Table of Contents
Dedication
Title page
Copyright page
Contributors
Preface
CHAPTER 1: Health care reform: The scope of the problem
The waste and the cost
The causes: Expanded list
CHAPTER 2: Only studies which are necessary
Scope of the issue
Ideal solution
Practical solution
Follow-up folly
Conclusion
CHAPTER 3: Radiation dose reduction
Scope of the issue
Ideal solution
Workable solution
Conclusions
CHAPTER 4: Alternate imaging studies to CT
Scope of the issue
Discussion of specific US indications
Drawbacks of US
Ideal solution
Workable solution
CHAPTER 5: Patient information
Scope of the issue
Ideal solution
Workable solution
CHAPTER 6: Are we doing the right study?
Introduction
Medical imaging's image: More and more is less and less
CT: Increasing radiation exposure versus public health and safety
Protecting our children
Historical efforts to solve the problem of medical imaging overutilization: Limitations of radiology benefits management programs
The meaningful use of health information technology: Computerized decision support systems
Progress in reducing the overuse and misuse in imaging
Impediments
Conclusions and recommendations
CHAPTER 7: Radiology medical education
Scope of the issue
Future directions
Radiology education beyond Radiology residency—medical students and residents from other areas
Conclusions
CHAPTER 8: Quality metrics for radiology practice
Overview
Quality
Diagnostic accuracy of reports
Safety
Conclusions
CHAPTER 9: Medicolegal reform
Scope of the issue
Ideal solution
Workable solution
CHAPTER 10: Pressures on reduced compensation for clinical service
Scope of the issue
Ideal solution
Workable solution
Conclusions
CHAPTER 11: National health care systems
Scope of the issue
Ideal solution
Workable solution
Conclusions
CHAPTER 12: Research in radiology
Scope of the issue
Research: basic, clinical, and translational
Evidence-based research
Grant foundations
Postmodern medical imaging for end-of-life care: A case for research
DNA double-strand breaks as biological markers for radiation-induced DNA damages in radiology
Conclusions
Subject index
To the memory of Gunther Semelka and Joseph Armao
Copyright © 2013 by John Wiley & Sons, Inc. All rights reserved
Published by John Wiley & Sons, Inc., Hoboken, New Jersey
Published simultaneously in Canada
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Library of Congress Cataloging-in-Publication Data:
Semelka, Richard C., author.
Health care reform in radiology / Richard C. Semelka and Jorge Elias Jr.
p. ; cm.
Includes bibliographical references and index.
ISBN 978-1-118-64217-7 (pbk. : alk. paper) – ISBN 978-1-118-64221-4 (ePDF) – ISBN 978-1-118-64227-6 – ISBN 978-1-118-64229-0 (ePub) – ISBN 978-1-118-64236-8 (eMobi)
I. Elias, Jorge, Jr, author. II. Title.
[DNLM: 1. Radiology–economics–United States. 2. Radiology–trends–United States. 3. Costs and Cost Analysis–United States. 4. Health Care Reform–United States. 5. Quality of Health Care–United States. 6. Unnecessary Procedures–economics–United States. WN 100]
RC78.15
616.07'570681–dc23
2013018319
Cover image: Caduceus © iStockphoto.com/James Steidl; Piggy bank © iStockphoyo/Tom Schmucker; Hand and head x-ray, De-identified diagnostic images courtesy of University of North Carolina Hospitals, Chapel Hill, North Carolina
Cover design by Wiley
Contributors
Diane Armao
University of North Carolina at Chapel Hill, School of Medicine, Department of Radiology and Pathology and Laboratory Medicine, Chapel Hill, North Carolina, USA
Michael Brand
Department of Radiology, University Hospital of Erlangen, Erlangen, Germany
Lauren M. B. Burke
University of North Carolina at Chapel Hill, School of Medicine, Department of Radiology, Chapel Hill, North Carolina, USA
Jorge Elias Jr
The School of Medicine of Ribeirao Preto, University of Sao Paulo, Brazil
Michael A. Kuefner
Department of Radiology, University Hospital of Erlangen, Erlangen, Germany
Richard C. Semelka
University of North Carolina at Chapel Hill, School of Medicine, Department of Radiology, Chapel Hill, North Carolina, USA
John Stonestreet
Hopecare Clinical Solutions, Chapel Hill, North Carolina, USA
Michael Uder
Department of Radiology, University Hospital of Erlangen, Erlangen, Germany
Preface
“Patients first” was the motto for the 98th Assembly and Meeting of the Radiological Society of North America (RSNA). Our intention of writing this book is to provide a road map to achieve that goal. We describe major issues in health care that affect Radiology and describe for each of these ideal and workable solutions. The subjects we cover in this book encompass some novel concepts that we believe will be valuable additions to the practice of Radiology. Foremost among these are: recommendations for development and adoption of what we have termed Diagnostic Imaging Appropriateness Score, as a measure to determine if a study should be performed; anonymous evaluation of radiologist's performance; holding medical experts legally accountable for their opinions if they differ from the norm; incorporation of radiologists serving as blinded reviewers in medicolegal cases as a method to obtain continuing education credits; and that the US health care system should emulate the Australian system as a model. We believe that the recommendations we have provided would serve to dramatically improve the quality and safety of Radiology practice. As with most important improvements, there has to be the will to change before it is too late, and these improvements will certainly need the involvement of the entire Radiology community as well as governmental agencies.
Richard C. Semelka
Jorge Elias Jr
CHAPTER 1
Health care reform: The scope of the problem
There is virtually no disagreement that serious problems exist in the US health care system. Prodigal outlays for medical care are undeniable. From a global perspective, the USA pays more per capita in health care than any other country and yet ranks 37th in the world regarding quality of health care; in part this is because approximately 45 million individuals (1 in 6.5) remain uninsured. From a national perspective, per capita Medicare spending in different parts of the country varies dramatically. Medicare enrollees in higher spending regions receive more care than those in lower spending regions but do not have increased access to care, better quality care, improved health outcomes or patient satisfaction [1]. Moreover, there even exists a negative association between higher health care expenditures and outcomes, such as mortality at the regional level [2]. The notion that additional growth in health care cost is primarily driven by advances in science and technology and that more spending will result in improved quality of care is no longer tenable.
Radiologists are ideally positioned to discuss health care issues from a physician's perspective. Due to the nature of their specialty, radiologists are the main diagnostic consultants for virtually all branches of medical practice and hence are familiar with the breadth of medical care. Based on the range of their experience, radiologists can help guide the mechanics involved in health care costs, patient safety and comparative effectiveness metrics. Costs and appropriateness criteria relate to evaluating whether certain diagnostic studies are warranted, while patient safety addresses issues centered on radiation dose reduction in imaging studies, including substitution of alternate examinations in particular clinical settings. In order to achieve these goals, accurate patient information is paramount.
As pointed out by the US Congressional Research Service in 2007 the USA spends more money on health care than any other country in the Organisation for Economic Co-operation and Development (OECD), which comprises 30 countries that represent the most economically advanced countries in the world. The USA spent $6102 per capita on health care in 2004; double that spent by OECD and 19.9% more than Luxembourg, the second-highest spending country. In that year, 15.3% of the US economy was devoted to health care, compared with 8.9% in the average OECD country and 11.6% in second-placed Switzerland. The OECD has stated that US prices for medical care commodities and services are significantly higher than in other countries and serve as a key determinant of higher overall spending.
One striking example of high health care costs has been recently reported in McAllen, Texas, which possesses the lowest US household income but has the second most expensive US health care market, spending twice the national average [3, 4]. Indeed, patients in McAllen get more diagnostic testing, more hospital treatment, more surgery, and more home care compared to any another town, with no recognition of overall quantity by hospital administrators [3, 4].
In a 2008 analysis by Price Waterhouse Health Research Institute (PwC) on sources of financial waste in the US health care system, there was approximately $1 trillion in waste, comprising more than a half the total spending, with $200 billion attributable to defensive health care practice [5]. However, due to the ubiquitous nature of defensive health care practice, such cost may be considerably underestimated.
The PwC indicates that the recession that began in 2007 has changed the trend of medical cost in the USA. Medical cost had a surprisingly low growth rate of 7.5% in 2010, after an estimate of 9%, but increased to 8% in 2011 and was expected to increase to 8.5% in 2012. This trend represents the projected increase in the costs of medical services assumed in setting premiums for health insurance plans. The largest single component of spending is physician services, which accounts for about 33% of all benefit costs. Outpatient hospital services and prescriptions account for 17% and 15%, respectively. Other services such as home health, skilled nursing, and medical equipment account for a meager 4% of benefit costs.
Expectations surrounding US government health reform, as manifested by the American Reinvestment and Recovery Act of 2009 and the Patient Protection and Affordable Care Act of 2010 (PPACA), will certainly contribute to cost shifting, but the magnitude of its impact on cost-ineffective services versus more cost-effective but underutilized services is not completely clear. One likely scenario involves physicians and hospitals being paid higher levels of compensation for more cost-effective services relative to their costs but lower levels of payment at or below cost for less cost-effective services [6]. Actually, the American College of Radiology recently dedicated a whole issue of the Journal of the American College of Radiology (JACR) to this issue, bringing various aspects related to cost, utilization, value and coverage regarding the US Health Reform [7–14]. What seems more than certain is that US health care reform, one way or another, will dominate the scenario of change for patients, physicians, and all other stakeholders for years to come—all hope for a change to the better.
Because of the intrinsic complexity of the problem and the multifactorial nature of causality, it is not an easy task to determine the main causes of high medical costs, since they can change over time due to multiple confounding factors. A dominant influence is also the subjective bias of the interested observer's point of view. Interestingly, this can also explain why many have failed to present a definitive solution, and few have attempted to address the core of the problem.
Nonetheless, certain causes are clearly identifiable as reflecting a “frequent flyer” list irrespective of the observer's role in the US health care system, or self-interest as a stakeholder.
An attempt to categorize these causes was made by PwC, and they grouped them as follows: 1) behavioral—where individual behaviors are shown to lead to health problems, and have compromised opportunities for earlier, preventative interventions; 2) operational—where administrative or other business processes appear to add costs without creating value; and 3) clinical—where medical care itself is considered inappropriate, entailing overuse, misuse or under-use of particular interventions, missed opportunities for earlier interventions, and overt errors leading to poor quality care for the patient and added health care cost.
A basic but yet expanded list of rising medical costs is presented in Box 1.1. These causes will be discussed in more detail in this publication.
Physician shortages and high prices of physicians' services
Medical litigation
Defensive medicine
Excessive ordering of expensive medical tests
Excessive charge per procedure
Spending on pharmaceuticals
Small or no success to address preventable health risk factors (such as obesity, smoking, and alcohol abuse)
Excessive health care expenditure on the terminally ill
Health care fraud
References
1. Fisher ES, Wennberg DE, Stukel TA, Gottlieb DJ, Lucas FL, Pinder EL. The implications of regional variations in Medicare spending. Part 1: The content, quality, and accessibility of care. Ann Intern Med 2003; 138:273–287.
2. Fisher ES, Wennberg DE, Stukel TA, Gottlieb DJ, Lucas FL, Pinder EL. The implications of regional variations in Medicare spending. Part 2: Health outcomes and satisfaction with care. Ann Intern Med 2003; 138:288–298.
3. Gawande AA, Fisher ES, Gruber J, Rosenthal MB. The cost of health care—highlights from a discussion about economics and reform. N Engl J Med 2009; 361:1421–1423.
4. Kauffman-Pickelle C. Radiology and the Culture of Money. ImagingBiz 2009. Available online at: http://www.imagingbiz.com/articles/view/radiology-and-the-culture-of-money1 [accessed February 19, 2013].
5. The price of excess: Identifying waste in healthcare spending. Report Document from PricewaterhouseCoopers' Health Research Institute 2008; 22. Available online at: http://www.pwc.com/us/en/healthcare/publications/the-price-of-excess.jhtml [accessed February 19, 2013].
6. Weinstein MC, Skinner JA. Comparative effectiveness and health care spending—implications for reform. N Engl J Med 2010; 362:460–465.
7. Rawson JV. Roots of health care reform. J Am Coll Radiol 2012; 9:684–688.
8. Norbash A, Hindson D, Heineke J. The accountable health care act of Massachusetts: Mixed results for an experiment in universal health care coverage. J Am Coll Radiol 2012; 9:734–739.
9. Lexa FJ. A radiologist's guide to the federal election of 2012: What you should know before you go into the booth. J Am Coll Radiol 2012; 9:740–744.
10. Lexa FJ. Drivers of health reform in the United States: 2012 and beyond. J Am Coll Radiol 2012; 9:689–693.
11. Lee CI, Enzmann DR. Measuring radiology's value in time saved. J Am Coll Radiol 2012; 9:713–717.
12. Duszak R, Jr, Berlin JW. Utilization management in radiology, part 1: Rationale, history, and current status. J Am Coll Radiol 2012; 9:694–699.
13. Duszak R, Jr, Berlin JW. Utilization management in radiology, part 2: Perspectives and future directions. J Am Coll Radiol 2012; 9:700–703.
14. Carlos RC, Rawson JV. Introduction to the special issue-health care reform: Darkness before dawn? J Am Coll Radiol 2012; 9:682–683.
CHAPTER 2
Only studies which are necessary
Components critical to evaluating whether imaging studies are necessary include: 1) an intermediate to high pre-test probability patient population; 2) the seriousness of the disease entity; 3) the treatability of the disease process (taking into consideration lesion size and stage of disease); 4) the sensitivity, specificity, predictive values, and accuracy of the test; 5) the safety of the procedure, including ionizing radiation and incidence and severity of complications; 6) the nature and number of prior imaging studies for the same clinical condition; and 7) the comparative effectiveness with other approaches, including, importantly, doing no test.
Quality health care, according the National Committee for Quality Assurance (NCQA) is defined as “the extent to which patients get the care they need in a manner that most effectively protects or restores their health” [1]. As described by the Patient-Centered Outcomes Research Institute (PCORI), an increasing body of clinical comparative effectiveness research (CCER) compares the relative effectiveness and safety of alternative, preventative, diagnostic, or treatment options [2]. A high priority of CCER is to evaluate the health effects of clinical practices that have been widely adapted by clinicians, despite limited evidence about the risks and benefits [3].
Clinical practice is oftentimes shaped by the dominant and pervasive influence of available diagnostic imaging. In turn, powerful imaging marketing strategies focusing on profit engenders the rapid purchase of machines prior to completely understanding how this technology should be implemented to improve outcomes [4]. Such dynamics between the ease of acceptance in clinical practice and the lure of profitable marketing and investment has created excess imaging capacity, confounded by few evidence-based guidelines for its use. A study published in a premier public health care and policy journal addressed the problem of rapid expansion of diagnostic imaging in the face of limited, measurable health outcomes [5]. To illustrate this issue, using census data on imaging units and Medicare claims data, the authors investigated the rapid diffusion of computed tomography angiography (CTA) use for assessing abdominal–pelvic abnormalities, including abdominal aortic aneurysm, versus catheter angiography. Patients who newly received the less invasive CTA but would not have received catheter angiography before could have benefited if the additional screening depicted disease that would have gone undetected before. To provide some evidence of this, the authors analyzed whether the additional diagnostic testing was associated with changes in therapeutic procedure rates. Such treatment rates provide a key mechanism by which improved health outcomes might be expected to occur. If expanded availability and use of diagnostic imaging catches treatable conditions, and conditions that merit treatment, the authors expected to observe a higher rate of therapeutic procedures, including direct repairs for ruptured aneurysms, endovascular repairs, and endarterectomies [5]. However, the authors concluded that for each additional 100 CTA users in a metropolitan area, statistically there were only about 1.1 more beneficiaries who received one or more of these treatments [5].
The role of diagnostic imaging in patient care is costly. In 2007, Medicare expenditures for imaging services totaled $11.4 billion, representing a material increase from the $8.4 billion spent in 2002 [6]. The direct cost of imaging studies is over $100 billion annually [7]. There is serious concern that expensive imaging tests are ordered and performed without an evidence base to support their appropriateness or health benefit [8]. Further, CCER experts argue that there is almost no evidenciary bar at all to gain Food and Drug Administration approval of imaging technologies [9]. No doubt, technologic and diagnostic capabilities in imaging have soared over recent years due, in part, to an ever enlarging enterprise of research. Yet, research that quantifies the long-term effects of imaging on patient outcomes remains disproportionately sparse [6].
Hence little of what is termed evidence-based medicine is actually evidence-based—mainly because the proxies used for evidence are short term or only examine a portion of the clinical picture, rather than long term and evaluating the totality of the patient's condition. Experience has shown that limited perspective evidence-based studies ultimately are often shown to have little to no merit. We have to train ourselves to look at the whole picture and for longer time periods. In particular, radiologists, as physician and patient providers, need to work to become better informed of the natural history of the diseases we evaluate, as excessive imaging may not only be more expensive but also be worse than the disease itself. Besides the personal health costs of over-radiation, unnecessary advanced diagnostic imaging has engendered an epidemic of indeterminate, incidental findings at least as troubling to both physician and patient as the events that prompted the initial imaging exam [10]. The author of a recent editorial in Imaging for the Clinician Special Section laments “I know radiologists who have never seen a normal CT exam. They dictate 2-page reports describing in excruciating detail every dot in the lung bases, liver, spleen and kidney; every top normal lymph node is measured, every benign ovarian cyst is described, every hedge is sat upon. To make matters worse, each of these heroic poems ends with recommendations for further imaging to include ultrasound (US) of the pelvis, US of the kidneys, magnetic resonance imaging of the pelvis, CT of the full chest, and repeat studies with additional contrast or thin-section evaluations of specific organs for the ‘ditzels’ described. What is a well-meaning clinician to do with such generally worthless information?” [10].
There is widespread agreement that a considerable number of imaging procedures performed are unnecessary [11–15]. In one publication it was estimated that one-third of CTs are unnecessary [16]. Unfortunately, the current circumstance is aptly comparable to Mark Twain's observation: “many people talk about the weather, but nobody is doing anything about it.” Many authorities discuss the problem [17], but concrete proposals are lacking. Hence we have created a heightened environment of anxiety, but with no solutions in sight.
Some publications suggest that 20–50% of high-tech imaging, such as multisection CT, magnetic resonance imaging (MRI), and positron emission tomography (PET), fail to provide information that improves patients' welfare and hence may represent unnecessary imaging services [18]. By definition, overutilization may be defined as application of imaging procedures in clinical situations where imaging tests are unlikely to improve patient outcomes [18]. Inappropriate imaging augments health care costs without increasing the quality of health care. Recent research shows that approximately one-third of health care spending is duplicative, unhelpful, or makes patients worse [19]. Unnecessary imaging studies seldom reveal the cause of the patient's complaint yet may reveal incidental findings that require further imaging or interventional procedures to clarify [20]. These further investigations, the so-called “snowball effect,” often result in undue anxiety, further imaging, and further therapy that cause more harm than good.
The rapid rise of medical imaging reflects ongoing advances in technology and expanded applications in high-tech modalities. This growth rate is abetted by reflexive acceptance of imaging as standard of care, without an evidence base to create formal practice guidelines. Major causes of inappropriate utilization of medical imaging include: 1) medical liability fears, 2) patient demand, 3) economically motivated in-office self-referral, and 4) physician inexperience and lack of support in the appropriate clinical application of diagnostic imaging [21, 22].
Such a lack of rigorous, systematic compliance with appropriateness criteria has created a serious gap between health care delivery and high-quality patient-centered outcomes. As a case in point, a recent retrospective analysis from an academic medical center of a large group of CT and MRI examinations for appropriateness using evidence-based guidelines revealed that 26% did not meet appropriateness criteria [21]. In this analysis, in the appropriate study group 58% had positive findings that affected medical management, whereas within the inappropriate group only 13% had positive findings that affected management. Notably, the highest percentage of inappropriate examinations was CT studies of the brain without contrast [21]. Additionally, there was a high negativity rate among these inappropriate examinations; the odds were 3.5 times higher that a negative finding would be associated with an inappropriate versus an appropriate examination. This is critical information for policy makers in the pursuit of utilization guidelines for medical imaging. Patients, physicians, payers, and the public should become better informed about the positive predictive value of imaging tests, while simultaneously making the commitment to decrease costs and ensure quality and safety in our nation's health.
In general, imaging appropriateness criteria consist of radiology expert consensus, including the American College of Radiology (ACR) Appropriateness Criteria and the Royal College of Radiology (RCR) Guidelines [23]. Medical imaging appropriateness criteria are often supplemented by indication and procedure pairs created by expert consensus panels of primary care physicians and clinicians in relevant clinical specialties [24]. However, knowledge of imaging appropriateness criteria is not widespread, and utilization is voluntary, resulting in fragmented adherence. Well-designed computerized radiology order entry and decision support systems are particularly well suited to help clinicians navigate through evidence-based guidelines at the point of care [24]. The goals of guidelines such as those of the ACR are important and laudable efforts. A potential problem that has not been evaluated is the actual level of expertise of expert panels, and individuals have a tendency to believe whatever methodology they primarily use is the appropriate one. A further problem with imaging society appropriateness criteria is that although their criteria recommends the best test for a condition (e.g. noncontrast head CT for potential intracranial bleed) they generally provide no guidance whether any study should be performed to begin with. This forms the foundation of the criteria that we propose below that should take both imaging appropriateness and clinical appropriateness into consideration.
One perfect test for any and all diseases is beyond any achievement in our era. Diseases and microorganisms evolve, and the host component changes, reflecting changes in an aging population, interaction between human and environment, and increasing population size. Probably, the closest to an ideal solution for such complicated problems may be based on a futuristic science-based strategy. Already steps are made toward using genetic information to determine the probability of disease occurrence. The best-known example of this is BRAC1 and BRAC2 for breast cancer. It is not farfetched to imagine that we will be able to detect all possible disease, by searching predisposition through understanding our DNA codes before we are even born and probabilistically determining disease likelihood based on our entire genetic makeup. We anticipate that in that future imaging will maintain an important role in detecting actual disease in individuals who are determined to be at risk, or susceptible, to that particular disease. Imaging will likely not be supplanted, but augmented, by genetic profiling.
In January 2012 the X PRIZE Foundation and Qualcomm Foundation announced the launch of the $10 million Qualcomm Tricorder X PRIZE, a global competition that they claim will revolutionize health care (see http://www.qualcommtricorderxprize.org) [25]. In this competition, teams will leverage technology innovation in areas such as artificial intelligence and wireless sensing—much like the fictional medical Tricorder—to make medical diagnoses independent of a physician or health care provider [25]. A tricorder is a device used by the Star Trek character Dr. Leonard McCoy, a.k.a. “Bones,” which he would wave over the body of a subject and instantly discover whatever disease they had, without even touching the individual. Could this be the future?
It is clearly important to have timely and accurate diagnoses of diseases that are treatable, and in many clinical circumstances these diagnoses would be of “pre-malignant” conditions, which ultimately can be cured, prior to the disease becoming frankly malignant. In many of these clinical circumstances diagnosing a disease early may not change the natural history of disease, and controversy exists on this subject for many diseases, including prostate cancer. This is termed lead-time bias, and both the detection of prostate cancer and of breast cancer has been scrutinized with the recognition of this bias in mind. It is our opinion however, and we may be in the majority, that it is always important to recognize disease early. It is appropriate treatment that needs to mature. Worse still, all medical involvement that follows an initial diagnosis, that is more imaging and more treatment, may cause more harm than good, while at the same time be associated with high cost. Some of the most disturbing health care scenarios are the high-cost, highly toxic strategies of some chemotherapy regimens, which may translate into 2 weeks extra of life, rendered miserable because of side effects of the therapy anyway, for $500,000 in added cost. That is why solid medical research is the main foundation to pave the path to a more ideal solution.
Our practical solution was inspired, in part, by the recent Institute of Medicine's (IOM) response to the request of the largest grassroots network of breast cancer survivors and activists in the USA, Susan G. Koman for the Cure, to perform a comprehensive and evidence-based review of environmental causes and risk factors for breast cancer, with a focus on identifying evidence-based actions that can be taken to reduce risk [4, 26]. The IOM concluded that the two environmental factors most strongly associated with breast cancer were combined postmenopausal hormone therapy and exposure to ionizing radiation [26]. Surprising in the IOM review is the emphasis on the avoidance of medical imaging as one of the most important steps toward reducing cancer risk [4].
As previously discussed, imaging technology is at the center of the overutilization that has permeated routine practice, oftentimes for medical problems for which there is no evidence of the test's effectiveness or cost-effectiveness; this effect has been termed “test ordering leakage” [27]. We herein propose a platform whereby service provision and quality improvement could occur through the adaptation of a grading scheme or an “imaging scorecard” to assess appropriate versus avoidable imaging. The imaging scorecard, which we term the Diagnostic Imaging Appropriateness Score (DIAS), would be used to increase the effectiveness of imaging and close the “performance gap” between inappropriate imaging and health care quality improvement. Our development of DIAS takes into consideration both the appropriateness of the imaging test in general (analogous to the ACR appropriateness criteria) but also the appropriateness of imaging specifically for the suspected clinical indications, which at present remains unaddressed. We recommend a scoring system like the Glasgow Coma scale, as scoring systems of this type are already accepted and in use in medical practice, and therefore are readily relatable to practicing physicians.
The fields used to evaluate whether studies are likely to be appropriate or avoidable include all of the following.
In summary, the system to determine whether an imaging system is indicated includes imaging components and clinical components, analogous to other scales, as used for the Glasgow Coma scale [28] and St. Anne-Mayo grading system for astrocytomas [29]. In total seven components are measured, each rated from 1 to 4, where 1 is minimal indication, 2 is mild indication, 3 is moderate indication, and 4 is strong indication. These values are then added into a composite score, where the total possible value is 28. A lower level should be set below which performing the imaging study is not indicated or marginally indicated, which in the preliminary state we set at 10. This approach differs from other imaging appropriateness systems, which generally evaluate only the imaging components and do not include clinical components. We intend this as a starting point for the assignment of appropriateness to imaging. In our DIAS system the highest score is 28, where we would describe a score of 26–28 as definitely indicated, 22–25 probably indicated, 18–21 possibly indicated (but needs careful clinical scrutiny), 14–17 possibly not indicated, 10–13 probably not indicated, and <10 definitely not indicated.
Our suggestion would also be to use a body of medical experts who do not have a vested interest in these procedures to render an opinion on these determinations, with the obvious requirement that they will solicit input from experts in the field. A logical specialty to render opinions on radiology would be pathologists.
Our scoring scheme is a prototype yet provides a solid workable foundation for future development. For example, as CER is expanded and strengthened in clinical radiology, a criterion for CER is critical. Although we have already included CER in our DIAS system, we recognize that this assessment has not been effectively established. In addition, although still heavily debated as to whether or not economic analysis should be included in CER, we believe that future incorporation of a cost analysis score would be essential in order to evaluate high-value imaging care at a reasonable cost versus expensive low-yield imaging services [6]. Our grading scheme requires tool validation for implementation. Equally important are ongoing multidisciplinary consensus recommendations in order to clearly define clinical scenarios within a patient's entire episode of care, where high-cost imaging can exert the maximum medical benefit.
We will illustrate three common clinical paradigms as examples of how this imaging scorecard DIAS would be implemented.
We have published research that shows that young adults, aged 18–45 years, who undergo pulmonary embolism (PE) CT have a low (5%) incidence of PE [30]. A recent, larger landmark study by Mamlouk et al. revealed that in the setting of no thromboembolic risk factors, it is extraordinarily unlikely (0.95% chance) to have a CT angiogram positive for PE. Another recent large multicenter prospective study, with 11 US emergency departments and 5940 patients enrolled, reported that one-third of imaging performed for suspected PE may be categorized as avoidable [31].
With this as a backdrop, let us look at a CT PE study in a 25-year-old woman with low risk factors, this being the first time study and first CT ever.
The DIAS in this patient is 20 of a possible 28 points. Possibly indicated, close clinical evaluation.
Low back pain is common. It has a lifetime prevalence of 80% and is the fifth most common reason for all physician visits in the USA [32, 33]. Imaging for low back pain is common, with recent data showing that 42% of patients receive imaging within 1 year [34]. Of these 60% had imaging on the same day as index diagnosis and 80% within 1 month of diagnosis of back pain [34]. Evidence is clear, based on high-quality systematic reviews and meta-analysis, that imaging patients with acute low back pain of less than 6 weeks' duration and no red flag symptoms, defined as severe or progressive neurologic deficits or serious underlying conditions such as cancer or osteomyelitis, results in no clinical benefits [35]. Instead, such avoidable imaging is associated with harms including patient labeling, diminished sense of well-being, radiation exposure, and unnecessary surgery [36].
A recent initiative of the National Physicians Alliance delineated a list of five activities in primary care where changes in practice would foster higher-quality care and ensure more judicious use of finite health care resources [37]. One of the top 5 recommendations was “Do not do imaging for low back pain within the first 6 weeks unless red flags are present” [32, 37].
Although MRI and CT imaging are significantly more costly than standard lumbar radiographs, their use as modalities for spinal imaging in low back pain is increasing [32]. Medicare coverage for MRI of the lumbar spine between 1994 and 2005 increased 307% [38]. Standard lumbar radiographs have such low yield for important common indications, such as disc herniation, that this test is generally of very limited value.
With the above as a backdrop, let us consider a CT of the lumbar spine in a 35-year-old woman within 5 weeks of onset of pain; this is her second CT of the torso within 1 year for various indications:
Total DIAS score =11. Probably not indicated.
A third example is a topic that we have considerable publishing and clinical experience of: imaging of the liver in patients with chronic liver disease [39–46]. In this patient group a primary diagnostic end point is detecting small hepatocellular carcinomas. Let us select a 50-year-old man with Hepatitis C cirrhosis for an annual screening study for hepatocellular carcinoma (HCC). Using contrast-enhanced MRI as the diagnostic test, the following are the evaluations: pt 1 = 4, pt 2 = 4, pt 3 = 4, pt 4 = 4, pt 5 = 4, pt 6 = 4, pt 7 = 4. The DIAS score for MRI is 28, definitely indicated. Substituting in contrast-enhanced CT as the diagnostic test, the evaluations are: pt 1 = 4, pt 2 = 4, pt 3 = 4, pt 4 = 2 (CT is not that sensitive for <2 cm HCCs, which we are targeting with this imaging study), pt 5 = 2 (triple-pass CT is a relatively high radiation exposure, 25 mSv; at 50 years of age he is at mild to moderate risk), pt 6 = 2 (MRI is a better study), pt 7 = 3 (recognizing this is a triple pass we add a 1 point deduction because it is similar to a repeat CT study). The DIAS score for CT in this patient is 21, possibly indicated, clinical assessment. Part of the clinical assessment is that MRI rates 28 and therefore should be used instead. Substituting in noncontrast US, the evaluations are: pt 1 = 4, pt 2 = 4, pt 3 = 4, pt 4 = 1, pt 5 = 4, pt 6 = 2, pt 7 = 4, for a total of 23. This score suggests that US is probably indicated, but the 28 rating of MRI suggests that it is necessary. However, it does also suggest that the use of US is supported in developing countries, where high-quality MRI may not be available. For this patient, the clinical aspects and the safety of the procedure resulted in a higher rating of US over CT, although in most imaging investigations CT may perform slightly better than US for this general disease detection in this patient population from a purely diagnostic standpoint.
An ideal target for DIAS assessment is cardiology imaging practice. Cardiology is unfortunately an especially egregious offender in overutilization of imaging, an illustration of which is that myocardial perfusion imaging (MPI; approximately 9 million studies per year in the USA) is the single test with the highest radiation burden, is often performed multiple times in a given patient, and is considered the “gatekeeper” test for suspected coronary artery disease; this is despite the fact that Patel et al. in the Duke study showed that only 38% of patients undergoing invasive coronary angiography had obstructive coronary artery disease [47]. Another recent study reported that multiple testing with MPI was common and in many patients associated with high cumulative estimated doses of radiation [48]. Moreover, more than 80% of initial and 90% of repeat MPI examinations were performed in patients with known cardiac disease or symptoms consistent with it [48].
The presented imaging scorecard used to determine whether a test is necessary or avoidable has two components that are extremely delicate: the seriousness of the disease entity, and the treatability of the disease process (taking into consideration lesion size and stage of disease). Tremendous emotional debate has surrounded this as it applies to excessive health care expenditure on the terminally ill. The famous expression of “death squads” has been used in this context. Approximately 30% of the health care budget is spent on the final 6 months of life [49]. This point clearly has strong ethical and emotional implications as far as denying health care is concerned [50]. Ultimately, to examine the question from a national perspective, it is more beneficial and cost-effective to invest national health care dollars in prevention and early treatment of disease than to pay for a one month's intensive care unit (ICU) stay for a patient with advanced metastatic cancer [13]. The consideration of this point explains why health care costs are so much greater in the USA than in other countries [50]; other countries do not allow terminally ill patients in the ICU, or other extreme health care measures close to the end of life, to this extent, with the benefits realized of only a few extra days of life. The decisions to limit health care have been developed by a number of national health care programs, many of which are based on limiting services using defined age criteria and defined life/wellness functional evaluations [51]. Ultimately, these clinical situations would also be handled when using the formula presented.
A second category of overuse is the timing of follow-up studies and the extent to which they are performed. With more than 20 years' clinical experience we have come to realize that we obtain follow-up imaging studies until the patient decides not to come back. This is reminiscent of the dialogue of Woody Allen in the film Sleeper