Department of Intelligent Systems, Jožef Stefan Institute, Ljubljana, Slovenija.
Department of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
PLoS One. 2018 Mar 1;13(3):e0190323. doi: 10.1371/journal.pone.0190323. eCollection 2018.
This paper addresses patient-reported outcomes (PROs) and telemonitoring in congestive heart failure (CHF), both increasingly important topics. The interest in CHF trials is shifting from hard end-points such as hospitalization and mortality, to softer end-points such health-related quality of life. However, the relation of these softer end-points to objective parameters is not well studied. Telemonitoring is suitable for collecting both patient-reported outcomes and objective parameters. Most telemonitoring studies, however, do not take full advantage of the available sensor technology and intelligent data analysis. The Chiron clinical observational study was performed among 24 CHF patients (17 men and 7 women, age 62.9 ± 9.4 years, 15 NYHA class II and 9 class III, 10 of ishaemic, aetiology, 6 dilated, 2 valvular, and 6 of multiple aetiologies or cardiomyopathy) in Italy and UK. A large number of physiological and ambient parameters were collected by wearable and other devices, together with PROs describing how well the patients felt, over 1,086 days of observation. The resulting data were mined for relations between the objective parameters and the PROs. The objective parameters (humidity, ambient temperature, blood pressure, SpO2, and sweeting intensity) could predict the PROs with accuracies up to 86% and AUC up to 0.83, making this the first report providing evidence for ambient and physiological parameters to be objectively related to PROs in CHF patients. We also analyzed the relations in the predictive models, gaining some insights into what affects the feeling of health, which was also generally not attempted in previous investigations. The paper strongly points to the possibility of using PROs as primary end-points in future trials.
本文探讨了心力衰竭(CHF)患者报告结局(PRO)和远程监测这两个日益重要的话题。CHF 临床试验的关注点正从住院和死亡率等硬性终点转向健康相关生活质量等软性终点。然而,这些软性终点与客观参数的关系尚未得到充分研究。远程监测适用于收集患者报告的结局和客观参数。然而,大多数远程监测研究并没有充分利用现有的传感器技术和智能数据分析。Chiron 临床观察性研究在意大利和英国的 24 名 CHF 患者(17 名男性和 7 名女性,年龄 62.9±9.4 岁,15 名 NYHA 心功能分级 II 级,9 名 III 级,病因 10 例为缺血性,6 例为扩张型,2 例为瓣膜性,6 例为多种病因或心肌病)中进行。通过可穿戴设备和其他设备收集了大量生理和环境参数,以及描述患者感觉的 PRO,共观察 1086 天。对这些数据进行挖掘,以寻找客观参数与 PRO 之间的关系。客观参数(湿度、环境温度、血压、SpO2 和出汗强度)可以预测 PRO,准确率高达 86%,AUC 高达 0.83,这是首次报道环境和生理参数与 CHF 患者的 PRO 具有客观相关性。我们还分析了预测模型中的关系,深入了解了哪些因素会影响健康感觉,这在以前的研究中也很少尝试。本文强烈指出,未来的临床试验中可能将 PRO 作为主要终点。