Evidence generation for side effect burden item Q168
Project summary
In their most recent Guidance for Industry on Core Patient-Reported Outcomes in Cancer Clinical Trials, the US Food and Drug Administration (FDA) describes the EORTC item Q168 and FACIT item GP5 as examples of single items that can be used to assess patient-reported side effect burden from cancer treatment (see https://www.fda.gov/media/149994/download). However, clear evidence of the use of singe items is still scarce. This project aims to fill this gap.
By applying qualitative and quantitative research methods, this project aims to generate evidence in support of (or potentially questioning) the use of single items on side effect burden as part of clinical trials and research.
Achievements
- A narrative review exploring the existing guidance and recommendations for single item measures of treatment burden has been conducted and the drafting of the article is underway
- A systematic scoping review to determine the scope of the use of single item measures of side effect burden is underway with data extraction in progress
- An interview guide has been developed and piloted tested with patients to evaluate how patients understand items Q168 and GP5.
Future plans
Expected completion mid-2027.
For patients
Measuring side-effect burden of cancer treatment is an important aspect of clinical trials and research. The US Food and Drug Administration has recently recommended using a single question to collect an overall impression of side effect burden. This project aims to determine whether a single question is a reliable and valid way to measure overall side effect burden during cancer treatment.