Evidence map›Paper›PMID 32068189›Full record

ArticleContemporary clinical trials2020

Supporting Treatment Adherence Regimens in young children with epilepsy and their families: Trial design and baseline characteristics.

Avani C Modi, Tracy A Glauser, Shanna M Guilfoyle

Abstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Sudden Unexpected Death in Epilepsy (SUDEP): A Review of Risk Factors and Possible Interventions in Children.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021
    Review
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.

Avani C ModiCincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Cincinnati, OH 45229, United States of America; College of Medicine, University of Cincinnati, Cincinnati, OH 45267, United States of America. Electronic address: avani.modi@cchmc.org.
Tracy A GlauserCincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Cincinnati, OH 45229, United States of America; College of Medicine, University of Cincinnati, Cincinnati, OH 45267, United States of America. Electronic address: Tracy.glauser@cchmc.org.
Shanna M GuilfoyleCincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Cincinnati, OH 45229, United States of America; College of Medicine, University of Cincinnati, Cincinnati, OH 45267, United States of America. Electronic address: shanna.guilfoyle@cchmc.org.

Funding

Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR TrialR01HD073115 · NICHD · CINCINNATI CHILDRENS HOSP MED CTR · PI MODI, AVANI C · 2013 to 2017
$2.7M
NICHD NIH HHS R01 HD073115
6 · The paper itself

Abstract

This article describes the methodology, recruitment, design, and baseline participant characteristics of the Supporting Treatment Adherence Regimens (STAR) trial. STAR is a randomized controlled clinical trial of an education and problem-solving adherence intervention for young children (2-12 years old) with newly diagnosed epilepsy and their families. Using an enrichment design, only participants who demonstrated non-adherence to anti-epileptic drugs within the baseline period were randomized to treatment or control arms. Randomized participants received 8 intervention sessions over a 4-month period and completed three follow-up visits (3, 6, and 12 months following intervention). Two-hundred participants were recruited for the study. The primary outcome was electronically monitored adherence, while secondary and exploratory outcomes included seizure freedom and health-related quality of life. Novel aspects of the trial design (e.g., enrichment, sequential randomization, daily adherence data use), as well as recruitment and retention challenges are discussed.

Indexed as

AnticonvulsantsDrug MonitoringEpilepsyFamilyPatient Education as TopicChildChild, PreschoolFemaleHumansMaleProblem SolvingRandomized Controlled Trials as TopicResearch DesignAnticonvulsantsBehavioral treatmentComplianceEnrichment designPediatricRandomized controlled clinical trialSeizures

Identifiers

PMID32068189
PMCPMC7089777

What OpenQuestion holds

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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.