Work

Single-item measures of perceived side effect burden for people with cancer: A systematic scoping review

Year: 2026

Type: review

Abstract: BACKGROUND: The US Food and Drug Administration (FDA) recommends the use of single-item measures in cancer clinical trials to capture patients' global perceptions of treatment-related side effect burden. This systematic scoping review aimed to summarise the (1) use of single-item measures in published studies and registered clinical trials, and (2) psychometric and content-related evidence for two items highlighted by the FDA: EORTC item Q168 and FACIT item GP5. METHODS: MEDLINE, Embase, Scopus, and PsycINFO were searched alongside major clinical trial registries. Eligible records included studies and trials involving people with cancer that used or evaluated single-item measures of perceived side effect burden. Data were summarised narratively to describe patterns of use, psychometric, and content-related evidence. RESULTS: The search yielded 2395 unique records. Following screening, 67 published studies and 74 clinical trial records were included. In published studies, EORTC item Q168 remains concentrated within pancreatic and biliary cancer settings, whereas clinical trials registrations suggest increasing use in other cancer types; meanwhile, FACIT item GP5 has been used across various study designs and cancer types. Published studies reported findings related to content, convergent, and known-groups validity, reliability, and responsiveness, most of which related to FACIT item GP5 (n = 27), with substantially fewer studies examining EORTC item Q168 (n = 2). However, important conceptual limitations remain, particularly regarding the inherent difficulty of attributing symptoms to treatment rather than to disease or other factors. CONCLUSIONS: Single-item measures may be pragmatic indicators of perceived treatment-related side effect burden; particularly where minimising respondent burden is important. However, further research is needed to strengthen evidence regarding content validity, measurement properties, and their added value alongside multidimensional patient-reported outcome measures.

Source: European Journal of Cancer

DOI: 10.1016/j.ejca.2026.117763