| Title |
A multi-dataset time-reversal approach to clinical trial placebo response and the relationship to natural variability in epilepsy
|
|---|---|
| Published in |
Seizure, October 2017
|
| DOI | 10.1016/j.seizure.2017.10.016 |
| Pubmed ID | |
| Authors |
Daniel M. Goldenholz, Alex Strashny, Mark Cook, Robert Moss, William H. Theodore |
| Abstract |
Clinical epilepsy drug trials have been measuring increasingly high placebo response rates, up to 40%. This study was designed to examine the relationship between the natural variability in epilepsy, and the placebo response seen in trials. We tested the hypothesis that 'reversing' trial direction, with the baseline period as the treatment observation phase, would reveal effects of natural variability. Clinical trial simulations were run with time running forward and in reverse. Data sources were: SeizureTracker.com (patient reported diaries), a randomized sham-controlled TMS trial, and chronically implanted intracranial EEG electrodes. Outcomes were 50%-responder rates (RR50) and median percentage change (MPC). The RR50 results showed evidence that temporal reversal does not prevent large responder rates across datasets. The MPC results negative in the TMS dataset, and positive in the other two. Typical RR50s of clinical trials can be reproduced using the natural variability of epilepsy as a substrate across multiple datasets. Therefore, the placebo response in epilepsy clinical trials may be attributable almost entirely to this variability, rather than the "placebo effect". |
X Demographics
The data shown below were collected from the profiles of 14 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 5 | 36% |
| United Kingdom | 1 | 7% |
| Turkey | 1 | 7% |
| Mexico | 1 | 7% |
| Unknown | 6 | 43% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 9 | 64% |
| Scientists | 3 | 21% |
| Science communicators (journalists, bloggers, editors) | 1 | 7% |
| Practitioners (doctors, other healthcare professionals) | 1 | 7% |
Mendeley readers
The data shown below were compiled from readership statistics for 38 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 38 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Bachelor | 8 | 21% |
| Student > Master | 6 | 16% |
| Researcher | 6 | 16% |
| Student > Ph. D. Student | 5 | 13% |
| Student > Doctoral Student | 2 | 5% |
| Other | 3 | 8% |
| Unknown | 8 | 21% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 8 | 21% |
| Agricultural and Biological Sciences | 5 | 13% |
| Psychology | 4 | 11% |
| Neuroscience | 3 | 8% |
| Engineering | 2 | 5% |
| Other | 5 | 13% |
| Unknown | 11 | 29% |
Attention Score in Context
This research output has an Altmetric Attention Score of 8. 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 22 January 2018.
All research outputs
#4,603,546
of 25,382,440 outputs
Outputs from Seizure
#462
of 2,691 outputs
Outputs of similar age
#76,751
of 338,323 outputs
Outputs of similar age from Seizure
#7
of 59 outputs
Altmetric has tracked 25,382,440 research outputs across all sources so far. Compared to these this one has done well and is in the 81st percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 2,691 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 5.1. This one has done well, scoring higher than 82% 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 338,323 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 77% of its contemporaries.
We're also able to compare this research output to 59 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 88% of its contemporaries.