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The ethics of using placebo in randomised controlled trials: a case study of a Plasmodium vivax antirelapse trial

Overview of attention for article published in BMC Medical Ethics, March 2018
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  • In the top 25% of all research outputs scored by Altmetric
  • High Attention Score compared to outputs of the same age (89th percentile)

Mentioned by

blogs
1 blog
twitter
25 tweeters
video
1 video uploader

Readers on

mendeley
19 Mendeley
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Title
The ethics of using placebo in randomised controlled trials: a case study of a Plasmodium vivax antirelapse trial
Published in
BMC Medical Ethics, March 2018
DOI 10.1186/s12910-018-0259-4
Pubmed ID
Authors

Phaik Yeong Cheah, Norbert Steinkamp, Lorenz von Seidlein, Ric N. Price

Abstract

The use of placebos in randomised controlled trials is a subject of considerable ethical debate. In this paper we present a set of considerations to evaluate the ethics of placebo controlled trials that includes: social value of the study; need for a randomised controlled trial and placebo; standards of care; risks of harm due to administration of placebo and the harm benefit balance; clinical equipoise; and double standards. We illustrate the application of these considerations using a case study of a large ongoing multicentre, placebo-controlled, double-blinded, randomised trial to determine primaquine anti-relapse efficacy in vivax malaria. There is an urgent need for primaquine anti-relapse studies in order to rationalise the management of a potentially fatal disease. An ethical justification for the use of the placebo arm is provided on the grounds that the actual current applied standard of care in most endemic places does not include primaquine. It has also been argued that there is clinical equipoise among the primaquine study arms and that the risk of harms of being in the placebo arm is the risk of having relapse, which is no more than not being included in the trial, and that there are no double standards. Based on our set of considerations, we conclude that a placebo arm is not only justified but imperative in this study. We propose that similar considerations should be prospectively applied to other placebo controlled trials and observational control arms where no treatment is offered.

Twitter Demographics

The data shown below were collected from the profiles of 25 tweeters who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 19 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 19 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 4 21%
Student > Master 4 21%
Student > Ph. D. Student 2 11%
Librarian 1 5%
Student > Doctoral Student 1 5%
Other 1 5%
Unknown 6 32%
Readers by discipline Count As %
Medicine and Dentistry 7 37%
Immunology and Microbiology 1 5%
Agricultural and Biological Sciences 1 5%
Psychology 1 5%
Social Sciences 1 5%
Other 1 5%
Unknown 7 37%

Attention Score in Context

This research output has an Altmetric Attention Score of 22. 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 03 October 2018.
All research outputs
#903,464
of 15,478,474 outputs
Outputs from BMC Medical Ethics
#80
of 680 outputs
Outputs of similar age
#28,978
of 279,210 outputs
Outputs of similar age from BMC Medical Ethics
#1
of 1 outputs
Altmetric has tracked 15,478,474 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 94th percentile: it's in the top 10% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 680 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 14.6. This one has done well, scoring higher than 88% 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 279,210 tracked outputs that were published within six weeks on either side of this one in any source. This one has done well, scoring higher than 89% of its contemporaries.
We're also able to compare this research output to 1 others from the same source and published within six weeks on either side of this one. This one has scored higher than all of them