Abstract
A clinical score was recently proposed to rule out concomitant DVT in patients with a clinical suspicion of SVT. This study aimed to assess the external validity of this score in patients from the STEPH study. We performed a post-hoc analysis of data from the STEPH study. The STEPH study was a prospective multicenter community-based study conducted during a 1-year period in the resident adult population of the Greater Saint-Etienne urban area (France). Every patient with a clinical suspicion of SVT underwent a venous compression ultrasonography, to confirm SVT and to assess the presence of a concomitant DVT or not. Odds ratios for concomitant DVT were calculated for each item of the ICARO score. We then computed the score for each patient, and performed a receiver operating characteristic (ROC) curve analysis. In univariate analysis, none of the ICARO items were significantly different given the presence of a concomitant DVT. Given computed scores, 55 patients (45.1%) had a low risk, 17 (13.9%) had an intermediate risk and 50 (41.0%) had a high risk of a concomitant DVT. The area under the ROC curve was 0.386 [95% CI, 0.268–0.504]. When risk levels were dichotomized as low vs intermediate-high risk, the ICARO score had a sensitivity of 36.0%, a specificity of 40.2%, a positive predictive value of 13.4% and a negative predictive value of 70.9%. Our study does not confirm the utility of the ICARO clinical score to rule out concomitant DVT in case of SVT.
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Acknowledgements
We thank Jennifer Hasselgard-Rowe for her editorial advice.
Author contributions
PF, QB and LB served on the steering committee which designed the study and had final responsibility for study supervision and data analysis. PF, QB, BS, HD and LB participated in the STEPH study coordination, data collection and/or the administrative, technical, or logistic support. PF performed statistical analysis of the data. Each author made substantial contribution to data interpretation. PF and LB wrote the first draft of the manuscript. Each author critically reviewed and participated in revising the manuscript, and each author approved the final version.
Funding
The STEPH study was supported by a grant from the French Ministry of Health and Sports (Programme Hospitalier de Recherche Clinique 2011).
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Paul Frappé, Quentin Brosse, Laurent Bertoletti and Benjamin Seffert declare that they have no conflict of interest. Hervé Décousus reports personal fees from ASPEN, personal fees from Pfizer/BMS, personal fees from Daiichi-Sankyo Pharma, personal fees from Bayer, grants from Daiichi-Sankyo Pharma and grants from Bayer, outside of the submitted work.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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Frappé, P., Brosse, Q., Seffert, B. et al. Ruling out deep vein thrombosis in patients with superficial vein thrombosis: external validation of the ICARO score. J Thromb Thrombolysis 47, 96–101 (2019). https://doi.org/10.1007/s11239-018-1754-7
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DOI: https://doi.org/10.1007/s11239-018-1754-7