Simplifying Electronic Data Capture in Clinical Trials: Workflow Embedded Image and Biosignal File Integration and Analysis via Web Services.
To improve data quality and save cost, clinical trials are nowadays performed using electronic data capture systems (EDCS) providing electronic case report forms (eCRF) instead of paper-based CRFs. However, such EDCS are insufficiently integrated into the medical workflow and lack in interfacing wit...
| Publicado en: | Journal of Digital Imaging Vol. 27; no. 5; pp. 571 - 581 |
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| Autores principales: | , , , , |
| Formato: | tables/charts Journal Article |
| Publicado: |
Springer Nature
Oct2014
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=103894373&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 103894373 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 08971889 DOQ jtl: Journal of Digital Imaging issn: 08971889 maglogo: N pubinfo: dt: Oct2014 vid: 27 iid: 5 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 103894373 98419615 10.1007/s10278-014-9694-z NLM24802371 PMC4171435 103894373 ppf: 571 ppct: 10 formats: fmt: @attributes: type: P tig: atl: Simplifying Electronic Data Capture in Clinical Trials: Workflow Embedded Image and Biosignal File Integration and Analysis via Web Services. aug: au: Haak, Daniel Samsel, Christian Gehlen, Johan Jonas, Stephan Deserno, Thomas affil: Department of Medical Informatics, Uniklinik RWTH Aachen, Pauwelsstr. 30 52057 Aachen Germany sug: subj: Data Management Clinical Trials Systems Analysis Systems Integration Data Collection Methods Medical Record Linkage World Wide Web Applications ab: To improve data quality and save cost, clinical trials are nowadays performed using electronic data capture systems (EDCS) providing electronic case report forms (eCRF) instead of paper-based CRFs. However, such EDCS are insufficiently integrated into the medical workflow and lack in interfacing with other study-related systems. In addition, most EDCS are unable to handle image and biosignal data, although electrocardiography (EGC, as example for one-dimensional (1D) data), ultrasound (2D data), or magnetic resonance imaging (3D data) have been established as surrogate endpoints in clinical trials. In this paper, an integrated workflow based on OpenClinica, one of the world's largest EDCS, is presented. Our approach consists of three components for (i) sharing of study metadata, (ii) integration of large volume data into eCRFs, and (iii) automatic image and biosignal analysis. In all components, metadata is transferred between systems using web services and JavaScript, and binary large objects (BLOBs) are sent via the secure file transfer protocol and hypertext transfer protocol. We applied the close-looped workflow in a multicenter study, where long term (7 days/24 h) Holter ECG monitoring is acquired on subjects with diabetes. Study metadata is automatically transferred into OpenClinica, the 4 GB BLOBs are seamlessly integrated into the eCRF, automatically processed, and the results of signal analysis are written back into the eCRF immediately. pubtype: Academic Journal doctype: tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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