Pub Date : 2024-09-13DOI: 10.1016/j.thromres.2024.109152
Introduction
Sepsis-induced coagulopathy (SIC) is a severe complication of sepsis, characterized by poor prognosis and high mortality. However, the predictors of SIC in pediatric patients have yet to be identified. Our aim was to develop a user-friendly and efficient nomogram for predicting SIC in sepsis patients admitted to the pediatric intensive care unit (PICU).
Materials and methods
We screened 948 sepsis patients admitted to the PICU in three hospitals located in Shandong, China. Least absolute shrinkage and selector operation (LASSO) regression was used in the training cohort for variable selection and regularization. The selected variables were utilized to construct a nomogram for predicting the risk of SIC among sepsis patients admitted to the PICU.
Results
Overall, SIC was observed in 324 (40.3 %) patients. The morbidity of SIC in sepsis patients is associated with age, fibrinogen, prothrombin time, C-reactive protein, lactate and the pediatric sequential organ failure assessment score. We developed a nomogram for the early identification of SIC in the training cohort (area under the curve [AUC] 0.869, 95 % confidence interval [CI] 0.830–0.907, sensitivity 75.7 %, specificity 84.8 %) and validation cohorts (validation cohort 1: AUC 0.854, 95 % CI 0.805–0.903, sensitivity 72.0 %, specificity 86.9 %; validation cohort 2: AUC 0.853, 95 % CI 0.796–0.910, sensitivity 70.1 %, specificity 87.8 %). The calibration plots of the nomogram demonstrated a high level of concordance in the SIC probabilities between the observed and predicted values.
Conclusions
The novel nomogram showed excellent predictive performance for the morbidity of SIC among sepsis patients admitted to the PICU, potentially assisting healthcare professionals in early identification and intervention for SIC.
导言败血症诱发凝血病(SIC)是败血症的一种严重并发症,其特点是预后差、死亡率高。然而,儿科患者 SIC 的预测因素尚未确定。我们的目的是开发一种方便用户且高效的提名图,用于预测儿科重症监护室(PICU)收治的败血症患者的 SIC。在训练队列中使用最小绝对收缩和选择器操作(LASSO)回归进行变量选择和正则化。结果 324 例(40.3%)患者出现 SIC。脓毒症患者的SIC发病率与年龄、纤维蛋白原、凝血酶原时间、C反应蛋白、乳酸和儿科序贯器官衰竭评估评分有关。我们在训练队列(曲线下面积 [AUC] 0.869,95% 置信区间 [CI] 0.830-0.907,灵敏度 75.7%,特异度 84.8%)和验证队列(验证队列 1:AUC 0.854,95% CI 0.805-0.903,灵敏度 72.0%,特异度 86.9%;验证队列 2:AUC 0.853,95% CI 0.796-0.910,灵敏度 70.1%,特异度 87.8%)。结论 该新型提名图对 PICU 败血症患者的 SIC 发病率具有出色的预测性能,可帮助医护人员早期识别和干预 SIC。
{"title":"Novel nomogram for the prediction of sepsis-induced coagulopathy in the PICU: A multicentre retrospective study","authors":"","doi":"10.1016/j.thromres.2024.109152","DOIUrl":"10.1016/j.thromres.2024.109152","url":null,"abstract":"<div><h3>Introduction</h3><p>Sepsis-induced coagulopathy (SIC) is a severe complication of sepsis, characterized by poor prognosis and high mortality. However, the predictors of SIC in pediatric patients have yet to be identified. Our aim was to develop a user-friendly and efficient nomogram for predicting SIC in sepsis patients admitted to the pediatric intensive care unit (PICU).</p></div><div><h3>Materials and methods</h3><p>We screened 948 sepsis patients admitted to the PICU in three hospitals located in Shandong, China. Least absolute shrinkage and selector operation (LASSO) regression was used in the training cohort for variable selection and regularization. The selected variables were utilized to construct a nomogram for predicting the risk of SIC among sepsis patients admitted to the PICU.</p></div><div><h3>Results</h3><p>Overall, SIC was observed in 324 (40.3 %) patients. The morbidity of SIC in sepsis patients is associated with age, fibrinogen, prothrombin time, C-reactive protein, lactate and the pediatric sequential organ failure assessment score. We developed a nomogram for the early identification of SIC in the training cohort (area under the curve [AUC] 0.869, 95 % confidence interval [CI] 0.830–0.907, sensitivity 75.7 %, specificity 84.8 %) and validation cohorts (validation cohort 1: AUC 0.854, 95 % CI 0.805–0.903, sensitivity 72.0 %, specificity 86.9 %; validation cohort 2: AUC 0.853, 95 % CI 0.796–0.910, sensitivity 70.1 %, specificity 87.8 %). The calibration plots of the nomogram demonstrated a high level of concordance in the SIC probabilities between the observed and predicted values.</p></div><div><h3>Conclusions</h3><p>The novel nomogram showed excellent predictive performance for the morbidity of SIC among sepsis patients admitted to the PICU, potentially assisting healthcare professionals in early identification and intervention for SIC.</p></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142233732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-12DOI: 10.1016/j.thromres.2024.109150
Background
In patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI), antiplatelet medication usage is crucial for preventing thrombotic events. However, it requires careful monitoring, especially because of the risk of life-threatening bleeding complications. In hemorrhagic complications, assessment of patient background and risk of gastrointestinal bleeding (GIB) remain limited for GIB that develops during long-term observation after hospital discharge. This study aimed to examine the incidence of GIB and patient characteristics in CAD post-PCI.
Methods
All CAD patients undergoing PCI for urgent, emergent, or elective indications were enrolled in the Keio Interhospital Cardiovascular Studies (JCD-KiCS)-PCI registry (January 2009 and December 2017) and followed up to 2 years after PCI discharge. From the JCD-KiCS PCI registry, 8864 patients (median [interquartile range [IQR]] age: non-GIB: 69.0 y [16 y], upper GIB (UGI): 72.0 y [15.5 y], lower GIB (LGI): 73.0 y [IQR: 13 y]) were categorized based on the occurrence of hospitalization-requiring GIB. Patient characteristics and detailed information regarding these GIB events, including the location (upper vs lower GI) and bleeding severity, were analyzed.
Results
Overall, 36 patients experienced UGI, while 85 patients experienced LGI. The rates of dual antiplatelet therapy (DAPT) and triple therapy were significantly different among the non-GIB (n = 8734), UGI (n = 36) and LGI (n = 85) groups (DAPT [aspirin + P2Y12 (clopidogrel/prasugrel/ticlopidine)]: 64 [76.2 %] in the LGI group vs 24 [68.6 %] in the UGI group vs 7330 [84.6 %] in the non-GIB group; triple therapy [aspirin + P2Y12 (clopidogrel/prasugrel/ticlopidine)] + oral anticoagulant (OAC) (warfarin/direct oral anticoagulant [DOAC]): 17 [20.2 %] in the LGI group vs 8 [22.9 %] in the UGI group vs 836 [9.6 %] in the non-GIB group; p < 0.001). In the LGI and UGI groups, aspirin and warfarin were used in 2 (2.4 %) and 2 (5.7 %) patients, respectively, but not in combination with DOAC. The 2-year post-PCI hospitalization incidence for GIB was 1.4 % (LGI, 1.0 %; UGI, 0.4 %). The most common causes were colonic diverticular hemorrhage (43.5 %) for LGI and duodenal ulcer (21.9 %) for UGI. No significant differences were found in the cumulative 2-year post-PCI risks between the LGI and UGI groups (log-rank p = 0.97). Most GIB events were Bleeding Academic Research Consortium 2-equivalent (hemoglobin decrease <3 g/dL). Notably, the use of OACs at PCI discharge, bleeding complications within 72 h, and preprocedural anemia were significantly correlated with an increased GIB risk.
Conclusions
The real-world incidence of LGI is two times higher than that of UGI in CAD patients undergoing PCI, and most events are mild. OAC use at PCI discharge is the strongest potential risk factor for GIB development.
{"title":"Comparative incidence and risk factors for gastrointestinal bleeding following percutaneous coronary intervention for coronary artery disease: Insights from the Keio Cardiovascular Registry in Japan","authors":"","doi":"10.1016/j.thromres.2024.109150","DOIUrl":"10.1016/j.thromres.2024.109150","url":null,"abstract":"<div><h3>Background</h3><p>In patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI), antiplatelet medication usage is crucial for preventing thrombotic events. However, it requires careful monitoring, especially because of the risk of life-threatening bleeding complications. In hemorrhagic complications, assessment of patient background and risk of gastrointestinal bleeding (GIB) remain limited for GIB that develops during long-term observation after hospital discharge. This study aimed to examine the incidence of GIB and patient characteristics in CAD post-PCI.</p></div><div><h3>Methods</h3><p>All CAD patients undergoing PCI for urgent, emergent, or elective indications were enrolled in the Keio Interhospital Cardiovascular Studies (JCD-KiCS)-PCI registry (January 2009 and December 2017) and followed up to 2 years after PCI discharge. From the JCD-KiCS PCI registry, 8864 patients (median [interquartile range [IQR]] age: non-GIB: 69.0 y [16 y], upper GIB (UGI): 72.0 y [15.5 y], lower GIB (LGI): 73.0 y [IQR: 13 y]) were categorized based on the occurrence of hospitalization-requiring GIB. Patient characteristics and detailed information regarding these GIB events, including the location (upper vs lower GI) and bleeding severity, were analyzed.</p></div><div><h3>Results</h3><p>Overall, 36 patients experienced UGI, while 85 patients experienced LGI. The rates of dual antiplatelet therapy (DAPT) and triple therapy were significantly different among the non-GIB (n = 8734), UGI (n = 36) and LGI (n = 85) groups (DAPT [aspirin + P2Y12 (clopidogrel/prasugrel/ticlopidine)]: 64 [76.2 %] in the LGI group vs 24 [68.6 %] in the UGI group vs 7330 [84.6 %] in the non-GIB group; triple therapy [aspirin + P2Y12 (clopidogrel/prasugrel/ticlopidine)] + oral anticoagulant (OAC) (warfarin/direct oral anticoagulant [DOAC]): 17 [20.2 %] in the LGI group vs 8 [22.9 %] in the UGI group vs 836 [9.6 %] in the non-GIB group; p < 0.001). In the LGI and UGI groups, aspirin and warfarin were used in 2 (2.4 %) and 2 (5.7 %) patients, respectively, but not in combination with DOAC. The 2-year post-PCI hospitalization incidence for GIB was 1.4 % (LGI, 1.0 %; UGI, 0.4 %). The most common causes were colonic diverticular hemorrhage (43.5 %) for LGI and duodenal ulcer (21.9 %) for UGI. No significant differences were found in the cumulative 2-year post-PCI risks between the LGI and UGI groups (log-rank p = 0.97). Most GIB events were Bleeding Academic Research Consortium 2-equivalent (hemoglobin decrease <3 g/dL). Notably, the use of OACs at PCI discharge, bleeding complications within 72 h, and preprocedural anemia were significantly correlated with an increased GIB risk.</p></div><div><h3>Conclusions</h3><p>The real-world incidence of LGI is two times higher than that of UGI in CAD patients undergoing PCI, and most events are mild. OAC use at PCI discharge is the strongest potential risk factor for GIB development.</p></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0049384824002822/pdfft?md5=183c1e641cf929263bc192156fd36c12&pid=1-s2.0-S0049384824002822-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142239592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-11DOI: 10.1016/j.thromres.2024.109148
<div><h3>Background</h3><div>Randomized controlled trials suggest that prophylactic doses of anticoagulants effectively prevent venous thromboembolism (VTE) in hospitalized medical patients with high thromboembolic risk. However, no prospective studies exist regarding the real-world prevalence of prophylactic anticoagulant use. This prospective study aimed to determine the rate and predictors of thromboprophylaxis in an unselected population of patients hospitalized in medical departments.</div></div><div><h3>Methods</h3><div>We conducted a multicenter prospective observational study (AURELIO – rAte of venous thrombosis in acutely iLl patIents hOspitalized) to assess the rate of deep vein thrombosis (DVT) in unselected acutely ill patients hospitalized in medical wards using compression ultrasound (CUS) at admission and discharge. Additionally, we evaluated the rate of pharmacological thromboprophylaxis administration in this population and analyzed the thrombotic risk by assessing RAMs (Risk Assessment Models) such as the IMPROVE-VTE and PADUA scores following the clinician's decision to administer thromboprophylaxis. Patients with IMPROVE-VTE scores ≥3 and/or PADUA scores ≥4 were classified as high thrombotic risk; those with IMPROVE-VTE scores <3 and/or PADUA scores <4 were classified as low risk.</div></div><div><h3>Results</h3><div>We recruited 2371 patients (1233 males [52 %] and 1138 females [48 %]; mean age 72 ± 16 years). The median length of hospitalization was 13 ± 12 days. Overall, 442/2371 (18.6 %) patients received prophylactic parenteral anticoagulants (subcutaneous low weight molecular heparin or fondaparinux once daily) at admission. Assessing the thrombotic risk of the population recruited 1016 (42.9 %) patients were classified as high risk and 1354 (57.1 %) were low risk. Among high-risk patients, 339/1016 (33.4 %) received anticoagulant prophylaxis compared to 103/1354 (7.6 %) low-risk patients. During hospitalization, 9 patients developed DVT, comprising 7 asymptomatic and 2 symptomatic cases of proximal DVT. Of these, 3 patients were on anticoagulant prophylaxis, while 6 were not. Among the high-risk population, 7 out of 1016 patients (0.7 %) experienced proximal DVT during hospitalization, with 2 out of these 7 (28 %) receiving anticoagulant thromboprophylaxis. In the low-risk population, 2 out of 1354 patients (0.2 %) developed DVT, with 1 out of these 2 (50 %) receiving anticoagulant thromboprophylaxis. Age, heart or respiratory failure, pneumonia, active neoplasia, previous VTE, reduced mobility, and absence of kidney failure were more frequent in patients receiving prophylaxis. Multivariable logistic regression identified age (RR 1.010; CI 95 % 1002–1019; <em>p</em> = 0.015), heart/respiratory failure (RR 1.609; CI 95 % 1248–2075; <em>p</em> < 0.0001), active neoplasia (RR 2.041; CI 95 % 1222–2141; p < 0.0001), pneumonia (RR 1.618; CI 95 % 1557–2676; p < 0.0001), previous VTE (RR 1.954; CI 95 % 1222–3125;
{"title":"Rate and predictors of thromboprophylaxis in internal medicine wards: Results from the AURELIO study","authors":"","doi":"10.1016/j.thromres.2024.109148","DOIUrl":"10.1016/j.thromres.2024.109148","url":null,"abstract":"<div><h3>Background</h3><div>Randomized controlled trials suggest that prophylactic doses of anticoagulants effectively prevent venous thromboembolism (VTE) in hospitalized medical patients with high thromboembolic risk. However, no prospective studies exist regarding the real-world prevalence of prophylactic anticoagulant use. This prospective study aimed to determine the rate and predictors of thromboprophylaxis in an unselected population of patients hospitalized in medical departments.</div></div><div><h3>Methods</h3><div>We conducted a multicenter prospective observational study (AURELIO – rAte of venous thrombosis in acutely iLl patIents hOspitalized) to assess the rate of deep vein thrombosis (DVT) in unselected acutely ill patients hospitalized in medical wards using compression ultrasound (CUS) at admission and discharge. Additionally, we evaluated the rate of pharmacological thromboprophylaxis administration in this population and analyzed the thrombotic risk by assessing RAMs (Risk Assessment Models) such as the IMPROVE-VTE and PADUA scores following the clinician's decision to administer thromboprophylaxis. Patients with IMPROVE-VTE scores ≥3 and/or PADUA scores ≥4 were classified as high thrombotic risk; those with IMPROVE-VTE scores <3 and/or PADUA scores <4 were classified as low risk.</div></div><div><h3>Results</h3><div>We recruited 2371 patients (1233 males [52 %] and 1138 females [48 %]; mean age 72 ± 16 years). The median length of hospitalization was 13 ± 12 days. Overall, 442/2371 (18.6 %) patients received prophylactic parenteral anticoagulants (subcutaneous low weight molecular heparin or fondaparinux once daily) at admission. Assessing the thrombotic risk of the population recruited 1016 (42.9 %) patients were classified as high risk and 1354 (57.1 %) were low risk. Among high-risk patients, 339/1016 (33.4 %) received anticoagulant prophylaxis compared to 103/1354 (7.6 %) low-risk patients. During hospitalization, 9 patients developed DVT, comprising 7 asymptomatic and 2 symptomatic cases of proximal DVT. Of these, 3 patients were on anticoagulant prophylaxis, while 6 were not. Among the high-risk population, 7 out of 1016 patients (0.7 %) experienced proximal DVT during hospitalization, with 2 out of these 7 (28 %) receiving anticoagulant thromboprophylaxis. In the low-risk population, 2 out of 1354 patients (0.2 %) developed DVT, with 1 out of these 2 (50 %) receiving anticoagulant thromboprophylaxis. Age, heart or respiratory failure, pneumonia, active neoplasia, previous VTE, reduced mobility, and absence of kidney failure were more frequent in patients receiving prophylaxis. Multivariable logistic regression identified age (RR 1.010; CI 95 % 1002–1019; <em>p</em> = 0.015), heart/respiratory failure (RR 1.609; CI 95 % 1248–2075; <em>p</em> < 0.0001), active neoplasia (RR 2.041; CI 95 % 1222–2141; p < 0.0001), pneumonia (RR 1.618; CI 95 % 1557–2676; p < 0.0001), previous VTE (RR 1.954; CI 95 % 1222–3125;","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142318637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-10DOI: 10.1016/j.thromres.2024.109144
Background
Ovulation induction for in vitro fertilization (IVF) may increase intravascular thromboses among patients with antiphospholipid autoantibodies (aPLs) or antiphospholipid syndrome (APS) due to the high estrogen levels. While natural or modified natural IVF treatment cycles (MNC) are sometimes used instead of stimulated cycles with empiric anticoagulant treatment among these infertile patients, their efficacy is unclear.
Materials and methods
A retrospective cohort study including all IVF cycles of patients diagnosed with aPLs or APS in a tertiary, university-affiliated hospital between 2012 and 2022. The outcomes of stimulated cycles with anticoagulants and MNC and natural IVF cycle attempts were compared.
Results
121 oocyte retrievals from 38 women were analyzed: 93 stimulated and 28 MNC or natural IVF cycles. The rates of cycle cancellation (0 % vs. 17.9 %, p < 0.001) and cycles in which no oocytes were retrieved (0 % vs. 43.5 %, p < 0.001) were significantly lower following stimulated cycles vs. natural and MNC. In parallel, positive β-hCG (31.9 % vs. 10.9 %, p = 0.03), clinical pregnancy rate (23.6 % and 3.6 %, p < 0.001) and live birth rates (18.1 % vs. 3.6 %, p = 0.01) were significantly higher following stimulated cycles. No thrombotic events or bleeding occurred in any cycle.
Conclusion
Ovarian stimulation for IVF is more effective for successful pregnancy and delivery than natural cycles and MNC and can be safely undertaken in aPLs or APS women undergoing IVF. Rates of complication from hormonal treatment are not increased when treated with LMWH during ovarian stimulation.
{"title":"Outcomes of IVF treatments in women with antiphospholipid antibodies or antiphospholipid syndrome","authors":"","doi":"10.1016/j.thromres.2024.109144","DOIUrl":"10.1016/j.thromres.2024.109144","url":null,"abstract":"<div><h3>Background</h3><p>Ovulation induction for in vitro fertilization (IVF) may increase intravascular thromboses among patients with antiphospholipid autoantibodies (aPLs) or antiphospholipid syndrome (APS) due to the high estrogen levels. While natural or modified natural IVF treatment cycles (MNC) are sometimes used instead of stimulated cycles with empiric anticoagulant treatment among these infertile patients, their efficacy is unclear.</p></div><div><h3>Materials and methods</h3><p>A retrospective cohort study including all IVF cycles of patients diagnosed with aPLs or APS in a tertiary, university-affiliated hospital between 2012 and 2022. The outcomes of stimulated cycles with anticoagulants and MNC and natural IVF cycle attempts were compared.</p></div><div><h3>Results</h3><p>121 oocyte retrievals from 38 women were analyzed: 93 stimulated and 28 MNC or natural IVF cycles. The rates of cycle cancellation (0 % vs. 17.9 %, <em>p</em> < 0.001) and cycles in which no oocytes were retrieved (0 % vs. 43.5 %, p < 0.001) were significantly lower following stimulated cycles vs. natural and MNC. In parallel, positive β-hCG (31.9 % vs. 10.9 %, <em>p</em> = 0.03), clinical pregnancy rate (23.6 % and 3.6 %, <em>p</em> < 0.001) and live birth rates (18.1 % vs. 3.6 %, <em>p</em> = 0.01) were significantly higher following stimulated cycles. No thrombotic events or bleeding occurred in any cycle.</p></div><div><h3>Conclusion</h3><p>Ovarian stimulation for IVF is more effective for successful pregnancy and delivery than natural cycles and MNC and can be safely undertaken in aPLs or APS women undergoing IVF. Rates of complication from hormonal treatment are not increased when treated with LMWH during ovarian stimulation.</p></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142233730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-07DOI: 10.1016/j.thromres.2024.109143
Background
Accurate identification of incident venous thromboembolism (VTE) for quality improvement and health services research is challenging. The purpose of this study was to evaluate the performance of a novel incident VTE phenotyping algorithm defined using standard terminologies, requiring three key indicators documented in the electronic health record (EHR): VTE diagnostic code, VTE-related imaging procedure code, and anticoagulant medication code.
Methods
Retrospective chart reviews were conducted to assess the performance of the algorithm using a random sample of phenotype(+) and phenotype(−) diagnostic encounters from primary care practices and acute care sites affiliated with five hospitals across a large integrated care delivery system in Massachusetts. The performance of the algorithm was evaluated by calculating the positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity, using the phenotype(+) and phenotype(−) diagnostic encounters sample and target population data.
Results
Based on gold-standard manual chart review, the algorithm had a PPV of 95.2 % (95 % CI: 93.1–96.8 %), NPV of 97.1 % (95 % CI: 95.3–98.4 %), sensitivity of 91.7 % (95 % CI: 90.8–92.6 %), and specificity of 98.4 % (95 % CI: 98.1–98.6 %). The algorithm systematically misclassified a low number of specific types of encounters, highlighting potential areas for improvement.
Conclusions
This novel phenotyping algorithm offers an accurate approach for identifying incident VTE in general populations using EHR data and standard terminologies, and accurately identifies the specific encounter and date of diagnosis of the incident VTE. This approach can be used for measurement of incident VTE to drive quality improvement, research to expand the evidence, and development of quality metrics and clinical decision support to improve the diagnostic process.
{"title":"Accurately identifying incident cases of venous thromboembolism in the electronic health record: Performance of a novel phenotyping algorithm","authors":"","doi":"10.1016/j.thromres.2024.109143","DOIUrl":"10.1016/j.thromres.2024.109143","url":null,"abstract":"<div><h3>Background</h3><p>Accurate identification of incident venous thromboembolism (VTE) for quality improvement and health services research is challenging. The purpose of this study was to evaluate the performance of a novel incident VTE phenotyping algorithm defined using standard terminologies, requiring three key indicators documented in the electronic health record (EHR): VTE diagnostic code, VTE-related imaging procedure code, and anticoagulant medication code.</p></div><div><h3>Methods</h3><p>Retrospective chart reviews were conducted to assess the performance of the algorithm using a random sample of phenotype(+) and phenotype(−) diagnostic encounters from primary care practices and acute care sites affiliated with five hospitals across a large integrated care delivery system in Massachusetts. The performance of the algorithm was evaluated by calculating the positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity, using the phenotype(+) and phenotype(−) diagnostic encounters sample and target population data.</p></div><div><h3>Results</h3><p>Based on gold-standard manual chart review, the algorithm had a PPV of 95.2 % (95 % CI: 93.1–96.8 %), NPV of 97.1 % (95 % CI: 95.3–98.4 %), sensitivity of 91.7 % (95 % CI: 90.8–92.6 %), and specificity of 98.4 % (95 % CI: 98.1–98.6 %). The algorithm systematically misclassified a low number of specific types of encounters, highlighting potential areas for improvement.</p></div><div><h3>Conclusions</h3><p>This novel phenotyping algorithm offers an accurate approach for identifying incident VTE in general populations using EHR data and standard terminologies, and accurately identifies the specific encounter and date of diagnosis of the incident VTE. This approach can be used for measurement of incident VTE to drive quality improvement, research to expand the evidence, and development of quality metrics and clinical decision support to improve the diagnostic process.</p></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142272020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-06DOI: 10.1016/j.thromres.2024.109147
{"title":"Knowledge and raising awareness are the CURES for alleviating sex disparities in PE care","authors":"","doi":"10.1016/j.thromres.2024.109147","DOIUrl":"10.1016/j.thromres.2024.109147","url":null,"abstract":"","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142230776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-06DOI: 10.1016/j.thromres.2024.109146
Background
Pulmonary embolism (PE) is a common and potentially fatal disease, with differences in mortality rates among PE patients of different sexes. This study aims to investigate the disparities in clinical manifestations and in-hospital mortality rates between sexes in PE patients, as well as the association of clinical symptoms with in-hospital mortality.
Methods
We analyzed data from the China pUlmonary thromboembolism REgistry Study (CURES), a nationwide, multicenter, prospective registry focusing on patients with acute PE. Using propensity score matching (PSM) to pair male and female patients with PE, we explored the correlation between clinical symptoms and in-hospital mortality through multivariable regression analysis.
Results
A total of 15,203 patients with acute PE were enrolled, and 380 died during hospitalization. The incidence of chest pain, hemoptysis, and palpitations was significantly higher in males compared to females. The incidence of dyspnea, fever, and syncope was higher in females. Hemoptysis and dyspnea were associated with increased in-hospital mortality in males, whereas dyspnea, fever, and palpitations were linked to higher mortality in females. Overall, males exhibited a higher in-hospital mortality than females (2.9 % vs. 2.1 %, p = 0.002). After matching 13,130 patients using the PSM method, the mortality rate of males remained higher than that of females (2.7 % vs. 2.1 %, p = 0.020).
Conclusions
Our study demonstrates that male patients with PE have a higher risk of in-hospital mortality than females. Significant differences in clinical symptoms between sexes are associated with increased mortality risk, emphasizing the need for clinical awareness.
背景肺栓塞(PE)是一种常见且可能致命的疾病,不同性别的PE患者死亡率存在差异。方法 我们分析了中国肺血栓栓塞登记研究(CURES)的数据,该研究是一项全国性、多中心、前瞻性登记研究,主要针对急性 PE 患者。利用倾向评分匹配(PSM)将男性和女性 PE 患者配对,我们通过多变量回归分析探讨了临床症状与院内死亡率之间的相关性。 结果 共登记了 15203 名急性 PE 患者,其中 380 人在住院期间死亡。男性胸痛、咯血和心悸的发生率明显高于女性。女性呼吸困难、发烧和晕厥的发生率更高。男性的咯血和呼吸困难与院内死亡率升高有关,而女性的呼吸困难、发烧和心悸则与死亡率升高有关。总体而言,男性的院内死亡率高于女性(2.9% 对 2.1%,P = 0.002)。结论我们的研究表明,男性 PE 患者的院内死亡风险高于女性。我们的研究表明,男性 PE 患者的院内死亡风险高于女性。性别间临床症状的显著差异与死亡风险的增加有关,这强调了临床认识的必要性。
{"title":"Sex disparities of clinical manifestations in acute pulmonary embolism and predictive value for in-hospital mortality: Insights from CURES","authors":"","doi":"10.1016/j.thromres.2024.109146","DOIUrl":"10.1016/j.thromres.2024.109146","url":null,"abstract":"<div><h3>Background</h3><p>Pulmonary embolism (PE) is a common and potentially fatal disease, with differences in mortality rates among PE patients of different sexes. This study aims to investigate the disparities in clinical manifestations and in-hospital mortality rates between sexes in PE patients, as well as the association of clinical symptoms with in-hospital mortality.</p></div><div><h3>Methods</h3><p>We analyzed data from the China pUlmonary thromboembolism REgistry Study (CURES), a nationwide, multicenter, prospective registry focusing on patients with acute PE. Using propensity score matching (PSM) to pair male and female patients with PE, we explored the correlation between clinical symptoms and in-hospital mortality through multivariable regression analysis.</p></div><div><h3>Results</h3><p>A total of 15,203 patients with acute PE were enrolled, and 380 died during hospitalization. The incidence of chest pain, hemoptysis, and palpitations was significantly higher in males compared to females. The incidence of dyspnea, fever, and syncope was higher in females. Hemoptysis and dyspnea were associated with increased in-hospital mortality in males, whereas dyspnea, fever, and palpitations were linked to higher mortality in females. Overall, males exhibited a higher in-hospital mortality than females (2.9 % vs. 2.1 %, <em>p</em> = 0.002). After matching 13,130 patients using the PSM method, the mortality rate of males remained higher than that of females (2.7 % vs. 2.1 %, <em>p</em> = 0.020).</p></div><div><h3>Conclusions</h3><p>Our study demonstrates that male patients with PE have a higher risk of in-hospital mortality than females. Significant differences in clinical symptoms between sexes are associated with increased mortality risk, emphasizing the need for clinical awareness.</p></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142150925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-05DOI: 10.1016/j.thromres.2024.109145
Introduction
Hospital-acquired venous thromboembolism (VTE) is a major cause of preventable deaths. Incidence of VTE and adequacy of thromboprophylaxis have rarely been reported in low-resourced countries. The aim of this study was to estimate the incidence of VTE and to evaluate the adequacy of thromboprophylaxis in acutely-ill medical hospitalized patients.
Methods
The PROFMiG is a prospective cohort study conducted in Brazil. We consecutively enrolled adult (> 18 years) acutely-ill hospitalized medical patients at admission. Risk assessment for VTE was evaluated by the IMPROVE7 (International Medical Prevention Registry on Venous Thromboembolism). Outcomes were death and VTE events during hospital stay up to 90 days after discharge. All VTE and death events were adjudicated. We also evaluated pulmonary embolism-related death and adequacy of thromboprophylaxis. VTE incidence was estimated by competing risk methods.
Results
A total of 2380 participants was included. Median age was 70 years, 56.1 % women, median length of hospital stay was 10 days. A total of 2052 (86.3 %) patients were classified as low-risk for VTE, 30 (1.3 %) patients had objectively confirmed VTE, and 1449 (60.8 %) received inadequate thromboprophylaxis. The overall mortality rate was 14.0 %. Cumulative incidence of VTE was 2.0 % (95 % confidence interval 0.9 %–3.8 %) at 130 days after admission when considering death as competing risk.
Conclusion
The cumulative incidence of VTE in this cohort corroborates with that reported in high-resourced countries. Despite recommendation, thromboprophylaxis was mostly inadequate. We suggest the adoption of competing risk analysis to estimate the cumulative incidence of VTE in hospitalized patients.
{"title":"Incidence of venous thromboembolism and adequacy of thromboprophylaxis in 2380 acutely-ill hospitalized patients: Results from the PROFMiG cohort study","authors":"","doi":"10.1016/j.thromres.2024.109145","DOIUrl":"10.1016/j.thromres.2024.109145","url":null,"abstract":"<div><h3>Introduction</h3><p>Hospital-acquired venous thromboembolism (VTE) is a major cause of preventable deaths. Incidence of VTE and adequacy of thromboprophylaxis have rarely been reported in low-resourced countries. The aim of this study was to estimate the incidence of VTE and to evaluate the adequacy of thromboprophylaxis in acutely-ill medical hospitalized patients.</p></div><div><h3>Methods</h3><p>The PROFMiG is a prospective cohort study conducted in Brazil. We consecutively enrolled adult (> 18 years) acutely-ill hospitalized medical patients at admission. Risk assessment for VTE was evaluated by the IMPROVE7 (<em>International Medical Prevention Registry on Venous Thromboembolism</em>). Outcomes were death and VTE events during hospital stay up to 90 days after discharge. All VTE and death events were adjudicated. We also evaluated pulmonary embolism-related death and adequacy of thromboprophylaxis. VTE incidence was estimated by competing risk methods.</p></div><div><h3>Results</h3><p>A total of 2380 participants was included. Median age was 70 years, 56.1 % women, median length of hospital stay was 10 days. A total of 2052 (86.3 %) patients were classified as low-risk for VTE, 30 (1.3 %) patients had objectively confirmed VTE, and 1449 (60.8 %) received inadequate thromboprophylaxis. The overall mortality rate was 14.0 %. Cumulative incidence of VTE was 2.0 % (95 % confidence interval 0.9 %–3.8 %) at 130 days after admission when considering death as competing risk.</p></div><div><h3>Conclusion</h3><p>The cumulative incidence of VTE in this cohort corroborates with that reported in high-resourced countries. Despite recommendation, thromboprophylaxis was mostly inadequate. We suggest the adoption of competing risk analysis to estimate the cumulative incidence of VTE in hospitalized patients.</p></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142150924","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-30DOI: 10.1016/j.thromres.2024.109135
Background
Despite medical interventions, COVID-19 continues to persist at pandemic proportions. A hypercoagulation state was rapidly observed in the severely ill, and the incidence of thromboembolic events remains elevated. Interleukin inhibitors have demonstrated positive effects on the hyperactivation of the immune system in COVID-19, with the interleukin-6 inhibitor tocilizumab showing promising results in reducing mortality. Nevertheless, the impact of interleukin inhibitors on the coagulation system remains incompletely understood.
Methods
In this clinical trial conducted in Stockholm, Sweden, interleukin inhibitors, namely anakinra (ANA) or tocilizumab (TOCI), were randomly administered in addition to standard care (SC) to hospitalized patients with COVID-19. A control group received only SC. The primary outcome sought to measure effects on global hemostasis, as indicated by changes in functional coagulation tests, specifically Rotational Thromboelastometry (ROTEM) or Overall Hemostatic Potential (OHP), visualized through scanning electron microscopy images. Secondary outcomes included effects on conventional coagulation laboratory tests.
Results
The study enrolled 74 patients who were randomized to receive either ANA or TOCI in addition to SC, or SC alone. In the TOCI group, ROTEM variables exhibited less hypercoagulation after 29 days compared with ANA or SC treatment groups, characterized by prolonged clot formation time and decreased clot firmness. OHP decreased, but there were no significant differences among the three treatment groups. Plasma fibrinogen levels, initially elevated, decreased significantly in TOCI recipients over time.
Conclusion
Tocilizumab treatment demonstrated a significant reduction of hypercoagulation in hospitalized COVID-19 patients, by improvements in both global coagulation tests and conventional laboratory tests, in comparison with anakinra or SC alone. This finding underscores the significance of tocilizumab as a viable treatment option in severe COVID-19 cases, with the potential to decrease thrombosis incidence.
{"title":"Tocilizumab reduces hypercoagulation in COVID-19 – Perspectives from the coagulation and immunomodulation Covid assessment (Coag-ImmCovA) clinical trial","authors":"","doi":"10.1016/j.thromres.2024.109135","DOIUrl":"10.1016/j.thromres.2024.109135","url":null,"abstract":"<div><h3>Background</h3><p>Despite medical interventions, COVID-19 continues to persist at pandemic proportions. A hypercoagulation state was rapidly observed in the severely ill, and the incidence of thromboembolic events remains elevated. Interleukin inhibitors have demonstrated positive effects on the hyperactivation of the immune system in COVID-19, with the interleukin-6 inhibitor tocilizumab showing promising results in reducing mortality. Nevertheless, the impact of interleukin inhibitors on the coagulation system remains incompletely understood.</p></div><div><h3>Methods</h3><p>In this clinical trial conducted in Stockholm, Sweden, interleukin inhibitors, namely anakinra (ANA) or tocilizumab (TOCI), were randomly administered in addition to standard care (SC) to hospitalized patients with COVID-19. A control group received only SC. The primary outcome sought to measure effects on global hemostasis, as indicated by changes in functional coagulation tests, specifically Rotational Thromboelastometry (ROTEM) or Overall Hemostatic Potential (OHP), visualized through scanning electron microscopy images. Secondary outcomes included effects on conventional coagulation laboratory tests.</p></div><div><h3>Results</h3><p>The study enrolled 74 patients who were randomized to receive either ANA or TOCI in addition to SC, or SC alone. In the TOCI group, ROTEM variables exhibited less hypercoagulation after 29 days compared with ANA or SC treatment groups, characterized by prolonged clot formation time and decreased clot firmness. OHP decreased, but there were no significant differences among the three treatment groups. Plasma fibrinogen levels, initially elevated, decreased significantly in TOCI recipients over time.</p></div><div><h3>Conclusion</h3><p>Tocilizumab treatment demonstrated a significant reduction of hypercoagulation in hospitalized COVID-19 patients, by improvements in both global coagulation tests and conventional laboratory tests, in comparison with anakinra or SC alone. This finding underscores the significance of tocilizumab as a viable treatment option in severe COVID-19 cases, with the potential to decrease thrombosis incidence.</p></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142121725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-30DOI: 10.1016/j.thromres.2024.109132
Background
Venous thromboembolism (VTE) is a leading cause of death among cancer patients. Despite this, studies show that patients with cancer feel inadequately informed about the VTE risk and symptoms, which may impede their ability to recognise symptoms and react promptly. Patients with lung cancer are especially vulnerable due to a high relative risk of developing VTE combined with a high prevalence of low health literacy. This study aimed to explore the VTE information needs of lung cancer patients and how patients and healthcare professionals (HCPs) communicate about VTE.
Material and methods
Data was collected via semi-structured interviews with patients with lung cancer and HCPs. All participants (n = 20) were recruited from an oncological department. The analysis was performed in an inductive manner using a Ricoeur inspired strategy.
Findings
Patients had varying information needs regarding VTE, but HCPs did not routinely communicate about VTE, as the topic tended to be lowly prioritised. HCPs communicated about VTE when patients expressed a need or presented symptoms of VTE. HCPs expressed concerns about adding to patient's emotional burden by informing about VTE, while some patients emphasised the importance of being mentally prepared for potential complications.
Conclusion
The study demonstrates the challenging balance HCPs must maintain between adequately communicating about VTE and not causing undue psychological distress. However, given patient's often limited awareness of VTE, the responsibility to initiate communication about VTE must fall on the HCPs.
{"title":"TO INFORM OR NOT TO INFORM about venous thromboembolisms – A qualitative study on communication between healthcare professionals and patients with lung cancer","authors":"","doi":"10.1016/j.thromres.2024.109132","DOIUrl":"10.1016/j.thromres.2024.109132","url":null,"abstract":"<div><h3>Background</h3><p>Venous thromboembolism (VTE) is a leading cause of death among cancer patients. Despite this, studies show that patients with cancer feel inadequately informed about the VTE risk and symptoms, which may impede their ability to recognise symptoms and react promptly. Patients with lung cancer are especially vulnerable due to a high relative risk of developing VTE combined with a high prevalence of low health literacy. This study aimed to explore the VTE information needs of lung cancer patients and how patients and healthcare professionals (HCPs) communicate about VTE.</p></div><div><h3>Material and methods</h3><p>Data was collected via semi-structured interviews with patients with lung cancer and HCPs. All participants (<em>n</em> = 20) were recruited from an oncological department. The analysis was performed in an inductive manner using a Ricoeur inspired strategy.</p></div><div><h3>Findings</h3><p>Patients had varying information needs regarding VTE, but HCPs did not routinely communicate about VTE, as the topic tended to be lowly prioritised. HCPs communicated about VTE when patients expressed a need or presented symptoms of VTE. HCPs expressed concerns about adding to patient's emotional burden by informing about VTE, while some patients emphasised the importance of being mentally prepared for potential complications.</p></div><div><h3>Conclusion</h3><p>The study demonstrates the challenging balance HCPs must maintain between adequately communicating about VTE and not causing undue psychological distress. However, given patient's often limited awareness of VTE, the responsibility to initiate communication about VTE must fall on the HCPs.</p></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0049384824002640/pdfft?md5=9ece8be26f2abd8b2553e966058f9ec2&pid=1-s2.0-S0049384824002640-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142163981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}