Evidence map›Paper›PMID 39121682›Full record

ArticleComputers in biology and medicine2024

Distributed management of patient data-sharing informed consents for clinical research.

Anh Pham, Maxim Edelson, Armin Nouri, Tsung-Ting Kuo

Abstract read
In one paragraph

Article in Computers in biology and medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 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.

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 synthesis or guideline pooled it.

  1. Pooled it
  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

4 authors.

Anh PhamUCSD Health Department of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA.
Maxim EdelsonUCSD Department of Computer Science and Engineering, University of California San Diego, La Jolla, CA, USA.
Armin NouriDepartment of Biomedical Engineering, Fu Foundation School of Engineering, Columbia University, New York, NY, USA.
Tsung-Ting KuoUCSD Health Department of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA; Department of Biomedical Informatics and Data Science, School of Medicine, Yale University, New Haven, CT, USA; Department of Surgery, School of Medicine, Yale University, New Haven, CT, USA. Electronic address: tsung-ting.kuo@yale.edu.

Funding

San Diego Biomedical Informatics Education & Research (SABER)T15LM011271 · NLM · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SHAMIM NEMATI · 2012 to 2026
$9.7M
iAGREE: A Multi-Center, Networked Patient Consent StudyR01HG011066 · NHGRI · YALE UNIVERSITY · PI OHNO-MACHADO, LUCILA · 2020 to 2024
$4.2M
SOCAL: Privacy-protecting Sharing Of Clinical Data Across LaboratoriesR01EB031030 · NIBIB · YALE UNIVERSITY · PI KUO, TSUNG-TING · 2022 to 2025
$1.3M
NHGRI NIH HHS R01 HG011066NIBIB NIH HHS R01 EB031030NLM NIH HHS T15 LM011271
6 · The paper itself

Abstract

backgroundThe consent protocol is now a critical part in the overall orchestration of clinical research. We aimed to demonstrate the feasibility of an Ethereum-based informed consent system, which includes an immutable and automated channel of consent matching, to simultaneously assure patient privacy and increase the efficiency of researchers' data access.

methodWe simulated a multi-site scenario, each assigned 10000 consent records. A consent record contained one patient's data-sharing preference with regards to seven data categories. We developed a blockchain-based infrastructure with a smart contract to record consents on-chain, and to query consenting patients corresponding to specific criteria. We measured our system's recording efficiency against a baseline design and verified accuracy by testing an exhaustive list of possible queries.

resultsOur method achieved ∼3-4% lead with an average insertion speed of ∼2 s per record per node on either a 3-, 4- or 5-node network, and 100 % accuracy. It also outperformed other solutions in external validation. DISCUSSION: The speed we achieved is reasonable in a real-world system under the realistic assumption that patients may not change their minds too frequently, with the added benefit of immutability. Furthermore, the per-insertion time did improve slightly as the number of network nodes increased, attesting to the benefit of node parallelism as it suggests no attrition of insertion efficiency due to scale of nodes.

conclusionsOur work confirms the technical feasibility of a blockchain-based consent mechanism, assuring patients with an immutable audit trail, and providing researchers with an efficient way to reach their cohorts.

Indexed as

Biomedical ResearchInformed ConsentBlockchainElectronic Health RecordsHumansInformation DisseminationClinical information systemsElectronic health recordsNational health information infrastructurePrivacy and securitySoftware architecture

Identifiers

PMID39121682
PMCPMC11380755

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.