Evidence map›Paper›PMID 28778857›Full record

ArticlePediatrics2017

Methodological and Ethical Issues in Pediatric Medication Safety Research.

Delesha Carpenter, Daniel Gonzalez, George Retsch-Bogart, Betsy Sleath, Benjamin Wilfond

Abstract read
In one paragraph

Article in Pediatrics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Article
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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

5 authors.

Delesha CarpenterDivision of Pharmaceutical Outcomes and Policy, dmcarpenter@unc.edu.
Daniel GonzalezDivision of Pharmacotherapy and Experimental Therapeutics.
George Retsch-BogartDepartment of Pediatrics, School of Medicine.
Betsy SleathDivision of Pharmaceutical Outcomes and Policy.
Benjamin WilfondTreuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, University of Washington, Seattle, Washington.

Funding

North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
Use of Physiologically-Based PK/PD Models to Streamline Drug ApprovalsK23HD083465 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GONZALEZ, DANIEL · 2015 to 2019
$727k
ADDRESSING METHODOLOGICAL AND ETHICAL ISSUES IN PEDIATRIC MEDICATION SAFETY RESEARCHR13HS024471 · AHRQ · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CARPENTER, DELESHA MILLER · 2016 to 2016
$33k
AHRQ HHS R13 HS024471NCATS NIH HHS UL1 TR001111NICHD NIH HHS K23 HD083465
6 · The paper itself

Abstract

In May 2016, the Eshelman School of Pharmacy at The University of North Carolina at Chapel Hill convened the PharmSci conference to address the topic of "methodological and ethical issues in pediatric medication safety research." A multidisciplinary group of experts representing a diverse array of perspectives, including those of the US Food and Drug Administration, children's hospitals, and academia, identified important considerations for pediatric medication safety research and opportunities to advance the field. This executive summary describes current challenges that clinicians and researchers encounter related to pediatric medication safety research and identifies innovative and ethically sound methodologies to address these challenges to improve children's health. This article addresses 5 areas: (1) pediatric drug development and drug trials; (2) conducting comparative effectiveness research in pediatric populations; (3) child and parent engagement on study teams; (4) improving communication with children and parents; and (5) assessing child-reported outcomes and adverse drug events.

Indexed as

Ethics, ResearchPatient SafetyChildDrug-Related Side Effects and Adverse ReactionsHospitals, PediatricHumansParentsResearch DesignUnited StatesUnited States Food and Drug Administration

Identifiers

PMID28778857
PMCPMC5574727

What OpenQuestion holds

Textmetadata
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.