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Do Patient-Reported Outcome Measures (PROMs) Used Within Radiotherapy Clinical Trials Reflect the Impact of
Danielle Fairweather1, Rachel M Taylor2,3, Laura Allington1
1Cancer Division, University College London Hospitals NHS Foundation Trust, London NW1 2BU, UK.
Cancers
|November 27, 2024
Summary
Patient-reported outcome measures (PROMs) in radiotherapy trials often fail to capture specific side-effects. This study highlights the need for more targeted PROMs to accurately assess treatment outcomes and differences between radiotherapy and proton beam therapy.
Area of Science:
- Radiation Oncology
- Clinical Trial Methodology
- Patient-Reported Outcomes
Background:
- Patient-reported outcome measures (PROMs) are crucial for evaluating treatment efficacy and patient experience in clinical trials.
- Radiotherapy and proton beam therapy (PBT) have distinct side-effect profiles that require accurate measurement.
- Existing PROMs may not adequately capture the nuances of treatment-specific adverse events.
Purpose of the Study:
- To assess the extent to which current PROMs used in radiotherapy clinical trials capture specific side-effects.
- To provide guidance for researchers on selecting appropriate PROMs for radiotherapy and PBT trials.
- To identify gaps in existing PROMs regarding the measurement of treatment-related toxicities.
Main Methods:
- Systematic identification of PROMs utilized in radiotherapy clinical trials.
- Assessment of identified PROMs against established guidelines for tumour-site-specific side-effects (UK Royal College of Radiologists).
- Analysis of PROM coverage for common radiotherapy side-effects, including fatigue and skin reactions.
Main Results:
- None of the 51 evaluated PROMs fully captured the spectrum of radiotherapy side-effects.
- Limited coverage for key toxicities: only 25 PROMs addressed fatigue, and 6 addressed radiation-induced skin reactions.
- A significant majority (88%) of PROMs lacked specificity for radiotherapy and PBT, risking the detection of treatment differences.
Conclusions:
- Current PROMs are insufficient for comprehensively measuring radiotherapy and PBT side-effects in clinical trials.
- There is a critical need for the development or improvement of targeted PROMs for radiation oncology research.
- Careful selection and consideration of limitations are essential when using existing PROMs as trial endpoints.
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