A new risk-assessment tool for venous thromboembolism in advanced lung cancer: a prospective, observational study.
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ABSTRACT:
SUBMITTER: Tsubata Y
PROVIDER: S-EPMC8981807 | biostudies-literature | 2022 Apr
REPOSITORIES: biostudies-literature
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A new risk-assessment tool for venous thromboembolism in advanced lung cancer: a prospective, observational study.
Tsubata Yukari Y Hotta Takamasa T Hamai Kosuke K Furuya Naoki N Yokoyama Toshihide T Saito Ryota R Nakamura Atsushi A Masuda Takeshi T Hamaguchi Megumi M Kuyama Shoichi S Honda Ryoichi R Senoo Tadashi T Nakanishi Masamoto M Yamasaki Masahiro M Ishikawa Nobuhisa N Fujitaka Kazunori K Kubota Tetsuya T Kobayashi Kunihiko K Isobe Takeshi T
Journal of hematology & oncology 20220404 1
Management of cancer-associated venous thromboembolism (VTE) is essential in treatment selection and cancer prognosis. However, to date, there is no method to assess the risk of VTE specifically associated with advanced lung cancer. Our aim was to create a new risk assessment scoring system that can predict the concomitant or incidence of VTE in advanced lung cancer. We used the dataset of 1008 patients with lung cancer in the Rising-VTE/NEJ037 study, of which 100 (9.9%) developed VTE. The items ...[more]
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Project description:ObjectivesOur health system launched an initiative to regulate venous thromboembolism (VTE) risk assessment and prophylaxis with electronically embedded risk assessment models based on validated clinical prediction rules. Prior to system-wide implementation, usability testing was conducted on the VTE clinical decision support system (CDSS) to assess provider perceptions, facilitate adoption, and usage of the tool. The objective of this study was to conduct usability testing with end users on the CDSS' risk assessment model and prophylaxis ordering components.MethodsThis laboratory usability testing study was conducted with 24 health care providers. Participants were given two case scenarios that mirrored real-world scenarios to assess likelihood of use and adoption. During each case scenario, participants engaged in a think-aloud session, verbalizing their decision-making process while interacting with the tool. Following each case scenario, participants completed the System Usability Scale (SUS) and a posttask interview. Participants' comments and interactions with the VTE CDSS were placed into coding categories and analyzed for generalizable themes by three independent coders.ResultsOf the 24 participants, 50% were female and the mean age of all participants was 32.76 years. The average SUS across the different services lines was 72.39 (C grade). Each participant's comments were grouped into three overarching themes: functionality, visibility/navigation, and content. Comments included personalizing workflow for each service line, minimizing the number of clicks, clearly defining risk models, including background on risk scores, and providing treatment guidelines for order sets.ConclusionAn important step toward providing quality health care to patients at risk of developing a VTE event is providing user-friendly tools to providers. Following usability testing, our study revealed opportunities to positively impact provider behavior and acceptance. The rigor and breadth of this usability testing study and adoption of the optimizations should increase provider adoption and retention of the VTE CDSS.
| S-EPMC9797348 | biostudies-literature
Project description:Venous thromboembolism (VTE) is frequently observed in patients with advanced cancer. The objective of this prospective observational study was to estimate, based on intensive screening, using computed tomography, lower-extremity ultrasonography, and D-dimer testing, the prevalence of VTE in patients with advanced cancer. Patients with metastatic or locally advanced cancer without anticoagulant therapy, who were planning to receive chemotherapy during 4 weeks, were eligible. Evaluations of VTE were performed at pretreatment, 12 weeks, and 24 weeks after the start of chemotherapy. Primary endpoint was cumulative incidence of VTE for 24 weeks. Secondary endpoints included incidence of VTE (pretreatment, 12 weeks, and 24 weeks after the start of chemotherapy), VTE according to primary cancer site, symptomatic VTE, pulmonary thromboembolism (PE), and treatment of VTE. We enrolled 860 patients with a median age of 68 years, including 34% female and 71% lung cancer. Cumulative incidence of VTE for 24 weeks was 22.6% (95% confidence interval: 19.8%-25.5%) (194 of 860 patients). Incidence of VTE was 11.3% pretreatment, 16.8% 12 weeks, and 14.1% 24 weeks. Symptomatic VTE was observed in 4.0% and PE in 1.0% of patients. By multivariate analysis, sex, D-dimer level, and platelet count were independent risk factors of VTE for 24 weeks. This large prospective observational study showed that cumulative incidence of VTE was high in advanced cancer patients, mainly lung cancer. Although most patients showed asymptomatic VTE, intensive screening of VTE may be considered in advanced cancer patients, especially in women with high level of D-dimer and decreased platelet count (UMIN000015243).
| S-EPMC7897954 | biostudies-literature
Project description:BackgroundPostoperative venous thromboembolism (VTE) is a well-documented cause of morbidity and mortality in lung cancer patients. However, risk identification remains limited. In this study, we sought to analyze the risk factors for VTE and verify the predictive value of the modified Caprini risk assessment model (RAM).MethodsThis prospective single-center study included patients with resectable lung cancer who underwent resection between October 2019 and March 2021. The incidence of VTE was estimated. Logistic regression was used to analyze the risk factors for VTE. Receiver operating characteristic (ROC) curve analysis was performed to test the ability of the modified Caprini RAM to predict VTE.ResultsThe VTE incidence was 10.5%. Several variables, including age, D-dimer, hemoglobin (Hb), bleeding, and patient confinement to bed were significantly associated with VTE after surgery. The difference between the VTE and non-VTE groups in the high-risk levels was statistically significant (P<0.001), while the low and moderate risk levels showed no significant difference. The combined use of the modified Caprini score and the Hb and D-dimer levels showed an area under the curve (AUC) was 0.822 [95% confidence interval (CI): 0.760-0.855. P<0.001].ConclusionsThe risk-stratification approach of the modified Caprini RAM is not particularly valid after lung resection in our population. The use of the modified Caprini RAM combined with Hb and D-dimer levels shows a good diagnostic performance for VTE prediction in patients with lung cancer undergoing resection.
| S-EPMC10323546 | biostudies-literature
Project description:BackgroundInpatients with high risk of venous thromboembolism (VTE) usually face serious threats to their health and economic conditions. Many studies using machine learning (ML) models to predict VTE risk overlook the impact of class-imbalance problem due to the low incidence rate of VTE, resulting in inferior and unstable model performance, which hinders their ability to replace the Padua model, a widely used linear weighted model in clinic. Our study aims to develop a new VTE risk assessment model suitable for Chinese medical inpatients.Methods3284 inpatients in the medical department of Peking Union Medical College Hospital (PUMCH) from January 2014 to June 2016 were collected. The training and test set were divided based on the admission time and inpatients from May 2016 to June 2016 were included as the test dataset. We explained the class imbalance problem from a clinical perspective and defined a new term, "fuzzy population", to elaborate and model this phenomenon. By considering the "fuzzy population", a new ML VTE risk assessment model was built through population splitting. Sensitivity and specificity of our method was compared with five ML models (support vector machine (SVM), random forest (RF), gradient boosting decision tree (GBDT), logistic regression (LR), and XGBoost) and the Padua model.ResultsThe 'fuzzy population' phenomenon was explained and verified on the VTE dataset. The proposed model achieved higher specificity (64.94% vs. 63.30%) and the same sensitivity (90.24% vs. 90.24%) on test data than the Padua model. Other five ML models couldn't simultaneously surpass the Padua's sensitivity and specificity. Besides, our model was more robust than five ML models and its standard deviations of sensitivities and specificities were smaller. Adjusting the distribution of negative samples in the training set based on the 'fuzzy population' would exacerbate the instability of performance of five ML models, which limited the application of ML methods in clinic.ConclusionsThe proposed model achieved higher sensitivity and specificity than the Padua model, and better robustness than traditional ML models. This study built a population-split-based ML model of VTE by modeling the class-imbalance problem and it can be applied more broadly in risk assessment of other diseases.
| S-EPMC11686901 | biostudies-literature
Project description:Sheikh Khalifa Medical City (SKMC) in Abu Dhabi is the main tertiary care referral hospital in the United Arab Emirates (UAE) with 560 bed capacity that is fully occupied most of the time. SKMC senior management has made a commitment to make quality and patient safety a top priority. Venous thromboembolism (VTE) risk assessment has been identified as a critical patient safety measure and key performance indicator. The electronic VTE risk assessment form a computerized decision support tool was introduced to improve adherence with deep venous thrombosis (DVT) prophylaxis recommendations. A multidisciplinary task force team was formed and led this quality improvement project. The purpose of this publication is to indicate the quality improvement interventions implemented to enhance compliance with VTE risk assessment and the outcomes of those interventions. We chose to conduct the pilot study in General Medicine as it is the busiest department in the hospital. The study period was from April 2014 till August 2015.The lessons learned were disseminated throughout the hospital. Our aim was to improve VTE risk assessment compliance by using the electronic form in order to ensure patient safety and reduce preventable harm. VTE risk assessment compliance improved in general medicine from 4% to 98%, and overall SKMC compliance from 21% to above 90%.
| S-EPMC4693050 | biostudies-literature
Project description:An invasive phlebological treatment is still not free from complications such as thrombosis. As in other surgical populations, not only the treatment modality, but also patient condition-related venous thromboembolism (VTE) risk factors matter. The current protocols used in varicose vein surgery centers are based mostly on individual risk assessment as well as on an implementation and extrapolation of general surgery VTE prophylaxis guidelines. In the presented study, the efficacy of routine VTE pharmacological thromboprophylaxis in patients undergoing saphenous varicose vein surgery was prospectively evaluated. In the result assessment, VTE risk factor evaluation and Caprini score results were included; however, due to the limited size of the projected study group, as well as expected limited deep vein thrombosis (DVT) prevalence in this clinical scenario, it was not possible to perform the validation of the Caprini model efficacy in the projected study model. In the study, 141 patients undergoing saphenous vein stripping and miniphlebectomy in spinal anesthesia were included. In all of the patients, VTE risk factors (including Caprini score evaluation) were assessed, and the routine thromboprophylaxis with enoxaparin 40 mg for 10 days was used. The venous ultrasounds were undertaken before the surgery and on the 10th and 30th day after surgery. The study endpoint was the presence of symptomatic or asymptomatic DVT confirmed in the imaging study. The study safety endpoint was major bleeding occurrence intraoperatively or within 30 days after surgery. The presence of a postoperative DVT was diagnosed in five cases (3.5%) In all of these cases, only distal DVT was confirmed. Despite extensive saphenous varicose vein surgery with stripping and miniphlebectomy performed in nontumescent but spinal anesthesia, no proximal lower leg episode was diagnosed. Three out of five DVT cases were diagnosed on day 10 postoperative control, while a further two were confirmed in the ultrasound examination performed 30 days after procedure. No clinically documented pulmonaly embolism (PE) as well as no bleeding episodes were noticed. Among the factors related to the statistically significant higher DVT occurrence, the results of the Caprini score were identified with odds ratio (OR) = 2.04 (95% CI = (0.998; 4.18)). Another factor that became statistically significant in terms of the higher postoperative DVT prevalence was the reported Venous Clinical Severity Score (VCSS) results (OR = 1.98; 95% CI (1.19; 3.26)). In the multiple logistic regression analysis, the patient age (OR = 0.86; 95% CI (0.75-0.99)), Caprini score evaluation results (OR = 4.04; 95% CI (1.26-12.9)) and VCSS results (OR = 2.4; 95% CI (1.23-4.7)) were of statistical significance as predictors for postoperative DVT occurrence, with a p value of 0.029 for age, and p = 0.017 and p = 0.009 for Caprini score results and VCSS results, respectively. Due to the confirmed limited number of the DVT events in our study cohort, as well as the descriptive and explorative nature of the achieved results, the final clinical potential and significance of the identified parameters, including Caprini score rate and VCSS rate, should be interpreted with caution and studied in the further trials in these clinical settings. All the patients undergoing varicose vein surgery should undergo VTE risk evaluation based on the individual assessment. In VTE risk evaluation, patient and surgical procedure characteristics based on the factors included into the Caprini score but also on specific chronic venous disease-related factors should be taken into consideration. Further studies are needed to propose an objective and validated VTE risk assessment model, as well as a validated antithrombotic prophylaxis protocol in this particular patient group.
| S-EPMC7762368 | biostudies-literature
Project description:An initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. The design was an observational prospective study of risk factors embedded in a randomised controlled study. Acute whiplash patients from units, general practitioners in four Danish counties were referred to two research centres. During a 2-year inclusion period, acute consecutive whiplash-injured (age 18-70 years, rear-end or frontal-end car accident and WAD (whiplash-associated disorders) grades I-III, symptoms within 72 h, examination prior to 10 days postinjury, capable of written/spoken Danish, without other injuries/fractures, pre-existing significant somatic/psychiatric disorder, drug/alcohol abuse and previous significant pain/headache). 688 (438 women and 250 men) participants were interviewed and examined by a study nurse after 5 days; 605 were completed after 1 year. A risk score which included items of initial neck pain/headache intensity, a number of non-painful complaints and active neck mobility was applied. The primary outcome parameter was 1-year work disability. The risk score and number of sick-listing days were related (Kruskal-Wallis, p<0.0001). In stratum 1, less than 4%, but in stratum 7, 68% were work-disabled after 1 year. Early work assessment (p<0.0001), impact of the event questionnaire (p<0.0006), psychophysical pain measures being McGill pain questionnaire parameters (p<0.0001), pressure pain algometry (p<0.0001) and palpation (p<0.0001) showed a significant relationship with risk stratification. Findings confirm previous studies reporting intense neck pain/headache and distress as predictors for work disability after whiplash. Neck-mobility was a strong predictor in this study; however, it was a more inconsistent predictor in other studies. Application of the risk assessment score and use of the risk strata system may be beneficial in future studies and may be considered as a valuable tool to assess return-to-work following injuries; however, further studies are needed.
| S-EPMC3563124 | biostudies-literature
Project description:BackgroundICU patients have a high incidence of VTE. The American College of Chest Physicians antithrombotic practice guidelines recommend assessing the risk of VTE in all ICU patients. Although several VTE risk assessment tools exist to evaluate the risk factors among hospitalized patients, there is no validated tool specifically for assessing the risk of VTE in ICU patients.MethodsA retrospective corhort study was conducted between June 2018 and October 2022. We obtained data from the electronic medical records of patients with a variety of diagnoses admitted to a mixed ICU. Multivariable logistic regression analysis was used to evaluate the independent risk factors of VTE. Receiver operating characteristic (ROC) curves were used to analyse the predictive accuracy of different tools.ResultsA total of 566 patients were included, and VTE occurred in 89 patients (15.7%), 62.9% was asymptomatic VTE. A prediction model (the ICU-VTE prediction model) was derived from the independent risk factors identified using multivariate analysis. The ICU-VTE prediction model included eight independent risk factors: history of VTE (3 points), immobilization ≥4 days (3 points), multiple trauma (3 points), age ≥70 years (2 points), platelet count >250 × 103/μL (2 points), central venous catheterization (1 point), invasive mechanical ventilation (1 point), and respiratory failure or heart failure (1 point). Patients with a score of 0-4 points had a low (1.81%) risk of VTE. Patients were at intermediate risk, scoring 5-6 points, and the overall incidence of VTE in the intermediate-risk category was 17.1% (odds ratio [OR], 11.1; 95% confidence interval [CI], 4.2-29.4). Those with a score ≥7 points had a high (44.1%) risk of VTE (OR, 42.6; 95% CI, 16.4-110.3). The area under the curve (AUC) of the ICU-VTE prediction model was 0.838, and the differences in the AUCs were statistically significant between the ICU-VTE prediction model and the other three tools (ICU-VTE score, Z = 3.723, P < 0.001; Caprini risk assessment model, Z = 6.212, P < 0.001; Padua prediction score, Z = 7.120, P < 0.001).ConclusionsWe identified eight independent risk factors for acquired VTE among hospitalized patients in the ICU, deriving a new ICU-VTE risk assessment model. The model aims to predict asymptomatic VTE in ICU patients. The new model has higher predictive accuracy than the current tools. A prospective study is required for external validation of the tool and risk stratification in ICU patients.
| S-EPMC11367689 | biostudies-literature
Project description:BackgroundGenetics plays an important role in venous thromboembolism (VTE). Factor V Leiden (FVL or rs6025) and prothrombin gene G20210A (PT or rs1799963) are the genetic variants currently tested for VTE risk assessment. We hypothesized that primary VTE risk assessment can be improved by using genetic risk scores with more genetic markers than just FVL-rs6025 and prothrombin gene PT-rs1799963. To this end, we have designed a new genetic risk score called Thrombo inCode (TiC).Methods and resultsTiC was evaluated in terms of discrimination (Δ of the area under the receiver operating characteristic curve) and reclassification (integrated discrimination improvement and net reclassification improvement). This evaluation was performed using 2 age- and sex-matched case-control populations: SANTPAU (248 cases, 249 controls) and the Marseille Thrombosis Association study (MARTHA; 477 cases, 477 controls). TiC was compared with other literature-based genetic risk scores. TiC including F5 rs6025/rs118203906/rs118203905, F2 rs1799963, F12 rs1801020, F13 rs5985, SERPINC1 rs121909548, and SERPINA10 rs2232698 plus the A1 blood group (rs8176719, rs7853989, rs8176743, rs8176750) improved the area under the curve compared with a model based only on F5-rs6025 and F2-rs1799963 in SANTPAU (0.677 versus 0.575, P<0.001) and MARTHA (0.605 versus 0.576, P=0.008). TiC showed good integrated discrimination improvement of 5.49 (P<0.001) for SANTPAU and 0.96 (P=0.045) for MARTHA. Among the genetic risk scores evaluated, the proportion of VTE risk variance explained by TiC was the highest.ConclusionsWe conclude that TiC greatly improves prediction of VTE risk compared with other genetic risk scores. TiC should improve prevention, diagnosis, and treatment of VTE.
| S-EPMC4323784 | biostudies-literature
Project description:ObjectiveVenous thromboembolism (VTE) is a preventable cause of hospitalization-related morbidity and mortality. VTE prevention requires accurate risk stratification. Federal agencies mandated VTE risk assessment for all hospital admissions. We have shown that the widely used Caprini (30 risk factors) and Padua (11 risk factors) VTE risk-assessment models (RAMs) have limited predictive ability for VTE when used for all general hospital admissions. Here, we test whether combining the risk factors from all 23 available VTE RAMs improves VTE risk prediction.MethodsWe analyzed data from the first hospitalizations of 1,282,014 surgical and non-surgical patients admitted to 1298 Veterans Affairs facilities nationwide between January 2016 and December 2021. We used logistic regression to predict VTE within 90 days of admission using risk factors from all 23 available VTE RAMs. Area under the receiver operating characteristic curves (AUC), sensitivity, specificity, and positive (PPV) and negative predictive values (NPV) were used to quantify the predictive power of our models. The metrics were computed at two diagnostic thresholds that maximized (1) the value of sensitivity + specificity-1; and (2) PPV and were compared using McNemar's test. The Delong-Delong test was used to compare AUCs.ResultsAfter excluding those with missing data, 1,185,633 patients (mean age, 66 years; 93% male; and 72% White) were analyzed, of whom 33,253 (2.8%) had a VTE (deep venous thrombosis [DVT], n = 19,218, 1.6%; pulmonary embolism [PE], n = 10,190, 0.9%; PE + DVT, n = 3845, 0.3%). Our composite RAM included 102 risk factors and improved prediction of VTE compared with the Caprini RAM risk factors (AUC composite model: 0.74; AUC Caprini risk-factor model: 0.63; P < .0001). When the sum of sensitivity and specificity-1 was maximized, the composite model demonstrated small improvements in sensitivity, specificity and PPV; NPV was high in both models. When PPV was maximized, the PPV of the composite model was improved but remained low. The nature of the relationship between NPV and PPV precluded any further gain in PPV by sacrificing NPV and sensitivity.ConclusionsUsing a composite of 102 risk factors from all available VTE RAMs, we improved VTE prediction in a large, national cohort of >1 million general hospital admissions. However, neither model has a sensitivity or PPV that permits it to be a reliable predictor of VTE. We demonstrate the limits of currently available VTE risk prediction tools; no available RAM is ready for widespread use in the general hospital population.
| S-EPMC11764112 | biostudies-literature