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Abstract Background Total hip, knee and shoulder arthroplasties (THKSA) are increasing due to expanding demands in ageing population. Material surveillance is important to prevent severe complications involving implantable medical devices (IMD) by taking appropriate preventive measures. Automating the analysis of patient and IMD features could benefit physicians and public health policies, allowing early issue detection and decision support. The study aimed to demonstrate the feasibility of automated cohorting of patients with a first arthroplasty in two hospital data warehouses (HDW) in France. Methods The study included adult patients with an arthroplasty between 2010 and 2019 identified by 2 data sources: hospital discharge and pharmacy. Selection was based on the health insurance thesaurus of IMDs in the pharmacy database: 1,523 distinct IMD references for primary THSKA. In the hospital discharge database, 22 distinct procedures for native joint replacement allowing a matching between IMD and surgical procedure of each patient selected. A program to automate information extraction was implemented in the 1st hospital data warehouse using natural language processing (NLP) on pharmacy labels, then it was then applied to the 2nd hospital. Results The e-cohort was built with a first arthroplasty for THKSA performed in 7,587 patients with a mean age of 67.4 years, and a sex ratio of 0.75. The cohort involved 4,113 hip, 2,630 knee and 844 shoulder surgical patients. Obesity, cardio-vascular diseases and hypertension were the most frequent medical conditions. Discussion The implementation of an e-cohort for material surveillance will be easily workable over HDWs France wild. Using NLP as no international IMD mapping exists to study IMD, our approach aims to close the gap between conventional epidemiological cohorting tools and bigdata approach. Conclusion This pilot study demonstrated the feasibility of an e-cohort of orthopaedic devices using clinical data warehouses. The IMD and patient features could be studied with intra-hospital follow-up and will help analysing the infectious and unsealing complications.

BackgroundTo reduce the mortality related to bladder cancer, efforts need to be concentrated on early detection of the disease for more effective therapeutic intervention. Strong risk factors (eg, smoking status, age, professional exposure) have been identified, and some diagnostic tools (eg, by way of cystoscopy) have been proposed. However, to date, no fully satisfactory (noninvasive, inexpensive, high-performance) solution for widespread deployment has been proposed. Some new models based on cytology image classification were recently developed and bring good perspectives, but there are still avenues to explore to improve their performance. ObjectiveOur team aimed to evaluate the benefit of combining the reuse of massive clinical data to build a risk factor model and a digital cytology image–based model (VisioCyt) for bladder cancer detection. MethodsThe first step relied on designing a predictive model based on clinical data (ie, risk factors identified in the literature) extracted from the clinical data warehouse of the Rennes Hospital and machine learning algorithms (logistic regression, random forest, and support vector machine). It provides a score corresponding to the risk of developing bladder cancer based on the patient’s clinical profile. Second, we investigated 3 strategies (logistic regression, decision tree, and a custom strategy based on score interpretation) to combine the model’s score with the score from an image-based model to produce a robust bladder cancer scoring system. ResultsWe collected 2 data sets. The first set, including clinical data for 5422 patients extracted from the clinical data warehouse, was used to design the risk factor–based model. The second set was used to measure the models’ performances and was composed of data for 620 patients from a clinical trial for which cytology images and clinicobiological features were collected. With this second data set, the combination of both models obtained areas under the curve of 0.82 on the training set and 0.83 on the test set, demonstrating the value of combining risk factor–based and image-based models. This combination offers a higher associated risk of cancer than VisioCyt alone for all classes, especially for low-grade bladder cancer. ConclusionsThese results demonstrate the value of combining clinical and biological information, especially to improve detection of low-grade bladder cancer. Some improvements will need to be made to the automatic extraction of clinical features to make the risk factor–based model more robust. However, as of now, the results support the assumption that this type of approach will be of benefit to patients.

Abstract Background Electronic health records (EHRs) contain valuable information for clinical research; however, the sensitive nature of healthcare data presents security and confidentiality challenges. De-identification is therefore essential to protect personal data in EHRs and comply with government regulations. Named entity recognition (NER) methods have been proposed to remove personal identifiers, with deep learning-based models achieving better performance. However, manual annotation of training data is time-consuming and expensive. The aim of this study was to develop an automatic de-identification pipeline for all kinds of clinical documents based on a distant supervised method to significantly reduce the cost of manual annotations and to facilitate the transfer of the de-identification pipeline to other clinical centers. Methods We proposed an automated annotation process for French clinical de-identification, exploiting data from the eHOP clinical data warehouse (CDW) of the CHU de Rennes and national knowledge bases, as well as other features. In addition, this paper proposes an assisted data annotation solution using the Prodigy annotation tool. This approach aims to reduce the cost required to create a reference corpus for the evaluation of state-of-the-art NER models. Finally, we evaluated and compared the effectiveness of different NER methods. Results A French de-identification dataset was developed in this work, based on EHRs provided by the eHOP CDW at Rennes University Hospital, France. The dataset was rich in terms of personal information, and the distribution of entities was quite similar in the training and test datasets. We evaluated a Bi-LSTM + CRF sequence labeling architecture, combined with Flair + FastText word embeddings, on a test set of manually annotated clinical reports. The model outperformed the other tested models with a significant F1 score of 96,96%, demonstrating the effectiveness of our automatic approach for deidentifying sensitive information. Conclusions This study provides an automatic de-identification pipeline for clinical notes, which can facilitate the reuse of EHRs for secondary purposes such as clinical research. Our study highlights the importance of using advanced NLP techniques for effective de-identification, as well as the need for innovative solutions such as distant supervision to overcome the challenge of limited annotated data in the medical domain.

BackgroundDisease surveillance systems capable of producing accurate real-time and short-term forecasts can help public health officials design timely public health interventions to mitigate the effects of disease outbreaks in affected populations. In France, existing clinic-based disease surveillance systems produce gastroenteritis activity information that lags real time by 1 to 3 weeks. This temporal data gap prevents public health officials from having a timely epidemiological characterization of this disease at any point in time and thus leads to the design of interventions that do not take into consideration the most recent changes in dynamics. ObjectiveThe goal of this study was to evaluate the feasibility of using internet search query trends and electronic health records to predict acute gastroenteritis (AG) incidence rates in near real time, at the national and regional scales, and for long-term forecasts (up to 10 weeks). MethodsWe present 2 different approaches (linear and nonlinear) that produce real-time estimates, short-term forecasts, and long-term forecasts of AG activity at 2 different spatial scales in France (national and regional). Both approaches leverage disparate data sources that include disease-related internet search activity, electronic health record data, and historical disease activity. ResultsOur results suggest that all data sources contribute to improving gastroenteritis surveillance for long-term forecasts with the prominent predictive power of historical data owing to the strong seasonal dynamics of this disease. ConclusionsThe methods we developed could help reduce the impact of the AG peak by making it possible to anticipate increased activity by up to 10 weeks.

BackgroundTraditionally, dengue prevention and control rely on vector control programs and reporting of symptomatic cases to a central health agency. However, case reporting is often delayed, and the true burden of dengue disease is often underestimated. Moreover, some countries do not have routine control measures for vector control. Therefore, researchers are constantly assessing novel data sources to improve traditional surveillance systems. These studies are mostly carried out in big territories and rarely in smaller endemic regions, such as Martinique and the Lesser Antilles. ObjectiveThe aim of this study was to determine whether heterogeneous real-world data sources could help reduce reporting delays and improve dengue monitoring in Martinique island, a small endemic region. MethodsHeterogenous data sources (hospitalization data, entomological data, and Google Trends) and dengue surveillance reports for the last 14 years (January 2007 to February 2021) were analyzed to identify associations with dengue outbreaks and their time lags. ResultsThe dengue hospitalization rate was the variable most strongly correlated with the increase in dengue positivity rate by real-time reverse transcription polymerase chain reaction (Pearson correlation coefficient=0.70) with a time lag of −3 weeks. Weekly entomological interventions were also correlated with the increase in dengue positivity rate by real-time reverse transcription polymerase chain reaction (Pearson correlation coefficient=0.59) with a time lag of −2 weeks. The most correlated query from Google Trends was the “Dengue” topic restricted to the Martinique region (Pearson correlation coefficient=0.637) with a time lag of −3 weeks. ConclusionsReal-word data are valuable data sources for dengue surveillance in smaller territories. Many of these sources precede the increase in dengue cases by several weeks, and therefore can help to improve the ability of traditional surveillance systems to provide an early response in dengue outbreaks. All these sources should be better integrated to improve the early response to dengue outbreaks and vector-borne diseases in smaller endemic territories.

Abstract Background Artificial intelligence (AI) has the potential to transform our healthcare systems significantly. New AI technologies based on machine learning approaches should play a key role in clinical decision-making in the future. However, their implementation in health care settings remains limited, mostly due to a lack of robust validation procedures. There is a need to develop reliable assessment frameworks for the clinical validation of AI. We present here an approach for assessing AI for predicting treatment response in triple-negative breast cancer (TNBC), using real-world data and molecular -omics data from clinical data warehouses and biobanks. Methods The European “ITFoC (Information Technology for the Future Of Cancer)” consortium designed a framework for the clinical validation of AI technologies for predicting treatment response in oncology. Results This framework is based on seven key steps specifying: (1) the intended use of AI, (2) the target population, (3) the timing of AI evaluation, (4) the datasets used for evaluation, (5) the procedures used for ensuring data safety (including data quality, privacy and security), (6) the metrics used for measuring performance, and (7) the procedures used to ensure that the AI is explainable. This framework forms the basis of a validation platform that we are building for the “ITFoC Challenge”. This community-wide competition will make it possible to assess and compare AI algorithms for predicting the response to TNBC treatments with external real-world datasets. Conclusions The predictive performance and safety of AI technologies must be assessed in a robust, unbiased and transparent manner before their implementation in healthcare settings. We believe that the consideration of the ITFoC consortium will contribute to the safe transfer and implementation of AI in clinical settings, in the context of precision oncology and personalized care.

BackgroundOften missing from or uncertain in a biomedical data warehouse (BDW), vital status after discharge is central to the value of a BDW in medical research. The French National Mortality Database (FNMD) offers open-source nominative records of every death. Matching large-scale BDWs records with the FNMD combines multiple challenges: absence of unique common identifiers between the 2 databases, names changing over life, clerical errors, and the exponential growth of the number of comparisons to compute. ObjectiveWe aimed to develop a new algorithm for matching BDW records to the FNMD and evaluated its performance. MethodsWe developed a deterministic algorithm based on advanced data cleaning and knowledge of the naming system and the Damerau-Levenshtein distance (DLD). The algorithm’s performance was independently assessed using BDW data of 3 university hospitals: Lille, Nantes, and Rennes. Specificity was evaluated with living patients on January 1, 2016 (ie, patients with at least 1 hospital encounter before and after this date). Sensitivity was evaluated with patients recorded as deceased between January 1, 2001, and December 31, 2020. The DLD-based algorithm was compared to a direct matching algorithm with minimal data cleaning as a reference. ResultsAll centers combined, sensitivity was 11% higher for the DLD-based algorithm (93.3%, 95% CI 92.8-93.9) than for the direct algorithm (82.7%, 95% CI 81.8-83.6; P98% in all subgroups. Our algorithm matched tens of millions of death records from BDWs, with parallel computing capabilities and low RAM requirements. We used the Inseehop open-source R script for this measurement. ConclusionsOverall, sensitivity/recall was 11% higher using the DLD-based algorithm than that using the direct algorithm. This shows the importance of advanced data cleaning and knowledge of a naming system through DLD use. Statistically significant differences in sensitivity between groups could be found and must be considered when performing an analysis to avoid differential biases. Our algorithm, originally conceived for linking a BDW with the FNMD, can be used to match any large-scale databases. While matching operations using names are considered sensitive computational operations, the Inseehop package released here is easy to run on premises, thereby facilitating compliance with cybersecurity local framework. The use of an advanced deterministic matching algorithm such as the DLD-based algorithm is an insightful example of combining open-source external data to improve the usage value of BDWs.

BackgroundDespite the many opportunities data reuse offers, its implementation presents many difficulties, and raw data cannot be reused directly. Information is not always directly available in the source database and needs to be computed afterwards with raw data for defining an algorithm. ObjectiveThe main purpose of this article is to present a standardized description of the steps and transformations required during the feature extraction process when conducting retrospective observational studies. A secondary objective is to identify how the features could be stored in the schema of a data warehouse. MethodsThis study involved the following 3 main steps: (1) the collection of relevant study cases related to feature extraction and based on the automatic and secondary use of data; (2) the standardized description of raw data, steps, and transformations, which were common to the study cases; and (3) the identification of an appropriate table to store the features in the Observation Medical Outcomes Partnership (OMOP) common data model (CDM). ResultsWe interviewed 10 researchers from 3 French university hospitals and a national institution, who were involved in 8 retrospective and observational studies. Based on these studies, 2 states (track and feature) and 2 transformations (track definition and track aggregation) emerged. “Track” is a time-dependent signal or period of interest, defined by a statistical unit, a value, and 2 milestones (a start event and an end event). “Feature” is time-independent high-level information with dimensionality identical to the statistical unit of the study, defined by a label and a value. The time dimension has become implicit in the value or name of the variable. We propose the 2 tables “TRACK” and “FEATURE” to store variables obtained in feature extraction and extend the OMOP CDM. ConclusionsWe propose a standardized description of the feature extraction process. The process combined the 2 steps of track definition and track aggregation. By dividing the feature extraction into these 2 steps, difficulty was managed during track definition. The standardization of tracks requires great expertise with regard to the data, but allows the application of an infinite number of complex transformations. On the contrary, track aggregation is a very simple operation with a finite number of possibilities. A complete description of these steps could enhance the reproducibility of retrospective studies.

Abstract The reverse transcription-polymerase chain reaction (RT-PCR) assay is the accepted standard for coronavirus disease 2019 (COVID-19) diagnosis. As any test, RT-PCR provides false negative results that can be rectified by clinicians by confronting clinical, biological and imaging data. The combination of RT-PCR and chest-CT could improve diagnosis performance, but this would requires considerable resources for its rapid use in all patients with suspected COVID-19. The potential contribution of machine learning in this situation has not been fully evaluated. The objective of this study was to develop and evaluate machine learning models using routine clinical and laboratory data to improve the performance of RT-PCR and chest-CT for COVID-19 diagnosis among post-emergency hospitalized patients. All adults admitted to the ED for suspected COVID-19, and then hospitalized at Rennes academic hospital, France, between March 20, 2020 and May 5, 2020 were included in the study. Three model types were created: logistic regression, random forest, and neural network. Each model was trained to diagnose COVID-19 using different sets of variables. Area under the receiving operator characteristics curve (AUC) was the primary outcome to evaluate model’s performances. 536 patients were included in the study: 106 in the COVID group, 430 in the NOT-COVID group. The AUC values of chest-CT and RT-PCR increased from 0.778 to 0.892 and from 0.852 to 0.930, respectively, with the contribution of machine learning. After generalization, machine learning models will allow increasing chest-CT and RT-PCR performances for COVID-19 diagnosis.

BackgroundTraditionally, dengue surveillance is based on case reporting to a central health agency. However, the delay between a case and its notification can limit the system responsiveness. Machine learning methods have been developed to reduce the reporting delays and to predict outbreaks, based on non-traditional and non-clinical data sources. The aim of this systematic review was to identify studies that used real-world data, Big Data and/or machine learning methods to monitor and predict dengue-related outcomes.Methodology/principal findingsWe performed a search in PubMed, Scopus, Web of Science and grey literature between January 1, 2000 and August 31, 2020. The review (ID: CRD42020172472) focused on data-driven studies. Reviews, randomized control trials and descriptive studies were not included. Among the 119 studies included, 67% were published between 2016 and 2020, and 39% used at least one novel data stream. The aim of the included studies was to predict a dengue-related outcome (55%), assess the validity of data sources for dengue surveillance (23%), or both (22%). Most studies (60%) used a machine learning approach. Studies on dengue prediction compared different prediction models, or identified significant predictors among several covariates in a model. The most significant predictors were rainfall (43%), temperature (41%), and humidity (25%). The two models with the highest performances were Neural Networks and Decision Trees (52%), followed by Support Vector Machine (17%). We cannot rule out a selection bias in our study because of our two main limitations: we did not include preprints and could not obtain the opinion of other international experts.Conclusions/significanceCombining real-world data and Big Data with machine learning methods is a promising approach to improve dengue prediction and monitoring. Future studies should focus on how to better integrate all available data sources and methods to improve the response and dengue management by stakeholders.

BackgroundLinking 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]). ObjectiveThis 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. MethodsA 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. ResultsThe 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

Direct oral anticoagulants and vitamin K antagonists are considered as potentially inappropriate medications (PIM) in several situations according to Beers Criteria. Drug–drug interactions (DDI) occurring specifically with these oral anticoagulants considered PIM (PIM–DDI) is an issue since it could enhance their inappropriate character and lead to adverse drug events, such as bleeding events. The aim of this study was (1) to describe the prevalence of oral anticoagulants as PIM, DDI and PIM–DDI in elderly patients in primary care and during hospitalization and (2) to evaluate their potential impact on the clinical outcomes by predicting hospitalization for bleeding events using machine learning methods. This retrospective study based on the linkage between a primary care database and a hospital data warehouse allowed us to display the oral anticoagulant treatment pathway. The prevalence of PIM was similar between primary care and hospital setting (22.9% and 20.9%), whereas the prevalence of DDI and PIM–DDI were slightly higher during hospitalization (47.2% vs. 58.9% and 19.5% vs. 23.5%). Concerning mechanisms, combined with CYP3A4–P-gp interactions as PIM–DDI, were among the most prevalent in patients with bleeding events. Although PIM, DDI and PIM–DDI did not appeared as major predictors of bleeding events, they should be considered since they are the only factors that can be optimized by pharmacist and clinicians.

Effective and timely disease surveillance systems have the potential to help public health officials design interventions to mitigate the effects of disease outbreaks. Currently, healthcare-based disease monitoring systems in France offer influenza activity information that lags real-time by one to three weeks. This temporal data gap introduces uncertainty that prevents public health officials from having a timely perspective on the population-level disease activity. Here, we present a machine-learning modeling approach that produces real-time estimates and short-term forecasts of influenza activity for the twelve continental regions of France by leveraging multiple disparate data sources that include, Google search activity, real-time and local weather information, flu-related Twitter micro-blogs, electronic health records data, and historical disease activity synchronicities across regions. Our results show that all data sources contribute to improving influenza surveillance and that machine-learning ensembles that combine all data sources lead to accurate and timely predictions.

Abstract 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 e ntrepôt 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.

Abstract Background Primary care data gathered from Electronic Health Records are of the utmost interest considering the essential role of general practitioners (GPs) as coordinators of patient care. These data represent the synthesis of the patient history and also give a comprehensive picture of the population health status. Nevertheless, discrepancies between countries exist concerning routine data collection projects. Therefore, we wanted to identify elements that influence the development and durability of such projects. Methods A systematic review was conducted using the PubMed database to identify worldwide current primary care data collection projects. The gray literature was also searched via official project websites and their contact person was emailed to obtain information on the project managers. Data were retrieved from the included studies using a standardized form, screening four aspects: projects features, technological infrastructure, GPs’ roles, data collection network organization. Results The literature search allowed identifying 36 routine data collection networks, mostly in English-speaking countries: CPRD and THIN in the United Kingdom, the Veterans Health Administration project in the United States, EMRALD and CPCSSN in Canada. These projects had in common the use of technical facilities that range from extraction tools to comprehensive computing platforms. Moreover, GPs initiated the extraction process and benefited from incentives for their participation. Finally, analysis of the literature data highlighted that governmental services, academic institutions, including departments of general practice, and software companies, are pivotal for the promotion and durability of primary care data collection projects. Conclusion Solid technical facilities and strong academic and governmental support are required for promoting and supporting long-term and wide-range primary care data collection projects.