Evidence map›Paper›PMID 32070405›Full record

ArticleTrials2020

Evaluating the re-identification risk of a clinical study report anonymized under EMA Policy 0070 and Health Canada Regulations.

Janice Branson, Nathan Good, Jung-Wei Chen, Will Monge, Christian Probst, Khaled El Emam

Abstract readEvaluation Study
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

  1. Article
  2. Review
  3. Observational
  4. Managing re-identification risks while providing access to the All of Us research program.Journal of the American Medical Informatics Association : JAMIA · 2023
    Article
  5. Article
  6. Article
  7. Article
  8. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2021
    Article
  9. Optimizing the data available via Health Canada's clinical information portal.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2021
    Article
  10. Article
  11. Enabling realistic health data re-identification risk assessment through adversarial modeling.Journal of the American Medical Informatics Association : JAMIA · 2021
    Article
  12. 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

6 authors.

Janice BransonNovartis, Basel, Switzerland.
Nathan GoodGood Research, El Cerrito, CA, USA.
Jung-Wei ChenGood Research, El Cerrito, CA, USA.
Will MongeGood Research, El Cerrito, CA, USA.
Christian ProbstPrivacy Analytics, Ottawa, Canada.
Khaled El EmamPrivacy Analytics, Ottawa, Canada. kelemam@ehealthinformation.ca.ORCID http://orcid.org/0000-0003-3325-4149

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRegulatory agencies, such as the European Medicines Agency and Health Canada, are requiring the public sharing of clinical trial reports that are used to make drug approval decisions. Both agencies have provided guidance for the quantitative anonymization of these clinical reports before they are shared. There is limited empirical information on the effectiveness of this approach in protecting patient privacy for clinical trial data.

methodsIn this paper we empirically test the hypothesis that when these guidelines are implemented in practice, they provide adequate privacy protection to patients. An anonymized clinical study report for a trial on a non-steroidal anti-inflammatory drug that is sold as a prescription eye drop was subjected to re-identification. The target was 500 patients in the USA. Only suspected matches to real identities were reported.

resultsSix suspected matches with low confidence scores were identified. Each suspected match took 24.2 h of effort. Social media and death records provided the most useful information for getting the suspected matches.

conclusionsThese results suggest that the anonymization guidance from these agencies can provide adequate privacy protection for patients, and the modes of attack can inform further refinements of the methodologies they recommend in their guidance for manufacturers.

Indexed as

PrivacyCanadaClinical Trials as TopicData AnonymizationElectronic Health RecordsHumansResearch Design

Identifiers

PMID32070405
PMCPMC7029478

What OpenQuestion holds

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Registered trials

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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.