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Verification, analytical validation and clinical validation (V3) of wearable dosimeters and light loggers

BACKGROUND: Light exposure is an important driver and modulator of human physiology, behavior and overall health, including the biological clock, sleep-wake cycles, mood and alertness. Light can also be used as a directed intervention, e.g., in the form of light therapy in seasonal affective disorde...

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Autores principales: Spitschan, Manuel, Smolders, Karin, Vandendriessche, Benjamin, Bent, Brinnae, Bakker, Jessie P, Rodriguez-Chavez, Isaac R, Vetter, Céline
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9806438/
https://www.ncbi.nlm.nih.gov/pubmed/36601285
http://dx.doi.org/10.1177/20552076221144858
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author Spitschan, Manuel
Smolders, Karin
Vandendriessche, Benjamin
Bent, Brinnae
Bakker, Jessie P
Rodriguez-Chavez, Isaac R
Vetter, Céline
author_facet Spitschan, Manuel
Smolders, Karin
Vandendriessche, Benjamin
Bent, Brinnae
Bakker, Jessie P
Rodriguez-Chavez, Isaac R
Vetter, Céline
author_sort Spitschan, Manuel
collection PubMed
description BACKGROUND: Light exposure is an important driver and modulator of human physiology, behavior and overall health, including the biological clock, sleep-wake cycles, mood and alertness. Light can also be used as a directed intervention, e.g., in the form of light therapy in seasonal affective disorder (SAD), jetlag prevention and treatment, or to treat circadian disorders. Recently, a system of quantities and units related to the physiological effects of light was standardized by the International Commission on Illumination (CIE S 026/E:2018). At the same time, biometric monitoring technologies (BioMeTs) to capture personalized light exposure were developed. However, because there are currently no standard approaches to evaluate the digital dosimeters, the need to provide a firm framework for the characterization, calibration, and reporting for these digital sensors is urgent. OBJECTIVE: This article provides such a framework by applying the principles of verification, analytic validation and clinical validation (V3) as a state-of-the-art approach for tools and standards in digital medicine to light dosimetry. RESULTS: This article describes opportunities for the use of digital dosimeters for basic research, for monitoring light exposure, and for measuring adherence in both clinical and non-clinical populations to light-based interventions in clinical trials.
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spelling pubmed-98064382023-01-03 Verification, analytical validation and clinical validation (V3) of wearable dosimeters and light loggers Spitschan, Manuel Smolders, Karin Vandendriessche, Benjamin Bent, Brinnae Bakker, Jessie P Rodriguez-Chavez, Isaac R Vetter, Céline Digit Health Review Article BACKGROUND: Light exposure is an important driver and modulator of human physiology, behavior and overall health, including the biological clock, sleep-wake cycles, mood and alertness. Light can also be used as a directed intervention, e.g., in the form of light therapy in seasonal affective disorder (SAD), jetlag prevention and treatment, or to treat circadian disorders. Recently, a system of quantities and units related to the physiological effects of light was standardized by the International Commission on Illumination (CIE S 026/E:2018). At the same time, biometric monitoring technologies (BioMeTs) to capture personalized light exposure were developed. However, because there are currently no standard approaches to evaluate the digital dosimeters, the need to provide a firm framework for the characterization, calibration, and reporting for these digital sensors is urgent. OBJECTIVE: This article provides such a framework by applying the principles of verification, analytic validation and clinical validation (V3) as a state-of-the-art approach for tools and standards in digital medicine to light dosimetry. RESULTS: This article describes opportunities for the use of digital dosimeters for basic research, for monitoring light exposure, and for measuring adherence in both clinical and non-clinical populations to light-based interventions in clinical trials. SAGE Publications 2022-12-25 /pmc/articles/PMC9806438/ /pubmed/36601285 http://dx.doi.org/10.1177/20552076221144858 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Review Article
Spitschan, Manuel
Smolders, Karin
Vandendriessche, Benjamin
Bent, Brinnae
Bakker, Jessie P
Rodriguez-Chavez, Isaac R
Vetter, Céline
Verification, analytical validation and clinical validation (V3) of wearable dosimeters and light loggers
title Verification, analytical validation and clinical validation (V3) of wearable dosimeters and light loggers
title_full Verification, analytical validation and clinical validation (V3) of wearable dosimeters and light loggers
title_fullStr Verification, analytical validation and clinical validation (V3) of wearable dosimeters and light loggers
title_full_unstemmed Verification, analytical validation and clinical validation (V3) of wearable dosimeters and light loggers
title_short Verification, analytical validation and clinical validation (V3) of wearable dosimeters and light loggers
title_sort verification, analytical validation and clinical validation (v3) of wearable dosimeters and light loggers
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9806438/
https://www.ncbi.nlm.nih.gov/pubmed/36601285
http://dx.doi.org/10.1177/20552076221144858
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