International validation of the EORTC Patient-Reported Outcome Measure (PROM) in breast reconstruction (BRR): Evaluating health related quality of life (HRQL) and clinical effectiveness

Introduction: PROMs are integral to assessing clinical effectiveness after BRR. The European Organization for Research and Treatment of Cancer (EORTC) BRR questionnaire (QLQ-BRR24) was developed for use alongside the EORTC PROMs: QLQ-C30 (cancer) and QLQ-BR23 (breast cancer). Methods: Patients (n=514) from 9 countries covering 6 languages self-reported the EORTC QLQ-C30, QLQ-BR23 and the QLQ-BRR24 before and after BRR including a debriefing questionnaire/interview. Prospective patients (n=274) completed the QLQ-BRR24 at baseline (before mastectomy and BRR and at 5–8 months after (response to change analysis, RCA). Cross-sectional patients (n=240) were at 1–5 years after BRR to capture long-term HRQL effects and test-retest reliability through two rounds of QLQ-BRR24 completion (3–8 weeks apart). Scale convergent validity was tested using Pearson's correlations. Results: Patient groups: implant alone (n=204), donor flap (n=215) and control (mastectomy or staged-delayed, n=88). Six HRQL scales: i) sexuality; ii) treatment side effects; iii) donor symptoms; cosmetic [iv) breast; v) nipple; vi) surgery satisfaction] and 4 single questions (well-fitting bra, loss or preserve nipple, donor scars satisfaction) were psychometrically tested. Patients did not report difficulties. Good reliability of QLQ-BRR24 scales, except for treatment-related arm symptoms (tingling and fullness) and poor test-retest of two single questions (nipple loss and donor-satisfaction). Significant (p<0.01) correlations (convergent validity) between conceptually related scales of QLQ-BRR24 and QLQ-C30, QLQ-BR23. Clinically significant effects-sizes (Cohen's d: 0.37–0.54) and RCA were demonstrated for sexuality, treatment side effects and well-fitting bra. Conclusions: EORTC-QLQ-BRR24 is internationally validated for BRR in breast cancer patients. Future studies should consider comparing it to the BREAST-Q.