Observational Cohort Study Dedicated to Autism Spectrum Disorder: Milestone Steps, Results Updates, Perspectives.

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by persistent difficulties in two domains: social communication and interaction, alongside with restricted, repetitive pattern of behaviors. It affects children and persists into adolescence and adulthood. Its causes and underlying psychopathological mechanisms are unknown and remain to be discovered. TEDIS cohort study developed over the decade 2010-2022, in Ile-de-France region, includes 1300 patients' files up to date, with valuable health information drawn from ASD evaluation. It provides researchers and decision makers with reliable data source to improve knowledge and practice in the context of ASD patients.

TEDIS, a Comprehensive Data Model for In-Depth Clinical Assessment of Patients Affected with Neuro-Developmental Disorders Including Autism.

TEDIS, an information system dedicated to patients affected with neuro-developmental disorders including autism, focuses on patient data generated during in-depth clinical assessment in nine expert centers in Ile-de-France region. Long term partnership involving methodologists and domain experts is necessary to support quality data production and analyses and to guarantee quality data and information governance in a domain characterized by frequent evolutions in clinical assessment instruments and in diagnostic criteria and classification.

Security Policy and Infrastructure in the Context of a Multi-Centeric Information System Dedicated to Autism Spectrum Disorder.

Autism spectrum disorders (ASD) are complex neuro-developmental disorders affecting children in their early age. The diagnosis of ASD relies on multidisciplinary investigations, in psychiatry, neurology, genetics, electrophysiology, neuro-imagery, audiology and ophthalmology. In order to support clinicians, researchers and public health decision makers, we designed an information system dedicated to ASD, called TEDIS. TEDIS was designed to manage systematic, exhaustive and continuous multi-centric patient data collection via secured Internet connections. In this paper, we present the security policy and security infrastructure we developed to protect ASD' patients' clinical data and patients' privacy. We tested our system on 359 ASD patient records in a local secured intranet environment and showed that the security system is functional, with a consistent, transparent and safe encrypting-decrypting behavior. It is ready for deployment in the nine ASD expert assessment centers in the Ile de France district.

Strengthening Data Confidentiality and Integrity Protection in the Context of a Multi-Centric Information System Dedicated to Autism Spectrum Disorder.

Autism spectrum disorders (ASD) are complex neuro-developmental disorders affecting children in early age. Diagnosis relies on multidisciplinary investigations, in psychiatry, neurology, genetics, electrophysiology, neuro-imagery, audiology, and ophthalmology. To support clinicians, researchers, and public health decision makers, we developed an information system dedicated to ASD, called TEDIS. It was designed to manage systematic, exhaustive and continuous multi-centric patient data collection via secured internet connections. TEDIS will be deployed in nine ASD expert assessment centers in Ile-DeFrance district. We present security policy and infrastructure developed in context of TEDIS to protect patient privacy and clinical information. TEDIS security policy was organized around governance, ethical and organisational chart-agreement, patients consents, controlled user access, patients' privacy protection, constrained patients' data access. Security infrastructure was enriched by further technical solutions to reinforce ASD patients' privacy protection. Solutions were tested on local secured intranet environment and showed fluid functionality with consistent, transparent and safe encrypting-decrypting results.

Patient information, consents and privacy protection scheme for an information system dedicated to pervasive developmental disorders.

Patients explicit and unambiguous information, patients consents and privacy protection are reviewed in this article, in the frame of the deployment of the information system TEDIS dedicated to autism spectrum disorders. The role of the Delegate to the Protection of Data is essential at this stage. We developed a privacy protection scheme based on storing encrypted patients personal data on the server database and decrypting it on the Web browser. It tries to respond to the end-users request to manage nominative data in a human readable form and to meet with privacy protection framework.

Risk factors of mild rectal bleeding in very low birth weight infants: a case control study.

BACKGROUND: Mild rectal bleeding (MRB) is a particular clinical entity different from necrotizing enterocolitis, which significantly influences neonatal care in preterm infants. We aimed to determine the risk factors and to evaluate prospectively the clinical course of MRB. METHODS: We consecutively included in a case-control study all infants with birth weight ≤ 1500 g or gestational age ≤ 32 weeks admitted to our unit, and presenting MRB, defined as either isolated or associated with mild clinical or radiological signs. We matched each Case with two Controls. Clinical data before, after and at time of MRB were collected, together with stool cultures at time of MRB (or at similar postnatal age in Controls). Multiple logistic regression analysis was performed to determine independent risk factors for the development of MRB. RESULTS: During 4 years, among 823 very low birth weight (VLBW) infants admitted to our unit, 72 (8.8%) had MRB. The median duration of rectal bleeding was 1.1 [1-2] days and the fasting period lasted 2.9 [2-10] days. A relapse occurred in 24% of cases. In multivariate analysis, only hypertension during pregnancy (p = 0.019), growth restriction at onset of bleeding (p = 0.026), and exposure to ibuprofen (p = 0.003) were independent risk factors for MRB. In Cases there were more infants with Clostridium Difficile in stools than in Controls (p = 0.017). CONCLUSION: Hypertension during pregnancy, even without intrauterine growth restriction, appeared to carry the same risk for MRB as exposure to ibuprofen and extrauterine growth restriction.

Postnatal steroids in extremely low birth weight infants: betamethasone or hydrocortisone?

AIM: To compare the efficacy and tolerance of betamethasone (BTM) and hydrocortisone (HC) in weaning extremely low birth weight (ELBW) infants with bronchopulmonary dysplasia (BPD) from the ventilator. METHODS: Monocentric, retrospective, cohort analysis based on prospective, standardized collection of data between 2005 and 2011 in ELBW receiving postnatal steroids (PS) after the second week of life. We used BTM for the first 4 years, and thereafter HC. We compared extubation rates, growth, glycaemia and blood pressure. RESULTS: Sixty-seven infants received PS: 35 BTM and 32 HC. Most infants (83% BTM vs. 72% HC) were extubated during treatment (p = 0.281). During PS, the need for insulin was similar. Mean arterial blood pressure was similar at day 3 of PS, but was significantly lower in infants treated by BTM 30 days after the end of treatment. The z-scores for body weight and head circumference indicated significantly greater loss in BTM than HC group. This persisted only for body weight after adjustment for differences in energy intake and corticosteroid dose. CONCLUSION: Our study suggests that HC may be as efficient as BTM in facilitating the extubation of ELBW infants, without short-term adverse effects. Blood pressure monitoring and investigation of long-term neurodevelopment are nevertheless needed.

TEDIS, Pervasive Developmental Disorder' patients information system, preliminary results.

TEDIS, an information system dedicated to patients with Pervasive Developmental Disorder (PDD) was tested. Results focused on the process of behavioural changes among physicians and health professionals with regard to structured organized patient information.The experiment encouraged changes in professionals' habits for further documenting and systematizing patient information collection. TEDIS' project federated professionals for developing methods for a systematic and exhaustive patient data management, in a longitudinal and cross-domain perspective, for improving knowledge and health care management.

Methicillin-resistant Staphylococcus capitis with reduced vancomycin susceptibility causes late-onset sepsis in intensive care neonates.

BACKGROUND: Coagulase-negative staphylococci, mainly Staphylococcus epidermidis, are the most frequent cause of late-onset sepsis (LOS) in the neonatal intensive care unit (NICU) setting. However, recent reports indicate that methicillin-resistant, vancomycin-heteroresistant Staphylococcus capitis could emerge as a significant pathogen in the NICU. We investigated the prevalence, clonality and vancomycin susceptibility of S. capitis isolated from the blood of NICU infants and compared these data to adult patients. METHODOLOGY/PRINCIPAL FINDINGS: We conducted a retrospective laboratory-based survey of positive blood cultures in NICU infants ≥ 3 days of age (n = 527) and in adult ICU patients ≥ 18 years of age (n = 1473) who were hospitalized from 2004 to 2009 in two hospital centers in Lyon, France. S. capitis was the most frequent pathogen in NICU infants, ahead of S. epidermidis (39.1% vs. 23.5% of positive blood cultures, respectively). Conversely, S. capitis was rarely found in adult ICU patients (1.0%) compared to S. epidermidis (15.3%). S. capitis bloodstream isolates were more frequently resistant to methicillin when collected from NICU infants than from adult patients (95.6% vs. 53.3%, respectively). Furthermore, we collected and characterized 53 S. capitis bloodstream isolates from NICU infants and adult patients from six distant cities. All methicillin-resistant S. capitis isolates from NICU infants were clonally related as determined by pulsed-field gel electrophoresis. These isolates harbored a type V-related staphylococcal chromosomal cassette mec element, and constantly showed either vancomycin resistance (37.5%) or heteroresistance (62.5%). Conversely, the isolates that were collected outside of the NICU were genetically diverse and displayed much lower rates of vancomycin resistance and heteroresistance (7.7% and 23.1%, respectively). CONCLUSIONS/SIGNIFICANCE: A clonal population of methicillin-resistant S. capitis strains has spread into several French NICUs. These isolates exhibit reduced susceptibility to vancomycin, which is the most widely used antimicrobial agent in the NICU setting.

Implementation and experimentation of TEDIS: an information system dedicated to patients with pervasive developmental disorders.

This article aims at describing the implementation and experimentation of TEDIS, an information system dedicated to patients with Pervasive Developmental Disorder. The experiment included 30 prospective patient records aged from 3.2 to 7.5 with an average of 6.3. Preliminary patient data analysis highlighted the need of improving the data collection process, by making relevant data systematically and accurately documented. Despite a small study ample size, data analysis also showed the interest of such information system in making evident improvements in patient care and resources allocation after medical and clinical expert assessment.

TEDIS: an information system dedicated to patients with pervasive developmental disorders.

Pervasive Development Disorders (PDD) represent a life disorder which significantly affects individuals and families. It requires long term specialized institutions health care, education and social accompaniment. In France, 350,000 to 600,000 patients are estimated to be affected and 5,000 to 8,000 newborns will develop the disorder every year. In 2005, Autism Resource Centres were created in each of the 23 regions in France, to support the PDD hospital reference centres in providing formal clinical assessment for each patient. Such assessments will support the prescription of health care measures, educative and intuitional orientation and accompaniment. An information system called TEDIS was designed to assist the psychiatrists and multidisciplinary medical experts at Necker child-psychiatry hospital, in organizing PDD patient's information and providing ground for improving knowledge about the disorder, its epidemiology and underlying biological mechanisms. The professionals' involvement from the beginning in the development process facilitated TEDIS design and implementation. The results of first experimentations are encouraging. They are described as well as the short term and mid-term deployment planning.

CEMARA an information system for rare diseases.

Rare diseases cover a group of conditions characterized by a low prevalence, affecting less than 1 in 2,000 people; 5000 to 7000 rare diseases have been currently identified in Europe. Most diseases do not have any curative treatment. They represent thus an important public health concern. CEMARA is based on a n-tier architecture. Its main objective is to collect continuous and complete records of patients with rare diseases, and their follow-up through a web-based Information System, and to analyse the epidemiological patterns. In France, 41 out of 131 labelled Reference Centres (RC) are sharing CEMARA. Presently 56,593 cases have been registered by more than 850 health care professionals belonging to 171 clinical sites. The national demand of care was explored in relation with the offer of care in order to reach an improved match. Within 2 years, CEMARA stimulated sharing a common platform, a common ontology with Orphanet and initiating new cohorts of rare diseases for improving patient care and research.

An XML schema for automated data integration in a Multi-Source Information System dedicated to end-stage renal disease.

Data exchange and interoperability between clinical information systems represent a crucial issue in the context of patient record data collection. An XML representation schema adapted to end-stage renal disease (ESRD) patients was developed and successfully tested against patient data in the dedicated Multi-Source Information System (MSIS) active file (more than 16,000 patient records). The ESRD-XML-Schema is organized into Schema subsets respecting the coherence of the clinical information and enriched with coherent data types. Tests are realized against XML-data files generated in conformity with the ESRD-XML Schema. Manual tests allowed the XML schema validation of the data format and content. Programmatic tests allowed the design of generic XML parsing routines, a portable object data model representation and the implementation of automatic data-exchange flows with the MSIS database system. The ESRD-XML-Schema represents a valid framework for data exchange and supports interoperability. Its modular design offers opportunity to simplify physicians' multiple tasks in order to privilege their clinical work.

Equity of accessibility to dialysis facilities.

Patients' end-stage renal disease (ESRD) characteristics are changing. Improving the quality of care requires a steady adaptation of treatment modalities together with equity of access to dialysis facilities. We explored the ability of the health system to cope with the demand of ESRD care. An analysis of a 5-year follow-up cohort of ESRD patients in the Limousin region, France, was performed. Data were entered in the Multi-Source Information System of the Renal Epidemiology and Information Network (REIN). The participation rate of centres was complete. We analysed patient characteristics, therapeutic options and driving time to reach dialysis facilities. We investigated geographic accessibility by defining areas within 45 minutes from dialysis units. We constructed scenarios to assess the impact of health care reorganization. In-centre haemodialysis units represented 73% of treatment modalities. One quarter of patients lived at more than 45 minutes of their dialysis unit. Based on a scenario of creating an additional In-centre unit, the number of patients living far from their centre would decrease by 31%. This study emphasizes important issues related to ESRD epidemiology, comorbidity and health care planning. It stimulates the development of new scenarios allowing the assessment of equity in accessing health care facilities.

CEMARA: a Web dynamic application within a N-tier architecture for rare diseases.

Rare diseases include a group of conditions characterized by a prevalence lower than 5 per 10,000 in the community. In France, any rare disease affects less than 30,000 patients and often much less. Three to 4% of children and 6% of the population in Europe are affected. It is a true public health stake since most diseases do not have any curative treatment. In France, the Ministry of Health has initiated a National Rare Diseases Plan. Twenty five out of 132 labelled Reference Centres (RC) decided to share a common Information System named CEMARA. It is dedicated to collect continuous and complete records of all patients presenting with a rare disease, and their follow-up. The main objective of CEMARA is to contribute to the missions of the RC regarding the registration and description of their activities, coordination of the network of their correspondents, organization of the follow-up of rare diseases, and analysis of the epidemiological patterns. A description of CEMARA is provided as well as its cooperation with Orphanet and Genatlas, and a presentation of 11803 current records collected by more than 300 health care professionals belonging to more than 70 sites.

Log files analysis to assess the use and workload of a dynamic web server dedicated to end-stage renal disease.

A Multi-Source Information System (MSIS), has been designed for the Renal Epidemiology and Information Network (REIN) dedicated to End-Stage Renal Disease (ESRD). MSIS aims at providing reliable follow-up data for ESRD patients. It is based on an n-tier architecture, made out of a universal client, a dynamic Web server connected to a production database and to a data warehouse. MSIS is operational since 2002 and progressively deployed in 9 regions in France. It includes 16,677 patients. We show that the analysis of MSIS web log files allows evaluating the use of the system and the workload in a public-health perspective.

SIGNe: A Geographic Information System on the Web for End-Stage Renal Disease.

A Web-based Geographic Information System (Web-GIS), the SIGNe (Système d'Information Géographique pour la Néphrologie), was designed for the Renal Epidemiology and Information Network (REIN) dedicated to End-Stage Renal Disease (ESRD). This Web-GIS was coupled to a data warehouse and embedded in an n-tier architecture designed as the Multi-Source Information System (MSIS). It allows to access views of ESRD concerning the epidemiology of the demand and the supply of care. It also provides maps matching the offer of care to the demand. It is presented with insights on the design and underlying technologies. It is dedicated to professionals and to public health care decision-makers in the domain of ESRD.

A Multi-Source Information System via the Internet for End-Stage Renal Disease: Scalability and Data Quality.

A Multi-Source Information System (MSIS), has been designed for the Renal Epidemiology and Information Network (REIN) dedicated to End-Stage Renal Disease (ESRD). MSIS aims at providing reliable follow-up data for ESRD patients. It is based on an n-tier architecture, made out of a universal client, a dynamic Web server connected to a production database and to a data warehouse. MSIS is operational since 2002 and progressively deployed in 9 regions in France. It includes 11,500 patients. MSIS facilitates documenting medical events which occur during the course of ESRD patient' health care and provides means to control the quality of each patient's record and reconstruct the patient trajectory of care. Consolidated data are made available to a data warehouse and to a geographic information system for analysis and data representation in support of public-health decision making.

A Web-based GIS for health care decision-support.

This Web-based application allows to access views of End-Stage Renal Disease (ESRD) concerning the epidemiology of the demand and the supply of care. It is a Web-based Geographic Information System (Web-GIS), the SIGNe (Système d'Information Géographique pour la Néphrologie), designed for the Renal Epidemiology and Information Network (REIN) dedicated to ESRD. It is a visualisation and decision-support tool. This Web-GIS was coupled to a data warehouse and embedded in an n-tier architecture designed as the Multi-Source Information System (MSIS). It provides maps matching the offer of care to the demand. It is presented with insights on the design and underlying technologies. It is dedicated to professionals and to public health care decision-makers.

A dynamic Web application within an n-tier architecture: a Multi-Source Information System for end-stage renal disease.

A Multi-Source Information System (MSIS) has been designed for the Renal Epidemiology and Information Network (REIN) dedicated to End-Stage Renal Disease. Interoperability has been considered at 4 levels: semantics, network, formats and contents. An n-tier architecture has been chosen at the network level. It is made out of a universal client, a dynamic Web server connected to a production database and to a data warehouse. The MSIS is patient-oriented, based on a regional organization. Its implementation in the context of a regional experimentation is presented with insights on the design and underlying technologies. The n-tier architecture is a robust model and flexible enough to aggregate multiple information sources and integrate modular developments. The data warehouse is dedicated to support health care decision-making.