OBJECTIVES: EORTC QLQ-C30, FACT-B, and EORTC QLQ-BR23 are three commonly used patient-reported outcome (PRO) instruments in breast cancer patients under treatment. The present systematic review was designed to identify the validation studies of each instrument, evaluate issues that matter most to breast cancer patients, and assess instruments’ applicability.

METHODS: A comprehensive search using relevant search terms related to the instrument validation was conducted using PubMed, Embase, and Cochrane from database initiations to May 1, 2019. Studies were eligible only if the validation was performed in breast cancer patients, and the publication was in English. Methodological quality of each eligible study was evaluated using an 18-item checklist developed by Francis et.al 2016 that assessed multiple domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (5) scoring and interpretation, and (6) respondent burden and presentation.

RESULTS: A total of nine validation studies were identified for EORTC QLQ-C30, EORTC QLQ-BR23, and FACT-B. All three instruments have undergone extensive psychometric analysis and showed adequate reliability, validity, and sensitivity to change over time. EORTC QLQ-C30 (Cronbach's alpha 0.69 to 0.90; Test-retest reliabilities 0.63 to 0.87; Correlation coefficient with POMS 0.56) encompasses nine domains comprising physical, role, cognitive, emotional, social, fatigue, pain, nausea and vomiting. FACT-B (Internal consistency 0.90; Spearman correlations between FBSI and FACT 0.34 to 0.84) contained six domains comprising physical well-being, social/family well-being, relationship with doctor, emotional well-being, functional well-being, and additional concerns. EORTC QLQ-BR23 included five domains containing systemic therapy side effects, breast symptoms, arm symptoms, and body image, and sexuality. EORTC QLQ-BR23 was recommended to be administered in conjunction with the core instrument EORTC QLQ-C30.

CONCLUSIONS: This systematic review summarizes the validation of the three breast cancer PRO measures and their appropriateness for a specific study objective as good references for future users.