Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Thrombosis Research Unit, Department of Medicine I, Division Hematology, University Hospital "Carl Gustav Carus" Dresden, Dresden, Germany.
J Thromb Haemost. 2019 Mar;17(3):499-506. doi: 10.1111/jth.14388. Epub 2019 Feb 13.
Essentials In 2016 the SSC proposed definitions for effective hemostasis in management of major bleeding. To validate these definitions, we studied the use in three large anticoagulant-reversal studies. Method agreement analysis and interobserver reliability showed at least acceptable agreement. Recommendations were made, advising use of the definition in hemostatic effectiveness studies. SUMMARY: Introduction In 2016 the Scientific and Standardization Subcommittee (SSC) on Control of Anticoagulation of the International Society on Thrombosis and Haemostasis (ISTH) proposed criteria to evaluate the effectiveness of anticoagulant reversal in major bleeding management. Testing and validation of these criteria are required. Objective To investigate the method agreement, interobserver reliability and applicability of the ISTH proposed definitions for hemostatic effectiveness. Methods Patient data from three anticoagulant-antidote studies were used for hemostatic effectiveness assessment using the ISTH-proposed definitions and clinical opinion. For every patient a case document was produced. For each cohort, four adjudicators were asked to assess the hemostatic effectiveness independently on a case-by-case basis. Agreement between the two methods of hemostatic effectiveness assessment was calculated using Cohen's kappa (κ), with a calculated sample size of at least 73 cases. Results The full dataset consisted of 116 cases, resulting in 464 assessments. Method agreement in outcome was observed in 364 of 464 assessments (78.5%), resulting in κ of 0.634 (95% CI: 0.575-0.694), or "substantial agreement." Interobserver reliability analysis of the proposed definitions computed an overall agreement of 54.2% with κ of 0.312 ("fair agreement"). Discussion Method agreement analysis shows that the conclusions drawn using the ISTH definitions have "substantial agreement" with clinical opinion. Interobserver reliability analysis demonstrated acceptable agreement. In-depth analysis provided minor opportunities for further improvement and correct application of the definition. The definition is recommended to be used in all future studies evaluating hemostatic effectiveness, taking the suggested recommendations into account.
2016 年，SSC 提出了用于管理大出血的有效止血的定义。为了验证这些定义，我们在三项大型抗凝逆转研究中进行了研究。方法一致性分析和观察者间可靠性显示出至少可接受的一致性。建议使用止血有效性研究中的定义。
2016 年，国际血栓止血学会（ISTH）的抗凝控制科学和标准化小组委员会（SSC）提出了评估抗凝逆转在大出血管理中有效性的标准。需要对这些标准进行测试和验证。
调查 ISTH 提出的止血有效性定义的方法一致性、观察者间可靠性和适用性。
使用 ISTH 提出的定义和临床意见，对三项抗凝-解毒剂研究中的患者数据进行止血有效性评估。为每位患者制作了一份病例文件。对于每个队列，要求四名裁判独立地对每个病例进行止血有效性评估。使用 Cohen's kappa（κ）计算两种止血有效性评估方法之间的一致性，计算的样本量至少为 73 例。
完整数据集包含 116 例，共 464 次评估。在 464 次评估中的 364 次（78.5%）中观察到了结果的方法一致性，κ 值为 0.634（95%CI：0.575-0.694），或“高度一致”。对提出的定义进行观察者间可靠性分析，得出总体一致率为 54.2%，κ 值为 0.312（“一般一致”）。
方法一致性分析表明，使用 ISTH 定义得出的结论与临床意见“高度一致”。观察者间可靠性分析显示出可接受的一致性。深入分析为进一步改进和正确应用该定义提供了机会。建议在所有未来评估止血有效性的研究中使用该定义，并考虑到建议的建议。
