Evidence map›Paper›PMID 29938250›Full record

ReviewDigital biomarkers

Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010-2016: A Systematic Literature Review.

Brian Perry, Will Herrington, Jennifer C Goldsack, Cheryl A Grandinetti, Kaveeta P Vasisht, Martin J Landray, Lauren Bataille, Robert A DiCicco, Corey Bradley, Ashish Narayan and 7 more

Open access · goldAbstract readReview
In one paragraph

Review in Digital biomarkers. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 3 pooled it
23.5field-weighted citation impact, top 1% of its field
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

50 citing papers in PubMed, 3 syntheses or guidelines pooled it, 82 citations in OpenAlex.

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  16. Digital Phenotyping in Clinical Neurology.Seminars in neurology · 2022
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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

17 authors at 12 institutions in 2 countries.

Brian PerryDepartment of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.
Will HerringtonNuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
Jennifer C GoldsackClinical Trials Transformation Initiative, Durham, North Carolina, USA.
Cheryl A GrandinettiCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Kaveeta P VasishtCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Martin J LandrayNuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
Lauren BatailleThe Michael J. Fox Foundation for Parkinson's Research, New York, New York, USA.
Robert A DiCiccoGlaxoSmithKline, King of Prussia, Pennsylvania, USA.
Corey BradleyDuke University Hospital, Durham, North Carolina, USA.
Ashish NarayanMount Sinai Health System, New York, New York, USA.
Elektra J PapadopoulosCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Nirav ShethMicroMedicine, Watertown, Massachusetts, USA.
Ken SkodacekCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USA.
Komathi StemmonARC Bionetworks, Palo Alto, California, USA.
Theresa V StrongFoundation for Prader-Willi Research, Walnut, California, USA.
Marc K WaltonJanssen Research and Development, Titusville, New Jersey, USA.
Amy CorneliDepartment of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.
United States Food and Drug Administration · USDuke University · USUniversity of Oxford · GBClinical Research Institute · USDuke University Hospital · USFoundation for Prader-Willi Research · USGlaxoSmithKline (United States) · USJanssen (United States) · USMichael J. Fox Foundation · USMount Sinai Health System · USSage Bionetworks · USWatertown City School District · US

Funding

FDA HHS R18 FD005292FDA HHS U18 FD005292Medical Research Council MR/R007764/1
6 · The paper itself

Abstract

backgroundThe use of mobile devices in clinical research has advanced substantially in recent years due to the rapid pace of technology development. With an overall aim of informing the future use of mobile devices in interventional clinical research to measure primary outcomes, we conducted a systematic review of the use of and clinical outcomes measured by mobile devices (mobile outcomes) in observational and interventional clinical research.

methodWe conducted a PubMed search using a range of search terms to retrieve peer-reviewed articles on clinical research published between January 2010 and May 2016 in which mobile devices were used to measure study outcomes. We screened each publication for specific inclusion and exclusion criteria. We then identified and qualitatively summarized the use of mobile outcome assessments in clinical research, including the type and design of the study, therapeutic focus, type of mobile device(s) used, and specific mobile outcomes reported.

resultsThe search retrieved 2,530 potential articles of interest. After screening, 88 publications remained. Twenty-five percent of the publications (

conclusionMobile devices are being widely used in clinical research to assess outcomes, although their use in interventional research to assess therapeutic effectiveness is limited. For mobile devices to be used more frequently in pivotal interventional research - such as trials informing regulatory decision-making - more focus should be placed on: (1) consolidating the evidence supporting the clinical meaningfulness of specific mobile outcomes, and (2) standardizing the use of mobile devices in clinical research to measure specific mobile outcomes (e.g., data capture frequencies, placement of device). To that aim, this manuscript offers a broad overview of the various mobile outcome assessments currently used in observational and interventional research, and categorizes and consolidates this information for researchers interested in using mobile devices to assess outcomes in interventional research.

Indexed as

BiomarkersCardiac biomarkersClinical trialsEndpointsGastric refluxGlucoseInertial injuryMobile devicesMobilityOutcome assessmentsPhysical activityRespiratory biomarkersSleep

Identifiers

PMID29938250
PMCPMC6008882
OpenAlexW2791577102

What Socratic holds

Textmetadata
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 Socratic graph.