Best Practices for BREAST-Q Research: A Systematic Review of Study Methodology.

BACKGROUND: Data heterogeneity and methodologic errors hinder the ability to draw clinically meaningful conclusions from studies using the BREAST-Q Reconstruction Module patient-reported outcome measure. In this systematic review, the authors evaluate the quality of BREAST-Q Reconstruction Module administration in relation to the BREAST-Q version 2.0 user's guide and the reporting of key methodology characteristics. The authors also describe a framework for improving the quality of BREAST-Q data analysis and reporting. METHODS: The authors conducted a systematic search of PubMed, Embase, Cochrane CENTRAL, and Ovid HAPI databases to identify articles on the BREAST-Q Reconstruction Module to assess postmastectomy breast reconstruction outcomes. The authors registered the protocol before study implementation on Open Science Framework ( https://osf.io/c5236 ) and adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Data on mode of BREAST-Q administration, time horizon justification, and sample size calculation were collected. RESULTS: The authors included 185 studies in the analysis. Errors in BREAST-Q administration were identified in 36 studies (19.5 percent). Appropriate administration of the BREAST-Q could not be determined in 63 studies (34.1 percent) because of insufficient reporting. Time horizon for the primary outcome was reported in 71 studies (38.4 percent), with only 17 (9.2 percent) reporting a sample size calculation. CONCLUSIONS: The authors identified important yet actionable shortcomings in the BREAST-Q literature. Researchers are encouraged to review the BREAST-Q user's guide in the study design phase to mitigate errors in patient-reported outcome measure administration and reporting for future trials using the BREAST-Q Reconstruction Module. Adhering to these guidelines will allow for greater clinical utility and generalizability of BREAST-Q research.

Laterality and Patient-Reported Outcomes following Autologous Breast Reconstruction with Free Abdominal Tissue: An 8-Year Examination of BREAST-Q Data.

BACKGROUND: Despite the rise in rates of contralateral prophylactic mastectomy, few studies have used patient-reported outcomes to assess satisfaction between unilateral and bilateral breast reconstruction with autologous tissue. The purpose of this study was to investigate patient satisfaction and quality of life following autologous reconstruction to determine whether differences exist between unilateral and bilateral reconstructions to better guide clinical decision-making. METHODS: The current study examined prospectively collected BREAST-Q results following abdominal free flap breast reconstruction procedures performed at a tertiary academic medical center from 2009 to 2017. The reconstruction module of the BREAST-Q was used to assess outcomes between laterality groups (unilateral versus bilateral) at 1 year, 2 years, 3 years, and more than 3 years. RESULTS: Overall, 405 patients who underwent autologous breast reconstruction completed the BREAST-Q. Cross-sectional analysis at 1 year, 2 years, and 3 years revealed similar satisfaction scores between groups; however, bilateral reconstruction patients demonstrated higher satisfaction scores at more than 3 years (p = 0.04). Bilateral reconstruction patients reported lower scores of abdominal well-being at 1 year, 2 years, and more than 3 years (p = 0.01, p = 0.03, and p = 0.01, respectively). CONCLUSIONS: These results suggest that satisfaction with breasts does not differ with the laterality of the autologous reconstruction up to 3 years postoperatively but may diverge thereafter. Bilateral reconstruction patients, however, have lower satisfaction with the abdominal donor site. These data can be used in preoperative counseling, informed consent, and expectations management in patients considering contralateral prophylactic mastectomy.

Long-term Patient-reported Outcomes Following Postmastectomy Breast Reconstruction: An 8-year Examination of 3268 Patients.

OBJECTIVE: To better understand the long-term patient-reported outcomes (PROs) in satisfaction and health-related quality of life (QOL) following post-mastectomy reconstruction (PMR) using the BREAST-Q, comparing PROs from patients undergoing implant-based breast reconstruction (IBR) or autologous breast reconstruction (ABR). SUMMARY OF BACKGROUND DATA: Multiple studies have demonstrated growth in mastectomy rates and concurrent increase in PMR utilization. However, most studies examining PMR PROs focus on short postoperative time periods-mainly within 2 years. METHODS: BREAST-Q scores from IBR or ABR patients at a tertiary center were prospectively collected from 2009 to 2017. Mean scores and standard deviations (SDs) were calculated for satisfaction with breast, satisfaction with outcome, psychosocial well-being, physical well-being of the chest, and sexual well-being. Satisfaction with breasts and physical well-being of the chest were compared using regression models at postoperative years 1, 3, 5, and 7. RESULTS: Overall, 3268 patients were included, with 336 undergoing ABR and 2932 undergoing IBR. Regression analysis demonstrated that ABR patients had greater postoperative satisfaction with breast scores at all timepoints compared with IBR patients. Postoperative radiation and mental illness adversely impacted satisfaction with breast scores. Furthermore, mental illness impacted physical wellbeing of the chest at all timepoints. IBR patients had satisfaction scores that remained stable over the study period. CONCLUSION: This study presents the largest prospective examination of PROs in PMR to date. Patients who opted for ABR had significantly higher satisfaction with their breast and QOL at each assessed time point, but IBR patients had stable long-term satisfaction and QOL postoperatively.