Dana Farber Cancer Institute, Boston Children's Hospital, Boston MA.
Primary Children's Medical Center, Salt Lake City UT.
J Pediatr Surg. 2014 Jan;49(1):154-8; discussion 158. doi: 10.1016/j.jpedsurg.2013.09.047. Epub 2013 Oct 5.
The Children's Oncology Group (COG) renal tumor study (AREN03B2) requires real-time central review of radiology, pathology, and the surgical procedure to determine appropriate risk-based therapy. The purpose of this study was to determine the inter-rater reliability of the surgical reviews.
Of the first 3200 enrolled AREN03B2 patients, a sample of 100 enriched for blood vessel involvement, spill, rupture, and lymph node involvement was selected for analysis. The surgical assessment was then performed independently by two blinded surgical reviewers and compared to the original assessment, which had been completed by another of the committee surgeons. Variables assessed included surgeon-determined local tumor stage, overall disease stage, type of renal procedure performed, presence of tumor rupture, occurrence of intraoperative tumor spill, blood vessel involvement, presence of peritoneal implants, and interpretation of residual disease. Inter-rater reliability was measured using the Fleiss' Kappa statistic two-sided hypothesis tests (Kappa, p-value).
Local tumor stage correlated in all 3 reviews except in one case (Kappa=0.9775, p<0.001). Similarly, overall disease stage had excellent correlation (0.9422, p<0.001). There was strong correlation for type of renal procedure (0.8357, p<0.001), presence of tumor rupture (0.6858, p<0.001), intraoperative tumor spill (0.6493, p<0.001), and blood vessel involvement (0.6470, p<0.001). Variables that had lower correlation were determination of the presence of peritoneal implants (0.2753, p<0.001) and interpretation of residual disease status (0.5310, p<0.001).
The inter-rater reliability of the surgical review is high based on the great consistency in the 3 independent review results. This analysis provides validation and establishes precedent for real-time central surgical review to determine treatment assignment in a risk-based stratagem for multimodal cancer therapy.
儿童肿瘤学组(COG)的肾肿瘤研究(AREN03B2)需要实时进行放射学、病理学和手术过程的中心审查,以确定基于风险的适当治疗方法。本研究的目的是确定手术审查的组内一致性。
在 AREN03B2 的前 3200 名入组患者中,选择了一个富含血管受累、溢出、破裂和淋巴结受累的 100 例样本进行分析。然后由两名盲法手术审查员独立进行手术评估,并与委员会外科医生完成的原始评估进行比较。评估的变量包括外科医生确定的局部肿瘤分期、总体疾病分期、进行的肾脏手术类型、肿瘤破裂的存在、术中肿瘤溢出的发生、血管受累、腹膜种植的存在以及残留疾病的解释。使用 Fleiss' Kappa 统计双侧假设检验(Kappa、p 值)来衡量组内一致性。
除了 1 例外,所有 3 次评估均显示局部肿瘤分期相关(Kappa=0.9775,p<0.001)。同样,总体疾病分期也具有很好的相关性(0.9422,p<0.001)。肾脏手术类型(0.8357,p<0.001)、肿瘤破裂(0.6858,p<0.001)、术中肿瘤溢出(0.6493,p<0.001)和血管受累(0.6470,p<0.001)的相关性较强。相关度较低的变量是腹膜种植的存在(0.2753,p<0.001)和残留疾病状态的解释(0.5310,p<0.001)。
基于 3 次独立审查结果的高度一致性,手术审查的组内一致性很高。这项分析提供了验证,并为实时中央手术审查建立了先例,以确定基于风险的多模式癌症治疗策略中的治疗分配。