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Item 356: Phase-II Study of Infliximab for the Prophylaxis of Acute Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (AHSCT)(American Society for Blood and Marrow Transplantation, 2008-02-01) Hamadani, M.; Phillips, G.; Elder, P.; Jansak, B.; Blum, W.; Penza, S.; Lin, T.S.; Farag, S.S.; Devine, S.M.; Medicine, School of MedicineItem A pragmatic, stepped-wedge, hybrid type II trial of interoperable clinical decision support to improve venous thromboembolism prophylaxis for patients with traumatic brain injury(Springer Nature, 2024-08-05) Tignanelli, Christopher J.; Shah, Surbhi; Vock, David; Siegel, Lianne; Serrano, Carlos; Haut, Elliott; Switzer, Sean; Martin, Christie L.; Rizvi, Rubina; Peta, Vincent; Jenkins, Peter C.; Lemke, Nicholas; Thyvalikakath, Thankam; Osheroff, Jerome A.; Torres, Denise; Vawdrey, David; Callcut, Rachael A.; Butler, Mary; Melton, Genevieve B.; Surgery, School of MedicineBackground: Venous thromboembolism (VTE) is a preventable medical condition which has substantial impact on patient morbidity, mortality, and disability. Unfortunately, adherence to the published best practices for VTE prevention, based on patient centered outcomes research (PCOR), is highly variable across U.S. hospitals, which represents a gap between current evidence and clinical practice leading to adverse patient outcomes. This gap is especially large in the case of traumatic brain injury (TBI), where reluctance to initiate VTE prevention due to concerns for potentially increasing the rates of intracranial bleeding drives poor rates of VTE prophylaxis. This is despite research which has shown early initiation of VTE prophylaxis to be safe in TBI without increased risk of delayed neurosurgical intervention or death. Clinical decision support (CDS) is an indispensable solution to close this practice gap; however, design and implementation barriers hinder CDS adoption and successful scaling across health systems. Clinical practice guidelines (CPGs) informed by PCOR evidence can be deployed using CDS systems to improve the evidence to practice gap. In the Scaling AcceptabLE cDs (SCALED) study, we will implement a VTE prevention CPG within an interoperable CDS system and evaluate both CPG effectiveness (improved clinical outcomes) and CDS implementation. Methods: The SCALED trial is a hybrid type 2 randomized stepped wedge effectiveness-implementation trial to scale the CDS across 4 heterogeneous healthcare systems. Trial outcomes will be assessed using the RE2-AIM planning and evaluation framework. Efforts will be made to ensure implementation consistency. Nonetheless, it is expected that CDS adoption will vary across each site. To assess these differences, we will evaluate implementation processes across trial sites using the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation framework (a determinant framework) using mixed-methods. Finally, it is critical that PCOR CPGs are maintained as evidence evolves. To date, an accepted process for evidence maintenance does not exist. We will pilot a "Living Guideline" process model for the VTE prevention CDS system. Discussion: The stepped wedge hybrid type 2 trial will provide evidence regarding the effectiveness of CDS based on the Berne-Norwood criteria for VTE prevention in patients with TBI. Additionally, it will provide evidence regarding a successful strategy to scale interoperable CDS systems across U.S. healthcare systems, advancing both the fields of implementation science and health informatics.Item Evaluation of an Extended-duration Chemoprophylaxis Regimen for Venous Thromboembolism after Microsurgical Breast Reconstruction(Wolters Kluwer, 2021-08) Pittelkow, Eric M.; DeBrock, Will C.; Mailey, Brian; Ballinger, Tarah J.; Socas, Juan; Lester, Mary E.; Hassanein, Aladdin H.; Medicine, School of MedicinePatients undergoing free flap breast reconstruction are at a high risk for venous thromboembolism based upon Caprini scores. Guidelines for venous thromboembolism prophylaxis recommend high-risk groups receive extended chemoprophylaxis for several weeks after gynecological, orthopedic, and surgical oncology cases. Extended prophylaxis has not been studied in free flap breast reconstruction. The purpose of this study was to compare outcomes of free flap breast reconstruction patients who received extended venous thromboembolism (VTE) prophylaxis with those who received standard inpatient-only prophylaxis. Methods: Patients undergoing microsurgical breast reconstruction were divided into two groups: standard VTE prophylaxis (Group I) and extended prophylaxis (Group II). Both groups received prophylactic subcutaneous heparin or enoxaparin preoperatively and enoxaparin 40 mg daily postoperatively while inpatient. Group II was discharged with a home regimen of enoxaparin 40 mg daily for an additional 14 days. Results: In total, 103 patients met inclusion criteria (36 patients in Group I, 67 patients in Group II). The incidence of VTE was 1.5% in Group II compared with 2.8% in Group I (P = 0.6). There was no difference in reoperative hematoma between Group I (n = 0) and Group II (n = 1) (P = 0.7). Total flap loss was 2.2%. Conclusions: Although this retrospective pilot study did not show statistical significance in VTE between those receiving extended home chemoprophylaxis (1.5% incidence) compared with inpatient-only chemoprophylaxis (2.8%), the risk of bleeding complications was similar. These results indicate that a larger, higher powered study is justified to assess if an extended home chemoprophylaxis protocol should be standard of care post free flap breast reconstruction.Item Hepatitis B Virus Reactivation in Cancer Patients Receiving Direct-Acting Antivirals for Hepatitis C Virus Infection(Wiley, 2021) Pritchard, Haley; Hwang, Jessica P.; Angelidakis, Georgios; Yibirin, Marcel; Wang, Lan; Miller, Ethan; Torres, Harrys A.; Medicine, School of MedicineDirect-acting antivirals (DAAs) against hepatitis C virus (HCV) infection can cause hepatitis B virus (HBV) reactivation in HBV/HCV co-infected patients. Cancer patients undergoing immunosuppressant treatment or chemotherapy are at risk for HBV reactivation. To our knowledge, no prospective studies have examined the risk of HBV reactivation during DAA treatment for HCV infection in cancer patients with HBV/HCV co-infection. Here, we report the results of one such study. In a prospective observational study, we enrolled HCV-infected cancer patients undergoing DAA treatment at The University of Texas MD Anderson Cancer Center between January 2015 and March 2018. Data regarding demographics, cancer history, and prior HCV treatment history were collected. Patients were assessed for HBV status before DAA treatment and for HBV-related outcomes, including HBV reactivation, hepatitis flare, and HBV-associated hepatitis, during DAA treatment. Demographic and treatment variables were analyzed using descriptive statistics. One hundred sixty-six patients were analyzed. Forty-eight patients received systemic chemotherapy within 6 months before to 6 months after treatment with DAAs. Ledipasvir plus sofosbuvir was the most common DAA regimen, administered to 88 patients (53%). Fifty-one patients (31%) had past HBV infection, and 4 (2.4%) had chronic HBV infection. No patient experienced HBV reactivation, hepatitis flare, or HBV-associated hepatitis induced by DAA treatment. In HCV-infected cancer patients, DAA treatment is safe regardless of whether patients have past or chronic HBV infection. However, HBV screening is still recommended before the initiation of and during DAA treatment, as is anti-HBV prophylactic treatment in selected cases.