Lagendijk Mirelle, Vos Elvira L, Nieboer Daan, Verhoef Cornelis, Corten Evelien M L, Koppert Linetta B
Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Department of Public Health, Erasmus MC, Rotterdam, The Netherlands.
Breast J. 2018 Jul;24(4):519-525. doi: 10.1111/tbj.12980. Epub 2018 Jan 8.
Cosmetic outcome is an important quality of life-related end point following breast-conserving therapy (BCT). To advise on a gold standard, we compare cosmetic outcome evaluated by panel and an objective evaluation (BCCT.core software). Second, patient-reported outcome measures (PROMs) are compared to cosmetic outcome evaluation by panel and BCCT.core. Sixty-eight breast cancer patients were included following BCT between 2007 and 2012. Two independent 6-member panels and two observers using the BCCT.core evaluated cosmetic outcome. First, reproducibility, repeatability, and relatedness of panel and BCCT.core were analyzed using the interclass correlation coefficient (ICC). Second, the association between panel/BCCT.core with PROMs (EORTC-QLQ-C30/BR23, EQ-5D-5L, and BREAST-Q) was analyzed with a linear regression and the goodness of fit by the R . Both panel and BCCT.core evaluations showed "excellent" intraobserver agreement (ICC 0.93 [95% CI: 0.83; 0.97] and 0.93 [95% CI: 0.84; 0.97]) for respectively panel 1 and BCCT.core 1 and "excellent" interobserver agreement (ICC 0.94 [95% CI: 0.90; 0.96] and 0.85 [95% CI: 0.77; 0.91]) respectively for panel and BCCT.core. Association between panel and BCCT.core varied, ICC 0.59-0.69. Only the PROM BREAST-Q showed a significant association with both panel evaluations and BCCT.core observers (panel 1 and BCCT.core 1; R of .157 [P = .002] and .178 [P = .001]). Both panel and BCCT.core showed comparable "excellent" intraobserver and interobserver agreement. For future trials evaluating cosmetic outcome following BCT, one of those can be chosen. Solely, the PROM BREAST-Q showed a significant association with panel and/or BCCT.core evaluation. To enable standardized cosmetic outcome evaluation and corresponding patient satisfaction in future trials, at least the BREAST-Q should be combined with a panel or BCCT.core evaluation.
保乳治疗（BCT）后，美容效果是一个与生活质量相关的重要终点。为了提出一个金标准，我们比较了由专家小组评估的美容效果和客观评估（BCCT.core软件）。其次，将患者报告的结局指标（PROMs）与专家小组和BCCT.core的美容效果评估进行比较。纳入了2007年至2012年间接受BCT的68例乳腺癌患者。两个独立的6人专家小组和两名使用BCCT.core的观察者对美容效果进行了评估。首先，使用组内相关系数（ICC）分析专家小组和BCCT.core的可重复性、重复性和相关性。其次，通过线性回归分析专家小组/BCCT.core与PROMs（欧洲癌症研究与治疗组织生活质量问卷C30/BR23、EQ-5D-5L和BREAST-Q）之间的关联，并通过R分析拟合优度。专家小组和BCCT.core评估均显示，对于专家小组1和BCCT.core 1，观察者内一致性“优秀”（ICC分别为0.93[95%CI：0.83；0.97]和0.93[95%CI：0.84；0.97]），对于专家小组和BCCT.core，观察者间一致性“优秀”（ICC分别为0.94[95%CI：0.90；0.96]和0.85[95%CI：0.77；0.91]）。专家小组和BCCT.core之间的关联各不相同，ICC为0.59 - 0.69。只有PROM BREAST-Q与专家小组评估和BCCT.core观察者均显示出显著关联（专家小组1和BCCT.core 1；R分别为0.157[P = 0.002]和0.178[P = 0.001]）。专家小组和BCCT.core均显示出相当的“优秀”观察者内和观察者间一致性。对于未来评估BCT后美容效果的试验，可以选择其中之一。仅PROM BREAST-Q与专家小组和/或BCCT.core评估显示出显著关联。为了在未来的试验中实现标准化的美容效果评估和相应的患者满意度，至少应将BREAST-Q与专家小组或BCCT.core评估相结合。
