Toolbox for Research, or how to facilitate a central data management in small-scale research projects.

BACKGROUND: In most research projects budget, staff and IT infrastructures are limiting resources. Especially for small-scale registries and cohort studies professional IT support and commercial electronic data capture systems are too expensive. Consequently, these projects use simple local approaches (e.g. Excel) for data capture instead of a central data management including web-based data capture and proper research databases. This leads to manual processes to merge, analyze and, if possible, pseudonymize research data of different study sites. RESULTS: To support multi-site data capture, storage and analyses in small-scall research projects, corresponding requirements were analyzed within the MOSAIC project. Based on the identified requirements, the Toolbox for Research was developed as a flexible software solution for various research scenarios. Additionally, the Toolbox facilitates data integration of research data as well as metadata by performing necessary procedures automatically. Also, Toolbox modules allow the integration of device data. Moreover, separation of personally identifiable information and medical data by using only pseudonyms for storing medical data ensures the compliance to data protection regulations. This pseudonymized data can then be exported in SPSS format in order to enable scientists to prepare reports and analyses. CONCLUSIONS: The Toolbox for Research was successfully piloted in the German Burn Registry in 2016 facilitating the documentation of 4350 burn cases at 54 study sites. The Toolbox for Research can be downloaded free of charge from the project website and automatically installed due to the use of Docker technology.

Is there an association between spatial accessibility of outpatient care and utilization? Analysis of gynecological and general care.

BACKGROUND: In rural regions with a low population density, distances to health care providers as well as insufficient public transport may be barriers for the accessibility of health care. In this analysis it was examined whether the accessibility of gynecologists and GPs, measured as travel time both by car and public transport has an influence on the utilization of health care in the rural region of Western Pomerania in Northern Germany. METHODS: Utilization data was obtained from the population based Study of Health in Pomerania (SHIP). Utilization was operationalized by the parameter "at least one physician visit during the last 12 months". To determine travel times by car and by public transport, network analyses were conducted in a Geographic Information System (GIS). Multivariate logistic regression models were calculated to identify determinants for the utilization of gynecologists and GPs. RESULTS: There is no significant association between the accessibility by car or public transport and the utilization of gynecologists and GPs. Significant predictors for the utilization of gynecologists in the regression model including public transport are age (OR 0.960, 95% CI 0.950-0.971, p < 0.0001), social class (OR 1.137, 95% CI 1.084-1.193, p < 0.0001) and having persons ≥18 years in the household (OR 2.315, 95% CI 1.116-4.800, p = 0.0241). CONCLUSIONS: In the examined region less utilization of gynecologists is not explainable with long travel times by car or public transport.

Accessibility of general practitioners and selected specialist physicians by car and by public transport in a rural region of Germany.

BACKGROUND: The accessibility of medical care facilities in sparsely populated rural regions is relevant especially for elderly people which often represent a large segment of the population in such regions. Elderly people have higher morbidity risks and a higher demand for medical care. Although travelling with private cars is the dominating traffic mode in rural regions, accessibility by public transport is increasingly important especially because of limited mobility of elderly people. The aim of this study was to determine accessibility both by car and public transport to general practitioners (GP) and selected specialist physicians for a whole region and to detect areas with poor to no access in the county Vorpommern-Greifswald, which is a rural and sparsely populated region in the very northeast of Germany. METHODS: Accessibility of medical care facilities by car was calculated on the basis of a network analysis within a geographic information system (GIS) with routable street data. Accessibility by public transport was calculated using GIS and a network analysis based on the implementation of Dijkstra's algorithm. RESULTS: The travelling time to general practitioners (GP) by car in the study region ranges from 0.1 to 22.9 min. This is a significant difference compared to other physician groups. Traveling times to specialist physicians are 0.4 to 42.9 min. A minority of 80 % of the inhabitants reach the specialist physicians within 20 min. The accessibility of specialist physicians by public transport is poor. The travel time (round trip) to GPs averages 99.3 min, to internists 143.0, to ophthalmologists 129.3 and to urologists 159.9 min. These differences were significant. Assumed was a one hour appointment on a Tuesday at 11 am. 8,973 inhabitants (3.8 %) have no connection to a GP by public transport. 15,455 inhabitants (6.5 %) have no connection to specialist internists. CONCLUSIONS: Good accessibility by public transport is not a question of distance but of transport connections. GIS analyses can detect areas with imminent or manifest deficits in the accessibility of health care providers. Accessibility analyses should be established instruments in planning issues.

A workflow-driven approach to integrate generic software modules in a Trusted Third Party.

BACKGROUND: Cohort studies and registries rely on massive amounts of personal medical data. Therefore, data protection and information security as well as ethical aspects gain in importance and need to be considered as early as possible during the establishment of a study. Resulting legal and ethical obligations require a precise implementation of appropriate technical and organisational measures for a Trusted Third Party. METHODS: This paper defines and organises a consistent workflow-management to realize a Trusted Third Party. In particular, it focusses the technical implementation of a Trusted Third Party Dispatcher to provide basic functionalities (including identity management, pseudonym administration and informed consent management) and measures required to meet study specific conditions of cohort studies and registries. Thereby several independent open source software modules developed and provided by the MOSAIC project are used. This technical concept offers the necessary flexibility and extensibility to address legal and ethical requirements of individual scenarios. RESULTS: The developed concept for a Trusted Third Party Dispatcher allows mapping single process steps as well as individual requirements and characteristics of particular studies to workflows, which in turn can be combined to model complex Trusted Third Party processes. The uniformity of this approach permits unrestricted re-combination of the available functionalities (depending on the applied software modules) for various research projects. CONCLUSION: The proposed approach for the technical implementation of an independent Trusted Third Party reduces the effort for scenario specific implementations as well as for maintenance. The applicability and the efficacy of the concept for a workflow-driven Trusted Third Party could be confirmed during the establishment of several nationwide studies (e.g. German Centre for Cardiovascular Research and the National Cohort).

Improving hospital hygiene to reduce the impact of multidrug-resistant organisms in health care--a prospective controlled multicenter study.

BACKGROUND: Nosocomial infections are the most common complication during inpatient hospital care. An increasing proportion of these infections are caused by multidrug-resistant organisms (MDROs). This report describes an intervention study which was designed to address the practical problems encountered in trying to avoid and treat infections caused by MDROs. The aim of the HARMONIC (Harmonized Approach to avert Multidrug-resistant Organisms and Nosocomial Infections) study is to provide comprehensive support to hospitals in a defined study area in north-east Germany, to meet statutory requirements. To this end, a multimodal system of hygiene management was implemented in the participating hospitals. METHODS/DESIGN: HARMONIC is a controlled intervention study conducted in eight acute care hospitals in the 'Health Region Baltic Sea Coast' in Germany. The intervention measures include the provision of written recommendations on methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE) and multi-resistant Gram-negative bacteria (MRGN), supplemented by regional recommendations for antibiotic prescriptions. In addition, there is theoretical and practical training of health care workers (HCWs) in the prevention and handling of MDROs, as well as targeted and critically gauged applications of antibiotics. The main outcomes of the implementation and analysis of the HARMONIC study are: (i) screening rates for MRSA, VRE and MRGN in high-risk patients, (ii) the frequency of MRSA decolonization, (iii) the level of knowledge of HCWs concerning MDROs, and (iv) specific types and amounts of antibiotics used. The data are predominantly obtained by paper-based questionnaires and documentation sheets. A computer-assisted workflow-based documentation system was developed in order to provide support to the participating facilities. The investigation includes three nested studies on risk profiles of MDROs, health-related quality of life, and cost analysis. A six-month follow-up study investigates the quality of life after discharge, the long-term costs of the treatment of infections caused by MDROs, and the sustainability of MRSA eradication. DISCUSSION: The aim of this study is to implement and evaluate an area-wide harmonized hygiene program to control the nosocomial spreading of MDROs. Comparability between the intervention and control group is ensured by matching the hospitals according to size (number of discharges per year/number of beds) and level of care (standard or maximum). The results of the study may provide important indications for the implementation of regional MDRO management programs.

A mobile and asynchronous electronic data capture system for epidemiologic studies.

A Central Data Management (CDM) system based on electronic data capture (EDC) software and study specific databases is an essential component for assessment and management of large data volumes in epidemiologic studies. Conventional CDM systems using web applications for data capture depend on permanent access to a network. However, in many study settings permanent network access cannot be guaranteed, e.g. when participants/patients are visited in their homes. In such cases a different concept for data capture is needed. The utilized EDC software must be able to ensure data capture as stand-alone instance and to synchronize captured data with the server at a later point in time. This article describes the design of the mobile information capture (MInCa) system an EDC software meeting these requirements. In particular, we focus on client and server design, data synchronization, and data privacy as well as data security measures. The MInCa software has already proven its efficiency in epidemiologic studies revealing strengths and weaknesses concerning both concept and practical application which will be addressed in this article.