Timeline representation of clinical data: usability and added value for pharmacovigilance.

BACKGROUND: Pharmacovigilance consists in monitoring and preventing the occurrence of adverse drug reactions (ADR). This activity requires the collection and analysis of data from the patient record or any other sources to find clues of a causality link between the drug and the ADR. This can be time-consuming because often patient data are heterogeneous and scattered in several files. To facilitate this task, we developed a timeline prototype to gather and classify patient data according to their chronology. Here, we evaluated its usability and quantified its contribution to routine pharmacovigilance using real ADR cases. METHODS: The timeline prototype was assessed using the biomedical data warehouse eHOP (from entrepôt de données biomédicales de l'HOPital) of the Rennes University Hospital Centre. First, the prototype usability was tested by six experts of the Regional Pharmacovigilance Centre of Rennes. Their experience was assessed with the MORAE software and a System and Usability Scale (SUS) questionnaire. Then, to quantify the timeline contribution to pharmacovigilance routine practice, three of them were asked to investigate possible ADR cases with the "Usual method" (analysis of electronic health record data with the DxCare software) or the "Timeline method". The time to complete the task and the data quality in their reports (using the vigiGrade Completeness score) were recorded and compared between methods. RESULTS: All participants completed their tasks. The usability could be considered almost excellent with an average SUS score of 82.5/100. The time to complete the assessment was comparable between methods (P = 0.38) as well as the average vigiGrade Completeness of the data collected with the two methods (P = 0.49). CONCLUSIONS: The results showed a good general level of usability for the timeline prototype. Conversely, no difference in terms of the time spent on each ADR case and data quality was found compared with the usual method. However, this absence of difference between the timeline and the usual tools that have been in use for several years suggests a potential use in pharmacovigilance especially because the testers asked to continue using the timeline after the evaluation.

Personalized and automated remote monitoring of atrial fibrillation.

AIMS: Remote monitoring of cardiac implantable electronic devices is a growing standard; yet, remote follow-up and management of alerts represents a time-consuming task for physicians or trained staff. This study evaluates an automatic mechanism based on artificial intelligence tools to filter atrial fibrillation (AF) alerts based on their medical significance. METHODS AND RESULTS: We evaluated this method on alerts for AF episodes that occurred in 60 pacemaker recipients. AKENATON prototype workflow includes two steps: natural language-processing algorithms abstract the patient health record to a digital version, then a knowledge-based algorithm based on an applied formal ontology allows to calculate the CHA2DS2-VASc score and evaluate the anticoagulation status of the patient. Each alert is then automatically classified by importance from low to critical, by mimicking medical reasoning. Final classification was compared with human expert analysis by two physicians. A total of 1783 alerts about AF episode >5 min in 60 patients were processed. A 1749 of 1783 alerts (98%) were adequately classified and there were no underestimation of alert importance in the remaining 34 misclassified alerts. CONCLUSION: This work demonstrates the ability of a pilot system to classify alerts and improves personalized remote monitoring of patients. In particular, our method allows integration of patient medical history with device alert notifications, which is useful both from medical and resource-management perspectives. The system was able to automatically classify the importance of 1783 AF alerts in 60 patients, which resulted in an 84% reduction in notification workload, while preserving patient safety.

Comparing Drools and ontology reasoning approaches for telecardiology decision support.

Implantable cardioverter defibrillators can generate numerous alerts. Automatically classifying these alerts according to their severity hinges on the CHA2DS2VASc score. It requires some reasoning capabilities for interpreting the patient's data. We compared two approaches for implementing the reasoning module. One is based on the Drools engine, and the other is based on semantic web formalisms. Both were valid approaches with correct performances. For a broader domain, their limitations are the number and complexity of Drools rules and the performances of ontology-based reasoning, which suggests using the ontology for automatically generating a part of the Drools rules.

Leveraging National Claims and Hospital Big Data: Cohort Study on a Statin-Drug Interaction Use Case.

BACKGROUND: Linking different sources of medical data is a promising approach to analyze care trajectories. The aim of the INSHARE (Integrating and Sharing Health Big Data for Research) project was to provide the blueprint for a technological platform that facilitates integration, sharing, and reuse of data from 2 sources: the clinical data warehouse (CDW) of the Rennes academic hospital, called eHOP (entrepôt Hôpital), and a data set extracted from the French national claim data warehouse (Système National des Données de Santé [SNDS]). OBJECTIVE: This study aims to demonstrate how the INSHARE platform can support big data analytic tasks in the health field using a pharmacovigilance use case based on statin consumption and statin-drug interactions. METHODS: A Spark distributed cluster-computing framework was used for the record linkage procedure and all analyses. A semideterministic record linkage method based on the common variables between the chosen data sources was developed to identify all patients discharged after at least one hospital stay at the Rennes academic hospital between 2015 and 2017. The use-case study focused on a cohort of patients treated with statins prescribed by their general practitioner or during their hospital stay. RESULTS: The whole process (record linkage procedure and use-case analyses) required 88 minutes. Of the 161,532 and 164,316 patients from the SNDS and eHOP CDW data sets, respectively, 159,495 patients were successfully linked (98.74% and 97.07% of patients from SNDS and eHOP CDW, respectively). Of the 16,806 patients with at least one statin delivery, 8293 patients started the consumption before and continued during the hospital stay, 6382 patients stopped statin consumption at hospital admission, and 2131 patients initiated statins in hospital. Statin-drug interactions occurred more frequently during hospitalization than in the community (3800/10,424, 36.45% and 3253/14,675, 22.17%, respectively; P<.001). Only 121 patients had the most severe level of statin-drug interaction. Hospital stay burden (length of stay and in-hospital mortality) was more severe in patients with statin-drug interactions during hospitalization. CONCLUSIONS: This study demonstrates the added value of combining and reusing clinical and claim data to provide large-scale measures of drug-drug interaction prevalence and care pathways outside hospitals. It builds a path to move the current health care system toward a Learning Health System using knowledge generated from research on real-world health data.

Cancer risk in dialyzed patients with and without diabetes.

BACKGROUND: The risk of cancer is higher in patients with renal diseases and diabetes compared with the general population. The aim of this study was to assess in dialyzed patients, the association between diabetes and the risk to develop a cancer after dialysis start. METHODS: All patients who started dialysis in the French region of Poitou-Charentes between 2008 and 2015 were included. Their baseline characteristics were extracted from the French Renal Epidemiology and Information Network and were linked to data relative to cancer occurrence from the Poitou-Charentes General Cancer Registry using a procedure developed by the INSHARE platform. The association between diabetes and the risk of cancer was assessed using the Fine & Gray model that takes into account the competing risk of death. RESULTS: Among the 1634 patients included, 591 (36.2 %) had diabetes and 91 (5.6 %) patients developed a cancer (n = 24 before or at dialysis start, and n = 67 after dialysis start). The risk to develop a cancer after dialysis initiation was lower in dialyzed patients with diabetes than without diabetes (SHR = 0.54; 95 %CI: 0.32-0.91). Moreover, compared with the general population, the cancer risk was higher in dialyzed patients without diabetes, but not in those with diabetes. CONCLUSION: The risk of developing a cancer in the region of Poitou-Charentes is higher in dialyzed patients without diabetes than with diabetes.

eHOP Clinical Data Warehouse: From a Prototype to the Creation of an Inter-Regional Clinical Data Centers Network.

Creation of networks such as clinical data centers within the hospital enables efficient exploitation of clinical data from a local to an inter-regional scope. This work present the structuration of the French Western Clinical Data Center Network (FWCDCN) conducted between 2016 and 2018. As of November 2018, FWCDCD is compounded with 7 institutions. CDW of the combinded Clinical Data Centers (CDC) contains the data of over 4 million patients followed since 2000.

Remote Monitoring of Cardiac Implantable Devices: Ontology Driven Classification of the Alerts.

The number of patients that benefit from remote monitoring of cardiac implantable electronic devices, such as pacemakers and defibrillators, is growing rapidly. Consequently, the huge number of alerts that are generated and transmitted to the physicians represents a challenge to handle. We have developed a system based on a formal ontology that integrates the alert information and the patient data extracted from the electronic health record in order to better classify the importance of alerts. A pilot study was conducted on atrial fibrillation alerts. We show some examples of alert processing. The results suggest that this approach has the potential to significantly reduce the alert burden in telecardiology. The methods may be extended to other types of connected devices.

Automatic computation of CHA2DS2-VASc score: information extraction from clinical texts for thromboembolism risk assessment.

The CHA2DS2-VASc score is a 10-point scale which allows cardiologists to easily identify potential stroke risk for patients with non-valvular fibrillation. In this article, we present a system based on natural language processing (lexicon and linguistic modules), including negation and speculation handling, which extracts medical concepts from French clinical records and uses them as criteria to compute the CHA2DS2-VASc score. We evaluate this system by comparing its computed criteria with those obtained by human reading of the same clinical texts, and by assessing the impact of the observed differences on the resulting CHA2DS2-VASc scores. Given 21 patient records, 168 instances of criteria were computed, with an accuracy of 97.6%, and the accuracy of the 21 CHA2DS2-VASc scores was 85.7%. All differences in scores trigger the same alert, which means that system performance on this test set yields similar results to human reading of the texts.