Notice Number: NOT-NR-11-010

Key Dates
Release Date: February 16, 2011
Response Date: April 2, 2011

Issued by
National Institute of Nursing Research (NINR)

Purpose

The National Institute of Nursing Research (NINR) is seeking input about the concept of an initiative which will establish common data elements across biobehavioral symptom trials in an effort to advance scientific discovery and accelerate knowledge in the treatment and prevention of symptoms. This input will provide information regarding the feasibility and direction of this initiative.

Background

The NINR is considering an initiative to promote standardized outcomes and the development of an integrated database focused on biobehavioral symptom research. This initiative would seek to establish a core set of biobehavioral symptom measures that can be used in trials across a variety of patient populations with acute or chronic illnesses in different settings in an effort to accelerate scientific advances. The standardization of biobehavioral symptom trial measures has the potential to 1) improve comparability of results among basic and clinical studies, 2) enable translational symptom research, 3) encourage development of cooperative multicenter networks and projects, 4) facilitate meta-analysis, 5) promote reporting of relevant outcomes, and 6) avoid duplication of efforts. The standardization of measures facilitates the collection, use and reporting of symptom data and addresses a critical gap that currently constrains rapid progress in symptom research.

The objectives of this initiative may include 1) identifying optimal measures for assessing symptoms along a biobehavioral continuum; 2) establishing projects that incorporate standardized biobehavioral symptom assessment within a research network; and 3) creating a virtual symptom data repository for effective data mining and sharing. This initiative will target 12 of the most common symptoms: fatigue, dyspnea, pain, nausea, constipation, depression, anxiety, cognitive impairment, lack of appetite, itching, insomnia, mucosal dryness.

Request for Comments

The NINR is inviting the scientific community, health professionals, industry representatives, scientific organizations, students and other interested parties to provide input and advice on this initiative by responding to the items listed below.

1. Your overall impression of an initiative focused on standardizing measures for the biobehavioral assessment of symptoms.
2. Are there symptoms that should be added to or removed from the 12 listed above?
3. To what extent would the community of scientists who conduct research utilize a toolkit of standardized measures for assessing symptoms along a biobehavioral continuum?
4. How measures (primary and supplemental) can be identified and/or developed that reflects the following: 1) subjective, multidimensional nature of symptoms; 2) molecular entities (genes, proteins, metabolites) that underlie symptom development, sequelae and associated predispositions; and 3) physiologic, clinical and imaging information to document and characterize symptom occurrence.
5. How symptom research could effectively leverage data elements and biospecimens found in existing large/networks/databases?
6. Any other comments or recommendations you wish to offer regarding a symptom initiative?

How to Submit Response

Responses will be accepted until (April 2, 2011) and are limited to 500 words per question. You may respond via our Web site (http://www.ninr.nih.gov/symptoms.htm). Any identifiers (e.g., names, institutions, e-mail addresses, etc) will be removed when responses are compiled. Only the processed, anonymized results will be shared with expert working groups convened by the NINR, as appropriate. While responses will be held confidential, the NINR cannot guarantee the confidentiality of the information provided; therefore no proprietary information should be submitted. Acknowledgement of receipt of responses may not be made, nor will respondents be notified of the NINR evaluation of the information received.

This Request for Information (RFI) is for planning purposes only and should not be construed as a solicitation for applications or an obligation of the part of the Federal government. The NINR does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the government's use of such information. No basis for claims against the NINR shall arise as a result of a response to this request for information or the NINR’s use of such information as either part of our evaluation process or in developing specifications for any subsequent announcement.

Inquiries

Interested parties may contact:

Sue Marden, Ph.D.
National Institute of Nursing Research
Phone: 301-496-9623
Email: mardens@mail.nih.gov