Validation and reliability testing of the Swedish version of the BREAST-Q reconstruction

This study validates and assesses the reliability of the Swedish version of the BREAST-Q Reconstruction Module, a patient-reported outcome measure (PROM) designed to evaluate satisfaction and health-related quality of life (HRQoL) before and after breast reconstruction.

This observational study included 300 patients undergoing breast reconstruction at Sahlgrenska University Hospital. The psychometric evaluation involved content validity through cognitive interviews, internal consistency (Cronbach's α), test-retest reliability, convergent validity (comparison with the EORTC QLQ-BRECON 23), responsiveness (Wilcoxon rank test), and analysis of floor and ceiling effects. BREAST-Q version 1.0 was used to maintain item richness and comparability with historical data.

Content validity was confirmed through interviews. Internal consistency was acceptable across all domains (Cronbach's α = 0.70-0.95). Test-retest reliability showed good agreement on the group level. Moderate correlations with BRECON-23 supported convergent validity. Responsiveness was demonstrated with significant improvements across all domains postoperatively (mean difference = 20.3, p < 0.001). Ceiling effects were observed preoperatively in Physical Well-being abdomen (40.1%) and postoperatively in four domains, notably Physical Well-being chest (45.5%). These effects may reflect true clinical success but also suggest limited sensitivity in high-functioning populations.

The Swedish BREAST-Q Reconstruction Module demonstrates good validity, reliability, and responsiveness. However, ceiling effects in several domains highlight limitations in detecting subtle differences among patients with high levels of satisfaction, suggesting a need for stratified analysis and potential refinement of the scale.

ClinicalTrials.gov Identifier: NCT05233891 and NCT04714463.