Department of Radiation Oncology, University of Washington, Seattle, WA.
Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.
Semin Radiat Oncol. 2023 Oct;33(4):358-366. doi: 10.1016/j.semradonc.2023.07.002.
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.
临床医生对患者症状的漏报是一种常见且有据可查的现象，这导致将患者报告的结局 (PROs) 整合为临床试验的终点。虽然 PROs 常用于测量疾病症状、癌症治疗毒性和生活质量，但它们也可以评估患者的一般体验和偏好。随着电子病历的广泛应用和肿瘤学领域的数字健康革命，从纸质到电子患者报告结局 (ePROs) 的转变也促进了 PROs 纳入常规护理。临床试验的证据迅速涌现，支持将 ePROs 作为一种护理提供创新，因为 ePROs 有可能通过及时评估和响应患者的需求来改善患者的结局。同时，正在努力理解和解决 ePRO 的使用和公平整合的挑战，包括患者、临床医生和医疗系统的技术和语言障碍。尽管如此，医疗系统和监管机构仍在不断制定规定，以促进 ePROs 的使用。在此，我们回顾了在肿瘤学前瞻性临床试验中，从终点到干预措施的 PRO 演变。
