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A -- Quality of Life Outcomes in Neurological Disorders

Notice Date
Notice Type
Solicitation Notice
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Institute of Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, MD, 20892-9531
ZIP Code
Solicitation Number
Archive Date
Point of Contact
Laurie Leonard, Contracting Officer, Phone 301 496-1813, Fax 301 402-4225, - Ida Lirette, Program Specialist, Phone 301 496-1813, Fax 301 402-4225,
E-Mail Address
ll44s@nih.gov, il26v@nih.gov
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 address: (http://www.ninds.nih.gov/funding/currentrfps.htm) 15 or more calendar days after the issuance of this synopsis. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THIS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency. Refer to numbered note 26. ****
SN00314148-W 20030501/030429213339 (fbodaily.com)
FedBizOpps.gov Link to This Notice
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