Realizing the Promise of Individualized Health



By rights, the American population should be the healthiest in the world. The United States is a world leader in advanced medical technologies and practice. Its citizens spend almost twice as much on medical care as citizens of other developed countries.1 Yet this extraordinary investment pays a poor return when it comes to citizens’ overall health. United States ranks 26th in life expectancy, 31st in infant mortality, and first in the incidence of adult obesity out of the 34 OECD countries.[1]

What’s behind this extraordinary waste of resources? Poor use of health information-- false health beliefs combined with non-scientific use of health data--is a substantial root cause. For example, it makes sense to most Americans that more medical care is better care; most believe that controlling consumption of medical services amounts to “rationing.” More care may help to treat illnesses for which there are well-defined solutions. Yet only 15 percent of the $500 billion Medicare spends annually goes toward “effective” or “necessary” care: treatments that provide benefits that substantially outweigh their risks[2]. Moreover, each medical contact increases the likelihood of medical errors, false positive diagnoses that can expose patients to risky treatments, or the unproductive use of limited resources. As Dartmouth Professor Gilbert Welch recently asked in the New York Times: “Isn’t it time to learn which practices, in fact, improve our health, and which ones don’t?”[3]

While Americans struggle with the abundance and complexity of existing health information, a tsunami of new information is reaching its crest. Twenty years ago, revolutions in biotechnology and information unleashed an earthquake of new bioscience and medical data— DNA sequences, RNA expression levels, protein structures, epigenetic markers, structural and functional images of the brain, and other “big data.” This wave of information represents both a challenge and an opportunity.

Creative use of the emerging biological data can unravel the mysteries of an individual’s health and disease. These data can help us to understand what distinguishes one person from another and to tailor prevention, diagnosis and treatment to improve health dramatically. By allowing us to manage health and disease on an individual level, this emerging data can also reduce the waste in our current health expenditures.

The goal of the Johns Hopkins individualized Health Initiative or “Hopkins inHealth” is to develop and disseminate tools that facilitate the intelligent use of existing and emerging information to individualized health and health care. Toward this end, Hopkins inHealth will discover how best to define, measure, and communicate each person’s health state and the trajectory along which it is changing, and use these measurements to guide that trajectory in ways that enhance health and quality of life.

A compelling example involves screening for common cancers. By integrating population data about the age and risk factor-specific prevalence rates with personal data on family history and other factors, we can individualize each person’s cancer screening protocol. Doing so increases the chance of detecting the cancer early, while minimizing the risk and costs of false-positive screens and inappropriate invasive tests or treatments. Each person’s risk of developing one of the major cancers is unique; therefore, each should have a unique screening algorithm. In addition, Johns Hopkins and other institutions are developing new genomic and epigenetic screening tools. These tests will generate a new kind of information that can further individualize detection and treatment, then substantially increase savings over the coming decade.

Through the inHealth Initiative, three Johns Hopkins Institutions — the University, Johns Hopkins Health System, and the Applied Physics Laboratory — will combine their assets to demonstrate how to use health information effectively to make world-class, affordable health a 21st- century American reality. They will first demonstrate the value of a new information-based strategy in populations managed by the Johns Hopkins Health System. They will then share the approach with the much larger Department of Defense and Veterans Administration populations via the Johns Hopkins Military and Veterans Health Institute. These efforts will lead the way forward for society as a whole.

Johns Hopkins is uniquely qualified to discover, implement, and disseminate information-based solutions to key aspects of the American health crisis. Collectively, the Johns Hopkins Schools of Public Health, Medicine and Nursing comprise the best academic health institutions in the world. Faculty in Johns Hopkins’ schools of Engineering and Arts and Sciences, and scientists at the Applied Physics Laboratory bring world-class expertise in statistics, applied mathematics, computer science, and systems engineering.  Johns Hopkins has a strong tradition of entrepreneurial faculty seeking solutions to societal problems. The Johns Hopkins Health System, rated among the best in the United States for more than two decades, is poised to innovate by testing information-driven, individualized health tools. It has 275,000 health-plan members with whom health decision-support tools can be implemented and continuously improved. The Applied Physics Laboratory (APL) is an internationally renowned leader in designing and engineering information-systems to solve complex problems. APL will disseminate Johns Hopkins inHealth advances to the Department of Defense, for whom it serves as a trusted agent, expanding the utility of Johns Hopkins discoveries to the country as a whole.

Hopkins inHealth is ambitious. It is our plan to lead, from the inside out, a transformation toward intelligent use of health data in the American health care system. It starts with the individual – empowering each person to use information, including emerging, complex data, to take full responsibility for his or her health and healthcare choices. Hopkins inHealth also has sharp focus. The initiative will create and continuously update a list of the top ten targets necessary to advance affordable health. Individualizing cancer screening is first on the list. Johns Hopkins solutions will be tested locally, then disseminated internationally. Building on its strength as a trusted provider of world-class medicine, Johns Hopkins will become a promoter of world-class health.

What is the objective of the Johns Hopkins Individualized Health Initiative, or Hopkins inHealth?

In simplest terms, Hopkins inHealth (HiH) is an initiative to discover, test, and implement health information tools that allow the individual to understand, track, and guide his or her unique health state and its trajectory over time. The goal of a health care system, then, is to consistently guide each individual’s trajectory toward a health state that supports a better quality of life.

Figure 1. The Johns Hopkins individualized Health Initiative (Hopkins inHealth). The four cores depict methods research and tool development, while the pilot projects illustrates the four initial health applications. The green arrows indicate the replications of the initial successful pilots across many medical disciplines (vertical arrow) and across ever-larger populations (horizontal arrow). The ultimate objective, shown in the red circle on the right is to improve health at more affordable costs.

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Like an airplane, one’s health changes over time, producing a trajectory. In both cases, the goal is for the individual to arrive safely at a chosen destination. Pilots are aided by flight controllers and radars that monitor position and trajectory. Similarly, individuals need tools to monitor and manage their health trajectories. Johns Hopkins inHealth will discover how to define, measure and communicate health state and health trajectories meaningfully, allowing individuals and their clinicians to make educated decisions—to guide their own trajectories toward overall health and away from disabling conditions and diseases. When diseases do occur, inHealth will provide information essential to individualized early detection and treatments that minimize loss of function and maximize engagement.

How will the Johns Hopkins individualized Health Initiative be organized?

inHealth is envisioned as an initiative, not a center or institute or department. It will weave itself throughout the JHU, JHHS and APL fabric to achieve its goals by providing intellectual and material capital in support of a large number of existing centers, institutes and programs such as the Armstrong Institute for Patient Safety and Quality, the Center for Public Health Informatics, the Institute for Clinical and Translational Science, the Global mHealth Initiative, and the Systems Institute.

Figure 1 shows that inHealth will initially comprise four cores and four start-up applications.

Information Technology for Health will, one health problem at a time, define health state and develop tracking systems--analogous to radar for tracking an aircraft--using statistical models, simulation, and Bayesian network methods[4]. As we develop experience in tracking and defining health states, we will partner with others to develop a new platform for inHealth IT applications or “inHealth apps.” These applications will support health experts to create innovative tools that improve decision making for population and patient health. These tools will extend the reach of Johns Hopkins doctors and health experts to communities around the country and globe.

Learning communities for health will allow each Johns Hopkins patient or study participant to benefit from knowledge gained and catalogued from previous patients and participants. These learning communities will develop the bioethics, biostatistics, and clinical research methods to combine information from clinical research and care over time and across populations. It will improve the quality and affordability of health care by eliminating the arbitrary and inefficient divide between clinical research and practice.

Bioscience discovery to advance health will make targeted investments in Pasteur’s Quadrant[5] of basic science to discover solutions to health measurement problems identified by the inHealth Initiative. Just as the discovery of radio waves enabled radar, this core will seek basic discoveries that lead to new measurement technologies for tracking health trajectories.

Organizational Models for Affordable Healthcare. The long-term goal of this core is to test, and apply the information-science tools from the first three cores to improve a population’s health at more affordable cost. Johns Hopkins HealthCare, an inHealth partner, currently provides capitated medical care for 275,000 persons. The inHealth methods and products will be tested here first.

The four initial case studies have been selected to represent the breadth of potential projects. Cancer screening and obesity/diabetes management represent major components of the wasted health investment, within the Johns Hopkins populations and across the country. The brain imaging and autoimmune disease case studies will motivate and test the inHealth approach on specific technically challenging problems.

Why Johns Hopkins?

Johns Hopkins will combine the assets of its University, Health System, and Applied Physics Laboratory—leaders in their fields—to improve the quality and affordability of health for people within the Johns Hopkins community. We will then disseminate the lessons learned to make world-class affordable health available to all Americans. Johns Hopkins Health System (JHHS) is a $5 billion per year integrated global health enterprise and one of the leading health systems in the United States. JHHS comprises four academic and community hospitals, four suburban health care and surgery centers, and 35 primary health care outpatient sites serving a total of more than 1,000,000 patients per year. Johns Hopkins Health Care manages care for 275,000 persons in three plans. Our Home Care Group treats 82,000 adults per year. For 21 consecutive years, U.S. News and World Report has ranked Johns Hopkins Hospital the best in the nation.

The Johns Hopkins University comprises nine schools. Together, they cover the academic fields essential to addressing the U.S. health care crisis: population health, medicine, bioscience, behavioral science, computational and data science, and systems engineering. Seventy-five percent of Johns Hopkins professors—roughly 2,000 of its 2,600 faculty—work on problems of human health. The Johns Hopkins University is the largest recipient of federal funding for health research, and our faculty thrives within a culture that encourages entrepreneurial approaches to solving societal problems.

Of particular importance, the Bloomberg School of Public Health was the world’s first school of public health and remains the best. Its population health expertise is essential to population health management. The Johns Hopkins School of Medicine, among the best in the world, is a leader in basic bioscience and in clinical research. The School of Nursing is ranked first in the nation. It can play a central role in devising effective ways to communicate information to healthy persons, patients and their care providers. Finally, the Whiting School of Engineering is home to the country’s top-rated biomedical engineering department and is a leader in systems engineering, central to a successful inHealth program.

The Applied Physics Laboratory (APL) brings the capacity to engineer and implement the inHealth methods and tools. Comprised of 3,000 scientific and engineering staff, APL offers enormous expertise in designing and building complex information systems and powerful analytic tools. With an annual budget of $1 billion, APL is a global leader in applying information science and systems engineering to national security and defense, space science, and bioscience. APL is already working with the U.S. Department of Defense to ensure that its medical manpower is deployed efficiently and to discover the utility of genomic data to individualize uniformed service members’ health care.

How will inHealth benefit the patient?

inHealth will enable both patient and doctor to better understand the patient’s health state and its trajectory to make better-informed health decisions. Approximately 25% of Medicare expenditure goes toward “preference-sensitive” care, whereby patients are confronted with different treatment options with different outcomes.[6] For example, in prostate cancer treatment, watchful waiting and surgery are options that depend critically on patient preferences. Where information is presented clearly and effectively to patients and their physicians, they are empowered to make better decisions that improve health outcomes at reduced costs.

In the near future, it will become routine for a doctor to order targeted genomic and epigenomic profiles in those situations where the new information has value. When analyzed carefully, these profiles can improve prevention, diagnosis and treatment decisions. Of course, the patient’s complete health record—showing the genetic and epigenetic profile, medical history, and much more— will follow the patient wherever he or she may go, precluding the need for new diagnostic tests every time there is a move or change of doctors.

Consider inHealth’s potential in the field of cancer screening and early detection. Clinical trials have suggested that the prostate-specific antigen test (PSA) for prostate cancer can save lives. Yet the imprecision of this tool is well-documented. Its advantages are offset by overuse among people who can derive little benefit, and by over-treatment of non-life-threatening cancers that the test reveals. Biostatisticians estimate that, to save a single life from prostate cancer, more than 1,400 men over age 50 would need to have PSA tests. These tests, in turn, would lead to 47 unnecessary radical prostatectomies, many with severe side effects such as impotence and incontinence. 

Using inHealth tools, Johns Hopkins doctors will be able to clearly communicate each person’s individual odds of positive and negative outcomes from screening and then better tailor the screening approach to manage the risks. Johns Hopkins researchers are also actively pursuing methods to identify and classify cancer tissue using non-invasive genomic and epigenomic technologies. The key next step is to engineer methods that work using small numbers of cells that are available in a serum sample. These methods can be much more accurate and sensitive than PSA. In fact, the tests we envisage will be capable of detecting many of the common cancers—not only colon or prostate cancer. By testing and deploying these tests in managed care populations such as the Johns Hopkins Employee Health Plan, inHealth will enhance the usefulness of prostate cancer screening, benefiting everyone. 

How can the experience of many patients inform an individual’s treatment decision?

Under the inHealth initiative, the individual patient contributes to the wider community as an anonymous source of medical data and information. What works for a particular patient —and for patients with similar profiles—is logged and recorded into a database. When data from thousands of similar individuals are compiled and analyzed, the results provide substantial knowledge about what is likely to work best for the particular patient at hand. Because data is collected and shared systematically, and because decision support tools are scientifically more rigorous, the quality of decision making improves. The combination of essential health information and valid, optimal methods of analysis is what Johns Hopkins scientists call the health state datascope; like a microscope, datascope allows the scientist or clinician to view the underlying disease process more clearly and, as a result, to make better decisions.

How can inHealth reduce health-care costs across populations?

In the United States, one dollar in every six is invested in health care—a figure 50 percent larger than the second-highest OECD[7] country. According to a 2010 report from the Congressional Budget Office, medical care costs are anticipated to grow at 6.8 percent per year from 2012 to 2020. Not only is this level of spending unsustainable, it inhibits our investing—as individuals, businesses, and as a nation—in other areas critical to quality of life.

For Medicare, the largest single American health care payer, only 15 percent of annual expenditures go toward “effective” or “necessary” care.[8] Another 60 percent of expenditures go toward treatment strategies that vary dramatically, based upon the availability of services in a given region. For example, the rate of cardiology visits for persons with chronic diseases in the last two years of life varies by a factor of four across geographic regions. Clearly, supply drives demand; there are more cardiology visits where there are more cardiologists.[9]

This uneven distribution and use of services that do not significantly improve health is the major factor that makes medicine in the United States so much more expensive than any other country in the world. Under inHealth, these unproductive costs will be reduced by more rapid scientific evaluation and dissemination of whether particular services contribute to health. Systems engineering principles and methods will be employed to systematically implement the best current knowledge into practice.

Johns Hopkins inHealth is working to reduce burgeoning healthcare costs through its partnership with Johns Hopkins HealthCare (JHHC). A major first goal of the partnership is to reinvent the Johns Hopkins Employee Health Plan (EHP) as a “learning health community” in which the employees, providers, and payers all “own” the community’s health outcomes and where appropriate incentives encourage each group to promote affordable health. Johns Hopkins is planning to re-launch EHP as a randomized controlled trial[10] to quantify precisely where and how implementing the new organizational structure improves health and saves on wasted resources.

A second goal is to prioritize those decision-support tools that will benefit JHHC populations the most and then to design, test, and implement them. Scientists will evaluate these new tools, and those that are most successful in contributing to affordable health will be implemented first in JHHC populations. JHCC will also market successful tools to other health care providers and companies.

An additional important opportunity for inHealth to influence national health care policy is through the “trusted agent” relationship that APL has with the Department of Defense (DoD). For 50 years, APL has provided unbiased advice to DoD in implementing systems engineering solutions to problems of national defense, space exploration, and other technical fields. The DoD now spends $53 billion per year to provide health care to its employees and their families. Recently, it asked APL for advice on population health issues. Many of the solutions we build for JHHC will likely apply readily to problems that DoD and other large populations face.

How will Johns Hopkins’ leadership in systems engineering be an advantage with inHealth?

Achieving the inHealth goals will be no easy task. But Johns Hopkins will heed the advice set forth by the Institute of Medicine and National Academy of Engineering[11], using systems engineering best practices to establish a learning health care system.

An excellent illustration of how systems engineering brings clarity, cohesion, and successful completion to a project is APL’s five-year Messenger mission to Mercury. Its primary objective was to send a satellite into elliptical orbit around Mercury to collect planet data. To accomplish this goal, each component – the power system, thermal management, guidance and control system, propulsion, sensors, and communications – had to be engineered to “best-of-breed” standards. Then, the entire vehicle system had to be engineered to work together to achieve the mission objective of reaching the planet, successfully inserting itself into an elliptical orbit, and collecting and transmitting data for one year.

In some respects, the task of transforming a major academic health center into a learning health system that practices individualized health is even more complex. After all, such a health system is governed by the vagaries of human behavior, not the laws of physics. An approach based on systems engineering principles will allow researchers to develop analogous “best-of-breed” standards in various components such as health promotion, early disease detection, decision support tools, electronic health records, financial models that incentivize prevention, and more. These elements will then be coordinated to achieve the overall goal of improving population and individual health in a new learning health care system. The application of systems engineering methods, in which the Johns Hopkins Whiting School of Engineering and APL are world leaders, represents a unique opportunity for Johns Hopkins to marshal its expertise in biological, medical, and information sciences to engineer a new way to advance health for the 21st century.

What will Hopkins inHealth cost over the next decade?

Johns Hopkins University, Johns Hopkins Health System, and APL intend to invest more than $1.6 billion in Johns Hopkins inHealth initiatives over the coming decade. Johns Hopkins Medicine will invest $800 million of its own resources over 10 years to develop an integrated, patient-centered electronic health record system. This system will serve more than 1,000,000 patients annually.

Johns Hopkins researchers are committed to bring another $375 million in new grants and contracts to pursue the information tools necessary to achieve the inHealth aims. Finally, while more difficult to quantify with any certainty, we anticipate $25 million in revenues from commercializing intellectual property discovered in this initiative.

But private philanthropy is essential to our success, especially in the early, proof-of-concept phase. We seek $500 million in philanthropic assistance over ten years to invest in inHealth components that are not readily fundable by competitive federal grants or health system revenues. These investments are summarized by cores and projects in the following table.

Cores/ProjectsFaculty

Number

MillionsStaff

Number

MillionsStudents

Number

MillionsStart-up funding

MillionsEquipment and Supplies

MillionsTotal

MillionsI. Information systems15

$37.7510

$2020

$16

$5

$30$108.75

(27%)II. Learning communities10

$22.510

$1020

$16

$5

$1$54.4

(13%)III. LABS15

$37.755

$520

$16

$5

$30$93.75

(23%)IV. Affordable health orgs10

$22.55

$520

$16

$5

$1$49.5

(12%)Phase I projects5

$11.255

$520

$16

$5

$1$43.25

(10%)Phase II projects5

$11.255

$520

$16

$10

$1$43.25

(10%)Director’s office2

$5.510

$105

$4

$2$21.5

(5%)Total$140

(35%)$60

(15%)$100

(25%)$35

(9%)$65

(16%)$400

What will be the inHealth deliverables in Year 1?

Individualized cancer screening methodology with computer and smartphone applications for patients and for clinicians: prostate and cervical cancers

Individualized rheumatoid arthritis diagnosis and treatment protocols using patient questionnaire, joint imaging, and immunologic biomarker data

Plan for an applications platform (Core I) that can decrease the development time for individualization protocol and applications development; partnership with corporate software developer

Bioethics protocol whereby all Johns Hopkins patients, except those that opt out, become a part of the “health learning community” that shares data for the purposes of individualizing care

Plan for integrating genomic and/or epigenomic data in the detection or treatment selection for at least one cancer

Agreement by JHU and JHHS for launching a new employee health plan based upon the intelligent use of information to individualize health

Agreement with venture capitalist organization(s) to invest in companies created to disseminate information tools invented by inHealth Initiative

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[1] See OECD Health Data 2011—Frequently requested data. Accessed online 08/30/11 at:

[2] Wennberg E. 2010. Tracking medicine. Oxford University Press, New York, page 8.

[3] Welch, H. Gilbert. 2012. Testing what we think we know. New York Times, Aug 19.

[4] Congdon, Peter D. 2010. Applied Bayesian Hierarchical Methods. Chapman Hall/CRS Press.

[5] Donald E. Stokes, Pasteur's Quadrant – Basic Science and Technological Innovation, Brookings Institution Press, 1997

[6] Wennberg E. 2010. Tracking medicine. Oxford University Press, New York, page 9.

[7] The 34 signatory countries in the Organization for Economic Cooperation and Development.

[8] Wennberg E. 2010. Tracking medicine. Oxford University Press, New York, page 8.

[9] Dartmouth Atlas of Health Care. 2008. Tracking the care of patients with severe chronic illness, page 11, figure 1.3.

[10] Brown, CA and Lilford, RJ. 2006. The stepped wedge trial design: a systematic review. BMC Medical Research Methodology., 6:54.

[11] Reid PP, Compton WD, Grossman JH, Fanjiang G, editors. 2005. Building a better delivery system; a new engineering/health care partnership. National Academy of Engineering and Institute of Medicine of the National Academies. The National Academies Press. Washington, D.C.

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08

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Johns Hopkins will

advance population health through the intelligent use of information to individualize health promotion, disease prevention, detection, and treatment.

Realizing the Promise of individualized Health

Hopkins inHealth

What is Hopkins inHealth? – Ask Bal Carter, Professor of Urology and a prostate cancer screening and treatment specialist. – “Hopkins inHealth will allow us to implement a uniquely Johns Hopkins strategy for tailoring cancer screening protocols to the needs of each individual. Each person has unique risks of cancer based upon their age, family history and other individual factors. By designing a protocol specifically for a person’s risk, we will improve our capacity to detect cancers early and reduce the fraction of false-positive tests that frighten the patient and sometimes lead to unhelpful, invasive procedures with non-trivial medical risks.”

“Our goal is to implement this individualized screening method in an on-line system that has a patient and clinician module. We want to educate both groups about how best to manage the cancer risks. With patients and doctors working together, relying on more careful analysis of health information, we will save lives, reduce fear, and reduce the costs of population health.

“What we learn from the cancer screening project will carry over into a multitude of other clinical areas and beyond the walls of Johns Hopkins. The project is a chance to change medical screening practice around the country and the world.”

To perform meaningful cancer screening, we must know the population rates of a particular cancer for persons like the individual being screened - those of a similar age and with a similar family history, prior lab results, and so forth. Designing studies and collecting and analyzing such data is the work of epidemiologists, such as those employed at the Welch Center, jointly operated by the Bloomberg School of Public Health and the School of Medicine. We call such population data the “prior” or “starting place” for diagnosing the individual. Cores I and II exist to collect and manage population information drawn from both research participants and from JHHS patients.

Of course, the best way to improve cancer screening is to invent a sensitive, minimally-invasive urine or blood test that can detect genetic or epigenetic markers of the cancer. This is goal of

Core III. The screening methods produced in Cores I-III will be put to the real test by seeing whether they can improve health among Johns Hopkins cohorts in Core IV.

Hopkins inHealth will help create the infrastructure for cancer screening, but also for hundreds of other clinical decisions that determine the health of our population. This infrastructure will dramatically accelerate our progress toward truly individualized health.

How will genomic data improve my cancer treatment? Ask Dr. William Nelson, Director of the Kimmel Comprehensive Cancer Center. “Most of the new so-called targeted drugs, including trastuzumab for breast cancer, gefitinib for lung cancer, and imatinib for chronic myelogenous leukemia, are effective only for a small fraction of affected individuals: those whose cancers carry a specific gene defect.  Increasingly, doctors test for these gene defects using cancer biopsies and then prescribe medications only to those who will benefit.  Through inHealth, Johns Hopkins physicians and other doctors will be better able to use the genomic information in the patient’s record to determine whether or not such a drug will be effective. Doctors can then focus treatments where they can provide benefit, and avoid them where they can only cause undesirable, serious side-effects.”

How can my radiation therapy experience benefit another patient? Ask Jon Lewin, Chair of Johns Hopkins Radiology. “When a radiation oncologist reviews images of a patient’s tumor to decide upon the proper radiation dose, she relies upon past experience with other patients with similar tumors. But experience has its limits, especially as the amount of information that must be processed grows. Until now, the images of those tumors were stored mainly in clinicians’ minds. Thanks to a joint venture of Johns Hopkins Radiology with the Harris Corporation, we now store images in a “cloud,” or shared electronic repository, so that any oncologist can reference thousands of such images in making medical decisions for the individual patient. But the utility of thousands of images for an individual patient requires careful analysis using the methods of inHealth. Your data will be a part of the evidence base that informs decisions about other patients in similar situations. What is wonderful about inHealth is that you benefit from all the patients who came before you, and you contribute to all who come after.”

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