Evidence map›Paper›PMID 41571173›Full record

ArticleJournal of biomedical informatics2026

A multidimensional hierarchical framework for sources of bias in real-world healthcare evidence: a scoping review.

Haeun Lee, Christelle Xiong, Derek Baughman, Chen Dun, Jiayi Tong, Benjamin Martin, Harold Lehmann, Paul Nagy

Abstract readScoping Review
In one paragraph

Article in Journal of biomedical informatics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. 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

8 authors.

Haeun LeeBiomedical Informatics and Data Science, Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: hlee292@jh.edu.
Christelle XiongBiomedical Informatics and Data Science, Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Derek BaughmanBiomedical Informatics and Data Science, Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Chen DunBiomedical Informatics and Data Science, Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Department of Surgery, Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Jiayi TongDepartment of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Benjamin MartinBiomedical Informatics and Data Science, Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Harold LehmannBiomedical Informatics and Data Science, Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Paul NagyBiomedical Informatics and Data Science, Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, MD, USA.

Funding

Johns Hopkins Training Program in Biomedical Informatics and Data ScienceT15LM013979 · NLM · JOHNS HOPKINS UNIVERSITY · PI CHRISTOPHER G CHUTE, Hadi Kharrazi · 2022 to 2026
$2.2M
NLM NIH HHS T15 LM013979
6 · The paper itself

Abstract

objectiveThis study identifies and categorizes bias sources throughout the real-world evidence (RWE) generation process from electronic health records (EHRs), and we develop a multi-dimensional conceptual framework to characterize how bias arises in large-scale multinational federated network studies.

methodsA three-phase bias framework spanning healthcare delivery, data management, and research was developed through the synthesis of existing frameworks, a structured literature review, and iterative assessment by multidisciplinary expert panels. A scoping review was conducted following PRISMA-ScR guidelines, analyzing studies between 2016 and 2025 in PubMed and Web of Science and focusing on bias in observational studies using real-world data. Bias sources were classified using directed content analysis based on their occurrence stage in the RWE generation process.

resultsAnalysis of 220 papers within this framework identified 209 distinct bias sources categorized into seven specific levels: Access to medical care (n = 40), provision of care (n = 29), data acquisition and measurement (n = 39), clinical documentation and coding practices (n = 32), data extraction (n = 22), data modeling (n = 11), and data analytics (n = 36). Healthcare phase biases were most prevalent (n = 108), followed by data management (n = 54) and research levels (n = 47).

conclusionThis multi-dimensional framework reveals that bias sources in RWE generation are interconnected across patient, provider, administrative, information technology, informatics, and analytical domains, and provides a structural foundation for understanding where and how bias may arise across the RWE process in large-scale observational research.

Indexed as

Delivery of Health CareElectronic Health RecordsBiasHumansCoding SystemCommon Data ModelData ManagementExtractHealthcare Systemload (ETL)Observational StudiesSource of BiasTransform

Identifiers

PMID41571173
PMCPMC13371881

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.