       Date:  2019-12-23       Impact factor: 2.279

5.  Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials: study protocol.

Authors:  Stuart G Nicholls; Kelly Carroll; Jamie Brehaut; Charles Weijer; Spencer Phillips Hey; Cory E Goldstein; Merrick Zwarenstein; Ian D Graham; Joanne E McKenzie; Lauralyn McIntyre; Vipul Jairath; Marion K Campbell; Jeremy M Grimshaw; Dean A Fergusson; Monica Taljaard
Journal:  BMC Med Ethics       Date:  2018-11-20       Impact factor: 2.652

6.  Ethical Issues in the Design and Conduct of Pragmatic Cluster Randomized Trials in Hemodialysis Care: An Interview Study With Key Stakeholders.

Authors:  Stuart G Nicholls; Kelly Carroll; Charles Weijer; Cory E Goldstein; Jamie Brehaut; Manish M Sood; Ahmed Al-Jaishi; Erika Basile; Jeremy M Grimshaw; Amit X Garg; Monica Taljaard
Journal:  Can J Kidney Health Dis       Date:  2020-10-26

7.  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
  7 in total

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