Evidence map›Paper›PMID 30719547›Full record

ArticleVirchows Archiv : an international journal of pathology2019

European follow-up of incorrect biomarker results for colorectal cancer demonstrates the importance of quality improvement projects.

Cleo Keppens, Kelly Dufraing, Han J van Krieken, Albert G Siebers, George Kafatos, Kimberly Lowe, Gaston Demonty, Elisabeth M C Dequeker

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Virchows Archiv : an international journal of pathology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

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

  1. Guideline
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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

8 authors.

Cleo KeppensDepartment of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, Kapucijnenvoer 35 block d, 1st floor, box 7001, 3000, Leuven, Belgium.
Kelly DufraingDepartment of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, Kapucijnenvoer 35 block d, 1st floor, box 7001, 3000, Leuven, Belgium.
Han J van KriekenDepartment of Pathology, Radboud University Medical Center, Geert Grooteplein 10 (route 812), P.O.Box 9101, 6500 HB, Nijmegen (824), The Netherlands.
Albert G SiebersDepartment of Pathology, Radboud University Medical Center, Geert Grooteplein 10 (route 812), P.O.Box 9101, 6500 HB, Nijmegen (824), The Netherlands.
George KafatosAmgen Ltd, 1 Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH, UK.
Kimberly LoweAmgen Inc, One Amgen Center Drive, MS 17-2-A, Thousand Oaks, CA, 91320, USA.
Gaston DemontyAmgen Belgium S.A./N.V, Arianelaan 5, 1200, Brussels, Belgium.
Elisabeth M C DequekerDepartment of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, Kapucijnenvoer 35 block d, 1st floor, box 7001, 3000, Leuven, Belgium. els.dequeker@kuleuven.be.

Funding

Amgen not applicable
6 · The paper itself

Abstract

Biomarker analysis for colorectal cancer has been shown to be reliable in Europe with 97% of samples tested by EQA participants to be correctly classified. This study focuses on errors during the annual EQA assessment. The aim was to explore the causes and actions related to the observed errors and to provide feedback and assess any improvement between 2016 and 2017. An electronic survey was sent to all laboratories with minimum one genotyping error or technical failure on ten tumor samples. A workshop was organized based on 2016 survey responses. Improvement of performance in 2017 was assessed for returning participants (n = 76), survey respondents (n = 13) and workshop participants (n = 4). Survey respondents and workshop participants improved in terms of (maximum) analysis score, successful participation, and genotyping errors compared to all returning participants. In 2016, mostly pre- and post-analytical errors (both 25%) were observed caused by unsuitability of the tumor tissue for molecular analysis. In 2017, most errors were due to analytical problems (50.0%) caused by methodological problems. The most common actions taken (n = 58) were protocol revisions (34.5%) and staff training (15.5%). In 24.1% of issues identified no action was performed. Corrective actions were linked to an improved performance, especially if performed by the pathologist. Although biomarker testing has improved over time, error occurrence at different phases stresses the need for quality improvement throughout the test process. Participation to quality improvement projects and a close collaboration with the pathologist can have a positive influence on performance.

Indexed as

Diagnostic ErrorsBiomarkers, TumorColorectal NeoplasmsCongresses as TopicEuropeFollow-Up StudiesFormative FeedbackGenetic Predisposition to DiseaseHealth Care SurveysHumansLaboratory Proficiency TestingMolecular Diagnostic TechniquesObserver VariationPhenotypePredictive Value of TestsQuality ImprovementBiomarkers, TumorBiomarker analysisColorectal cancerCorrective actionsError analysisExternal quality assessmentMolecular pathology

Identifiers

PMID30719547
PMCPMC6611891

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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.