ArticlePloS one2021
Towards remote monitoring in pediatric care and clinical trials-Tolerability, repeatability and reference values of candidate digital endpoints derived from physical activity, heart rate and sleep in healthy children.
Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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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.
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.
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- It is Feasible for 3 to 5-Year-Old Children to Use Smartwatch Activity Trackers: A Systematic Review.Acta paediatrica (Oslo, Norway : 1992) · 2025Pooled it
- Monitoring Steps and Heart Rate Using a Withings Smartwatch in Children and Adolescents With Cancer: Validation Study.JMIR cancer · 2026Article
- Self-care strategies and interventions to address antimicrobial resistance: evidence review and recommendations for national programs, service providers, caregivers, and self-carers.Frontiers in public health · 2026Review
- Treatment of Gaming Disorder in Children and Adolescents: A Systematic Review.Journal of the Korean Academy of Child and Adolescent Psychiatry · 2025Article
- The Long-Term Uptake of Home Spirometry in Regular Cystic Fibrosis Care: Retrospective Multicenter Observational Study.Journal of medical Internet research · 2025Observational
- Applied body-fluid analysis by wearable devices.Nature · 2024Review
- Unleashing the full potential of digital outcome measures in clinical trials: eight questions that need attention.BMC medicine · 2024Review
- Monitoring Activity and Gait in Children (MAGIC) using digital health technologies.Pediatric research · 2024Article
- Longitudinally tracking personal physiomes for precision management of childhood epilepsy.PLOS digital health · 2022Article
- Automated growth monitoring app (GROWIN): a mobile Health (mHealth) tool to improve the diagnosis and early management of growth and nutritional disorders in childhood.Journal of the American Medical Informatics Association : JAMIA · 2022Article
- 10Vida: A Mental and Physical Health Intervention for Chronically Ill Adolescents and Their Caregivers in the Hospital Setting: An Open Study.International journal of environmental research and public health · 2022Article
- Using wearable devices to generate real-world, individual-level data in rural, low-resource contexts in Burkina Faso, Africa: A case study.Frontiers in public health · 2022Article
- Is mHealth a useful therapy for improving physical or emotional health in adolescents with cystic fibrosis? A systematic review.Current psychology (New Brunswick, N.J.) · 2021Article
- Objective Home-Monitoring of Physical Activity, Cardiovascular Parameters, and Sleep in Pediatric Obesity.Digital biomarkersArticle
- Postdischarge Recovery after Acute Pediatric Lung Disease Can Be Quantified with Digital Biomarkers.Respiration; international review of thoracic diseasesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDigital devices and wearables allow for the measurement of a wide range of health-related parameters in a non-invasive manner, which may be particularly valuable in pediatrics. Incorporation of such parameters in clinical trials or care as digital endpoint could reduce the burden for children and their parents but requires clinical validation in the target population. This study aims to determine the tolerability, repeatability, and reference values of novel digital endpoints in healthy children.
methodsApparently healthy children (n = 175, 46% male) aged 2-16 were included. Subjects were monitored for 21 days using a home-monitoring platform with several devices (smartwatch, spirometer, thermometer, blood pressure monitor, scales). Endpoints were analyzed with a mixed effects model, assessing variables that explained within- and between-subject variability. Endpoints based on physical activity, heart rate, and sleep-related parameters were included in the analysis. For physical-activity-related endpoints, a sample size needed to detect a 15% increase was calculated.
findingsMedian compliance was 94%. Variability in each physical activity-related candidate endpoint was explained by age, sex, watch wear time, rain duration per day, average ambient temperature, and population density of the city of residence. Estimated sample sizes for candidate endpoints ranged from 33-110 per group. Daytime heart rate, nocturnal heart rate and sleep duration decreased as a function of age and were comparable to reference values published in the literature.
conclusionsWearable- and portable devices are tolerable for pediatric subjects. The raw data, models and reference values presented here can be used to guide further validation and, in the future, clinical trial designs involving the included measures.
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Registered trials
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.