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Timeline representation of clinical data: usability and added value for pharmacovigilance

Thibault Ledieu, Guillaume Bouzillé, Frantz Thiessard, Karine Berquet, Pascal Van Hille, Eric Renault, Elisabeth Polard, Marc Cuggia
2018 BMC Medical Informatics and Decision Making  
Conclusions: The results showed a good general level of usability for the timeline prototype.  ...  However, this absence of difference between the timeline and the usual tools that have been in use for several years suggests a potential use in pharmacovigilance especially because the testers asked to  ...  Catherine Plaisant, Associate Director of Research of the Human-Computer Interaction Laboratory for her advices in the methodological choices and her attentive reading of the manuscript.  ... 
doi:10.1186/s12911-018-0667-x fatcat:ljmrm6t4fjhxzahwt2ucykzedq

Adverse drug event presentation and tracking (ADEPT): semiautomated, high throughput pharmacovigilance using real-world data

Alon Geva, Jason P Stedman, Shannon F Manzi, Chen Lin, Guergana K Savova, Paul Avillach, Kenneth D Mandl
2020 JAMIA Open  
Objective To advance use of real-world data (RWD) for pharmacovigilance, we sought to integrate a high-sensitivity natural language processing (NLP) pipeline for detecting potential adverse drug events  ...  (ADEs) with easily interpretable output for high-efficiency human review and adjudication of true ADEs.  ...  We then developed ADEPT to increase precision for the integrated task of clinical pharmacovigilance using the NLP data.  ... 
doi:10.1093/jamiaopen/ooaa031 pmid:33215076 pmcid:PMC7660953 fatcat:jdcjdfbkijfpdbsclojkqqtzfi

Data interoperability in health surveillance: a literature review to support the development of One Health frameworks

Fernanda Dórea, Victor H.S. Oliveira
2022 Zenodo  
As OH relies on data reuse across multiple health sectors, and preservation of the original context of the data is fundamental for correct inference and decision making, particular focus was given to semantic  ...  In all contexts presented, however, a clear narrative was repeated, with approaches based on the use of data models and coding of data based on specific terminologies (schema representation approaches)  ...  While this meant that extra effort was needed to create a representation for the public health data being exposed, this option offered greater extensibility, generalizability and sustainability.  ... 
doi:10.5281/zenodo.6620262 fatcat:wkd6s3chrvbu5oigpwjmkpmwyq

Data interoperability in health surveillance: a literature review to support the development of One Health frameworks

Fernanda Dórea, Victor H.S. Oliveira
2022 Zenodo  
As OH relies on data reuse across multiple health sectors, and preservation of the original context of the data is fundamental for correct inference and decision making, particular focus was given to semantic  ...  In all contexts presented, however, a clear narrative was repeated, with approaches based on the use of data models and coding of data based on specific terminologies (schema representation approaches)  ...  Associating this information to raw data of individually reported diseases cases is not trivial, and graphical data representations seem to have more and more become the tool of choice as systems got more  ... 
doi:10.5281/zenodo.6531580 fatcat:ockn74msvratdfwtkmmuba3oqq

A Systematic Review of Knowledge Visualization Approaches Using Big Data Methodology for Clinical Decision Support [chapter]

Mehrdad Roham, Anait R. Gabrielyan, Norm Archer
2019 Advances in Intelligent and Personalized Clinical Decision Support Systems [Working Title]  
This chapter reports on results from a systematic review of peer-reviewed studies related to big data knowledge visualization for clinical decision support (CDS).  ...  The aims were to identify and synthesize sources of big data in knowledge visualization, identify visualization interactivity approaches for CDS, and summarize outcomes.  ...  Temporal or timeline visualization is another major category of knowledge visualization for clinical decision support (n = 10, 59%).  ... 
doi:10.5772/intechopen.90266 fatcat:afs5dd4aszcnzhlcatim2acwxu

Unlocking Big Data for better health

Steven Munevar
2017 Nature Biotechnology  
value-added analysis and visualisation resources.  ...  EMTRAIN: A platform for education and training covering the whole life cycle of medicines research, from basic science through clinical development to pharmacovigilance.  ... 
doi:10.1038/nbt.3918 pmid:28700551 fatcat:oqiurm5cgzec7lfenvjvlemxoy

MEV: Visual Analytics for Medication Error Detection

Tabassum Kakar, Xiao Qin, Cory Tapply, Oliver Spring, Derek Murphy, Daniel Yun, Elke Rundensteiner, Lane Harrison, Thang La, Sanjay Sahoo, Suranjan De
2019 Proceedings of the 14th International Joint Conference on Computer Vision, Imaging and Computer Graphics Theory and Applications  
Post-study qualitative interviews illustrates analysts' interest in the use of visual analytics for FAERS reports analysis operations, opportunities for improving the capabilities of MEV, and new directions  ...  A multi-layer treemap visualizes the count and severity of the errors conveyed in the underlying reports, while the interaction between these layers aid in the analysis of the corresponding data attributes  ...  The analyst can select one or multiple data values on each treemap and the system will immediately show what other data attributes correspond to a selected value.  ... 
doi:10.5220/0007366200720082 dblp:conf/grapp/Kakar0TSMYRHLSD19 fatcat:qpsoxbqxqvbodh5yrbtrk62amy

Visual Analytics for Electronic Health Records: A Review

Neda Rostamzadeh, Sheikh S. Abdullah, Kamran Sedig
2021 Informatics  
Despite the growing demand for adopting EHRs, the large amount of clinical data has made some analytical and cognitive processes more challenging.  ...  The increasing use of electronic health record (EHR)-based systems has led to the generation of clinical data at an unprecedented rate, which produces an untapped resource for healthcare experts to improve  ...  Acknowledgments: We would like to thank all authors and publishers who shared images of their tools with us.  ... 
doi:10.3390/informatics8010012 fatcat:2ys5kn6esrfv7gim4ygkcteewq

Transitioning Chemistry, Manufacturing and Controls (CMC) Content with a Structured Data Management Solution: Streamlining Regulatory Submissions

Marquerita Algorri, Nina S. Cauchon, Michael J. Abernathy
2020 Journal of Pharmaceutical Sciences  
The goal is for industry and health authorities to collaborate in the development of SCM for CMC applications, in order to potentially streamline compilation of quality data in regulatory submissions.  ...  The process of assembling regulatory documents for submission to multiple global health agencies can present a repetitive cycle of authoring, editing, and data verification, which increases in complexity  ...  The authors would like to thank Simon Hotchin, Cenk Undey, and Linda Narhi for their helpful suggestions.  ... 
doi:10.1016/j.xphs.2020.01.020 pmid:32004537 fatcat:ys56kcqgmbe3vkibjfwyhku5cy

Opportunities and challenges in using real-world data for health care

Vivek A. Rudrapatna, Atul J. Butte
2020 Journal of Clinical Investigation  
Real-world data (RWD) continue to emerge as a new source of clinical evidence.  ...  In this Review, we describe 21 potential uses for RWD across the spectrum of health care. We also discuss important challenges and limitations relevant to the translation of these data into evidence.  ...  Patel, Lisa Dahm, and Jeffrey Martin for valuable discussion and input.  ... 
doi:10.1172/jci129197 pmid:32011317 fatcat:qtlfndr3ljgfhmcfwnids42hky

Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys

AJ Avery, C Anderson, CM Bond, H Fortnum, A Gifford, PC Hannaford, L Hazell, J Krska, AJ Lee, DJ McLernon, E Murphy, S Shakir (+1 others)
2011 Health Technology Assessment  
Second, the HTA programme provides grants for clinical trials for researchers who identify research questions. These are assessed for importance to patients and the NHS, and scientific rigour.  ...  The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC  ...  , analysis and interpretation of findings, and the writing up and dissemination of the project.  ... 
doi:10.3310/hta15200 pmid:21545758 fatcat:v6au5ict2zcfzefvtzsnxgabke

Report describing communication plan and governance (D5.2)

Alison Oliver, Sally Stephens
2021 Zenodo  
The deliverable focuses on outlining a general messaging approach through ConcePTION channels (amplified by partner local channels) to promote pharmacovigilance (PV) systems and the breastmilk biobank,  ...  as well as to raise awareness of ConcePTION resources that are in development (Knowledge Bank).  ...  Focus will be the combination of usable information on practical situations with importance of gathering more data based on practice experience -Magazine/ journals for HCP -Newsletters for HCP -Social  ... 
doi:10.5281/zenodo.5828872 fatcat:73w7w4m4jbfonkl2ic2s5h7gji

Requirements For Certification Of Ecrin Data Centres, With Explanation And Elaboration Of Standards, Version 4.0 [article]

Steve Canham, Alex Bernalte Gasco, Will Crocombe, Nancy De Bremaeker, Carlos Domingues, Michael Faherty, Maria Teresa Garcia Morales, Laura Houston, Jens Lauritsen, Enrico Bjørn Nicolis, Christian Ohmann, Catherine Pham (+3 others)
2018 Zenodo  
This is version 4.0 of the 'Requirements for certification of data centres', published by ECRIN, the European Clinical Research Infrastructure Network.  ...  Over and above their use for certification, the requirements are intended to describe good practice in data and IT management in clinical research, and in clinical trials in particular.  ...  The most obvious are probably monitoring and pharmacovigilance, though management of laboratory derived data, the use of data standards and the preparation of data for archiving and data sharing have also  ... 
doi:10.5281/zenodo.618250 fatcat:yevzvgwqtzagpj4qfv4ydzjdfu

Changes in Research and Development of Medicinal Products since the Paediatric Regulation [chapter]

Adriana Ceci, Mariana Catapano, Cristina Manfredi, Ian Wong, Mine Orlu-Gul, Annarita Meneguz, Paola Baiardi, Oscar Della, Achille Iolascon, Maurizio Scarpa, Antje Neubert
2011 Drug Development - A Case Study Based Insight into Modern Strategies  
non conventional approaches in terms of study design and size of the population, choice of adequate endpoints), and post-marketing issues (need for ad hoc pharmacovigilance measures).  ...  Pharmacovigilance: The need for ad hoc measures According to the World Health Organisation (WHO), pharmacovigilance is defined as "the science and activities relating to the detection, assessment, understanding  ...  This book represents a case study based overview of many different aspects of drug development, ranging from target identification and characterization to chemical optimization for efficacy and safety,  ... 
doi:10.5772/28797 fatcat:yo6jbw56xndd7hp4uogywgwege

Increasing uptake of comparative effectiveness and patient-centered outcomes research among stakeholders: insights from conference discussion

Ernest Law, Rachel Harrington, G Caleb Alexander, Soumi Saha, Elisabeth Oehrlein, Eleanor M Perfetto
2018 Journal of Comparative Effectiveness Research  
Payers are often working with unpublished data and short timelines for making coverage decisions make incorporation of CER a unique challenge.  ...  European Network of Centres for Pharmacoepidemiology and Pharmacovigilance also creates a collaborative environment wherein members can access resources for conducting research in pharmacovigilance and  ... 
doi:10.2217/cer-2017-0060 pmid:29465252 fatcat:un3fzeyaifb3jbkiygex4z7zlq
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