QUALITY OF LIFE OUTCOMES IN NEUROLOGICAL DISORDERS

RELEASE DATE:  February 3, 2003

NOTICE:  NOT-NS-03-007

National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov)

The National Institute of Neurological Disorders and Stroke (NINDS) is 
considering issuing a contract to develop a coordinated approach to defining 
and measuring quality of life in neurological disorders.  NINDS is attempting 
to identify competent sources to establish and coordinate the research 
activities leading to new measurement approaches.

Background

Many of the traditional clinical or functional measures of disease status, 
such as tests of muscle strength or counts of seizure frequency, do not 
adequately represent the full scope of the impact of disease on an individual 
with a chronic neurological disorder.  More subjective components of 
patients' functioning, such as social, psychological, and mental well-being, 
may be more important indicators of disease impact.  Measurement of patient-
oriented outcomes is a particular concern in clinical trials, where small 
differences in clinical measurements or imaging results may not translate 
into important benefit to the patients.  

Some aspects of "health-related quality of life" have been incorporated into 
many recent or current clinical trials in neurology, usually as secondary 
outcome measures.  Many measurement scales have been developed for use in 
various disease settings; however, some of the existing scales have 
questionable validity and there is no consensus on what methods should be 
used within or across studies or disease areas.  The lack of consensus about 
the best tools or approaches creates a situation where based on the existing 
literature, it is not possible to compare the relative burden of various 
neurological conditions to each other or more importantly, to compare the 
relative benefits of one treatment over another on the same patient-centered 
outcome.  An additional issue is the apparent reluctance to design trials 
with the primary objective of comparing quality of life, presumably because 
these outcomes appear to be too subjective, too hard to define concisely, too 
complex to administer, and too difficult to interpret.  Additionally, there 
is a paucity of condition-targeted quality of life surveys for persons with 
neurological diseases that are reliable, valid, responsive, and are brief 
enough to be feasibly administered in the clinical trials setting.  
Supporting a research agenda that will create such a tool for persons with 
neurological diseases would greatly increase the probability that the 
research community would incorporate patient-centered measures as primary and 
secondary outcomes in clinical trials.  

Goals of the Contract

The overall objective of the proposed contract is to develop a 
psychometrically robust measurement tool that is accepted by the neurology 
clinical trials and clinical research community.   Specific goals of the 
contract are:

1.  Develop a core set of questions that will address dimensions of quality 
of life that are universal to patients with chronic neurological disease. 

2.  Develop supplemental questions that address additional concerns that may 
be specific to particular groups of patients defined by disease, age, or 
other factor.

It is expected that the contract will be structured in two phases.  The first 
phase will encompass qualitative research focusing on the identification of 
content area and the development of instrument(s).  The second phase 
addresses the formal testing and refining of the final instrument(s).   

Information Requested

Information in the following areas will aid in the design of the proposed 
solicitation.  We ask that interested organizations identify critical 
criteria to include in the solicitation.  The information supplied in 
response to this request need not be limited to these areas.

o  General scientific approach to identifying content and developing 
measures, considering the current state-of the-art in qualitative and 
quantitative psychometric methods;
o  Overall estimation of the number of personnel required and specific 
expertise needed, with approximate level of effort required for each;
o  Availability of technology;
o  Target populations (e.g., source, characteristics, numbers needed for each 
phase);
o  Human subjects concerns;
o  Methods of evaluation of phase I and phase II data;
o  Database/data management requirements;
o  Project timeline.

This Request for Information (RFI) is for information and planning purposes 
only and shall not be construed as a solicitation or as an obligation on the 
part of the Government.  The Government does not intend to award a contract 
on the basis of responses nor otherwise pay for the preparation of any 
information submitted or the Government's use of such information.  
Acknowledgement of receipt of responses will not be made, nor will 
respondents be notified of the Government's evaluation of the information 
received.  However, should such a requirement materialize, no basis for 
claims against the Government shall arise as a result of a response to this 
request for information or the Government's use of such information as either 
part of our evaluation process or in developing specifications for any 
subsequent requirement.  Responses will be held in a confidential manner.  
Any proprietary information should be so marked.

All respondents are asked to indicate the type and size of your business 
organization, e.g., Large Business, Small Business, Veteran-Owned Small 
Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small 
Business, Small Disadvantaged Business, Women-Owned Business, 8(a), 
Historically Black College or University/Minority Institution (HBCU/MI), 
educational institution, profit/non-profit hospital, or other nonprofit 
organization. 

Responses should be limited to 20 pages, should be identified with NINDS RFI 
No. 03-007 and are due by February 24, 2003.  Please submit three (3) copies 
of your response to: 

Laurie A. Leonard 
Contracting Officer 
Contracts Management Branch 
National Institute of Neurological Disorders and Stroke 
NIH
6001 Executive Boulevard, Room 3287  MSC 9531 
Bethesda, Maryland 20892-9531.  
(for FedEx or courier, use: Rockville, MD 20852)

E-mail responses, sent to [email protected], will also be accepted.

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