LOINC: Origin, development of and perspectives for medical research and biobanking – 20 years on the way to implementation in Germany

2019 ◽  
Vol 43 (6) ◽  
pp. 359-382 ◽  
Author(s):  
Sebastian C. Semler
Keyword(s):  
Medical Research ◽  
Grey Literature ◽  
National Level ◽  
Laboratory Data ◽  
Data Communication ◽  
Research Field ◽  
Snomed Ct ◽  
The One ◽  
Definition Of ◽  
Year 2000

Abstract Twenty-five years of LOINC (Logical Observation Identifier Names and Codes) and almost 20 years of experience with the implementation of LOINC in Germany – without having so far achieved a binding national definition of or a relevant routine use of LOINC in laboratory data communication. This article sketches the development of LOINC use in Germany since the year 2000 on the basis of grey literature. For the first time, the use of LOINC in Germany is experiencing a significant impetus at the national level: On the one hand, the current health legislation with its stipulations for a legally defined electronic patient record provides the necessary framework for nationwide stipulations; on the other hand, there is a significant impulse from the German Medical Informatics Initiative (MII) out of the medical research field for implementing a uniform LOINC subset. In recognition of the 25th anniversary of the LOINC nomenclature (1995–2019), the article traces the emergence of LOINC – which is characterized by interactions between European (EUCLIDES, READ, NPU) and US (HL7, LOINC, SNOMED CT) developments and the interplay of various standardization initiatives. Different national definitions and e-health strategies resulting from this history will be a challenge for the future e-health harmonization in the EU. The concerns of medical research and biobanking must be taken into account here, since the standardization of lab data according to international nomenclatures is of utmost importance for them.

PP469 From Theory To Practice: Which Value Framework Is Applied For Onco-Hematology Therapies In Italy? A 5-year Retrospective Analysis

2020 ◽  
Vol 36 (S1) ◽  
pp. 37-37
Author(s):  
Americo Cicchetti ◽  
Rossella Di Bidino ◽  
Entela Xoxi ◽  
Irene Luccarini ◽  
Alessia Brigido
Keyword(s):  
Real World ◽  
Ad Hoc ◽  
Grey Literature ◽  
National Level ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
The Real ◽  
R Process ◽  
The One ◽  
The Impact

IntroductionDifferent value frameworks (VFs) have been proposed in order to translate available evidence on risk-benefit profiles of new treatments into Pricing & Reimbursement (P&R) decisions. However limited evidence is available on the impact of their implementation. It's relevant to distinguish among VFs proposed by scientific societies and providers, which usually are applicable to all treatments, and VFs elaborated by regulatory agencies and health technology assessment (HTA), which focused on specific therapeutic areas. Such heterogeneity in VFs has significant implications in terms of value dimension considered and criteria adopted to define or support a price decision.MethodsA literature research was conducted to identify already proposed or adopted VF for onco-hematology treatments. Both scientific and grey literature were investigated. Then, an ad hoc data collection was conducted for multiple myeloma; breast, prostate and urothelial cancer; and Non Small Cell Lung Cancer (NSCLC) therapies. Pharmaceutical products authorized by European Medicines Agency from January 2014 till December 2019 were identified. Primary sources of data were European Public Assessment Reports and P&R decision taken by the Italian Medicines Agency (AIFA) till September 2019.ResultsThe analysis allowed to define a taxonomy to distinguish categories of VF relevant to onco-hematological treatments. We identified the “real-world” VF that emerged given past P&R decisions taken at the Italian level. Data was collected both for clinical and economical outcomes/indicators, as well as decisions taken on innovativeness of therapies. Relevant differences emerge between the real world value framework and the one that should be applied given the normative framework of the Italian Health System.ConclusionsThe value framework that emerged from the analysis addressed issues of specific aspects of onco-hematological treatments which emerged during an ad hoc analysis conducted on treatment authorized in the last 5 years. The perspective adopted to elaborate the VF was the one of an HTA agency responsible for P&R decisions at a national level. Furthermore, comparing a real-world value framework with the one based on the general criteria defined by the national legislation, our analysis allowed identification of the most critical point of the current national P&R process in terms ofsustainability of current and future therapies as advance therapies and agnostic-tumor therapies.

scholarly journals Limits of permissible intervention in biomedical studies of somatic human rights

2020 ◽  
pp. 92-96
Author(s):  
Myroslava Hromovchuk
Keyword(s):  
Human Rights ◽  
Civil Rights ◽  
Biomedical Research ◽  
National Level ◽  
Central Place ◽  
Legal Regulation ◽  
Constitutional Rights ◽  
Moral Ideal ◽  
The One ◽  
Definition Of

The article examines the features of the essence and content of the constitutional principles of human rights as a basis for legalregulation of biomedical research of somatic human rights. The author reveals the essence and content of international and nationallegal principles of human biomedical research. It was found that there are currently no standards of legal regulation of human rightsprotection during biomedical research at the national level and at the level of international acts in this field. It is pointed out that theissue of human and civil rights and freedoms in the conditions of formation and development of civil society in democratic states occupiesa central place. It is established that the effective provision of constitutional rights and freedoms of man and citizen is associatedwith the need for restrictions in their implementation. It is determined that it is of fundamental importance that the attitude to law, tohuman rights and freedoms for the Ukrainian legal consciousness is impossible only through the awareness of a certain moral ideal asa goal in one’s own life. Therefore, any legal problem for the Ukrainian mentality is inextricably linked with the values of goodnessand justice, truth and humanity.It is noted that the approaches to the definition of “freedom” have both common and different features or certain clarificationsregarding certain manifestations. Without resorting to controversy about the truth or falsity of each of them, by generalizing their content,we can conclude that freedom, on the one hand, is an action according to their own desires, on the other - an action against them.The limits of permissible intervention in conducting biomedical research with human participation have been studied, as well asthe ethical examination of biomedical research as a way to protect human rights has been determined.

Insights from corporate social innovation: a research agenda

2020 ◽  
Vol 16 (3) ◽  
pp. 317-338 ◽  
Author(s):  
Sabrina Tabares
Keyword(s):  
Systematic Review ◽  
Research Agenda ◽  
Social Innovation ◽  
Grey Literature ◽  
Research Field ◽  
The Body ◽  
Content Type ◽  
Definition Of ◽  
Corporate Social Innovation ◽  
Corporate Social

Purpose The purpose of this study is to analyse the contributions, major discussions and trends in the literature driving the research agenda in corporate social innovation (CSI). This is done through a systematic review on CSI publications in an open time span. Salient themes and emerging research topics in this literature, as well as research questions and limitations, are identified, culminating in a discussion of what is next for CSI research. Design/methodology/approach A systematic review was undertaken from academic and grey literature. Results were analysed following a bibliometric and interpretative content analysis. Findings The study provides novel insights on CSI research by drawing attention to discussions around the consensus on a definition of CSI, its disciplinary origins and the denominations referring to this field. Although CSI struggles to gain independence as a research field, the evidence shows that CSI is a cross-disciplinary concept nourished by multiple disciplines. Research limitations/implications Analysis in this paper has implications for research by highlighting the state of scholarship on CSI. Given the use of multiple denominations of CSI, several studies using low diffused denominations could be discarded. Originality/value This research contributes to the body of knowledge in the field of CSI by bringing clarity to former discussions and by suggesting how the field can move forward to a more advanced and mature state in research.

scholarly journals Pharmaceutical Law and Pharmaceutical Legislation in Spain and in the European Union: Concept, Evolution and Sources

2021 ◽  
Vol 87 (87(03)) ◽  
pp. 275-322
Author(s):  
Alfonso Noguera Peña ◽  
Carlos del Castillo Rodríguez
Keyword(s):  
European Union ◽  
National Level ◽  
Professional Activity ◽  
Third Generation ◽  
The European Union ◽  
Concept Evolution ◽  
The Subject ◽  
Regulatory Development ◽  
The One ◽  
Definition Of

Medicines and the professional activity of the pharmacists are the subject of study of Pharmaceutical Law and Pharmaceutical Legislation. In this paper, on the one hand, the definition of these disciplines is examined, as well as their field of study, evolution and sources. On the other hand, the development of Pharmaceutical Legislation in the European Union is analysed in three clearly differentiated periods and related to different juridic enactments of generations of norms that affect medicines. Special attention has been paid to the so–called third generation standards, as the regulatory developments at European Union level and national level have been depened in the last three decades. Finally, those areas of the pharmaceutical sector that could have a regulatory development in the coming years are detailed.

Application of Scanning Electron Microscopy to Medical Research

1969 ◽  
Vol 27 ◽  
pp. 12-13
Author(s):  
J. D. Hutchison
Keyword(s):  
Electron Microscopy ◽  
Electron Microscope ◽  
Medical Research ◽  
Prosthetic Heart Valve ◽  
School Of Medicine ◽  
Transmission Electron ◽  
Definition Of ◽  
Mechanism Of Failure ◽  
The Brain ◽  
Scanning Electron

When the transmission electron microscope was commercially introduced a few years ago, it was heralded as one of the most significant aids to medical research of the century. It continues to occupy that niche; however, the scanning electron microscope is gaining rapidly in relative importance as it fills the gap between conventional optical microscopy and transmission electron microscopy.IBM Boulder is conducting three major programs in cooperation with the Colorado School of Medicine. These are the study of the mechanism of failure of the prosthetic heart valve, the study of the ultrastructure of lung tissue, and the definition of the function of the cilia of the ventricular ependyma of the brain.

Understanding functional illiteracy from a policy, adult education, and cognition point of view: Towards a joint referent framework

2019 ◽  
Vol 30 (2) ◽  
pp. 109-122
Author(s):  
Aleksandar Bulajić ◽  
Miomir Despotović ◽  
Thomas Lachmann
Keyword(s):  
Adult Education ◽  
Operational Definition ◽  
Literacy Skills ◽  
Point Of View ◽  
Industrialized Countries ◽  
Functional Illiteracy ◽  
Scale Levels ◽  
Components Of Reading ◽  
The One ◽  
Definition Of

Abstract. The article discusses the emergence of a functional literacy construct and the rediscovery of illiteracy in industrialized countries during the second half of the 20th century. It offers a short explanation of how the construct evolved over time. In addition, it explores how functional (il)literacy is conceived differently by research discourses of cognitive and neural studies, on the one hand, and by prescriptive and normative international policy documents and adult education, on the other hand. Furthermore, it analyses how literacy skills surveys such as the Level One Study (leo.) or the PIAAC may help to bridge the gap between cognitive and more practical and educational approaches to literacy, the goal being to place the functional illiteracy (FI) construct within its existing scale levels. It also sheds more light on the way in which FI can be perceived in terms of different cognitive processes and underlying components of reading. By building on the previous work of other authors and previous definitions, the article brings together different views of FI and offers a perspective for a needed operational definition of the concept, which would be an appropriate reference point for future educational, political, and scientific utilization.

Democracy and Political Culture

2019 ◽  
Author(s):  
Ross McKibbin
Keyword(s):  
Political Culture ◽  
Case Studies ◽  
Social System ◽  
Political System ◽  
Democratic Politics ◽  
Social Structures ◽  
The Political ◽  
The Subject ◽  
The One ◽  
Definition Of

This book is an examination of Britain as a democratic society; what it means to describe it as such; and how we can attempt such an examination. The book does this via a number of ‘case-studies’ which approach the subject in different ways: J.M. Keynes and his analysis of British social structures; the political career of Harold Nicolson and his understanding of democratic politics; the novels of A.J. Cronin, especially The Citadel, and what they tell us about the definition of democracy in the interwar years. The book also investigates the evolution of the British party political system until the present day and attempts to suggest why it has become so apparently unstable. There are also two chapters on sport as representative of the British social system as a whole as well as the ways in which the British influenced the sporting systems of other countries. The book has a marked comparative theme, including one chapter which compares British and Australian political cultures and which shows British democracy in a somewhat different light from the one usually shone on it. The concluding chapter brings together the overall argument.

An LQ Approach to Active Control of Vibrations in Helicopters

1996 ◽  
Vol 118 (3) ◽  
pp. 482-488 ◽  
Author(s):  
Sergio Bittanti ◽  
Fabrizio Lorito ◽  
Silvia Strada
Keyword(s):  
Optimal Control ◽  
Active Control ◽  
Linear Quadratic ◽  
Control Effort ◽  
Vibration Effect ◽  
Suitable Definition ◽  
Lq Optimal Control ◽  
The One ◽  
Definition Of ◽  
And Control

In this paper, Linear Quadratic (LQ) optimal control concepts are applied for the active control of vibrations in helicopters. The study is based on an identified dynamic model of the rotor. The vibration effect is captured by suitably augmenting the state vector of the rotor model. Then, Kalman filtering concepts can be used to obtain a real-time estimate of the vibration, which is then fed back to form a suitable compensation signal. This design rationale is derived here starting from a rigorous problem position in an optimal control context. Among other things, this calls for a suitable definition of the performance index, of nonstandard type. The application of these ideas to a test helicopter, by means of computer simulations, shows good performances both in terms of disturbance rejection effectiveness and control effort limitation. The performance of the obtained controller is compared with the one achievable by the so called Higher Harmonic Control (HHC) approach, well known within the helicopter community.

Defining Preterm Birth and Stillbirth in the Western Pacific: A Systematic Review

2021 ◽  
pp. 101053952110260
Author(s):  
Mairead Connolly ◽  
Laura Phung ◽  
Elise Farrington ◽  
Michelle J. L. Scoullar ◽  
Alyce N. Wilson ◽  
...  
Keyword(s):  
Preterm Birth ◽  
National Level ◽  
Health Indicators ◽  
Western Pacific ◽  
World Health ◽  
Middle Income ◽  
Middle Income Countries ◽  
Definition Of ◽  
Health Organization ◽  
The Impact

Preterm birth and stillbirth are important global perinatal health indicators. Definitions of these indicators can differ between countries, affecting comparability of preterm birth and stillbirth rates across countries. This study aimed to document national-level adherence to World Health Organization (WHO) definitions of preterm birth and stillbirth in the WHO Western Pacific region. A systematic search of government health websites and 4 electronic databases was conducted. Any official report or published study describing the national definition of preterm birth or stillbirth published between 2000 and 2020 was eligible for inclusion. A total of 58 data sources from 21 countries were identified. There was considerable variation in how preterm birth and stillbirth was defined across the region. The most frequently used lower gestational age threshold for viability of preterm birth was 28 weeks gestation (range 20-28 weeks), and stillbirth was most frequently classified from 20 weeks gestation (range 12-28 weeks). High-income countries more frequently used earlier gestational ages for preterm birth and stillbirth compared with low- to middle-income countries. The findings highlight the importance of clear, standardized, internationally comparable definitions for perinatal indicators. Further research is needed to determine the impact on regional preterm birth and stillbirth rates.

scholarly journals The Smart Forest Conundrum: Contextualizing Pitfalls of Sensors and AI in Conservation Science for Tropical Forests

2021 ◽  
Vol 14 ◽  
pp. 194008292110147
Author(s):  
Dipto Sarkar ◽  
Colin A. Chapman
Keyword(s):  
Tropical Forests ◽  
National Park ◽  
Critical Discussion ◽  
Research Field ◽  
Kibale National Park ◽  
Conservation Science ◽  
Field Station ◽  
Data Production ◽  
Global Corporations ◽  
The One

The term ‘smart forest’ is not yet common, but the proliferation of sensors, algorithms, and technocentric thinking in conservation, as in most other aspects of our lives, suggests we are at the brink of this evolution. While there has been some critical discussion about the value of using smart technology in conservation, a holistic discussion about the broader technological, social, and economic interactions involved with using big data, sensors, artificial intelligence, and global corporations is largely missing. Here, we explore the pitfalls that are useful to consider as forests are gradually converted to technological sites of data production for optimized biodiversity conservation and are consequently incorporated in the digital economy. We consider who are the enablers of the technologically enhanced forests and how the gradual operationalization of smart forests will impact the traditional stakeholders of conservation. We also look at the implications of carpeting forests with sensors and the type of questions that will be encouraged. To contextualize our arguments, we provide examples from our work in Kibale National Park, Uganda which hosts the one of the longest continuously running research field station in Africa.

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