Design-related bias in studies investigating diagnostic tests for venous thromboembolic diseases: a systematic review and meta-analysis
BackgroundEarly detection and diagnosis of venous thromboembolism are vital for effective treatment. To what extent methodological shortcomings exist in studies of diagnostic tests and whether this affects published test performance is unknown.ObjectivesWe aimed to assess the methodological quality...
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Frontiers Media S.A.
2024-11-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2024.1420000/full |
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| author | Laura Boschetti Laura Boschetti Henning Nilius Henning Nilius Hugo Ten Cate Walter A. Wuillemin Walter A. Wuillemin Livia Faes Livia Faes Livia Faes Patrick M. Bossuyt Lucas M. Bachmann Michael Nagler Michael Nagler |
| author_facet | Laura Boschetti Laura Boschetti Henning Nilius Henning Nilius Hugo Ten Cate Walter A. Wuillemin Walter A. Wuillemin Livia Faes Livia Faes Livia Faes Patrick M. Bossuyt Lucas M. Bachmann Michael Nagler Michael Nagler |
| author_sort | Laura Boschetti |
| collection | DOAJ |
| description | BackgroundEarly detection and diagnosis of venous thromboembolism are vital for effective treatment. To what extent methodological shortcomings exist in studies of diagnostic tests and whether this affects published test performance is unknown.ObjectivesWe aimed to assess the methodological quality of studies evaluating diagnostic tests for venous thromboembolic diseases and quantify the direction and impact of design characteristics on diagnostic performance.MethodsWe conducted a literature search using Medline and Embase databases for systematic reviews summarizing diagnostic accuracy studies for five target disorders associated with venous thromboembolism. The following data were extracted for each primary study: methodological characteristics, the risk of bias scored by the QUADAS QUADAS-2 instrument, and numbers of true-positives, true-negatives, false-positives, and false-negatives. In a meta-analysis, we compared diagnostic accuracy measures from studies unlikely to be biased with those likely to be biased.ResultsEighty-five systematic reviews comprising 1’818 primary studies were included. Adequate quality assessment tools were used in 43 systematic reviews only (51%). The risk of bias was estimated to be low for all items in 23% of the primary studies. A high or unclear risk of bias in particular domains of the QUADAS/QUADAS-2 tool was associated with marked differences in the reported sensitivity and specificity.ConclusionsSignificant limitations in the methodological quality of studies assessing diagnostic tests for venous thromboembolic disorders exist, and studies at risk of bias are unlikely to report valid estimates of test performance. Established guidelines for evaluation of diagnostic tests should be more systematically adopted.Systematic Review RegistrationPROSPERO (CRD 42021264912). |
| format | Article |
| id | doaj-art-4a448a8fca78405b821ab408d3e5c95a |
| institution | Kabale University |
| issn | 2297-055X |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj-art-4a448a8fca78405b821ab408d3e5c95a2024-11-29T07:09:12ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2024-11-011110.3389/fcvm.2024.14200001420000Design-related bias in studies investigating diagnostic tests for venous thromboembolic diseases: a systematic review and meta-analysisLaura Boschetti0Laura Boschetti1Henning Nilius2Henning Nilius3Hugo Ten Cate4Walter A. Wuillemin5Walter A. Wuillemin6Livia Faes7Livia Faes8Livia Faes9Patrick M. Bossuyt10Lucas M. Bachmann11Michael Nagler12Michael Nagler13Department of Clinical Chemistry, Inselspital University Hospital, University of Bern, Bern, SwitzerlandDivision of Haematology, Cantonal Hospital of Lucerne, Lucerne, SwitzerlandDepartment of Clinical Chemistry, Inselspital University Hospital, University of Bern, Bern, SwitzerlandGraduate School for Health Sciences, University of Bern, Bern, SwitzerlandLaboratory of Clinical Thrombosis and Haemostasis, and Cardiovascular Research Institute, Maastricht University Medical Center, Maastricht, NetherlandsDivision of Haematology, Cantonal Hospital of Lucerne, Lucerne, SwitzerlandUniversity of Bern, Bern, SwitzerlandMedignition Inc., Zurich, SwitzerlandMedical Faculty, University of Zurich, Zurich, SwitzerlandNIHR Biomedical Research Center, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United KingdomDepartment of Clinical Epidemiology, Biostatistics & Bioinformatics, Academic Medical Center-University of Amsterdam, Amsterdam, NetherlandsMedignition Inc., Zurich, SwitzerlandDepartment of Clinical Chemistry, Inselspital University Hospital, University of Bern, Bern, SwitzerlandUniversity of Bern, Bern, SwitzerlandBackgroundEarly detection and diagnosis of venous thromboembolism are vital for effective treatment. To what extent methodological shortcomings exist in studies of diagnostic tests and whether this affects published test performance is unknown.ObjectivesWe aimed to assess the methodological quality of studies evaluating diagnostic tests for venous thromboembolic diseases and quantify the direction and impact of design characteristics on diagnostic performance.MethodsWe conducted a literature search using Medline and Embase databases for systematic reviews summarizing diagnostic accuracy studies for five target disorders associated with venous thromboembolism. The following data were extracted for each primary study: methodological characteristics, the risk of bias scored by the QUADAS QUADAS-2 instrument, and numbers of true-positives, true-negatives, false-positives, and false-negatives. In a meta-analysis, we compared diagnostic accuracy measures from studies unlikely to be biased with those likely to be biased.ResultsEighty-five systematic reviews comprising 1’818 primary studies were included. Adequate quality assessment tools were used in 43 systematic reviews only (51%). The risk of bias was estimated to be low for all items in 23% of the primary studies. A high or unclear risk of bias in particular domains of the QUADAS/QUADAS-2 tool was associated with marked differences in the reported sensitivity and specificity.ConclusionsSignificant limitations in the methodological quality of studies assessing diagnostic tests for venous thromboembolic disorders exist, and studies at risk of bias are unlikely to report valid estimates of test performance. Established guidelines for evaluation of diagnostic tests should be more systematically adopted.Systematic Review RegistrationPROSPERO (CRD 42021264912).https://www.frontiersin.org/articles/10.3389/fcvm.2024.1420000/fulldiagnostic testssensitivity and specificitymeta-analysisvenous thromboembolismvenous thrombosis |
| spellingShingle | Laura Boschetti Laura Boschetti Henning Nilius Henning Nilius Hugo Ten Cate Walter A. Wuillemin Walter A. Wuillemin Livia Faes Livia Faes Livia Faes Patrick M. Bossuyt Lucas M. Bachmann Michael Nagler Michael Nagler Design-related bias in studies investigating diagnostic tests for venous thromboembolic diseases: a systematic review and meta-analysis Frontiers in Cardiovascular Medicine diagnostic tests sensitivity and specificity meta-analysis venous thromboembolism venous thrombosis |
| title | Design-related bias in studies investigating diagnostic tests for venous thromboembolic diseases: a systematic review and meta-analysis |
| title_full | Design-related bias in studies investigating diagnostic tests for venous thromboembolic diseases: a systematic review and meta-analysis |
| title_fullStr | Design-related bias in studies investigating diagnostic tests for venous thromboembolic diseases: a systematic review and meta-analysis |
| title_full_unstemmed | Design-related bias in studies investigating diagnostic tests for venous thromboembolic diseases: a systematic review and meta-analysis |
| title_short | Design-related bias in studies investigating diagnostic tests for venous thromboembolic diseases: a systematic review and meta-analysis |
| title_sort | design related bias in studies investigating diagnostic tests for venous thromboembolic diseases a systematic review and meta analysis |
| topic | diagnostic tests sensitivity and specificity meta-analysis venous thromboembolism venous thrombosis |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2024.1420000/full |
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