Dr. Meredith Harris, Board Chair, called the 31st meeting of the NABMRR to order at 8:30 a.m. Minutes from the previous meeting were approved.
Future Board Meetings
December 1-2, 2005
May 4-5, 2006
December 7-8, 2006
|Meredith Harris, Chair
Ada Sue Hinshaw
William Zev Rymer
Ex-Officio Members Present
|Mindy Aisen, VA
Duane Alexander, NICHD
Daofen Chen, NINDS
|Gilbert Devey, NSF
Robert Jaeger, NIDRR
Naomi Kleitman, NINDS
|Michael Weinrich, NICHD|
Ex-Officio Members Absent
|John Crews, CDC
Amy Donahue, NIDCD
Martin Gould, NCD
|Kathy Koepke, NINR
Anne O'Mara, NCI
James Panagis, NIAMS
|Rosemary Yancik, NIA|
NICHD Staff and Visitors
INTRODUCTIONS AND UPDATE ON MEMBER ACTIVITIES
As in previous meetings, Board members provided updates on their outside efforts to promote medical rehabilitation research and the activities of the NCMRR.
Meredith Harris is continuing her studies on postural control and balance to prevent falls in the elderly as well as studies on childhood obesity and nutrition.
Alan Jette is chairing the Institute of Medicine (IOM) committee to update the 1991 report, Disability in America; he would welcome input from other Board members.
Zev Rymer is hosting the annual International Conference on Rehabilitation Robotics at the end of June.
Ken Giacin is involved with Stemcyte TM to promote research on the use of stem cells derived from umbilical cord blood. He has begun a collaboration with Wise Young to explore the use of stem cells in animal models of neural damage, and he is also making a presentation to the American Enterprise Institute on stem cells.
Alberto Esquenazi coordinated the relocation of clinical facilities at Moss Rehabilitation Research Institute, which includes 150 rehabilitation and 60 acute care beds. Current programs focus on gait, movement disorders, orthotics, prosthetics, and overuse syndromes. He is also involved in the education of prosthetists and will be making a presentation at the upcoming International Society of Physical and Rehabilitation Medicine in Sao Paulo, Brazil.
Marca Sipski is working with the American Spinal Cord Injury Association to develop standards for autonomic nervous function and validating outcomes in spinal cord injury.
Diana Cardenas is involved in several projects in the area of spinal cord injury, including improved catheter design and the use of hypnosis for treatment of pain. She is also involved in studies of youth with spinal bifida and will be working with the IOM update the report on disabilities, Enabling America.
Murray Goldstein participated in some high-profile meetings relating to physiotherapy and support of multidisciplinary rehabilitation research. As director of United Cerebral Palsy Research and Educational Foundation, he has been working with the Kiskin Trust in Great Britain to improve classification schemes for children with cerebral palsy (to be published August 2005). As president of the Academy of Medicine of Washington, he participated in a panel on the role of military physicians in the interrogation of prisoners.
Ken Viste participated in a rehabilitation research summit to discuss funding and infrastructure and is especially interested in support of junior trainees and in establishing partnerships among industry, patients, and clinicians. He is also serving on the Commission on Accreditation of Rehabilitation Facilities.
Lawrence Becker will be participating in the triennial conference on post-polio health in St. Louis in June 2005, and continues to examine issues of justice, disability, and positive health in connection to physical medicine.
Patrick Kochanek discussed Child Abuse Awareness Month, highlighting a project on the diagnosis of shaken baby syndrome. He is working with the U.S. military to improve the treatment of cardiac arrest, possibly through suspended animation, and in linking acute care and rehabilitation medicine. Within the Safer Center at Pittsburgh, he is working to improve the connection between acute treatments and resuscitation to improve outcomes in brain and central nervous system injury.
Audrey Holland is developing an archive of children’s language through Talk Bank, a research project funded by the National Science Foundation (NSF). This project has applications for treating aphasia and in the use of positive psychology to reduce disability. She is also participating in translational research to connect animal models to the treatment of aphasia in adults.
Ada Sue Hinshaw is working to improve the work environment for nurses to allow them to be more effective in promoting patient outcomes. In her role as academic dean, she is participating in international activities with China and Mexico to build leadership capacity in the field of nursing. She highlighted the fact that there is a major shortage of rehabilitation faculty and that the field may have to consider career incentives.
Gail Gamble developed a rehabilitation summit through the American Academy of Physical Medicine and Rehabilitation (AAPMR). She discussed the problem of young researchers advancing to physical medicine and rehabilitation (PM&R) chairmanships without adequate mentorship. She also discussed her clinical interest in cancer therapy and the lack of attention to rehabilitative needs, functional issues, and quality of life. She is working with PM&R residents and is particularly interested in the acceptance and accommodation of medical students with disabilities.
Rory Cooper is leading a workshop at the June meeting of the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) and is working with the NCMRR to develop a special issue of the Journal of Assistive Technology. He is participating in a number of workshops at Walter Reed Hospital dealing with wheelchairs, assistive technologies, and spinal cord injury, with future meetings on sensory impairment and prostheses. He also participated in the rehabilitation summit.
REPORT OF THE NICHD DIRECTOR
Duane Alexander indicated that these have been both busy and difficult times for the National Institutes of Health (NIH). The President’s budget proposed only a 0.6 percent increase in funding for the NIH, which will make it difficult to maintain current paylines and will result in further reductions in on going projects. However, this small increase for the NIH is better than funding proposals for some other federal agencies. Annual hearings in the House involved mostly the NIH Director; other NIH Institute directors were there for background reference. Likewise, Senate hearings focused almost exclusively on the NIH Director. Senator Arlen Specter has proposed a $1.5 billion increase for the NIH, but it is unlikely that the increase will reach the appropriations committee. Despite these fiscal limitations, the NICHD will try to maintain a 14 percent payline through the June Council round.
The NIH has tightened oversight of conflict-of-interest regulations, focusing on the issue of consultation with pharmaceutical and biotech firms (affecting mostly intramural researchers) as well as a review of all non-professional outside activities of NIH staff. Current regulations require NIH staff to divest holdings in pharmaceutical and biotech firms, and this divestment even extends into the holdings of family members. The NIH is also reviewing policy on NIH scientists who hold elected positions in professional organizations. This increased scrutiny has caused an exodus of personnel from government positions and increased recruiting problems. The Secretary of the U.S. Department of Health and Human Services has acknowledged that these interpretations may be excessive, and there are indications that congress would also support relief from these increased regulations. Reorganization, changes in oversight of support staff, and slowness in recruitment have created increased difficulty for NIH staff and reduced morale throughout the organization.
To increase public access to research findings, all NIH grantees must submit copies of their research articles to PubMed in the National Library of Medicine within one year of publication. However, this will not be retroactive to earlier papers, which may not already be in the PubMed database.
To create a more balanced administrative structure, the NICHD has reorganized three current extramural programs into the new Center for Developmental Biology and Perinatal Medicine, which will be headed by James Hanson, a clinician with a background in pediatrics and developmental disabilities.
The Advisory Board asked Dr. Alexander how the NICHD is balancing current support for extramural programs and intramural research with the potential for launching new initiatives and research opportunities. Dr. Alexander indicated that much of the planning for fiscal year 2006 is already done and that the NICHD will have to further reduce and postpone most new initiatives. However, there will also be some opportunities for new investigator-initiated proposals, especially as the current bolus of funded grants concludes their funding cycles. In addition, the Institute will try to protect new and young investigators through continued grant support, training grants, and targeted workshops. Although the current NIH appropriation allows for a small increase in the overall number of grants funded, the number of new applications is increasing at an even faster rate. The NICHD welcomes increased involvement of the outside community and the Council in forward planning.
In response to requests from the Board, Patrick Kochanek discussed his role as liaison from the Advisory Board to the National Advisory Child Health and Human Development (NACHHD) Council. The Council supports the funding of investigator-initiated proposals through en bloc concurrence but also considers staff recommendations to fund selected applications submitted in response to requests for applications (RFAs). The Council also discusses the balance among RFAs, investigator-initiated grants, and large-scale programs such as the National Children’s Study. During his time on the Council, Dr. Kochanek was impressed by the variety of programs supported by the NICHD and the overall fairness of Council deliberations. With the end of his term on the Board, Patrick Kochanek will be replaced by Zev Rymer as liaison to the NACHHD Council. The Board indicated that it would be interested in getting regular reports on Council activities in the future.
REPORT OF THE NCMMR DIRECTOR
Michael Weinrich updated the Board on NCMRR activities. Janice Wahlmann has been brought in to the NCMRR to replace Kristy Alston as senior program assistant for the Center. Beth Ansel has been working through negotiations for the Traumatic Brain Injury clinical trials network, including the use of CDP-choline in drug trials. Ralph Nitkin has been involved with the renewal of the national Rehabilitation Medicine Scientist Training program as well as renewal of the Medical Rehabilitation Research Infrastructure grants. Carol Nicholson is starting up the newly funded Pediatric Critical Care and Rehabilitation research network. Louis Quatrano is continuing his collaborations with the Office of Disability. Nancy Shinowara is working on a research initiative to develop improved controllers for multi-electrical cortical arrays that will be used to deliver functional electrical stimulation to patients with severe paralysis. And Carol Sheredos is working on the new NCMRR newsletter and helping to develop a database of NCMRR grantees.
The NCMRR has participated in several recent conferences, some of which are listed at http://www.nichd.nih.gov/about/org/ncmrr/pages/index.aspx. Recommendations from the conference on Physical Disabilities through the Lifespan (July 2003) are finally available, and copies may be requested through the NCMRR. In February 2005, the Center participated in a workshop to develop a research agenda on Appropriate Settings for Rehabilitation and will continue to work with the Center for Medicare and Medicaid Services (CMS) to provide special support for patients enrolled in clinical trials. Later this month (May 2005), the NCMRR will participate in a workshop to increase the quality and quantity of multiple sclerosis research particularly connections to rehabilitative issues. Also in May, the NCMRR will participate in a meeting on Research Opportunities: Translating Defense and Civilian Technologies for Pediatric Critical Care and Rehabilitation. The NCMRR will help co-sponsor the 25th anniversary meeting of the RESNA as well as an early fall meeting on alternative study designs for rehabilitation. Finally, the biennial NCMRR training workshop will take place in early December. This meeting is especially relevant to postdoctoral fellows and beginning investigators in medical rehabilitation research careers; further information is available at http://www.nichd.nih.gov/about/org/ncmrr/pages/index.aspx. The Board indicated that it would like to be updated on results from these various summits and workshops and perhaps engage in broader discussions with professional societies and consumer interest groups.
In the past grant cycle, the NICHD has struggled to maintain a 14th percentile payline, which has required additional administrative reductions to the grants that were funded. The first round of applications submitted under the trans-NIH program announcement, Research Partnerships for Improving Functional Outcomes, was reviewed in the spring. It was a very rigorous review, and it raised the issue of whether these applications should be evaluated by a separate, specialized peer-review group rather than having them distributed among standing peer-review groups that may have appropriate scientific expertise. The NCMRR continues to pursue a research initiative on inpatient rehabilitation, but needs commitment from CMS to support some of the treatment costs. The NCMRR also extended the contract solicitation Powered Home Robotic Devices for Rehabilitation.
As with other programs in the NICHD, current fiscal constraints have largely precluded the development of new initiatives. The Center seeks opportunities to leverage funds by partnering with other NIH Institutes and federal agencies, although they have similar funding limitations. The NCMRR is participating in a summit on Training for Allied Health Professionals, which is led by Daofen Chen of the National Institute for Neurological Disorders and Stroke (NINDS). Naomi Kleitman, also of the NINDS, briefly highlighted collaborations with the NCMRR on activities related to spinal cord injury and clinical trials; however she noted that there has been some staff turnover in some of the key NINDS programs that have relevance to medical rehabilitation.
The Board returned to the issue of support for junior investigators, especially during these times of tighter paylines. Dr. Weinrich indicated that applications from “new investigators” are generally flagged during the review process, although some peer-review groups may choose to minimize this consideration in their scoring. Special mechanisms exist to support junior researchers across the NIH, including postdoctoral fellowships (F32s) and career development awards (e.g., K01, K08, K23, and K25). Research supplements are also available to support qualified researchers at any level who are from underrepresented minorities, disadvantaged backgrounds, or have physical disabilities. The Board also discussed support of smaller research grant mechanisms (e.g., R03 and R21) that may help junior researchers transition to R01 grants, but wondered whether peer reviewers had the appropriate orientation to supporting the careers of junior applicants who are using these specialized mechanisms. The Board considered setting up a future session on support of junior investigators and potential strategies used in other NIH Institutes.
The Board asked Dr. Weinrich for an update on the National Children’s Study. He indicated that this ambitious research initiative that was mandated by congress. The NICHD was designated as lead Institute along with several other federal partners from the NIH and beyond. The study, which has already received substantial funding from the NICHD, is supposed to begin full-scale recruiting in 2006, but the Institute is still seeking substantial funds from other partners to gear up for these activities.
BACKGROUND ON INCOMING BOARD MEMBERS
The following new members will join the Board in December 2005.
Dr. Carolee Winstein is currently an associate professor of biokinesiology, physical therapy and kinesiology at the University of Southern California. Dr. Winstein directs the Motor Behavior Laboratory where she conducts behavioral research using psychometric and biomechanical techniques to explore the processes underlying the preparation, control, and learning of functional motor behaviors in humans. Most recently, her research has focused on the nature of change in these behaviors with specific forms of brain damage (e.g., stroke, Parkinson’s disease, and Alzheimer’s disease) and the implications for recovery and rehabilitation. She is active in the neurological section of the American Physical Therapy Association (APTA).
Dr. Lisa Iezzoni is a professor of medicine at Harvard Medical School and co-director of Research in the Division of General Medicine and Primary Care, Department of Medicine, at Beth Israel Deaconess Medical Center in Boston, Massachusetts. Dr. Iezzoni has conducted research for the Agency for Healthcare Research and Quality, Medicare, and private foundations on a variety of topics, including evaluating methods for predicting costs, clinical outcomes, and substandard quality of care. A 1996 recipient of the Investigator Award in Health Policy Research from the Robert Wood Johnson Foundation, she is studying health policy issues relating to persons with disabilities, especially in the area of mobility.
Dr. Leticia Castillo is an assistant professor of pediatrics in the Department of Critical Care and Anesthesia, Children’s Hospital, Harvard Medical School, Harvard University. Her research focuses on molecular medicine and nutrition in critical illness, including such topics as metabolic pathways involved in oxidative injury, translational modification of arginated proteins, profiling in oxidative injury in critical illness, metabolic acids in inflammation and injury, and nutritional requirements of specific amino acids in critical illness.
Dr. Margaret Turk is professor of physical medicine and rehabilitation at the State University of New York Upstate Medical University at Syracuse, with a joint appointment in the Department of Pediatrics. She is also medical director of rehabilitation services at St. Camillus Health and Rehabilitation Center. Dr. Turk is active nationally with the AAPMR and was the chair for the 2000 AAPMR Annual Assembly. In addition to her clinical and administrative responsibilities, Dr. Turk is involved in rehabilitation research and has been funded by Centers for Disease Control and Prevention over the past ten years for projects related to secondary conditions of and health promotion for person with disabilities with a particular interest in cerebral palsy.
NOMINATIONS FOR NEW CHAIR-ELECT
With the conclusion of this meeting, Meredith Harris will finish her one-year term as Board chair, and Rory Cooper will advance from the position of chair-elect to chair. Nominations were sought for the next chair-elect and after brief discussion, two excellent nominees emerged. Dr. Alberto Esquenazi was elected by majority vote through written balloting.
APHASIA THERAPIES: GETTING THE WORD OUT
Before retiring from the Board, Audrey Holland was asked to share some of her clinical and research interests in the area of aphasia. She indicated that several NIH Institutes have an interest in communication disorders, including the National Institute on Deafness and Communication Disorders (NIDCD), the NINDS, the NICHD, and even the NSF. Aphasia is a significant problem in stroke and other brain disorders; research in this area will also help to understand normal language development. There are currently about three treatment studies on aphasia supported by the NCMRR, with another ten or so supported by the NIDCD.
Aphasia is a complicated disorder and treatment strategies vary, ranging from “fixing” the person to altering the environment. Evolving treatment concepts for aphasia are similar to those used for treating stuttering, hearing loss, and other communication disorders. While aphasia is defined as a disorder of language following a left-hemisphere event, should it be conceptualized as a language problem or a communication disorder? Generally other communication mechanisms are not affected, but aphasia remains an “interpersonal” disorder because it affects the ability to communicate with others.
Rehabilitation resources sometime get diverted in pursuit of a “cure”, however the underlying conditions are often chronic and not necessarily curable. Moreover, the prevailing attitude is that progress can only be made in the acute phase. However, there is increasing evidence that long-term plasticity and experience-dependent learning can lead to further improvements even in the chronic phase. But should the focus be on the impairment itself or the consequences of the impairment?
Currently, aphasia is assessed by a formal inventory of linguistic and cognitive tests. Treatments strategies are based on applied behavior, cognitive psychology, and, more recently, on retraining the individual on specific abilities. But there should be more priority on communication, psychosocial support, and environmental manipulations, especially on strategies that build on the subject’s strengths. The timing and intensity of therapies is crucial, as is an understanding of the subject’s attitudes (e.g., motivation, depression, and other secondary conditions). Current research has explored treatments involving impairment-based cueing, errorless and/or implicit learning, constraint-induced language treatment, mapping therapies, and patient-family integrated goals.
Future research on aphasia should draw on basic neuroscience, animal models of plasticity, alterations in the neurological substrate, and assistive technologies. Key research issues include timing (early versus late) and intensity (spaced versus mass practice) of therapies, amount of practice needed to maintain advances, and appropriate clinical design for evaluating communication therapies.
NCMRR SUPPORT OF CLINICAL TRIALS
Ralph Nitkin provided some background on NCMRR support of clinical trials. This effort includes research to promote new diagnostic/therapeutic approaches, modify and optimize existing therapies, adapt current approaches to novel clinical populations, follow up issues of long-term safety and efficacy, and provide evidence to drive health-care management and policy. Within the rehabilitation field, there is an acute need for evidenced-based studies to justify current therapeutic approaches and to increase support of rehabilitative activities in the chronic setting. Clinical trials should be designed to isolate or control for the “active ingredient” in the rehabilitative therapy, with appropriate controls, choice of outcome measures, and overall statistical design. However, clinical trials in medical rehabilitation may be complicated by the involvement of diverse patient populations and individualized treatments. Moreover, interventions tend to be at the level of function and/or disability, which are further removed from “biological” mechanisms. Previous health history, personal resources, psychosocial support, and other environmental factors may also come into consideration. Nonetheless, the NCMRR supports a number of small clinical trials and translational research studies through investigator-initiated applications (R01s), clinical trial planning grants (R34), specific RFAs, and two clinical trial networks (focusing on traumatic brain injury and on pediatric critical care).
Dr. Weinrich observed that applications to the NCMRR for clinical trials cross domains and address several patient populations. In the last few years, NCMRR applications have increased in sophistication and complexity, in some cases involving proposals for phase III randomized clinical trials. While the NICHD has a role in supporting clinical trials and other evidence-based research, the inherent costs of these applications require significant fiscal planning and prioritization of resources.
Dr. Weinrich also addressed some specific issues that arise in the design of rehabilitation studies. Although every patient is individualized and treatments are often tailored to the functional needs and goals of the subject, trials have to be designed with standardized therapies and quantifiable outcomes, so that results can be generalized to larger classes of subjects and across diverse clinical and health service environments. Moreover, studies can not necessarily compare a specific intervention to “standard therapy”, especially if the standard therapy does not really have a strong evidence base. Preparations for clinical trials may involve extensive background work to “educate” local institutional review boards as well as the peer-review groups on current practice and treatment opportunities in medical rehabilitation. Although rehabilitation trials often test the role of some “activity” as the active ingredient (versus trials of direct physiological or pharmacological agents), responses are still based on fundamental biological and/or sociobehavioral processes; therefore the trial still needs to be discussed in mechanistic terms.
Scott Janis discussed support of clinical trials by the NINDS. The Institute has been supporting major trials from the late 1970s onward. For example in fiscal year 2003, the NINDS spend $89 million (about 6 percent of its total appropriation) on clinical trials. This included 31 major phase III trials in such areas as cerebral vascular disease, movement disorders, and trauma. Over the years, the NINDS has supported 367,230 clinical research projects, including 40,887 clinical trials (23,762 at Phase III).
The NINDS supports preclinical research as well as pilot trials of safety and efficacy through the R01 mechanism. In addition, the Institute supports the development of the manual of operations, networking procedures, and recruitment strategies through the R34 mechanism. The Institute takes a very proactive stance with potential clinical trial applicants, offering web site resources and encouraging phone contact and face-to-face meetings prior to the submission of any formal applications. In addition, proposals for trials involving $1 million in annual direct costs must be evaluated and prioritized by a panel of the NINDS Advisory Council before they can be submitted for peer review. If the application receives a meritorious score in peer review, NINDS staff continues to work with applicant on cost containment, recruitment strategies, and overall resource allocation in preparation of the award. The entire process from initial discussions to possible award can often take up to 18 months, and NINDS staff continues to aggressively monitor progress throughout the duration of the grant. Thus, administration of clinical trials at the NINDS is very labor intensive and several members of Program Staff are dedicated to this process.
Steven Wolf of Emory University talked about lessons learned from the EXCITE (Extremity Constraint-Induced Therapy Evaluation), a major stroke trial funded by the NCMRR and the NINDS. EXCITE continues to be a multisite, collaborative effort among physicians, researchers, and graduate students.
Dr. Wolf provided some history on the development of the proposal. In 1996, he and Edward Taub made a presentation for a trial to the APTA based on earlier findings in primate studies and the original clinical forced use studies undertaken by Wolf. The idea was for a randomized clinical trial with follow-up through phone calls. The neurology section of the APTA provided $6,000 for a planning meeting at Emory and subsequent standardization and training at UAB as well as pilot data collection by participating sites. In June 1997, they presented a letter of intent to the NCMRR that provided data on budget, standardization of procedures, dose-response curves and intensity of treatment, and pilot data derived from seven representative sites. Due to funding constraints, the NICHD stipulated that the proposed budget had to be less than $1 million per year. In June 1998, a formal application for a clinical trial was submitted to the NICHD using the R01 mechanism. Peer-review comments were favorable, but they recommended increased surveillance of data and other minor changes, which necessitated an increase in the budget to about $1.5 million per year. The revised R01 application was approved for funding one year later, with some administrative reductions; the NINDS also provided 15% of the funding for the grant.
The EXCITE trial has very explicit inclusion/exclusion criteria and extensive procedures to standardize treatments and outcome measures across clinical sites. Subjects are recruited three to nine months post stroke and randomized into either treatment or delayed-treatment groups. For the purposes of data analysis, subjects are further stratified into those with higher- versus lower-functioning hand use. During treatment, the good limb was immobilized with a mitt for several hours per day to encourage increased use of the limb on the stroke-affected side. Subjects are periodically evaluated in the clinic and are provided with a log to document home activity. There is also one-year follow up to determine the persistence of any potential improvements. The primary outcome measures in this study focus on motor function and home activity.
Dr. Wolf discussed some lessons learned from the administration of a multisite clinical trial. Putting together the trial required significant interaction among biostatistical, clinical, and other professional colleagues. The proposal for the large trial had to be carefully written and justified with respect to scientific, clinical, and administrative issues with critical input from several sources. The preparation and administration of the trial proved to be especially time consuming requiring strong oversight across sites especially in the area of subject recruitment. Other considerations included psychosocial factors in the evolution from acute to chronic stroke, family dynamics and support, adherence to protocols, and even cultural differences. The manual of operations alone evolved into a 500-page document, and the data and safety monitoring board was particularly sensitive to possible adverse events.
The EXCITE trial has resulted in some spin-offs studies, including research on caregiver support, virtual reality environments, and neuroimaging of brain plasticity. EXCITE has resulted in 14 publications with 38 more in preparation. The focus is not just on clinical outcomes, but on functional improvement and reduction of disability (e.g., what can the patient do now that they could not do before?). Constraint-induced therapy is also being applied to related conditions that affect motor function.
INTERAGENCY ACTIVITIES IN REHABILITATION
Dr. Weinrich provided some background on the Interagency Committee on Disability Research (ICDR). As mandated by congress, the ICDR meets four times per year to coordinate activities across some 35 relevant federal agencies. It has subcommittees on statistics, technology, medical rehabilitation, employment, and the New Freedom Initiative. Current activities focus on support for longitudinal studies, clinical applications of the International Classification of Function (ICF), hearing aid and mobile phone interference, best practices for surveys involving people with disabilities, and increasing research capacity among allied health academic departments. The Committee also tries to support joint funding initiatives, but this support is often complicated by differences in administrative procedures, receipt schedules, review criteria, and funding regulations across agencies. The Committee regularly seeks input from the public and especially from the disability community through consumer focus groups, public meetings, and the web site www.icdr.us .
NIH PATIENT-REPORTED OUTCOMES MEASUREMENT
Deborah Ader of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) provided an update on the Patient-Reported Outcomes Measurement Information System (PROMIS), an initiative to improve assessment of outcomes and quality of life across a wide variety of clinical conditions. PROMIS is supported through NIH Road Map in the area of reengineering the clinical enterprise. PROMIS seeks to develop a large item bank with computer-assisted technologies to improve survey adaptability and efficiency of subject input. In the first round of competition, PROMIS funded a centralized data coordinating center and seven research grants that explore a range of outcomes in such areas as disability (e.g., spinal cord injury, trauma and cerebral palsy), psychiatry, arthritis and aging, cancer and cardiovascular disorders, ecological real-time assessment, multiple sclerosis and fibromyalgia, and childhood disorders (especially asthma and literacy). Each group will generate data on relevant domains, such as: the physical aspects of pain and fatigue; mental aspects of anxiety; depression and addiction; and the psychosocial aspects of societal roles and social support. More information can be found at the PROMIS Web site at http://www.nihpromis.org/ .
ACKNOWLEDGEMENT OF RETIRING BOARD MEMBERS AND COMMENTS
The NCMRR noted its appreciation for the efforts of the following Board members who have completed their terms: Lawrence Becker, Gail Gamble, Audrey Holland, and Patrick Kochanek. The retiring members were presented with special certificates signed by the NIH Director. The retiring members shared some personal reflections, professional passions, and thanked their Board colleagues and NCMRR staff for the productive interactions.
NEW BUSINESS AND AGENDA FOR NEXT MEETING
The Board raised the following topics as potential items for agendas: support of clinical trials; manpower training in medical rehabilitation; infrastructure grants and networks; CMS support of clinical trials; outcomes of various recent research summits; coalition of the Friends of Rehabilitation Research; follow-up of NCMRR trainees and junior researchers; support of trauma research across the NIH; professional and consumer organizations; accomplishments and impact of rehabilitation research; and fate of recent NCMRR research initiatives. In addition, at the December 2005 meeting, the Board will be called on to help the NCMRR evaluate its report to the NACHHD Council, which is being prepared as part of the periodic NICHD reporting process. The NCMRR report, which was last presented in September 2001, is a wide-ranging discussion of public health issues, research opportunities, and future directions in medical rehabilitation research.
The meeting was adjourned at 11:45 a.m.
|Ralph M. Nitkin, Ph.D. Date
||Meredith Harris, P.T., Ed.D. Date|
|Executive Secretary, NABMRR