Evidence map›Paper›PMID 32913915›Full record

ArticleContemporary clinical trials communications2020

Learning from patient and site perspectives to develop better digital health trials: Recommendations from the Clinical Trials Transformation Initiative.

Cindy Geoghegan, Virginia Nido, Angie Botto-van Bemden, Zachary Hallinan, Les Jordan, Lindsay S Kehoe, Steve L Morin, Amanda Niskar, Petros G Okubagzi, William A Wood

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. 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.

Cindy GeogheganPatient and Partners LLC, Madison, CT, USA.
Virginia NidoGenentech, Inc., South San Francisco, CA, USA.
Angie Botto-van BemdenArthritis Foundation, Atlanta, GA, USA.
Zachary HallinanClinical Trials Transformation Initiative, Durham, NC, USA.
Les JordanTarget Health Inc., New York, NY, USA.
Lindsay S KehoeClinical Trials Transformation Initiative, Durham, NC, USA.
Steve L MorinOffice of Health and Constituent Affairs, US Food and Drug Administration, Silver Spring, MD, USA.
Amanda NiskarPatient Voice Representative, Atlanta, GA, USA.
Petros G OkubagziMedStar Health, Columbia, MD, USA.
William A WoodUniversity of North Carolina, Chapel Hill, NC, USA.

Funding

FDA HHS U18 FD005292
6 · The paper itself

Abstract

In order to harness the potential of digital health technologies to enhance the quality of clinical research, it is critical to first understand how to engage patients and research sites when planning and conducting digital health trials. To pave the way for the more effective use of digital health technologies in trials, the Clinical Trials Transformation Initiative has developed the first comprehensive, evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials. While directed primarily at sponsors, these recommendations are expected to be valuable for all stakeholders including investigators.

Indexed as

DHT, Digital Health TrialsDigital health technologyDigital trialsHybrid trialsMobile clinical trialsMobile devicesPatient engagementSite engagementSite support

Identifiers

PMID32913915
PMCPMC7473867

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.