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Treatment Trials for Neonatal Seizures: The Effect of Design on Sample Size

Overview of attention for article published in PLOS ONE, November 2016
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3 tweeters

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8 Dimensions

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46 Mendeley
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1 CiteULike
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Title
Treatment Trials for Neonatal Seizures: The Effect of Design on Sample Size
Published in
PLOS ONE, November 2016
DOI 10.1371/journal.pone.0165693
Pubmed ID
Authors

Nathan J. Stevenson, Geraldine B. Boylan, Lena Hellström-Westas, Sampsa Vanhatalo

Abstract

Neonatal seizures are common in the neonatal intensive care unit. Clinicians treat these seizures with several anti-epileptic drugs (AEDs) to reduce seizures in a neonate. Current AEDs exhibit sub-optimal efficacy and several randomized control trials (RCT) of novel AEDs are planned. The aim of this study was to measure the influence of trial design on the required sample size of a RCT. We used seizure time courses from 41 term neonates with hypoxic ischaemic encephalopathy to build seizure treatment trial simulations. We used five outcome measures, three AED protocols, eight treatment delays from seizure onset (Td) and four levels of trial AED efficacy to simulate different RCTs. We performed power calculations for each RCT design and analysed the resultant sample size. We also assessed the rate of false positives, or placebo effect, in typical uncontrolled studies. We found that the false positive rate ranged from 5 to 85% of patients depending on RCT design. For controlled trials, the choice of outcome measure had the largest effect on sample size with median differences of 30.7 fold (IQR: 13.7-40.0) across a range of AED protocols, Td and trial AED efficacy (p<0.001). RCTs that compared the trial AED with positive controls required sample sizes with a median fold increase of 3.2 (IQR: 1.9-11.9; p<0.001). Delays in AED administration from seizure onset also increased the required sample size 2.1 fold (IQR: 1.7-2.9; p<0.001). Subgroup analysis showed that RCTs in neonates treated with hypothermia required a median fold increase in sample size of 2.6 (IQR: 2.4-3.0) compared to trials in normothermic neonates (p<0.001). These results show that RCT design has a profound influence on the required sample size. Trials that use a control group, appropriate outcome measure, and control for differences in Td between groups in analysis will be valid and minimise sample size.

Twitter Demographics

The data shown below were collected from the profiles of 3 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 46 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Finland 1 2%
Unknown 45 98%

Demographic breakdown

Readers by professional status Count As %
Student > Master 11 24%
Researcher 10 22%
Other 6 13%
Student > Postgraduate 3 7%
Librarian 2 4%
Other 5 11%
Unknown 9 20%
Readers by discipline Count As %
Medicine and Dentistry 18 39%
Neuroscience 5 11%
Psychology 3 7%
Nursing and Health Professions 2 4%
Engineering 2 4%
Other 3 7%
Unknown 13 28%

Attention Score in Context

This research output has an Altmetric Attention Score of 2. 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 28 June 2017.
All research outputs
#13,254,325
of 20,585,116 outputs
Outputs from PLOS ONE
#107,969
of 177,664 outputs
Outputs of similar age
#180,932
of 312,876 outputs
Outputs of similar age from PLOS ONE
#2,308
of 3,779 outputs
Altmetric has tracked 20,585,116 research outputs across all sources so far. This one is in the 33rd percentile – i.e., 33% of other outputs scored the same or lower than it.
So far Altmetric has tracked 177,664 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 14.4. This one is in the 35th percentile – i.e., 35% of its peers scored the same or lower than it.
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 312,876 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 39th percentile – i.e., 39% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 3,779 others from the same source and published within six weeks on either side of this one. This one is in the 34th percentile – i.e., 34% of its contemporaries scored the same or lower than it.