Wang Anya, Kim Esther, Kwon Daniel, Coleman-Belin Janet, Oleru Olachi, Seyidova Nargiz, Taub Peter J
From the Division of Plastic and Reconstructive Surgery, Icahn School of Medicine at Mount Sinai.
Plast Reconstr Surg. 2025 May 1;155(5):845e-853e. doi: 10.1097/PRS.0000000000011798. Epub 2024 Oct 1.
Acellular dermal matrix (ADM) is pivotal in breast surgery, yet the statistical robustness of surgical outcomes remains underexplored. This study uses the fragility index (FI), reverse FI, and fragility quotient (FQ) to investigate the statistical fragility of ADM breast reconstruction outcomes.
Randomized controlled trials (2013 to present) with dichotomous outcomes were sourced from PubMed, Embase, SCOPUS, Medline, and Cochrane databases. FI and reverse FI (event reversals needed to alter outcome significance) and FQ (standardized fragility across trials) were computed and reported as median (interquartile range [IQR]). Subgroup analysis focused on intervention types.
Of 33 studies screened, 19 RCTs comprising 204 outcomes were included, with a median FI of 4 (IQR, 3 to 5) and FQ of 0.039 (IQR, 0.029 to 0.070). Twenty-six outcomes achieved statistical significance, with a median FI of 3.5 (IQR, 1 to 5) and FQ of 0.033 (IQR, 0.010 to 0.073). The remaining 178 outcomes were not significant, exhibiting a median FI of 4 (IQR, 3 to 5) and FQ of 0.040 (IQR, 0.030 to 0.070). Of the 204 outcomes, 18% had a number of patients lost to follow-up equal to or surpassing the FI. By intervention type, the median FIs were similar in value but remained low.
ADM-related breast reconstruction outcomes are statistically fragile; thus, reversal of a few outcomes or maintaining follow-up with patients may alter the significance of findings. Future researchers are thus recommended to report FI and FQ metrics with P values to accurately portray reconstructive surgery outcomes.
脱细胞真皮基质（ADM）在乳腺手术中至关重要，但手术结果的统计稳健性仍未得到充分探索。本研究使用脆弱性指数（FI）、反向FI和脆弱性商数（FQ）来研究ADM乳房重建结果的统计脆弱性。
从PubMed、Embase、SCOPUS、Medline和Cochrane数据库中获取2013年至今具有二分结果的随机对照试验。计算FI和反向FI（改变结果显著性所需的事件逆转数）以及FQ（各试验间的标准化脆弱性），并报告为中位数（四分位间距[IQR]）。亚组分析聚焦于干预类型。
在筛选的33项研究中，纳入了19项随机对照试验，共204个结果，FI中位数为4（IQR，3至5），FQ为0.039（IQR，0.029至0.070）。26个结果具有统计学显著性，FI中位数为3.5（IQR，1至5），FQ为0.033（IQR，0.010至0.073）。其余178个结果无显著性，FI中位数为4（IQR，3至5），FQ为0.040（IQR，0.030至0.070）。在204个结果中，18%的失访患者数量等于或超过FI。按干预类型划分，FI中位数在数值上相似但仍然较低。
ADM相关的乳房重建结果在统计学上较为脆弱；因此，少数结果的逆转或与患者保持随访可能会改变研究结果的显著性。因此，建议未来的研究人员在报告P值时同时报告FI和FQ指标，以准确描述重建手术结果。
