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Software which de-identifies and indexes clinical data for a queryable research database was created. Users have the ability to save radiology reports and request de-identified medical images via the system’s web interface. Additionally, the opt-out paradigm provided a substantial number of consented patients and maximized the amount of data available to researchers. Autonomous operation of our dedicated research system resulted in minimal PACS performance degradation.
A system to mine, organize, anonymize, and request de-identified images from a radiological database was required to fulfill the needs of biomedical researchers. The system must function autonomously from a clinical PACS to minimize its impact on performance during clinical use. Independent operation allows keyword queries of anonymized radiology reports through a web interface; this interface also functions as a database creation and de-identified image request system. A custom database interface was designed to fill this need.
The software includes (1) Perl and VB apps to extract data from a clinical PACS and anonymize PHI in accordance with IRB and HIPAA standards; (2) an indexing search engine that allows keyword queries via a web browser; (3) PHP-based exporting of queried radiology reports with an option to request associated de-identified images through the Human Imaging Research Office at our institution. An “opt-out” IRB paradigm was created: outpatients in radiology reception areas are presented with an opt-out form to establish consent for use of clinical images and associated data for research.
The “opt-out” paradigm began in October 2008; to date 128,000 patients are enrolled and de-identified image data is available for query via our database interface. 1,324 patients have declined the study resulting in a 1% withdrawal rate. Previous “opt-in” paradigms resulted in an enrollment of less than 3,000 patients over a 5 year period. Over 1.2 million radiology reports encompassing over a decade of data were anonymized and indexed from our PACS and are available for use in medical research.
Radiological Society of North America 2013 Scientific Assembly and Annual Meeting; 12/2013
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ABSTRACT: Managing and supervising the complex imaging examinations performed for clinical research in an academic medical center can be a daunting task. Coordinating with both radiology and research staff to ensure that the necessary imaging is performed, analyzed, and delivered in accordance with the research protocol is nontrivial. The purpose of this communication is to report on the establishment of a new Human Imaging Research Office (HIRO) at our institution that provides a dedicated infrastructure to assist with these issues and improve collaborations between radiology and research staff.
The HIRO was created with three primary responsibilities: 1) coordinate the acquisition of images for clinical research per the study protocol, 2) facilitate reliable and consistent assessment of disease response for clinical research, and 3) manage and distribute clinical research images in a compliant manner.
The HIRO currently provides assistance for 191 clinical research studies from 14 sections and departments within our medical center and performs quality assessment of image-based measurements for six clinical research studies. The HIRO has fulfilled 1806 requests for medical images, delivering 81,712 imaging examinations (more than 44.1 million images) and related reports to investigators for research purposes.
The ultimate goal of the HIRO is to increase the level of satisfaction and interaction among investigators, research subjects, radiologists, and other imaging professionals. Clinical research studies that use the HIRO benefit from a more efficient and accurate imaging process. The HIRO model could be adopted by other academic medical centers to support their clinical research activities; the details of implementation may differ among institutions, but the need to support imaging in clinical research through a dedicated, centralized initiative should apply to most academic medical centers.
Academic radiology 04/2012; 19(6):762-71. · 2.09 Impact Factor
Medical Physics 01/2011; 38(6):3406-. · 2.91 Impact Factor
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Tracking and managing imaging performed for clinical trials and research purposes can be a daunting task, particularly in a large academic medical center. Coordinating with both radiology and medical research staff to ensure that the necessary imaging is performed, analyzed and delivered in a manner that is compliant with the research protocol is non-trivial. A dedicated infrastructure was created to assist with these issues and improve collaborations between radiology and research staff: the Human Imaging Research Office (HIRO).
METHOD AND MATERIALS
The HIRO was created with three primary responsibilities: (1) coordinating the acquisition of imaging data for clinical trials and research studies in a manner consistent with study protocols, (2) providing assessment and measurement of disease response for clinical trials in a consistent and coherent manner, and (3) managing and distributing clinical image data for research studies in an IRB- and HIPAA-compliant manner. Two full-time staff members, as well as several part-time staff members, are employed by this office.
After one year of operation, the HIRO’s Image Acquisition section has assisted 25 clinical trials from 8 different clinical departments. The Measurement and Analysis section has assisted 3 clinical trials and has performed quality assessments for each trial. The Image Collection and Database section has fulfilled over 184 requests for clinical images, delivering over 7.7 million images and related reports to investigators for research purposes.
Implementation of the HIRO has increased the level of satisfaction and interaction among medical investigators, research subjects, and imaging science clinicians and professionals, and various policies have created efficient workflows and avoided redundancies. Research studies and clinical trials that utilize the HIRO have benefited from a more efficient and accurate imaging experience. Further development of this model will continue to increase these benefits for radiology and clinical research staff.
Managing research imaging and providing image data to investigators in a large medical center is a non-trivial task, and our workflow and infrastructure provide a mechanism to do so efficiently.
Radiological Society of North America 2010 Scientific Assembly and Annual Meeting;