OBJECTIVES: To evaluate the nature and extent of reporting of patient-reported outcomes (PROs) among patients with breast cancer undergoing chemotherapy (with or without other types of therapies) in published registry audit articles

METHODS: After prospectively registering the study protocol with the Open Science Framework, we searched PubMed for relevant records published between 1-Jan-2012 and 21-Jun-2022 using appropriate search strategies. Publication details, demographics, intervention details, and details of PROs were extracted from eligible records.

RESULTS: Out of 522 records screened, 17 studies (10 cross-sectional studies; 4 prospective and 3 retrospective observational studies) involving 7001 women with different types and stages of breast cancer were included. A total of 19 registries from 8 countries were analyzed by the studies; 11 registries were from USA; 10 were hospital-based and 7 were population-based registries. The included studies evaluated a total of 44 PROs (17 unique PROs), the two most frequent being HRQOL and symptoms (17 and 5 studies respectively). Thirty-six different PRO scales were used, of which most frequently used were SF-36 (4 studies), FACT-B and FACT-G (3 studies each) for HRQoL, and HADS for anxiety-depression (3 studies). Only 4 studies measured PROs in pairs for before-after comparison

CONCLUSIONS: Recording and analyzing PROs in breast cancer registry audit papers is inadequate and has a large amount of variation