Do Patient-Reported Outcome Measures (PROMs) Used Within Radiotherapy Clinical Trials Reflect the Impact of Treatment?

Abstract

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.