Clinical Research Information Systems: Using Electronic Health Records for Research

SummaryBackground: Pharmaceutical clinical trials are primarily conducted across many countries, yet recruitment numbers are frequently not met in time. Electronic health records store large amounts of potentially useful data that could aid in this process. The EHR4CR project aims at re-using EHR data for clinical research purposes.Objective: To evaluate whether the protocol feasibility platform produced by the Electronic Health Records for Clinical Research (EHR4CR) project can be installed and set up in accordance with local technical and governance requirements to execute protocol feasibility queries uniformly across national borders.Methods: We installed specifically engineered software and warehouses at local sites. Approvals for data access and usage of the platform were acquired and terminology mapping of local site codes to central platform codes were performed. A test data set, or real EHR data where approvals were in place, were loaded into data warehouses. Test feasibility queries were created on a central component of the platform and sent to the local components at eleven university hospitals.Results: To use real, de-identified EHR data we obtained permissions and approvals from ‘data controllers‘ and ethics committees. Through the platform we were able to create feasibility queries, distribute them to eleven university hospitals and retrieve aggregated patient counts of both test data and de-identified EHR data.Conclusion: It is possible to install a uniform piece of software in different university hospitals in five European countries and configure it to the requirements of the local networks, while complying with local data protection regulations. We were also able set up ETL processes and data warehouses, to reuse EHR data for feasibility queries distributed over the EHR4CR platform.

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Clinical Research Informatics: Contributions from 2017

Yearbook of Medical Informatics ◽

10.1055/s-0038-1641220 ◽

2018 ◽

Vol 27 (01) ◽

pp. 177-183 ◽

Cited By ~ 1

Author(s):

Christel Daniel ◽

Dipak Kalra ◽

Keyword(s):

Electronic Health Records ◽

Clinical Research ◽

Association Studies ◽

Bias Reduction ◽

Lessons Learned ◽

Editorial Team ◽

Private Industry ◽

Health Records ◽

Clinical Research Informatics ◽

Electronic Health

Objectives: To summarize key contributions to current research in the field of Clinical Research Informatics (CRI) and to select best papers published in 2017. Method: A bibliographic search using a combination of MeSH descriptors and free terms on CRI was performed using PubMed, followed by a double-blind review in order to select a list of candidate best papers to be then peer-reviewed by external reviewers. A consensus meeting between the two section editors and the editorial team was organized to finally conclude on the selection of best papers. Results: Among the 741 returned papers published in 2017 in the various areas of CRI, the full review process selected five best papers. The first best paper reports on the implementation of consent management considering patient preferences for the use of de-identified data of electronic health records for research. The second best paper describes an approach using natural language processing to extract symptoms of severe mental illness from clinical text. The authors of the third best paper describe the challenges and lessons learned when leveraging the EHR4CR platform to support patient inclusion in academic studies in the context of an important collaboration between private industry and public health institutions. The fourth best paper describes a method and an interactive tool for case-crossover analyses of electronic medical records for patient safety. The last best paper proposes a new method for bias reduction in association studies using electronic health records data. Conclusions: Research in the CRI field continues to accelerate and to mature, leading to tools and platforms deployed at national or international scales with encouraging results. Beyond securing these new platforms for exploiting large-scale health data, another major challenge is the limitation of biases related to the use of “real-world” data. Controlling these biases is a prerequisite for the development of learning health systems.

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Quality and Certification of Electronic Health Records

Applied Clinical Informatics ◽

10.4338/aci-2010-02-r-0009 ◽

2010 ◽

Vol 01 (02) ◽

pp. 149-164 ◽

Cited By ~ 6

Author(s):

E. Ammenwerth ◽

A. Hoerbst

Keyword(s):

Information Systems ◽

Electronic Health Records ◽

Qualitative Content Analysis ◽

Real Life ◽

Health Records ◽

Selection Processes ◽

Quality Certification ◽

The Us ◽

Service Oriented ◽

Electronic Health

Summary Background: Numerous projects, initiatives, and programs are dedicated to the development of Electronic Health Records (EHR) worldwide. Increasingly more of these plans have recently been brought from a scientific environment to real life applications. In this context, quality is a crucial factor with regard to the acceptance and utility of Electronic Health Records. However, the dissemination of the existing quality approaches is often rather limited. Objectives: The present paper aims at the description and comparison of the current major quality certification approaches to EHRs. Methods: A literature analysis was carried out in order to identify the relevant publications with regard to EHR quality certification. PubMed, ACM Digital Library, IEEExplore, CiteSeer, and Google (Scholar) were used to collect relevant sources. The documents that were obtained were analyzed using techniques of qualitative content analysis. Results: The analysis discusses and compares the quality approaches of CCHIT, EuroRec, IHE, openEHR, and EN13606. These approaches differ with regard to their focus, support of service-oriented EHRs, process of (re-)certification and testing, number of systems certified and tested, supporting organizations, and regional relevance. Discussion: The analyzed approaches show differences with regard to their structure and processes. System vendors can exploit these approaches in order to improve and certify their information systems. Health care organizations can use these approaches to support selection processes or to assess the quality of their own information systems. Citation: Hoerbst A, Ammenwerth E. Quality and certification of electronic health records – An overview of current approaches from the US and Europe. Appl Clin Inf 2010; 1: 149–164 http://dx.doi.org/10.4338/ACI-2010-02-R-0009

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Barriers and facilitators to data quality of electronic health records used for clinical research in China: a qualitative study

BMJ Open ◽

10.1136/bmjopen-2019-029314 ◽

2019 ◽

Vol 9 (7) ◽

pp. e029314 ◽

Cited By ~ 2

Author(s):

Kaiwen Ni ◽

Hongling Chu ◽

Lin Zeng ◽

Nan Li ◽

Yiming Zhao

Keyword(s):

Qualitative Study ◽

Electronic Health Records ◽

Clinical Research ◽

Data Quality ◽

Healthcare Professionals ◽

Barriers And Facilitators ◽

Health Records ◽

Improve Data Quality ◽

Electronic Health

ObjectivesThere is an increasing trend in the use of electronic health records (EHRs) for clinical research. However, more knowledge is needed on how to assure and improve data quality. This study aimed to explore healthcare professionals’ experiences and perceptions of barriers and facilitators of data quality of EHR-based studies in the Chinese context.SettingFour tertiary hospitals in Beijing, China.ParticipantsNineteen healthcare professionals with experience in using EHR data for clinical research participated in the study.MethodsA qualitative study based on face-to-face semistructured interviews was conducted from March to July 2018. The interviews were audiorecorded and transcribed verbatim. Data analysis was performed using the inductive thematic analysis approach.ResultsThe main themes included factors related to healthcare systems, clinical documentation, EHR systems and researchers. The perceived barriers to data quality included heavy workload, staff rotations, lack of detailed information for specific research, variations in terminology, limited retrieval capabilities, large amounts of unstructured data, challenges with patient identification and matching, problems with data extraction and unfamiliar with data quality assessment. To improve data quality, suggestions from participants included: better staff training, providing monetary incentives, performing daily data verification, improving software functionality and coding structures as well as enhancing multidisciplinary cooperation.ConclusionsThese results provide a basis to begin to address current barriers and ultimately to improve validity and generalisability of research findings in China.

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Information Systems and Healthcare XXXIII: An Institutional Theory Perspective on Physician Adoption of Electronic Health Records

Communications of the Association for Information Systems ◽

10.17705/1cais.02607 ◽

2010 ◽

Vol 26 ◽

Cited By ~ 6

Author(s):

Susan A. Sherer

Keyword(s):

Information Systems ◽

Electronic Health Records ◽

Institutional Theory ◽

Health Records ◽

Electronic Health ◽

Physician Adoption

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Assessing the Financial Impact of Reusing Electronic Health Records Data for Clinical Research: Results from the EHR4CR European Project

Journal of Health & Medical Informatics ◽

10.4172/2157-7420.1000235 ◽

2016 ◽

Vol 7 (3) ◽

Cited By ~ 5

Author(s):

Danielle Dupont ◽

Ariel Beresniak

Keyword(s):

Electronic Health Records ◽

Clinical Research ◽

Financial Impact ◽

Health Records ◽

Research Results ◽

European Project ◽

Electronic Health

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Intérêt des dossiers de santé électroniques hospitaliers pour la recherche clinique

médecine/sciences ◽

10.1051/medsci/2018235 ◽

2018 ◽

Vol 34 (11) ◽

pp. 972-977 ◽

Cited By ~ 1

Author(s):

Danielle Dupont ◽

Ariel Beresniak ◽

Dipak Kalra ◽

Pascal Coorevits ◽

Georges De Moor

Keyword(s):

Electronic Health Records ◽

Clinical Research ◽

Qualité Des Soins ◽

Health Records ◽

Recherche Clinique ◽

Electronic Health

Les dossiers de santé électroniques hospitaliers contribuent à l’amélioration de la qualité des soins en permettant une meilleure gestion des informations cliniques. Les bases de données numériques ainsi constituées facilitent l’échange des informations de santé avec les prestataires de soins et optimisent la coordination multidisciplinaire pour de meilleurs résultats thérapeutiques. Le projet européen EHR4CR (electronic health records for clinical research) a développé une plateforme pilote innovante permettant de réutiliser ces données numériques pour la recherche clinique. En améliorant et en accélérant les procédures de recherche clinique, cette approche permet d’envisager la réalisation d’études cliniques de manière plus efficiente, plus rapide et plus économique.

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