Developing Digital Tools for Remote Clinical Research: How to Evaluate the Validity and Practicality of Active Assessments in Field Settings.

Developing Digital Tools for Remote Clinical Research: How to Evaluate the Validity and Practicality of Active Assessments in Field Settings.
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DOI:
10.2196/26004
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发表时间:
2021-06-18
影响因子:
7.4
通讯作者:
Munafò MR
Munafò MR
中科院分区:
医学2区
文献类型:
--
作者:
Ferrar J;Griffith GJ;Skirrow C;Cashdollar N;Taptiklis N;Dobson J;Cree F;Cormack FK;Barnett JH;Munafò MR

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远程研究工具收集关于症状和数字生物标志物的颗粒状高频数据的能力是一个重要的优势,因为它规避了传统临床试验的许多限制,提高了捕获临床相关数据的能力。这种方法使研究人员能够捕获更强大的基线,并获得新的表型,以提高诊断精度和结果的准确性。然而,开发这些工具的过程是复杂的,因为数据需要以有意义但对参与者或患者来说不是负担的频率收集。此外,依赖固定条件来验证评估的传统技术可能不适合验证旨在在灵活条件下获取数据的工具。本文讨论了确定数字评估是否适合远程研究的过程,并就如何验证这些新工具提供了建议。
The ability of remote research tools to collect granular, high-frequency data on symptoms and digital biomarkers is an important strength because it circumvents many limitations of traditional clinical trials and improves the ability to capture clinically relevant data. This approach allows researchers to capture more robust baselines and derive novel phenotypes for improved precision in diagnosis and accuracy in outcomes. The process for developing these tools however is complex because data need to be collected at a frequency that is meaningful but not burdensome for the participant or patient. Furthermore, traditional techniques, which rely on fixed conditions to validate assessments, may be inappropriate for validating tools that are designed to capture data under flexible conditions. This paper discusses the process for determining whether a digital assessment is suitable for remote research and offers suggestions on how to validate these novel tools.
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