Evidence map›Paper›PMID 33623887›Full record

ArticleJAMIA open2020

The FDA MyStudies app: a reusable platform for distributed clinical trials and real-world evidence studies.

Zachary Wyner, Sascha Dublin, Christina Chambers, Shyam Deval, Chayim Herzig-Marx, Shanthala Rao, Adam Rauch, Juliane Reynolds, Jeffrey S Brown, David Martin

Abstract read
In one paragraph

Article in JAMIA open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Automatic Population of the Case Report Forms for an International Multifactorial Adaptive Platform Trial Amid the COVID-19 Pandemic.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2024
    Article
  2. Machine Learning in Clinical Trials: A Primer with Applications to Neurology.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Review
  3. Mobile Health Study Incorporating Novel Fitness Test.Journal of cardiovascular translational research · 2023
    Article
  4. The US Food and Drug Administration Sentinel System: a national resource for a learning health system.Journal of the American Medical Informatics Association : JAMIA · 2022
    Article
  5. Article
  6. 21st Century Cures Act: ethical recommendations for new patient-facing products.Journal of the American Medical Informatics Association : JAMIA · 2022
    Article
  7. Article
  8. Article
  9. Review
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

10 authors.

Zachary WynerDana-Farber Cancer Institute, Boston, Massachusetts, USA.
Sascha DublinKaiser Permanente Washington Health Research Institute, Kaiser Permanente Washington, Seattle, Washington, USA.
Christina ChambersDepartment of Pediatrics, University of California, San Diego, La Jolla, California, USA.
Shyam DevalBoston Technology Corporation, Boston, Massachusetts, USA.
Chayim Herzig-MarxDivision of Therapeutics Research and Infectious Disease Epidemiology, Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Shanthala RaoBoston Technology Corporation, Boston, Massachusetts, USA.
Adam RauchLabKey, Seattle, Washington, USA.
Juliane ReynoldsDivision of Therapeutics Research and Infectious Disease Epidemiology, Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Jeffrey S BrownDivision of Therapeutics Research and Infectious Disease Epidemiology, Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
David MartinModerna, Inc, Cambridge, Massachusetts, USA.

Funding

FDA HHS HHSF223201400030I
6 · The paper itself

Abstract

We developed a mobile application and secure patient data storage platform, FDA MyStudies, to address privacy, engagement, and extensibility challenges in mobile clinical research. The system extends the capabilities of the mobile frameworks Apple ResearchKit and ResearchStack through an intuitive front-end application and secure storage environment that can support health research studies. The platform supports single or multisite studies via role-based access and can be implemented within highly secure data environments. As a proof-of-concept, pregnant women participated in a descriptive study via the app in which data not routinely captured in electronic health records (EHR) were collected and linked with existing patient data to provide a more wholistic view of the patient and illustrate how patient data combined with EHR data could be used to support public health research.

Indexed as

clinical trialsdigital healthmobile appmobile devicesopen sourcepatient-generated datareal-world evidenceResearchKitResearchStackresearch studiesweb-based configuration

Identifiers

PMID33623887
PMCPMC7886578

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.