Risk stratification for hospital-acquired venous thromboembolism in medical patients (RISE): Protocol for a prospective cohort study

Abstract

Background Hospital-acquired venous thromboembolism (VTE) is one of the leading preventable causes of in-hospital mortality. However, its risk assessment in medically ill inpatients is complicated due to the patients’ heterogeneity and complexity of currently available risk assessment models (RAMs). The simplified Geneva score provides simplicity but has not yet been prospectively validated. Immobility is an important predictor for VTE in RAMs, but its definition is inconsistent and based on subjective assessment by nurses or physicians. In this study, we aim to prospectively validate the simplified Geneva score and to examine the predictive performance of a novel and objective definition of in-hospital immobilization using accelerometry. Methods and analysis RISE is a multicenter prospective cohort study. The goal is to recruit 1350 adult inpatients admitted for medical illness in three Swiss tertiary care hospitals. We collect data on demographics, comorbidities, VTE risk and thromboprophylaxis. Mobility from admission to discharge is objectively measured using a wrist-worn accelerometer. Participants are followed for 90 days for the occurrence of symptomatic VTE (primary outcome). Secondary outcomes are the occurrence of clinically relevant bleeding, and mortality. The evolution of autonomy in the activities of daily living, the length of stay, and the occurrence of readmission are also recorded. Time-dependent area under the curve, sensitivity, specificity, and positive and negative predictive values are calculated for each RAM (i.e. the simplified and original Geneva score, Padua, and IMPROVE score) with and without the objective mobility measures to assess their accuracy in predicting hospital-acquired VTE at 90 days. Ethics and expected impact The ethics committee approved the protocol and the study was registered on ClinicalTrials.gov as NCT04439383. RISE has the potential to optimize VTE risk stratification, and thus to improve the quality of care of medically hospitalized patients.

Risk Assessment Models for Venous Thromboembolism in Medical Inpatients

“…Even though guidelines, including those from the American College of Chest Physicians or the National Institute for Health and Care Excellence, encourage the use of RAMs to identify medical inpatients at high VTE risk, our results emphasize the need for more accurate risk prediction strategies, as already advocated by others . For example, it is unclear whether the use of objective mobility measures or artificial intelligence–based models could improve VTE risk prediction . In addition, the clinical benefit associated with applying RAMs is unclear .…”

“… 8 For example, it is unclear whether the use of objective mobility measures or artificial intelligence–based models could improve VTE risk prediction. 19 , 31 In addition, the clinical benefit associated with applying RAMs is unclear. 8 , 25 Except for a single randomized trial that showed a reduction in VTE rates with a computer-alert program incorporating the Kucher RAM, 32 no prospective comparative study has, to our knowledge, demonstrated improved clinical or economic outcomes with the application of RAMs in clinical practice.…”

“…RISE (Risk Stratification for Hospital-Acquired Thromboembolism in Medical Patients) is a multicenter prospective cohort study of medical patients admitted to 3 Swiss tertiary care hospitals from June 18, 2020, to January 4, 2022 (ClinicalTrial.gov NCT04439383). The methods have been previously described . Reporting conforms to the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) reporting guideline and checklist for prediction model validation .…”

“…The methods have been previously described. 19 Reporting conforms to the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis ( TRIPOD ) reporting guideline and checklist for prediction model validation. 20 The study was conducted in accordance with all applicable legal and regulatory requirements.…”

In-Hospital versus Out-of-Hospital Pulmonary Embolism: Clinical Characteristics, Biochemical Markers and Echocardiographic Indices

“…Other researchers support that the probability (the "risk") of PE can be objectified successfully in both out-of-hospital and in-hospital patients [23]. Most of these studies are retrospective in nature and/or non-consecutive patients were included [20][21][22], while a large prospective cohort study will improve our knowledge about the risk stratification and the diagnostic dilemmas in hospitalised patients with PE [24].…”