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Existing barriers and recommendations of real-world data standardisation for clinical research in China: a qualitative study

Junkai Lai, Xiwen Liao, Chen Yao, Feifei Jin, Bin Wang, Chen Li, Jun Zhang, Larry Liu
2022 BMJ Open  
research by using clinical data models, and improving traceability to source data for transparency to guide efforts in data standardisation in the future.  ...  ObjectiveTo investigate the existing barriers and recommendations of real-world data (RWD) standardisation for clinical research through a qualitative study on different stakeholders.DesignThis qualitative  ...  Although data are standardized for clinical research, the data elements in these databases are usually very different from each other, and we may have to focus on data elements that are more widely available  ... 
doi:10.1136/bmjopen-2021-059029 pmid:35922113 fatcat:wmppslijsvekjjmi427zdpvkva

Development of a standardised tool to survey MDR-/XDR-TB case management in Europe

G. Sotgiu, R. Centis, L. D'ambrosio, S. De Lorenzo, M. D'arcy Richardson, C. Lange, D. Manissero, G. B. Migliori
2010 European Respiratory Journal  
The tool incorporates a scoring system for the final survey data elements.  ...  Data elements were organised taking into account the following. 1) Structure and content of clinical records in a sample of European countries participating in the ECDC European survey on case management  ... 
doi:10.1183/09031936.00186409 pmid:20595168 fatcat:nkeaofr7ibgzdiikpt6xy2smoy

Towards standardisation of evidence-based clinical care process specifications

Scott McLachlan, Evangelia Kyrimi, Kudakwashe Dube, Graham Hitman, Jennifer Simmonds, Norman Fenton
2020 Health Informatics Journal  
elements and relationship to the other clinical care process specification types.  ...  There is a strong push towards standardisation of treatment approaches, care processes and documentation of clinical practice.  ...  The benefits of standardisation in the context of CCPS computerization Standardisation of clinical documents has been observed to improve data collection, data quality, and to enable automated coding and  ... 
doi:10.1177/1460458220906069 pmid:32186428 fatcat:m3qcq3fv6nbuhband5vro43nr4

Applying openEHR's Guideline Definition Language to the SITS international stroke treatment registry: a European retrospective observational study

Nadim Anani, Michael V. Mazya, Rong Chen, Tiago Prazeres Moreira, Olivier Bill, Niaz Ahmed, Nils Wahlgren, Sabine Koch
2017 BMC Medical Informatics and Decision Making  
Interoperability standards intend to standardise health information, clinical practice guidelines intend to standardise care procedures, and patient data registries are vital for monitoring quality of  ...  care and for clinical research.  ...  Also, archetype data elements can be bound to standardised terms from terminologies like SNOMED CT or ICD.  ... 
doi:10.1186/s12911-016-0401-5 pmid:28073358 pmcid:PMC5223429 fatcat:2yzgzp4lsbd67dgvy5t4xmt7hi

Standardisation of data collection in traumatic brain injury: key to the future?

Andrew IR Maas
2009 Critical Care  
Pooling data from different studies may provide the best possible source of evidence we can get in a cost efficient way. Standardisation of data collection and coding is essential to this purpose.  ...  The difficulties in performing a meta-analysis of individual patient data were recently illustrated in the IMPACT project (International Mission on Prognosis and Clinical Trial Design in TBI): merging  ...  Acknowledgements This commentary is based upon extensive collaborative work, performed by the IMPACT study group and the interagency working group on Demographics and Clinical Assessment.  ... 
doi:10.1186/cc8163 pmid:20053300 pmcid:PMC2811931 fatcat:ql7urgykubdi7ndjt5d2jshg6a

Utilising the FOXS Stack for FAIR Architected Data Access [chapter]

John Meredith, Nik Whitehead, Michael Dacey
2021 Studies in Health Technology and Informatics  
A FOXS stack assembles HL7 FHIR, openEHR, IHE XDS and SNOMED CT as an operational clinical data platform to build digital systems.  ...  highlights the benefit of the blended approach to operational technology stacks for health systems, and a need for industry standard technologies to enable greater semantic coherence for primary/secondary data  ...  Additionally, openEHR acts as a proxy for common data elements, essential for FAIR data sharing [19] .  ... 
doi:10.3233/shti210832 pmid:34795097 fatcat:4ioi7oigazcxzm2jzgpr7sof4u

Balancing centralised and decentralised EHR approaches to manage standardisation

Kirstine Hjære Rosenbeck, Anne Randorff Rasmussen, Pia Britt Elberg, Stig Kjær Andersen
2010 Studies in Health Technology and Informatics  
Based on the knowledge obtained in these studies a 'clinical content format' was developed to facilitate the work of the regions, where the clinical content of EHR systems is modelled.  ...  Bridging is necessary to achieve interoperability between regional EHR systems, without neglecting the clinical usefulness.  ...  Acknowledgements We would like to thank the clinical content organisations in the Capital Region and Odense University Hospital for interview.  ... 
pmid:20841668 fatcat:vdng7re5mvh3xcxwwukfknyanm

A system dynamics analysis determining willingness to wait and pay for the implementation of data standards in clinical research

Luciana Cofiel, Guilherme R Zammar, Amrapali J Zaveri, Jatin Y Shah, Elias Carvalho, Meredith Nahm, Gustavo Kesselring, Ricardo Pietrobon
2010 Health Research Policy and Systems  
the adoption of data standards by clinical researchers.  ...  SD analysis indicated that although initially extra time and cost are necessary for clinical study standardisation, there is a decrease in both over time.  ...  Clinical Data Acquisition Standards Harmonisation (CDASH) is aimed at standardising the structure of a study's data and meta-data, promising to significantly expedite clinical studies as well as the exchange  ... 
doi:10.1186/1478-4505-8-38 pmid:21194455 pmcid:PMC3024294 fatcat:pt5defa6kbe6fl7i3hwabhi7um

TBDBT: A TB DataBase Template for collection of harmonized TB clinical research data in REDCap, facilitating data standardisation for inter-study comparison and meta-analyses

Taryn Allie, Amanda Jackson, Jon Ambler, Katherine Johnston, Elsa Du Bruyn, Charlotte Schultz, Linda Boloko, Sean Wasserman, Angharad Davis, Graeme Meintjes, Robert J. Wilkinson, Nicki Tiffin (+1 others)
2021 PLoS ONE  
This failure to harmonise clinical phenotype data or apply standardised data collection and storage standards in turn limits the opportunity to undertake meta-analyses using data generated across multiple  ...  This template can be used to set up a new tuberculosis research database with a built-in set of standardised data conventions, to ensure standardised data capture across research projects and programs.  ...  This database template addresses standardisation at four levels (Table 1) : 'Description'-the way the data element, or 'field', is described and interpreted; 'Field name'-the way the data element is named  ... 
doi:10.1371/journal.pone.0249165 pmid:33770143 fatcat:7ooo5e3ldffivbqhjw7ixzazpi

Impact of adverse drug reaction and predictivity of quality of life status in tuberculosis

N. Guo, F. Marra, J. M. Fitzgerald, R. K. Elwood, C. A. Marra
2010 European Respiratory Journal  
The tool incorporates a scoring system for the final survey data elements.  ...  Data elements were organised taking into account the following. 1) Structure and content of clinical records in a sample of European countries participating in the ECDC European survey on case management  ... 
doi:10.1183/09031936.00159409 pmid:20595167 fatcat:47z2tn56u5cyvjhfe7e4vacdla

AN INVESTIGATION INTO THE VALUE OF A STANDARDISED GLOBAL PHARMACOVIGILANCE REPORTING SYSTEM

Maximillian Juan Schurer, Louzanne Bam, Imke De Kock
2017 South African Journal of Industrial Engineering  
This paper proposes the value of a standardised global PV reporting system by evaluating the systemic effects of the lack of such a standardised system.  ...  The large number of different PV systems, the equally large number of stakeholders within such systems (pharmaceutical companies, government regulatory bodies, national and international clinical regulatory  ...  A standardised reporting form would include a comprehensive list of unique data elements, prompting the extraction of all demographically and clinically relevant data relating to the patient and the ADR  ... 
doi:10.7166/28-3-1841 fatcat:577eft5itbcddcevbpjuvzwwhi

National data elements for the clinical management of acute coronary syndromes

Derek P B Chew, Roger M Allan, Constantine N Aroney, Noella J Sheerin, Acute Coronary Syndrome Data Set Writing Group, Acute Coronary Syndrome Data Set Working Group
2005 Medical Journal of Australia  
Data elements for monitoring clinical management of patients with acute coronary syndromes have been adapted from internationally accepted definitions and incorporated into the National Health Data Dictionary  ...  The challenge is in effectively applying evidence in clinical practice. Objectivity and standardised quantification of clinical practice are essential in understanding the evidence-practice gap.  ...  It is hoped that with this nationally standardised set of data elements, people with a need or interest in these data can converse in the same language.  ... 
pmid:15865580 fatcat:z2a4aquidzcznjtuzgywmhcsye

Clinical Caremap Development: How Can Caremaps Standardise Care When They Are Not Standardised?

Scott McLachlan, Evangelia Kyrimi, Kudakwashe Dube, Norman Fenton
2019 Proceedings of the 12th International Joint Conference on Biomedical Engineering Systems and Technologies  
Standardising care is seen to improve patient safety and outcomes, and to reduce the costs of providing healthcare services but contemporary caremaps are not standardised.  ...  Caremaps were developed to standardise care. They have evolved from text-based descriptions to flow-based diagrams.  ...  The elements are inspired by the standardised pictorial elements seen in UML and hard state chart notations.  ... 
doi:10.5220/0007522601230134 dblp:conf/biostec/McLachlanKDF19 fatcat:efwcyaeo55bonnm32urmz6bzfi

Nurses' protocol-based care decision making: a multiple case study

Mónica Vázquez-Calatayud, Cristina Oroviogoicoechea, Laura Pittiglio, María Jesús Pumar-Méndez
2020 Journal of Clinical Nursing  
Protocol-Based Care is a strategy to reduce variability in clinical practice. There are no studies looking at Protocol-Based Care decision making.  ...  The multiple embedded case study revealed Protocol-Based Care decision-making as a linear and variable process that depends on the context and consists of multiple interrelated elements, among which the  ...  Studies on decision-making in the standardisation of care have further investigated the elements involved in this type of decision-making, suggesting that there are many elements that act in an interrelated  ... 
doi:10.1111/jocn.15524 pmid:33007122 fatcat:k4pvux5y6ff6fb75dj3pyfn4gq

Health Information Standardisation as a basis for Learning Health Systems [article]

Scott McLachlan
2020 arXiv   pre-print
Electronic health records were already intended to provide clinicians with real-time access to clinical knowledge and care plans while also recording and storing vast amounts of patient data.  ...  Clinical care process specifications are a primary form of clinical documentation used in all aspects of healthcare, but they lack standardisation.  ...  Current efforts for standardisation in health informatics often focus on some element of: (i) how the clinician interacts with the system; or, (ii) data entry or composition.  ... 
arXiv:2004.04811v1 fatcat:jvmsbelikrczzilpyj6iljmasu
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