RELEASE DATE:  April 30, 2003

NOTICE:  NOT-NS-03-015

National Institute of Neurological Disorders and Stroke (NINDS)

The National Institute of Neurological Disorders and Stroke (NINDS) is 
seeking an innovative approach to measuring health-related quality of life 
(HRQL) that will be responsive to the needs of researchers in a variety of 
neurological disorders and settings, with a particular emphasis on measuring 
outcomes in clinical trials.  

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 
of chronic neurological disorders and their treatments.  More subjective 
aspects of patients' functioning, such as social, psychological, and mental 
well-being, may be more important components of a disease intervention.  
Measurement of patient-oriented outcomes is a particular concern in clinical 
trials, where 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 HRQL assessment methods should be used within or across 
studies or disease areas.  Because of the lack of consensus about the best 
tools or measurement approaches, it is not possible to compare the relative 
burden of various neurological conditions to each other or to non-
neurological diseases; nor is it possible to compare the relative benefits of 
one treatment over another based on the same patient-centered outcome.  
Investigators are reluctant 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.  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 a clinical 
trials setting.  The availability of 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.  

The overall objective of the planned contract is to develop a 
psychometrically robust HRQL measurement tool that is accepted by the 
neurology clinical trials and clinical research communities.   

Specific goals of the contract are as follows:  1)  to develop a core set of 
questions that will address dimensions of HRQL that are universal to patients 
with chronic neurological disease; and 2)  To develop supplemental questions 
or modules that address additional concerns that are specific to particular 
groups of patients defined by disease, age, or other factor.  

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).   

It is anticipated that one cost-reimbursement type contract will be made for 
a period of five years and could be made on or about December 2003.  This is 
not a Request for Proposals (RFP).  THIS SOLICITATION WILL BE AVAILABLE 
ELECTRONICALLY ONLY.  Request for Proposal (RFP) No. NIH-NINDS-03-04 will be 
available electronically and may be accessed through the FedBizOpps (URL: 
http://www.fedbizopps.gov) or through the NINDS website at the following URL 
(http://www.ninds.nih.gov/funding/funding_announcements/RFP_all.htm) 15 or more 
calendar days after the issuance of this synopsis.  OFFERORS ARE RESPONSIBLE 
PROVIDED.  All responsible sources may submit a proposal, which shall be 
considered by the agency.  Refer to numbered note 26.

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NIH Funding Opportunities and Notices

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Research (OER)
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Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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