Notice Number: NOT-OD-10-078

Key Dates
Release Date: April 20, 2010
Response Date: May 25, 2010

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

This Request for Information (RFI) is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and/or the NIH Adherence Research Network. The NIH 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.

Purpose

The NIH Office of Behavioral and Social Sciences Research (OBSSR) and the NIH Adherence Research Network are seeking input from the scientific community, health professionals, patient advocates, community-based organizations, students, and the general public about current and emerging priorities in adherence research that offer the greatest potential for improving the nation’s health and well-being. This input will inform the Adherence Research Network’s strategic planning process and help the Network meet its mission of pursuing opportunities for strengthening adherence research at NIH while innovating beyond existing investments.

Definition: Adherence, for the purpose of this Notice, is defined as the extent to which a person complies with the recommended medical and health regimen (e.g., taking medication, following dietary recommendations, modifying habits or engaging in preventive services).

Background

The Adherence Research Network is a working group with representatives from multiple NIH Institutes, Centers and Offices whose goal is to provide leadership and vision for adherence research at NIH. It was initially launched in May 2007. Seventeen NIH Institutes, Centers, and programs within the Office of the Director (including the OBSSR) participate in the Network. Additional information about the Adherence Research Network can be found at http://obssr.od.nih.gov/scientific_areas/health_behaviour/adherence/adherenceresearchnetwork.aspx

The mission of the Adherence Research Network is to pursue opportunities for strengthening adherence research at the NIH while innovating beyond existing investments. Its main goals are to:

• Provide leadership, vision, and support to promote a strong body of adherence research funded by the NIH; and
• Evaluate and disseminate scientific information and funding opportunities for adherence research at NIH.

Adherence research in the behavioral and social sciences is relevant to the nation’s health and well-being. Poor adherence to prescription medications and treatments has been labeled a “worldwide problem of striking magnitude” (World Health Organization, 2003). Over the last 40 years, researchers have observed and documented universally poor adherence to prescription medications and behavioral treatments (e.g., diet change for hypertension, smoking cessation and screenings for cancer). For example, up to 20% of patients fail to fill new prescriptions and approximately 50% of people with chronic health conditions discontinue their medication within 6 months. Adherence to behavioral and biobehavioral treatments remains also poor. For example, no more that 30% of patients quit smoking when advised by their health care providers that quitting smoking was essential for their health, even those affected with lung conditions.

Access to medical care is vitally important but it can lead to better health outcomes only if it is accompanied by patient adherence to recommendations by healthcare professionals. The following specific aspects are particularly important in the context of adherence research and the need to develop innovative methods to enhance adherence:

• Treatments have become increasingly more efficacious (if properly adhered to);
• Conversely, poor adherence to medication and treatment regimens degrades health outcomes and increase medical costs;
• The aging population shows a trend for high rates of chronic diseases that often require patients to follow complex medication and treatment regimens;
• Adherence to healthy lifestyle behaviors (e.g., smoking abstinence, maintaining a healthy body weight) may reduce the prevalence and incidence of many diseases;
• Complementary and alternative approaches to treatment gain popularity but little is known of the role of adherence in these forms of treatment as well as how involvement in complementary and alternative forms of care affects adherence to conventional medical regimens;
• Primary responsibility for treatment adherence has traditionally focused on the patient, but because of cultural and economic challenges within health care systems, responsibility for compliance with the medical regimen is shifting in part to secondary caregivers and others, further complicating the picture.

Despite this need for enhancing adherence at both the individual and population levels, research on interventions related to adherence remains underdeveloped. As documented in a recent review (for reference go to http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD000011/frame.html) most published intervention trials intended to improve adherence rates produced little improvements or enhancement of patient outcomes. Moreover, many of these studies included small samples of volunteers, which may have resulted in sampling bias and/or insufficient power to detect any benefit. In addition, most of the to date research on interventions to improve adherence involved studies that were of relatively short duration, did not include clinical outcomes, and/or failed to measure the durability of the effect once the intervention ended. These methodological shortcomings, as well as the clinical imperative to improve health care outcomes, underscore the need for transformative changes in the field of adherence research.

Information Requested

This RFI seeks information that will help NIH to identify priorities for adherence research that are consistent with the mission of the NIH Adherence Network. Ideas for both short-term (1-2 years) and long-term (3-5 years) activities that focus on adherence are welcome. Members of the scientific community, scientific organizations, healthcare professionals, patient advocates, and the public are invited to respond to the following:

1. The Challenge — Describe the critical gaps in the science of adherence. Gaps can be at the level of basic mechanisms, measurement, methodology and/or intervention.
2. The Potential Solution — Describe what you believe to be the most innovative research approaches to address these challenges. Solutions should focus on potential research methodologies that could address scientific gaps in adherence science.

We especially welcome suggestions on adherence that address the research priorities and public health challenges addressed in the NIH mission, which is to improve health and save lives across the full range of diseases and health problems (http://www.nih.gov/about/).

Responses

Responses will be accepted until May 25, 2010 via email to: Wendy Nilsen, Ph.D. at nilsenwj@od.nih.gov. Please mark your responses with this RFI identifier NOT-OD-10-078. For each suggested high priority area of adherence research, please provide brief background information, define the challenge and outline the potential solution. Reponses are expected to be no longer than approximately 700 words.

Respondents will receive an automated email confirmation acknowledging receipt of their response, but will not receive individualized feedback.

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 internally with scientific working groups convened by the NIH, as appropriate. Nonetheless, no proprietary information should be submitted.

Inquiries

Interested parties may contact:

Wendy Nilsen, Ph.D.
Office of Behavioral and Social Sciences Research
National Institutes of Health
Suite B1-C19 (MSC 2027)
31 Center Drive, Room B1-C19
MSC 2027
Bethesda, MD 20892-2027
Telephone: 301-496-0979
Fax: 301-402-1150
Email: nilsenwj@od.nih.gov

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