Rationale, design and conduct of a comprehensive evaluation of a primary care based intervention to improve the quality of life of osteoarthritis patients. The PraxArt-project: a cluster randomized controlled trial [ISRCTN87252339] ; study protocol

Background: Osteoarthritis (OA) has a high prevalence in primary care. Conservative, guideline orientated approaches aiming at improving pain treatment and increasing physical activity, have been proven to be effective in several contexts outside the primary care setting, as for instance the Arthritis Self management Programs (ASMPs). But it remains unclear if these comprehensive evidence based approaches can improve patients' quality of life if they are provided in a primary care setting. Methods/Design: PraxArt is a cluster randomised controlled trial with GPs as the unit of randomisation. The aim of the study is to evaluate the impact of a comprehensive evidence based medical education of GPs on individual care and patients' quality of life. 75 GPs were randomised either to intervention group I or II or to a control group. Each GP will include 15 patients suffering from osteoarthritis according to the criteria of ACR. In intervention group I GPs will receive medical education and patient education leaflets including a physical exercise program. In intervention group II the same is provided, but in addition a practice nurse will be trained to monitor via monthly telephone calls adherence to GPs prescriptions and advices and ask about increasing pain and possible side effects of medication. In the control group no intervention will be applied at all. Main outcome measurement for patients' QoL is the GERMAN-AIMS2-SF questionnaire. In addition data about patients' satisfaction (using a modified EUROPEP-tool), medication, health care utilization, comorbidity, physical activity and depression (using PHQ-9) will be retrieved. Measurements (pre data collection) will take place in months I-III, starting in June 2005. Post data collection will be performed after 6 months. Discussion: Despite the high prevalence and increasing incidence, comprehensive and evidence based treatment approaches for OA in a primary care setting are neither established nor evaluated in Germany. If the evaluation of the presented approach reveals a clear benefit it is planned to provide this GP-centred interventions on a much larger scale

ELSID-diabetes study-evaluation of a large scale implementation of disease management programmes for patients with type 2 diabetes. Rationale, design and conduct : a study protocol

Background: Diabetes model projects in different regions of Germany including interventions such as quality circles, patient education and documentation of medical findings have shown improvements of HbA1c levels, blood pressure and occurrence of hypoglycaemia in before-after studies (without control group). In 2002 the German Ministry of Health defined legal regulations for the introduction of nationwide disease management programs (DMP) to improve the quality of care in chronically ill patients. In April 2003 the first DMP for patients with type 2 diabetes was accredited. The evaluation of the DMP is essential and has been made obligatory in Germany by the Fifth Book of Social Code. The aim of the study is to assess the effectiveness of DMP by example of type 2 diabetes in the primary care setting of two German federal states (Rheinland-Pfalz and Sachsen-Anhalt). Methods/Design: The study is three-armed: a prospective cluster-randomized comparison of two interventions (DMP 1 and DMP 2) against routine care without DMP as control group. In the DMP group 1 the patients are treated according to the current situation within the German-Diabetes-DMP. The DMP group 2 represents diabetic care within ideally implemented DMP providing additional interventions (e.g. quality circles, outreach visits). According to a sample size calculation a sample size of 200 GPs (each GP including 20 patients) will be required for the comparison of DMP 1 and DMP 2 considering possible drop-outs. For the comparison with routine care 4000 patients identified by diabetic tracer medication and age (> 50 years) will be analyzed. Discussion: This study will evaluate the effectiveness of the German Diabetes-DMP compared to a Diabetes-DMP providing additional interventions and routine care in the primary care setting of two different German federal states

Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management) : study protocol

Background: Chronic congestive heart failure (CHF) is a complex disease with rising prevalence, compromised quality of life (QoL), unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP) can improve patients' QoL. Methods/Design: HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific selfmanagement, (non)pharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation). Patients from control group receive usual care by their GPs, who were introduced to guidelineoriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ), depression and anxiety disorders (PHQ-9, GAD-7), adherence (EHFScBS and SANA), quality of care measured by an adapted version of the Patient Chronic Illness Assessment of Care questionnaire (PACIC) and NTproBNP. In addition, comprehensive clinical data are collected about health status, comorbidity, medication and health care utilisation. Discussion: As the targeted patient group is mostly cared for and treated by GPs, a comprehensive primary care-based guideline implementation including somatic, psychosomatic and organisational aspects of the delivery of care (HICMAn) is a promising intervention applying proven strategies for optimal care. Trial registration: Current Controlled Trials ISRCTN30822978

Estimating Production of Brewery and Distillery Spent Grains in Tennessee and Identifying Sustainable Uses

Brewery and distillery spent grains (BDSG) are a by-product of the fermentation process and consists of various grains, hops, and flavor additives. Large breweries and distilleries can establish and maintain marketing channels to dispose of BDSG typically as a livestock feed. However, small-scale businesses may lack the necessary resources and contacts to dispose of BDSG, thus creating the potential disposal of BDSG through a landfill or wastewater system. This study aims to estimate the production of BDSG by craft breweries and distilleries in the state of Tennessee and identify sustainable uses and marketing channels for the product, which includes use as animal feeds and composts, soil amendments, or fertilizers for traditional agriculture and urban agriculture.The objectives of the study are: i) determine the quantity of BDSG being produced in Tennessee by craft breweries and distilleries; ii) determine current BDSG disposal practices; and iii) determine the cost-savings for farmers resulting from BDSG disposal by breweries and distilleries as a livestock feed. These objectives were accomplished by surveying craft breweries and distilleries in Tennessee regarding their production practices and developing a linear programming model to determine the value of BDSG as a livestock feed for beef cattle.Results of the survey indicate that the majority of breweries and distilleries are disposing of their spent grains as a livestock feed, with 100 percent of breweries and 87 percent of distilleries indicating that they dispose of at least a portion of their spent grains in this manner. Conversely, few breweries and distilleries are disposing of their spent grains as a compost, soil amendment, or fertilizer with only 15 percent of breweries and eight percent of distilleries selecting this method of disposal. Average annual production of BSG and DSG per brewery and distillery in the survey was 65,800 pounds and 51,808 gallons. Results of the least-cost winter feed ration suggest that significant cost savings can be afforded to farmers by including spent grains at their average daily production rate of 7.2 pounds of BSG and 47.1 pounds of DSG

Data Privacy in European Medical Research

The European Data Protection Regulation applies since May 25th, 2018. It creates a uniform data protection legal framework within the EU. National and international medical research projects, regardless of whether they were started before or after the introduction of the GDPR, are obliged to follow this new regulation and implement it promptly. This raises various challenges for a large number of medical research projects. The University Medicine Greifswald commissioned this legal report, that was prepared by DIERKS+COMPANY. Two real-world research projects, the Baltic Fracture Competence Centre (BFCC) as well as the German Centre for Cardiovascular Research (DZHK) provide use cases, questions, and context for this legal report. It addresses questions regarding all steps of data processing. The report provides practical answers to a wide array of technical and organisational questions in the area of data protection-compliant processing of research data. A comprehensive guide to GDPR-compliant data processing has been developed, which both summarises the broad legal environment and provides specific assistance in the design and implementation of GDPR-compliant data management processes, including Informed Consent, Legal Consequences of Withdrawal, and Privacy by Design

Open Government in Deutschland - welche Ziele des Koalitionsvertrags hat die aktuelle Bundesregierung bis jetzt erreicht?

Dieses Paper geht auf eine Prüfungsleistung vom 14.02.2016 in der Lehrveranstaltung „Aktuelle Entwicklungen im Informationsmanagement“ im Wintersemester 2015/16 aus dem Studiengang Informationsmanagement (berufsbegleitend) der Hochschule Hannover unter Frau Dr. Ina Blümel zurück. Das Ergebnis dieser Untersuchung ist eine umfassenden Literatur- und Internetrecherche zum Thema Open Government in Deutschland. Hierbei steht die Fragestellung "Welche Ziele hat die aktuelle Bundesregierung bis jetzt erreicht?" auf Basis des Koalitionsvertrags der 18.Legislaturperiode im Mittelpunkt. Es wird eine Übersicht über die Gesetzesgrundlage mit einem Fokus auf dem e-Government-Gesetz gegeben. Zudem wird der aktuelle Sachstand des Koalitionsvertrags betreffend Open Government an neun Punkten betrachtet und abschließend bewertet

Big Data in Context: Legal, Social and Technological Insights

privacy; data protection; data mining; predictive analytic

Privacy and data protection in India and Germany: A comparative analysis

This research report offers a comparative analysis of privacy and data protection in Germany and India. It compares the two regimes on four counts. First, it examines how the right to privacy and/or its allied rights have developed in the two countries historically. In this, it explores the political factors contributing to the understanding and acceptability of the principles of privacy in the decades after the Second World War. Second, it delves into the instruments and forms of state surveillance employed by both the countries and analyses how the presence of parliamentary and judicial oversight on intelligence agencies impacts individual privacy. In the third section, it compares how biometric identity systems have been deployed in the two countries, the safeguards designed around the same, and the legal challenges they have thrown up. Lastly, it evaluates data subject rights as defined under the General Data Protection Regulation (GDPR) together with the Bundesdatenschutzgesetz-Neu (BDSG-Neu) and how they compare with those as defined under the Draft Personal Data Protection Bill, 2018 in the Indian context