BACKGROUND: The application of rehabilitation robots has grown during the last decade. While meta-analyses have shown beneficial effects of robotic interventions for some patient groups, the evidence is less in others. We established the Advanced Robotic Therapy Integrated Centers (ARTIC) network with the goal of advancing the science and clinical practice of rehabilitation robotics. The investigators hope to exploit variations in practice to learn about current clinical application and outcomes. The aim of this paper is to introduce the ARTIC network to the clinical and research community, present the initial data set and its characteristics and compare the outcome data collected so far with data from prior studies. METHODS: ARTIC is a pragmatic observational study of clinical care. The database includes patients with various neurological and gait deficits who used the driven gait orthosis Lokomat® as part of their treatment. Patient characteristics, diagnosis-specific information, and indicators of impairment severity are collected. Core clinical assessments include the 10-Meter Walk Test and the Goal Attainment Scaling. Data from each Lokomat® training session are automatically collected. RESULTS: At time of analysis, the database contained data collected from 595 patients (cerebral palsy: n = 208; stroke: n = 129; spinal cord injury: n = 93; traumatic brain injury: n = 39; and various other diagnoses: n = 126). At onset, average walking speeds were slow. The training intensity increased from the first to the final therapy session and most patients achieved their goals. CONCLUSIONS: The characteristics of the patients matched epidemiological data for the target populations. When patient characteristics differed from epidemiological data, this was mainly due to the selection criteria used to assess eligibility for Lokomat® training. While patients included in randomized controlled interventional trials have to fulfill many inclusion and exclusion criteria, the only selection criteria applying to patients in the ARTIC database are those required for use of the Lokomat®. We suggest that the ARTIC network offers an opportunity to investigate the clinical application and effectiveness of rehabilitation technologies for various diagnoses. Due to the standardization of assessments and the use of a common technology, this network could serve as a basis for researchers interested in specific interventional studies expanding beyond the Lokomat®.
- Keywords
- CÚER, listinný recept, elektronický podpis, zákon o léčivech,
- MeSH
- Databases as Topic organization & administration utilization MeSH
- Electronic Prescribing * MeSH
- Pharmacies organization & administration legislation & jurisprudence MeSH
- Drug Prescriptions * MeSH
- Jurisprudence MeSH
- Data Collection MeSH
Im Zuge des europäischen E-Health Großprojektes (“ep- SOS”) kam es zu einer Vielzahl an Diskussionen über die Umsetzung einer gesamteuropäischen E-Health Infrastruktur. Dabei traten großen Unterschiede zwischen den nationalen Rechtsordnungen im Bereich E-Health zu Tage, die ernsthafte Hindernisse für den europaweiten Austausch von Gesundheitsdaten darstellen. Auch wenn es sehr schwierig ist, alle Anforderungen der betroffenen Ländern einzuhalten, ist dies eine notwendige Voraussetzung für einen reibungslosen Austausch von Patientendaten. Die rechtswidrige Verwendung von personenbezogenen Gesundheitsdaten kann zu Imageverlusten, Verwaltungsstrafen und der Notwendigkeit interne Arbeitsabläufe mit großem Aufwand umstrukturieren zu müssen, führen. Die Kenntnis der aktuellen Rechtslage hilft dies zu vermeiden. Die Kenntnis der zukünftigen Rechtslage erleichtert strategische Entscheidungen und erlaubt eine Führungsrolle im Innovationsprozess zu übernehmen. Vor diesem Hintergrund soll der gegenständliche Beitrag zu einem besseren Verständnis der aktuellen österreichischen Rechtslage und den Neuerungen, die auf Grund nationaler und europäischer Projekte zu erwarten sind, beitragen. Die Entwicklungen auf nationaler und europäischer Ebene sind nach wie vor im Gange. Der vorliegende Beitrag, insbesondere der Ausblick des Kapitels 2, beruht auf dem Informationsstand April 2012.
In the context of the European large-scale pilot on e-health (“epSOS”) numerous discussions on the implementation of a pan-European e-health infrastructure have been held. They all proved that differences among the national ehealth legislations pose serious obstacles to the Europeanwide exchange of personal health data. Even if it is very difficult to meet all requirements of the involved countries, this is an absolute pre-condition for a smooth exchange of patient data. The unlawful usage of personal health data can result in the loss of reputation, administrative fines and the need to restructure internal workflows at high costs. Being aware of the current legal framework avoids such. To know about future innovations to the legal framework facilitates strategic decisions and enables to take over leadership in the innovative process. Recognising this, the aim of this paper is to provide a better understanding of the current Austrian e-health legislation and the innovations to come, inspired by national and European projects. As development is still ongoing at national and European level, the information provided, especially regarding the outlook, is to be understood as of April 2012.
- Keywords
- epSOS,
- MeSH
- Medical Records Systems, Computerized organization & administration utilization legislation & jurisprudence MeSH
- Databases as Topic organization & administration utilization legislation & jurisprudence MeSH
- European Union MeSH
- Information Systems utilization MeSH
- International Cooperation MeSH
- Systems Integration MeSH
- Telemedicine trends utilization legislation & jurisprudence MeSH
- Information Storage and Retrieval methods legislation & jurisprudence MeSH
- Universal Health Insurance utilization legislation & jurisprudence MeSH
- Medical Informatics Applications MeSH
- Computer Security legislation & jurisprudence MeSH
- Legislation as Topic MeSH
- Geographicals
- Austria MeSH
V tomto sdělení popisujeme národní infrastrukturu výzkumných biobank BBMRI_CZ. Infrastruktura byla založena Ministerstvem školství, mládeže a tělovýchovy a stala se partnerem evropské infrastruktury biobank BBMRI. Infrastruktura je navržena jako síť biobank, které skladují vzorky získané od asociovaných zdravotnických institucí. Biobanky sestávají z dlouhodobého úložiště (různé typy tkání klasifikované podle diagnózy, peroperační sérum, genomová DNA, RNA) a krátkodobého úložiště (séra pacientů odebíraná v čase). Diskutujeme způsob práce infrastruktury, který musí odpovídat její distribuované povaze: získávání vzorků musí být doprovázeno extrakcí dat z nemocničních informačních systémů a tato data musejí být katalogizována v centrálním indexu pro potřeby vyhledávání. Jelikož BBMRI_CZ slouží pouze pro potřeby vědy a výzkumu, jsou data před uložením do indexu anonymizována. Index je poté k dispozici registrovaným výzkumným pracovníkům, kteří mohou o vybrané vzorky podat žádosti správcům biobank. Článek poskytuje přehled struktury dat uložených v indexu. Diskutujeme také monitorovací systém biobank, který je do BBMRI_CZ začleněn pro dohled nad dodržováním kvality uskladnění vzorků.
We introduce the national research biobanking infrastructure, BBMRI_CZ. The infrastructure has been founded by the Ministry of Education and became a partner of the European biobanking infrastructure BBMRI.eu. It is designed as a network of individual biobanks where each biobank stores samples obtained from associated healthcare providers. The biobanks comprise long term storage (various types of tissues classified by diagnosis, serum at surgery, genomic DNA and RNA) and short term storage (longitudinally sampled patient sera). We discuss the operation workflow of the infrastructure that needs to be the distributed system: transfer of the samples to the biobank needs to be accompanied by extraction of data from the hospital information systems and this data must be stored in a central index serving mainly for sample lookup. Since BBMRI_CZ is designed solely for research purposes, the data is anonymised prior to their integration into the central BBMRI_CZ index. The index is then available for registered researchers to seek for samples of interest and to request the samples from biobank managers. The paper provides an overview of the structure of data stored in the index. We also discuss monitoring system for the biobanks, incorporated to ensure quality of the stored samples.
- Keywords
- biobanka, výzkum rakoviny,
- MeSH
- Biological Specimen Banks * organization & administration MeSH
- Biomedical Research organization & administration MeSH
- Databases, Genetic MeSH
- Databases as Topic * organization & administration MeSH
- Interinstitutional Relations MeSH
- Pathology, Clinical * organization & administration MeSH
- Humans MeSH
- Specimen Handling methods MeSH
- Database Management Systems MeSH
- Information Storage and Retrieval methods MeSH
- Research organization & administration MeSH
- Check Tag
- Humans MeSH
- Publication type
- Database MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Czech Republic MeSH
- MeSH
- Medical Records Systems, Computerized standards organization & administration MeSH
- Databases as Topic standards organization & administration MeSH
- Financing, Organized MeSH
- Precision Medicine trends MeSH
- Information Systems standards organization & administration MeSH
- Medical Informatics Computing MeSH
- Humans MeSH
- Evidence-Based Medicine economics organization & administration trends MeSH
- International Cooperation MeSH
- Registries standards MeSH
- Systems Integration MeSH
- Decision Support Systems, Clinical organization & administration MeSH
- Information Storage and Retrieval standards trends MeSH
- Check Tag
- Humans MeSH
- Publication type
- Review MeSH
Kritika elektronické zdravotní karty (e-karty) ze strany lékařů a lékárníků dále narůstá: v mnoha německých lékařských ordinacích jsou vystaveny seznamy, na nichž pacienti mohou svým podpisem vyjádřit nesouhlas s jejím zavedením.
- MeSH
- Databases as Topic economics organization & administration legislation & jurisprudence MeSH
- Confidentiality standards legislation & jurisprudence MeSH
- Electronic Prescribing MeSH
- Pharmacists standards organization & administration legislation & jurisprudence MeSH
- Patient Identification Systems organization & administration utilization legislation & jurisprudence MeSH
- Information Systems economics utilization legislation & jurisprudence MeSH
- Physicians organization & administration legislation & jurisprudence MeSH
- Pharmacies economics organization & administration legislation & jurisprudence MeSH
- Drug Prescriptions economics standards MeSH
- Humans MeSH
- Legislation, Pharmacy economics standards MeSH
- Records standards legislation & jurisprudence MeSH
- Insurance, Health standards legislation & jurisprudence MeSH
- Check Tag
- Humans MeSH
- Geographicals
- Germany MeSH
Effective planning of clinical trials requires an appropriate number of patients who fulfil given inclusion criteria. In the case of so called "orphan" diseases, such as Duchenne and Becker muscular dystrophy (DMD/BMD), the number of suitable patients within one country is usually limited. We developed a detailed registry of Czech and Slovak DMD/BMD patients which may contribute to cooperation on the European level. The registry uses internet and database technologies with a multilevel architecture. Patients may view their own data. As of May 2008, 163 patients have been registered in the database. The registry provides a detailed phenotypic and genotypic description of patients. The main purpose of such a registry is the time-effective recruitment of eligible patients for a clinical trial or therapy and may allow the anticipation of possible future effects of appropriate therapy on individual patients. The importance of the DMD/BMD patient registries has recently also been rising with new clinical trials focused on mutation-specific approaches. Other outputs include assessment of epidemiology, phenotype and genotype relationships, or standards of care.
- MeSH
- Databases as Topic organization & administration trends MeSH
- Genetic Carrier Screening methods MeSH
- Child MeSH
- Muscular Dystrophy, Duchenne epidemiology genetics therapy MeSH
- Genetic Predisposition to Disease genetics MeSH
- Genetic Testing methods trends MeSH
- Clinical Trials as Topic methods trends MeSH
- Humans MeSH
- Mutation genetics MeSH
- DNA Mutational Analysis methods trends MeSH
- Registries statistics & numerical data MeSH
- Data Collection methods MeSH
- Muscle Proteins genetics MeSH
- Patient Selection MeSH
- Check Tag
- Child MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Czech Republic MeSH
- Slovakia MeSH
