Discretionary Cooperative Agreement To Support Research To Evaluate the Validity of a Functional Capacity Index That Measures the Consequences of Injuries Sustained in Motor Vehicle Crashes

Topics:  National Highway Traffic Safety Administration

Donald C. Bischoff
Federal Register
July 19, 1994

[Federal Register: July 19, 1994]


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DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration

 
Discretionary Cooperative Agreement To Support Research To 
Evaluate the Validity of a Functional Capacity Index That Measures the 
Consequences of Injuries Sustained in Motor Vehicle Crashes

agency: National Highway Traffic Safety Administration (NHTSA), DOT.

action: Announcement of Discretionary Cooperative Agreement Program.

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summary: The National Highway Traffic Safety Administration (NHTSA), 
having developed an index for measuring the reduction of functional 
capacity as a result of injuries sustained in motor vehicle crashes, 
announces a discretionary cooperative agreement program to support 
research in the validation of this index and solicits applications for 
projects under this program.

dates: Applications must be received at the office designated below on 
or before September 14, 1994.

addresses: Applications must be submitted to the National Highway 
Traffic Safety Administration, Office of Contracts and Procurement 
(NAD-30), Attn: Linda Boor, 400 7th Street SW., room 5301, Washington, 
DC 20590. All applications submitted must include a reference to NHTSA 
Cooperative Agreement Program No. DTNH22-94H-06014. Interested 
applicants are advised that no separate application package exists 
beyond the content of this announcement.

for further information contact: General administrative questions may 
be directed to Linda Boor, Office of Contracts and Procurement, at 
(202) 366-0607. Questions relating to this cooperative agreement should 
be directed to Joan Harris, Planning and Policy Development Division, 
(NPP-32), National Highway Traffic Safety Administration, 400 7th 
Street SW., room 5208, Washington, DC 20590; (202) 366-2578. Copies of 
documents referenced in this announcement will be provided upon request 
to Joan Harris. Such documents include the final report results from 
NHTSA Cooperative Agreement No. DTNH22-89-Z-06019 and the list of 
approximately 300 injuries that most frequently occur in motor vehicle 
crashes.

SUPPLEMENTARY INFORMATION:

Background

    As a result of numerous improvements in highway and traffic safety, 
the number of fatalities resulting from motor vehicle crashes has been 
in a long term downtrend. The incidence of injured survivors, however, 
has been increasing. As a result, although NHTSA's attention to 
countermeasures to reduce fatalities continues undiminished, it is 
being supplemented by attention to countermeasures that reduce the long 
term consequences of serious injuries both to the injured individual 
and society as a whole. In order to estimate these long term societal 
and personal impacts, new analytical tools are being developed. One 
such tool, called the Functional Capacity Index, measures the degree to 
which an injured person will not be able to function as he/she did 
before the injury. The Functional Capacity Index combines decrements in 
each of ten dimensions of functioning into a whole body score. The 
index was described in a request for comment on the proposed index (57 
FR 13157; April 15, 1992). Basically, the index consists of qualitative 
descriptions of level of functioning for ten attributes of total 
functioning, (eating, excretory function, sexual function, ambulation, 
hand and arm function, bending and lifting, visual function, auditory 
function, speech, and cognitive function), and a numerical value for 
each combination of levels of functioning derived from a sample of 
value judgments of a diverse set of sub-populations.

General Description

    The basic assumption of the Functional Capacity Index is that life 
is its own best measure of value. This is in distinction to the human 
capital economic approach to measuring consequences that assumes that 
people are producers and consumers of goods and services. If there are 
things a person cannot do as well following an injury as before, there 
is a reduction in the person's overall functional capacity. With the 
functional capacity approach, the consequences of an injury to 
individuals of the same age and gender are the same, independent of 
their economic contribution to society.
    The Functional Capacity Index (FCI) assigns scores to the AIS 
injury descriptions on a scale of 0 to 1.00, where 0 represents no 
limitation of function and 1.00 represents maximum limitation of 
function. The overall consequences of an injury are found by 
multiplying the FCI by the injured person's remaining life expectancy. 
This results in the Life-years Lost to Injury (LLI). The Functional 
Capacity Index can vary with time as the injured person's condition 
changes. Any effects of reduced life expectancy as a result of the 
injury also can be accounted for. If the injury was fatal, all of the 
remaining life expectancy is counted.
    The initial phase of the development of the Functional Capacity 
Index has been completed. It consisted of developing definitions of the 
functional attributes and their various capacity levels, choosing a 
scaling approach, obtaining judgments of a cross section of the 
population on the value of each attribute and capacity level, 
developing an algorithm for combining values into a ``whole-body'' 
index based on multiattribute rating techniques, and applying the 
attributes and capacity levels to the injuries described in the AIS 90 
dictionary according to the composite opinion of a multi-disciplinary 
panel of experts.
    This request for applications is concerned with the next phase of 
the development of the Functional Capacity Index, which is to perform 
the necessary research to validate the conclusions reached through 
initial development of the Index under Cooperative Agreement No. 
DTNH22-89-Z-06019. It is assumed that the applicant is thoroughly 
familiar with the Abbreviated Injury Scale 1990 revision.
    The experimental design should consider a number of issues of 
interest to the agency. In general, these relate to the need for 
balance between a thorough and complete validation of the index, and 
validation of injuries or categories of injuries of particular interest 
to the agency.
    1. The recipient will evaluate the functional capacity of people 
injured in motor vehicle crashes, and the evaluation methods identified 
may differ for injuries to the different body regions. In some cases 
existing data may be available, and in others data may have to be 
obtained by testing people for performance of the functional capacity 
descriptors. It also is possible that disparate data sets will be used 
for different body regions. The validation will be conducted for the 
different body regions and different severity levels shown in the AIS 
`90 dictionary with priority given to those injuries described in a 
NHTSA listing of approximately 300 injuries that most frequently occur 
in motor vehicle crashes. In addition, the validation process shall not 
neglect minor and moderate injuries in any body region. The methodology 
for each body region shall balance the cost and time required for 
acquiring the data and the resulting statistical significance. In order 
to apply the FCI, all injury data used in the evaluation shall be 
converted, if necessary, to AIS-90.
    2. The validation must include as a minimum a representative sample 
of injuries to each body region and each severity level, as well as 
injuries that affect each of the attributes of the index. This must be 
balanced against the need to emphasize the less than 300 injuries that 
most frequently occur in motor vehicle crashes out of the more than 
1,300 injuries listed in the AIS `90 dictionary.
    3. When weighted to the incidence of injury in motor vehicle 
crashes, 88.5 percent of the most frequently occurring injuries had a 
zero value for the FCI, as estimated by the expert panel. The research 
effort must include validation of injuries with a zero value of FCI as 
well as those with non-zero values.
    4. The research design must include objective criteria for 
determining agreement/disagreement with the results of the prior 
effort.

Limitations

    The concept of the Functional Capacity Index is broadly applicable 
to all injuries, all ages, and changes in functional capacity as the 
injured person experiences long term effects either to increase or 
decrease capacity. At its present state of development, the index has 
certain limitations which must be recognized in the validation 
research:
    1. The current index is directly applicable only to the conditions 
one year post-injury for a previously healthy adult between the ages of 
18 and 55. Changes in functional capacity from pre-existing conditions 
are not included.
    2. The index in its present form is not applicable to young 
children, as the present functional capacity definitions do not take 
into account the age dependent developmental levels of normal healthy 
children.
    3. The index in its present state of development is not applicable 
to older persons, as it is well documented that similar trauma has a 
greater effect on older persons.
    4. The index in its present form is applicable to single injuries. 
Methodologies to estimate the change in functional capacity resulting 
from any synergistic effects of more than one injury, particularly 
injuries to different body regions, remain to be developed.
    5. The present Functional Capacity Index is limited to the injury 
definitions in the 1990 version of the Abbreviated Injury Scale. 
Although the International Classification of Disease (ICD) injury 
descriptions are widely used, they generally do not contain sufficient 
detail for the agency's countermeasure development purposes. Any 
efforts to revise the current translation programs between ICD-9 and 
AIS 85 to reflect the descriptions in AIS 90 would be applicable to the 
Functional Capacity Index and minimize this limitation.
    6. Although the psycho-behavioral consequences of injuries are 
known to be significant, they are not included in the Functional 
Capacity Index in its present state of development.
    7. The Functional Capacity Index does not intend to include the 
effect of ``fates worse than death''. These are states where people say 
they would rather die than continue living with the particular 
impairment. The agency position is that these are states of preference 
rather than states of function.

NHTSA Involvement

    NHTSA, Planning and Policy Development Division, will be involved 
in all activities undertaken as part of the performance of this 
cooperative agreement 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 participate in the planning and management of 
the cooperative agreement and to 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.

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 for up to 27 
months. The total anticipated funding level is $250,000, with $125,000 
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), 400 7th Street SW., Room 5301, Washington, DC 20590. 
Applications must include a reference to NHTSA Cooperative Agreement 
Program No. DTNH22-94H-06014. Only complete application packages 
received on or before September 14, 1994 shall be considered. 
Submission of three additional copies will expedite processing, but is 
not required.

Application Content

    1. The application package must be submitted with OMB 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. In preparing their cost proposals, applicants shall assume that 
awards will be made by September 30, 1994, and should prepare their 
applications accordingly.
    2. A description of the objectives, goals, and anticipated outcomes 
of the proposed research effort and the method or methods that will be 
used must be included. This shall include an overall description of the 
experimental design including a discussion of why this design is the 
minimal cost program that can lead to a reliable validation of the 
Functional Capacity Index. The validation effort should address 
representative injuries for each body region and severity level, even 
though those injuries may not be included on the priority listing. The 
discussion will include at least the following:
    (a) The approaches to be taken to compare the functional capacity 
of persons who have received a variety of injuries to the estimated 
level of functional capacity one year following injury for a previously 
healthy adult. This discussion should cover the methods to be used for 
each of the ten attributes as described in a request for comment on the 
proposed index (57 F.R. 13157; April 15, 1992), and for each body 
region described in the Abbreviated Injury Scale 1990 Revision as 
published by the Association for the Advancement of Automotive 
Medicine.
    (b) The types and sources of data that will be used in the 
validation process and how the actual comparison with the expert 
judgement from the earlier work, as provided by NHTSA, will be 
accomplished. It is recognized that a number of approaches may be taken 
to validate the Functional Capacity Index pertaining to injuries to 
different body regions or different severity levels. If the use of 
disparate data sources are planned, the discussion shall indicate how 
these data will be treated to insure that they are compatible.
    (c) The arrangements made or agreements entered into to assure 
access to data needed in the validation process. 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) The size of the population(s) used for the validation and the 
statistical significance that can be expected from such a population.
    (e) The criteria that will be used to accept or reject differences 
between the final report from the earlier work to be provided by NHTSA 
and the evaluation data.
    (f) The approaches to insuring compatibility of data, particularly 
if data from disparate data sets are used. In addition, applicant shall 
address coordination of effort if multiple sites are included in the 
proposal.
    (g) An outline of the anticipated milestones and projected schedule 
for completion of work.
    3. In addition to the minimal cost program recommended that will 
lead to a reliable validation of the Functional Capacity Index, 
applicants may choose to describe alternate methodologies that may be 
more costly than the basic approach but will result in greater 
statistical validity or have other desirable features compared to the 
basic approach.
    4. 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.
    5. A discussion of the management approach to be employed to ensure 
that the research will be completed in a timely manner.
    6. A description of the applicant's previous experience or on-going 
research program that is related to this proposed research effort.
    7. If data sources other than those owned by the applicant are to 
be used in the proposed research, letters of intent to release the data 
shall be included.

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 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, the relative 
level of effort proposed for professional, technical and support staff.
    3. The approaches to be employed to ensure timely completion of the 
research.

Terms and Conditions of the Award

    1. Prior to award, each 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 Learning, Hospitals and Other 
Non-Profit Organizations; the cost principles of OMB Circulars A-21, or 
A-122, or FAR 31.2, as applicable to the recipients, and the 
requirements for a drug-free workplace set forth in 49 CFR Part 29.
    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 Subtitle A 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 contract award, any data bases and computer 
programs developed as part of this cooperative agreement on or before 
the completion date of this award, and a camera ready reproducible 
final report and technical summary within 27 months of contract award. 
An original and two copies of each report shall be submitted to the 
COTR.

    Issued on: July 14, 1994.
Donald C. Bischoff,
Associate Administrator for Plans and Policy.
[FR Doc. 94-17497 Filed 7-18-94; 8:45 am]
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