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The development and deployment of Common Data Elements for tissue banks for translational research in cancer – An emerging standard based approach for the Mesothelioma Virtual Tissue Bank

Sambit K Mohanty, Amita T Mistry, Waqas Amin, Anil V Parwani, Andrew K Pople, Linda Schmandt, Sharon B Winters, Erin Milliken, Paula Kim, Nancy B Whelan, Ghada Farhat, Jonathan Melamed (+4 others)
2008 BMC Cancer  
Combining these approaches creates a set of International Standards Organization (ISO) -compliant Common Data Elements (CDEs) for the mesothelioma tissue banking initiative supported by the National Institute  ...  Methods: The purpose of the project is to develop a core set of data elements for annotating mesothelioma specimens, following standards established by the CAP checklist, ADASP cancer protocols, and the  ...  Acknowledgements This work is supported by the Centers for Disease Control and Prevention (CDC) and the National Institute for Occupational Safety and Health (NIOSH) Grant 1U19OH009077-01 (IRB #0608194  ... 
doi:10.1186/1471-2407-8-91 pmid:18397527 pmcid:PMC2329649 fatcat:fimhdwbxwrd77nrdadnj24fx3m

Improving the value of clinical research through the use of Common Data Elements

Jerry Sheehan, Steven Hirschfeld, Erin Foster, Udi Ghitza, Kerry Goetz, Joanna Karpinski, Lisa Lang, Richard P Moser, Joanne Odenkirchen, Dianne Reeves, Yaffa Rubinstein, Ellen Werner (+1 others)
2016 Clinical Trials  
CDEs, especially when they conform to accepted standards, are identified by research communities from variable sets currently in use or are newly developed to address a designated data need.  ...  The use of Common Data Elements (CDEs) can facilitate cross study comparisons, data aggregation and meta-analyses, simplify training and operations, improve overall efficiency, promote interoperability  ...  Acknowledgments Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.  ... 
doi:10.1177/1740774516653238 pmid:27311638 pmcid:PMC5133155 fatcat:47lpdw3udzh6helkiv6vzgo4dq

Cooperating on Data: The Missing Element in Bringing Real Innovation to Europe's Healthcare Systems

Denis Horgan, Chiara Bernini, Pierre P.M. Thomas, Servaas A. Morre
2019 Public Health Genomics  
There was strong appreciation of the merits of data sharing and readiness - under the right circumstances - to share personal health data for research purposes and to undergo genetic sequencing.  ...  The responses demonstrated a widespread genuine will to promote research and innovation, and its take-up, for the betterment of healthcare.  ...  Also, thanks to the contribution from the consortium of DigitalHealthEurope: Support to a Digital Health and Care Innovation initiative in the context of Digital Single Market strategy.  ... 
doi:10.1159/000503296 pmid:31634895 pmcid:PMC6943808 fatcat:u4ilzu3oujhk3gokpmww42c3si

Blockchain and genomic research legal regulation: element in mechanism for interest's balancing

Aleksey Kubyshkin, Daria Ponomareva, F.V. Fetyukov
2022 SHS Web of Conferences  
Examples of the use of blockchain technology in healthcare are given, and proposals of various researchers on the use of this technology in the field of genomic research are analyzed.  ...  At the same time, the place of blockchain technology in the specified mechanism is determined, conclusions and approaches are proposed for using this technology to ensure a balance of private, group and  ...  Initially, this technology was used for the formation and circulation of so-called cryptocurrencies.  ... 
doi:10.1051/shsconf/202213400073 fatcat:7nicv5ejfvhhbdyjpqljjegjhe

Common Data Elements and Federal Interagency Traumatic Brain Injury Research Informatics System for TBI Research

Hilaire J. Thompson, Monica S. Vavilala, Frederick P. Rivara
2015 Annual Review of Nursing Research  
As a result of federal interagency efforts, common data elements (CDEs) for TBI have now been developed.  ...  A specific exemplar using the CDEs and lessons learned from working with the CDEs and FITBIR are included to aid future researchers.  ...  Acknowledgments This work was supported, in part, by a grant from the NIH/National Institute of Neurologic Diseases and Stroke R01NS077913.  ... 
doi:10.1891/0739-6686.33.1 pmid:25946381 pmcid:PMC4704986 fatcat:3cw44h6vgbhnjmxihbrk72fjhm

A Scoping Review and Analysis of Simulation Facilitator Essential Elements

Lori Hardie, Lori Lioce
2020 Nursing & Primary Care  
, which were then coded, and themes abstracted using a computer assisted qualitative data analysis software.  ...  quality and safety improvement, and 7) Committment to professional development at every level.  ...  The NLN program has profoundly impacted us personally and professionally.  ... 
doi:10.33425/2639-9474.1152 fatcat:fbkuxa6odbh53pr7g4hasfzznu

Mapping clinical phenotype data elements to standardized metadata repositories and controlled terminologies: the eMERGE Network experience

Jyotishman Pathak, Janey Wang, Sudha Kashyap, Melissa Basford, Rongling Li, Daniel R Masys, Christopher G Chute
2011 JAMIA Journal of the American Medical Informatics Association  
and metadata resources was initiated by eMERGE investigators.  ...  A key aspect in facilitating such studies requires standardized representation of the phenotype data using common data elements (CDEs) and controlled biomedical vocabularies.  ...  Funding The eMERGE Network was initiated and funded by NHGRI, in conjunction with additional funding from NIGMS through the following grants: U01-HG-004610 (Group Health Cooperative); U01-HG-004608 (Marshfield  ... 
doi:10.1136/amiajnl-2010-000061 pmid:21597104 pmcid:PMC3128396 fatcat:nesbi7ztfbgx7imlbbxsf36y4m

ACC/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Chronic Heart Failure

Martha J. Radford
2005 Journal of the American College of Cardiology  
It is hoped that these clinical data standards will: 1. Improve cross-comparison of results and clinical outcomes between different trials and registries. 2.  ...  focus and enable the use of these data elements in many situations by many users.  ...  Quality of life is a distinct concept that refers to patients' integration of their current symptoms and functioning with their desired symptoms and functioning.  ... 
doi:10.1016/j.jacc.2005.07.013 fatcat:plabrwxyjrenhekbiwlf5vr2ce

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)

Vojtech Huser, Chandan Sastry, Matthew Breymaier, Asma Idriss, James J. Cimino
2015 Journal of Biomedical Informatics  
ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data).  ...  ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts.  ...  We would like to thank the BTRIS team for contributing relevant information regarding the NIH clinical research data repository.  ... 
doi:10.1016/j.jbi.2015.06.023 pmid:26188274 pmcid:PMC4714951 fatcat:gj5czthspffy3ccejhzrdq4kmi

Common Elements in Rare Kidney Diseases: Conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference

Ségolène Aymé, Detlef Bockenhauer, Simon Day, Olivier Devuyst, Lisa M. Guay-Woodford, Julie R. Ingelfinger, Jon B. Klein, Nine V.A.M. Knoers, Ronald D. Perrone, Julia Roberts, Franz Schaefer, Vicente E. Torres (+56 others)
2017 Kidney International  
EUCERD core recommendations on rare disease patient registration and data collection, 5 June  ...  The current gold standard for the diagnosis of cystinosis is the detection of elevated cystine levels in white blood cells.  ...  Social media Information Simple film, audio and print in- formation targeting visual or auditory learners may be most effective Patient associations Involved at every level Provide support Research  ... 
doi:10.1016/j.kint.2017.06.018 pmid:28938953 fatcat:i2fa6bqpyjf3ho2pchmjd3ri4i

Composite CDE: modeling composite relationships between common data elements for representing complex clinical data

Hye Hyeon Kim, Yu Rang Park, Suehyun Lee, Ju Han Kim
2020 BMC Medical Informatics and Decision Making  
The ISO/IEC 11179 Metadata Registry (MDR) standard has been highlighted as a solution for standardizing and registering clinical data elements (DEs).  ...  The present study created new and further extended existing semantic types (hybrid atomic and repeated and dictionary composite common data elements [CDEs]) with four constraints: ordered, operated, required  ...  Acknowledgements Authors thank the five institutions to generously provided their clinical document for common data element evaluations.  ... 
doi:10.1186/s12911-020-01168-0 pmid:32620117 fatcat:a7y5x4nra5fvjhyvmpjwgniyym

Designing Data Elements and Minimum Data Set (MDS) for Creating the Registry of Patients with Gestational Diabetes Mellitus

Maryam Ahmadi, Esmat Mirbagheri
2019 Journal of Medicine and Life  
The validity of the questionnaire was examined by a team of experts and its reliability was examined by using Cronbach's alpha.  ...  Collection of patients' data is commonly conducted through using medical records.  ...  Acknowledgment This study has been funded and supported by Iran University of Medical Sciences (IUMS); Grant No.96-04-136-31843.  ... 
doi:10.25122/jml-2019-0011 pmid:31406518 pmcid:PMC6685309 fatcat:tcn6vhu4y5fkdbi7j4n6yvswhi

Teaching Pharmacovigilance: the WHO-ISoP Core Elements of a Comprehensive Modular Curriculum

Jürgen Beckmann, Ulrich Hagemann, Priya Bahri, Andrew Bate, Ian W. Boyd, Gerald J. Dal Pan, Brian D. Edwards, I. Ralph Edwards, Kenneth Hartigan-Go, Marie Lindquist, John McEwen, Yola Moride (+6 others)
2014 Drug Safety  
and appropriate software 7P2 Enter data from an ICSR into an electronic database using the ICH-E2B format and available software 7P3 Retrieve ICSRs from a database with various questions and at  ...  : standardised entry screens, search support, stratification of data 7.4.3 Descriptive statistics (presenting numbers; not analysing and testing) 7.4.4 Format of retrieval results: line listings,  ... 
doi:10.1007/s40264-014-0216-1 pmid:25171836 fatcat:yrz55y3h2fcv7oz5wol6mzzqtm

Identification of genetic elements in metabolism by high-throughput mouse phenotyping

Jan Rozman, Birgit Rathkolb, Manuela A. Oestereicher, Christine Schütt, Aakash Chavan Ravindranath, Stefanie Leuchtenberger, Sapna Sharma, Martin Kistler, Monja Willershäuser, Robert Brommage, Terrence F. Meehan, Jeremy Mason (+52 others)
2018 Nature Communications  
We further identify common regulatory elements in promoters of candidate genes.  ...  from a 21 h indirect calorimetry trial, m RER females, respiratory exchange ratio, n RER females, respiratory exchange ratio.  ...  Each site follows the IMPC's standardized operating procedures (IMPReSS), which were developed during the pilot programs EUMORPHIA and OMIM database Fig. 1 Strategical abstract depicting the research  ... 
doi:10.1038/s41467-017-01995-2 pmid:29348434 pmcid:PMC5773596 fatcat:p6ihdat7rffevkv3ts3fb6lvsa

Web services-based access to local clinical trial databases: a standards initiative of the Association of American Cancer Institutes

Douglas C Stahl, Richard M Evans, Lawrence B Afrin, Richard M DeTeresa, Dave Ko, Kevin Mitchell
2003 AMIA Annual Symposium Proceedings  
Automated discovery efforts to date have been hindered by issues such as disparate database schemas, vocabularies, and insufficient standards for easy intersystem exchange of high-level data, but adequate  ...  This paper describes the current state (design and implementation) of the Web Services Specification for Publication and Discovery of Clinical Trials as developed by the Technology Task Force of the Association  ...  Relevant vocabulary standards work is currently being pursued by a number of investigators and organizations, including Health Level Seven (HL7) 14 , Clinical Data Interchange Standards Consortium (CDISC  ... 
pmid:14728248 pmcid:PMC1480052 fatcat:il356tbbgfcadcd3dfoqa46l7y
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