Method agreement analysis and interobserver reliability of the ISTH proposed definitions for effective hemostasis in management of major bleeding
Author(s): ,
Rahat A. Abdoellakhan
Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
Correspondence: Rahat A. Abdoellakhan, Department of Hematology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ Groningen, the Netherlands|Tel.: +31 50 361 0225|E‐mail:
Jan Beyer‐Westendorf
Thrombosis Research Unit, Department of Medicine I, Division Hematology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany. Kings Thrombosis Service, Department of Hematology, Kings College London, London, UK
Sam Schulman
Department of Medicine, McMaster University, Hamilton, Canada
Ravi Sarode
Division of Transfusion Medicine and Hemostasis, Department of Pathology, University of Texas Southwestern Medical Center, Dallas, USA
Karina Meijer
Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
Nakisa Khorsand
Department of Pharmacy, OLVG, Amsterdam, the Netherlands
ISTH Academy. Rahat A. Mar 1, 2019; 273400
Abdoellakhan Rahat
Abdoellakhan Rahat
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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.
To investigate the method agreement, interobserver reliability and applicability of the ISTH proposed definitions for hemostatic effectiveness.
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.
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”).
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.
anticoagulants, bleeding, hemostasis, outcome assessment, prothrombin complex concentrates
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