Neuroscience

AHRQ Comment Deadline: Outcome Measure Harmonization and Data Infrastructure for Patient Centered Outcomes Research in Depression

The Agency for Healthcare Research and Quality (AHRQ) is seeking public comments on a proposed data collection titled "Outcome Measure Harmonization and Data Infrastructure for Patient Centered Outcomes Research in Depression." 

On November 6, 2019 (84 FR 59811), AHRQ extended the comment deadline from October 21, 2019, to December 6, 2019. 

AHRQ funded a prior project to harmonize the outcome measures collected across patient registries and routine clinical practice, with the goals of supporting the development of a robust data infrastructure that can consistently and efficiently collect high-quality data on outcome measures that are relevant to patients and clinicians and supporting patient-centered outcomes research and quality improvement. Harmonized outcome measures would also form the foundation for learning healthcare systems. Of note, AHRQ has supported the development of the Outcome Measures Framework (OMF). The OMF is a conceptual model for classifying outcomes that are relevant to patients and providers across most conditions. AHRQ, in collaboration with the US Food and Drug Administration and the National Library of Medicine, recently supported an effort to use the OMF as a content model for developing harmonized outcome measures in specific disease areas, including depression.

Major depressive disorder (MDD) is a common mental disorder that affects an estimated 16.2 million adults and 3.1 million adolescents in the United States. Characterized by changes in mood, cognitive function, and/or physical function that persist for two or more weeks, MDD can reduce quality of life substantially, impair function at home, work, school, and in social settings, and result in increased mortality due to suicide. MDD also is a major cause of disability, with an economic burden of approximately $210.5 billion per year in the United States.

Despite the burden of MDD and the availability of treatment, the condition is often undiagnosed and untreated. In 2016, the U.S. Preventive Services Task Force recommended screening for depression in the general adult population, including pregnant and postpartum women, and in adolescents. While routine screening is intended to improve diagnosis and treatment of MDD, many questions remain, such as about the comparative effectiveness of different treatment approaches, the incidence of adverse events, when to add medications for patients who do not respond to an initial course of treatment, how and why depression recurs, and how to classify and treat treatment-resistant depression. Patient registries capture a wealth of data on depression treatment patterns and outcomes in the United States and could serve as the foundation for a national research infrastructure to address these and other research questions. Yet, a lack of harmonization in the outcome measures collected by each registry makes it challenging, if not impossible, to link and compare data across registries and related efforts. As documented in the prior project, existing registries use different outcome measures (e.g., remission as defined by the PHQ-9 vs. HAM-D) and capture data at different timepoints.

Depression registries offer an excellent opportunity to demonstrate the feasibility and value of implementing the harmonized outcome measures. Existing registries already capture some of the harmonized depression measures for quality reporting, although at different timepoints; capture of these measures and the additional measures at consistent intervals will enable the registries to generate more robust data suitable for research purposes.

AHRQ is now proposing to implement the harmonized depression outcome measures developed under the prior project in two patient registries (the PRIME Registry and PsychPRO) and a health system setting. The purpose of this project is to demonstrate that capturing the harmonized outcome measures in the clinical workflow and submitting these data to different registries can improve clinical care, reduce the burden of registry participation, and increase the utility of registry data for research purposes. The objectives of the project are to:

  • Demonstrate that collection of the harmonized outcome measures is feasible, sustainable, and useful for clinicians participating in primary care and mental health patient registries.
  • Demonstrate that collection of the harmonized outcome measures is feasible, sustainable, and useful for clinicians in a health system setting.
  • Evaluate whether collection of the harmonized measures increases the utility of registry data for research purposes.

Members of the public may submit comments by email. More information is available at this Federal Register notice.

Senate Hearing: Nomination of Stephen M. Hahn, MD, to Serve as FDA Commissioner

The Senate Committee on Health, Education, Labor, and Pensions will hold a confirmation hearing to consider the nomination of Stephen M. Hahn, MD, to serve as the Commissioner of the Food and Drug Administration (FDA). 

Members of the public may attend in person or via webcast. More information is available at the Committee's website.

FDA Comment Deadline: Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction

The Food and Drug Administration (FDA) seeks public comments to accompany its September 17, 2019 public hearing entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” The hearing relates to the draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs.

This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.

Members of the public may submit comments online at Regulations.gov, or via mail. More information is available at this Federal Register notice.

NIH Meeting: Rural Health Seminar

The National Institutes of Health (NIH), Rural Health Interest Group, will hold its inaugural Rural Health Seminar. Preserving health and healthcare in rural communities is key to maintaining the economic stability of the underserved rural populations. The objective is to provide a space where these important, timely topics can be explored and to enhance opportunities for interchanging ideas about how innovations in clinical and translational science can improve rural health outcomes.

The health care challenges facing rural America call for more rigorous scientific research, successful implementation of evidence-based practice in rural settings and use of innovative technology to improve rural health outcomes. The NIH Rural Health Interest Group provides a forum to connect translational scientists from diverse disciplines across the NIH to research communities and decision makers, as well as provide opportunities for professional development, networking, and community engagement. In addition to establishing a listserv for announcements and information sharing, the group has regular meetings on campus featuring invited speakers and members of the interest group presenting and discussing their research, including the annual rural health seminar series and activities observing National Rural Health Day.

Members of the public may attend in person with advance registration, or via webcast. More information is available at this event registration website

OSTP Meeting: President's Council of Advisors on Science and Technology

The Office of Science and Technology Policy (OSTP) will hold a meeting of the President's Council of Advisors on Science and Technology (PCAST). During this open meeting, PCAST is scheduled to discuss the identification of science and technology issues that PCAST members will address and also discuss setting priorities.

PCAST is an advisory group of the nation's leading scientists and engineers, appointed by the President to augment the science and technology advice available to him from inside the White House, cabinet departments, and other Federal agencies. PCAST is consulted about and provides analyses and recommendations concerning a wide range of issues where understandings from the domains of science, technology, and innovation may bear on the policy choices before the President. PCAST is chaired by Dr. Kelvin Droegemeier, OSTP Director.

Members of the public may attend in person with advance email registration. More information is available at this Federal Register notice.

USCC Meeting: 2019 Annual Report to Congress

The US-China Economic and Security Review Commission (USCC) will hold a meeting to release its 2019 Annual Report to Congress. The Commission's 2019 Annual Report to Congress addresses key findings and recommendations for Congressional action based upon the Commission's hearings, research, travel, and review of the areas designated by Congress in its mandate, including focused work this year on: China's internal and external challenges; artificial intelligence, new materials, and new energy; US companies in China and Chinese companies in the United States.; health and pharmaceuticals; China's ambitions to build a “world-class” military; China-Russia relations; China's ambitions in space; Taiwan; Hong Kong; changing regional dynamics in Oceania and Singapore; and a review of economics, trade, security, political, and foreign affairs developments in 2019.

The Commission is mandated by Congress to investigate, assess, and report to Congress annually on "the national security implications of the economic relationship between the United States and the People's Republic of China."

Members of the public may attend in person. More information is available at this Federal Register notice.

House Markup: Rural STEM Education, Advancing Research to Prevent Suicide, Election Technology Research

The House Committee on Science, Space, and Technology will hold a markup session to consider three bills. Namely, the Committee will consider: 

  • HR 4979: "Rural STEM Education Act"
  • HR 4704: "Advancing Research to Prevent Suicide Act"
  • HR 4990: "Election Technology Research Act"

Members of the public may attend in person or via webcast. More information is available at the Committee's website.

House Hearing: Cybersecurity Challenges and Cyber Risk Management at the Department of Veterans Affairs

The House Committee on Veterans' Affairs, Subcommittee on Technology Modernization, will hold a hearing titled "Cybersecurity Challenges and Cyber Risk Management at the Department of Veterans Affairs." The purpose of the hearing is to assess how the Department of Veterans Affairs (VA) manages its cybersecurity program, including controlling access to confidential data, supply-chain management, and the safeguarding of information technology assets. 

Members of the public may attend in person or via webcast. More information is available at the Committee's website.

NASEM Workshop: Educating Health Professionals to Address the Social Determinants of Mental Health

The National Academies of Sciences, Engineering, and Medicine (NASEM), Board on Global Health, will hold a workshop titled "Educating Health Professionals to Address the Social Determinants of Mental Health." The workshop agenda will explore how health professions education and practice organizations and programs are currently addressing social determinants that contribute to mental health disparities across the lifespan. The workshop will also set the stage for discussions on how disparities can affect the mental health and well-being of patients, families, communities, and care providers across the learning continuum.

Members of the public may attend in person or via webcast with advance registration. More information is available at this http://www.nationalacademies.org/hmd/Activities/Global/InnovationHealthProfEducation/2019-NOV-14.aspxNASEM website.

Senate Markup: Bills in Energy, Nanotechnology, Cybersecurity, and Neuroscience Policy

The Senate Committee on Commerce, Science, and Transportation will hold a markup session to consider 22 bills, including some related to energy, nanotechnology, cybersecurity, and neuroscience policy. Those bills include:

Energy Policy

  • S 1640: Portable Fuel Container Safety Act of 2019

Nanotechnology Policy

  • S 999: Sustainable Chemistry Research and Development Act of 2019​

Cybersecurity Policy

  • S 2775: Harvesting American Cybersecurity Knowledge through Education (HACKED) Act of 2019

Neuroscience Policy

  • S 481: Nicholas and Zachary Burt Memorial Carbon Monoxide Poisoning Prevention Act of 2019
  • HR 3153: Expanding Findings for Federal Opioid Research and Treatment (EFFORT) Act 

Members of the public may attend in person or via webcast. More information is available at the Committee's website.

Senate Hearing: Examining the Response to Lung Illnesses and Rising Youth Electronic Cigarette Use

The Senate Committee on Health, Education, Labor, and Pensions will hold a hearing titled "Examining the Response to Lung Illnesses and Rising Youth Electronic Cigarette Use." 

Witnesses include:

  • Mitch Zeller: Director, Center for Tobacco Products, US Food and Drug Administration, Silver Spring, MD
  • Anne Schuchat, MD: Principal Deputy Director, Centers for Disease Control and Prevention, Atlanta, GA

Members of the public may attend in person or via webcast. More information is available at the Committee's website.

House Markup: Legislation Including the Reversing the Youth Tobacco Epidemic Act of 2019

The House Committee on Energy and Commerce, Subcommittee on Health, will hold a markup session to consider four bills, including HR 2339, the Reversing the Youth Tobacco Epidemic Act of 2019. 

HR 2339 would increase the minimum age to purchase tobacco products to 21; prohibit characterizing flavors in all tobacco products, including mint and menthol; and direct the Food and Drug Administration (FDA) to issue regulations to prohibit non-face-to-face sales of all tobacco products, including e-cigarettes. HR 2339 would also make it unlawful to market, advertise, or promote any e-cigarette product to individuals under the age of 21. This would include requiring manufacturers of all tobacco products, including e-cigarettes, to be held to the same advertising and sales requirements currently applied to the sale, distribution, and use of traditional cigarettes. Finally, the bill authorizes FDA to collect user fees from manufacturers of all tobacco products, including e-cigarettes, and increases the total amount of fees collected by $100 million. An amendment in the nature of a substitute will be offered during markup of HR 2339 that incorporates FDA technical assistance as well as other changes.

Members of the public may attend in person or via webcast. More information is available at the Committee's website.