Connecting healthcare and clinical research: Workflow optimizations through seamless integration of EHR, pseudonymization services and EDC systems

被引：18

作者：

Bruland, Philipp ^{[1
]}

Doods, Justin ^{[1
]}

Brix, Tobias ^{[1
]}

Dugas, Martin ^{[1
]}

Storck, Michael ^{[1
]}

机构：

[1] Univ Munster, Inst Med Informat, Albert Schweitzer Campus 1 A11, D-48149 Munster, Germany

来源：

INTERNATIONAL JOURNAL OF MEDICAL INFORMATICS | 2018年 / 119卷

关键词：

Data management; Electronic data capture; Health information systems; Pseudonymization; Workflow optimization; ELECTRONIC DATA CAPTURE; PATIENT RECRUITMENT; SECONDARY USE; TIME; DOCUMENTATION; IMPLEMENTATION; INTERRUPTION; ARCHITECTURE; SUPPORT; PROJECT;

D O I：

10.1016/j.ijmedinf.2018.09.007

中图分类号：

TP [自动化技术、计算机技术];

学科分类号：

0812 ;

摘要：

Objective: In the last years, several projects promote the secondary use of routine healthcare data based on electronic health record (EHR) data. In multicenter studies, dedicated pseudonymization services are applied for unified pseudonym handling. Healthcare, clinical research and pseudonymization systems are generally disconnected. Hence, the aim of this research work is to integrate these applications and to evaluate the workflow of clinical research. Methods: We analyzed and identified technical solutions for legislation compliant automatic pseudonym generation and for the integration into EHR as well as electronic data capture (EDC) systems. The Mainzelliste was used as pseudonymization service, which is available as open source solution and compliant with the data privacy concept in Germany. Subject of the integration was the local EHR and an in-house developed EDC system. A time and motion study was conducted to evaluate the effects on the workflow. Results: Integration of EHR, pseudonymization service and EDC systems is technically feasible and leads to a less fragmented usage of all applications. Generated pseudonyms are obtained from the service hosted at a trusted third party and can now be used in the EDC as well as in the EHR system for direct access and re-identification. The evaluation of 90 registration iterations shows that the time for documentation has been significantly reduced in average by 39.6 s (56.3%) from 71 +/- 8 s to 31 +/- 5 s per registered study patient. Conclusions: By incorporating EHR, EDC and pseudonymization systems, it is now feasible to support multicenter studies and registers out of an integrated system landscape within a hospital. Optimizing the workflow of patient registration for clinical research allows reduction of double data entry and transcription errors as well as a seamless transition from clinical routine to research data collection.

引用

页码：103 / 108

页数：6

共 37 条

[1] Pseudonymization of patient identifiers for translational research [J].

Aamot, Harald ;

Kohl, Christian Dominik ;

Richter, Daniela ;

Knaup-Gregori, Petra .

BMC MEDICAL INFORMATICS AND DECISION MAKING, 2013, 13

[2] The Time Needed for Clinical Documentation versus Direct Patient Care - A Work-sampling Analysis of Physicians' Activities [J].

Ammenwerth, E. ;

Spoetl, H.-P. .

METHODS OF INFORMATION IN MEDICINE, 2009, 48 (01) :84-91

[3]

Athey Brian D, 2013, AMIA Jt Summits Transl Sci Proc, V2013, P6

[4] A workflow-driven approach to integrate generic software modules in a Trusted Third Party [J].

Bialke, Martin ;

Penndorf, Peter ;

Wegner, Tim ;

Bahls, Thomas ;

Havemann, Christoph ;

Piegsa, Jens ;

Hoffmann, Wolfgang .

JOURNAL OF TRANSLATIONAL MEDICINE, 2015, 13

[5] Launching HITECH [J].

Blumenthal, David .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (05) :382-385

[6] Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting [J].

Bruland, Philipp ;

McGilchrist, Mark ;

Zapletal, Eric ;

Acosta, Dionisio ;

Proeve, Johann ;

Askin, Scott ;

Ganslandt, Thomas ;

Doods, Justin ;

Dugas, Martin .

BMC MEDICAL RESEARCH METHODOLOGY, 2016, 16

[7] Does single-source create an added value? Evaluating the impact of introducing x4T into the clinical routine on workflow modifications, data quality and cost-benefit [J].

Bruland, Philipp ;

Forster, Christian ;

Breil, Bernhard ;

Staender, Sonja ;

Dugas, Martin ;

Fritz, Fleur .

INTERNATIONAL JOURNAL OF MEDICAL INFORMATICS, 2014, 83 (12) :915-928

[8]

CDISC e, 2018, LEV CDISC STAND FAC

[9] Secure Secondary Use of Clinical Data with Cloud-based NLP Services Towards a Highly Scalable Research Infrastructure [J].

Christoph, J. ;

Griebel, L. ;

Leb, I. ;

Engel, I. ;

Koepcke, F. ;

Toddenroth, D. ;

Prokosch, H. -U. ;

Laufer, J. ;

Marquardt, K. ;

Sedlmayr, M. .

METHODS OF INFORMATION IN MEDICINE, 2015, 54 (03) :276-282

[10]

Clinical Data Interchange Standards Consortium, 2018, ODM OP DAT MOD

← 1 2 3 4 →