Linda B. Bresolin

A Collaborative Enterprise for Multi-Stakeholder Participation in the Advancement of Quantitative Imaging

Medical imaging has seen substantial and rapid technical advances during the past decade, including advances in image acquisition devices, processing and analysis software, and agents to enhance specificity. Traditionally, medical imaging has defined anatomy, but increasingly newer, more advanced, imaging technologies provide biochemical and physiologic information based on both static and dynamic modalities. These advanced technologies are important not only for detecting disease but for characterizing and assessing change of disease with time or therapy. Because of the rapidity of these advances, research to determine the utility of quantitative imaging in either clinical research or clinical practice has not had time to mature. Methods to appropriately develop, assess, regulate, and reimburse must be established for these advanced technologies. Efficient and methodical processes that meet the needs of stakeholders in the biomedical research community, therapeutics developers, and health care delivery enterprises will ultimately benefit individual patients. To help address this, the authors formed a collaborative program-the Quantitative Imaging Biomarker Alliance. This program draws from the very successful precedent set by the Integrating the Healthcare Enterprise effort but is adapted to the needs of imaging science. Strategic guidance supporting the development, qualification, and deployment of quantitative imaging biomarkers will lead to improved standardization of imaging tests, proof of imaging test performance, and greater use of imaging to predict the biologic behavior of tissue and monitor therapy response. These, in turn, confer value to corporate stakeholders, providing incentives to bring new and innovative products to market.

Quantitative Imaging Test Approval and Biomarker Qualification: Interrelated but Distinct Activities

UNLABELLED Quantitative imaging biomarkers could speed the development of new treatments for unmet medical needs and improve routine clinical care. However, it is not clear how the various regulatory and nonregulatory (eg, reimbursement) processes (often referred to as pathways) relate, nor is it clear which data need to be collected to support these different pathways most efficiently, given the time- and cost-intensive nature of doing so. The purpose of this article is to describe current thinking regarding these pathways emerging from diverse stakeholders interested and active in the definition, validation, and qualification of quantitative imaging biomarkers and to propose processes to facilitate the development and use of quantitative imaging biomarkers. A flexible framework is described that may be adapted for each imaging application, providing mechanisms that can be used to develop, assess, and evaluate relevant biomarkers. From this framework, processes can be mapped that would be applicable to both imaging product development and to quantitative imaging biomarker development aimed at increasing the effectiveness and availability of quantitative imaging. SUPPLEMENTAL MATERIAL http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100800/-/DC1.

Web Modules on Professionalism and Ethics

Health care disciplines have always held resolutely to a commitment to professionalism and high ethical standards. With the present emphasis on public accountability, professionalism and ethics are receiving enhanced attention in health care education and practice. A challenge for radiologists, radiation oncologists, and medical physicists is to define the scope and depth of knowledge about professionalism and ethics that are necessary for the practice of the disciplines. A further challenge is to develop accessible educational materials that encompass this required knowledge. About 2 years ago, the ABR Foundation decided to address these challenges through the development of an ethics and professionalism curriculum and production of a series of Web-based educational modules that follow the curriculum. Six organizations agreed initially to contribute financially to construction of the curriculum and modules and were later joined by a seventh. The curriculum was developed by the ABR Foundation and included in a request for proposals that was widely distributed. Teams of authors for each of 10 modules were selected from respondents to the request for proposals. As the modules were developed, they were reviewed in 3 successive stages, including peer review by members of the ACR Committee on Professionalism and the RSNA-ACR Task Force on an Ethics Curriculum. After revisions were prepared in response to the reviews, the modules were translated into a format compatible with the e-learning platform on which they are mounted. The modules are now available to all who wish to study them.

Introduction to metrology series

The molecular bases of health and disease have become increasingly well understood in the past 20 years, leading to the need for tests that can provide such information in objective, reproducible forms for clinical research and practice. Much of this clinical information needed by contemporary medicine is referred to as biomarkers. A widely accepted definition of a biomarker, used by both National Institute of Health (NIH) and Food and Drug Administration, is ‘‘a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or a response to a therapeutic intervention.’’ The term ‘‘biomarker’’ is often assumed to imply a laboratory test, but it can also refer to a clinical measurement like blood pressure or the output of a clinical imaging scan. During the past two decades, remarkable advances in medical imaging technology have made it possible to obtain from clinical images high resolution anatomic, functional, metabolic, and physiologic information, all of which reflect in some way the molecular substrate of the healthy or diseased tissue, organ or person being imaged. With appropriate calibration, most of these imaging technologies can provide quantitative information about some properties of the material with which the energy has interacted. For example:

Methods and Resources for Physics Education in Radiology Residency Programs: Survey Results

Over the past 2 years, ongoing efforts have been made to reevaluate and restructure the way physics education is provided to radiology residents. Program directors and faculty from North American radiology residency programs were surveyed about how physics is being taught and what resources are currently being used for their residents. Substantial needs were identified for additional educational resources in physics, better integration of physics into clinical training, and a standardized physics curriculum closely linked to the initial certification examination of the American Board of Radiology.

Education techniques for lifelong learning: international variations in initial certification and maintenance of certification in radiology: a multinational survey.

A survey was sent to representatives of national and regional radiology societies around the world regarding the status of certification, maintenance of certification (MOC), and continuing medical education (CME) requirements. Data were forthcoming from 24 countries (response rate, 71%), including the United States. The survey results indicated that most responding countries now have a standardized process and requirements for initial certification of diagnostic and therapeutic radiologists. Similarly, most reporting countries now have some form of mandatory CME, although the degree to which compliance is tracked varies. There is considerable heterogeneity in what these countries require for recertification or MOC, and the development of such requirements is cited as a goal for many of the countries. The standardization and institutionalization of certification and recertification requirements is in rapid evolution globally.

Resident Learning Portfolio

The medical education paradigm for physicians has changed from a series of unconnected certifying examinations to one that focuses on lifelong learning organized around the clinical practice and educational needs of individual physicians. This philosophy underpins the Maintenance of Certification process implemented by the American Board of Radiology, but it also increasingly applies to the education and training of residents in the fields of radiology, medical physics, and radiation oncology. The mechanisms by which this process of career-long learning can be implemented, documented, and shared with others have also been evolving. The concept of a personal learning portfolio (PLP), which documents and displays one’s individual educational goals and achievements, has become an integral part of the training and education paradigm. In its most recent requirements for residency training programs, the Accreditation Council for Graduate Medical Education (ACGME) has mandated that each resident maintain a resident PLP that documents his or her education, training, and professional development activities throughout residency training. The new requirements dictate that residency programs begin to maintain these resident portfolios beginning July 1, 2008. The resident portfolio comprises approximately 10 required components, which span a spectrum of considerations such as professional credentials, involvement in didactic and practicebased learning, supervisory evaluations, objective testing, and compliance with hospital and institutional policies. Training programs have unofficially kept such records in various forms for many years. The new ACGME requirement, however, specifies that the documents be aggregated together in resident-specific portfolios that are readily accessible by the residents, their program directors, and accrediting teams from the Residency Review Committee of the ACGME. Many residency programs have already committed to maintaining these records in paper format. However, the Radiological Society of North America (RSNA®) and the Association of Program Directors in Radiology (APDR) have collaborated to create an electronic portfolio that will allow training programs and residents to maintain an electronic version of the PLP as a paperless alternative. This online program, the Resident Learning Portfolio, is being offered free of charge to all training programs, residents, and practicing physicians who are members of the RSNA. Just as a reminder, membership in the RSNA is free to all residents: The only requirement is to sign up. Although designed to meet the ACGME requirements for training programs, the Resident Learning Portfolio contains many components that are useful for practicing physicians. Any RSNA member has the ability to create and maintain a learning portfolio by going to www .rsna.org/myportfolio and diving in. An online user’s manual is available and can help guide you through the process of establishing a PLP. Training programs can begin the process by contacting the RSNA at residents_portfolio@rsna .org to create an institutional account. With the institutional account, program administrators can create and view the portfolios of all residents who designate the institution as their own. Program coordinators and program directors who are not members of the RSNA will still be able to access the online portfolios of residents from their respective institutions. The RSNA and APDR hope that the newly launched portfolio product will become a useful tool to support residency training and education, promote Maintenance of Certification documentation, and facilitate the lifelong professional development of its members. We encourage feedback about ways to improve and refine the portfolio to ensure that it becomes increasingly user-friendly and complete (contact us at residents_portfolio@rsna.org). RadioGraphics 2008; 28:1306 • Published online 10.1148

RSNA Support for Lifelong Learning

In this issue, Dr Jannette Collins provides an excellent, in-depth discussion of lifelong learning and its increasing emphasis in the professional lives of physicians (1). Most physicians are already engaged in lifelong learning but have not necessarily looked at the process from this perspective. The current discussion about the importance of lifelong learning may result in heightened selfawareness by physicians and may facilitate an ongoing learning process, which can, in turn, make it easier to document those processes in the manner required by the American Board of Radiology (ABR) Maintenance of Certification (MOC). RSNA® (Radiological Society of North America) has numerous programs and products intended to assist physicians in their lifelong learning process, regardless of whether or not the physician is officially participating in MOC. The most obvious offerings are the many types of continuing medical education (CME) activities available through RadioGraphics, the RSNA Annual Meeting, various workshops (offered throughout the year), and those that are continuously accessible online at www.rsna.org/education. Learners may use the content codes associated with each course, article, or program to find the CME opportunities that are most relevant to their interests, educational needs, and clinical practice. Physicians can also keep tabs on their CME history by accessing the CME gateway at www.cmegateway.org. Physicians may wish to develop and periodically update a more organized plan for their education and training. If so, a newly developed online tool takes learners through a process of self-reflection, analysis, and planning that results in a roadmap for future learning. Accessible at www.rsna.org /education/MOC, My Professional Learning Map can be completed and confidentially stored online or printed as a PDF. Self-assessment modules (SAMs) combine CME with an assessment of learning. Incorporating a mix of RadioGraphics articles, electronic refresher courses, and cases of the day, RSNA SAMs are free to members. Even for physicians not engaged in a formal MOC process, use of SAMs can consolidate learning by providing users with an immediate appraisal of their learning. These tools will also provide feedback about their performance relative to that of peers. In-person SAMs can be completed at the RSNA Annual Meeting, and online SAMs are available at www .rsna.org/education/MOC. There is also an increasing emphasis on moving past what physicians know to what physicians do in their daily practice. This focus on performance can be demonstrated through participation in individual or group quality improvement projects. Participants in the ABR MOC are required to engage in Performance Quality Improvement (PQI) activities throughout the certification cycle. All physicians can learn from measuring what they do, developing a strategy for improvement, and then measuring whether improvement has been achieved. Basic information about how to do quality improvement projects is available on the RSNA Web site at www.rsna.org /quality. Readers should also be alert for articles on quality improvement topics in RadioGraphics (new articles in the series, coordinated by Jonathan Kruskal, MD, PhD, appear online ahead of print issues at radiographics.rsnajnls.org).