Summary Minutes - December 1-2, 2003

Dr. John Whyte, Board Chair, called the 28th meeting of the NABMRR to order at 9:00 a.m. Current and new Board members, as well as visitors introduced themselves. Minutes from the previous meeting were approved.

Future Board Meetings

December 2-3, 2004
May 2-3, 2005

Members Present

Members Absent

Ex-Officio Members Present

Ex-Officio Members Absent

Invited Speakers

Tessa Hart

NICHD Staff and Visitors

REPORT OF THE NICHD DIRECTOR

Dr. Yvonne Maddox, Deputy Director of the NICHD, substituted for NICHD Director Dr. Duane Alexander, who was away on travel. She highlighted the recent 40th anniversary celebration of the NICHD and its research accomplishments. The NIH still does not have an official budget for fiscal year (FY) 2004, although the President's proposal is for $1.245 billion, an increase of only 4.9% over FY 2003 levels. This reduced rate of growth would impact on funding rates within all NIH institutes, and especially within the NICHD. The NIH has enjoyed moderate growth in previous years (doubling over a five-year cycle), but the budget for the NICHD increased at only about half this rate, perhaps because the NICHD responds to a broad range of interests but lacks focused support in the appropriation process. Current FY 2004 projections would allow the institute to fund 454 new and competing grants, which is only slightly above FY 2003 levels. Nonetheless, the institute remains committed to supporting investigator-initiated research grants.

Dr. Maddox briefed the Board on NIH Roadmap activities. Soon after becoming the Director of the NIH in May 2002, Dr. Elias Zerhouni convened a series of meetings to chart a roadmap for medical research in the 21st century. The purpose of these meetings was to identify major opportunities and gaps in biomedical research that no single institute at the NIH could tackle alone, but that the agency as a whole must address to make the biggest impact on the progress of medical research. The NICHD is involved in several of these initiatives. For further details, go to https://commonfund.nih.gov/sites/default/files/ADecadeofDiscoveryNIHRoadmapCF.pdf (PDF - 9.15 MB).

Dr. Maddox provided some insight on the NICHD appropriation process and how its gets translated into funding priorities. The commitment base for the institute includes support for ongoing programs, such as the autism research centers, clinical research networks, the neonatal and maternal-fetal research networks, the mental retardation and developmental disabilities research centers, and so forth. But, to respond to emerging scientific opportunities and public needs, the institute must support investigator-initiated grants in a manner that is competitive with that of the other NIH institutes. In the FY 2003 budget, 84.5% of NICHD funds were committed to ongoing programs and continuing grants, leaving 9.8% for new investigator-initiated research proposals, 2.6% for special initiatives, and 2.9% for the necessary re-competition of current programs. FY 2004 funds will be reduced by a Department-wide rescission, as well as by especially large taps within the NIH to fund trans-NIH initiatives. The success rate for applications across the NIH in FY 2003 was 31%, but the corresponding rate for NICHD was less than 27%; these rates will be significantly worse in FY 2004. Within the NICHD, declining success rates are linked to the size of current grants, the proportion of funds set aside for Requests for Applications (RFAs) and contracts, and the number of unfunded mandates that the institute has to respond to. In the next few years, the institute may have to postpone or significantly reduce upcoming funding initiatives, including the pediatric critical care network and new programs on pediatric obesity (trans-NIH), newborn screening, and the physiological basis of pharmacokinetics during pregnancy. In addition, the NICHD will take a lead role in some of the NIH Roadmap initiatives and will support participation in several others. Another consideration is the National Children's Study, which may be expanded to include more of a family focus.

Dr. Maddox provided background on the NICHD's planning process, which generally begins with initiatives developed by program staff in response to institute priorities and legislative mandates. The initiatives are presented to senior NICHD staff and institute advisory groups. The NICHD Office of the Director prioritizes these initiatives, balancing resources across the diverse centers and programs of the institute. Set asides for special initiatives must be balanced by support for investigator-initiated proposals in order to maintain a reasonable institute payline. Low paylines can be especially disheartening for new investigators and emerging program. Nonetheless it is difficult to reduce or terminate large ongoing programs. Dr. Maddox indicated that the NICHD needs to enhance promotion of biomedical advances and research successes.

REPORT OF THE NCMRR DIRECTOR

Dr. Michael Weinrich, NCMRR Director, discussed the recent growth of the NCMRR in terms of staff and resources. In FY 2003, the Center supported 265 grants ($65 million in funds) and has been increasing at an annual rate of about 20% over the last few years, a rate significantly faster than the NICHD as a whole. The Center has gotten more than its fair share of special opportunities for RFAs, networks and other set asides, although the future for such initiatives within the NICHD is uncertain. The vast majority of NCMRR funds go to investigator-initiated proposals, including R01 grants (about 50%), a small number of program projects (P01s), pilot projects and small grants (R03s and R21s), research networks, a relatively large number of small business research grants (typically, technology development, rehabilitation engineering, and assistive devices), a clinical network in traumatic brain injury, and several training and career-development grants. In FY 2005, the Center will initiate the pediatric critical care network and will re-compete the medical rehabilitation research networks. The NCMRR will continue to support medical rehabilitation research, although with decreasing institute paylines, this support may require transferring grants to relevant programs in other NIH institutes and agencies. One example of such a trans-NIH collaboration is the Bioengineering Research Partnership (BRP) program, which involves program administrators from across the NIH. Another policy that will have significant impact on extramural activities is the outsourcing of administrative support, which will require some adjustments in the short term.

CONCEPT CLEARANCE

Because of its broad expertise, the Advisory Board is sometimes called on to provide an additional level of review for certain NCMRR research initiatives. Brief background material on three proposals was distributed to the Board prior to the meeting. As head of the NICHD Division of Scientific Review, Dr. Robert Stretch presided over this process.

Dr. Weinrich presented a proposal for a Request for Applications (RFA) to solicit Small Business Innovative Research (SBIR) grants for devices that improve sensory feedback for use with upper-body prostheses and orthoses. Most of the current research has focused on motor output with little consideration of sensory feedback. This feedback would be especially important in refining the control of upper extremities. The Board discussed the appropriateness of the SBIR mechanism to promote research design and product development. NCMRR staff pointed out that SBIR funds are distinct from research funds, and therefore would not detract from the already tight funding line for investigator-initiated research grants. The Board felt that the initiative should include studies on lower extremities as well and hoped this work could be linked to the broader NIH Bioengineering Research Partnership (BRP) program. The concept was approved.

Dr. Weinrich presented a second RFA, which would solicit SBIR proposals to develop measurement tools for altered autonomic function in persons with chronic disabilities. Monitoring physiological processes as blood pressure, sweating, and heart function is especially important for persons with spinal cord injury, Parkinson disease, epilepsy, degenerative conditions, cognitive impairments, and other conditions where autonomic feedback is reduced. The initiative would encourage the development of devices appropriate for home and community settings as well as for the clinic, with the potential to gather physiological data in real-world settings and transmit it to a centralized clinical facility. This concept was approved with minimal discussion.

The final proposal was for a Program Announcement (PA) to encourage developmental or exploratory studies (R21s) on strategies to reduce obesity in children and adolescents with mobility disorders. The focus would be on individuals who typically rely on mobility aids, such as wheelchairs, prostheses, and orthoses. The Board questioned whether the initiative should be limited to just children, but acknowledged that children have unique issues, and that there would be a higher payoff from focusing exclusively on this population. The Board encouraged the NCMRR to partner with the Centers for Disease Control and Prevention (CDC) on the development of demographic data. They also discussed the impact of obesity issues on caregivers and family. The concept was approved with the suggestion that the NCMRR seek partnership with other governmental agencies on this important initiative.

DISCUSSION OF REGIONAL RESEARCH NETWORKS

The NCMRR sought some final advice on particular technologies that would be useful for the research community. The Board discussed opportunities in systems biology (biological states), nanotechnology, clinical trials methodology, instrumentation for remote sensing, and rehabilitation engineering. This highly successful program will be re-competed in the early spring, perhaps with more of a focus on expertise-driven centers and translational opportunities as based on earlier discussions with the Board.

INCREASING THE IMPACT OF THE NCMRR ADVISORY BOARD

The NCMRR initiated a dialogue with the Board to determine ways to increase the effectiveness of the Board in promoting medical rehabilitation research, especially among the professional and public organizations where Board members have leadership positions. Participants noted a need to connect with grass-roots constituencies, as well as professional organizations to promote biomedical research and increase the visibility of medical rehabilitation research in particular. This outreach is especially timely when a significant part of the national budget involves expenditures for Social Security, Medicaid, and Medicare, and rehabilitation has to figure into legislative activities and prioritization of resources. NIH research is primarily focused on increasing survival, with limited support for rehabilitative approaches and improved long-term outcomes, despite the fact that people with disabilities are a growing demographic that comprise a significant proportion of the U.S. population (54 million people).

Advocacy can be individual, at the association level, or through coalitions. Letters to local papers and mail/email to legislators can have significant impact on the national debate, especially when accompanied by supportive information and articles. Professional associations can be a good source of background information and advice. Legislators should be encouraged to visit research facilities and rehabilitation centers. Change is difficult; it requires broad-based coalitions and detailed, realistic goals.

Dr. Gail Gamble presented a report from the Board Member Responsibility Task Force. This subcommittee had met though a series of teleconferences to discuss Board member responsibilities (i.e., liaison, advocacy, interim, and mentorship), NCMRR responsibilities (i.e., communication and enhanced visibility), and overall advancement of the medical rehabilitation agenda. She challenged each Board member to consider how s/he could contribute to this process through professional and personal affiliations and what they might need from the NCMRR in terms of background and support materials. Each Board member discussed his/her relevant professional and public affiliations and proposed personal action items for his/her term on the Board. The NCMRR committed to providing background materials and responding to specific requests for additional information as needed. Board members were encouraged to coordinate efforts with the NCMRR when possible.

The Board also addressed the devastating impact of the projected funding reductions, especially on emerging medical rehabilitation programs and new investigators. They decided to draft a letter highlighting this to various high-level NIH officials.

REVIEW OF REHABILITATION THROUGH THE LIFESPAN CONFERENCE

The trans-NIH Rehabilitation Coordinating Committee, which is chaired by the NCMRR, came up with the concept of a conference on rehabilitation through the lifespan because it would address the changing needs of individuals with disabilities and could connect to the rehabilitation interests of the participating institutes and other federal partners. Although the Committee developed a broad, cross-cutting agenda, it decided to restrict the focus to physical disabilities and not include related issues in mental retardation and developmental disabilities or in mental health. Session chairs included researchers, clinicians, consumers, and advocates providing a broad mix of viewpoints. The two-day conference attracted 550 people to the Natcher Conference Center (NIH campus).

The conference started with general sessions on the demographics of disabilities and current policy, followed by more specific platform sessions and a variety of concurrent breakout sessions, which provided brief presentations followed by smaller group discussion. Conference organizers required speakers for the breakout sessions to have published in research journals, which may have created bias toward more academic viewpoints. Nonetheless, there were lively discussions and some consensus on future research opportunities. Summary recommendations from the conference are available on the NCMRR web site, at www.nichd.nih.gov/about/meetings/2003/Pages/ncmrr_lifespan.aspx. A more detailed summary will be published in the Journal of Neurorehabilitation and Neural Repair.

Two major themes emerged from the breakout sessions. The first was a need for relatively complex, interdisciplinary studies to bring together investigators with expertise in specialized research tools and those interested in outcomes for people with disabilities. Dr. Weinrich pointed out that this concept led to the development of a trans-NIH Program Announcement (PA) on Research Partnerships to Improve Functional Outcomes (see http://grants.nih.gov/grants/guide/pa-files/PAR-04-077.html). Second was the particular need for longitudinal studies on people with disabilities. Traditionally, these types of studies have not faired well in the NIH peer-review system; they have been viewed as expensive, lengthy in duration, and/or devoid of hypotheses. Researchers should consider what issues are uniquely suited to longitudinal studies before developing such proposals. Nonetheless, participants noted the need to develop broad-based support for these projects among the relevant government agencies.

The Board discussed how recommendations from the conference would impact the NIH research agenda. Certainly, they will be a key part of NCMRR strategic planning, which is due to be updated in the near future. Cognitive disabilities were referenced in a recent Surgeon General's report. NIH biomedical research that strives to preserve life should be extended to consider maintenance of function and support of life quality. State health systems could be influenced by the development of improved and more widely accepted measurement tools for disabilities and functional outcomes, especially in terms of eligibility criteria.

DEFINING REHABILITATION TREATMENTS

Drs. Tessa Hart and John Whyte presented a recent paper that they had published on rehabilitative treatments ( Am J Phys Med Rehabil 2003;82:639-652). The topic has been discussed in several recent meetings, including the annual American Congress of Rehabilitative Medicine (ACRM) meeting and at the Galveston Brain Injury Conference. They raised the following questions: How do you characterize rehabilitation treatments and mechanisms in order to define the "active ingredients"? What parts of the treatment package work best and for whom? Which parts are unnecessary? How can rehabilitation treatments be refined and improved? How can these treatments build on the natural recovery process?

The speakers indicated that medical rehabilitation lacks a common nomenclature. In some cases the same therapeutic labels refer to very different contents, and conversely diverse treatment packages may share significant components. Forcing therapists and clinicians to define and describe their treatments may push them to think in terms of hypotheses and mechanisms. Better definition also sharpens contrasts among similar treatments and increases opportunities to replicate and extend positive findings. Overall, the use of improved terminology allows for increased communication across disciplines.

What are the unique challenges to the field of medical rehabilitation? Concepts of dose, purity, active ingredients, and placebo often do not apply. Medical rehabilitation is heterogeneous in terms of clinical disciplines, settings, diagnoses, targets, and outcomes. Rehabilitation treatments are interactive, with respect to both the therapist/patient and the patient/environment. Individualized therapies are difficult to standardize and quantitate, because the patient takes an active role in setting treatment goals and ongoing assessment and treatment is a reiterative process. The medical rehabilitation field lacks theoretical models and frameworks for conceptualized interventions.

The Board had a lively discussion of these issues, which included the following points. Medical rehabilitation needs to improve communication and cross-fertilization among relevant disciplines, perhaps taking a lesson from the allied fields of mental health, education, and developmental disabilities. Treatment standards should be instituted and clinical decision making should be formalized, driven by the development of improved measurement tools and outcome measures. A theory-driven taxonomy should be developed that is inclusive enough to cover the diversity of conditions, treatments, and outcomes. Rehabilitation may be able to take advantage of the classification system developed by the nursing field, which relates diagnoses, interventions, and outcomes. Attempts should be made to quantitate and standardize the effects of clinician-patient interactions. Investigators should consider the role of positive psychology (e.g., learned optimism versus learned helplessness). Research studies should focus on outcomes that would be most sensitive to the rehabilitation treatments being used. Rather than continued observational studies of extant environments, the field should develop large-scale prospective studies to optimize and standardize rehabilitation therapies. Perhaps support for these large studies could come from the Center for Medicare and Medicaid Service (CMS), the Kaiser Family Foundation, and other public and private partners.

REVIEW OF ACTION ITEMS AND FUTURE AGENDA ITEMS

Sue Swenson, Rory Cooper, and Audrey Holland volunteered to draft a letter to NIH officials on the effects of the decreasing paylines on medical rehabilitation research, which would be serially signed off by Board members in the ensuing weeks.

Potential agenda items for the next meeting were discussed and prioritized:

• Measurement of psychosocial and spiritual impact (15 votes)
• Health services research and the NCMRR agenda (15)
• How rehabilitation engineering and assistive technologies fit into NCMRR plans (10)
• Transition from training to academic careers; status of institutional training programs (8)
• Evaluating the impact of NCMRR research (5)
• Status of the TBI Clinical Trials Network (4)
• Governmental coordination of rehabilitation, w/ Margaret Giannini and Steve Tingus (3)
• Update on the NICHD National Children's Study (3)
• Promoting sustainable outcomes (e.g., ecological validity, compliance, etc.) (2)

Although there was significant interest in a discussion on quality-of-life assessments, Lawrence Becker would not be available for the May 2004 meeting, so that topic will be considered as a future agenda item.

The meeting was adjourned at 11:30 a.m. Several Advisory Board members stayed in town to participate in the biennial NCMRR Trainee Workshop (for more information, go to www.nichd.nih.gov/about/meetings/2003/Pages/ncmrr_training.aspx).

Respectfully submitted,