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Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation

Overview of attention for article published in BMC Medical Ethics, February 2018
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  • In the top 5% of all research outputs scored by Altmetric
  • High Attention Score compared to outputs of the same age (92nd percentile)
  • High Attention Score compared to outputs of the same age and source (80th percentile)

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Title
Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation
Published in
BMC Medical Ethics, February 2018
DOI 10.1186/s12910-018-0253-x
Pubmed ID
Authors

Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Dean A. Fergusson, Jeremy M. Grimshaw, Austin R. Horn, Monica Taljaard

Abstract

Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs.

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The data shown below were collected from the profiles of 42 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 177 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 177 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 31 18%
Student > Bachelor 25 14%
Student > Ph. D. Student 16 9%
Researcher 14 8%
Student > Doctoral Student 6 3%
Other 24 14%
Unknown 61 34%
Readers by discipline Count As %
Medicine and Dentistry 37 21%
Nursing and Health Professions 28 16%
Social Sciences 10 6%
Psychology 9 5%
Business, Management and Accounting 3 2%
Other 25 14%
Unknown 65 37%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 37. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 19 September 2023.
All research outputs
#1,094,802
of 25,507,011 outputs
Outputs from BMC Medical Ethics
#72
of 1,108 outputs
Outputs of similar age
#24,279
of 343,802 outputs
Outputs of similar age from BMC Medical Ethics
#5
of 21 outputs
Altmetric has tracked 25,507,011 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 95th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 1,108 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 14.7. This one has done particularly well, scoring higher than 93% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 343,802 tracked outputs that were published within six weeks on either side of this one in any source. This one has done particularly well, scoring higher than 92% of its contemporaries.
We're also able to compare this research output to 21 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 80% of its contemporaries.