Literature DB >> 27385811

Randomized n-of-1 Trials: Quality Improvement, Research, or Both?

Joyce P Samuel1, Alyssa Burgart2, Susan H Wootton1, David Magnus2, John D Lantos3, Jon E Tyson1.   

Abstract

The regulatory demarcations between clinical research and quality improvement (QI) are ambiguous and controversial. Some projects that were undertaken as a form of QI were deemed by regulatory agencies to be research and thus to require institutional review board approval. In the era of personalized medicine, some physicians may ask some patients to participate in n-of-1 trials in an effort to personalize and optimize each patient's medical treatment. Should such activities be considered research, QI, or just excellent personalized medicine? Experts in research, research regulation, and bioethics analyze these issues.
Copyright © 2016 by the American Academy of Pediatrics.

Entities:  

Mesh：

Substances：

Year:  2016        PMID： 27385811      PMCID： PMC4960733          DOI： 10.1542/peds.2016-1103

Source DB:  PubMed          Journal:  Pediatrics        ISSN： 0031-4005            Impact factor:   7.124


  15 in total

1.  Variation in local institutional review board evaluations of a multicenter patient safety study.

Authors:  David A Thompson; Nancy Kass; Christine Holzmueller; Jill A Marsteller; Elizabeth A Martinez; Ayse P Gurses; Marc Kanchuger; Nanette Schwann; Charles S Gibson; Laura Bauer; Peter J Pronovost
Journal:  J Healthc Qual       Date:  2011-05-25       Impact factor: 1.095

2.  Scientific evidence underlying the ACC/AHA clinical practice guidelines.

Authors:  Pierluigi Tricoci; Joseph M Allen; Judith M Kramer; Robert M Califf; Sidney C Smith
Journal:  JAMA       Date:  2009-02-25       Impact factor: 56.272

Review 3.  Unproven therapies in clinical research and practice: the necessity to change the regulatory paradigm.

Authors:  Susan H Wootton; Patricia W Evans; Jon E Tyson
Journal:  Pediatrics       Date:  2013-09-16       Impact factor: 7.124

4.  Personalized medicine: Time for one-person trials.

Authors:  Nicholas J Schork
Journal:  Nature       Date:  2015-04-30       Impact factor: 49.962

5.  The views of quality improvement professionals and comparative effectiveness researchers on ethics, IRBs, and oversight.

Authors:  Danielle Whicher; Nancy Kass; Yashar Saghai; Ruth Faden; Sean Tunis; Peter Pronovost
Journal:  J Empir Res Hum Res Ethics       Date:  2015-02-23       Impact factor: 1.742

6.  Ethical oversight: serving the best interests of patients. Commentary.

Authors:  Joe V Selby; Harlan M Krumholz
Journal:  Hastings Cent Rep       Date:  2013 Jan-Feb       Impact factor: 2.683

7.  An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.

Authors:  Ruth R Faden; Nancy E Kass; Steven N Goodman; Peter Pronovost; Sean Tunis; Tom L Beauchamp
Journal:  Hastings Cent Rep       Date:  2013 Jan-Feb       Impact factor: 2.683

8.  The n-of-1 clinical trial: the ultimate strategy for individualizing medicine?

Authors:  Elizabeth O Lillie; Bradley Patay; Joel Diamant; Brian Issell; Eric J Topol; Nicholas J Schork
Journal:  Per Med       Date:  2011-03       Impact factor: 2.512

Review 9.  N-of-1 trials in the medical literature: a systematic review.

Authors:  Nicole B Gabler; Naihua Duan; Sunita Vohra; Richard L Kravitz
Journal:  Med Care       Date:  2011-08       Impact factor: 2.983

Review 10.  Single-patient (n-of-1) trials: a pragmatic clinical decision methodology for patient-centered comparative effectiveness research.

Authors:  Naihua Duan; Richard L Kravitz; Christopher H Schmid
Journal:  J Clin Epidemiol       Date:  2013-08       Impact factor: 6.437
View more
  2 in total

1.  Treating Hypertension in Children With n-of-1 Trials.

Authors:  Joyce P Samuel; Jon E Tyson; Charles Green; Cynthia S Bell; Claudia Pedroza; Don Molony; Joshua Samuels
Journal:  Pediatrics       Date:  2019-03-06       Impact factor: 7.124

Review 2.  Assessing the Effectiveness of Neurofeedback Training in the Context of Clinical and Social Neuroscience.

Authors:  Franklin Orndorff-Plunkett; Fiza Singh; Oriana R Aragón; Jaime A Pineda
Journal:  Brain Sci       Date:  2017-08-07
  2 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.