This is the first article that investigates whether the patient-reported outcome measures (PROMs) used in clinical trials effectively capture the specific side-effects of radiotherapy and proton beam therapy (PBT) and provides context for researchers selecting PROMs for clinical trials. PROMs from radiotherapy trials were identified from previous research and assessed against the United Kingdom Royal College of Radiologists’ guidelines for tumour-site-specific side-effects. The analysis revealed that none of the 51 identified PROMs captured the full range of side-effects, with only 25 addressing fatigue and 6 addressing radiation-induced skin reactions. Three PROMs failed to identify any common side-effects, and eight identified only one. Overall, 88% of PROMs lacked specificity to radiotherapy and PBT, posing a risk of missing significant differences between treatment techniques. This study emphasises the need for more targeted PROMs in future trials. Until new or improved PROMs are available, great thought and caution should be taken when selecting PROMs for trial endpoints.
本文首次探讨了临床试验中使用的患者报告结局指标（PROMs）是否能有效捕捉放疗及质子束治疗（PBT）的特异性副作用，并为研究者选择临床试验用PROMs提供了参考依据。通过既往研究识别出放疗试验中使用的PROMs，并依据英国皇家放射医学院制定的肿瘤部位特异性副作用指南进行评估。分析显示，在51个已识别的PROMs中，无一能全面覆盖所有副作用范围：仅25个涉及疲劳症状，6个涉及放射性皮肤反应。其中3个PROMs未能识别任何常见副作用，另有8个仅能识别一种副作用。总体而言，88%的PROMs缺乏针对放疗及质子束治疗的特异性，可能导致不同治疗技术间的显著差异被忽略。本研究强调未来临床试验需要更具针对性的PROMs。在新型或改进版PROMs问世前，选择试验终点用PROMs时应进行审慎考量。
肿瘤(癌症)患者之家