Interpretation of Change in Novel Digital Measures: A Statistical Review and Tutorial.

Q1 Computer Science Digital Biomarkers Pub Date : 2025-02-03 eCollection Date: 2025-01-01 DOI:10.1159/000543899

Andrew Trigg, Bohdana Ratitch, Frank Kruesmann, Madhurima Majumder, Andrejus Parfionovas, Ulrike Krahn

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Abstract

Background: Novel clinical measures assessed by a digital health technology tool require thresholds to interpret change over time, such as the minimal clinically important difference. Establishing such thresholds is a key component of clinical validation, facilitating understanding of relevant treatment effects.

Summary: Many of the approaches to derive interpretative thresholds for patient-reported outcomes can be applied to digital clinical measures. We present theoretical background to the use of interpretative thresholds, including the distinction between thresholds based on perceived importance versus measurement error, and thresholds for group- versus individual-level interpretations. We then review methods to estimate such thresholds, including anchor-based approaches. We illustrate the methods using data on cough frequency counts as measured by a wearable device in a clinical trial.

Key messages: This paper provides an overview of statistical methodologies to estimate thresholds for the interpretation of change.

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新数字测量变化的解释：统计回顾和教程。

背景：通过数字卫生技术工具评估的新型临床措施需要阈值来解释随时间的变化，例如最小临床重要差异。建立这样的阈值是临床验证的关键组成部分，有助于了解相关的治疗效果。总结：许多获得患者报告结果的解释性阈值的方法可以应用于数字临床测量。我们介绍了解释阈值使用的理论背景，包括基于感知重要性的阈值与测量误差的阈值之间的区别，以及群体与个人层面解释的阈值。然后，我们回顾了估计这些阈值的方法，包括基于锚点的方法。我们在临床试验中使用可穿戴设备测量的咳嗽频率计数数据来说明方法。关键信息：本文概述了估算变化解释阈值的统计方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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