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 3-4, 2012
Dr. John Chae, Board Chair, called the 43th meeting of the NABMRR to order at 9:00 am. Minutes from the previous meeting were approved.
John ChaeMichael DeanAlexandra EndersCarol Espy-WilsonDavid Good
Carmen GreenMarilyn HamiltonGeorge KraftTodd KuikenNicholas LaRocca
James RimmerLeslie Gonzalez RothiGary SmithDenise TateJonathan Wolpaw
Lynne Padgett, NCILois Tully, NINRMichael Weinrich, NICHD
Martin Gould, NCDLyndon Joseph, NIAJames Panagis, NIAMS
Beth Ansel, NICHDTheresa Cruz, NICHDMarc Goldstein, APTATammara Jenkins, NICHDLisa Kaeser, NICHDSusan Lin, AOTAMichael Marge, NICHD
Ralph Nitkin, NICHDJo Pelham, CSRLou Quatrano, NICHDMary Rodgers, NIBIBMona Rowe, NICHDKatie Rush, NICHDCarol Sheredos, NICHD
Nancy Shinowara, NICHDKaren Studwell, APADavid Thomas, NIDABiao Tian, CSRDick Verville, PPSVJanice Wahlmann, NICHD
The meeting was called to order at 9:00 am by Dr. John Chae. Minutes from the previous meeting were reviewed and approved. Dr. Ralph Nitkin reviewed the agenda for the meeting and then invited introductions from the Advisory Board Members and visitors.
Dr. Nitkin presented an analysis done by Dr. Theresa Cruz on the NCMRR R01 grant portfolio that targeted research initiatives over the past 5 years. This analysis was also designed to provide background to the Board for a later discussion on the renaming of the NCMRR Programs as part of the NICHD reorganization process. The analysis revealed a range of NCMRR applications and funded grants that spread across the domains of the World Health Organization International Classification of Functioning, Disability, and Health (WHO-ICF) model: pathophysiology, impairment, function, disability, and societal issues. The applications also distributed nicely across diseases and conditions, interventional versus mechanistic approaches, and clinical versus non-clinical approaches. Moreover, the success rate of NCMRR R01 applications was similar across these research domains, perhaps even slightly exceeding that of the NICHD as a whole. In order to visualize how NCMRR proposals cluster around certain key words and research domains, Dr. Cruz also used a document analysis tool from Pacific Northwest National Laboratories called IN-SPIRETM.
Dr. Nitkin presented data on the recent targeted initiatives published by the NCMRR and compared that to the distribution of initiatives from other programs at the NICHD. Although the NCMRR is one of the smaller divisions within the Institute, the Center supports targeted initiatives in career development programs, research infrastructure networks, and requests for investigator-initiated research in certain key domains. In response to the presentation, the Board noted a heavy emphasis on neurological conditions but less investment in musculoskeletal conditions. The Board also suggested the IN-SPIRETM software could be used to compare the current NCMRR portfolio with the goals for the Center that were articulated in the original congressional language to establish the NCMRR.
Dr. Michael Weinrich informed the Board that due to budgetary restrictions, the ability of Program Officers to travel to meetings or to host workshops has become severely limited. The NCMRR does have the resources to host a small number of Webinars, should the field find them to be useful. He presented some potential ideas to the group for discussion, including such topics as contractures, cerebral palsy, telerehabilitation, clinical trials, transcranial magnetic stimulation and direct current stimulation (TMS/DCS), adherence to exercise, mechanisms of constrain-induced movement therapy (CIMT), clinical-effectiveness research, chronic pain, the mirror neuron system, near infrared cerebral imaging, and virtual reality.
The Board asked several logistical questions: Who is the intended audience? How many Webinars would the Center be able to sponsor? Could the talks from the NCMRR 20th Anniversary Research Symposium (December 2011) be posted on the Web?
Overall, the Board liked the range of topics suggested, but offered the following suggestions. There was concern about duplication of effort because the NIH already hosts a wide variety of seminars many of which are archived for later viewing; so perhaps the NCMRR should provide links to those that are particularly relevant to rehabilitation researchers. Opportunities may also exist to work with other NIH Institutes and Centers to co-sponsor programs on topics of mutual interest, such as health disparities, women’s health, small business innovation research (SBIR), and research training and mentoring. The telerehabilitation topic could be expanded to include community-based interventions, family involvement, and patient discharge and follow-up. The Board was particularly interested in the possibility of a Webinar to promote clinical trials, especially with a focus on sample size and power, clinically significant outcomes, recruitment issues, and measurement tools and methodologies. The Board thought the Webinar medium would be best suited for didactic presentations, rather than interactive discussions. Continuing education credits could be provided to encourage attendance.
Dr. Nitkin presented a summary of Phase II/III clinical trials supported by the NCMRR over the past 15 years. The goal was to garner feedback from the Board on ways to promote translational research and to improve the quality and peer-review of rehabilitation applications. The Board agreed that trial design is the most significant barrier to effective clinical trials work. Given that the goal of clinical trials is to provide the evidence base to influence clinical practice, the Board suggested a review of the characteristics of key clinical trials that have influenced clinical practice, keeping in mind that they may not be the biggest or best-designed trials. The Board also stated that most clinical trial work focuses on drug treatments, which are vastly different and easier to control than those involving rehabilitative therapies. The Board also emphasized the importance of appropriate staff training and administrative oversight in rehabilitation studies, particularly multisite trials.
The Board suggested continued support for pilot trials to demonstrate feasibility, optimize dose, operationalize protocols, and document recruitment capabilities. Mechanisms to support protocol development and multisite coordination are also crucial. The Board also discussed how underpowered studies could be detrimental to the field; poorly executed studies cloud the field with un-interpretable data and could discourage follow-up of potential efficacious therapies that may work in more targeted populations. The Board also cited a recent Institute of Medicine (IOM) workshop on clinical trial recruitment and strategies for further information. Finally, the Board expressed concern that the quality of peer-review has declined, particularly with respect to the issue of appropriate contrast groups and whether standard-of-care controls are still appropriate. The Board felt that the current peer-review system represented the best and the worst aspects of the NIH.
With Dr. John Chae finishing his term as Board chair and Dr. Pamela Duncan moving up from chair-elect to chair at the December meeting, it was time to designate a new chair-elect. A couple of members allowed their names to be put in nomination and, after a brief period of discussion, Dr. Nicholas LaRocca was voted as chair-elect through private ballot.
As co-chair of the NIH BRP, Dr. John Chae presented the preliminary outcomes of the Panel discussions. He reviewed the background, membership, charge, process, and preliminary findings. As a starting point, the BRP defined rehabilitation research as: “the study of mechanisms and interventions that prevent, improve, restore or replace lost, underdeveloped or deteriorating function. ‘Function’ is defined at the level of impairment, activity and participation according to the WHO-ICF Model.”
The BRP examined the scope of research across the NIH and found that several NIH Institutes support research in medical rehabilitation; in fact, the NCMRR represents only about 20% of total NIH support for research in this area. The BRP also examined whether or not the NCMRR was fulfilling its legislative mandate.
Preliminary findings of the BRP suggest that the NCMRR is largely compliant with respect to the letter but not necessarily the spirit of the law and should be commended for achieving success with limited resources and staff. However, several opportunities for improvement exist, including: updating the research plan for medical rehabilitation research; increasing coordination across the NIH through the use of additional allocated resources; broadening rehabilitation research beyond the mostly neurological domains; developing a more clearly defined role for the NABMRR; and securing dedicated funding for the NCMRR. The BRP concluded that the NCMRR is functioning but not thriving; they also noted a decrease in NCMRR funding over the last few years, while other centers in the NICHD remained stable or received increased funding.
The BRP determined that rehabilitation research across the NIH and other federal agencies can and should be better coordinated. The group looked at other models across the NIH for the coordination of research activities, including the Office of Aids Research, the Office of Women’s Health Research, the Office of Behavioral and Social Science Research, and the Office of Autism Research Coordination. Coordination of rehabilitation could include the creation of advisory groups, strategic planning, targeted initiatives for research grants and training opportunities, and a dedicated budget for medical rehabilitation research funding.
The BRP also identified scientific opportunities for the NCMRR to increase the clinical and societal impact of rehabilitation research throughout the NIH, especially by addressing gaps in the continuum of translational research and the WHO-ICF model. Most of NIH funding is at the pathophysiology or impairment levels (T0 and T1 levels), rather than on function, disability or societal issues. The BRP encouraged the development of a trans-NIH strategic plan that would addresses disability research across the lifespan, incorporating trans-disciplinary approaches, and going beyond just neurological dysfunction. Dr. Chae added that rehabilitation research requires more public advocacy; he added that an estimated 10% to 12% of the U.S. population has a disability, but only 1.2% of the NIH budget is focused on rehabilitation research funding. The BRP concluded that more funds are needed to support rehabilitation research in addition to the gaps previously mentioned.
The BRP also investigated potential barriers to rehabilitation research. They concluded that rehabilitation scientists tended to be too self-focused and did not advocate appropriately for the broader needs of people with disabilities. They also noted a lack of understanding at the NIH of the rehabilitation culture; rehabilitation is not organ-specific, but rather focuses on promoting function, reducing disability, and even preventative strategies. The BRP concluded that currently, rehabilitation research is fragmented at the NIH with some redundancy and so clearly requires better coordination. Moreover, rehabilitation research requires better assessment tools, prognostic and outcome measures, and targeted funding to increase research capacity especially for young researchers. The BRP encouraged the development of a Center or other entity with independent control and a more stable budget. The Center should take a more active role in coordinating rehabilitation research within the NIH and across other federal agencies. The BRP also suggested more regular reporting of rehabilitation research findings and funding opportunities, with a particular emphasis on capacity-building and continued advocacy.
In order to meet the above functional specifications, the BRP recommended the establishment of an independent institute or center dedicated to rehabilitation research or an office in the NIH Office of the Director modeled after the Office of AIDS Research. The Chairs of the BRP will present their findings at the National Advisory Child Health and Human Development (NACHHD) Council on June 7, 2012. At that point, the Board would begin to develop a formal reaction to the BRP report.
Dr. Alan Guttmacher presented the NICHD Director’s Report. He explained that the NICHD would be celebrating its 50th anniversary in 2012 and would host a scientific symposium in December. The NICHD Scientific Vision statement to identify the most promising scientific opportunities of the next decade across the Institute’s mission was being finalized and publication was pending (see http://www.nichd.nih.gov/vision/). A Blue Ribbon Panel was assessing the research of the NICHD Intramural Program. Dr. Steven Hirschfeld was named Director of the National Children’s Study. Dr. Rick Greenwald, former Board member and current member of the NACHHD Council and the NIH Council of Councils, gave a talk entitled “Biomechanical Basis of Concussion: Monitoring Head Impacts in Sports” in April 2012 as part of the NICHD Director’s Lecture series. The NICHD was also proposing a reorganization of the extramural program, which would flatten the NICHD’s structure to better promote transdisciplinary research. The reorganization would also provide an opportunity (especially timely for the NCMRR) for branches and programs to establish new names to better reflect their research portfolios and provide more clarity to the external community. (See presentation below).
In NIH news, the National Center for Advancing Translational Science (NCATS) was established and the National Center for Research Resources (NCRR) was dismantled. The National Institute of General Medical Sciences (NIGMS) inherited some programs from the former NCRR, and also took on the newly established trans-NIH Office of Emergency Care Research. Dr. Guttmacher added that he was a member of the steering committee, so pediatric emergency medicine was well represented. The National Heart, Lung, and Blood Institute named Dr. Gary Gibbons its new Director.
Dr. Guttmacher also summarized key elements of the NIH’s extramural guidance for the fiscal year 2012. Regarding the budget, no inflationary increases would be provided for non-competing awards nor for out-years of new research grants awarded in fiscal year 2012, in order to keep the average size of grants at fiscal year 2011 levels or lower. However, stipends for predoctoral and postdoctoral fellowships increased 2%, and efforts continue to give “new investigators” preferential treatment in percentile ranking. Principal investigator salaries were now capped at Executive Level II. The reauthorization of the Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) programs passed, with modest increases to the set-asides for both these programs over the next 5 years. Overall, the budget for fiscal year 2012 provided a 0.3% increase for the NICHD. Other pending legislative actions relevant to the NICHD included the Best Pharmaceuticals for Children Act and the Traumatic Brain Injury Act of 2012. Also of interest, the National Science and Technology Council was forming an interagency working group to help coordinate, focus, and enhance federal efforts in the neurosciences.
Final funding levels for the fiscal year 2013 budget had not been announced, although congressional deliberations were under way and NIH Director Dr. Francis Collins testified before both House and Senate appropriations subcommittees. Given the election year, NIH leadership had minimal information on when a budget would be finalized and what level of funding would be available to the NIH.
The Board requested an update on the NIH outreach efforts to engage African Americans in biomedical and behavioral research. They also asked about NICHD’s role in women’s health research beyond just research in gynecological health and disease. They asked about the large number of senior staff leaving federal service for retirement or for private sector employment. Dr. Guttmacher noted that the NIH was implementing the new government-wide financial disclosure requirements for upper management, which could have an effect on employee recruitment and retention.
Dr. Michael Weinrich gave the NCMRR Director’s Report. He noted that Dr. Theresa Cruz was promoted to Program Officer, but added that Janice Wahlmann would be retiring from her role as administrative assistant for the Center in September 2012. As part of the NICHD reorganization, the Pediatric Critical Care Research Program would move out of the NCMRR to form a new branch focused on pediatric injury and critical care (i.e., the “Pediatric Trauma and Critical Illness Branch”), but pediatric rehabilitation would remain a focus of the NCMRR. And finally, he explained that Dr. Michael Marge was working on the publication of the proceedings of the NCMRR 20th Anniversary Research Symposium, which was held last December.
Following up on Dr. Guttmacher’s announcement about the proposed reorganization, Dr. Michael Weinrich highlighted again that the NICHD was providing extramural branches and programs with an opportunity to update their names. This provided the NCMRR with a chance to improve communication with researchers and other constituents, and to highlight research interests in certain key areas. A more detailed description of each program would be provided on the NCMRR Website. Current NCMRR program names are: Biological Sciences and Career Development; Behavioral Sciences and Rehabilitation Technology; Pediatric Critical Care and Rehabilitation; Spinal Cord and Musculoskeletal Disorders and Assistive Devices; and Traumatic Brain Injury and Stroke Rehabilitation. NCMRR staff proposed the reorganization along the following lines: Assistive Devices and Technology Development; Behavioral Sciences, Participation, and Health Services Research; Cognitive and Linguistic Rehabilitation; Plasticity, Adaptation, and the Lifespan Trajectory; and Sensory, Motor, and Musculoskeletal Rehabilitation.
The Board considered these names to be a significant improvement over the current structure, but had certain specific suggestions. They felt the term “Lifespan Trajectory” was opaque and deterministic and recommended instead “Development and Aging with Disabilities.” The Board also suggested that the topics of “Environment” and “Community-Based Participatory Research” should be included in the second program. They noted that the term “Behavioral Sciences” had multiple meanings: adherence, motivation, and behavioral rehabilitation strategies, as well as behavioral dysfunctions resulting from injury. These meanings should be clearly articulated in the accompanying descriptions on the NCMRR Website. They recommended that “Health Disparities” also be included. An alternative suggestion was made to structure the branches along more general names, such as Motor Rehabilitation, Sensory Rehabilitation, Neurological Rehabilitation, Musculoskeletal Rehabilitation, Environmental Rehabilitation, Developmental Rehabilitation, etc. Based on these recommendations, the NCMRR will provide follow-up to the Board through email discussions.
The Board began the second day with a wrap-up of the previous day’s discussions, especially the BRP recommendations. The Board decided that in order to preserve the integrity of the BRP process and its formal charge, it would not provide feedback on specific recommendations until the BRP recommendations were formally presented to the NICHD and the NIH. At that time, the Board would develop a formal response. The Board felt that this should be a major agenda item for the December meeting.
Given the lengthy timeline necessary to implement most of the likely BRP recommendations, the Board provided the NCMRR with some recommendations for improvements that could be made in the interim. The Board suggested that the NICHD provide more prominence for rehabilitation research on the NICHD Website. The Board requested that the research plan for rehabilitation research be updated. Dr. Weinrich noted that strategic planning at the NICHD had been suspended during the Vision process but would be possible in the future. The Board wanted to consider a more formal nomination process for the chair, as well as job descriptions for the chair and chair-elect. The Board also suggested the chair should be nominated from the projected “junior” rather than “senior” class so that chair would still be around in emeritus fashion for a second year to promote continuity of leadership.
The Board also wanted a mission statement to clarify its goals. The Board also articulated the need for greater advocacy for rehabilitation research noting that unfortunately, the consumer community has not yet taken up this charge. The Board also noted that the public needed to be educated about the impact of rehabilitation research. The Board also felt that, with regard to health disparities, people with disabilities should not be excluded from research studies; members suggested that the NIH consider a more formal policy to promote inclusion, much as women, minorities, and children are included in NIH research today. Finally, the Board suggested that enhanced coordination of rehabilitation research across the NIH and other federal agencies could be accomplished without major organizational change, provided that additional resources were targeted for this effort. They recommended support for an additional full-time NCMRR employee to direct coordination activities. As a follow-up to BRP recommendations, the Board wanted to look at successful models around the NIH for other coordinating bodies in order to identify a framework that would be appropriate for the NCMRR leadership.
Board member Dr. Carmen Green outlined the definition of pain (an unpleasant sensory and emotional experience) and the types of pain (acute, chronic, cancer, and cancer-related chronic pain). She explained that neuropathic pain is a common experience in both the disabled and cancer communities. Pain can be useful in the acute form but not in the chronic state. Early aggressive treatment for pain is the most important prognostic factor in reducing chronic pain. The experience of pain is multifactorial, including psychological, familial, gender, economic, biological, sociocultural, and racial factors that influence the pain experience. It often leads to feelings of fear and helplessness, depression, anxiety, post-traumatic stress disorder, and sleep deprivation. These co-morbidities must be addressed and treated as well. Chronic pain can have physiological, behavioral, psychological, and spiritual dimensions. Chronic pain is a major reason for healthcare utilization with costs exceeding $500 billion per year. The Institute of Medicine (IOM) suggests that over 100 million Americans are impacted by pain, but this number does not include the pediatric population or those wounded in battle. In addition, there is evidence that the pain experience varies based on age, gender, race and ethnicity, and by class. Nonetheless, the status of pain care for all Americans remains problematic.
Health disparities - by race, gender, and age - exist in the assessment, treatment and experience of pain. Pain is a subjective experience with limited metrics to quantifying patient report; it cannot be readily measured in an experimental setting, making techniques for measuring pain an important research topic. Experimental measures may not correlate with the clinical experience of pain. Likewise, clinical assessment and treatment of pain remains problematic; it is undertreated in the poor, ethnic and racial minorities, and the elderly. These populations may experience increased pain severity and be at risk for poor assessment and suboptimal treatment, while also experiencing worse outcomes.
There are a number of myths about pain and fear about treatment, such as addiction or accidental overdose, and the perception that pain occurs because the person is depressed. There is often a disconnection between perceptions and the evidence. Pharmaceuticals are only one strategy for pain treatment; other modalities are available for managing chronic pain. Multidisciplinary approaches are needed to treat chronic pain, which could include physical therapy, psychological counseling, occupational therapy, nerve blocks, and acupuncture. Self-management is a key and the mind-body connection must be optimized. Adequate clinical treatment requires: good assessment, goal-oriented plan of care, and access to a complete set of treatment options. Overall, more research and policy initiatives are needed to fully understand chronic pain and to support those who experience it.
With regard to public policy, pain management is an emerging health crisis. There are poor estimates of pain in the general population, a lack of longitudinal and translational studies on pain, an ongoing need for more pain research relevant to health policy and pain treatment in general, including intervention and implementation science focusing on the quality of pain care for an increasingly aging and diversifying population. Pain is included in the NCMRR charter and there have also been other legislative initiatives focusing on pain and pain research, such as the establishment of the Interagency Pain Research Coordinating Committee currently chaired by Dr. Story Landis, the Director of the National Institute of Neurological Disorders and Stroke (NINDS).
Dr. Green also shared some findings and recommendations from the 2010 IOM report on pain, as well as specific IOM reprints on Relieving Pain in America and Living Well with Chronic Illness. She concluded that chronic pain is a disease unto itself and requires comprehensive study, but noted that it is a topic particularly relevant to medical rehabilitation research.
Next, Dr. David Thomas from the National Institute on Drug Abuse (NIDA) and the NIH Pain Consortium gave an update on trans-NIH activities. He explained that the NIH funds about $360 million in pain research yearly and that the amount is increasing. The research is spread across basic, clinical, health disparities, and translational topics. Because pain is a cross cutting issue, most NIH institutes fund pain research. The NIH Pain Consortium was established in 1996. Currently, the consortium meets quarterly to coordinate activities. The Pain Consortium sponsors an annual Pain Symposium, which will next be held May 29-30, 2012, on the NIH campus, in conjunction with the Food and Drug Administration meeting of May 30-31.
The NIH Pain Consortium has issued a major program announcement entitled “Mechanisms, Models, Measurement, and Management in Pain Research.” Members are also seeking funds from a discretionary account established as part of the healthcare reform act to address pain measurement research using machine-learning algorithms to identify biomarkers for pain from facial expressions. The Pain Consortium is also addressing is the lack of pain education in medical school curricula by funding Centers of Excellence in Pain Education to support multidisciplinary programs across medical, pharmaceutical, dental and nursing schools. Dr. Thomas added that the multidisciplinary approach is crucial because pharmacists are actually on the frontline of the pain crisis. The staggering increase in unintentional deaths due to opioid overdose mirrors the rise in prescription use, with mortality levels approaching those of automobile accidents.
Dr. Thomas noted that one of the hot topics in neuroscience research is the role of glia, which function as more than just support cells for the nervous system. Researchers are asking: What role do glial cells have in pain management? Moreover, how can we get analgesia without side effects? For opioids, both the analgesia effect and the addictive effects appear to be activated through the same cell receptors, making it nearly impossible to separate these effects at the neuronal level. However, current research in animals shows that taking (+)-naloxone with opioids produces analgesia effects, but without the side effects. Through the actions on glia, (+)-naloxone blocks the addiction/preference side effects of the opioids. Dr. Thomas noted that although the short half-life of (+)-naloxone makes it an impractical adjuvant to opioid use at present, this line of research holds great promise for the future of pain treatment.
The Board acknowledged the five retiring members: Drs. John Chae, Alexandra Enders, Dennis Hogan, James Rimmer, and Leslie Gonzalez Rothi. The slate of new Board members was also announced.
The Board wanted to schedule a follow-up discussion of the BRP recommendations with invitations to the BRP co-chairs John Chae and Rebecca Craik. The Board would also like to know more about the NIH intramural labs that focus on rehabilitation and possibly even schedule a visit to the labs if time permits. The Board suggested quarterly conference calls to improve continuity and to make the biennial face-to-face meetings more productive. The Board also requested a follow-up on how specific suggestions from the Board have been implemented by NCMRR staff. The Board requested the NCMRR Research Plan be updated, even if the NCMRR has no specific funds to promote specific research opportunities. The Board suggested a marketing plan for rehabilitation, which may require outside expertise in execution. The Board also suggested future discussions on the topics of training opportunities and health equity (e.g., social determinants of health).
Action Items: the Board would draft a letter in response to the BRP Final Report when it is published this summer. It would also request NICHD leadership to add a staff member to the NCMRR for the sole purpose of coordinating rehabilitation research across the NIH. Meanwhile, the Board would look at existing models of NIH coordinating groups to identify a framework that would be most appropriate for the NCMRR.
The meeting was adjourned at 12:05 pm on Friday, May 4, 2012.