Notice Number: NOT-HD-15-032

Key Dates
Release Date: November 3, 2015
Response Date: December 11, 2015

Issued by
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Disease Prevention (ODP)
Office of Dietary Supplements (ODS)
Office of Research on Women’s Health (ORWH)

Purpose

This Notice is a time-sensitive Request for Information (RFI) inviting comments and suggestions on the priorities specified for the NIH-wide Rehabilitation Research Plan.

NOTE: It is important to read this entire RFI notice to ensure an adequate response is prepared and to have a full understanding of how your response will be utilized.

Background

In response to a legislative requirement (Public Law), NIH is developing a 5-year NIH-wide Research Plan to define the priorities in the area of Rehabilitation Research that is intended to benefit individuals with temporary or chronic limitations in physical, cognitive, or sensory function that require rehabilitation care. The leadership and staff from the participating Institutes, Centers, and Offices (ICOs) are contributing to the proposed direction and content of the Research Plan, with input from the National Advisory Board for Medical Rehabilitation Research. The priorities included below identify crosscutting areas of research that exemplify the breadth of the ICO's priorities and aims in the area of Rehabilitation Research and help us to achieve the NIH mission to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The Rehabilitation Research Plan is aimed at improving the health and function of individuals with functional limitations and/or temporary or chronic disability that are the result of illness or injury. The purpose and goal of the Rehabilitation Research Plan is not to reference specific disease applications for this work but to highlight major trans-NIH themes. The Research Plan is intended to be complete in late August 2016.

NIH-wide Rehabilitation Research Plan Priorities

I. Rehabilitation across the lifespan
1) Move toward a more comprehensive understanding of the effects of disability and functional limitations across the lifespan.

1. Determine through longitudinal and population studies the natural history of conditions that cause disability and common secondary conditions that develop over the life course.
2. Identify and test strategies to address care needs or delivery as the individual with disability moves from childhood to adolescence, adolescence to adulthood, and adulthood to late life.
3. Determine factors that affect rehabilitation service delivery as an individual with disability ages, including health disparities and the effects of multiple chronic health conditions.
4. Advance the understanding of the role of modifiable lifestyle and health behaviors (e.g., nutrition, physical activity, sleep) on effectiveness of rehabilitation interventions and secondary prevention of chronic health conditions in individuals with disability.
5. Examine symptoms (e.g., pain, cognitive impairment) and sequelae (e.g., depression) that may be associated with a disability; evaluate interventions that address these symptoms and sequelae.

2) Encourage investigation of rehabilitation interventions in the pediatric population.

1. Develop rehabilitation interventions that take into account developmental level or maturation of biological systems.
2. Evaluate the utility of interventions developed for adult populations, to include family and community involvement, for improving rehabilitation outcomes for infants, children, and adolescents.
3. Determine the effect of the transition to adulthood on health outcomes and interventions for individuals aging with disability and their family.
4. Provide new directions in flexible mobility systems, prosthetics, and orthotics for pediatric populations who have to grow with their devices.
5. Investigate the impact of health disparities on the implementation and effectiveness of rehabilitation interventions.

II. Family and Community
1) Examine the impact of sociodemographic influences, including geography, socioeconomic status, education, culture, etc. on rehabilitation success.

2) Develop self-management strategies that can be implemented in community settings to help individuals better understand and manage the disability and achieve/maintain positive quality of life and independence.

3) Examine the stressors and challenges experienced by caregivers of individuals with a disability, including the impact of these stressors and challenges on the health of the caregiver and the care recipient. Develop interventions to address stress, burden, and other adverse outcomes in caregivers.

III. Technology use and development
1) Advance the use of telehealth in rehabilitation assessment, delivery and adherence monitoring.

1. Examine novel telehealth platforms for delivery to remote locations or clinics or in-home protocols and evaluate their equivalence to person-to-person treatments.
2. Determine the feasibility of an in-home telehealth assessment or treatment protocol.
3. Explore the use of telehealth to address disparities or increase access to either specialty or general protocols for rehabilitation in specific populations.
4. Encourage health services research to test and validate delivery methods, treatment approaches, and quality of life or economic benefits of telemedicine for individuals with disability.
5. Develop tools and new technology to assist in the care and monitoring of individuals with disabilities.
6. Support technology development that incorporates telemetry and remote access in the acquisition, analysis and monitoring of data relevant to rehabilitation.

2) Advance the use of assistive technologies (AT), non-invasive sensors, and mHealth approaches in rehabilitation science.

1. Identify methods to incorporate needs and requirements of stakeholder groups and end users into technology design and outcome evaluation.
2. Better define metrics and outcomes of interest in the use of these technologies in rehabilitation medicine research.
3. Enhance the effective use of AT or sensors in monitoring adherence to rehabilitation therapies.
4. Integrate mHealth approaches into self-management of chronic conditions; determine best practices in provision of information to providers and alert systems.
5. Support the development of noninvasive sensor technologies for the detection, monitoring and quantitation of rehabilitation relevant data.
6. Integrate developmental and aging considerations into device or assistive technology development to allow for flexibility of application.

3) Provide an evidence base for device fabrication and implementation for individuals with disabilities

1. Support development of neuroprostheses and neuroengineering systems, invasive and non-invasive biologic control systems, robotics for rehabilitation (sensory and motor), intelligent hardware and software for the control of devices.
2. Examine the safety and utility of non-commercial (e.g., non-profit, open source) motor and sensory prosthetic design, especially in the pediatric population, and effectiveness of these devices compared to those made in commercial settings.
3. Identify solutions for improved integration and functionality of neural prostheses and biomaterials to enhance rehabilitation.
4. Improve control mechanisms for end effectors and attachments for existing devices to augment usage and adherence.
5. Encourage the use of computational models for the design and development of new rehabilitation technologies (including assistive technologies) and for evaluating their functional outcomes.

IV. Research design and methodology
1) Improve the design and methodology of rehabilitation investigations especially in the area of clinical trials.

1. Better define the pathway to clinical trials and clinical trial designs that may be most appropriate to rehabilitation medicine research and propose initiatives focused on these methodologies.
2. Enhance the development of methodologies that allow for consideration of individual treatment effects and patient-oriented outcomes.
3. Expand research toward understanding of mechanisms of action and integration of preclinical and modeling research to inform rehabilitation practice and trial design.
4. Explore the use of existing databases and registries as mechanisms for discovery.
5. Determine optimal practices for clinical translation and implementation to enhance reach and utilization of evidence based approaches.

2) Develop precision medicine approaches relevant to rehabilitation medicine

1. Advance the understanding of omic (genomic, epigenomic, proteomic, metabolomic, etc.) underpinnings of plasticity and response to rehabilitation interventions.
2. Characterize biomarkers to improve prescription of interventions.
3. Encourage a better understanding of environmental barriers and biological comorbidities that might impede rehabilitation adherence or efficacy of a rehabilitation intervention.
4. Examine psychosocial influences associated with rehabilitation interventions (e.g., social withdrawal, lack of social support, difficulty adjusting to disability).

3) Standardization of approaches and data elements of interest

1. Provide an evidence base for specific interventions or treatment approaches with an emphasis on validated protocols associated with improved outcomes for particular conditions that cut across populations of individuals with disability (e.g., spasticity, bowel and bladder control, gait disturbance).
2. Continue to develop, validate, and encourage the use of common data elements and metrics in sponsored projects to expand the available knowledge base and provide for aggregation of data and secondary analyses.
3. Harmonize terminology and standards for rehabilitation research to ensure comparability of findings across studies.
4. Support development and dissemination of shared standards and consensus recommendations for measurable outcome assessment tools.

Information Requested

This RFI seeks input from stakeholders throughout the scientific research community and the general public regarding the above proposed priorities for the NIH-wide Rehabilitation Research Plan.

The NIH seeks comments on any or all of, but not limited to, the following topics:

* Potential benefits, challenges, and areas of consideration for the proposed priority areas.
* Compatibility of the proposed priorities with the NIH mission
* Compatibility of the framework of the NIH Rehabilitation Research Plan with available models of rehabilitation research
* Comprehensive trans-NIH research themes in rehabilitation that have not been captured in the Priority Areas
* Future opportunities or emerging research needs

How to Submit a Response

All comments must be submitted electronically to [email protected].

Responses (no longer than 300 words in MS word or pdf format) must be received by 11:59:59 (ET) on December 11, 2015. You will see an electronic confirmation acknowledging receipt of your response.

Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government's use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government's use of such information.

We look forward to your input and hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to:

National Center for Medical Rehabilitation Research (NCMRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: [email protected]