[Federal Register Volume 60, Number 219 (Tuesday, November 14, 1995)]
[Notices]
[Pages 57259-57262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28100]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
Discretionary Cooperative Agreement Program to Support the
Development of an Index to Quantify the Functional Outcome of Pediatric
Motor Vehicle Injuries
AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.
ACTION: Announcement of Discretionary Cooperative Agreement Program to
Support the Development of an Index to Quantify the Functional Outcome
of Pediatric Motor Vehicle Injuries.
-----------------------------------------------------------------------
SUMMARY: The National Highway Traffic Safety Administration (NHTSA)
announces a discretionary cooperative agreement program to support
research in the development of a derivative of the Functional Capacity
Index that will be applicable to pediatric motor vehicle injuries, and
solicits applications for projects under this program.
DATES: Applications must be received on or before January 17, 1996.
ADDRESSES: Applications must be submitted to the National Highway
Traffic Safety Administration, Office of Contracts and Procurement
(NAD-30), Attn: Amy Poling, 400 7th Street S.W., Room 5301, Washington
DC 20590. All applications submitted must include a reference to NHTSA
Cooperative Agreement Program No. DTNH22-94-H-06001.
FOR FURTHER INFORMATION CONTACT:
Questions relating to this cooperative agreement program should be
directed to Stephen Luchter, Senior Policy Advisor, Office of Plans and
Policy (NPP-32), National Highway Traffic Safety Administration, 400
7th St. S.W., Room 5208, Washington, DC 20590; (202) 366-2576. General
administrative questions may be directed to Amy Poling, Office of
Contracts and Procurement, at (202) 366-9552.
SUPPLEMENTARY INFORMATION:
Background
NHTSA's mission is to reduce injuries and fatalities on the
nation's highways. In order to have an objective way to determine where
to place its limited resources, the agency has developed an expertise
in quantitative measures of the consequences of motor vehicle crashes.
These efforts have been largely devoted
[[Page 57260]]
to determining the economics costs resulting from the crash, including
the costs of any resulting injuries or fatalities.
Until recently the agency's focus has been on mitigating the
effects of the most serious injuries, those that result in fatality. As
fatality rates decreased, and knowledge of the magnitude of the long
term consequences of non-fatal injuries increased, more attention began
to be given to the non-fatal injury portion of the agency's mission. It
soon became apparent that although a thorough understanding of the
costs of injury was important, costs alone did not provide a complete
picture of injury consequences. A decision was made to develop a
measure of injury consequences in terms of time, and the product of
that effort is the Functional Capacity Index.\1\
The Functional Capacity Index consists of a set of alphabetical
indicators representing the level of functioning for each of ten
functional attributes, plus a numerical value that represents the
relative value of the combination on a scale from 0.0 to 1.0. A value
of 0.0 represents no loss of function, and a value of 1.0 represents a
complete loss of function. The attributes are: eating, excreting,
sexual function, arm/hand, bending/lifting, ambulation, sight, hearing,
speech, and cognitive functions. Rigorous definitions were developed
for each of these attributes at both full functioning and at
appropriate levels of reduced functioning. Using the methods of Multi-
Attribute Utility Theory, the value judgments of a diverse population
were determined for each level of functioning. Since these value
judgment followed a normal distribution, the mean value was taken as
representative. An algorithm was developed to combine the value
judgments into a ``whole-body'' numerical value using a multiplicative
model. An expert panel provided their judgment of the level of
functioning one year post-injury for a previously healthy adult for
each of the injuries listed in the AIS 90 dictionary.\2\
These efforts have resulted in a useable index, which has been
applied successfully to the agency's injury data base.\3\ When applied
to a population, the parameter of interest becomes the Life-years Lost
of Injury (LLI), which is the sum over the injured population of the
product of the Functional Capacity Index (FCI) and the injured person's
life expectancy. This parameter provides a measure of the effect on the
entire society of a particular injury. The average Life-years Lost to
Injury (LLI/incidence) is a measure of the relative severity of the
injury to the average member of the population with that injury.
At present, applications of the Index must be done with due care,
taking into account the known limitations:
Index values are based on the consensus judgment of an
expert panel, not on clinical data. (A clinical validation project is
currently underway to remove this limitation).
The Index is not applicable to the pediatric or geriatric
populations, due to the different effects of injury on these
populations as compared to healthy adults.
The Index is limited to single injuries. (The assumption
is made in applications that the injury with the highest value of FCI
can be used in a similar way as the highest AIS value injury is used as
an indication of injury severity. The current effort at clinical
validation is expected to yield data that will allow testing of
hypotheses on how to use the Index for multiple injuries).
The Index is applicable for a fixed time post injury. (A
one year post-injury timeframe was chosen because it is known that the
effects of many, though not all, injuries have stabilized at one year
after the injury. Future efforts will consider this issue).
This research effort focuses on removing the pediatric injury
limitation in the application of the Functional Capacity Index. The
possible use of the PEDI4 and WeeFim5 scales was considered
for this project, but rejected as they have a number of limitations;
these indices do not relate to specific injuries, but rather are
applicable in a clinical setting for all injuries. Also, although these
indices include the concept of age appropriate responses, these
responses are not defined as an implicit part of the index.
Objective
The Functional Capacity Index consists of objective definitions of
functional attributes at full functioning and at various levels of
reduced functioning for the injury descriptions in the 1990 Abbreviated
Injury Scale. The Index consists of two parts. The first part is a set
of ten alphabetical designations which indicate the anticipated
functional level for each attribute one year post injury. The second
part consists of a numerical ``whole body'' designation derived using
the value judgments of a representative population. The current Index
is applicable to previously healthy adults. The objective of this
effort is to develop a derivative of the Functional Capacity Index that
is applicable to previously health children, particularly those injured
in motor vehicle crashes.
The following issues have been identified and applicants should
include a discussion of their approach to resolving them in their
application.
Developmental Level--The agency's hypothesis is that there are
certain injuries where age is an important factor in estimating
functional capacity one year post injury and others where it is
not.6 Assuming this is correct, the work described here will
identify the injuries that fit into these two categories. For example,
healthy six-month-olds usually can't walk (but can crawl), can't speak
intelligibly (but can usually communicate via sound), nor can they
balance a checkbook. Thus injuries that affect mobility or vocal
communication for six-month-olds are not likely to be properly scaled
by the current Index. At age two most healthy children can perform the
first two of these functions, but not the third. Thus, any Index must
take into account these differences. Questions the applicant should
address include the following:
The current FCI levels were developed for ages 18 to 34,
but they are believed to be applicable to a somewhat younger
population. Is this limit 16, 12, 10? Are there different age limits
for different injuries?
How should the functional attributes be defined for the
pediatric population for those injuries where the current Index is not
applicable? Should they relate to what a child could do now (for
example, crawling by a six-month-old), or to what the child could do
when s/he becomes an adult (for example, being able to walk 150 feet
and climb 12 steps)?
In order to minimize complexity when applying the index
there must be a simple, straightforward approach to accommodating the
age variations. Is it necessary to have multiple indices, based on age
categories, or can there be an adjustment factor to the current Index
such as, if under 3, use the values in column B instead of the
``standard'' values in column A?
The relationships between chronological age and
developmental age are not single valued functions for the entire
population. How does one treat this issue in applying the Index?
Physiological Factors--The consequences of a particular injury may
be considerably different in young children than in adults. For
example, bones that are still soft may heal with less residual loss of
functional capacity than adult bones. On the other hand, injuries to
central nervous system components that have not fully developed may
arrest the development of the child and have a greater effect on long
term functional capacity. How
[[Page 57261]]
should these concerns be incorporated into the Index?
Value Judgment--The theoretical basis for the Index numerical
values is that they reflect the value judgments of the exposed
population. Not only does one not expect pre-schoolers to understand
the issues, it is unlikely that they would be able to communicate their
thoughts using the approach taken in the initial development of the
Index. However, it is conceivable that 8 or 10 year olds would be able
to comprehend these effects and be able to communicate them adequately.
The question then is whose judgments are applicable--parents,
pediatricians, educators, etc., and when should one consider the
child's judgment? If this method is not applicable at all, what other
approaches are appropriate to arrive at a quantitative whole body
value?
Compatibility with the Existing Functional Capacity Index--The
product of this research must be compatible with the Functional
Capacity Index. Although there are a number of ways to approach the
pediatric injury problem, there must be a seamless relationship between
the results of this research and the Index applicable to the adult
population.
Index Validation--The product of this research effort will be
clinically validated estimates of functional capacity one year post
injury for a representative set of pediatric injuries experienced in
motor vehicle crashes. What validation methods does the applicant
propose so that the results will be broadly representative of the
national experience?
NHTSA Involvement
NHTSA, Office of Plans and Policy, will be involved in all
activities undertaken as part oft he cooperative agreement program and
will:
1. Provide, on an as-available basis, one professional staff
person, to be designated as the Contracting Officer's Technical
Representative (COTR), to serve as a co-investigator participating in
the technical planning and management of the cooperative agreement
project and coordinate activities between the organization and NHTSA.
2. Make available information and technical assistance from
government sources, within available resources and as determined
appropriate by the COTR.
3. Provide liaison with other government agencies and
organizations, as appropriate.
4. Stimulate the exchange of ideas.
5. Due to the complex nature of this research, a multidisciplinary
intergovernmental group of representatives interested in pediatric
injuries will guide the substantive work under this agreement.
The NHTSA Contracting Officer's Technical representative will chair
this group. It is anticipated that this group will include
representatives from the National Institute of Child Health and Human
Development, the National Center for Rehabilitation Medicine and the
Bureau of Maternal and Child Health.
Period of Support
The research effort described in this announcement will be
supported through the award of a single cooperative agreement. It is
anticipated that the project performance period will be up to 27
months, including submission of the final report. The total anticipated
funding level is $200,000.00, with $100,000.00 to be provided in the
first incremental period. The application for Federal Assistance should
address what is proposed and can be accomplished within the time and
funding constraints.
Eligibility Requirements
In order to be eligible to participate in this cooperative
agreement program, an applicant must be an educational institution or
research organization. For-profit research organizations may apply;
however, no fee or profit will be allowed.
Application Procedure
Applicants must submit one original and two copies of their
application package to: NHTSA, Office of Contracts and Procurement
(NAD-30), Attn: Amy Poling, 400 7th Street SW., Room 5301, Washington,
DC 20590. Applications must include a reference to NHTSA Cooperative
Agreement Program No. DTNH22-96-H-06001. Only complete application
packages received on or before January 17, 1996 shall be considered.
Submission of three additional copies will expedite processing, but is
not required.
1. The application package must be submitted with a Standard Form
424 (rev. 4-88, including 424A and 424B), Application for Federal
Assistance, with the required information filled in and certified
assurances signed. While the Form 424A deals with budget information
and Section B identifies budget categories, the available space does
not permit a level of detail which is sufficient to provide for a
meaningful evaluation of the proposed total costs. A supplemental sheet
shall be provided which presents a detailed breakdown of the proposed
costs. The budget shall identify any cost-sharing contribution proposed
by the applicant, as well as any additional financial commitments made
by other sources. In preparing their cost proposals, applicants shall
assume that the award will be made by February 21, 1996, and should
prepare their applications accordingly.
2. Applications shall include a project narrative statement which
addresses the following:
(a) Identifies the objectives, goals, and anticipated outcomes of
the proposed research effort and the approach or methods that will be
used to achieve these ends, and discusses the specific issues
previously mentioned in this Notice, i.e., developmental level,
physiological factors, value judgment, compatibility with the existing
Functional Capability Index, and index validation;
(b) Identifies the proposed plan for conducting the activities of
the research effort, including a schedule of milestones and their
target dates, and for assessing the project accomplishments. It shall
also include a plan for the effective dissemination of the research
results;
(c) Identifies the types and sources of data that will be used in
this research effort, including approaches to insure compatibility of
data and the arrangements made or agreements entered into to insure
access to needed data. Prior to submitting any such data to NHTSA, the
recipient will be required to purge any information from which the
personal identity of individuals may be determined;
(d) Identifies the proposed program director and other key
personnel identified for participation in the proposed research effort,
including description of their qualifications and their respective
organizational responsibilities; and
(e) Describes the applicant's previous experience or on-going
research program that is related to this proposed research effort.
Review Process and Criteria
Initially, all applications will be reviewed to confirm that the
applicant is an eligible recipient and to assure that the application
contains all of the information required by the Application Contents
section of this notice.
Each complete application from an eligible recipient will then be
evaluated by a Technical Evaluation Committee. The Technical Evaluation
Committee will be augmented by non-voting specialty experts from the
National Institute of Child Health and Human Development, the National
Center for Rehabilitation Medicine and the Bureau
[[Page 57262]]
of Maternal and Child Health. The applications will be evaluated using
the following criteria:
1. The technical merit of the proposed research effort, including
the feasibility of the approach, planned methodology and anticipated
results.
2. The adequacy of the organizational plan for accomplishing the
proposed research effort, including the qualifications and experience
of the research team, the various disciplines represented, and the
relative level of effort proposed for professional, technical and
support staff.
3. The adequacy of the plans for disseminating the research results
to effectively contribute to the base of knowledge through the
scientific literature, popular press, etc.
Terms and Conditions of the Award
1. Prior to award, the recipient must comply with the certification
requirements of 49 CFR Part 20, Department of Transportation New
Restrictions on Lobbying, and 49 CFR Part 29, Department of
Transportation Government-wide Debarment and Suspension (Non-
procurement) and Government-wide Requirements for Drug-Free Workplace
(Grants).
2. During the effective period of the cooperative agreement awarded
as a result of this notice, the agreement shall be subject to the
general administrative requirements of 49 CFR Part 19, Department of
Transportation Uniform Administrative Requirements for Grants and
Agreements with Institutions of Higher Education, Hospitals and Other
Non-Profit Organizations; the cost principles of OMB Circular A-21, or
A-122, or FAR 31.2, as applicable to the recipient, and the NHTSA
General Provisions for Assistance Agreements.
3. If human subjects are to be used in any portions of this
research, applications must include certification that the applicable
provisions of 49 CFR Part 11 and NHTSA Order 700-1 will be followed.
4. Reporting Requirements and Deliverables: The recipient shall
submit a quarterly performance report in letter format within 15 days
after each quarter; a draft final report and draft technical summary
within 24 months after award; a camera ready reproducible final report
and technical summary, and any data bases and computer programs
developed as part of this cooperative agreement, within 27 months of
award. An original and two copies of each report shall be submitted to
the COTR.
Issued on: November 7, 1995.
Donald C. Bischoff,
Associate Administrator for Plans and Policy.
References
1. MacKenzie E J et al., Development of the Functional Capacity
Index (FCI), DOT HS 808 160 July 1994
2. Association for the Advancement of Automotive Medicine, The
Abbreviated Injury Scale, 1990 Revision, Des Plaines IL
3. Luchter S. An Estimate of the Long Term Consequences of Motor
Vehicle Injuries, Proceedings of the Enhanced Safety Vehicle
Conference, May 1994
4. Haley S M et al., Pediatric Evaluation of Disability
Inventory, New England Medical Center, 1989
5. Granger C V, Hamilton B B, Kayton R. Functional Independence
Measure for Children (WeeFIM), Research Foundation, State University
of New York, 1987
6. This hypothesis is an extension of the approach to pediatric
injury severity in the Abbreviated Injury Scale. Except for brain
hematomas, blood loss in severe lacerations, or internal bleeding
due to abdominal or thoracic injuries, the AIS '90 scale does not
differentiate between pediatric and other populations. See The
Abbreviated Injury Scale 1990 Revision p4 for a discussion of
pediatric injury severity.
[FR Doc. 95-28100 Filed 11-13-95; 8:45 am]
BILLING CODE 4910-59-M
