Rationale and Objectives
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.
Materials and Methods
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.
Results
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.
Conclusions
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.
Introduction
Clinical Radiology
Imaging has become ubiquitous in the practice of medicine. Technological advances have increased the breadth of settings for which imaging studies are indicated and have improved the capabilities of imaging in existing settings. Physicians have come to rely on it, whereas patients have come to expect it; when used judiciously, imaging can make a valuable contribution to the medical decision-making process . Surrounding this modern reality of clinical imaging is an extensive network of technical resources and administrative procedures, all of which are governed by myriad policies designed to protect the safety and confidentiality of patients, ensure compliance with governmental regulatory agencies, demarcate the role and liability of radiologists and technologists, prioritize the acquisition and interpretation of imaging studies, provide integration with the broader medical center enterprise, and, ultimately, guarantee the best possible experience and most complete diagnostic evaluation for the patients served . Hospital-wide scheduling, standardized billing codes, electronic medical records, detailed standard-of-care image acquisition protocols, radiologist reporting systems, and structured image requisition forms are all part of this expansive infrastructure that has evolved over many decades.
Such infrastructure necessarily involves numerous variables; consequently, radiology departments at different institutions have developed their own unique character. Beginning with the imaging equipment onsite, each department tailors its imaging infrastructure to the physical resources available. Other factors that affect the evolution of this infrastructure include the expertise of the radiology faculty in various subspecialties; the technologists’ workload; the needs, experiences, and expectations of the referring clinical faculty; the informatics capabilities of the institution; the accounting system; the volume of examinations performed; and the patient population.
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Clinical Research
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Organization
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Image Acquisition Arm
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Image Measurement and Analysis Arm
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Image Collection and Database Arm
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Statistics
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Table 1
Number of Active and Recently Closed Clinical Research Studies that Benefit from HIRO Services (as of March 2011)
Primary Department/Section Number of Open Studies Number of Now-closed Studies Cardiology 7 1 Endocrinology 3 1 Gastroenterology 1 - Hematology/oncology 84 3 Infectious disease 4 - Nephrology 2 - Neurology 16 6 Obstetrics/gynecology 3 2 Pediatrics 7 - Pulmonary medicine 11 1 Radiation oncology 3 1 Radiology 20 1 Rheumatology 2 1 Surgery 11 - Total 174 17
HIRO, Human Imaging Research Office.
Table 2
Number of Active Clinical Research Studies that Receive Services from the Three Operational Arms of the HIRO
HIRO Arm Number of Active Studies Image acquisition arm 94 Image measurement and analysis arm 6 Image collection and database arm 146
HIRO, Human Imaging Research Office.
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Discussion
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Conclusion
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Acknowledgments
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