Abstract
BACKGROUND: There are three patient reported outcome measure instruments (PROMs) that have adequate content validity for breast reconstruction, BREAST-Q, BRECON-31 and EORTC QLQ-BRECON-23, and they all have been robustly validated. The aim of this study was to systematically review scores giving meaning to validated PROMs for breast reconstruction after mastectomy and discuss methods to enable interpretation of them. METHODS: A systematic review was performed according to the recommendations of PRISMA. Prospero CRD42021255874. Included articles had to meet criteria defined in a SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research type). The included studies were critically appraised using the GRADE approach. RESULTS: Three articles were finally included in the review: two studies on scores for healthy controls and one on minimally important differences (MIDs), both of BREAST-Q. All of the studies were performed in North America. Only MIDs based on statistical characteristics, and not on what constitutes a relevant change for the patient, exist. The risk of bias was evaluated as very high and moderate, respectively, of inconsistencies as low, of indirectness as high, of imprecisions as low, and of publication bias as probably low. CONCLUSIONS: The overall certainty of evidence for scores giving meaning to PROMs for breast reconstruction is low (GRADE ƟƟОО). More studies are needed to establish relevant healthy control scores and what constitutes a relevant clinical difference for patient-reported outcome measures for breast reconstruction after mastectomy. Clinical implications of the findings and suggestions for further research are suggested in the article.