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Enhancing Emergency Care Research

RESEARCH CAPABILITY AND PRODUCTIVITY

Roger Lewis, professor of Emergency Medicine at Harbor–UCLA Medical Center, began the panel on enhancing emergency care research, which he defined broadly to include medical and nonmedical providers, emergency surgery and all of the associated acute care specialties, and basic science research. “We need to work hard to increase the cohort of well-trained, scientifically rigorous investigators. This involves factors such as research training (including the establishment of interdisciplinary and multidisciplinary collaborations), the need for protected time in an organization, and career tracks that support this work. It also requires access to research infrastructure such as laboratories and core facilities, and access to patient populations, often through research networks,” Lewis argued.

Furthermore, investigators need the data linkages and informatics required to support emergency care research. This includes appropriate standardized data collection tools, and perhaps access to shared medical records. The emergency department patient is usually cared for in multiple settings, including prehospital, in-hospital, and postacute rehabilitation. We need to be able to link those processes of care and outcomes so that we can start to answer the questions about what actually affects the long-term outcomes, Lewis said. Part of the equation is to have sufficient research funding aligned with important and promising directions in emergency care inquiry. Often the most promising research directions do not fall along the traditional organ-based lines within the National Institutes of Health (NIH), but are based on presenting syndromes and complaints. We need to help the NIH Institutes and other funders work together across their traditional boundaries to focus investiga-



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4 Enhancing Emergency Care Research RESEARCH CAPABILITY AND PRODUCTIVITY Roger Lewis, professor of Emergency Medicine at Harbor–UCLA Medi- cal Center, began the panel on enhancing emergency care research, which he defined broadly to include medical and nonmedical providers, emergency sur- gery and all of the associated acute care specialties, and basic science research. “We need to work hard to increase the cohort of well-trained, scientifically rig- orous investigators. This involves factors such as research training (including the establishment of interdisciplinary and multidisciplinary collaborations), the need for protected time in an organization, and career tracks that support this work. It also requires access to research infrastructure such as laboratories and core facilities, and access to patient populations, often through research networks,” Lewis argued. Furthermore, investigators need the data linkages and informatics required to support emergency care research. This includes appropriate standardized data collection tools, and perhaps access to shared medical records. The emer- gency department patient is usually cared for in multiple settings, including prehospital, in-hospital, and postacute rehabilitation. We need to be able to link those processes of care and outcomes so that we can start to answer the questions about what actually affects the long-term outcomes, Lewis said. Part of the equation is to have sufficient research funding aligned with important and promising directions in emergency care inquiry. Often the most promis- ing research directions do not fall along the traditional organ-based lines within the National Institutes of Health (NIH), but are based on presenting syndromes and complaints. We need to help the NIH Institutes and other funders work together across their traditional boundaries to focus investiga- 

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 NATIONAL EMERGENCY CARE ENTERPRISE tions on optimizing the management of patients before their disease is clearly identified. In Lewis’s opinion, there are three regulatory barriers that can hinder emergency care research. “First, under current rules there are many circum- stances in which informed consent cannot be appropriately obtained,” he said. “Appropriate consent strategies that will allow investigation of better treatments for those patients are needed. Second, the federalwide assurance program is a significant barrier to prehospital research because it limits participation of community hospitals and smaller EMS [emergency medical services] agencies. We need them for reliable outcomes data. Third, HIPAA [Health Insurance Portability and Accountability Act] regulations are clearly a barrier to much of the health services and outcomes research we need to truly determine the effectiveness of emergency care interventions.” BARRIERS TO EMERGENCY CARE RESEARCH Jerry Jurkovich, chief of trauma and surgical critical care at Harborview Medical Center and president of the American Association for the Surgery of Trauma, said there is a crisis in U.S. emergency care, as was well docu- mented in the 2006 Institute of Medicine (IOM) reports. Some solutions will be found in better research on how to provide emergency care. There are barriers to advancing this research, however, and these fall under the headings of time, treasure, and topics (Jurkovich was quick to add that it is not due to a lack of talent). With respect to research topics, as mentioned above, emergency and trauma care don’t fit neatly within the disciplinary lines established by the NIH, Agency for Healthcare Research and Quality (AHRQ), and Centers for Disease Control and Prevention (CDC). Some new thinking is needed about how to address this issue. Time and treasure also pose substantial barriers. Jurkovich said time for surgical investigation is hard to come by. Schools and deans depend on surgical income and they lose money when surgeons take time out to do research. Although trauma is the leading cause of death among people aged 1–44, little federal funding goes to research in this area. NIH salary caps are about 50 percent less than the average academic surgeon makes, which is already 25 percent less than the practicing surgeon makes. The salary cap for federal funds is currently $196,000. “Coinciden- tally, the average salary for a full-time academician in medicine is $196,000,” Jurkovich said. “I don’t mean to imply—­I mean to state directly—­that the fed- eral funds are tied to medicine, not to surgery.” He said medicine, pediatrics, and pathology all fall within or under the salary cap, but no other disciplines do, not obstetrics and gynecology, not surgery, not emergency medicine, not radiology. The average salary for a mid-level academic general surgeon is about $298,000. So departments must make up the difference.

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 ENHANCING EMERGENCY CARE RESEARCH The number of physicians going into academic careers in these special- ties is significantly hampered. No more than 5 percent of surgeons across all disciplines go into academic practice (whereas fully 25 percent of graduating emergency medicine residents enter academic practice). It is simply too much of a financial sacrifice for them to do it, Jurkovich said. OPPORTUNITIES FOR EMERGENCY CARE RESEARCH FUNDING Walter Koroshetz from the National Institute of Neurologic Disorders and Stroke (NINDS) said disease-based research is clearly the way to access NIH resources. Nearly all of the illnesses that affect and kill people in the emergency room are diseases that fall under the auspices of one or more NIH Institutes. Emergency physicians can access those resources effectively if they organize and develop research expertise. In fact, Koroshetz said, emergency medicine has an “amazing opportunity given that patients with all different sorts of illnesses are coming to one convergence point.” If the field could develop a generic, efficient system to identify and enroll patients and conduct research, “You would be able to really leverage multiple dif- ferent NIH Institutes with the same infrastructure to answer a myriad of scientific questions.” In addition to discovery research, the NIH and AHRQ are investing in comparative effectiveness research. There is an expectation that the country is going to move more and more in that direction in order to inform medical decision making. For the reasons mentioned above, emergency medicine is in a strong position to compete for these research funds. “If the research infrastructure is present, emergency medicine has access to patients, and a unique ability to test algorithms of medical decision making, compare treat- ments, and evaluate the utility of diagnostic testing,” Koroshetz said. “All of these might be studied in a much more cohesive and organized fashion in the emergency department setting.” “However, getting funded is only half the battle,” he said. “The other is executing the research.” The NIH is currently saddled with clinical trials that do not recruit well. As a result, NIH investigators are often forced to go overseas to recruit study subjects. Expenses double or triple because of the time involved in getting a trial executed. A system that is really efficient at enrolling patients will have the power to obtain grant funding. Over the past 2 years, the NIH has made a concerted effort to look at the opportunities and challenges to doing research in the emergency setting. In 2007, the NIH established a task force to respond to the 2006 IOM reports. It sent out a request for information and received scholarly responses from the emergency medicine community. Those informed a series of workshops: one on neurological and mental health issues, one on surgi- cal issues, and a third on trauma. At the end of these, workshop reports

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40 NATIONAL EMERGENCY CARE ENTERPRISE will go to the relevant individual Institutes and a composite report will be submitted to the Office of the Director. Koroshetz said at this point that he is “actually pretty enthusiastic that research in the emergency setting is going to get stronger and stronger.” UNFULFILLED RESEARCH AGENDAS Richard Hunt, director of the CDC Division of Injury Response, noted that many research agendas have gone unfulfilled. In 2006 a multi- disciplinary committee produced the CDC’s first acute injury care research agenda. The CDC received 38 applications in response to the Request for Proposals, many more than they had expected. However, the CDC only had the money to fund four of them, he said. This has been a source of frustra- tion for the agencies as well as for many outside the federal government. A number of well-executed research agendas across government have not been fulfilled, Hunt said. These agendas have been worked out in thoughtful ways, with a lot of time, energy, and input invested into them, but frankly, he said, we haven’t come close to meeting them. It is not just injury or EMS issues that are not being met. Other areas in emergency care, including strokes, myocardial infarctions, and other priorities, are not being addressed. “There will always be more research agendas,” he said, “but if we could fulfill the ones we already have, it would be extraordinary.” A central concern in the past has been lack of interagency collabora- tion at the federal level. But, recently, Hunt said, he has felt gratified by the collaboration that is developing among federal agencies. In particular he pointed to an early collaboration among the National Highway Traffic Safety Administration, Health Resources and Services Administration, and the CDC regarding triage of the injured patient. Interagency collaboration is being advanced through the Federal Interagency Committee on Emergency Medical Services and the Emergency Care Coordination Center. Although collaboration has not produced magical changes overnight, it has produced important leaps forward. Improving agency coordination will take time, but there is a clear commitment to make it happen. Finally, he said, in the current climate, Congress wants to know what the cost/benefit ratio is for each research-related item. “We have tackled the issue of costs head on, particularly with traumatic brain injury (TBI), where we showed millions of dollars of savings and significant number of lives saved if we institute the TBI guidelines,” he said. With respect to lives saved, creation of the CDC trauma triage guidelines were supported by the results of a paper by McKenzie and colleagues, showing that if the severely injured are treated at a Level One trauma center, there is a 25 percent decrease in their mortality. “But,” Hunt said, “you need to connect that with costs in order to move these initiatives uphill in Washington.”

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4 ENHANCING EMERGENCY CARE RESEARCH AHRQ’S ROLE IN EMERGENCY CARE RESEARCH AHRQ Economist Ryan Mutter said the mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. AHRQ-supported grants and contracts focus on topics such as payment mechanisms, organizational factors, and the effectiveness of interventions and treatments. “AHRQ is keenly aware that there are over 120 million emergency department encounters a year,” Mutter noted, “and that the ED [emergency department] is a window into the health care system.” AHRQ has supported research on the triage algorithm for EDs, ED crowding (causes and consequences), and ED pharmacists as a safety measure in emergency medicine. AHRQ has also sought to develop tools to improve the efficiency of patient flow through the ED. AHRQ data development and analysis includes the support of the Health Care Costs and Utilization Project (HCUP). HCUP is a federal– state–industry project to improve policy making and practice. It is a very useful tool for tracking ED frequent flyers, for example. Many of AHRQ’s quality measures have been endorsed by the National Quality Forum. One is the Prevention Quality Indicators, which provide estimates of potentially preventable admissions to the hospital. AHRQ has begun to modify that model so that it will measure encounters with the emergency department that might have been avoided. AUDIENCE DISCUSSION Ron Anderson, chief executive officer (CEO) of Parkland Hospital in Dallas, asked how studies can tie together patient encounters from multiple sites so that they go beyond what happens in the ED. He noted that many people receive care in the emergency department for a short period of time, “and then they go upstairs and you lose them, so to speak, to somebody else’s care, or they go back into the community.” The latter can be especially problematic for follow-up. ED personnel would like some way to close the loop. He acknowledged that one problem is the nonconsent issue, which the media can pick up on and label as unethical research. He said they do not seem to acknowledge that current standards of practice also may not be the best thing for people. Lewis of Los Angeles said it is ironic that it is considered ethical to keep providing treatments that have not been proven to work. Important research questions could be addressed with some abbreviated consent processes, and this would allow for the acquisition of outcome information. But he said this will require research into the acceptability of those strategies across diverse communities. We need to be more energetic in pursuing collaborations with ethics colleagues and other community linkages to figure out what is accept- able in the community.

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4 NATIONAL EMERGENCY CARE ENTERPRISE Trauma surgeon Jurkovich said rather than trying to squeeze emergency medicine questions into the construct we have available for other research, which is based on specific diseases, we should develop a construct for funding research that will answer trauma and emergency care questions. We should find an agency cooperative agreement, and provide a funding mechanism for it. Mutter said in order to facilitate the research, some questions need be answered with administrative data. HCUP is a potential tool for this because of the kind of data it provides. Take the case of someone who falls and ends up in the ED, is stabilized and sent home, then has an ambulatory surgery experience, gets infected, and ends up being admitted to the hospital. With HCUP, you can track that person and you know the amount of time between those encounters. That is a way to address some of those questions. Tom Scalea, the session chair and physician-in-chief at the University of Maryland Medical Center Shock Trauma Center, asked whether it is possible to take all of those data and put them into a digestible form. Now you have to link to multiple databases to answer specific questions. Hunt agreed and said he has asked the same question many times. “When I’ve talked to the people who do the data and ask really probing questions, I find almost a sense of paralysis, that maybe this is not really doable. But we have to figure this out,” Hunt asserted. He noted that the National EMS Information System (NEMSIS) made sure the national trauma databank and NEMSIS would have uniform datasets. PRIVATE RESEARCH DOLLARS Alex Valadka, a neurosurgeon from the University of Texas Medical Center, said he was surprised that no panelists talked about private fund- ing for research. He said these private foundations and industry are a rich source of support. There are problems now with conflict of interest and disclosure, but he said that in many ways, especially in terms of more tech- nologically driven applications, industry is going to be what drives much of this research. Also, he said some hospitals may be willing to start smaller quality improvement projects. Even the large insurers should be interested in research that would examine whether money can be spent more efficiently in EDs. Lewis said that industry sources of research have a tendency to be so closely tied to specific goals and objectives that they rarely address the most pressing questions. In one academic society with which he was closely involved, there was a period of time in which many of the board members became enamored with industry sponsorship as a potential source of research funding. “But,” Lewis said, “it became a distraction from the important research training and investigator development that is needed in

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4 ENHANCING EMERGENCY CARE RESEARCH our specialty.” As a general strategy for improving the research capability across the emergency care specialties, private research funding is unlikely to be very fulfilling. Koroshetz said he would leave the door open for diagnostic companies. If one is interested in biomarkers to diagnose X, Y, and Z, the emergency setting is probably the only place he could go to do that kind of research. BOLSTERING THE RESEARCH WORKFORCE Dr. Jon Mark Hirshon, of the University of Maryland, underscored that there are disease- and organ-specific silos among funders, and emergency care research appears to be almost an afterthought. As an emergency medi- cine researcher, he asked how he can convince junior physicians to become physician researchers. “I have to convince the residents, who can go out and make twice as much clinically as they do as academicians, that if I want to take them, I have to give them a quarter of their salary for the first year or two, and then convince them to do a K grant, which will pay them $75,000. And with that funding, they are supposed to devote 75 percent of their time to research.” Koroshetz replied that a generic problem in the country is that the higher the remuneration a specialty commands, the harder it seems to be to engage its members in research. One might have thought the opposite might be true. The more remunerative specialties should offer the least financial risk of pursuing a research career as a physician–scientist. In fact, many medical students and residents believe that the more remunerative the specialty is, the easier it should be to “make a living” with part-time clinical practice. In fact, however, when someone chooses the high remunerative specialties, they are less likely to persist in a research career. “NIH money is the taxpayers’ investment in developing new treatments,” he said. “The research salary covered by NIH grants is not based on the medical specialty.” In fact, most NIH researchers have Ph.D.s and their salary limits are generic. The current situation is a big problem as high-quality research is almost absent in some of the most expensive procedure-based specialities. The success rate in grant application by M.D.s versus Ph.D.s is exactly the same. The difference is if an M.D. is not funded, he or she is less likely to reapply. “Persistence is generally the key to the game,” Koroshetz said. Lewis said there are points early in one’s academic training where one is open to all kinds of possibilities, including the possibility of never making the amount of money one can make in clinical practice. That is a good time for students to make decisions about career paths. He observed that the research fellows he has observed who have been most successful secured their research training before they ever considered a career in pri- vate practice.

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44 NATIONAL EMERGENCY CARE ENTERPRISE Jurkovich said that for some specialties, work requirements should allow for work weeks that are longer than 40 hours. Instead of mandating that work time will be a 75 percent total commitment, the requirement should be 75 percent of a 40-hour work week, leaving the remaining hours in the week for other activities. That would give surgeons additional time to do their clinical work. The second way is to abandon the time commit- ment altogether and focus just on results. If you get good results, you get refunded; if not, you don’t. The third way, he said, is loan forgiveness for college expenses and providing research funding, not just money. That, he said, has been very effective in medicine, not so much in producing long- term researchers, but at least in getting more people excited about the concept of research. ENROLLMENT IN CLINICAL TRIALS THROUGH EDS Sandra Schneider, emergency physician from the University of Rochester, said that emergency medicine clearly would be able to help boost enroll- ment in clinical trials. EDs see 120 million patients, and even if you take out the ones that come back multiple times, you are still talking about 100 million people. She said we also have effective ways of screening and effective enrollment programs in many hospitals right now. The trouble, she said, is that most researchers approach EDs after their grant has been funded. Their approach is to put a sign on the wall saying, “If you see a patient with myesthesia gravis (for example), give us a call.” Emergency physicians are excluded from the process. Schneider asked how EDs can get funding to create infrastructures, whether they are patient enrollment programs or screening the 100 million patients who are unique to ED ser- vices each year. Koroshetz responded that this is a “chicken and egg problem.” Once you build a research infrastructure, then you have the leverage. But how do you build it first? Without anything to offer, what are your options? He agreed that if researchers from other specialties join with emergency physicians in a cohesive, collaborative manner, then everybody will be at the table and the project is more likely to succeed. “Our Institute [NINDS] has made a major investment in the Neurology Emergency Treatment [NET] Network,” Koroshetz explained. “The NET is led by emergency medicine physicians, working alongside neurologists and neurosurgeons. We are very hopeful that it will be a successful research effort. The key will be the abil- ity to engage the emergency medicine community and successfully enroll subjects into the first two initial trials, one on traumatic brain injury, and the other on status epilepticus.”

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4 ENHANCING EMERGENCY CARE RESEARCH TRANSLATING RESEARCH TO EVERYDAY PRACTICE Dr. Ramon Johnson of the American College of Emergency Physicians asked how one can convince a practicing physician in a community hospital to take something that has been researched at the academic institution, and change his or her practice with the patient in an era when physicians are driven more by a lack of liability protection. Lewis said that the NINDS stroke trial was a good example of a trial that is scientifically sound, but it failed in the second phase of translation. He defined the first part of translation, T1, as moving from the laboratory to the first bedside use. T2 is movement from a controlled clinical trial (in which efficacy is demonstrated) into routine clinical practice. The NINDS stroke trial was impressive, but uptake of the therapy for ischemic strokes has not been as enthusiastic as the Institute would have liked. One concern is whether the trial reflected community practice settings in terms of the immediate availability of a CT scan, the arrival time of patients, and the availability of a neuroradiologist to overread the patient’s scan. There is a discrepancy between the study conditions and conditions in the community hospitals. This is probably true of all T2 translations. Researchers who intend to influence the practice of community practi- tioners through large efficacy trials should first find out what the community practice practitioners have in terms of resources, control, privileges, and so on, Lewis said. If researchers expect that something will translate well into community practice just because it was shown to be efficacious in a Phase III trial, they may be disappointed. Koroshetz agreed that the T1 was way out ahead of the T2 in this case. But he said that what has happened over the past 10 years is that that trial has completely revolutionized the care of the stroke patient. What that trial did was force the building of systems to treat patients with TPA, so that now most places have that system. “In Massachusetts,” Koroshetz said, “every hospital had to declare whether they have a stroke care system in place. If they said no, the department of health diverted ambulances from that hospital to a stroke hospital. That is the kind of teeth that it takes to improve a health care system. But it never would have happened without that trial.” SUGGESTIONS FOR ADVANCING EMERGENCY CARE RESEARCH Workshop chair Arthur Kellermann asked the panelists and federal funders in the room, “What recommendations would you have to most directly and immediately advance science and emergency care research in the United States?” Lewis said the first thing he would emphasize would be research train- ing, and the development of funding streams for research training that target

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4 NATIONAL EMERGENCY CARE ENTERPRISE emergency care researchers. In addition, he would want to see addressed the practical and regulatory challenges involved in providing the data linkages that are needed to investigate patient-centered outcomes. Jurkovich said he would explore creative solutions for addressing the difficulty in maintaining higher compensated clinicians for conducting research. These might include debt forgiveness, raising the NIH salary cap, or dropping the time commitment requirement for K08 and R01 awards. Second, he said, there should be a focused, cross-agency effort directed at trying to fund systems research in emergency care, looking into which practices, policies, procedures, and constructs work best for providing emergency care in different environments. Koroshetz said if you are controlling 48 percent of admissions to the hospital, that is an amazingly powerful position from which to do research. All you need to do is organize. “With an efficient research infrastructure in emergency medicine, you are going to have people at your doorstep, wanting to work with you,” he said. Hunt reiterated his earlier statements. “We have to prove that we are going to reduce costs and save lives through research. “Begin with the end in mind, considering the goals of those who will be providing the resources. The proximate step to that is translating and defining systems practice. It is not just bad clinical care at a bedside that can kill patients. Bad systems can kill patients, too,” he said. Mutter emphasized payment systems and market mechanisms. He said that translating effective strategies into practice is significantly impacted by the financing system. We need to explore new research ideas on how pay- ment can impact adoption. We also need to investigate further strategies such as pay for performance, with research focusing on questions such as how much payment is needed to make difference and what the unintended consequences might be. Also, Mutter said, we need research to explore and understand some of the perverse incentives of the current payment system. INCREASING THE PERCEIVED VALUE OF EMERGENCY CARE RESEARCH The session chair closed by asking the panelists what are we going to do to create an atmosphere where emergency research is valued by the chair, the dean, and the public? Lewis said medical schools need to see increases in the quality and quantity of emergency care research as an important mission. Those that do should task their chairs with accomplishing that. The public values emergency care, but people need to see a closer tie between the quality of emergency care research and the actual quality of emergency care. We need

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4 ENHANCING EMERGENCY CARE RESEARCH to be honest about the limitations of our evidence base without sacrificing public trust, Lewis asserted. Koroshetz said he has found it easier to show value in the acute emer- gency conditions than in others that are more chronic, where the benefit of a treatment is less clear because it takes longer to appear. A person who was previously functioning at a high level and then suddenly is the victim of a potential catastrophic event lends itself to a very black/white outcome determination. The key is that you have to be able to link the acute interven- tion with the long-term outcome. If you confine data collection to a short- term, emergency medicine environment, then the research will not impact patients or medicine in general. Long-term follow-up of patient outcomes is what is critical to achieve. Hunt focused on the research outcomes that demonstrate lives saved and costs reduced. But the public must realize that this research is respon- sible for that improvement. He quoted a corporate executive who had said if [his company] had a million dollars to put into research, they would rather see it appear on the front page of USA Today than on the pages of New England Journal of Medicine. Mutter agreed that the most important thing is for the taxpaying public to see the story.

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