对肿瘤临床研究中分散临床试验和家庭护理的看法:对各实验基地临床研究专业人员的调查启示

Stefano Stabile, Veronica Franchina, S. Testoni, F. Mannozzi, Francesca Fabbri, I. Federici, Marta Betti, Francesca Zepponi, A. Frazzetto, Giovanni Micallo, Raffaella Bertolotti, Claudia Sangalli, Celeste Cagnazzo, Oriana Nanni
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引用次数: 0

摘要

背景:COVID-19 后,技术的飞速发展实现了远程医疗互动,促进了 DCT 活动的发展。赞助商和医疗机构通过将传统模式数字化、利用可穿戴设备和家庭护理来进行调整。然而,工作人员监督和物流等挑战要求对监管合规性进行仔细评估:方法:意大利肿瘤内科学协会的研究协调员工作组与意大利数据管理人员小组合作,对意大利肿瘤专业人员进行了匿名在线调查。调查旨在了解他们对肿瘤临床试验中远程患者监护、试验活动和家庭护理的看法:在 111 名专业人员(42.3% 为协调员,27.0% 为医生,18.8% 为护士)中,29.7% 缺乏远程患者数据采集经验,61.3% 有低度或中度经验。在 0-10 分的 VAS 量表中,58.6% 的人认为远程模式非常有用,在各种远程活动中得分较高(8-10 分),如生活质量数据采集(71.2%)、生命体征传输(66.7%)和家庭护理任务(65.8%)。关于肿瘤临床试验中的家庭护理,73.0% 的参与者(81 人)表示以前没有经验。然而,这种远程活动被认为对生物样本采集(76.6%)、生命体征采集(73.9%)、生活质量评估(71.2%)和不良事件监测(65.8%)等任务非常有用:结论:用于远程数据采集的电子设备在肿瘤试验中非常普遍,得到了相当一部分工作人员的积极认可。远程数据采集与工作量感知的改善相关。虽然家庭护理在意大利并不常见,但医护人员对其有积极的看法,这表明远程数据采集对提高临床试验效率和工作量有潜在的好处。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Perception of decentralized clinical trials and home nursing in oncology clinical research: insights from a survey of clinical research professionals across experimental sites
Background: Post-COVID-19, rapid technological progress enabled remote healthcare interactions, fostering DCT  activities. Sponsors and sites adapted by digitizing traditional model, utilizing wearables and home nursing. However, challenges like staff oversight and logistics demand careful evaluation for regulatory compliance. Methods: Italian association of medical oncology's study coordinators working group, in collaboration with Italian group of data managers, conducted an anonymous online survey among Italian oncology professionals. Survey aimed to explore their perceptions of remote patient monitoring, trial activities, and home nursing in oncology clinical trials. Results: Out of 111 professionals (42.3% coordinators, 27.0% physicians, 18.8% nurses), 29.7% lacked prior experience in remote patient data capture, while 61.3% had low or medium experience. On a 0-10 VAS scale, 58.6% found remote modalities very useful, with high scores (8-10) for various remote activities like quality of life data capture (71.2%), vital signs transmission (66.7%), and home nursing tasks (65.8%). Regarding home nursing in oncology clinical trials 73.0% of participants (n=81) have declared no previous experience. However this remote activity is considered highly useful for tasks such as biological samples collection (76.6%), vital signs collection (73.9%), quality of life evaluation (71.2%), and adverse events monitoring (65.8%). Conclusions: Electronic devices for remote data capture are prevalent in oncology trials, positively perceived by a significant portion of staff. Remote data collection correlates with improved workload perception. Although home nursing is less common in Italy, healthcare professionals show a positive perception, indicating potential benefits for clinical trial efficiency and workload improvement.
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