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KMID : 1146320220100020098
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Journal of Health Technology Assessment
2022 Volume.10 No. 2 p.98 ~ p.107
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Clinical Usefulness of Bleeding Time Test: A Systematic Review
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Shin Sang-Jin
Kim You-Lim
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Abstract
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Objectives: Through a systematic review, we aimed to assess clinical usefulness of bleeding time test as blood coagulation test.
Methods: A comprehensive search was performed in three foreign databases (MEDLINE, Embase, and CENTRAL) and five Korean databases up to August 2020 for a systematic review. A key question is this review was clinical safety and effectiveness of the bleeding time test as a screening test for bleeding disorders or as a preoperative bleeding risk assessment test. The risk of bias assessment was performed using Quality Assessment of Diagnostic Accuracy Studies-II, and a bivariate random effects model was used to reflect inter-study heterogeneity and correlation between test sensitivity and specificity was applied to perform meta-analysis.
Results: The bleeding time test is a diagnostic test that measures the time until bleeding stops after artificially injuring a subcutaneous blood vessel. Safety concerns have been pointed out as an invasive test that can cause bleeding and scarring due to the test, but there has been no literature reporting related safety indicators. As a result of synthesizing four quantitatively synthesizable articles out of six studies that reported the usefulness of bleeding time test for screening for bleeding disorders, the area under the summary receiver operating characteristics curve of the bleeding time test was 0.50, and the pooled sensitivity was 0.34 (95% confidence interval [CI] 0.24?0.46), and the pooled specificity was 0.85
(95% CI 0.69?0.93). The diagnostic accuracy of the bleeding time test was at a very low level compared to the PFA-100. In one study that evaluated diagnostic accuracy of the bleeding time test for the purpose of pre-operative bleeding risk assessment, sensitivity was very low at 0.11.
Conclusion: The bleeding time test was 520,000 cases within National Health Insurance in 2021. The bleeding
time test is not only limited by the diagnostic test itself, such as low diagnostic accuracy and difficulty in standardization of tests, but also limitations that can cause stress and burden on patients and medical staff due to the test limitation. In the current situation where many alternative tests to evaluate bleeding risk already exist, bleeding time test was an invalid method to screen hemorrhagic disorders and to assess preoperative bleeding risk.
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KEYWORD
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Hemorrhagic disorders, Bleeding time test, Health technology reassessment
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