Evidence map›Paper›PMID 29764880›Full record

ArticleBMJ open2018

Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial.

Stefanie Weigel, Joachim Gerss, Hans-Werner Hense, Miriam Krischke, Alexander Sommer, Jörg Czwoydzinski, Horst Lenzen, Laura Kerschke, Karin Spieker, Stefanie Dickmaenken and 6 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03377036 (Prospective Randomized Comparison of Digital Breast Tomosynthesis Plus Synthesized Images Versus Standard Full-field Digital Mammography in Population-based Screening), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

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

NCT03377036 naactive not recruitingnot on this map

Prospective Randomized Comparison of Digital Breast Tomosynthesis Plus Synthesized Images Versus Standard Full-field Digital Mammography in Population-based Screening (TOSYMA)

TypeinterventionalSponsorUniversity Hospital MuensterRan2018 to 2027Enrolled99,689ConditionsBreast Cancer ScreeningArmsDBT+s2D, 2D-FFDM
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Consensus Meeting of Breast Imaging: BI-RADS® and Beyond.Breast care (Basel, Switzerland) · 2019
    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

16 authors.

Stefanie WeigelInstitute of Clinical Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Münster, Germany.ORCID 0000-0002-8009-8831
Joachim GerssInstitute of Biostatistics and Clinical Research, IBKF, University of Münster, Münster, Germany.
Hans-Werner HenseInstitute of Epidemiology and Social Medicine, University of Münster, Münster, Germany.
Miriam KrischkeCenter for Clinical Trials Münster, University Hospital Münster, Münster, Germany.
Alexander SommerInstitute of Clinical Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Münster, Germany.
Jörg CzwoydzinskiInstitute of Clinical Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Münster, Germany.
Horst LenzenInstitute of Clinical Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Münster, Germany.
Laura KerschkeInstitute of Biostatistics and Clinical Research, IBKF, University of Münster, Münster, Germany.
Karin SpiekerCenter for Clinical Trials Münster, University Hospital Münster, Münster, Germany.
Stefanie DickmaenkenCenter for Clinical Trials Münster, University Hospital Münster, Münster, Germany.
Sonja BaierCenter for Clinical Trials Münster, University Hospital Münster, Münster, Germany.
Marc UrbanCenter for Clinical Trials Münster, University Hospital Münster, Münster, Germany.
Gerold HechtReference Center for Mammography North, Oldenburg, Germany.
Oliver HeidingerState Cancer Registry North Rhine-Westphalia, Münster, Germany.
Joachim KieschkeState Cancer Registry Lower Saxony, Oldenburg, Germany.
Walter HeindelInstitute of Clinical Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Münster, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDevelopment of digital breast tomosynthesis (DBT) provides a technology that generates three-dimensional data sets, thus reducing the pitfalls of overlapping breast tissue. Observational studies suggest that the combination of two-dimensional (2D) digital mammography and DBT increases diagnostic accuracy. However, because of duplicate exposure, this comes at the cost of an augmented radiation dose. This undesired adverse impact can be avoided by using synthesised 2D images reconstructed from the DBT data (s2D).We designed a diagnostic superiority trial on a high level of evidence with the aim of providing a comparison of screening efficacy parameters resulting from DBT+s2D versus the current screening standard 2D full-field digital mammography (FFDM) in a multicentre and multivendor setting on the basis of the quality-controlled, population-based, biennial mammography screening programme in Germany. METHODS AND ANALYSIS: 80 000 women in the eligible age 50-69 years attending the routine mammography screening programme and willing to participate in the TOSYMA trial will be assigned by 1:1 randomisation to either the intervention arm (DBT+s2D) or the control arm (FFDM) during a 12-month recruitment period in screening units of North Rhine-Westphalia and Lower Saxony. State cancer registries will provide the follow-up of interval cancers.Primary endpoints are the detection rate of invasive breast cancers at screening examination and the cumulative incidence of interval cancers in the 2 years after a negative examination. Secondary endpoints are the detection rate of ductal carcinoma in situ and of tumour size T1, the recall rate for assessment, the positive predictive value of recall and the cumulative 12-month incidence of interval cancers. An adaptive statistical design with one interim analysis provides the option to modify the design. ETHICS AND DISSEMINATION: This protocol has been approved by the local medical ethical committee (2016-132-f-S). Results will be submitted to international peer-reviewed journals.

trial registrationNCT03377036; Pre-results.

Indexed as

AgedBreast NeoplasmsCarcinoma, Intraductal, NoninfiltratingEquivalence Trials as TopicFemaleGermanyHumansMammographyMass ScreeningMiddle AgedPredictive Value of TestsRandomized Controlled Trials as TopicRegistriesbreast imagingdigital breast tomosynthesisfull-field digital mammographymulticenter randomized controlled trialpopulation-based screeningsynthetic mammography

Identifiers

PMID29764880
PMCPMC5961594

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Registered trials

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.