02-14384. Disability and Rehabilitation Research Projects (DRRP) Program

AGENCY:

National Institute on Disability and Rehabilitation Research (NIDRR), Office of Special Education and Rehabilitative Services, Department of Education.

ACTION:

Notice of final priorities.

SUMMARY:

The Assistant Secretary announces final priorities for one or more Burn Model Systems (BMS) Projects, one Burn Data Center (BDC), and for a Traumatic Brain Injury Model Systems (TBIMS) Program. The Assistant Secretary may use one or more of these priorities for competitions in FY 2002 and in later years. We take this action to focus research attention on identified national needs. We intend these priorities to improve the rehabilitation services and outcomes for individuals with severe burn injuries and Traumatic Brain Injury (TBI).

EFFECTIVE DATE:

These priorities are effective June 7, 2002.

FOR FURTHER INFORMATION CONTACT:

Donna Nangle, U.S. Department of Education, 400 Maryland Avenue, SW., Room 3412, Switzer Building, Washington, DC 20202-2645. Telephone: [phone] or via the Internet: [e-mail].

If you use a telecommunications device for the deaf (TDD), you may call the TDD number at [phone].

Individuals with disabilities may obtain this document in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) on request to the contact person listed under FOR FURTHER INFORMATION CONTACT.

SUPPLEMENTARY INFORMATION:

The purpose of the DRRP Program is to plan and conduct research, demonstration projects, training, and related activities that help to maximize the full inclusion and integration of individuals with disabilities into society and to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (the Act).

This priority reflects issues discussed in the New Freedom Initiative (NFI) and NIDRR's Long-Range Plan (the Plan). The NFI can be accessed on the Internet at: http://www.whitehouse.gov/​news/​freedominitiative/​freedominiative.html.

The Plan can be accessed on the Internet at: http://www.ed.gov/​offices/​OSERS/​NIDRR/​Products.

We published a notice of proposed priorities (NPP) for the Burn Model Systems (BMS) Projects and the Burn Data Center (BDC) in the Federal Register on March 5, 2002 (67 FR 10088). We also published a separate notice of proposed priority for Traumatic Brain Injury Model Systems (TBIMS) in the Federal Register on March 5, 2002 (67 FR 10094). We have combined in this notice of final priorities the priorities for the BMS, BDC, and TBIMS. This NFP contains several significant changes from the NPP. Specifically for the BMS, we have made the conference reflect the topic rather than the title. We will determine the location of the project directors' meeting after award, rather than specify at this time that the meeting must be held in Washington, DC. Specifically for the TBIMS, we added a priority on measures, we added neurological recovery as a possible research issue, and we expanded the settings in which research on diagnostic procedures can occur. We fully explain these changes in the Analysis of Comments and Changes elsewhere in this notice.

The backgrounds for each of the priorities were published in their respective notices of proposed priority.

Analysis of Comments and Changes

In response to our invitation in the NPPs, several parties submitted comments on the proposed priorities (seven parties for the BMS, one party for the BDC, and 28 parties for the TBIMS). An analysis of the comments and of any changes in the priorities since publication of the NPPs is published as an appendix at the end of this notice. We discuss comments under the priority to which they pertain.

Generally, we do not address technical and other minor changes and suggested changes the law does not authorize us to make under the applicable statutory authority.

Note:

This notice does not solicit applications. In any year in which we choose to use these priorities, we invite applications through a notice in the Federal Register. When inviting applications we designate the priority as absolute, competitive preference, or invitational.

Priorities

Priority 1—Burn Model System Projects

This priority supports one or more Burn Model System projects for the purpose of generating new knowledge through research to improve treatment and service delivery outcomes for persons with burn injury. A BMS project must:

(1) Establish a multidisciplinary system that begins with acute care and encompasses rehabilitation services specifically designed to meet the needs of individuals with burn injuries. This system must encompass a continuum of care, including emergency medical services, acute care services, acute medical rehabilitation services, post-acute services, psychosocial/vocational services, and long-term community follow up.

(2) Participate as directed by the Assistant Secretary in national studies of burn injuries by contributing to a national database and by other means as required by the Assistant Secretary; and

(3) Conduct no more than five research studies in burn injury rehabilitation, ensuring that each project has sufficient sample size and methodological rigor to generate robust findings that will contribute to the advancement of knowledge in accordance with the NFI and the Plan. These studies may be done in collaboration with other BMS projects.

In proposing research studies, applicants must demonstrate their potential impact on rehabilitation goals and objectives. Applicants may select from the following research directives related to specific areas of the NFI and the Plan:

• Integrating Individuals with Disabilities into the Workforce: (1) Assess intervention strategies for improving employment outcomes of individuals surviving severe burns; or (2) Identify environmental factors that either enable or impede community and workplace integration.
• Maintaining Health and Function: (1) Study interventions to improve rehabilitation potential in the acute care setting such as nutritional support, early therapeutic exercise to increase mobility, treatment for scar tissue, or the prevention and treatment of secondary conditions; (2) Develop and evaluate rehabilitation treatment/interventions for individuals surviving severe burns; or (3) Design and test service delivery models that provide quality rehabilitation care for burn survivors under constraints imposed by recent changes in the health care financing system.
• Assistive and Universally Designed Technologies:

(1) Evaluate the impact of selected innovations in technology (e.g., assistive devices, biomaterials) on outcomes such as function, independence, and employment of individuals with burn injuries; or (2) Investigate the impact of national telecommunications and information policy on the access of individuals with burn injuries to related education, work, and other opportunities.

• Full Access to Community Life: Assess the value of peer support and early onset of services from community and social support organizations to improve outcomes such as independence, community integration, employment, function, and health maintenance.
• Associated Areas: Develop and refine measures of treatment effectiveness in burn rehabilitation to incorporate environmental factors in the assessment of function.

(4) Provide widespread consumer-oriented dissemination activities to other burn projects, rehabilitation practitioners, researchers, individuals with burn injuries and their families and representatives, and other public and private organizations involved in burn care and rehabilitation.

In carrying out these purposes, the projects must:

• Involve individuals with disabilities or their family members or both, individuals who are members of groups that have traditionally been underrepresented, and consumers, as appropriate, in all stages of the research and demonstration endeavor;
• Demonstrate culturally appropriate and sensitive methods of data collection, measurements, and dissemination addressing needs of burn survivors with diverse backgrounds;
• Demonstrate the research and clinical capacity to participate in collaborative projects, clinical trials, or technology transfer with other BMS projects, other NIDRR grantees, and similar programs of other public and private agencies and institutions; and
• In conjunction with other BMS projects, plan and conduct a state-of-the-science conference late in the fourth year on new trends in burn injury rehabilitation and publish a comprehensive report on the final outcomes of the conference. The report must be published in the fifth year of grant.

Priority 2—Burn Data Center

This priority supports a Burn Data Center (BDC) for the purpose of managing and facilitating the use of information collected by the BMS projects on individuals with burn injury. The BDC must:

(1) Establish and maintain a database repository for data from BMS projects while providing for confidentiality, quality control, and data retrieval capabilities, using cost-effective and user-friendly technology;

(2) Ensure data quality, reliability, and integrity by providing training and technical assistance to BMS projects on data collection procedures, data entry methods, and use of study instruments;

(3) Provide consultation to NIDRR and to directors and staff of the BMS projects on utility and quality of data elements;

(4) Support efforts to improve the research findings of the BMS projects by providing statistical and other consultation regarding the national database;

(5) Facilitate dissemination of information generated by the BMS projects, including statistical information, scientific papers, and consumer materials;

(6) Evaluate the feasibility of linking and comparing BMS data to population-based data sets or other available burn data and provide technical assistance for such linkage, as appropriate; and

(7) Develop guidelines to provide access to BMS data by individuals and institutions, ensuring that data are available in accessible formats for individuals with disabilities.

In carrying out these purposes, the center must:

• Demonstrate knowledge of culturally appropriate methods of data collection, including understanding of culturally sensitive measurement approaches; and
• Collaborate with other NIDRR-funded projects, e.g., the Model Spinal Cord Injury and TBIMS Data Centers, regarding issues such as database development and maintenance, center operations, and data management.

Priority 3—Traumatic Brain Injury Model Systems

This priority supports Traumatic Brain Injury Model System projects for the purpose of generating new knowledge through research to improve treatment and services delivery outcomes for individuals with TBI. A TBIMS project must:

(1) Have a multidisciplinary system of rehabilitation care specifically designed to meet the needs of individuals with TBI. This system must: (a) Encompass a continuum of care, including emergency medical services, acute care services, acute medical rehabilitation services, and post-acute services; and (b) demonstrate the ability to enroll adequate numbers of subjects in order to conduct rigorous research projects.

(2) Conduct no more than three research studies focused on areas identified in the NFI and the Plan, ensuring that each project has sufficient sample size and methodological rigor to generate robust findings. These studies may be done in collaboration with other TBIMS projects.

(3) Participate as directed by the Assistant Secretary in national studies of TBI by contributing to a national database and by other means as required by the Assistant Secretary, collect data on TBIMS participants, adhering to data collection and data quality guidelines developed by the TBINDC in consultation with NIDRR, and demonstrating capacity to maintain long-term retention of participants.

(4) Disseminate research findings to clinical and consumer audiences, using accessible formats, and evaluate impact of these findings on improved outcomes for individuals with TBI.

(5) Collaborate, as appropriate, with other system projects in ongoing research and dissemination efforts, providing information on coordination mechanisms, quality control, and impact on overall management of the system project.

In carrying out these purposes, the TBIMS project may select one of the following research objectives related to specific areas of the NFI or the Plan:

• Integrating Individuals with Disabilities into the Workforce: (1) Develop and evaluate strategies that improve the employment outcomes of individuals with TBI, particularly focusing on job quality and job stability; and (2) Investigate the relationship between treatment in TBIMS and improved employment outcomes for individuals with TBI.
• Maintaining Health and Function: (1) Study the impact of diagnostic innovations, such as use of intracranial pressure and functional MRI, on management of rehabilitation outcomes; (2) Identify pharmacologic interventions of psychoactive drugs and other pharmacologic agents to enhance cognitive and behavioral outcomes, (3) Design and test rehabilitation interventions that improve neurological recovery (including motor and cognitive recovery), functional, and long-term outcomes of individuals with TBI; or (4) Examine treatment alternatives for depression and other affective disorders.
• Assistive and Universally Designed Technologies: (1) Evaluate the impact of selected innovations in technology or rehabilitation engineering or both on outcomes such as function, independence, and employment; or (2) Evaluate the impact of selected innovations in technology or rehabilitation engineering or both on service delivery to individuals with TBI.
• Full Access to Community Life: (1) Develop and test strategies for improving the independent living/community integration outcomes of individuals with TBI, including identifying predictors of community participation and interventions that may affect it; (2) Evaluate the role of family and social supports in facilitating the independent living/community integration outcomes of individuals with disabilities; or (3) Examine the impact of environmental and attitudinal barriers on the outcomes of individuals with TBI.
• Associated Areas: Conduct research to develop new or assess existing measures to support the research goals described above.

In carrying out these purposes, the TBIMS project must:

• Involve, as appropriate, individuals with disabilities or their family members or both, individuals who are members of groups that have traditionally been underrepresented in all aspects of the research as well as in design of clinical services and dissemination activities.
• Demonstrate knowledge of culturally appropriate methods of data collection, including understanding of culturally sensitive measurement approaches; Collaborate with other related projects, including the other funded TBIMS projects.

Intergovernmental Review

This program is not subject to Executive Order 12372 and the regulations in 34 CFR part 79.

Applicable Program Regulations: 34 CFR part 350.

Electronic Access to This Document

You may review this document, as well as all other Department of Education documents published in the Federal Register, in text or Adobe Portable Document Format (PDF) on the Internet at the following site: www.ed.gov/​legislation/​FedRegister.

To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at [phone].

Note:

The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available on GPO access at: http://www.access.gpo.gov/​nara/​index.html.

Program Authority: 29 U.S.C. 762(g) and 764(b).

(Catalog of Federal Domestic Assistance Number 84.133A, Disability and Rehabilitation Research Project)

Dated: June 3, 2002.

Robert H. Pasternack,

Assistant Secretary for Special Education and Rehabilitative Services.

Appendix—Analysis of Comments and Changes

Priority 1—Burn Model Systems (BMS) Projects

Comment: One commenter asked that the priority include a focus on unique issues regarding social integration and psychosocial rehabilitation faced by children with severe burn injuries.

Discussion: An applicant could propose a study pertaining to these issues; however, NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: Several commenters noted that the new model seems to emphasize the clinical and logistical aspects of rehabilitation (e.g., functional recovery, ADLs), but lacked emphasis on psychological interventions and treatments for targeting problems of self-image, pain, or depression.

Discussion: Psychological treatment is an important component of burn care rehabilitation. An applicant could propose a study pertaining to these issues; however, NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: One commenter suggested that, in the background statement, scars, contractures, etc. should be identified as primary complications rather than secondary complications.

Discussion: NIDRR's concern is the impact of complications in general on outcomes of individuals with serious burns. An applicant could propose a study pertaining to these issues; however, NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: One commenter stated that neuropathy is not a common complication.

Discussion: Literature cited in the notice of proposed priorities identified neuropathy as a common complication in older and critically ill individuals with severe burn.

Changes: None.

Comment: One commenter asked that the state-of-the-science conference be held at Year five instead of Year four.

Discussion: NIDRR views the state-of-the-science conference as an important dissemination effort to stakeholders, scientific, and consumer communities, as well as burn survivors and their families. On this basis, NIDRR decided that the conference should be held late in the Year four so that the conference proceedings can be published during Year five.

Changes: None.

Comment: One commenter suggested that the conference title be changed to “Current Status of Burn Rehabilitation.”

Discussion: Funded centers will have the opportunity to name the conference.

Changes: Priority has been changed to reflect the conference topic rather than title.

Comment: One commenter suggested that funded centers meet at the American Burn Association (ABA) once a year and not in Washington, DC.

Discussion: Funded centers will have the opportunity to discuss this issue at the first Project Director's meeting in Washington, DC. Meeting in Washington, DC would allow other NIDRR staff to attend Project Directors' meetings.

Changes: We are no longer requiring the meeting to be in held in Washington, DC. NIDDR will make this determination after award, rather than specify at this time that the meeting must be held in Washington, DC.

Comment: One commenter suggested removing reference to crab shells research.

Discussion: Applicants may choose to conduct research to evaluate the impact of selected innovations in technology. Choice of technologies for study, such as bio-technology based products, is up to the applicant; however, NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: One commenter suggested expanding the focus on Telehealth.

Discussion: NIDRR concurs that Telehealth has potential for advancing burn care rehabilitation. An applicant could propose a study pertaining to this; however, NIDRR has no basis to determine that all applicants should be required to focus on this issue. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: One commenter suggested that the background discussion of environmental factors reflect both reality and the new paradigm.

Discussion: An applicant could propose a study pertaining to these issues; however, NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: Several commenters asked for clarification regarding the number of proposed site-specific projects and collaborative projects.

Discussion: Applicants may choose to propose up to five research projects. One project must be designed as a collaborative study. NIDRR imposed a limit of five projects in order to encourage applicants to focus and to design more rigorous studies. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: Several commenters asked about the funding level and number of proposed centers.

Discussion: The Notice Inviting Applications will specify the proposed number of centers and the proposed funding level.

Changes: None.

Comment: One commenter suggested that research on long-term behavioral adjustment not be limited to pediatric burn survivors.

Discussion: An applicant could propose a study pertaining to these issues; however, NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Priority 2—Burn Data Center (BDC)

Comment: One commenter suggests that the BDC create formal linkages between the Burn Model Systems Data and the ABA/TRACS National Burn Repository.

Discussion: NIDRR will explore the mechanism to link the two centers within the context of the Department's policy.

Changes: None.

Priority 3—Traumatic Brain Injury Model Systems (TBIMS)—General Comments

Traumatic Brain Injury Model Systems (TBIMS)—General

Comment: A number of commenters asked whether there is a requirement that three projects be proposed.

Discussion: Applicants must conduct at least one but no more than three research studies. There is no requirement that applicants must propose three projects.

Changes: None.

Comment: A number of commenters asked whether the proposed research studies must fall within one single area or research objective.

Discussion: There is no requirement that all projects fall into one area. Applicants may propose projects that fall into different areas or across areas.

Changes: None.

Comment: A commenter asked for clarification on how the proposed limit of no more than three studies will be applied over a multiyear grant. For instance, does NIDRR expect each study to run for the complete multiyear funding period? Can serial substudies be proposed over multiple years in a single study for up to three study areas?

Discussion: The design and duration of research studies is left up to each individual applicant. There is no requirement that each study run for the complete multiyear funding period. Serial substudies can be proposed over multiple years in a single study for up to three study areas.

Changes: None.

Comment: Several commenters asked if multi-center collaborations are allowed in addition to the three projects referenced in the announcement, stressing the importance of such collaboration for increasing sample size and reducing repetitive efforts.

Discussion: The purpose of the limit of three projects is to encourage applicants to focus and to design more rigorous studies. For this reason, NIDRR has determined that applicants should not propose more than three projects in total. However, nothing prohibits an applicant from proposing collaborative efforts as one of the three research projects. In fact, NIDRR has supported increased collaboration across centers and plans to fund multi-center collaborative TBI research projects in FY03.

Changes: None.

Comment: One commenter asked if new applicants for TBMIS have to compete with currently funded projects.

Discussion: The competition is for the next five years of funding for the TBMIS. It is open to all eligible applicants, including currently funded projects that must compete for renewed funding.

Changes: None.

Comment: One commenter asked how likely is it that newcomers (e.g., first-time applicants) could be successful in applying for this grant program.

Discussion: Applications for the TBIMS grant program are subject to an independent peer review process. Each application is reviewed on its merits based upon the evaluation criteria published with the final notice. Prior membership in the TBIMS is not an evaluation criterion.

Changes: None.

Comment: A number of commenters requested that the priority include consideration of children age 16 and younger. Children sustain significant physical, neurocognitive, psychosocial, and developmental deficits as a result of TBI.

Discussion: NIDRR is very concerned about the rehabilitation of children who experience TBI and currently funds several projects examining rehabilitation interventions and outcomes of individuals under age 16. The TBIMS projects were designed to focus on adult populations. At this time, NIDRR does not propose to expand the TBIMS projects to include children. However, NIDRR is considering mechanisms by which to expand research on rehabilitation for adolescents and children with TBI.

Changes: None.

Comment: One commenter noted that achieving good rehabilitation outcomes requires addressing the needs of the family system. Therefore, projects should examine the impact of brain injury on families and the impact of families on rehabilitation outcomes.

Discussion: An applicant could propose a study pertaining to these topics; however, NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: One commenter identified a need for the TBIMS projects to adopt a broader view of rehabilitation for brain injury. The TBIMS projects have historically been managed by medical schools and centers and, therefore, focused on medical models of rehabilitation. University-based schools of education, for example, could collaborate with other partners to examine such topics as education for children, youth, and young adults.

Discussion: NIDRR will consider applications from any applicant that meets the statutory requirements under the funding authority, encompassing States, public or private agencies, including for-profit agencies, public or private organizations, including for-profit organizations, institutions of higher education, and Indian tribes and tribal organizations. The peer review process will evaluate the merits of the approach used by the applicant.

Changes: None.

Comment: Several commenters spoke to the need for TBIMS projects to collaborate formally or informally with other nationally funded projects, such as State projects funded by the Health Resources Services Administration's Maternal and Child Health Bureau, Center for Disease Control projects, or State initiatives.

Discussion: NIDRR encourages collaboration across Federal, State, and other funding mechanisms. The peer review process will evaluate merits of the proposal. However, NIDRR has no basis to determine that all applicants should be required to collaborate with other national or State-funded projects.

Changes: None.

Comment: One commenter asked whether letters of collaboration are required for proposed collaboration sites.

Discussion: The evaluation criteria include a requirement that evidence of commitment be provided for collaborators.

Changes: None.

Comment: One commenter asked how applicants can be expected to specify the type and number of staff, staff deployment, and training and supervision for longitudinal data collection when the priority does not specify what data will need to be collected, where, and with what frequency. Future changes in inclusion criteria could also have significant implications for the volume, site, and nature of data collection.

Discussion: Applicants should budget costs associated with data collection on elements in the current data base (the data elements are available by linking to http://www.tbims.org

Changes: None.

Comment: One commenter expressed concern about using the current inclusion criteria for the TBIMS. These inclusion criteria target individuals who receive inpatient rehabilitation immediately following acute care. Four issues are identified: (1) a sample using this approach will be unrepresentative of persons with moderate and severe TBI; (2) required enrollment volumes will be increasingly difficult to maintain; (3) applications of individual centers in geographic areas with high managed care penetration may be penalized, and (4) recruitment and followup costs will be impossible to project if inclusion criteria are to be changed partway through a funding cycle.

Discussion: Changing the inclusion criteria was a subject of considerable discussion among the model systems directors during the last funding cycle; however, the model systems' directors reached no final decision on this issue. NIDRR anticipates that further discussion of inclusion criteria will occur and that modifications to the inclusion criteria are likely. For purposes of this priority, applicants must use the existing criteria for making projections of the number of subjects submitted to the model system database. NIDRR will work collectively and individually with programs to solve any cost implications that may result from changes to the inclusion criteria during the funding cycle.

Changes: None.

Comment: One commenter recommended that a quota be established for national database enrollment so that all centers will be required to submit the same number of cases per year.

Discussion: While not planning on establishing a quota for enrollment, NIDRR plans to monitor closely proposed and actual numbers of cases submitted to the national database during the funding cycle. Projects proposing to submit fewer than 35 cases per year would seem to be seriously limited in their ability to carry out rigorous research. The peer review process will evaluate merits of the proposal. For purpose of responding to this notice, prospective applicants should base their proposals on the anticipated numbers of individuals who meet the current inclusion criteria of the TBIMS.

Changes: None.

Comment: One commenter expressed concern that required collaboration could not take place if one or more of the involved projects are not funded.

Discussion: It seems reasonable to assume that, given the anticipated number of centers, it will be possible to replace a collaborator who is not funded. NIDRR recommends that applicants propose collaborations as deemed necessary for the studies that each project undertakes. NIDRR will work with any center where the lack of funding of a proposed collaborator creates a problem.

Changes: None.

Comment: One commenter expressed concern about how changes to data requirements for the national dataset would impact collaborative and other research.

Discussion: Changes involving the national dataset will be applied to every center equally. One criterion by which to evaluate decisions to remove data elements from the data set will be whether these are currently being used in a study. Also, an individual project or collaborating group has the option of continuing to collect data for purposes of an individual study even if the data are no longer required for the national dataset. Thus, it would appear that there is no limitation resulting from potential changes to the longitudinal dataset.

Changes: None.

Comment: One commenter expressed concern that the priority provides a disincentive to performance of high-quality efficacy research as planning multi-center treatment trials with unknown collaborators is virtually impossible.

Discussion: NIDRR will be announcing its TBI collaborative research funding grant program soon after the announcement of awards for the TBIMS. NIDRR anticipates that there will be 2-3 awards under this program, with funding sufficient to carry out multi-center trials and maintain research management oversight. For the current competition, NIDRR recommends collaboration as appropriate to increase sample size.

Changes: None.

Specific

Comment: Several commenters expressed concern about the study of diagnostic interventions, inquiring about the acceptability of conducting studies of positron emission tomography (PET), SPECT, TMS, etc. on the management of rehabilitation outcomes.

Discussion: The diagnostic procedures mentioned in the proposed priority are examples. An applicant could propose a study pertaining to these; however, NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: Several commenters stated that the study of diagnostic innovations should not be limited to acute management (in reference to point 1 of the Health and Function research area). Persons with TBI in the post-acute period often have residual impairments that may benefit from innovative new diagnostic procedures that may lead to more appropriate treatments.

Discussion: These comments make a valid point. NIDRR is interested in research that may improve outcomes for persons with TBI across the continuum of health care.

Changes: The word acute has been eliminated from this point in the final priority.

Comment: One commenter argued that research in the employment area should focus on developing a knowledge base to support specific interventions that address the unique challenges faced by individuals with brain injury while engaging in work.

Discussion: NIDRR strongly supports efforts to translate research into practice. Employment is a critical issue for persons with TBI. Applicants could propose to address this issue within the priority areas outlined in the priority. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: One commenter urged NIDRR to consider the impact of failure to classify TBI properly in the emergency room or in other service delivery settings in establishing its priorities.

Discussion: An applicant could propose a study pertaining to this; however, NIDRR has no basis to determine that all applicants should be required to focus on this issue. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: One commenter suggested that natural supports and volunteerism be included as possible research topics for the model systems.

Discussion: An applicant could propose a study pertaining to these research topics; however, NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: One commenter was concerned about a perceived emphasis on predictors within the priority, stating that predictors may be used to screen out people from treatments or resources.

Discussion: NIDRR is interested in identifying factors that help predict whether interventions contribute to positive outcomes for persons with TBI. It is not interested in funding research that limits access to treatments or resources for individuals with TBI.

Changes: None.

Comment: Several commenters focused on the need for strong dissemination plans. TBIMS projects should be encouraged to have clear management plans with strong dissemination components. Model Systems should be charged with producing more materials that are research based and widely disseminated to the field, concerning subjects that are of importance to the field.

Discussion: Dissemination and operational plans are selection criteria for TBIMS projects. Thus, applicants are encouraged to provide evidence of their strengths in both dissemination and management, providing, for example, information on strategies, tools, and personnel to manage the project and disseminate its findings. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: Applicants should be required to focus research in areas of critical need for research-to-practice and to provide strong training components within each project.

Discussion: NIDRR supports training through a number of mechanisms, including the Fellowship program, the Advanced Rehabilitation Research Training program, and the Rehabilitation Research Training Center program. Because of funding levels, the TBIMS projects are not required to provide training as a component of the program but rather are required to emphasize service delivery and research as well as longitudinal data collection on the natural history of individuals with TBI.

Changes: None.

Comment: One commenter asked why the priority does not give mention activities described in Chapter 7 of NIDRR's Long-Range Plan, “Associated Disability Research Areas.” There is a need for validation and development of measures of environment and accommodation, especially as the latter may apply to cognitive abilities. Other constructs such as community integration and quality of life require measurement refinement. It was suggested that some mention be given to these areas as they might relate to the four areas of research delineated in the proposed priority.

Discussion: NIDRR agrees that development of measures across the four areas delineated in the proposed priority could be an appropriate research activity for TBIMS projects.

Changes: The priority has been modified to permit applicants to choose to do research on TBI measures.

Comment: Consistent with the World Health Organization's shift to a multifaceted conceptualization of health and functioning as reflected in the recent publication of the International Classification of Functioning and Disability, TBIMS projects should focus on environmental barriers and facilitators.

Discussion: An applicant could propose a study pertaining to these topics; however, NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: The TBIMS would be able to recruit substantially more participants if they were permitted to enroll subjects at the point of admission to acute rehabilitation instead of acute care. This option preserves premium rehabilitation care and enhances the national database.

Discussion: The TBIMS project directors discussed this possibility during the last funding cycle. It is anticipated that there will be further discussion in the future.

Changes: None.

Comment: The use of the word “impact” in the priority, “Study the impact of diagnostic interventions * * *” suggests that the diagnostic innovations should be studied in relation to treatment interventions based on the results of the testing. However, basic studies establishing a relationship between neuroimaging results and rehabilitation outcome must be done before interventions can be designed. Can the priority include wording that allows for pre-interventional studies such as those assessing the predictive ability of diagnostic innovations?

Discussion: NIDRR funds applied rehabilitation research. While applicants are not precluded from proposing pre-interventional studies, they are urged to demonstrate the potential for designing new interventions. NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: One commenter suggested that research on the use of homeopathic medicine in treating persons with traumatic rehabilitation be added to the priority.

Discussion: An applicant could propose a study pertaining to this; however, NIDRR has no basis to determine that all applicants should be required to focus on this issue. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: In the ER setting, a person may be diagnosed with a spinal cord injury or multiple trauma. Due to the nature of the emergency, TBI, especially mild TBI, is frequently overlooked. Can NIDRR require that the TBIMS address these issues?

Discussion: NIDRR agrees that mild TBI and dual diagnoses are a significant problem. TBIMS focus on moderate to severe health injury, but NIDRR funds other research on mild head injury. An applicant could propose a study pertaining to these topics; however, NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: Several commenters urged NIDRR to ensure that the TBIMS projects have true participatory involvement of people who have sustained brain injuries.

Discussion: NIDRR concurs with this comment, and the priority reflects its commitment to consumer participation.

Changes: None.

Comment: It is recommended that the TBIMS projects include development and evaluation of TBI education and service referral methods that will improve individual transition to the community, especially those individuals who have received medical and rehabilitation services at a location other than their home community.

Discussion: An applicant could propose a study pertaining to this; however, NIDRR has no basis to determine that all applicants should be required to focus on this issue. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: One commenter encouraged the use of a variety of research methodologies based on the nature of the research question to be addressed as well as multidisciplinary research that encourages, respects, and validates the breadth of research perspectives.

Discussion: NIDRR agrees with this comment and urges applicants to be cognizant of these issues in writing their applications.

Changes: None.

Comment: Add the following research objectives to the section on Integrating Persons with Disabilities into the Workforce: (a) Develop and evaluate strategies that improve employment outcomes of persons with TBI, including transition and youth; and (b) Identify effective employment strategies such as job sharing and self-employment.

Discussion: Applicants may propose these topics as they fall within the priorities as written. However, NIDRR has no basis to determine that all applicants should be required to focus on these issues. The peer review process will evaluate merits of the proposal.

Changes: None.

Comment: Add the following objective to Full Access to Community Life: a) Examine the impact of environmental and attitudinal barriers on the outcomes of persons with TBI.

Discussion: NIDRR concurs with this recommendation.

Changes: The priority has been modified to allow applicants to choose to do research on attitudinal barriers.

Comment: One commenter proposed that the priority include a requirement to design and test rehabilitation interventions that improve neurological recovery (including motor and cognitive recovery), functional, and longterm outcomes for persons with TBI.

Discussion: NIDRR concurs with this recommendation.

Changes: The priority has been modified to include neurological recovery (including motor and cognitive recovery).