临床试验和临床实践中的患者报告结局(PROs):来自意大利医学肿瘤学会(AIOM)第21届全国会议的报告
Patient-reported outcomes (PROs) in clinical trials and in clinical practice: report from the XXI national conference of the Italian Association of Medical Oncology (AIOM).
作者信息
Puccini Alberto, Viscardi Giuseppe, Ciani Oriana, Efficace Fabio, Piattelli Angela, Beretta Giordano Domenico, Petruzzelli Davide, Popoli Patrizia, De Lorenzo Francesco, Longo Francesco, Zibellini Marco, Gitto Lara, Brunello Antonella, Maiello Evaristo, Servetto Alberto, Pagliuca Martina, Raimondi Alessandra, Marandino Laura, Cinieri Saverio, Iannelli Elisabetta, Ripamonti Carla Ida, Bossi Paolo, Numico Gianmauro, Latiano Tiziana, Pinto Carmine, Quaglini Silvana, Locati Laura, Gussoni Gualberto, Mignone Gianluca, Carrera Pricivel M, Basch Ethan, Di Maio Massimo, Perrone Francesco
机构信息
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.
IRCCS Humanitas Research Hospital, Rozzano, Italy.
出版信息
BMJ Oncol. 2025 Jun 17;4(1):e000783. doi: 10.1136/bmjonc-2025-000783. eCollection 2025.
OBJECTIVE
Patient-reported outcomes (PROs) are considered the gold standard for the assessment of subjective symptoms, quality of life (QoL) and patient well-being in both clinical trials and clinical practice. Here, we report key discussions and findings from the 21st National Conference of the Italian Association of Medical Oncology, held in Bologna on 21-22 June 2024, with a focus on the integration and impact of PROs in oncology research and clinical practice.
METHODS AND ANALYSIS
Leading national and international experts presented and analysed data regarding the use of PROs in clinical trials and routine oncology care. Topics included the role of electronic PROs (ePROs), digital therapeutics, financial toxicity as a PRO and methodologies for standardising QoL assessment. Insights were drawn from expert presentations, consensus discussions and practical experiences shared during the conference sessions.
RESULTS
Experts emphasised that PROs should be included as key endpoints in clinical trials, with timely publication of results and standardised methodologies for analysis and interpretation. The conference highlighted the critical importance of incorporating PROs and QoL measures throughout the cancer care continuum-from screening to survivorship. In clinical practice, PROs improve patient-centred care and communication, particularly when oncologists are trained to interpret QoL data. The use of ePROs was noted as a valuable tool to support digital health interventions. Financial toxicity emerged as a significant PRO, with screening tools recommended to identify and support at-risk patients. Key organisational challenges were identified, including technological barriers, resource constraints and the need for responsive infrastructure to support real-time PRO integration.
CONCLUSION
The implementation of PROs, including ePROs and financial toxicity assessments, is essential for advancing quality cancer care. Standardisation, digital innovation and targeted clinician education are critical to integrating PROs effectively in both research and clinical settings. Addressing infrastructural and technological challenges will be vital for optimising patient outcomes and ensuring optimal care across the cancer journey.
目的
患者报告结局(PROs)被视为在临床试验和临床实践中评估主观症状、生活质量(QoL)和患者幸福感的金标准。在此,我们报告2024年6月21日至22日在博洛尼亚举行的第21届意大利医学肿瘤学协会全国会议的关键讨论内容和研究结果,重点关注PROs在肿瘤学研究和临床实践中的整合及影响。
方法与分析
国内和国际领先专家展示并分析了关于PROs在临床试验和常规肿瘤护理中应用的数据。主题包括电子PROs(ePROs)的作用、数字疗法、作为PRO的经济毒性以及QoL评估标准化方法。见解源于专家报告、共识讨论以及会议期间分享的实践经验。
结果
专家强调PROs应作为临床试验的关键终点纳入,同时及时公布结果以及采用标准化分析和解释方法。会议强调了在从筛查到生存的整个癌症护理连续过程中纳入PROs和QoL测量的至关重要性。在临床实践中,PROs改善了以患者为中心的护理和沟通,尤其是当肿瘤学家接受过解读QoL数据的培训时。ePROs的使用被视为支持数字健康干预的宝贵工具。经济毒性成为一个重要的PRO,推荐使用筛查工具来识别和支持有风险的患者。确定了关键的组织挑战,包括技术障碍、资源限制以及需要响应式基础设施来支持实时PRO整合。
结论
实施PROs,包括ePROs和经济毒性评估,对于推进高质量癌症护理至关重要。标准化、数字创新和有针对性的临床医生教育对于在研究和临床环境中有效整合PROs至关重要。应对基础设施和技术挑战对于优化患者结局以及确保整个癌症治疗过程中的最佳护理至关重要。
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