临床试验中的患者报告结果: 从终点到癌症护理中的干预措施
Patient-Reported Outcomes in Clinical Trials: From an Endpoint to an Intervention in Cancer Care.
发表日期:2023 Oct
作者:
Lakshmi Rekha Narra, Nicholas Verdini, Kaitlyn Lapen, Ryan Nipp, Erin F Gillespie
来源:
SEMINARS IN RADIATION ONCOLOGY
摘要:
临床医生对患者症状的低报与欠报是一个常见且得到充分记录的现象,这已经导致将患者报告的结果(PROs)作为临床试验的终点进行整合。虽然PROs经常用来衡量疾病症状、癌症治疗的毒性和生活质量,但它们也能评估患者的一般经历和偏好。随着电子病历的广泛使用和肿瘤学数字健康革命的出现,从纸质PROs转变为电子PROs(ePROs)也促进了PROs的融入日常护理。临床试验的证据迅速涌现,支持ePROs作为一种护理创新,因为ePROs有可能通过及时评估和响应患者需求来改善患者结果。与此同时,我们正在努力了解和解决ePRO使用和公平融合的挑战,包括患者、临床医生和卫生系统面临的技术和语言障碍。然而,卫生系统和监管机构仍在制定相关规定,以推广ePROs的使用。本文将回顾在临床肿瘤学前瞻性临床试验中,PROs从终点发展到干预的演变过程。版权所有 © 2023 Elsevier Inc. 保留所有权利。
Underreporting of patient symptoms by clinicians is a common and well-documented phenomenon that has led to integrating patient-reported outcomes (PROs) as endpoints into clinical trials. While PROs are often used to measure disease symptoms, cancer therapy toxicities, and quality of life, they can also assess patients' general experiences and preferences. With the increasing use of electronic medical records and the digital health revolution in oncology, conversion from paper to electronic PROs (ePROs) has also facilitated the integration of PROs into routine care. Evidence from clinical trials is rapidly emerging to support ePROs as a care delivery innovation, given the potential for ePROs to improve patient outcomes through timely evaluation and response to patient needs. Meanwhile, work is ongoing to understand and address ePRO use and challenges to equitable integration, including technical and language barriers for patients, clinicians, and health systems. Nonetheless, the health system and regulatory bodies continue to develop stipulations to promote the use of ePROs. Herein, we review the evolution of PROs from an endpoint to an intervention in prospective clinical trials in oncology.Copyright © 2023 Elsevier Inc. All rights reserved.