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胰十二指肠切除术后国际胰腺外科研讨组(ISGPS)定义的并发症的观察者间变异性:一项国际横断面多中心研究。

Interobserver Variability in the International Study Group for Pancreatic Surgery (ISGPS)-Defined Complications After Pancreatoduodenectomy: An International Cross-Sectional Multicenter Study.

机构信息

Amsterdam UMC, location University of Amsterdam, Department of Surgery, Amsterdam the Netherlands.

Cancer Center Amsterdam, the Netherlands.

出版信息

Ann Surg. 2024 Nov 1;280(5):728-733. doi: 10.1097/SLA.0000000000006473. Epub 2024 Aug 1.

Abstract

OBJECTIVE

To determine the interobserver variability for complications of pancreatoduodenectomy as defined by the International Study Group for Pancreatic Surgery (ISGPS) and others.

BACKGROUND

Good interobserver variability for the definitions of surgical complications is of major importance in comparing surgical outcomes between and within centers. However, data on interobserver variability for pancreatoduodenectomy-specific complications are lacking.

METHODS

International cross-sectional multicenter study including 52 raters from 13 high-volume pancreatic centers in 8 countries on 3 continents. Per center, 4 experienced raters scored 30 randomly selected patients after pancreatoduodenectomy. In addition, all raters scored 6 standardized case vignettes. This variability and the "within centers" variability were calculated for 2-fold scoring (no complication/grade A vs grade B/C) and 3-fold scoring (no complication/grade A vs grade B vs grade C) of postoperative pancreatic fistula, postpancreatoduodenectomy hemorrhage, chyle leak, bile leak, and delayed gastric emptying. Interobserver variability is presented with Gwet AC-1 measure for agreement.

RESULTS

Overall, 390 patients after pancreatoduodenectomy were included. The overall agreement rate for the standardized cases vignettes for 2-fold scoring was 68% (95% CI: 55%-81%, AC1 score: moderate agreement), and for 3-fold scoring 55% (49%-62%, AC1 score: fair agreement). The mean "within centers" agreement for 2-fold scoring was 84% (80%-87%, AC1 score; substantial agreement).

CONCLUSIONS

The interobserver variability for the ISGPS-defined complications of pancreatoduodenectomy was too high even though the "within centers" agreement was acceptable. Since these findings will decrease the quality and validity of clinical studies, ISGPS has started efforts aimed at reducing the interobserver variability.

摘要

目的

确定国际胰腺外科学研究组(ISGPS)和其他组织定义的胰十二指肠切除术并发症的观察者间变异性。

背景

良好的观察者间变异性对于手术并发症的定义非常重要,因为这可以在中心之间和中心内部比较手术结果。然而,缺乏胰十二指肠切除术特异性并发症的观察者间变异性数据。

方法

这是一项包括来自 8 个国家 3 大洲 13 个大容量胰腺中心的 52 名评估者的国际横断面多中心研究。每个中心的 4 名经验丰富的评估者对 30 名随机选择的胰十二指肠切除术后患者进行评分。此外,所有评估者都对 6 个标准化病例进行了评分。计算了两种评分方法(无并发症/等级 A 与等级 B/C)和三种评分方法(无并发症/等级 A 与等级 B 与等级 C)的术后胰瘘、胰十二指肠切除术后出血、乳糜漏、胆漏和胃排空延迟的观察者间变异性,并以 Gwet AC-1 测量值表示一致性。

结果

总共纳入了 390 例胰十二指肠切除术后患者。标准化病例的观察者间总体一致性评分在两种评分方法下分别为 68%(95%CI:55%-81%,AC1 评分:中度一致)和 55%(49%-62%,AC1 评分:适度一致)。两种评分方法下的“中心内”平均一致性分别为 84%(80%-87%,AC1 评分;高度一致)。

结论

即使“中心内”的一致性可以接受,但胰十二指肠切除术 ISGPS 定义的并发症的观察者间变异性仍然过高。由于这些发现将降低临床研究的质量和有效性,ISGPS 已开始努力降低观察者间变异性。

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