Comparison of the validity, perceived usefulness and usability of I-MeDeSA and TEMAS, two tools to evaluate alert system usability: a study protocol.

INTRODUCTION: Research has shown that improvements to the usability of medication alert systems are needed. For designers and decisions-makers to assess usability of their alert systems, two paper-based tools are currently available: the instrument for evaluating human-factors principles in medication-related decision support alerts (I-MeDeSA) and the tool for evaluating medication alerting systems (TEMAS). This study aims to compare the validity, usability and usefulness of both tools to identify their strengths and limitations and assist designers and decision-makers in making an informed decision about which tool is most suitable for assessing their current or prospective system. METHODS AND ANALYSIS: First, TEMAS and I-MeDeSA will be translated into French. This translation will be validated by three experts in human factors. Then, in 12 French hospitals with a medication alert system in place, staff with expertise in the system will evaluate their alert system using the two tools successively. After the use of each tool, participants will be asked to fill in the System Usability Scale (SUS) and complete a survey on the understandability and perceived usefulness of each tool. Following the completion of both assessments, participants will be asked to nominate their preferred tool and relay their opinions on the tools. The design philosophy of TEMAS and I-MeDeSA differs on the calculation of a score, impacting the way the comparison between the tools can be performed. Convergent validity will be evaluated by matching the items of the two tools with respect to the usability dimensions they assess. SUS scores and answers to the survey will be statistically compared for I-MeDeSA and TEMAS to identify differences. Free-text responses in surveys will be analysed using an inductive approach. ETHICS AND DISSEMINATION: Ethical approval is not required in France for a study of this nature. The results will be published in a peer-reviewed journal.

A Deep Learning Framework for Automated ICD-10 Coding.

The International Statistical Classification of Diseases and Related Health Problems (ICD) is one of the widely used classification system for diagnoses and procedures to assign diagnosis codes to Electronic Health Record (EHR) associated with a patient's stay. The aim of this paper is to propose an automated coding system to assist physicians in the assignment of ICD codes to EHR. For this purpose, we created a pipeline of Natural Language Processing (NLP) and Deep Learning (DL) models able to extract the useful information from French medical texts and to perform classification. After the evaluation phase, our approach was able to predict 346 diagnosis codes from heterogeneous medical units with an accuracy average of 83%. Our results were finally validated by physicians of the Medical Information Department (MID) in charge of coding hospital stays.

Fetal heart rate baseline computation with a weighted median filter.

BACKGROUND: Automated fetal heart rate (FHR) analysis removes inter- and intra-expert variability, and is a promising solution for reducing the occurrence of fetal acidosis and the implementation of unnecessary medical procedures. The first steps in automated FHR analysis are determination of the baseline, and detection of accelerations and decelerations (A/D). We describe a new method in which a weighted median filter baseline (WMFB) is computed and A/Ds are then detected. METHOD: The filter weightings are based on the prior probability that the sampled FHR is in the baseline state or in an A/D state. This probability is computed by estimating the signal's stability at low frequencies and by progressively trimming the signal. Using a competition dataset of 90 previously annotated FHR recordings, we evaluated the WMFB method and 11 recently published literature methods against the ground truth of an expert consensus. The level of agreement between the WMFB method and the expert consensus was estimated by calculating several indices (primarily the morphological analysis discordance index, MADI). The agreement indices were then compared with the values for eleven other methods. We also compared the level of method-expert agreement with the level of interrater agreement. RESULTS: For the WMFB method, the MADI indicated a disagreement of 4.02% vs. the consensus; this value is significantly lower (p<10-13) than that calculated for the best of the 11 literature methods (7.27%, for Lu and Wei's empirical mode decomposition method). The level of inter-expert agreement (according to the MADI) and the level of WMFB-expert agreement did not differ significantly (p=0.22). CONCLUSION: The WMFB method reproduced the expert consensus analysis better than 11 other methods. No differences in performance between the WMFB method and individual experts were observed. The method Matlab source code is available under General Public Licence at http://utsb.univ-catholille.fr/fhr-wmfb.

Development of a Smart Mobile Data Module for Fetal Monitoring in E-Healthcare.

The fetal heart rate (FHR) is a marker of fetal well-being in utero (when monitoring maternal and/or fetal pathologies) and during labor. Here, we developed a smart mobile data module for the remote acquisition and transmission (via a Wi-Fi or 4G connection) of FHR recordings, together with a web-based viewer for displaying the FHR datasets on a computer, smartphone or tablet. In order to define the features required by users, we modelled the fetal monitoring procedure (in home and hospital settings) via semi-structured interviews with midwives and obstetricians. Using this information, we developed a mobile data transfer module based on a Raspberry Pi. When connected to a standalone fetal monitor, the module acquires the FHR signal and sends it (via a Wi-Fi or a 3G/4G mobile internet connection) to a secure server within our hospital information system. The archived, digitized signal data are linked to the patient's electronic medical records. An HTML5/JavaScript web viewer converts the digitized FHR data into easily readable and interpretable graphs for viewing on a computer (running Windows, Linux or MacOS) or a mobile device (running Android, iOS or Windows Phone OS). The data can be viewed in real time or offline. The application includes tools required for correct interpretation of the data (signal loss calculation, scale adjustment, and precise measurements of the signal's characteristics). We performed a proof-of-concept case study of the transmission, reception and visualization of FHR data for a pregnant woman at 30 weeks of amenorrhea. She was hospitalized in the pregnancy assessment unit and FHR data were acquired three times a day with a Philips Avalon® FM30 fetal monitor. The prototype (Raspberry Pi) was connected to the fetal monitor's RS232 port. The emission and reception of prerecorded signals were tested and the web server correctly received the signals, and the FHR recording was visualized in real time on a computer, a tablet and smartphones (running Android and iOS) via the web viewer. This process did not perturb the hospital's computer network. There was no data delay or loss during a 60-min test. The web viewer was tested successfully in the various usage situations. The system was as user-friendly as expected, and enabled rapid, secure archiving. We have developed a system for the acquisition, transmission, recording and visualization of RCF data. Healthcare professionals can view the FHR data remotely on their computer, tablet or smartphone. Integration of FHR data into a hospital information system enables optimal, secure, long-term data archiving.

Combining usability evaluations to highlight the chain that leads from usability flaws to usage problems and then negative outcomes.

Poor usability of health technology is thought to diminish work system performance, increase error rates and, potentially, harm patients. The present study (i) used a combination of usability evaluation methods to highlight the chain that leads from usability flaws to usage problems experienced by users and, ultimately, to negative patient outcomes, and (ii) validated this approach by studying two different discharge summary production systems. To comply with quality guidelines, the process of drafting and sending discharge summaries is increasingly being automated. However, the usability of these systems may modify their impact (or the absence thereof) in terms of production times and quality, and must therefore be evaluated. Here, we applied three successive techniques for usability evaluation (heuristic evaluation, user testing and field observation) to two discharge summary production systems (underpinned by different technologies). The systems' main usability flaws led respectively to an increase in the time need to produce a discharge summary and the risk of patient misidentification. Our results are discussed with regard to the possibility of linking the usability flaws, usage problems and the negative outcomes by successively applying three methods for evaluating usability (heuristic evaluation, user testing and in situ observations) throughout the system development life cycle.

Evaluation of a Computer Application for Retrospective Detection of Vitamin K Antagonist Treatment Imbalance.

OBJECTIVE: Management of vitamin K antagonists (VKAs) is difficult, and overdoses can have dramatic hemorrhagic consequences. The adverse drug event (ADE) scorecards is a tool intended for the detection and description of adverse drug reaction/ADE developed during a European computerized medical data processing project. It is used in a quality assurance process. Our objective was to evaluate the performance of the ADE scorecards in the detection of the contributing factors for VKA overdoses, among the cases where a VKA overdose is observed. METHODS: Twenty-eight rules allow the detection of VKA treatment overdose related to drug or a clinical situation. They were applied on 14,748 electronic medical records from a community hospital. Among 582 records including a VKA prescription, 59 cases of VKA overdoses (international normalized ratio ≥ 5) during the hospital stay have been identified. The ADE scorecards detected 49 of them. We evaluated the positive predictive value and sensitivity of these rules, by an expert review of the cases. RESULTS: The expert review confirmed the contribution of a detected risk factor to the VKA overdose in 11 cases. Therefore, the precision of the rules is 22.4%. The sensitivity is 84.6%. The risk factors were mainly infection and amiodarone introduction. The 4 cases of clinical injury related to a drug were properly designated by the rules. CONCLUSIONS: Our study shows the great potential of the ADE scorecards for detecting cofactors of VKA overdoses and gives an argument to include complex rules in the knowledge bases used for the detection and identification of ADEs in large medical databases.

Inappropriate anticholinergic drugs prescriptions in older patients: analysing a hospital database.

Background Although many anticholinergics are inappropriate in older patients, the prescription of these drugs in a hospital setting has not been extensively studied. Objective To describe prescriptions of anticholinergic drugs in terms of frequency, at risk situations and constipation in hospitalized, older adults. Setting Using a database from a French general hospital (period 2009-2013), we extracted information on 14,090 hospital stays by patients aged 75 and over. Methods Anticholinergic drug prescriptions were automatically detected, with a focus on prescriptions in three well-known at-risk situations: falls, dementia, and benign prostatic hyperplasia. Cases of constipation that might have been causally related to the administration of anticholinergic drugs were screened for and reviewed. Main outcome measure Prescriptions with a high associated risk of anticholinergic related adverse reactions. Results Administration of an anticholinergic drug was detected in 1412 (10.0%) of the hospital stays by older patients. At-risk situations were identified in 413 (36.5%) of these stays: 137 (9.7%) for falls, 243 (17.2%) for dementia, and 114 (8.1%) for benign prostatic hyperplasia; 78 (18.9%) of these 413 stays featured a combination of two or three at-risk situations. Cases of constipation induced by anticholinergic drug administration were identified in 188 (13.3%) patient stays by using validated adjudication rules for adverse drug reactions: 85 and 103 cases were respectively evaluated as "possible" or "probable" adverse drug reactions. Conclusions Anticholinergic drugs prescription was found in 10.0% of hospitalized, older patients. More than one third of these prescriptions occurred in at-risk situations and more than one in ten prescriptions induced constipation.

Underuse of Oral Anticoagulants and Inappropriate Prescription of Antiplatelet Therapy in Older Inpatients with Atrial Fibrillation.

BACKGROUND: Several studies have shown that the prescription of antiplatelet therapy (APT) is associated with an increased risk of oral anticoagulant (OAC) underuse in patients aged 75 years and over with atrial fibrillation (AF). An associated atheromatous disease may be the underlying reason for APT prescription. The objective of the study was to determine whether the association between underuse of OAC and APT prescription was explained by the presence of an atheromatous disease. METHODS AND RESULTS: We performed a retrospective, observational, single-centre study between 2009 and 2013 based on administrative data. Patients aged 75 years and over with non-valvular AF were identified in a database of 72,090 hospital stays. Prescriptions of anti-thrombotic medications and their association with the presence of atheromatous disease were evaluated by the mean of a logistic regression. A total of 2034 hospital stays were included (mean age 84.3 ± 5.2 years). The overall prevalence of known atheromatous disease was 25.9%. OAC underuse was observed in 58.5% of the stays. In multivariable analysis, the prescription of an APT was associated with an increased risk of OAC underuse [odds ratio (OR) 6.85; 95% confidence interval (CI) 5.50-8.58], independently of the presence of a concomitant known atheromatous disease (OR 0.78; 95% CI 0.60-1.01). Among the 692 stays with APT monotherapy (34.0%), 232 (33.5%) displayed an atheromatous disease. CONCLUSIONS: The underuse of OAC is associated with the prescription of APT in older patients with AF, regardless of the presence or absence of known atheromatous disease. Our results suggest that APT is often inappropriately prescribed instead of OAC.

Case-crossover study to examine the change in postpartum risk of pulmonary embolism over time.

BACKGROUND: Although the current guidelines recommend anticoagulation up until 6 weeks after delivery in women at high risk of venous thromboembolism (VTE), the risk of VTE may extend beyond 6 weeks. Our objective was to estimate the risk of a pulmonary embolism in successive 2-week intervals during the postpartum period. METHODS: In a population-based, case-crossover study, we analyzed the French national inpatient database from 2007 to 2013 (n = 5,517,680 singleton deliveries). Using ICD-10 codes, we identified women who were diagnosed with a postpartum pulmonary embolism between July 1st, 2008, and December 31st, 2013. Deliveries were identified during a case "period" immediately before the pulmonary embolism, and five different control periods one year before the pulmonary embolism. Using conditional logistic regression, Odds ratios (ORs) and 95% confidential intervals (CIs) were estimated for ten successive 2-week intervals that preceded the diagnosis of pulmonary embolism. RESULTS: We identified 167,103 cases with a pulmonary embolism during the inclusion period. After delivery, the risk of pulmonary embolism declined progressively over time, with an OR [95%CI] of 17.2 [14.0-21.3] in postpartum weeks 1 to 2 and 1.9 [1.4-2.7] in postpartum weeks 11 to 12. The OR [95%CI] in postpartum weeks 13 to 14 was 1.4 [0.9-2.0], and the OR did not fall significantly after postpartum week 14. CONCLUSIONS: Our findings indicate that women are at risk of a pulmonary embolism up to 12 weeks after delivery. The shape of the risk curve suggests that the risk decreases exponentially over time. Future research is needed to establish whether the duration of postpartum anticoagulation should be extended beyond 6 weeks.

Hospital-based health technology assessment in France: A focus on medical devices.

Hospital-based health technology assessment (HTA) guides decisions as to whether new healthcare products should be made available within hospital structures. Its extension to medical devices (MDs) makes it possible to analyse several relevant aspects of these healthcare products in addition to their clinical value, and such evaluations are of interest to national health authorities, other healthcare establishments and industry. The aim of this work was to formulate several recommendations for a blueprint for hospital-based HTA for MDs in France. Five themes based on the work of the European Adopting hospital-based HTA in the EU (AdHopHTA) project were defined. Each member of the roundtable was then allocated a documentation task based on their experience of the theme concerned, and a literature review was carried out. An inventory of hospital-based HTA was performed and six recommendations aiming to strengthen and improve this approach were put forward: (1) encouragement of the spread of the hospital-based HTA culture and participation in communications and the promotion of this approach to hospital decision-makers; (2) adaptation of hospital-based HTA to the needs of decision-makers, taking into account the financial timetable and strategic objectives of the healthcare establishment; (3) harmonisation of the dossiers requested from industry between healthcare establishments, based on a common core; (4) promotion of the sharing of hospital-based HTA data under certain conditions, with data dissociable from the HTA report and the use of a validated methodology for the literature review; (5) creation of a composite indicator reflecting data production effort and the sharing of HTA activities, to be taken into account in the distribution of funds allocated for teaching, research and innovation missions considered of general interest; (6) the transmission of information directly from local to national level by pioneering centres. This work highlights the major issues at stake in hospital-based HTA and the need to valorise such activities in France.

IT-CARES: an interactive tool for case-crossover analyses of electronic medical records for patient safety.

BACKGROUND: The significant risk of adverse events following medical procedures supports a clinical epidemiological approach based on the analyses of collections of electronic medical records. Data analytical tools might help clinical epidemiologists develop more appropriate case-crossover designs for monitoring patient safety. OBJECTIVE: To develop and assess the methodological quality of an interactive tool for use by clinical epidemiologists to systematically design case-crossover analyses of large electronic medical records databases. MATERIAL AND METHODS: We developed IT-CARES, an analytical tool implementing case-crossover design, to explore the association between exposures and outcomes. The exposures and outcomes are defined by clinical epidemiologists via lists of codes entered via a user interface screen. We tested IT-CARES on data from the French national inpatient stay database, which documents diagnoses and medical procedures for 170 million inpatient stays between 2007 and 2013. We compared the results of our analysis with reference data from the literature on thromboembolic risk after delivery and bleeding risk after total hip replacement. RESULTS: IT-CARES provides a user interface with 3 columns: (i) the outcome criteria in the left-hand column, (ii) the exposure criteria in the right-hand column, and (iii) the estimated risk (odds ratios, presented in both graphical and tabular formats) in the middle column. The estimated odds ratios were consistent with the reference literature data. DISCUSSION: IT-CARES may enhance patient safety by facilitating clinical epidemiological studies of adverse events following medical procedures. The tool's usability must be evaluated and improved in further research.

The risks of pulmonary embolism and upper gastrointestinal bleeding beyond 35days after total hip replacement for coxarthrosis among middle-aged patients: A cross-over cohort.

Prophylactic anticoagulation is recommended up to 35days after total hip replacement (THR). Although several observational studies have assessed the incidence of thrombotic events or bleeding events after THR, the corresponding measures of association have never been studied concomitantly. Here, we evaluated the duration of the elevated risks (relative to the baseline risk) of both venous thromboembolic events and bleeding events after THR for coxarthrosis among middle-aged patients. This was a population-based, cross-over cohort study of data extracted from the French national inpatient database between 2007 and 2013. We included middle-aged patients (aged 45 to 69) having undergone THR for coxarthrosis. We compared the numbers of pulmonary embolisms (PEs) (respectively upper gastrointestinal bleedings (UGIBs)) following the THR with the numbers occurring during three unexposed periods one year later. This enabled us to estimate the odds ratio (OR) [95% confidence interval (CI)] for each of six successive 35-day intervals. The study included 108,099 patients. The ORs for PE were respectively 12.4 (95% CI, 8.6-17.8) (absolute risk difference rate per 100,000 (ARD/100,000)=130) and 5.0 (95% CI, 3.4-7.4) (ARD/100,000=52) for the first two 35-day intervals, and the risk was close to 1 thereafter. The risk of UGIB fell quickly, with an OR of 6.5 (95% CI, 4.6-9.1) (ARD/100,000=83) and 0.8 (95% CI, 0.4-1.6) for the first two 35-day intervals, respectively. The majority of UGIBs occurred during the inpatient stay for THR. Among middle-aged patients, the risk of a PE remains elevated beyond 35days after THR for coxarthrosis, whereas the risk of a UGIB remains elevated for the first 35days only.

POLESAT an Innovative e-Geoplatform in Health Management.

UNLABELLED: Health geography and geomatics have become major disciplines in the last few years and are the source of attractive concepts for medical informatics. POLESAT's e-geoplatform was built to present information and support decision-making during medical consultation. We have improved its usability with innovative and modern methodology. Results show five steps of the process. 1: we select one of three hospitals. 2: thanks to PiNoKio's anatomy, the related activity segments are displayed. 3: the activity segment "AB-Orthopedics, Rheumatology" is displayed. 4: click on "AB02-Amputations" product line and 5: go to hospital activity choropleth map. CONCLUSION: This third e-geoplatform version is a showcase for advanced open-source geomatics via web-mapping possibilities. Health management based on geography concepts, geomatics, an amusing avatar for children, health and/or geographic open data represent the technology of tomorrow. This e-geoplatform concept presents an opportunity for the serious games industry, education and will reduce health access inequalities.

POLESAT an Innovative e-Geoplatform in Health Management.

UNLABELLED: Health geography and geomatics have become major disciplines in the last few years and are the source of attractive concepts for medical informatics. POLESAT's e-geoplatform was built to present information and support decision-making during medical consultation. We have improved its usability with innovative and modern methodology. Results show five steps of the process. 1: we select one of three hospitals. 2: thanks to PiNoKio's anatomy, the related activity segments are displayed. 3: the activity segment "AB-Orthopedics, Rheumatology" is displayed. 4: click on "AB02-Amputations" product line and 5: go to hospital activity choropleth map. CONCLUSION: This third e-geoplatform version is a showcase for advanced open-source geomatics via web-mapping possibilities. Health management based on geography concepts, geomatics, an amusing avatar for children, health and/or geographic open data represent the technology of tomorrow. This e-geoplatform concept presents an opportunity for the serious games industry, education and will reduce health access inequalities.

Adoption Space and the Idea-to-Market Process of Health Technologies.

Although Europe 'produces' excellent science, it has not been equally successful in translating scientific results into commercially successful companies in spite of European and national efforts invested in supporting the translation process. The Idea-to-Market process is highly complex due to the large number of actors and stakeholders. ITECH was launched to propose recommendations which would accelerate the Idea-to-Market process of health technologies leading to improvements in the competitiveness of the European health technology industry in the global markets. The project went through the following steps: defining the Idea-to-Market process model; collection and analysis of funding opportunities; identification of 12 gaps and barriers in the Idea-to-Market process; a detailed analysis of these supported by interviews; a prioritization process to select the most important issues; construction of roadmaps for the prioritized issues; and finally generating recommendations and associated action plans. Seven issues were classified as in need of actions. Three of these are part of the ongoing Medical Device Directive Reform (MDR), namely health technology assessment, post-market surveillance and regulatory process, and therefore not within the scope of ITECH. Recommendations were made for eHealth taxonomy; Education and training; Clinical trials and Adoption space and Human Factors Engineering (HFE).

Baseline fetal heart rate analysis: eleven automatic methods versus expert consensus.

Visual analysis of fetal heart rate (FHR) during labor is subject to inter- and intra-observer variability that is particularly troublesome for anomalous recordings. Automatic FHR analysis has been proposed as a promising way to reduce this variability. The major difficulty with automatic analysis is to determine the baseline from which accelerations and decelerations will be detected. Eleven methods for automatic FHR analysis were reprogrammed using description from the literature and applied to 66 FHR recordings collected during the first stage of delivery. The FHR baselines produced by the automatic methods were compared with the baseline defined by agreement among a panel of three experts. The better performance of the automatic methods described by Mongelli, Lu, Wrobel and Pardey was noted despite their different approaches on signal processing. Nevertheless, for several recordings, none of the automatic studied methods produced a baseline similar to that defined by the experts.

One Million Electrocardiograms of Primary Care Patients: A Descriptive Analysis.

In 722 cities of Minas Gerais (Brazil), primary care patients can have their ECGs remotely interpreted by cardiologists of the Telehealth Network of Minas Gerais (TNMG), a public telehealth service. As of December 2014, more than 1.9 million ECGs were interpreted. This study analyzed the database of all ECGs performed by the TNMG on primary care patients from 2009 to 2013 (n=1,101,993). Structured patient data and the results of automated ECG interpretation by the Glasgow Program are described. Mean patient age is 51 years old, 59% of them are women. The average body mass index is 25.9 kg/m2, with an average increase of 0.15 kg/m2 per civil year. Those patients notably have hypertension (33.2%), family history of coronary artery disease (14.5%), smoking (6.9%), diabetes (5.8%), obesity (5.8%) or Chagas Disease (3.0%). Seventy percent of ECGs are normal. This percentage is higher in women (72.3%) and decreases in average by 7.4 every 10 years of life. There are notably 12% of possible myocardial infarction, 10% of possible left ventricular hypertrophy and 8% of possible supraventricular extra systole.

Toward a Literature-Driven Definition of Big Data in Healthcare.

OBJECTIVE: The aim of this study was to provide a definition of big data in healthcare. METHODS: A systematic search of PubMed literature published until May 9, 2014, was conducted. We noted the number of statistical individuals (n) and the number of variables (p) for all papers describing a dataset. These papers were classified into fields of study. Characteristics attributed to big data by authors were also considered. Based on this analysis, a definition of big data was proposed. RESULTS: A total of 196 papers were included. Big data can be defined as datasets with Log(n∗p) ≥ 7. Properties of big data are its great variety and high velocity. Big data raises challenges on veracity, on all aspects of the workflow, on extracting meaningful information, and on sharing information. Big data requires new computational methods that optimize data management. Related concepts are data reuse, false knowledge discovery, and privacy issues. CONCLUSION: Big data is defined by volume. Big data should not be confused with data reuse: data can be big without being reused for another purpose, for example, in omics. Inversely, data can be reused without being necessarily big, for example, secondary use of Electronic Medical Records (EMR) data.

Multi-agent Architecture for the Multi-Skill Tasks Modeling at the Pediatric Emergency Department.

Patient journey in the Pediatric Emergency Department is a highly complex process. Current approaches for modeling are insufficient because they either focus only on the single ancillary units, or therefore do not consider the entire treatment process of the patients, or they do not account for the dynamics of the patient journey modeling. Therefore, we propose an agent based approach in which patients and emergency department human resources are represented as autonomous agents who are able to react flexible to changes and disturbances through pro-activeness and reactiveness. The main aim of this paper is to present the overall design of the proposed multi-agent system, emphasizing its architecture and the behavior of each agent of the model. Besides, we describe inter-agent communication based on the agent interaction protocol to ensure cooperation between agents when they perform the coordination of tasks for the users. This work is integrated into the ANR HOST project (ANR-11-TecSan-010).