scholarly journals eSource for Standardized Health Information Exchange in Clinical Research: A Systematic Review of Progress in the Last Year

2021 ◽  
Author(s):  
Maryam Garza ◽  
Sahiti Myneni ◽  
Susan H. Fenton ◽  
Meredith Nahm Zozus
Keyword(s):  
Clinical Research ◽  
Information Exchange ◽  
Health Information Exchange ◽  
Data Capture ◽  
Health Record ◽  
Use Case ◽  
Electronic Data Capture ◽  
Single Source ◽  
Single Institution ◽  
Data Standards

To identify studies conductedusing the direct, electronic extraction of electronic health record (EHR) datato electronic data capture (EDC) systems, also known as eSource, and toidentify any gaps or limitations present for promoting standardized healthinformation exchange in clinical research.Materials and Methods:Articleswere included only if the solution described (1) utilized eSource to directlyexchange data electronically from EHR-to-EDC and (2) was relevant to aprospective clinical study use case.Results:Intotal, 20 relevant articles were identified, describing a total of 15 uniqueeSource interventions. Of the 15interventions, 12 were single-site, single-EHR (SS-SE) implementations and 3were multi-site, multi-EHR (MS-ME) implementations. All 15 implementationsmentioned the use of standards, but nearly all referenced older data exchangestandards.  Discussion:Following the trajectory of work towardsdirect EHR-to-EDC, eSource data collection, we appear to have arrived at thepoint where information systems leveraging data standards can offer efficiencyand increased quality in clinical research. However, these methods need to betested for effectiveness and acceptance in the context of real multicenterclinical trials. Several early studies using a single source of data forresearch and patient care appeared over a decade ago. Since that time,implementations and evaluations have been scarce and almost always confined tosingle-EHR, single-EDC, single-institution implementations.Conclusion:These results only further emphasize the observation thatthe clinical trial use case continues to be the most difficult and leastdemonstrated eSource-related initiative. Thus, additional work is criticallyneeded in this area to address the gaps identified from the literature.

Future Developments of Medical Informatics from the Viewpoint of Networked Clinical Research

2009 ◽  
Vol 48 (01) ◽  
pp. 45-54 ◽  
Author(s):  
W. Kuchinke ◽  
C. Ohmann
Keyword(s):  
Clinical Research ◽  
Electronic Health Record ◽  
Open Source ◽  
Medical Informatics ◽  
Data Capture ◽  
Health Record ◽  
Electronic Data Capture ◽  
Electronic Data ◽  
Future Developments ◽  
Electronic Health

Summary Objectives: To be prepared for future developments, such as enabling support of rapid innovation transfer and personalized medicine concepts, interoperability of basic research, clinical research and medical care is essential. It is the objective of our paper to give an overview of developments, indicate problem areas and to specify future requirements. Methods: In this paper recent and ongoing large-scaled activities related to interoper-ability and integration of networked clinical research are described and evaluated. The following main topics are covered: necessity for general IT-conception, open source/open community approach, acceptance of eSource in clinical research, interoperability of the electronic health record and electronic data capture and harmonization and bridging of standards for technical and semantic inter-operability. Results: National infrastructures and programmes have been set up to provide general IT-conceptions to guide planning and development of software tools (e.g. TMF, ca BIG, NIHR). The concept of open research described by transparency achieved through open access, open data, open communication and open source software is becoming more and more important in clinical research infrastructure development (e.g. ca BIG, ePCRN). Meanwhile visions and rules for using eSource in clinical research are available, with the potential to improve interoperability between the electronic health record and electronic data capture (e.g. CDISC e SDI, eClinical Forum/PhRMA EDC/eSource Taskforce). Several groups have formulated user requirements, use cases and technical frameworks to advance these issues (e.g. NHIN Slipstream-project, EHR/CR-project, IHE). In order to achieve technical and semantic interoperability, existing standards (e.g. CDISC) have to be harmonized and bridged. Major consortia have been formed to provide semantical inter-operability (e.g. HL7 RCRIM under joint leadership of HL7, CDISC and FDA, or BRIDG covering CDISC, HL7, FDA, NCI) and to provide core sets of data collection fields (CDASH). Conclusions: The essential tasks for medical informatics within the next ten years will now be the development and implementation of encompassing IT conceptions, strong support of the open community and open source approach, the acceptance of eSource in clinical research, the uncompromising continuity of standardization and bridging of technical standards and the widespread use of electronic health record systems.

scholarly journals Web Based Data Capture for Clinical Research

10.28945/3201 ◽  
2008 ◽  
Author(s):  
Stephen Smith ◽  
Samuel Sambasivam
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Device ◽  
Rapid Development ◽  
Research Data ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Proof Of Concept ◽  
Web Based ◽  
Tools And Techniques

Electronic Data Capture (EDC) is increasingly being used in the pharmaceutical, biotech and medical device industries to gather research data worldwide from doctors, hospitals and universities participating in clinical trials. In this highly regulated environment, all systems and software must be thoroughly tested and validated, a task that is burdensome in terms of time and cost. Starting with database structures that are designed to be copied easily, this paper proposes a simple framework that allows for rapid development and minimal testing. The framework includes tools for building modules, for copying modules from one trial to the next, and tools to validate that the modules are the same as modules that have been fully tested previously. A proof-of-concept prototype has been built to demonstrate certain tools and techniques that can be used when designing and building a simplified EDC interface.

Implementation of Electronic Health Record (EHR) System in the Healthcare Industry

2016 ◽  
pp. 1001-1016
Author(s):  
Robert P Schumaker ◽  
Kavya P. Reganti
Keyword(s):  
Electronic Health Record ◽  
Information Exchange ◽  
Health Information Exchange ◽  
Health Management ◽  
Healthcare Delivery ◽  
Healthcare Services ◽  
Health Record ◽  
Healthcare Industry ◽  
Efficient Delivery ◽  
Electronic Health

The purpose of this research is to demonstrate the efficiency of the Electronic Health Record (EHR) software that is adopted in the healthcare industry to provide better patient care. The authors examine the impact of EHRs on the efficient delivery of healthcare services. More specifically, they detail the origin of EHR, its significance in modern healthcare delivery along with the selection and implementation criteria for EHR software. They present a survey on the extent of adoption of EHR by clinicians. They also highlight the challenges and barriers faced by organizations in adopting EHR software such as cost, workflow impact and data security. Finally, the authors contemplate the future of EHR, its role in the implementation of health information exchange and its implementation in the cloud. They conclude that the implementation of EHR in the cloud is an important step towards better health management across the population with the end-goal of better health outcomes.

It’s Time for Health Record Banking!

2014 ◽  
Vol 53 (02) ◽  
pp. 63-65 ◽  
Author(s):  
A. Shabo Shvo
Keyword(s):  
Health Information ◽  
Information Exchange ◽  
Health Information Exchange ◽  
State Of The Art ◽  
The State ◽  
Lessons Learned ◽  
Health Record ◽  
Health Records

SummaryThis article is part of a Focus Theme of Methods of Information in Medicine on Health Record Banking. This Focus Theme aims at describing the Health Record Banking (HRB) paradigm, which offers an alternative constellation of health information exchange and integration through sustainability of health records over the lifetime of individuals by independent and trusted organizations.It also aims at describing various approaches to HRB and reporting on the state-of-the-art HRB through actual implementations and lessons learned, as described in articles of this Focus Theme.

scholarly journals An Electronic Data Capture Framework (ConnEDCt) for Global and Public Health Research: Design and Implementation

10.2196/18580 ◽  
2020 ◽  
Vol 22 (8) ◽  
pp. e18580 ◽  
Author(s):  
Caleb J Ruth ◽  
Samantha Lee Huey ◽  
Jesse T Krisher ◽  
Amy Fothergill ◽  
Bryan M Gannon ◽  
...  
Keyword(s):  
Clinical Research ◽  
Data Storage ◽  
Data Entry ◽  
Public Health Research ◽  
Ease Of Use ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Electronic Data ◽  
Cross Sectional ◽  
Clinical Surveillance

Background When we were unable to identify an electronic data capture (EDC) package that supported our requirements for clinical research in resource-limited regions, we set out to build our own reusable EDC framework. We needed to capture data when offline, synchronize data on demand, and enforce strict eligibility requirements and complex longitudinal protocols. Based on previous experience, the geographical areas in which we conduct our research often have unreliable, slow internet access that would make web-based EDC platforms impractical. We were unwilling to fall back on paper-based data capture as we wanted other benefits of EDC. Therefore, we decided to build our own reusable software platform. In this paper, we describe our customizable EDC framework and highlight how we have used it in our ongoing surveillance programs, clinic-based cross-sectional studies, and randomized controlled trials (RCTs) in various settings in India and Ecuador. Objective This paper describes the creation of a mobile framework to support complex clinical research protocols in a variety of settings including clinical, surveillance, and RCTs. Methods We developed ConnEDCt, a mobile EDC framework for iOS devices and personal computers, using Claris FileMaker software for electronic data capture and data storage. Results ConnEDCt was tested in the field in our clinical, surveillance, and clinical trial research contexts in India and Ecuador and continuously refined for ease of use and optimization, including specific user roles; simultaneous synchronization across multiple locations; complex randomization schemes and informed consent processes; and collecting diverse types of data (laboratory, growth measurements, sociodemographic, health history, dietary recall and feeding practices, environmental exposures, and biological specimen collection). Conclusions ConnEDCt is customizable, with regulatory-compliant security, data synchronization, and other useful features for data collection in a variety of settings and study designs. Furthermore, ConnEDCt is user friendly and lowers the risks for errors in data entry because of real time error checking and protocol enforcement.

scholarly journals Search Functionality Within the Electronic Health Record and Health Information Exchange Databases

2020 ◽  
Vol 3 ◽  
Author(s):  
Brandon Gregory ◽  
Jordan Hill ◽  
Titus Schleyer
Keyword(s):  
Electronic Health Record ◽  
Health Information ◽  
Patient Information ◽  
Information Exchange ◽  
Health Information Exchange ◽  
Healthcare Delivery ◽  
Healthcare Providers ◽  
Health Record ◽  
Search Function ◽  
Electronic Health

Background and Hypothesis:  In the US today, over 95% of healthcare institutions operate using the electronic health record (EHR). While proven to be a substantial improvement to medical practice, the substantial amount of retained information within those records has made searching the EHR for relevant material difficult and too time consuming. We hypothesize that by providing a search function within the EHR with added capability of collaborative filtration, physicians will be better able to retrieve important patient information and thus provide more efficient care.     Project Methods:   Emergency Department physicians of Sidney & Lois Eskenazi Hospital and Indiana University Health Hospital were recruited to partake in this study based on their use and familiarity of the EHR Cerner and/or Health Information Exchange (HIE) CareWeb Search function. Participants filled out a pre-interview, Likert-scale questionnaire to determine their general impressions of search functions and the frequency with which they were used. Additional insight was obtained during an interview focusing on participants’ previous experiences searching within the EHR/HIE. Participants were then shown a mock-up of potential collaborative filtering integration into CareWeb in order to collect opinions regarding the feature’s usability/practicality, display/format, and a number of suggested terms.    Results:   From the pilot study, current challenges that limit clinician search function use include limited time in clinician workflow, information overload, and inaccurate results. Clinicians are more likely to conduct searches when treating patients who have limited medical history, complex histories, known recent visitations, and/or who have been seen at other institutions. Participants demonstrated interest in a collaborative filtration search feature; they expressed a preference to have the feature recommend five related search terms.    Potential Impact:   The data from this study aims to refine the way healthcare providers search within the EHR/HIE. This will allow healthcare providers to more efficiently extract relevant patient information for improved healthcare delivery and proficient clinician workflow. 

scholarly journals DICOM for Clinical Research: PACS-Integrated Electronic Data Capture in Multi-Center Trials

2015 ◽  
Vol 28 (5) ◽  
pp. 558-566 ◽  
Author(s):  
Daniel Haak ◽  
Charles-E. Page ◽  
Sebastian Reinartz ◽  
Thilo Krüger ◽  
Thomas M. Deserno
Keyword(s):  
Clinical Research ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Electronic Data

Implementation of Electronic Health Record (EHR) System in the Healthcare Industry

2014 ◽  
Vol 2 (2) ◽  
pp. 57-71 ◽  
Author(s):  
Robert P Schumaker ◽  
Kavya P. Reganti
Keyword(s):  
Electronic Health Record ◽  
Information Exchange ◽  
Health Information Exchange ◽  
Health Management ◽  
Healthcare Delivery ◽  
Healthcare Services ◽  
Health Record ◽  
Healthcare Industry ◽  
Electronic Health ◽  
The Impact

The purpose of this research is to demonstrate the efficiency of the Electronic Health Record (EHR) software that is adopted in the healthcare industry to provide better patient care. The authors examine the impact of EHRs on the efficient delivery of healthcare services. More specifically, they detail the origin of EHR, its significance in modern healthcare delivery along with the selection and implementation criteria for EHR software. They present a survey on the extent of adoption of EHR by clinicians. They also highlight the challenges and barriers faced by organizations in adopting EHR software such as cost, workflow impact and data security. Finally, the authors contemplate the future of EHR, its role in the implementation of health information exchange and its implementation in the cloud. They conclude that the implementation of EHR in the cloud is an important step towards better health management across the population with the end-goal of better health outcomes.

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