Prognosis in patients with cancer-associated venous thromboembolism: Comparison of the RIETE-VTE and modified Ottawa score.

BACKGROUND The RIETE-VTE score was derived to risk-stratify patients with cancer-associated venous thromboembolism (CAT). OBJECTIVES To externally validate the RIETE-VTE score and to compare its prognostic performance with the modified Ottawa score. PATIENTS/METHODS We studied 178 elderly patients with CAT in a prospective multicenter cohort and assessed 30-day all-cause mortality, 90-day overall complications (mortality, major bleeding, or venous thromboembolism [VTE] recurrence), and 6-month VTE recurrence. Patients were stratified into RIETE-VTE and modified Ottawa score risk classes (low, intermediate, high). We compared the discriminative power (area under the receiver operating characteristics [ROC] curve) to predict mortality, overall complications, and VTE recurrence. RESULTS Fifteen patients (8.4%) died within 30 days, 42 (23.6%) experienced an overall complication by day 90, and 6 (3.4%) had recurrent VTE within 6 months. The RIETE-VTE and the modified Ottawa score classified similar proportions of patients as low-risk (35.4% vs 31.5%; P = .37). No low-risk patient died within 30 days. Low-risk patients identified by the RIETE-VTE and modified Ottawa score had similar rates of overall complications (7.9% vs 8.9%) and VTE recurrence (1.6% vs 1.8%). The modified Ottawa score and the RIETE-VTE score had similar areas under the ROC curve for predicting all-cause mortality (0.84 vs 0.75; P = .21), overall complications (0.74 vs 0.68; P = .26), and VTE recurrence (0.67 vs 0.64; P = .78). CONCLUSIONS Both the RIETE-VTE and modified Ottawa score accurately identified elderly patients with CAT who are at low-risk for short-term mortality and who are potential candidates for outpatient care

Effects of a Multimodal Transitional Care Intervention in Patients at High Risk of Readmission: The TARGET-READ Randomized Clinical Trial.

IMPORTANCE Hospital readmissions are frequent, costly, and sometimes preventable. Although these issues have been well publicized and incentives to reduce them introduced, the best interventions for reducing readmissions remain unclear. OBJECTIVES To evaluate the effects of a multimodal transitional care intervention targeting patients at high risk of hospital readmission on the composite outcome of 30-day unplanned readmission or death. DESIGN, SETTING, AND PARTICIPANTS A single-blinded, multicenter randomized clinical trial was conducted from April 2018 to January 2020, with a 30-day follow-up in 4 medium-to-large-sized teaching hospitals in Switzerland. Participants were consecutive patients discharged from general internal medicine wards and at higher risk of unplanned readmission based on their simplified HOSPITAL score (≥4 points). Data were analyzed between April and September 2022. INTERVENTIONS The intervention group underwent systematic medication reconciliation, a 15-minute patient education session with teach-back, a planned first follow-up visit with their primary care physician, and postdischarge follow-up telephone calls from the study team at 3 and 14 days. The control group received usual care from their hospitalist, plus a 1-page standard study information sheet. MAIN OUTCOMES AND MEASURES Thirty-day postdischarge unplanned readmission or death. RESULTS A total of 1386 patients were included with a mean (SD) age of 72 (14) years; 712 (51%) were male. The composite outcome of 30-day unplanned readmission or death was 21% (95% CI, 18% to 24%) in the intervention group and 19% (95% CI, 17% to 22%) in the control group. The intention-to-treat analysis risk difference was 1.7% (95% CI, -2.5% to 5.9%; P = .44). There was no evidence of any intervention effects on time to unplanned readmission or death, postdischarge health care use, patient satisfaction with the quality of their care transition, or readmission costs. CONCLUSIONS AND RELEVANCE In this randomized clinical trial, use of a standardized multimodal care transition intervention targeting higher-risk patients did not significantly decrease the risks of 30-day postdischarge unplanned readmission or death; it demonstrated the difficulties in preventing hospital readmissions, even when multimodal interventions specifically target higher-risk patients. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03496896

Usefulness of D-dimer testing in predicting recurrence in elderly patients with unprovoked venous thromboembolism.

BACKGROUND Whether post-anticoagulation D-dimer levels are useful in predicting recurrence in elderly patients with unprovoked venous thromboembolism is unknown. METHODS We followed-up 157 patients aged ≥65 years with acute symptomatic unprovoked venous thromboembolism in a prospective multicenter cohort study. All patients completed 3-12 months of anticoagulation and then underwent quantitative D-dimer testing (ELISA, VIDAS DD) 12 months after the index venous thromboembolism. The outcome was recurrent symptomatic venous thromboembolism after D-dimer measurement. We examined associations between log-transformed and dichotomized D-dimer values and the time to venous thromboembolism recurrence using competing risk regression, adjusting for age, sex and overt pulmonary embolism. RESULTS There was no statistically significant association between quantitative or dichotomized D-dimer levels and venous thromboembolism recurrence. The area under the receiver operating characteristic curve for predicting recurrent venous thromboembolism was moderate (0.66, 95% confidence interval [CI] 0.51-0.82). The negative likelihood ratios were 0.34 (95% CI 0.05-2.38) at the usual and 0.34 (95% CI 0.09-1.29) at the age-adjusted cutoff values. Among patients with normal D-dimer results, venous thromboembolism recurrence rates were 6.8 (95% CI 2.2-21.2) per 100 patient-years using the usual and 7.1 (95% CI 3.2-15.8) per 100 patient-years using the age-adjusted cutoff values. CONCLUSION D-dimer testing alone may not be useful in identifying elderly patients with unprovoked venous thromboembolism who are at low risk of recurrent venous thromboembolism and in whom anticoagulants may be safely stopped

Risk Assessment Models for Venous Thromboembolism in Medical Inpatients.

IMPORTANCE Thromboprophylaxis is recommended for medical inpatients at risk of venous thromboembolism (VTE). Risk assessment models (RAMs) have been developed to stratify VTE risk, but a prospective head-to-head comparison of validated RAMs is lacking. OBJECTIVES To prospectively validate an easy-to-use RAM, the simplified Geneva score, and compare its prognostic performance with previously validated RAMs. DESIGN, SETTING, AND PARTICIPANTS This prospective cohort study was conducted from June 18, 2020, to January 4, 2022, with a 90-day follow-up. A total of 4205 consecutive adults admitted to the general internal medicine departments of 3 Swiss university hospitals for hospitalization for more than 24 hours due to acute illness were screened for eligibility; 1352 without therapeutic anticoagulation were included. EXPOSURES At admission, items of 4 RAMs (ie, the simplified and original Geneva score, the Padua score, and the IMPROVE [International Medical Prevention Registry on Venous Thromboembolism] score) were collected. Patients were stratified into high and low VTE risk groups according to each RAM. MAIN OUTCOMES AND MEASURES Symptomatic VTE within 90 days. RESULTS Of 1352 medical inpatients (median age, 67 years [IQR, 54-77 years]; 762 men [55.4%]), 28 (2.1%) experienced VTE. Based on the simplified Geneva score, 854 patients (63.2%) were classified as high risk, with a 90-day VTE risk of 2.6% (n = 22; 95% CI, 1.7%-3.9%), and 498 patients (36.8%) were classified as low risk, with a 90-day VTE risk of 1.2% (n = 6; 95% CI, 0.6%-2.6%). Sensitivity of the simplified Geneva score was 78.6% (95% CI, 60.5%-89.8%) and specificity was 37.2% (95% CI, 34.6%-39.8%); the positive likelihood ratio of the simplified Geneva score was 1.25 (95% CI, 1.03-1.52) and the negative likelihood ratio was 0.58 (95% CI, 0.28-1.18). In head-to-head comparisons, sensitivity was highest for the original Geneva score (82.1%; 95% CI, 64.4%-92.1%), while specificity was highest for the IMPROVE score (70.4%; 95% CI, 67.9%-72.8%). After adjusting the VTE risk for thromboprophylaxis use and site, there was no significant difference between the high-risk and low-risk groups based on the simplified Geneva score (subhazard ratio, 2.04 [95% CI, 0.83-5.05]; P = .12) and other RAMs. Discriminative performance was poor for all RAMs, with an area under the receiver operating characteristic curve ranging from 53.8% (95% CI, 51.1%-56.5%) for the original Geneva score to 58.1% (95% CI, 55.4%-60.7%) for the simplified Geneva score. CONCLUSIONS AND RELEVANCE This head-to-head comparison of validated RAMs found suboptimal accuracy and prognostic performance of the simplified Geneva score and other RAMs to predict hospital-acquired VTE in medical inpatients. Clinical usefulness of existing RAMs is questionable, highlighting the need for more accurate VTE prediction strategies

Effectiveness of Transition Care Intervention Targeted to High-Risk Patients to Reduce Readmissions: Study Protocol for the TARGET-READ Multicenter Randomized-Controlled Trial.

Hospital readmissions within 30 days represent a burden for the patients and the entire health care system. Improving the care around hospital discharge period could decrease the risk of avoidable readmissions. We describe the methods of a trial that aims to evaluate the effect of a structured multimodal transitional care intervention targeted to higher-risk medical patients on 30-day unplanned readmissions and death. The TARGET-READ study is an investigator-initiated, pragmatic single-blinded randomized multicenter controlled trial with two parallel groups. We include all adult patients at risk of hospital readmission based on a simplified HOSPITAL score of ≥4 who are discharged home or nursing home after a hospital stay of one day or more in the department of medicine of the four participating hospitals. The patients randomized to the intervention group will receive a pre-discharge intervention by a study nurse with patient education, medication reconciliation, and follow-up appointment with their referring physician. They will receive short follow-up phone calls at 3 and 14 days after discharge to ensure medication adherence and follow-up by the ambulatory care physician. A blind study nurse will collect outcomes at 1 month by phone call interview. The control group will receive usual care. The TARGET-READ study aims to increase the knowledge about the efficacy of a bundled intervention aimed at reducing 30-day hospital readmission or death in higher-risk medical patients

Prediction of in-hospital bleeding in acutely ill medical patients: External validation of the IMPROVE bleeding risk score.

INTRODUCTION Pharmacological thromboprophylaxis slightly increases bleeding risk. The only risk assessment model to predict bleeding in medical inpatients, the IMPROVE bleeding risk score, has never been validated using prospectively collected outcome data. METHODS We validated the IMPROVE bleeding risk score in a prospective multicenter cohort of medical inpatients. Primary outcome was in-hospital clinically relevant bleeding (CRB) within 14 days of admission, a secondary outcome was major bleeding (MB). We classified patients according to the score in high or low bleeding risk. We assessed the score's predictive performance by calculating subhazard ratios (sHRs) adjusted for thromboprophylaxis use, positive and negative predictive values (PPV, NPV), and the area under the receiver operating characteristic curves (AUC). RESULTS Of 1155 patients, 8 % were classified as high bleeding risk. CRB and MB within 14 days occurred in 0.94 % and 0.47 % of low-risk and in 5.6 % and 3.4 % of high-risk patients, respectively. Adjusted for thromboprophylaxis, classification in the high-risk group was associated with an increased risk of 14-day CRB (sHR 4.7, 95 % confidence interval [CI] 1.5-14.5) and MB (sHR 4.9, 95%CI 1.0-23.4). PPV was 5.6 % and 3.4 %, while NPV was 99.1 % and 99.5 % for CRB and MB, respectively. The AUC was 0.68 (95%CI 0.66-0.71) for CRB and 0.73 (95%CI 0.71-0.76) for MB. CONCLUSION The IMPROVE bleeding risk score showed moderate to good discriminatory power to predict bleeding in medical inpatients. The score may help identify patients at high risk of in-hospital bleeding, in whom careful assessment of the risk-benefit ratio of pharmacological thromboprophylaxis is warranted

Design and establishment of a biobank in a multicenter prospective cohort study of elderly patients with venous thromboembolism (SWITCO65+)

In the field of thrombosis and haemostasis, many preanalytical variables influence the results of coagulation assays and measures to limit potential results variations should be taken. To our knowledge, no paper describing the development and maintenance of a haemostasis biobank has been previously published. Our description of the biobank of the Swiss cohort of elderly patients with venous thromboembolism (SWITCO65+) is intended to facilitate the set-up of other biobanks in the field of thrombosis and haemostasis. SWITCO65+ is a multicentre cohort that prospectively enrolled consecutive patients aged ≥65years with venous thromboembolism at nine Swiss hospitals from 09/2009 to 03/2012. Patients will be followed up until December 2013. The cohort includes a biobank with biological material from each participant taken at baseline and after 12months of follow-up. Whole blood from all participants is assayed with a standard haematology panel, for which fresh samples are required. Two buffy coat vials, one PAXgene Blood RNA System tube and one EDTA-whole blood sample are also collected at baseline for RNA/DNA extraction. Blood samples are processed and vialed within 1h of collection and transported in batches to a central laboratory where they are stored in ultra-low temperature archives. All analyses of the same type are performed in the same laboratory in batches. Using multiple core laboratories increased the speed of sample analyses and reduced storage time. After recruiting, processing and analyzing the blood of more than 1,000 patients, we determined that the adopted methods and technologies were fit-for-purpose and robus

Overuse and underuse of thromboprophylaxis in medical inpatients.

Background Thromboprophylaxis (TPX) prescription is recommended in medical inpatients categorized as high risk of venous thromboembolism (VTE) by validated risk assessment models (RAMs), but how various RAMs differ in categorizing patients in risk groups, and whether the choice of RAM influences estimates of appropriate TPX use is unknown. Objectives To determine the proportion of medical inpatients categorized as high or low risk according to validated RAMs, and to investigate the appropriateness of TPX prescription. Methods This is a prospective cohort study of acutely ill medical inpatients from three Swiss university hospitals. Participants were categorized as high or low risk of VTE by validated RAMs (i.e., the Padua, IMPROVE, simplified, and original Geneva score). We assessed prescription of any TPX at baseline. We considered TPX prescription in high-risk and no TPX prescription in low-risk patients as appropriate. Results Among 1352 medical inpatients, the proportion categorized as high risk ranged from 29.8% with the IMPROVE to 66.1% with the original Geneva score. Overall, 24.6% were consistently categorized as high risk, and 26.3% as low risk by all four RAMs. Depending on the RAM used, TPX prescription was appropriate in 58.7-63.3% of high-risk (i.e., 36.7-41.3% underuse) and 52.4-62.8% of low-risk patients (i.e., 37.2-47.6% overuse). Conclusion The proportion of medical inpatients considered as high or low VTE risk varied widely according to different RAMs. Only half of patients were consistently categorized in the same risk group by all RAMs. While TPX remains underused in high-risk patients, overuse in low-risk patients is even more pronounced

Thrombophilia and outcomes of venous thromboembolism in older patients.

BACKGROUND Limited data exist on thrombophilic risk factors and clinical outcomes in the elderly with venous thromboembolism (VTE). OBJECTIVES To describe the prevalence of laboratory thrombophilic risk factors and their association with VTE recurrence or death in a cohort of elderly people with VTE. METHODS In 240 patients aged ≥65 years with acute VTE without active cancer or an indication for extended anticoagulation, we performed laboratory thrombophilia testing 1 year after the index VTE. Recurrence or death was assessed during the 2-year follow-up. RESULTS A total of 78% of patients had ≥1 laboratory thrombophilic risk factor(s). Elevated levels of von Willebrand factor, homocysteine, coagulant activity of factor VIII (FVIII:C), fibrinogen, FIX:C, and low antithrombin activity were the most prevalent risk factors (43%, 30%, 15%, 14%, 13%, and 11%, respectively). Additionally, 16.2% of patients experienced VTE recurrence and 5.8% of patients died. Patients with a von Willebrand factor of >182%, FVIII:C level >200%, homocysteine level >15μmol/L, or lupus anticoagulant had a significantly higher rate of recurrence than those without these risk factors (15.0 vs. 6.1 [P = .006], 23.5 vs. 8.2 [P = .01], 17.0 vs. 6.8 [P = .006], and 89.5 vs. 9.2 [P = .02] events per 100 patient-years, respectively). Furthermore, patients with a high fibrinogen level or hyperhomocysteinemia with a homocysteine level ≥30 μmol/L had significantly higher mortality than patients with normal levels (18.5 vs. 2.8 [P = .049] and 13.6 vs. 2 [P = .002] deaths per 100 patient-years, respectively). After adjustments for relevant confounders, these associations remained unchanged. CONCLUSION Laboratory thrombophilic risk factors are common in elderly people with VTE and allow for the identification of a population at the risk of worse clinical outcomes

Feasibility and Acceptability of an INtervention TO Increase MOBility in Older Hospitalized Medical Patients (INTOMOB): A Mixed-Methods Pilot Study.

Background: To reduce adverse outcomes of low hospital mobility, we need interventions that are scalable in everyday practice. This study assessed the feasibility and acceptability of the INTOMOB multilevel intervention addressing barriers to hospital mobility without requiring unavailable resources. Methods: The INTOMOB intervention, targeting older patients, healthcare professionals (HCPs) and the hospital environment, was implemented on acute general internal medicine wards of three hospitals (12/2022-03/2023). Feasibility and acceptability of the intervention were assessed and two types of accelerometers compared in a mixed methods study (patient and HCP surveys and interviews). Quantitative data were analyzed descriptively and qualitative data using a deductive approach. Results were integrated through meta-inferences. Results: Of 20 patients (mean age 74.1 years), 90% found the intervention helpful and 82% said the environment intervention (posters) stimulated mobility. The majority of 44 HCPs described the intervention as clear and helpful. There was no major implementation or technical issue. About 60% of patients and HCPs preferred a wrist-worn over an ankle-worn accelerometer. Conclusions: The INTOMOB intervention is feasible and well accepted. Patients' and HCPs' feedback allowed to further improve the intervention that will be tested in a cluster randomized trial and provides useful information for future mobility-fostering interventions