National Advisory Board on Medical Rehabilitation Research (NABMRR)
National Center for Medical Rehabilitation Research (NCMRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 1-2, 2008
Dr. Diana Cardenas, Board Chair, called the 36th meeting of the NABMRR to order at 9:00 a.m. Minutes from the previous meeting were approved.
Future Board meetings
December 1-2, 2008
May 7-8, 2009
December 7-8, 2009
Ex-Officio Members Present
|Robert Jaeger, VA
Naomi Kleitman, NINDS
Yvonne Maddox, NICHD
|Roger Miller, NIDCD
Art Sherwood, NIDRR
|Mark Swanson, CDC|
Michael Weinrich, NICHD
Ex-Officio Members Absent
|Martin Gould, NCD
Kathy Mann Koepke, NINR
|Anne O'Mara, NCI
James Panagis, NIAMS
|Rosemary Yancik, NIA|
Ted Conway, NSF
NICHD Staff and Visitors
|Rosalie Ackerman (AB)
John Berger (CNMC)
Margaret Campbell (NIDRR)
Rosemary Filart (NCRR)
Christine Gilmour (AAOS)
Marc Goldstein (APTA)
Andrew Guccione (VA)
Justin Hunter (Health South)
Sheila Lambowitz (CMS)
Susan Miller (CMS)
Elizabeth Rasch (NIH-RMD)
|David Scalzitti (APTA)|
Susanne Seagrave (CMS)
Peter Thomas (PPSV)
Carolyn Zollar (AMRPA)
INTRODUCTIONS AND UPDATE ON MEMBER ACTIVITIES
- Kim Anderson is working to improve outcome measures for spinal cord injury (SCI) using studies in rats that have also translated into pilot studies in humans.
- Leticia Castillo is working to improve awareness of child abuse and its connection to severe disabilities.
- Richard Greenwald has continued to study the biomechanics of head injury and is trying to develop an injury tolerance index. He is also working on robotic prosthetics.
- Marca Sipski is recruiting patients for a study on women with SCI or multiple sclerosis. She also described the Spinal Cord Outcomes Partnership Endeavor (SCOPE) study as well as an effort to improve autonomic and other neurological standards for treatment of SCI patients.
- Carolee Winstein highlighted ClinResNet, a clinical research network sponsored by the American Physical Therapy Association to build research capacity. She and her colleagues are currently involved in a phase III, randomized trial examining stroke rehabilitation.
- Martha Banks is studying the occurrence of traumatic brain injury (TBI) in domestic violence. She is also working on cultural considerations in psychological assessment.
- Lynn Gerber is seeking approval for a Ph.D. program in rehabilitation sciences to start in January 2010 at George Mason University. She is also involved in research on upper-extremity haptic interactions.
- Murray Goldstein highlighted some international studies on child rehabilitation that build on collaborations in the West Bank region of the Middle East. Results, to be published shortly, indicate that simplified physiotherapy can be just as effective as more detailed therapeutic approaches.
- Linda Robinson recently participated in some Department of Defense review panels focusing on post-traumatic stress disorder. She noted that she was impressed by the quality of the proposals. She is also gathering data on automotive accidents to correlate injury to the person with the condition of the car in order to provide important feedback to automotive engineers; one application involves the improved placement of sensory monitors for side air bags.
- Gale Whiteneck has been working with the Centers for Disease Control and Prevention (CDC) to study the rate of disability following hospitalization for patients with TBI versus those treated in other settings. He is also serving on the TBI Health Board in the Department of Medicine at Craig Hospital.
- Joy Hammel is helping to develop a new Ph.D. program in rehabilitation sciences at the University of Illinois at Chicago. She is also doing research to promote the use of an assessment tool to measure participation and recently attended a research summit related to this area. She is also working with the American Occupational Therapy Association to build research infrastructure across the country for occupational therapy researchers.
- Steve Wolf is finishing up work on the Extremity Constraint-Induced Therapy Evaluation (EXCITE) trial, a major stroke therapy trial that demonstrated that the beneficial effects of constraint therapy persist for more than a year and that earlier therapy may be even more effective than later interventions. He is also involved in a national network funded by the NCMRR to support career development in allied health, and he recently participated in a research summit for physiotherapists. He will also participate in the annual Enhancing Rehabilitation Research in the South (ERRIS) grantwriting workshop (http://erris.med.virginia.edu/workshop.htm ), partially funded by the NCMRR, which will be held in January 2009.
- Alan Jette is working with his co-chair, Lynn Gerber, to move forward on the implementation of the Institute of Medicine (IOM) report on Disability in America. He is also working to develop outcome measures which go beyond activities of daily living and instrumental activities of daily living to include cognitive factors. He described another project, which examines Medicare payments and assessments in different settings, including specific collaborations with Kaiser Permanente to study stroke patients.
- Diana Cardenas discussed her involvement in the executive leadership of Academic Medicine for Women and in the NCMRR Network to support mentoring of research physiatrists. She is also working on a clinical trial of hypothermia for acute SCI and a preliminary study of the use of Schwann cells to treat SCI in humans.
- Ken Giacin recently participated in a press conference with Dr. Wise Young to support the use of stem cells from umbilical-cord blood to treat SCI, specifically related to a clinical trial using lithium to enhance support of stem-cell proliferation and differentiation. He also discussed the development of a cord-cell blood bank in the Middle East to help treat childhood disorders in that region.
PROGRESS REPORT ON NCMRR INFRASTRUCTURE PROGRAMS
Dr. Ralph Nitkin provided some background on the NCMRR-funded Medical Rehabilitation Research Infrastructure Program. In 2000, the program began with four regional networks to enhance research capabilities through Web site materials, workshops, and grant mentoring. The infrastructure program was refined and expanded in 2005, with additional support from the National Institute of Neurological Disorders and Stroke (NINDS) and National Institute of Biomedical Imaging and Bioengineering (NIBIB), to fund six networks that provide access to expertise in specific domains relevant to rehabilitation research. The networks provide workshops and other didactic interactions, technological development, research collaborations, and judicious use of pilot grant funds. The success of the infrastructure program is evidenced by dozens of productive collaborations, the growing number of applications for pilot funding, and the increased submission of NIH research applications (including some that resulted in funded grants).
The Board discussed continued investment in this program, especially in the context of limited NIH resources, and noted the need to advance the research priorities in medical rehabilitation. Members considered the special opportunities research networks provide, especially in matching rehabilitation clinicians with basic researchers and in their potential to support the more complex, collaborative interactions necessary for advancing the rehabilitation model. There was strong support for the mentoring and networking that this program provides. The Board also discussed how these programs might build on research infrastructure provided by other parts of the NIH.
Because of its broad expertise, the Advisory Board is sometimes called on to provide an additional level of review for potential NCMRR research initiatives. Board members received background materials for such a review in the weeks prior to the meeting. As head of the NICHD Division of Scientific Review, Dr. Robert Stretch presided over the concept clearance process. Dr. Weinrich introduced the following three research initiatives.
The first proposal would solicit R24 grant applications to renew support for the Medical Rehabilitation Research Infrastructure Program networks. The Board encouraged strategies that would also support rehabilitation clinicians in their research careers. The Board strongly endorsed renewal of this productive program and encouraged expansion into underserved research domains, such as outcomes research, psychosocial support, assistive technologies, pediatric rehabilitation, health services, and animal models. Members encouraged NCMRR to solicit applications from appropriate research centers and to ensure review by a balanced panel with appropriate expertise in the specific domains proposed, but also with a broader perspective on the needs of the rehabilitation research community.
The second proposal was for renewal of the Collaborative Pediatric Critical Care Research Network (CPCCRN) and Data Coordinating Center to be funded through the U10 and U01 mechanisms, respectively. NCMRR staff reminded the Board that the Pediatric Critical Care and Rehabilitation Program, relatively program in the NICHD, provides support for pediatric critical care research; it was placed in the NCMRR to provide unique opportunities to promote pediatric rehabilitation research within the Center, while also encouraging critical care clinicians to consider longer-term rehabilitative outcomes. The Board discussed the link between pediatric critical care and rehabilitation research in general. Members suggested that the CPCCRN retain a focus on disability outcomes rather than on morbidity per se. The initiative was approved by a majority vote.
The third proposal would seek to renew the Pediatric Critical Care Scientist Development Program, which is funded through the K12 program. Staff explained that, as one of several dozen clinical career development programs supported by the NICHD, this particular program provides support for a national network of established researchers to mentor clinically trained individuals in scientific research and academic medicine, with a special focus on addressing the need to better understand critical illness and injury in children, and to minimize disabling morbidities in children. The Board approved renewal of this program as well, again encouraging linkages to rehabilitative outcomes.
NOMINATIONS FOR NEXT CHAIR-ELECT
With the conclusion of this meeting, Dr. Diana Cardenas would finish her one-year term as Chair, and Dr. Margaret Turk would advance from the position of Chair-elect to Chair. Thus, nominations were sought for the next Chair-elect. Dr. Joy Hammel was the sole member nominated, and she was approved by the Board without dissent.
SECONDARY CONDITIONS FOR PERSONS WITH SCI
Dr. Diane Cardenas briefly discussed her clinical work at Jackson Memorial Hospital, in collaboration with the Miami Project to Cure Paralysis, on the treatment of secondary conditions in SCI and other neurological conditions. Dr. Cardenas explained that a survey of the SCI research literature reveals that most of the recent articles on secondary conditions tended to focus on bowel and bladder problems. However, she added that nearly one-quarter to one-third of SCI patients are re-hospitalized in the initial year after their injury due to diseases of the genitourinary tract, skin problems, respiratory complications, or musculoskeletal issues. Dr. Cardenas discussed a particular study on the use of hydrophilic catheters to reduce urinary tract infections. She also cited research of pain treatment in SCI involving the use of neurotransmitters and neuroimaging markers and mentioned studies of to upper-extremity function improvement in tetraplegia.
REPORT OF NCMRR DIRECTOR
Dr. Michael Weinrich began by indicating that Congress renamed the NICHD in honor of Eunice Kennedy Shriver for her advocacy for children with disabilities and her role in the founding of the Institute. Henceforth, the Institute would be known as the Eunice Kennedy Shriver National Institute of Child Health and Human Development (but still abbreviated as NICHD).
In the current fiscal year, although the administrative budget for the NCMRR was cut by 45 percent, staff travel to professional meetings remained a priority. Recently, the Center supported a conference on combination therapies for the treatment of TBI. However, with the reduced availability of administrative funds, the NCMRR would be encouraging the use of the extramural R13 grant mechanism to support future conferences and workshops. The Center was also encouraging the use of Webinars (virtual meetings) to further reduce administrative costs; however, one disadvantage of these Webinars is that it does not provide an archived record of the meeting for later viewing.
The funding appropriation for the NICHD and that of other NIH Institutes has remained static over the last few years. In the current fiscal year (2008), the NICHD set the payline for R01 research grants at the 15th percentile, with administrative reductions on funded grants. The payline for smaller R21 and R03 grants had been at the 20th percentile, but was likely to be further reduced. Nonetheless, these paylines were somewhat better than those of some other NIH Institutes, and allowed the NCMRR to support a few rehabilitation proposals that were initially assigned elsewhere in the NIH. Figures from the previous fiscal year (2007) indicate that the NCMRR maintained a similar level of support (in terms of research dollars as well as numbers of grants) as in 2006, a finding that also demonstrates rehabilitation researchers continue to compete successfully for NIH research dollars, even in these difficult times.
Dr. Weinrich discussed a trans-NIH initiative to support research partnerships with the goal of to improving functional outcomes (PAR-044-077). However, response to this initiative had been limited (fewer than 30 applications per year), and most submissions to date failed to adequately demonstrate evidence of the required collaborative efforts, even in the crafting of the application itself. Therefore, the NCMRR developed an initiative to provide funds (up to $25,000) to help create the necessary multidisciplinary teams absent in the previous solicitation's submissions (http://grants.nih.gov/grants/guide/pa-files/PAR-08-207.html). Dr. Weinrich also highlighted a trans-NIH initiative to solicit input from the scientific community, health professionals, patient advocates, and the general public about innovative and crosscutting research ideas, which could be funded through the NIH Common Fund (used to fund NIH Roadmap initiatives). He provided the URL for members to get more details about the initiative (http://grants.nih.gov/grants/guide/notice-files/NOT-RM-08-014.html).
IOM REPORT DISABILITY IN AMERICAN: IMPLICATIONS FOR NCMRR
Dr. Alan Jette led a discussion about follow-up recommendations from the updated IOM report, Disability in America. Dr. Jette, who chaired the IOM committee and helped author the report, highlighted recommendations from the report that could be relevant to the NCMRR.
The IOM report advocated elevating the status of the NCMRR to that of a free-standing NIH Institute in an effort to allow it to set a research agenda, manage a specific research budget, and provide a singular focus of rehabilitation interests. Several rehabilitation professional and advocacy groups also endorsed this recommendation. However, NCMRR staff pointed out that this would require the NIH to set aside additional resources to provide the necessary administrative infrastructure for an Institute. It was also noted that the NICHD has nurtured rehabilitation research and even allowed NCMRR funding to grow at a faster rate than the general Institute appropriation; it is not clear that this rate of growth would be possible in the context of a free-standing NIH Institute especially during times of relatively flat funding across the NIH.
Another IOM recommendation highlighted the need to recognize the importance of disability perspectives in the training of future physicians. But, Board members noted that professional education is not really the domain of the NIH and added that this recommendation might be more appropriate for professional organizations and the National Science Foundation. Likewise, it was not clear that IOM recommendations highlighting the need for research on the continuum of care and research on transitions across the lifespan were particularly relevant to the mission of NIH.
The Board discussed a recommendation to sort and analyze NCMRR research across International Classification of Function (ICF) categories. The discussion noted that this would be a complex task because current NIH research applications were not readily tagged with ICF labels, meaning that hundreds of applications would have to be analyzed manually. Moreover, aside from identifying potential research trends, it was not clear how to interpret the results. For example, would the outcomes represent biases in the types of applications received or perceived inequities in how NIH applications were reviewed? Although the NIH is particularly strong in its support of rehabilitation research in the domains of pathophysiology, impairment, and function, applications on disability and societal domains were generally channeled to other federal agencies based on their missions.
The Board also discussed IOM recommendations to better coordinate rehabilitation activities among federal agencies. It was pointed out that some administrative duplication is good because it provides for the emergence of multiple scientific approaches and it allows applicants have access to multiple funding possibilities. Nonetheless, increased communication and collaboration among relevant rehabilitation agencies would help to avoid duplicative efforts and perhaps allow for channeling support to underserved research domains.
GROUP DISCUSSION FOR CENTERS FOR MEDICAID AND MEDICARE SERVICES (CMS): MEDICAL APPROPRIATENESS
Sheila Lambowitz, director of the CMS Division of Institutional Post-Acute Care, led a discussion on updating payment policy for inpatient rehabilitation facilities. She explained that CMS mainly supports health services for geriatric populations, but added that aging baby-boomers were putting additional pressure on access to health resources. Inpatient rehabilitation has emerged as a new setting for the delivery of rehabilitation services, a trend that has increased scrutiny of pre-admission requirements, medical supervision and delivery, and appropriate outcome measures. This situation was further complicated by the "75% rule", which stipulates that, for an inpatient rehabilitation facility to qualify for Medicare funding, at least 75 percent of its patients must fall in the 10 major diagnostic categories.
Lambowitz indicated that CMS was also grappling with the concept of what is "reasonable and necessary" for admission to an inpatient facility and with how these entry requirements might differ from those of a skilled nursing facility. Other CMS issues included defining the elements of appropriate therapy delivery and how these elements applied to group-therapy settings. She added that treatment facilities are pressured to move patients out of acute management after only a few days, even before the patients are medically stable, further complicating the management and assessment of rehabilitative treatments. CMS had to make long-term projections during a time of changing patient demographics and newly emerging therapeutic approaches. The Board pointed out the need for providing therapies to patients in the chronic phase, especially for those patients who might benefit from booster treatments. They also discussed the need to support cognitive rehabilitation, especially for TBI patients.
REVIEW AND WRAP-UP OF PREVIOUS DAY'S DISCUSSIONS
Additional time on the second day of the Board meeting was set aside to revisit some issues from the first day of Board discussions. NCMRR staff reiterated the historical reasons that the Pediatric Critical Care and Rehabilitation Program was placed in the NCMRR and its potential for providing NCMRR with increased focus on pediatric rehabilitation issues. Rehabilitation planning must begin with the management of acute care, and this need was especially true for children.
The Board also discussed whether NCMRR should consider developing "centers of excellence" to support rehabilitation research projects and provide centralized training. Such centers would integrate basic and clinical approaches. However, members noted that shifting funding to centers must be balanced by the need to continue to provide support for new investigators in diverse institutional settings. The Board also reiterated the need to support translational research and research in community settings. Another issue discussed was that although improved therapeutic strategies were emerging from research, it would be several years before they are incorporated into practice. The Board cited National Science Foundation Engineering Research Centers as a model for centralized research support; these centers were highly competitive with rigorous, annual peer review and a maximum lifespan of ten years.
The Board also discussed the possibility of providing a more formal group response to the CMS on the issues of medical appropriateness and standards for access to care. Such a response would also serve as an important opportunity to support research that could impact health policy. Board members were encouraged to also work through their professional organizations to respond to the CMS.
REPORT OF NICHD DEPUTY DIRECTOR
Dr. Yvonne Maddox, NICHD Deputy Director, provided an update on NICHD and NIH activities. She began by highlighting the NICHD's international research programs, which have supported work in developing countries on HIV/AIDS, infant mortality, poverty, and birth defects. She suggested that some rehabilitative approaches could be integrated into the programs and cited prosthetics development as a possibility. She noted that the NICHD recently hired Dr. Dan Singer as director of Prevention Research and International Programs. He is a physician with a master's degree in public health and a strong background in international health. Dr. Maddox also indicated that Dr. Anne Willoughby, a long-time NICHD science administrator in the area of pediatrics research and director of the Center for Research for Mothers and Children, retired.
NIH research funding for fiscal year 2008 did not increase over previous years. The President actually requested a slight decrease in the NIH budget, but Congress restored funding to fiscal year 2007 levels. The fiscal year 2008 appropriation was $29 billion, including $1.25 billion for the NICHD. For the previous fiscal year, the NICHD was able to maintain a success rate of 20%, supporting 1,816 research project grants (including 536 new or competing grants)-more than in any previous year. The NICHD supported research through a variety of funding mechanisms, including $66 million in center grants, a relatively large percentage for an Institute of the NICHD's size. Approximately $38 million was set aside to support training and career development; appropriations in this area have not increased in a number of years, even with the emergence of the new NIH Pathways to Independence Award (K99/R00). The NICHD also spent $139 million on research and development contracts, including a few in the area of medical rehabilitation. Dr. Maddox indicated that Congressional deliberations for the fiscal year 2009 budget were delayed, and that the Institutes would probably function under a continuing resolution through at least March 2009.
The TBI Reauthorization Act of 2008 (P.L. 110-206) recently passed, bringing together the CDC, the NIH, the Veterans Administration, and the Department of Defense to focus on the incidence and prevalence of TBI among returning veterans. The Act authorized specific research goals, although no specific funds were appropriated to support these activities.
Dr. Maddox indicated that the NICHD would try to maintain a 15% payline for R01 applications through the current fiscal year (2008), with a slightly increased payline for smaller grant mechanisms (R03 and R21). However, she added that this practice may delay funding for a few grants until fall 2008 when funds from fiscal year 2009 become available. During this time, she explained that the Institute would carefully examine meritorious applications just outside this category.
Dr. Maddox provided an update on the National Children's Study, a longitudinal study of children and their environments, with a particular focus on infant mortality, obesity, diabetes, injury, and autism. The study proposes to recruit a cohort of 100,000 children and their families, and follow them from before birth through age 21. In the current fiscal year, the NIH Office of the Director received $69 million in additional money to fund the Study, which will require a total $3.4 billion over the course of 25 years. The NCMRR recently helped convene a panel on childhood injury and follow-up for the National Children's Study.
The Board discussed several additional issues with Dr. Maddox. They asked what sort of a commitment the NICHD would be making to TBI research. Dr. Maddox noted the possibility of expanding current NICHD initiatives to include rehabilitative approaches and outcomes. She admitted that incremental efforts on TBI research would not be sufficient; targeted initiatives with set-aside funds would be needed to truly make strides in TBI research. She supported the need for additional research on clinical strategies for treating TBI symptoms and for evaluating the efficacy of clinical practices in this area. But she also noted that the TBI Reauthorization Act designated the Department of Defense as the lead agency provided $300 million to study TBI and post-traumatic stress syndrome.
TBI RESEARCH: INTER-AGENCY ACTIVITIES
Dr. Michael Weinrich indicated that multiple TBI trials and related activities are supported by various federal agencies, highlighting the need for improved coordination of efforts. He explained that, although roughly 160 major clinical trials in stroke and TBI were conducted, mostly based on encouraging results from animal studies, all but one has failed to show efficacy. He suggested that researchers go beyond approaches that focus on single agents to consider combinational approaches, a strategy that has been successful in the cancer and HIV/AIDS fields. In fact, he added that the Institute was developing a Request for Applications (RFA) to promote combinational approaches that could be moved into clinical trials (http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-08-003.html).
Dr. Weinrich also highlighted a recent trans-agency workshop on treatment for blast injury, an area currently under-researched. Blast injury results in unique pathologies and functional deficits not typically found in broader TBI cases. The workshop generated some effective discussion among the Department of Defense, the Veterans Administration, and the NIH. It was noted that, military facilities currently lack treatment guidelines and access to clinical outcome studies. He added that, within the NIH, the National Institute for Mental Health may be interested in supporting research on behavioral issues associated with blast injury; Likewise, this area of research may be of interest to the Department of Homeland Security.
ACKNOWLEDGEMENT OF RETIRING BOARD MEMBERS AND COMMENTS
The NCMRR noted its appreciation for the efforts of the following Board members who completed their terms with this meeting: Diana Cardenas, Ken Giacin, Murray Goldstein, Alan Jette, and Marca Sipski. Retiring members were presented with special certificates signed by the NIH Director.
The meeting was adjourned at 12:20 pm.
|Ralph M. Nitkin, Ph.D. Date
||Diana Cardenas, M.D. Date|
|Executive Secretary, NABMRR