Wearable Sensors to Monitor Physical Activity in Heart Failure Clinical Trials: State-of-the-Art Review.

Autor: Buendia R; Data Science, Late-Stage Development, Cardiovascular, Renal and Metabolic, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden. Electronic address: Ruben.Buendia@astrazeneca.com., Karpefors M; Data Science, Late-Stage Development, Cardiovascular, Renal and Metabolic, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Folkvaljon F; Patient Centered Science, BioPharmaceuticals Business, AstraZeneca, Gothenburg, Sweden., Hunter R; Regulatory, Late-Stage Development, Cardiovascular, Renal and Metabolic, BioPharmaceuticals R&D, AstraZeneca, Luton, UK., Sillen H; Digital Health R&D, AstraZeneca, Gothenburg, Sweden., Luu L; Digital Health R&D, AstraZeneca, Gaithersburg, MD, US., Docherty K; British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK., Cowie MR; Late-Stage Development, Cardiovascular, Renal and Metabolic, BioPharmaceuticals R&D, AstraZeneca, Boston, MA, US.
Jazyk: angličtina
Zdroj: Journal of cardiac failure [J Card Fail] 2024 May; Vol. 30 (5), pp. 703-716. Date of Electronic Publication: 2024 Mar 05.
DOI: 10.1016/j.cardfail.2024.01.016
Abstrakt: Background: Estimation of the effects that drugs or other interventions have on patients' symptoms and functions is crucial in heart failure trials. Traditional symptoms and functions clinical outcome assessments have important limitations. Actigraphy may help to overcome these limitations due to its objective nature and the potential for continuous recording of data. However, actigraphy is not currently accepted as clinically relevant by key stakeholders.
Methods and Results: In this state-of-the-art study, the key aspects to consider when implementing actigraphy in heart failure trials are discussed. They include which actigraphy-derived measures should be considered, how to build endpoints using them, how to measure and analyze them, and how to handle the patients' and sites' logistics of integrating devices into trials. A comprehensive recommendation based on the current evidence is provided.
Conclusion: Actigraphy is technically feasible in clinical trials involving heart failure, but successful implementation and use to demonstrate clinically important differences in physical functioning with drug or other interventions require careful consideration of many design choices.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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