Evidence map›Paper›PMID 32789155›Full record

ArticleTobacco regulatory science2020

Method Validation Approaches for Analysis of Constituents in ENDS.

Samantha M Reilly, Tianrong Cheng, Jenna DuMond

Abstract read
In one paragraph

Article in Tobacco regulatory science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. In Vivo Analysis of Extract of Leaves of Mistletoe as aVeterinary medicine international · 2022
    Article
  6. 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.

Samantha M ReillyOffice of Science, Center for Tobacco Products, Food and Drug Administration, Silver Spring, MD.
Tianrong ChengOffice of Science, Center for Tobacco Products, Food and Drug Administration, Silver Spring, MD.
Jenna DuMondOffice of Science, Center for Tobacco Products, Food and Drug Administration, Silver Spring, MD.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

objectiveWe assessed how many peer-reviewed publications reporting chemical quantities and/or yields from electronic nicotine delivery systems (ENDS) have included adequate method validation characteristics in the publication for appropriate interpretation of data quality for informing tobacco regulatory science.

methodsWe searched 5 databases (Web of Knowledge, PubMed, SciFinder, Embase, EBSCOhost) for ENDS publications between January 2007 and September 2018. Of the 283 publications screened, 173 publications were relevant for analysis. We identified the publications that report a certain degree of control in data quality, ie, the publications that report marginally validated methods (MVMs). MVMs refer to the methods that: (1) report 3 or more International Conference on Harmonisation (ICH) method validation characteristics, (2) state the method was validated, (3) cite their own previous publication(s) that report MVMs, or (4) use a method within the accreditation scope of an accredited laboratory.

resultsOverall, 97 publications (56%) report MVMs in their studies. This percentage also reflects the publication distribution for the majority of the 28 chemicals measured by MVMs.

conclusionsThis study highlights the need for reporting sufficient validation characteristics following appropriate guidance to ensure the accuracy and reliability of the published analytical data for proper data interpretations that may support policy.

Indexed as

analytical method validationconstituentsENDSInternational Conference on Harmonisation (ICH) guidelines

Identifiers

PMID32789155
PMCPMC7416875

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.