Evidence map›Paper›PMID 34228319›Full record

ReviewTherapeutic innovation & regulatory science2021

Radiologists and Clinical Trials: Part 1 The Truth About Reader Disagreements.

Annette M Schmid, David L Raunig, Colin G Miller, Richard C Walovitch, Robert W Ford, Michael O'Connor, Guenther Brueggenwerth, Josy Breuer, Liz Kuney, Robert R Ford

Abstract readReview
In one paragraph

Review in Therapeutic innovation & regulatory science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing 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

20 citing papers in PubMed.

  1. Review
  2. Article
  3. Tumor metrics imaging core labs: primer for radiologists.Abdominal radiology (New York) · 2026
    Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. A call for objectivity: Radiologists' proposed wishlist for response evaluation in solid tumors (RECIST 1.1).Cancer imaging : the official publication of the International Cancer Imaging Society · 2024
    Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

10 authors.

Annette M Schmid *Takeda, 300 Massachusetts Ave, Cambridge, MA, 02139, USA.
David L Raunig *Takeda, 300 Massachusetts Ave, Cambridge, MA, 02139, USA. draunig@snet.net.ORCID 0000-0003-4549-1280
Colin G MillerThe Bracken Group, Newtown, PA, USA.
Richard C WalovitchWorldCare Clinical, Boston, MA, USA.
Robert W FordThomas Jefferson University Hospital, Philadelphia, PA, USA.
Michael O'ConnorParexel, Billerica, MA, USA.
Guenther BrueggenwerthBayer AG, Berlin, Germany.
Josy BreuerConsultant, Lutherstadt Wittenberg, Saxony-Anhalt, Germany.
Liz KuneyKuney Consulting, LLC, Syracuse, NY, USA.
Robert R FordBioclinica, LLC, Princeton, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The debate over human visual perception and how medical images should be interpreted have persisted since X-rays were the only imaging technique available. Concerns over rates of disagreement between expert image readers are associated with much of the clinical research and at times driven by the belief that any image endpoint variability is problematic. The deeper understanding of the reasons, value, and risk of disagreement are somewhat siloed, leading, at times, to costly and risky approaches, especially in clinical trials. Although artificial intelligence promises some relief from mistakes, its routine application for assessing tumors within cancer trials is still an aspiration. Our consortium of international experts in medical imaging for drug development research, the Pharma Imaging Network for Therapeutics and Diagnostics (PINTAD), tapped the collective knowledge of its members to ground expectations, summarize common reasons for reader discordance, identify what factors can be controlled and which actions are likely to be effective in reducing discordance. Reinforced by an exhaustive literature review, our work defines the forces that shape reader variability. This review article aims to produce a singular authoritative resource outlining reader performance's practical realities within cancer trials, whether they occur within a clinical or an independent central review.

Indexed as

Artificial IntelligenceRadiologistsHumansClinical trialsImage interpretationIndependent reviewRadiologyReader disagreementVisual perception

Identifiers

PMID34228319
PMCPMC8259547

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.