scholarly journals Transfer of Clinical Drug Data to a Research Infrastructure on OMOP – A FAIR Concept

2021 ◽  
Author(s):  
Ines Reinecke ◽  
Michéle Zoch ◽  
Markus Wilhelm ◽  
Martin Sedlmayr ◽  
Franziska Bathelt
Keyword(s):  
Claim Data ◽  
Research Infrastructure ◽  
Common Data Model ◽  
Evidence Based ◽  
Medical Outcomes ◽  
Real World Data ◽  
Open Issue ◽  
Fair Principles ◽  
The Common ◽  
Clinical Drug

Generating evidence based on real-world data is gaining importance in research not least since the COVID-19 pandemic. The Common Data Model of Observational Medical Outcomes Partnership (OMOP) is a research infrastructure that implements FAIR principles. Although the transfer of German claim data to OMOP is already implemented, drug data is an open issue. This paper provides a concept to prepare electronic health record (EHR) drug data for the transfer to OMOP based on requirements analysis and descriptive statistics for profiling EHR data developed by an interdisciplinary team and also covers data quality issues. The concept not only ensures FAIR principles for research, but provides the foundation for German drug data to OMOP transfer.

scholarly journals Honeur (Heamatology Outcomes Network in Europe): A Federated Model to Support Real World Data Research in Hematology

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4839-4839
Author(s):  
Kristina Bardenheuer ◽  
Alun Passey ◽  
Maria d'Errico ◽  
Barbara Millier ◽  
Carine Guinard-Azadian ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Real World ◽  
Data Model ◽  
Quality Analysis ◽  
Common Data Model ◽  
Real World Data ◽  
World Data ◽  
New Concepts ◽  
The Common

Abstract Introduction: The Haematology Outcomes Network in EURope (HONEUR) is an interdisciplinary initiative aimed at improving patient outcomes by analyzing real world data across hematological centers in Europe. Its overarching goal is to create a secure network which facilitates the development of a collaborative research community and allows access to big data tools for analysis of the data. The central paradigm in the HONEUR network is a federated model whereby the data stays at the respective sites and the analysis is executed at the local data sources. To allow for a uniform data analysis, the common data model 'OMOP' (Observational Medical Outcomes Partnership) was selected and extended to accommodate specific hematology data elements. Objective: To demonstrate feasibility of the OMOP common data model for the HONEUR network. Methods: In order to validate the architecture of the HONEUR network and the applicability of the OMOP common data model, data from the EMMOS registry (NCT01241396) have been used. This registry is a prospective, non-interventional study that was designed to capture real world data regarding treatments and outcomes for multiple myeloma at different stages of the disease. Data was collected between Oct 2010 and Nov 2014 on more than 2,400 patients across 266 sites in 22 countries. Data was mapped to the OMOP common data model version 5.3. Additional new concepts to the standard OMOP were provided to preserve the semantic mapping quality and reduce the potential loss of granularity. Following the mapping process, a quality analysis was performed to assess the completeness and accuracy of the mapping to the common data model. Specific critical concepts in multiple myeloma needed to be represented in OMOP. This applies in particular for concepts like treatment lines, cytogenetic observations, disease progression, risk scales (in particular ISS and R-ISS). To accommodate these concepts, existing OMOP structures were used with the definition of new concepts and concept-relationships. Results: Several elements of mapping data from the EMMOS registry to the OMOP common data model (CDM) were evaluated via integrity checks. Core entities from the OMOP CDM were reconciled against the source data. This was applied for the following entities: person (profile of year of birth and gender), drug exposure (profile of number of drug exposures per drug, at ATC code level), conditions (profile of number of occurrences of conditions per condition code, converted to SNOMED), measurement (profile of number of measurements and value distribution per (lab) measurement, converted to LOINC) and observation (profile of number of observations per observation concept). Figure 1 shows the histogram of year of birth distribution between the EMMOS registry and the OMOP CDM. No discernible differences exist, except for subjects which have not been included in the mapping to the OMOP CDM due to lacking confirmation of a diagnosis of multiple myeloma. As additional part of the architecture validation, the occurrence of the top 20 medications in the EMMOS registry and the OMOP CDM were compared, with a 100% concordance for the drug codes, which is shown in Figure 2. In addition to the reconciliation against the different OMOP entities, a comparison was also made against 'derived' data, in particular 'time to event' analysis. Overall survival was plotted from calculated variables in the analysis level data from the EMMOS registry and derived variables in the OMOP CDM. Probability of overall survival over time was virtually identical with only one day difference in median survival and 95% confidence intervals identically overlapping over the period of measurement (Figure 3). Conclusions: The concordance of year of birth, drug code mapping and overall survival between the EMMOS registry and the OMOP common data model indicates the reliability of mapping potential in HONEUR, especially where auxiliary methods have been developed to handle outcomes and treatment data in a way that can be harmonized across platform datasets. Disclosures No relevant conflicts of interest to declare.

scholarly journals Implementing FAIR principles for dissemination of data from the French OZCAR Critical Observatory network: the Theia/OZCAR information system

2020 ◽  
Author(s):  
Isabelle Braud ◽  
Véronique Chaffard ◽  
Charly Coussot ◽  
Sylvie Galle ◽  
Rémi Cailletaud
Keyword(s):  
Information System ◽  
Data Management ◽  
Data Model ◽  
Distribution Systems ◽  
Critical Zone ◽  
Research Infrastructure ◽  
Common Data Model ◽  
In Situ Observation ◽  
Data Discovery ◽  
Fair Principles

<p>OZCAR-RI, the French Critical Zone Research Infrastructure gathers 20 observatories sampling various compartments of the Critical Zone, and having historically developed their own data management and distribution systems. However, these efforts have generally been conducted independently. This has led to a very heterogeneous situation, with different levels of development and maturity of the systems and a general lack of visibility of data from the entire OZCAR-RI community. To overcome this difficulty, a common Information System (Theia/OZCAR IS) was built to make these in situ observation FAIR (Findable, Accessible, Interoperable, Reusable). The IS will allow the data to be visible in the European eLTER-RI (European Long Term Ecosystem Research) Research Infrastructure to which OZCAR-RI contributes.</p><p>The IS architecture was designed after consultation of the users, data producers and IT teams involved in data management. A common data model including all the requested information and based on several metadata standards was defined to set up information fluxes between observatories IS and the Theia/OZCAR IS. Controlled vocabularies were defined to develop a data discovery web portal offering a faceted search with various criteria, including variables names and categories that were harmonized in a thesaurus published on the web. The communication will describe the IS architecture, the pivot data model and open source solutions used to implement the data portal that allows data discovery. The communication will also present future steps to implement data downloading and interoperability services that will allow a full implementation of these FAIR principles.</p>

scholarly journals Streamlining Data and Service Centers for Easier Access to Data and Analytical Services: The Strategy of ODATIS as the Gateway to French Marine Data

2020 ◽  
Vol 7 ◽  
Author(s):  
Sabine Schmidt ◽  
Gilbert Maudire ◽  
Cécile Nys ◽  
Joël Sudre ◽  
Valérie Harscoat ◽  
...  
Keyword(s):  
Data Availability ◽  
Research Infrastructure ◽  
Observation Data ◽  
Use Of Data ◽  
Frequency Monitoring ◽  
Fair Principles ◽  
Marine Data ◽  
Access To Data ◽  
Analytical Services ◽  
Induced Changes

The past few decades have seen a marked acceleration in the amount of marine observation data derived using both in situ and remote sensing measurements. For example, high-frequency monitoring of key physical-chemical parameters has become an essential tool for assessing natural and human-induced changes in coastal waters as well as their consequences on society. The number and variety of data acquisition techniques require efficient methods of improving data availability. The challenge is to make ocean data available via interoperable portals, which facilitate data sharing according to Findable, Accessible, Interoperable, and Reusable (FAIR) principles for producers and users. Ocean DAta Information and Services (ODATIS) aims to become a unique gateway to all French marine data, regardless of the discipline (e.g., physics, chemistry, biogeochemistry, biology, sedimentology). ODATIS is the ocean cluster of the Data Terra research infrastructure for Earth data, which relies on a network of data and service centers (DSC) supported by the major French oceanic research organizations (CNRS, CNES, Ifremer, IRD, SHOM; Marine Universities). ODATIS, through its components, is involved in European and international initiatives such as Copernicus, SeaDataCloud, and EMODnet. The first challenge of ODATIS is to catalog all open ocean and coastal data and facilitate data collection and access (discovery, visualization, extraction) through its web portal. A specific task is to develop tools for handling large amounts of data and generate products for policymakers, practitioners, and academics. This study presents the strategy used by ODATIS to implement the FAIR and CoreTrustSeal requirements in each of its DSCs and promote adherence within the scientific community (the main data producer) regarding the upload and/or use of data and suggestion of new products. A second challenge is to cover the end-user needs ranging from proximity to the producer to cross-analysis of data from all Earth compartments. This involves defining and organizing a classification of DSCs in the network, which will be developed within the framework of the French Data Terra research infrastructure, the only framework capable of providing the necessary IT and human resources.

scholarly journals Bias against Vitamin C in Mainstream Medicine: Examples from Trials of Vitamin C for Infections

Life ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. 62
Author(s):  
Harri Hemilä ◽  
Elizabeth Chalker
Keyword(s):  
Clinical Trials ◽  
Vitamin C ◽  
Common Cold ◽  
Evidence Based Medicine ◽  
Evidence Based ◽  
The Third ◽  
Nutritional Recommendations ◽  
Mainstream Medicine ◽  
The Common ◽  
Based Medicine

Evidence has shown unambiguously that, in certain contexts, vitamin C is effective against the common cold. However, in mainstream medicine, the views on vitamin C and infections have been determined by eminence-based medicine rather than evidence-based medicine. The rejection of the demonstrated benefits of vitamin C is largely explained by three papers published in 1975—two published in JAMA and one in the American Journal of Medicine—all of which have been standard citations in textbooks of medicine and nutrition and in nutritional recommendations. Two of the papers were authored by Thomas Chalmers, an influential expert in clinical trials, and the third was authored by Paul Meier, a famous medical statistician. In this paper, we summarize several flaws in the three papers. In addition, we describe problems with two recent randomized trial reports published in JAMA which were presented in a way that misled readers. We also discuss shortcomings in three recent JAMA editorials on vitamin C. While most of our examples are from JAMA, it is not the only journal with apparent bias against vitamin C, but it illustrates the general views in mainstream medicine. We also consider potential explanations for the widespread bias against vitamin C.

scholarly journals N.V. Gogol’s Works and Censorship

Literary Fact ◽  
2021 ◽  
pp. 238-256
Author(s):  
Igor A. Vinogradov
Keyword(s):  
Literary Criticism ◽  
Good Reason ◽  
Evidence Based ◽  
Previous Period ◽  
Analytical Review ◽  
Negative Role ◽  
The Common ◽  
The Government ◽  
First Time

For the first time, an analytical review of all, without exception, censorship stories of N.V. Gogol’s works is presented. An objective picture of Gogol's relationship with the censorship is being recreated. The findings of the study allow, with good reason, to judge about the interference of censors in the writer's works in a fundamentally different way, in comparison with the ideas offered by literary criticism of the previous period without solid evidence. Based on a thorough analysis, involving numerous archival sources, the common, stereotypical opinions about the extremely negative role of censorship in Gogol’s fate are being revised. The most significant negative result among all censorship interventions in Gogol's works was the activity of the censor of Westernizing views, opposed to the government, a professor at St. Petersburg University, A.V. Nikitenko. It is the numerous reductions of Nikitenko, И.А. Виноградов. Произведения Н .В. Гоголя и цензура 255 a friend of V.G. Belinsky, in Gogol's religious and patriotic book “Selected Passages from Correspondence with Friends” that the writer called “censorship murder”. No less significant was the intervention of the liberal censor in the texts of “Dead Souls”, “Theatrical Travel after the Presentation of a New Comedy” and other works of the writer. It is concluded that, with the exception of this “intrigue” against Gogol by the censor Nikitenko, on the whole Gogol's texts encountered relatively insignificant difficulties in censorship.

Chapter 9: Pathways Toward Desirable Futures

2021 ◽  
pp. 1-8
Author(s):  
Murray F. Mitchell ◽  
Hal A. Lawson ◽  
Hans van der Mars ◽  
Phillip Ward
Keyword(s):  
Physical Education ◽  
Common Good ◽  
Evidence Based ◽  
Societal Change ◽  
Special Issue ◽  
Distinctive Features ◽  
The Common ◽  
Education Profession ◽  
Education Model ◽  
Fierce Competition

This special issue was designed to facilitate futures-oriented planning, focused on identical, similar, and unique practice and policy priorities. Formal planning aimed at desirable futures is a practical necessity for every helping profession because rapid, sometimes dramatic, societal change continues nonstop. Like all futures-oriented analyses, ours is unavoidably selective. Selectivity, once recognized, is a strength because readers are not asked to view the main claims and recommendations as a final authority. Selective research and scholarship focused on the creation and safeguarding of desirable futures has generative propensities that can provide the impetus for subsequent proposals aimed at the common good. In this chapter, the authors offer an integrative summary of the work in this special issue. Our summary invites readers’ special attention to distinctive features in their respective home contexts. This perspective stands in stark contrast to 20th Century models often described as “one best system” and “one ideal physical education model.” Justifiable variability—where “justifiable” means evidence-based and harmonized values—is the new norm for the 21st Century. The authors conclude that the physical education profession will benefit to the extent that it adopts the theme offered in this special issue. Unity founded on diversity—an idea whose time has come in a field known for fierce competition over curricula and programs.

An Evidence-Based Health Information System Theory

2011 ◽  
pp. 1994-2011
Author(s):  
Daniel Carbone
Keyword(s):  
Information Systems ◽  
Systems Theory ◽  
Health Information ◽  
Health Sector ◽  
Health Information System ◽  
Building Blocks ◽  
Evidence Based ◽  
Supporting Evidence ◽  
The Common ◽  
Is Theory

The aim of this chapter is to bridge the gap between what is known about IS theory and the specifics characteristics of health to develop an evidence based health information systems theory. An initial background first sets the significance for the need to have a solid information systems theory in health and then argues that neither the information systems literature nor the health sector have been able to provide any satisfactory pathway to facilitate the adoption of information systems in health settings. The chapter further continues by reviewing the common pathway to develop information systems theory and the knowledge foundations used in the process, and then proceeds to highlight how this theory was developed. Subsequently, the building blocks (constructs, premises, supporting evidence and conclusions) that underpins the constructs and a brief explanation of the relationships between them is included. A discussion and limitation section is then followed by a conclusion.

Self-Directed Approaches to the Treatment of Depression

2016 ◽  
pp. 468-477
Author(s):  
Pim Cuijpers ◽  
Annet Kleiboer
Keyword(s):  
Depressive Disorders ◽  
Future Research ◽  
Evidence Based ◽  
Advantages And Disadvantages ◽  
Self Help ◽  
Treatment Of Depression ◽  
High Prevalence ◽  
Evidence Based Treatments ◽  
The Common

This article examines self-directed approaches to the treatment of depression. It first considers some of the reasons why the uptake of mental health services by depressed people is low, despite the high prevalence of depressive disorders and the availability of evidence-based treatments. It then looks at the role of self-management in increasing access to evidence-based treatments for depression. It also defines what self-directed treatments are and goes on to discuss the different types of self-directed therapy, the common components of self-directed interventions for depression, Internet-based interventions for depression, and the advantages and disadvantages of self-directed interventions. Finally, it summarizes the findings from research on self-directed interventions for depression and suggests directions for future research and development in this area. Some titles of self-help books that can be used in self-directed interventions are presented.

Common Factors: What Are They and What Do They Mean for Humanistic Psychology?

2019 ◽  
pp. 002216781985853
Author(s):  
David N. Elkins
Keyword(s):  
Common Factors ◽  
Humanistic Psychology ◽  
Evidence Based ◽  
Scientific Support ◽  
Clinical Literature ◽  
Relational Factors ◽  
Research Findings ◽  
The Common

Although common factors have been widely discussed in the clinical literature, the two questions addressed in this article remain relevant: (a) What are the common factors? (b) What do they mean for humanistic psychology? The first question is important because there is no “definitive list” of common factors, and lists presented in the literature often differ dramatically. In response to this question, the article suggests that an evidence-based list of nine common factors by Wampold provides a useful and credible list. The second question is also important, particularly to humanistic psychologists. Among other answers, the article shows that research findings on common factors provide scientific support for humanistic psychology’s emphasis on the importance of the human and relational factors in psychotherapy.

Sign in / Sign up

Export Citation Format

Share Document