Radiation Oncology Clinical Trials and Research Unit, Comprehensive Cancer Centre, Sir Charles Gairdner Hospital, Nedlands, WA, 6009, Australia.
Medical School, University of Western Australia, Nedlands, WA, 6009, Australia.
Radiat Oncol. 2018 Apr 13;13(1):68. doi: 10.1186/s13014-018-0998-x.
The purpose of this research was to assess agreement between four rating systems of cosmetic outcome measured in a subset of patients with early breast cancer participating in the randomised TARGIT-A trial. TARGIT-A compared risk-adapted single-dose intra-operative radiotherapy (TARGIT-IORT) to whole breast external beam radiotherapy (EBRT).
Patients, their Radiation Oncologist and Research Nurse completed a subjective cosmetic assessment questionnaire before radiotherapy and annually thereafter for five years. Objective data previously calculated by the validated BCCT.core software which utilizes digital photographs to score symmetry, colour and scar was also used. Agreement was assessed by the Kappa statistic and longitudinal changes were assessed by generalized estimating equations.
Overall, an Excellent-Good (EG) cosmetic result was scored more often than a Fair-Poor (FP) result for both treatment groups across all time points, with patients who received TARGIT-IORT scoring EG more often than those who received EBRT however this was statistically significant at Year 5 only. There was modest agreement between the four rating systems with the highest Kappa score being moderate agreement which was between nurse and doctor scores at Year 1 with Kappa = 0.46 (p < 0.001), 95% CI (0.24, 0.68).
Despite similar overall findings between treatment groups and rating systems, the inter-rater agreement was only modest. This suggests that the four rating systems utilized may not necessarily be used interchangeably and it is arguable that for an outcome such as cosmetic appearance, the patient's point of view is the most important.
TARGIT-A ISRCTN34086741 , Registered 21 July 2004, retrospectively registered.
本研究旨在评估在早期乳腺癌患者亚组中评估美容结果的四种评分系统之间的一致性，这些患者参与了随机 TARGIT-A 试验。TARGIT-A 比较了风险适应的单次术中放疗（TARGIT-IORT）与全乳外照射放疗（EBRT）。
患者、他们的放射肿瘤学家和研究护士在放疗前和此后每年完成一次主观美容评估问卷，为期五年。以前使用经过验证的 BCCT.core 软件计算的客观数据，该软件利用数字照片对对称性、颜色和疤痕进行评分，也被用于此研究。一致性通过 Kappa 统计量进行评估，纵向变化通过广义估计方程进行评估。
总体而言，在所有时间点，接受 TARGIT-IORT 治疗的患者比接受 EBRT 治疗的患者更常报告良好的美容效果（EG），而不是一般的或较差的效果（FP），但只有在第五年才具有统计学意义。这四种评分系统之间的一致性适中，最高 Kappa 评分表示中度一致性，第一年护士和医生的评分具有中度一致性，Kappa=0.46（p<0.001），95%CI（0.24，0.68）。
尽管治疗组和评分系统之间存在相似的总体发现，但评级者之间的一致性仅适中。这表明，使用的四种评分系统不一定可以互换使用，对于美容外观等结果，患者的观点是最重要的。
TARGIT-A 是 ISRCTN34086741，于 2004 年 7 月 21 日注册，为回顾性注册。
