Evidence map›Paper›PMID 41930302›Full record

ArticleESMO real world data and digital oncology2026

Evaluating the statistical utility and information loss in the transformation of a real-world oncology database from CDISC-SDTM to OMOP-CDM.

A Lambert, C Castagne, D Pau, J Chmiel, A Labarga, E Boernert, F Margraff, C Bachot, L Kaczmarek, D Toshev and 2 more

Abstract read
In one paragraph

Article in ESMO real world data and digital oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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2 · The registry

The trial behind it

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3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

12 authors.

A LambertRoche SAS, Boulogne-Billancourt, France.
C CastagneRoche SAS, Boulogne-Billancourt, France.
D PauRoche SAS, Boulogne-Billancourt, France.
J ChmielAvenga, Cologne, Germany.
A LabargaALG, Pamplona, Spain.
E BoernertF. Hoffmann-La Roche AG, Basel, Switzerland.
F MargraffF. Hoffmann-La Roche AG, Basel, Switzerland.
C BachotRoche SAS, Boulogne-Billancourt, France.
L KaczmarekF. Hoffmann-La Roche AG, Basel, Switzerland.
D ToshevF. Hoffmann-La Roche AG, Basel, Switzerland.
J Martinez GBillennium S.A., Warsaw, Poland.
T StoneRoche Products Limited, Welwyn Garden City, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: This project documented the conversion of a French real-world oncology study database from Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). The goal was to measure syntactic and semantic information loss resulting from this transformation. Patients and methods: Source data originated from a retrospective observational study of HER2-positive early breast cancer patients. Initially in CDISC-SDTM standards, the data included 73 variables detailing patient demographics, disease characteristics, surgery, and follow-up information such as adjuvant treatment. Data conversion to OMOP-CDM utilized extract, load and transform (ELT) procedures with Observational Health Data Sciences and Informatics (OHDSI) tools and the data build tool (dbt), encountering challenges in mapping specific variables and maintaining data granularity. Information loss assessments involved statistical analyses. Results: The source database was successfully mapped to OMOP-CDM and standardized terminologies. Statistical results from the OMOP-transformed database were consistent with those from the original SDTM database, achieving 100% concordance across all tested equality criteria for univariate, bivariate, logistic, survival, and correlation analyses at a 95% confidence interval or respective Conclusions: Statistical utility of the real-world oncology dataset was maintained after transformation to OMOP-CDM, ensuring reproducibility of statistical analyses. Information loss during conversion is significantly dependent on the intrinsic characteristics and level of standardization of the source database, particularly if not originally adhering to standard vocabularies.

Indexed as

CDISC-SDTMdbtOHDSIOMOP-CDMoncologyRWD

Identifiers

PMID41930302
PMCPMC13040891

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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.