2010-17244. Request for Information on Development of an Inventory of Comparative Effectiveness Research

AGENCY:

Office of the Assistant Secretary for Planning and Evaluation.

ACTION:

Request for Information.

SUMMARY:

The Office of the Assistant Secretary for Planning Evaluation (ASPE) is developing a national inventory of comparative effectiveness research (CER) and CER-related information. This initiative is driven by the American Recovery and Reinvestment Act of 2009 (ARRA) which provided $1.1 billion for research and development in the area of CER. ARRA allocated $400 million to the Office of the Secretary (OS) in the U.S. Department of Health and Human Services (HHS), $400 million to the National Institutes of Health (NIH), and $300 million to the Agency for Healthcare Research and Quality. ARRA also established the Federal Coordinating Council for CER, which, after significant public input, developed a strategic framework and recommended high-level priorities for OS funds. While the FCC's Report to Congress drew on an initial CER inventory focused on federal investments, the process of cataloguing CER activities and infrastructure will be critical to tracking ongoing and future investments in CER. An important component of this effort is creating an inventory of CER to ensure that patients, clinicians, and other decision makers can identify and locate relevant CER in a timely manner.

ASPE seeks input on approaches to developing a CER Inventory that capture ongoing and existing CER in the United States. This inventory will be accessible to the public, including patients, clinicians, and policymakers, through a web-based system. Comments should focus on appropriate resources and approaches for developing the CER Inventory, rather than the methodology of CER or suggestions for particular CER studies that should be included in the CER Inventory. Requested information includes suggestions regarding sources of CER and ways to encourage participation in the inventory; comments related to categorizing content; and approaches to ensure the CER Inventory is useful and sustainable over time.

DATES:

Submit comments by 11:59 p.m. Eastern Time on August 9, 2010.

ADDRESSES:

Written or electronic comments should be submitted to HHS as directed below.

Comments should be identified by referring to the “CER Inventory”, and may be submitted to the Department of HHS by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
• Mail: Written comments (one original and two copies) may be mailed to: Department of Health and Human Services, Attention: CER Inventory, Hubert H. Humphrey Building, Room 447-D, 200 Independence Avenue, SW., Washington, DC 20201.
• Hand or courier delivery: Comments may be delivered to Room 447-D, Department of Health and Human Services, Attention: CER Inventory, Hubert H. Humphrey Building, Room 447-D, 200 Independence Avenue, SW., and Washington, DC 20201. Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CER Inventory drop box located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain proof of filing by stamping in and retaining an extra copy of the comments being filed.

Written submissions should be brief (no more than three pages per submission), and should be in the form of a letter. Please do not submit duplicate comments. Please do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. Consequently, comments should not include any sensitive health information from medical records or other individually identifiable health information, or any non-public, corporate or trade association information, such as trade secrets or other proprietary information. Comments may be submitted anonymously.

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. All comments will be made available publicly on the internet at http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

FOR FURTHER INFORMATION CONTACT:

Pierre Yong, Office of the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services, [phone], [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

The American Recovery and Reinvestment Act of 2009 (ARRA) provided funding of $1.1 billion for CER and related activities, and established the Federal Coordinating Council for Comparative Effectiveness Research, which defined CER as the:

Conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings. The purpose of CER is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

• To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations and sub-groups.
• Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.
• This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results.^[1]

The FCC Report to Congress additionally described the criteria for prioritization of potential CER investments, a strategic framework for CER activity, and high-level priority recommendations for OS funds (http://www.hhs.gov/​recovery/​programs/​cer/​cerannualrpt.pdf). Because CER is inherently multi-disciplinary, the Department recognizes the importance of highlighting research that informs CER, including relevant published literature as well as ongoing research activity. To fulfill this goal the CER Inventory is intended to be a living document that will both facilitate access to CER for interested stakeholders; and assist in identifying priorities and gaps for future research. The goal is to routinize the inventory process, allow for easy updating and identifying gaps, and create a system that is sustainable. Connecting users to CER information via a publicly available, searchable online tool is an efficient approach to disseminating this breadth of information.

II. Request for Information

The Department of HHS is inviting public comment to aid in the development of the content and structure of the CER Inventory. This notice specifically requests suggestions for potential sources of information on ongoing and completed CER; ways to encourage participation in the Inventory; approaches to categorizing information; and ways to ensure that the CER Inventory is useful and sustainable.

ASPE is developing a system to catalog CER activities including ongoing and completed CER. The CER Inventory will be publicly available, and will be designed for a diverse community of stakeholders including researchers, policy makers, decision-makers, health care providers, patients, and consumers. The CER Inventory will include records (e.g., abstracts and other summary descriptive information) of CER and information related to CER, including research and resources on methods and training for CER, data infrastructure and databases to support CER, and methods and approaches for translation and dissemination of CER to help inform healthcare decisions and policies.

The information provided in response to this notice will be used to plan and develop the CER Inventory in order to ensure that it meets the needs of such users as researchers, policy makers, decision-makers, health care providers, patients, and consumers. We are seeking public comment on the following issues:

1. Sources for CER. The CER Inventory will draw electronically on existing sites (e.g., PubMed, HSRProj, and Clinicaltrials.gov) and will also permit direct entry of information. Please identify any sources of information, such as relevant sources of gray literature or research databases from private foundations, that would help meet the goals of the CER Inventory.

2. Encouraging participation/submission. What incentives would encourage the contribution of CER research abstracts and other relevant documents into the CER Inventory?

3. Categorization. CER projects and resources should be categorized in a manner that ensures that individuals from diverse backgrounds with varying levels of technical expertise (e.g., researchers, policy makers, clinicians, and patients and consumers) can access relevant information. How might such a categorization scheme and approach be designed? Please comment on the rationale behind suggested categorization schemes.

4. Data elements. Are there specific types of data or information regarding records or descriptions of CER entered into the CER Inventory that should be captured and available to users? Please identify key data and information, if any.

5. Features. Are there features of a web-based CER Inventory that would promote long-term use among the intended audiences?

6. Sustainability. What approaches or business models would provide for a sustainable inventory over time?

7. Additional considerations. Are there potential drawbacks, unintended consequences, or other specific issues that may limit participation in the CER Inventory?

The information submitted in response to this RFI will inform the planning and development of the CER Inventory to ensure that the resource meets the needs of the intended users, is accessible, and is easy to use.

Dated: July 9, 2010.

Sherry A. Glied,

Assistant Secretary for Planning and Evaluation.

Footnotes

1.  U.S. Department of Health and Human Services. Federal Coordinating Council for Comparative Effectiveness Research. Report to the President and the Congress. June 30, 2009. http://www.hhs.gov/​recovery/​programs/​cer/​cerannualrpt.pdf.