Evidence map›Paper›PMID 34365104›Full record

Trial reportSeizure2021

Can machine learning improve randomized clinical trial analysis?

Juan Romero, Sharon Chiang, Daniel M Goldenholz

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Seizure, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Machine Learning in Clinical Trials: A Primer with Applications to Neurology.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Juan RomeroHarvard Beth Israel Deaconess Medical Center, Boston MA, United States. Electronic address: jromero5@bidmc.harvard.edu.
Sharon ChiangUniversity of California San Francisco, San Francisco, CA, United States. Electronic address: Sharon.Chiang@ucsf.edu.
Daniel M GoldenholzHarvard Beth Israel Deaconess Medical Center, Boston MA, United States. Electronic address: daniel.goldenholz@bidmc.harvard.edu.

Funding

Institutional Career Development CoreKL2TR002542 · NCATS · HARVARD MEDICAL SCHOOL · PI BREDELLA, MIRIAM ANTOINETTE, RUTKOVE, SEWARD B. · 2018 to 2022
$8.7M
NINDS Research Education Programs for Residents and Fellows in Neurology, Neurosurgery, Neuropathology, Neuroradiology and Emergency Medicine (R25)R25NS070680 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOSEPHSON, SCOTT ANDREW · 2010 to 2023
$6.8M
NCATS NIH HHS KL2 TR002542NINDS NIH HHS R25 NS070680
6 · The paper itself

Abstract

purposeRecently a realistic simulator of patient seizure diaries was developed that can reproduce effects seen in randomized clinical trials (RCTs). RCTs suffer from high costs and statistical inefficiencies. Using realistic simulation and machine learning this study aimed to identify a more statistically efficient outcome metric.

methodsFive candidate deep learning architectures with 54 permutations of hyperparameters were compared to the traditional standard, median percent change (MPC). Each were also tested for type 1 error. All models had similar outcomes, with appropriate low levels of type 1 error.

resultsThe simplest model was equivalent to a logistic regression of a histogram of individual percentage changes in seizure rate, requiring 21-22% less patients to discriminate drug from placebo at 90% power. This model was referred to as LPC.

conclusionFuture studies to validate LPC may enable faster, cheaper and more efficient clinical trials.

Indexed as

Machine LearningSeizuresComputer SimulationHumansMachine learningMedicationModelingRandomized controlled trial

Identifiers

PMID34365104
PMCPMC8435025

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.