scholarly journals A Web-Based Clinical System for Cohort Surveillance of Specific Clinical Effectiveness and Safety Outcomes: A Cohort Study of Non–Vitamin K Antagonist Oral Anticoagulants and Warfarin

10.2196/13329 ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. e13329 ◽  
Author(s):  
Fong-Ci Lin ◽  
Shih-Tsung Huang ◽  
Rung Ji Shang ◽  
Chi-Chuan Wang ◽  
Fei-Yuan Hsiao ◽  
...  

Background Conventional systems of drug surveillance lack a seamless workflow, which makes it crucial to have an active drug surveillance system that proactively assesses adverse drug events. Objective The aim of this study was to develop a seamless, Web-based workflow for comparing the safety and effectiveness of drugs in a database of electronic medical records. Methods We proposed a comprehensive integration process for cohort surveillance using the National Taiwan University Hospital Clinical Surveillance System (NCSS). We studied a practical application of the NCSS that evaluates the drug safety and effectiveness of novel oral anticoagulants (NOACs) and warfarin by cohort tree analysis in an efficient and interoperable platform. Results We demonstrated a practical example of investigating the differences in effectiveness and safety between NOACs and warfarin in patients with nonvalvular atrial fibrillation (AF) using the NCSS. We efficiently identified 2357 patients with nonvalvular AF with newly prescribed oral anticoagulants between 2010 and 2015 and further developed 1 main cohort and 2 subcohorts for separately measuring ischemic stroke as the clinical effectiveness outcome and intracranial hemorrhage (ICH) as the safety outcome. In the subcohort of ischemic stroke, NOAC users exhibited a significantly lower risk of ischemic stroke than warfarin users after adjusting for age, sex, comorbidity, and comedication in an intention-to-treat (ITT) analysis (P=.01) but did not exhibit a significantly distinct risk in an as-treated (AT) analysis (P=.12) after the 2-year follow-up. In the subcohort of ICH, NOAC users did not exhibit a different risk of ICH both in ITT (P=.68) and AT analyses (P=.15). Conclusions With a seamless and Web-based workflow, the NCSS can serve the critical role of forming associations between evidence and the real world at a medical center in Taiwan.

2019 ◽  
Author(s):  
Fong-Ci Lin ◽  
Shih-Tsung Huang ◽  
Rung-Ji Shang ◽  
Chi-Chuan Wang ◽  
Fei-Yuan Hsiao ◽  
...  

BACKGROUND Active drug surveillance is the proactive process of assessing the adverse drug events (ADEs), but conventional systems lack a seamless workflow. OBJECTIVE This study aims to develop a seamless and online workflow for comparing the safety and effectiveness of drugs in a database of electronic medical records. METHODS We proposed a comprehensive integration process for clinical surveillance using the National Taiwan University Hospital Clinical Surveillance System (NCSS). We studied a practical application of the NCSS that evaluates the drug safety and effectiveness of novel oral-anticoagulants (NOACs) and warfarin by Cohort Tree Analysis in an efficient and interoperable platform. RESULTS We demonstrated a practical example of investigating the differences in effectiveness and safety between NOACs and warfarin in patients with non-valvular atrial fibrillation (AF) using the NCSS. We efficiently identified 2,357 non-valvular AF patients with newly prescribed oral anticoagulants between 2010 and 2015 and further developed one main cohort and two sub-cohorts for separately measuring ischemic stroke as the clinical effectiveness outcome and intracranial hemorrhage as the safety outcome. In the sub-cohort of ischemic stroke, NOACs users exhibited a significantly lower risk of ischemic stroke compared with warfarin users after adjusting for age, sex, comorbidity and co-medication in an intention-to-treat (ITT) analysis (P = 0.01) but exhibited a comparable risk in an as-treated (AT) analysis (P = 0.12) after the 2-year follow-up. In the sub-cohort of intracranial hemorrhage (ICH), NOACs users exhibited a comparable risk of ICH both in ITT (P = 0.68) and AT analyses (P = 0.15). CONCLUSIONS With a seamless and online workflow, the NCSS can serve the critical role of forming associations between evidence and the real world at a medical center in Taiwan.


2019 ◽  
Vol 76 (10) ◽  
pp. 1192 ◽  
Author(s):  
Ying Xian ◽  
Haolin Xu ◽  
Emily C. O’Brien ◽  
Shreyansh Shah ◽  
Laine Thomas ◽  
...  

2018 ◽  
Vol 33 (2) ◽  
pp. 136-141 ◽  
Author(s):  
Yoonsun Mo ◽  
Ayse Karakas-Torgut ◽  
Antony Q. Pham

Objective: The aim of this study is to assess patterns of potential drug–drug interactions (DDIs) with direct oral anticoagulants (DOACs) in an inpatient hospital setting. Methods: A retrospective chart review was conducted at the Brookdale University Hospital and Medical Center (BUHMC) from January 2014 to November 2016. All adult patients admitted to the BUHMC who were treated with a DOAC for at least 3 days were screened. Among them, those who received selected interacting drugs at any time during the course of DOAC therapy were included in this study. Results: This study included 165 patients with an average of 73 years (standard deviation [SD] = 12.3) and 233 cases. The most commonly used concomitant drug with a DOAC was aspirin (58%), followed by amiodarone (16%) and P2Y12 inhibitors (11%). The combined use of dual antiplatelet therapy and a DOAC was identified in 18 (6%) cases. Approximately one-third of the cases encountered were classified as the “avoidance” category. Conclusions: Despite computerized DDI alerts, potentially significant DDIs with DOACs still occur. While the present study provides insight into the current patterns of DDIs, further studies are needed to evaluate clinical outcomes of the potential DDIs with DOACs in practice.


2012 ◽  
Vol 153 (19) ◽  
pp. 732-736
Author(s):  
Gergely Hofgárt ◽  
Csilla Vér ◽  
László Csiba

Atrial fibrillation is a risk factor for ischemic stroke. To prevent stroke oral anticoagulants can be administered. Old and new types of anticoagulants are available. Nowadays, old type, acenocumarol based anticoagulants are used preferentially in Hungary. Aim: The advantages and the disadvantages of anticoagulants are well known, but anticoagulants are underused in many cases. Method: The authors retrospectively examined how frequent atrial fibrillation was and whether the usage of anticoagulants in practice was in accordance with current guidelines among acute stroke cases admitted to the Department of Neurology, Medical and Health Science Centre of Debrecen University in 2009. Results: Of the 461 acute stroke cases, 96 patients had known and 22 patients had newly discovered atrial fibrillation. Half of the patients did not receive proper anticoagulation. Only 8.4% of them had their INR levels within the therapeutic range. Conclusions: The findings are similar to those reported in other studies. Many factors may contribute to the high proportion of improper use of anticoagulants, and further investigations are needed to determine these factors. In any case, elimination of these factors leading to a failure of anticoagulation may decrease the incidence of stroke. Orv. Hetil., 2012, 153, 732–736.


BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zheng Wang ◽  
Jiangyong Miao ◽  
Lina Wang ◽  
Ying Liu ◽  
Hui Ji ◽  
...  

Abstract Background Presentation with massive systemic embolization as the initial manifestation of occult malignancy is infrequent. The standard management of cancer-related arterial thromboembolism has not yet been established. Case presentation We described a case of Trousseau’s syndrome resulting in acute ischemic stroke concomitant with multiple embolizations in the spleen and kidney during oral administration of dabigatran for pulmonary embolism preceding the diagnosis of a malignant tumor. A cancer-related hypercoagulable state was suspected because the patient was admitted to the neurology department due to acute ischemic stroke with three territory infarcts on diffusion-weighted imaging (DWI) in the absence of identifiable conventional risk factors and brain vessel narrowing. The patient was subsequently diagnosed with epidermal growth factor receptor (EGFR) mutation–positive non-small-cell lung cancer (NSCLC) (stage IV) with pleural metastasis. Administration of low-molecular-weight heparin followed by long-term dabigatran under effective cancer therapy comprising gefitinib and subsequent chemotherapy did not cause stroke relapse during the 1-year follow-up. Conclusions This case suggests that cancer-related hypercoagulability should be considered an important etiology for stroke patients who develop unexplained disseminated acute cerebral infarction without conventional stroke risk factors, especially concomitant with multiple organ embolization. Novel oral anticoagulants may be an alternative therapy for the long-term management of cancer-related arterial thromboembolism under effective cancer therapy.


Author(s):  
Mohammed H. Shash ◽  
Reda Abdelrazek ◽  
Nashwa M. Abdelgeleel ◽  
Rasha M. Ahmed ◽  
Adel H. El-baih

Abstract Background Biological markers of acute nerve cell damage can assist in the outcome of acute ischemic stroke, such as neuron-specific enolase (NSE) that have been tested for association with initial severity of stroke, extent of infarction, and functional outcome. Objective To determine short-term prognostic value of the biochemical marker neuron-specific enolase (NSE) in acute ischemic stroke. Methods A cohort study carried out on 37 patients with acute ischemic stroke. Data were gathered in a prepared data sheet. Initial serum NSE level was measured to the patients in the Emergency department within 6 h of the onset of stroke and another measurement after 48 h. National Institute of Health Stroke Scale (NIHSS) was held to the patients at presentation and after 28 days of stroke to determine short-term morbidity and mortality. Results Out of the 37 patients, 31 patients survived (no-death group) and 6 patients died (death group). The mean serum level of neuron-specific enolase at presentation and after 48 h was significantly higher in the death group than in the no-death group. There was a statistically significant positive correlation between neuron-specific enolase (NSE) serum level and clinical severity of stroke (NIHSS) among the patients at presentation (r = 0.737, p = 0.000). Conclusion Neuron-specific enolase (NSE) can be applied as single independent marker for prediction of mortality and short-term morbidity in ischemic stroke patients.


Author(s):  
Seon-Ju Kam ◽  
Young-Sun Yoo

Patients’ emotional responses to the hospital environment can be considered as important as medical technology and equipment. Therefore, this study investigated their experiences to determine whether the pattern using hospital identity (HI) elements, a widely used design method for patient clothing in university hospitals, can affect their emotional response and contribute to healing. It aimed to identify whether controlling the motif characteristics, arrangement, and spacing in this pattern design, and the direction between motifs, could be a method to design patient clothing for healing. To investigate patients’ emotional response and suggestions for patient clothing design, an interview-based qualitative approach was used. In-depth interviews were conducted with 12 patients discharged from Kyung Hee University Hospital Medical Center (KHUMC), Seoul. The interview questions consisted of two parts. One part featured questions about participants’ emotional responses to the medical environment and their latest patient clothing experience, and the other featured questions about their emotional response to, and suggestions for, the healing expression of pattern design using HI. The results confirmed that the motif characteristics, arrangement, and spacing, and the direction between motifs, influenced patients’ positive emotions and contributed to the healing effect. Therefore, when the HI elements of a medical institution are applied in the design of patient clothing with the characteristics of a healing design, patients perceive this as providing stability and comfort. The design of patient clothing becomes a medium that not only builds the brand image of medical institutions, but also enhances the quality of medical services centered on patient healing.


Sign in / Sign up

Export Citation Format

Share Document