Evidence map›Paper›PMID 39015515›Full record

ArticleDigital biomarkers

Digital Measures Development: Lessons Learned from an Expert Workshop Addressing Cross-Therapeutic Area Measures of Sleep.

Piper Fromy, Michael Kremliovsky, Emmanuel Mignot, Mark Aloia, Jonathan Berent, Farah Hasan, Dennis Hwang, Jiat-Ling Poon, Rebecca Malcolm, Christopher Miller and 2 more

Abstract read
In one paragraph

Article in Digital biomarkers. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

12 authors.

Piper FromyProject Lead, Digital Medicine Society, Boston, MA, USA.
Michael KremliovskyMedical Devices and eHealth, Bayer, Hanover, NJ, USA.
Emmanuel MignotProfessor of Sleep Medicine, Stanford University, Palo Alto, CA, USA.
Mark AloiaHead of Sleep and Behavioral Sciences, SleepIQ Health, Sleep Number Corporation and Associate Professor of Medicine, National Jewish Health, Denver Metropolitan Area, Denver, CO, USA.
Jonathan BerentCEO, Founder, NextSense, Inc, Mountain View, CA, USA.
Farah HasanPatient Representative, Philadelphia, PA, USA.
Dennis HwangPhysician, Kaiser Permanente, Tustin, CA, USA.
Jiat-Ling PoonSr Director Value, Evidence, and Outcomes, Eli Lilly and Company, Indianapolis, IN, USA.
Rebecca MalcolmProject Lead, Digital Medicine Society, Boston, MA, USA.
Christopher MillerScientific Advisor, Scientific Strategy and Innovation, Immediate Office of the Director, National Heart, Lung, and Blood Institute, National Institutes of Health, Washington, DC, USA.
Womba NawaCare Partner Representative, Scituate, MA, USA.
Jessie BakkerProject Lead, Digital Medicine Society, Boston, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: The Digital Measures Development: Core Measures of Sleep project, led by the Digital Medicine Society (DiMe), emphasizes the importance of sleep as a cornerstone of health and the need for standardized measurements of sleep and its disturbances outside the laboratory. This initiative recognizes the complex relationship between sleep and overall health, addressing it as both a symptom of underlying conditions and a consequence of therapeutic interventions. It aims to fill a crucial gap in healthcare by promoting the development of accessible, nonintrusive, and cost-effective digital tools for sleep assessment, focusing on factors important to patients, caregivers, and clinicians. Methods: A central feature of this project was an expert workshop conducted on April 19th, 2023. The workshop convened stakeholders from diverse backgrounds, including regulatory, payer, industry, academic, and patient groups, to deliberate on the project's direction. This gathering focused on discussing the challenges and necessities of measuring sleep across various therapeutic areas, aiming to identify broad areas for initial focus while considering the feasibility of generalizing these measures where applicable. The methodological emphasis was on leveraging expert consensus to guide the project's approach to digital sleep measurement. Results: The workshop resulted in the identification of seven key themes that will direct the DiMe Core Digital Measures of Sleep project and the broader field of sleep research moving forward. These themes underscore the project's innovative approach to sleep health, highlighting the complexity of omni-therapeutic sleep measurement and identifying potential areas for targeted research and development. The discussions and outcomes of the workshop serve as a roadmap for enhancing digital sleep measurement tools, ensuring they are relevant, accurate, and capable of addressing the nuanced needs of diverse patient populations. Conclusion: The Digital Medicine Society's Core Measures of Sleep project represents a pivotal effort to advance sleep health through digital innovation. By focusing on the development of standardized, patient-centric, and clinically relevant digital sleep assessment tools, the project addresses a significant need in healthcare. The expert workshop's outcomes underscore the importance of collaborative, multi-stakeholder engagement in identifying and overcoming the challenges of sleep measurement. This initiative sets a new precedent for the integration of digital tools into sleep health research and practice, promising to improve outcomes for patients worldwide by enhancing our understanding and measurement of sleep.

Indexed as

Digital evidenceMobile technologyObjective dataSleepSleep disturbance

Identifiers

PMID39015515
PMCPMC11250246

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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.