Evidence map›Paper›PMID 30891222›Full record

ArticleEcology and evolution2019

Equivalence analysis to support environmental safety assessment: Using nontarget organism count data from field trials with cisgenically modified potato.

Hilko van der Voet, Paul W Goedhart, Jenny Lazebnik, Geert J T Kessel, Ewen Mullins, Joop J A van Loon, Salvatore Arpaia

Abstract read
In one paragraph

Article in Ecology and evolution, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. 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

7 authors.

Hilko van der VoetWageningen University & Research Wageningen The Netherlands.ORCID https://orcid.org/0000-0003-0802-7382
Paul W GoedhartWageningen University & Research Wageningen The Netherlands.
Jenny LazebnikWageningen University & Research Wageningen The Netherlands.
Geert J T KesselWageningen University & Research Wageningen The Netherlands.
Ewen MullinsCrop Science Department Teagasc Carlow Ireland.
Joop J A van LoonWageningen University & Research Wageningen The Netherlands.
Salvatore ArpaiaEnergy and Environment Research Center ENEA, Italian National Agency for New Technologies Trisaia di Rotondella Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This paper considers the statistical analysis of entomological count data from field experiments with genetically modified (GM) plants. Such trials are carried out to assess environmental safety. Potential effects on nontarget organisms (NTOs), as indicators of biodiversity, are investigated. The European Food Safety Authority (EFSA) gives broad guidance on the environmental risk assessment (ERA) of GM plants. Field experiments must contain suitable comparator crops as a benchmark for the assessment of designated endpoints. In this paper, a detailed protocol is proposed to perform data analysis for the purpose of assessing environmental safety. The protocol includes the specification of a list of endpoints and their hierarchical relations, the specification of intended levels of data analysis, and the specification of provisional limits of concern to decide on the need for further investigation. The protocol emphasizes a graphical representation of estimates and confidence intervals for the ratio of mean abundances for the GM plant and its comparator crop. Interpretation relies mainly on equivalence testing in which confidence intervals are compared with the limits of concern. The proposed methodology is illustrated with entomological count data resulting from multiyear, multilocation field trials. A cisgenically modified potato line (with enhanced resistance to late blight disease) was compared to the original conventional potato variety in the Netherlands and Ireland in two successive years (2013, 2014). It is shown that the protocol encompasses alternative schemes for safety assessment resulting from different research questions and/or expert choices. Graphical displays of equivalence testing at several hierarchical levels and their interpretation are presented for one of these schemes. The proposed approaches should be of help in the ERA of GM or other novel plants.

Indexed as

environmental risk assessmentequivalence testhierarchical analysislimit of concernmulticriteria decision analysisoverdispersed Poisson

Identifiers

PMID30891222
PMCPMC6405891

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Registered trials

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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.