Author response: Enhancing methodological rigour in prepectoral breast reconstruction studies

Correspondence to: Shelley Potter (email: Shelley.potter@bristol.ac.uk)

Translational Health Sciences

Bristol Medical School

Learning and Research Building

Southmead Road

Bristol

BS10 5NB

UK

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BJS, https://doi.org/10.1093/bjs/znaf032, published 25 February 2025

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We thank Drs Venkataraman and Mokbel for highlighting the perceived methodological limitations of the Pre-BRA study1. They propose that the heterogeneity of the procedures performed in the study, in combination with variability in surgical skill and expertise limit the applicability of the results. They state that adopting standardized surgical practices for prepectoral breast reconstruction, including objective rippling assessment, would enhance future research and optimize patient outcomes.

While we agree that improving methodological rigour in breast reconstruction research is essential, we disagree with the proposed recommendations for the following reasons.

First, Pre-BRA was specifically designed as a pragmatic study to generate ‘real world’ evidence to support practice and decision-making. Rigid standardization of surgical technique is therefore neither necessary nor desirable. Indeed, the results of surgery performed by a small number of surgeons in a highly specialist unit, such as those presented by Venkataraman and Mokbel, while impressive, are unlikely to reflect the outcomes of prepectoral reconstruction in other centres. The Pre-BRA study recruited 338 women from 40 UK centres, so the results are likely to be more (rather than less) generalizable and have greater utility in supporting women making decisions about this type of reconstruction in the future.

We also agree that outcomes should be assessed using robustly developed validated tools, but the Vidya rippling scale recommended by Venkataraman and Mokbel was conceived by a small group of surgeons based on postoperative images of just 50 patients2. It has not been robustly developed, validated or adopted for use in research studies. Furthermore, it reflects the surgeon’s opinion of the outcome. Breast reconstruction is performed to improve well-being and quality of life so we would argue that it is the patient’s (rather than their surgeon’s) perception of their reconstruction that is the more meaningful.

We acknowledge that the lack of adjustment for confounders including radiation therapy is a limitation but the longitudinal assessment of patient-reported outcomes in Pre-BRA was internationally novel and hypothesis-generating. An exploratory analysis was undertaken but the relatively small numbers of patients precluded adjustment for multiple factors. The international iPREPARE registry study3, which aims to recruit 1,236 patients worldwide, will robustly evaluate the clinical and patient-reported outcomes of prepectoral reconstruction using validated measures and adjusting for confounders that may impact on outcomes.

Ultimately, outcomes following breast reconstruction are optimized by supporting women to make fully informed decisions about surgery based on realistic expectations of likely results. Well-designed large-scale studies such as Pre-BRA and iPREPARE, which generate generalizable real-world reconstruction outcome data, are vital to support this process.