Evidence map›Paper›PMID 39192753›Full record

ArticleCancer2025

Feasibility of structuring electronic health record data to facilitate real-world data research: ICAREdata methods applied to multicenter cancer clinical trials.

Suzanne George, Nancy Campbell, Shauna L Hillman, Elizabeth S Harlos, David W J Stein, Miranda Y Chan, Selina L Chow, Cassandra L Elrahi, Andre C Quina, Maeve C Kokolus and 9 more

Abstract read
In one paragraph

Article in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
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

19 authors.

Suzanne GeorgeDana-Farber/Harvard Cancer Center, Boston, Massachusetts, USA.
Nancy CampbellData Innovation Lab LLC, Alliance for Clinical Trials in Oncology, Boston, Massachusetts, USA.
Shauna L HillmanAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota, USA.
Elizabeth S HarlosAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota, USA.
David W J SteinThe MITRE Corporation, Bedford, Massachusetts, USA.
Miranda Y ChanThe MITRE Corporation, Bedford, Massachusetts, USA.
Selina L ChowAlliance for Clinical Trials in Oncology, Chicago, Illinois, USA.
Cassandra L ElrahiData Innovation Lab LLC, Alliance for Clinical Trials in Oncology, Boston, Massachusetts, USA.
Andre C QuinaThe MITRE Corporation, Bedford, Massachusetts, USA.
Maeve C KokolusThe MITRE Corporation, Bedford, Massachusetts, USA.
Michelle D CasagniThe MITRE Corporation, Tampa, Florida, USA.
Matthias WeissThedaCare Regional Cancer Center, Appleton, Wisconsin, USA.
Daniel M AndersonMetro-Minnesota Community Oncology Research Consortium, St Louis Park, Minnesota, USA.
Walter M StadlerUniversity of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.ORCID https://orcid.org/0000-0002-0435-2527
Olivia C HoffMetro-Minnesota Community Oncology Research Consortium, St Louis Park, Minnesota, USA.
Donna R RiveraOncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland, USA.
Paul G KluetzOncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland, USA.
Sumithra J MandrekarAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota, USA.
Steven PiantadosiBrigham and Women's Hospital, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-4409-9896

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
NCI NIH HHS U10 CA180821US Food and Drug Administration FDABAA-20-00123
6 · The paper itself

Abstract

backgroundThe use of electronic health record (EHR) data for research is limited by a lack of structure and a standard data model. The objective of the ICAREdata (Integrating Clinical Trials and Real-World Endpoints Data) project was to structure key research data elements in EHRs using a minimal Common Oncology Data Elements (mCODE) data model to extract and transmit data.

methodsThe ICAREdata project captured two EHR data elements essential to clinical trials: cancer disease status and treatment plan change. The project was implemented in clinical sites participating in Alliance for Clinical Trials in Oncology trials. Data were extracted from EHRs and sent by secure Fast Healthcare Interoperability Resource messaging (a standard for exchanging EHRs) to a database. Selected elements were compared with corresponding data from the trial's electronic data capture (EDC) system, Medidata Rave.

resultsBy December 2023, data were extracted and transmitted from 10 sites for 35 patients, involving 367 clinical encounters across 15 clinical trials. Data through March 2023 demonstrated that concordance for the elements treatment plan change and cancer disease status was 79% and 34%, respectively. When disease evaluation was reported by both EHR and EDC (n = 15), there was 87% agreement on cancer disease status.

conclusionsDocumentation, extraction, and aggregation of structured data elements in EHRs using mCODE and ICAREdata methods is feasible in multi-institutional cancer clinical trials. EDC as a reference data set allowed assessment of the completeness of EHR data capture. Future initiatives will focus on elements with shared definitions in clinical and research environments and efficient workflows. PLAIN LANGUAGE SUMMARY: Clinical trials use electronic case report forms to report data, and data must be manually entered on these forms, which is costly and time consuming. ICAREdata methods use structured, organized data from clinical trials that can be more easily shared instead having to enter free text into electronic health records.

Indexed as

Clinical Trials as TopicElectronic Health RecordsFeasibility StudiesNeoplasmsHumansclinical trialselectronic health recordIntegrating Clinical Trials and Real‐World Endpoints data (ICAREdata)interoperabilityminimal Common Oncology Data Elements (mCODE)structured electronic health record

Identifiers

PMID39192753
PMCPMC11693928

What OpenQuestion holds

Textmetadata
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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.