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Introduction: Quality, Technology, and Outcomes in Radiation Oncology
Volume 22, Number 1
January 2012
Introduction: Quality, Technology, and Outcomes in Radiation Oncology
M
odern radiotherapy is a highly technical field that is constantly involved in the development, testing, implementation, and evaluation (one way or another) of new technologies that can contribute to improved treatment for our patients. These new technologies improve current techniques and potentially enable new possibilities for treatment regimes, often while being quickly disseminated throughout the field. The speed of that dissemination often means that a given technology can be in widespread use before the best ways to use the technology are known, and perhaps before adequate clinical experience and/or quality assurance (QA) procedures are developed and disseminated. In addition, it often can be very difficult to perform studies of efficacy for a given technology once it is well disseminated, as various financial issues and intellectual investment in the given technology can make participation in such trials difficult on a number of levels. We do not have to look far to find recent examples of these challenges. Current debates, both within and outside the field of Radiation Oncology, consider the efficacy of proton therapy in various different clinical situations, concurrent with the ongoing discussion of how best to use our national health care dollars. However, intensity-modulated radiation therapy (IMRT) is perhaps a better example, as it demonstrates a quick dissemination of a new technology in modern health care, concurrent (at best) with the development of the relevant training, quality assurance procedures, and clinical experience. IMRT rapidly gained popularity throughout the field, especially in the United States, because it provided sophisticated treatment planning (ie. inverse planning) and delivery software and hardware to improve dose distributions. Because of the increased complexity and work necessary, reimbursement quickly grew, which further aided the dissemination of the new technology. As discussed elsewhere in this issue (see pages (3-9)), credentialing of IMRT dosimetry capabilities performed by the Radiological Physics Center for the first IMRT clinical trial (in head/neck cancer), developed by the Radiation Therapy Oncology Group, clearly showed that all centers did not really have the appropriate experience to apply this technology, as more than a 1053-4296/12/$-see front matter © 2012 Elsevier Inc. All rights reserved. doi:10.1016/j.semradonc.2011.10.001
decade after the clinical introduction of IMRT, the failure rate for the credentialing test was still significant. As a field, we continue to grapple with balancing the potential of new technologies to improve treatment planning and delivery with the need to ensure safe introduction of the technique and adequate quality assurance. Regulatory agencies, such as the Food and Drug Administration, users (therapists, radiation oncologists, dosimetrists, and medical physicists), research investigators, and manufacturers will need to continue working together to move our field forward for the benefit of patient care. The types of evidence that can be used to verify efficacy will also continue to change, although many different types of studies will continue to be useful. Treatment planning studies will allow investigation of the potential dosimetric advantages of one technique over another. Multiinstitutional prospective trials can show what is achievable clinically by following a protocol with minimum standards defined by credentialing and quality assurance. Registries may allow an evaluation of patient treatments in a wider variety of practice settings, although without the benefits of oversight by a cooperative group for the protocol and QA. The articles in this issue of Seminars in Radiation Oncology explore the relationship between technology evolution, quality assessment, and patient outcomes from radiation oncologist and medical physicist perspectives. One article considers the medical and ethical perspective for choosing the right treatment given the array of choices, how new technologies are adopted into clinic use, and the clinical evidence for their use. It also looks at how the standard of care changes with time. Another article investigates the clinical impact of measuring and controlling for quality indicators in clinical trials. It challenges us to think more broadly about how we gather evidence in radiation therapy as well as the heterogeneity in care that may be present outside of the clinical trial setting. One article discusses the impact of technology and how we evaluate quality indicators as planning and delivery techniques change for patient care in detail for breast cancer. Also, 1
2 clinical evidence and its role in technology adoption are explored across the continuum of radiation therapy treatments. Both IMRT and image-guided radiation therapy (IGRT) have required significant software and hardware changes for clinical implementation and they continue to evolve, leading our field to reevaluate the timing of key steps (IGRT on-line review vs. off-line review of patient setup prior to treatment) as well as the division of labor to accomplish the increased workload. To ensure that patients are receiving the benefits of technology changes, the role of quantitative metrics to assess plan quality is discussed. Another article presents how process control improvements can be used to relate improvements in quality to patient outcomes. The issue concludes with an article demonstrating changes that can be made in daily practice
J.M. Moran and B.A. Fraass in community and academic-based practices to improve quality in patient care today for all of our patients. We would like to thank all authors who contributed to this issue. Together, the authors present an in-depth evaluation of the current state of quality and outcomes and their relationships with new technology, along with descriptions of the application of tools for studying and improving quality in radiation therapy. Proper attention to the study of quality and technology implementation in our clinical practices should lead to improvement in clinical outcomes for our patients. Jean M. Moran, PhD Benedick A. Fraass, PhD Guest Editors
January 2012
Introduction: Quality, Technology, and Outcomes in Radiation Oncology
M
odern radiotherapy is a highly technical field that is constantly involved in the development, testing, implementation, and evaluation (one way or another) of new technologies that can contribute to improved treatment for our patients. These new technologies improve current techniques and potentially enable new possibilities for treatment regimes, often while being quickly disseminated throughout the field. The speed of that dissemination often means that a given technology can be in widespread use before the best ways to use the technology are known, and perhaps before adequate clinical experience and/or quality assurance (QA) procedures are developed and disseminated. In addition, it often can be very difficult to perform studies of efficacy for a given technology once it is well disseminated, as various financial issues and intellectual investment in the given technology can make participation in such trials difficult on a number of levels. We do not have to look far to find recent examples of these challenges. Current debates, both within and outside the field of Radiation Oncology, consider the efficacy of proton therapy in various different clinical situations, concurrent with the ongoing discussion of how best to use our national health care dollars. However, intensity-modulated radiation therapy (IMRT) is perhaps a better example, as it demonstrates a quick dissemination of a new technology in modern health care, concurrent (at best) with the development of the relevant training, quality assurance procedures, and clinical experience. IMRT rapidly gained popularity throughout the field, especially in the United States, because it provided sophisticated treatment planning (ie. inverse planning) and delivery software and hardware to improve dose distributions. Because of the increased complexity and work necessary, reimbursement quickly grew, which further aided the dissemination of the new technology. As discussed elsewhere in this issue (see pages (3-9)), credentialing of IMRT dosimetry capabilities performed by the Radiological Physics Center for the first IMRT clinical trial (in head/neck cancer), developed by the Radiation Therapy Oncology Group, clearly showed that all centers did not really have the appropriate experience to apply this technology, as more than a 1053-4296/12/$-see front matter © 2012 Elsevier Inc. All rights reserved. doi:10.1016/j.semradonc.2011.10.001
decade after the clinical introduction of IMRT, the failure rate for the credentialing test was still significant. As a field, we continue to grapple with balancing the potential of new technologies to improve treatment planning and delivery with the need to ensure safe introduction of the technique and adequate quality assurance. Regulatory agencies, such as the Food and Drug Administration, users (therapists, radiation oncologists, dosimetrists, and medical physicists), research investigators, and manufacturers will need to continue working together to move our field forward for the benefit of patient care. The types of evidence that can be used to verify efficacy will also continue to change, although many different types of studies will continue to be useful. Treatment planning studies will allow investigation of the potential dosimetric advantages of one technique over another. Multiinstitutional prospective trials can show what is achievable clinically by following a protocol with minimum standards defined by credentialing and quality assurance. Registries may allow an evaluation of patient treatments in a wider variety of practice settings, although without the benefits of oversight by a cooperative group for the protocol and QA. The articles in this issue of Seminars in Radiation Oncology explore the relationship between technology evolution, quality assessment, and patient outcomes from radiation oncologist and medical physicist perspectives. One article considers the medical and ethical perspective for choosing the right treatment given the array of choices, how new technologies are adopted into clinic use, and the clinical evidence for their use. It also looks at how the standard of care changes with time. Another article investigates the clinical impact of measuring and controlling for quality indicators in clinical trials. It challenges us to think more broadly about how we gather evidence in radiation therapy as well as the heterogeneity in care that may be present outside of the clinical trial setting. One article discusses the impact of technology and how we evaluate quality indicators as planning and delivery techniques change for patient care in detail for breast cancer. Also, 1
2 clinical evidence and its role in technology adoption are explored across the continuum of radiation therapy treatments. Both IMRT and image-guided radiation therapy (IGRT) have required significant software and hardware changes for clinical implementation and they continue to evolve, leading our field to reevaluate the timing of key steps (IGRT on-line review vs. off-line review of patient setup prior to treatment) as well as the division of labor to accomplish the increased workload. To ensure that patients are receiving the benefits of technology changes, the role of quantitative metrics to assess plan quality is discussed. Another article presents how process control improvements can be used to relate improvements in quality to patient outcomes. The issue concludes with an article demonstrating changes that can be made in daily practice
J.M. Moran and B.A. Fraass in community and academic-based practices to improve quality in patient care today for all of our patients. We would like to thank all authors who contributed to this issue. Together, the authors present an in-depth evaluation of the current state of quality and outcomes and their relationships with new technology, along with descriptions of the application of tools for studying and improving quality in radiation therapy. Proper attention to the study of quality and technology implementation in our clinical practices should lead to improvement in clinical outcomes for our patients. Jean M. Moran, PhD Benedick A. Fraass, PhD Guest Editors