Evidence map›Paper›PMID 28497316›Full record

ArticleVirchows Archiv : an international journal of pathology2017

Quality assurance trials for Ki67 assessment in pathology.

M Raap, S Ließem, J Rüschoff, A Fisseler-Eckhoff, A Reiner, S Dirnhofer, R von Wasielewski, H Kreipe

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Virchows Archiv : an international journal of pathology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Clinical validity and clinical utility of Ki67 in early breast cancer.Therapeutic advances in medical oncology · 2022
    Review
  7. Response to Zhang and Yang.Journal of the National Cancer Institute · 2021
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Ki-67 is an independent predictor of prostate cancer death in routine needle biopsy samples: proving utility for routine assessments.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2019
    Article
  16. Observational
  17. 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

8 authors.

M RaapInstitute of Pathology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.ORCID http://orcid.org/0000-0001-8338-6209
S LießemInstitute of Pathology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
J RüschoffInstitute of Pathology Nordhessen, Kassel, Germany.
A Fisseler-EckhoffInstitute of Pathology and Cytology, Wiesbaden, Germany.
A ReinerDepartment of Pathology and Bacteriology, Danube Hospital, Vienna, Austria.
S DirnhoferInstitute of Pathology, University Hospital of Basel, Basel, Switzerland.
R von WasielewskiInstitute of Pathology, Nordstadt Hospital, Hannover, Germany.
H KreipeInstitute of Pathology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany. Kreipe.Hans@MH-hannover.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ki67 is a broadly used proliferation marker in surgical pathology with an obvious need for standardization to improve reproducibility of assessment. Here, we present results of the so far only existing round robin tests on Ki67, organized annually in Germany, Austria, and Switzerland from 2010 to 2015 with up to 160 participating laboratories (QuIP). In each quality assessment trial, eight probes from each breast cancer, neuroendocrine tumor, and malignant lymphoma were compiled on a tissue microarray (TMA). TMAs were stained in the participants' laboratories with antibodies and procedures also applied in their daily routine. Participating pathologists were expected to assign Ki67 values to one of four different categories for each tumor type. All local stainings and evaluations were reassessed by the organizing panel and compared to a preset standard. On average, 95% of participants reached the benchmark of over 80% concordance rates with the Ki67 category pre-established by the panel. Automatization and type of antibody did not affect the success rate. Concordance rates differed between tumor entities being highest in each tumor type with either very high or very low labeling indices. Lower rates were seen for intermediate Ki67 levels. Staining quality improved during the observation period as did inter-observer concordance with 85% of participants achieving excellent agreement (kappa > 0.8) in the first year and over 95% in 2015. In conclusion, regular external quality assurance trials have been established as a tool to improve the reproducibility and reliability of the prognostic and predictive proliferation marker Ki67.

Indexed as

Quality Assurance, Health CareBiomarkers, TumorHumansImmunohistochemistryKi-67 AntigenObserver VariationPathology, ClinicalReproducibility of ResultsTissue Array AnalysisBiomarkers, TumorKi-67 AntigenBreast cancerKi67Neuroendocrine tumorQuality assurance trialRound robin test

Identifiers

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.