Data Science, Late-Stage Development, Cardiovascular, Renal and Metabolic, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Data Science, Late-Stage Development, Cardiovascular, Renal and Metabolic, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
J Card Fail. 2024 May;30(5):703-716. doi: 10.1016/j.cardfail.2024.01.016. Epub 2024 Mar 5.
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.
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.
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.
在心力衰竭试验中，评估药物或其他干预措施对患者症状和功能的影响至关重要。传统的症状和功能临床结局评估存在重要的局限性。由于其客观性质和连续记录数据的潜力，活动记录仪可能有助于克服这些局限性。然而，活动记录仪目前尚未被关键利益相关者视为具有临床相关性。
在这项最先进的研究中，讨论了在心力衰竭试验中实施活动记录仪时需要考虑的关键方面。它们包括应考虑哪些源自活动记录仪的测量指标、如何使用它们构建终点、如何测量和分析它们，以及如何处理患者和站点在试验中整合设备的物流问题。根据当前证据提供了全面的建议。
活动记录仪在涉及心力衰竭的临床试验中在技术上是可行的，但要成功实施并使用活动记录仪来证明药物或其他干预措施在身体功能方面具有临床意义上的差异，需要仔细考虑许多设计选择。
