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 ll44s@nih.gov, will also be accepted.
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