03-1913. Nominations of Topics for Evidence-based Practice Centers (EPCs)

AGENCY:

The Agency for Healthcare Research and Quality (AHRQ).

ACTION:

Nominations of topics for evidence reports and technology assessments.

SUMMARY:

AHRQ invites nominations of topics for evidence reports and technology assessments relating to the prevention, diagnosis, treatment and management of common diseases and clinical conditions, as well as topics relating to organization and financing of health care. AHRQ's previous requests for topic nominations were published in the Federal Register on December 23, 1996, November 28, 1997, May 4, 1999, November 13, 2000, and February 14, 2002.

DATES:

Topic nominations should be submitted by March 31, 2003 in order to be considered for the next group of evidence reports and technology assessments to be funded in Fiscal Year 2003. In addition to timely responses to this request for nominations, AHRQ also accepts topic nominations on an ongoing basis. AHRQ is not able to reply to individual responses, but will consider all nominations during the selection process. Topics selected will be announced from time to time in the Federal Register and through AHRQ press releases.

ADDRESSES:

Topic nominations should be submitted to Jacqueline Besteman, J.D., M.A., Director, Evidence-based Practice Centers (EPC) Program, Center for Practice and Technology Assessment, AHRQ, 6010 Executive Boulevard, Suite 300, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Jacqueline Besteman, J.D., M.A., Center for Practice and Technology Assessment, AHRQ, 6010 Executive Blvd., Suite 300, Rockville, MD 20852; Phone: [phone]; Fax: [phone]; Fax: [phone]; E-mail: [e-mail].

Arrangement for Public Inspection: All nominations will be available for public inspection at the Center for Practice and Technology Assessment, telephone [phone], weekdays between 8:30 a.m. and 5 p.m. (Eastern time).

SUPPLEMENTARY INFORMATION:

1. Background

Under Title IX of the Public Health Service Act (42 U.S.C. 299a-299c) as amended by Pub. L. 106-129 (1999), AHRQ is charged with enhancing the quality, appropriateness, and effectiveness of health care services and access to such services. AHRQ accomplishes these goals through scientific research and through promotion of improvements in clinical practice and health systems practices including the prevention of diseases and other health conditions.

2. Purpose

The purpose of Federal Register notice is to encourage participation and collaboration of professional societies, health systems, payors, and providers, with AHRQ as it carries out its mission to promote the practice of evidence-based health care. AHRQ serves as the science partner with private-sector and public organizations in their efforts to improve the quality, effectiveness, and appropriateness of health care delivery in the United States, and to expedite the translation of evidence-based research findings into improved health care services. AHRQ awards task order contracts to its Evidence-based Practice Centers (EPCs) to undertake scientific analyses and evidence syntheses on high-priority topics. The EPCs produce science syntheses—evidence reports and technology assessments—that provide to public and private organizations the foundation for developing and implementing their own practice guidelines, performance measures, educational programs, and other strategies to improve the quality of health care and decision-making related to the effectiveness and appropriateness of specific health care technologies and services. The evidence reports and technology assessments also may be used to inform coverage and reimbursement policies.

In addition to clinical and behavioral research, as the body of scientific studies related to the organization and financing of health care expands, systematic review and analyses of these studies can provide health system organizations with a scientific foundation for developing system-wide policies and practices. These reports may address and evaluate topics such as risk adjustment methodologies, market performance measures, provider payment mechanisms, and insurance purchasing tools, as well as provider integration of new scientific findings regarding health care and delivery innovations. To review topics that have been assigned to the EPCs between FY 1997 and FY 2002, visit AHRQ's Web site at http://www.ahrq.gov/​clinic/​epc#centers.

3. Evidence-based Practice Centers (EPCs)

The EPCs prepare evidence reports and technology assessments on topics for which there is significant demand for information by health care providers, insurers, purchasers, health-related societies, and patient advocacy organizations. Such topics may include the prevention, diagnosis and/or treatment of particular clinical and behavioral conditions, use of alternative or complementary therapies, and appropriate use of commonly provided services, procedures, or technologies. Topics also may include issues related to the organization and financing of care. AHRQ widely disseminates the EPC evidence reports and technology assessments, both electronically and in print. The EPC evidence reports and technology assessments do not include clinical recommendations or recommendations on reimbursement and coverage policies.

4. Role/Responsibilities of Partners

Nominators of topics selected for development of an EPC evidence report or technology assessment assume the role of Partners to AHRQ and the EPCs, with defined roles and responsibilities. AHRQ places high value on these relationships, and plans to review Partners' past performance of these responsibilities at such time in subsequent years when AHRQ is considering whether to accept additional topics nominated by an organization. Specifically, Partners are expected to serve as resources to EPCs as they develop the evidence reports and technology assessments related to their nominated topic; serve as members of external peer reviewers of relevant draft evidence report and assessment; and commit to (a) timely translation of the EPC reports and assessments into their own quality improvement tools (e.g., clinical practice guidelines, performance measures), educational programs, and reimbursement policies; and (b) dissemination of these derivative products to their membership. AHRQ also is interested in members' use of these derivative products and the products' impact on enhanced healthcare. AHRQ will look to the Partners to provide these use and impact data on products that are based on EPC evidence reports and technology assessments.

The AHRQ will review topic nominations and supporting information and determine final topics, seeking additional information as appropriate. AHRQ is very interested in receiving topic nominations from professional societies and organizations comprised of members of minority populations, as well as nomination of topics that have significant impact on the health status of women, children, ethnic and racial populations.

5. Topic Nomination and Selection Process

The processes that AHRQ employs to select topics nominated for analyses by the EPCs is described below. Section A addresses AHRQ's nomination process and selection criteria for clinical and behavioral topics. Section B addresses AHRQ's nomination process and selection criteria for organization and financing topics.

Section A: Clinical and Behavioral Topics

(a) Nomination Process for Clinical and Behavioral Topics

Nominations of clinical and behavioral topics for AHRQ evidence reports and technology assessments should focus on specific aspects of prevention, diagnosis, treatment and/or management of a particular condition, or on an individual procedure, treatment, or technoloy. Potential topics should be carefully defined and circumscribed so that the relevant published literature and other databases can be searched, evidence systematically reviewed, supplemental analyses performed, draft reports and assessments circulated for external peer review, and final evidence reports or technology assessments produced. Some reports and assessments can be completed within six months, if there is a small volume of literature to be systematically reviewed and analyzed. Other evidence reports and technolgy assessments may require up to 12 months for completion due to complexity of the topic, the volume of literature to be searched, abstracted, and analyzed, and completion of the external peer review process. Topics selected will not duplicate current and widely available research syntheses, unless new evidence is available that suggests the need for revisions or updates.

For each topic, the nominating organization must provide the following information: (a) Rationale and supporting evidence on the clinical relevance and importance of the topic; and (b) plans for rapid translation of the evidence reports and technology assessments into clinical guidelines, performance measures, educational programs, or other strategies for strengthening the quality of health care services, or plans to inform development of reimbursement or coverage policies; (c) plans for dissemination of these derivative products to their membership; (d) process by which the nominating organization will measure the use of these products by their members, and impact of such use; and (e) process by which the organization will measure the impact of such use.

Specifically, nomination information should include:

• Defined condition and target population.
• Three to five very focused questions to be answered.
• Incidence or prevalence, and indication of the disease burden (e.g., mortality, morbidity, functional impairment) in the U.S. general population or in subpopulations (e.g., Medicare and Medicaid populations). For prevalence, the number of cases in the U.S. and the number of affected persons per 1,000 persons in the general U.S. population should be provided. For incidence, the number of new cases per 100,000 a year should be provided.
• Costs associated with the clinical or behavioral condition, including average reimbursed amounts for diagnostic and therapeutic interventions (e.g., average U.S. costs and number of persons who receive care for diagnosis or treatment in a year, citing ICD9-CM and CPT codes, if possible).
• Impact potential of the evidence report or technology assessment to decrease health care costs or to improve health status or clinical outcomes.
• Availability of scientific data and bibliographies of studies on the topic.
• References to significant differences in practice patterns and/or results; alternative therapies and controversies.
• Plans of the nominating organization to incorporate the report into its managerial or policy decision making (i.e., rapid translation of the report or assessment into derivative products such as clinical practice guidelines or other quality improvement tools, or to inform reimbursement or coverage policies about a particular technology or service).
• Plans of the nominating organization for dissemination of these derivative products to its membership.
• Process by which the nominating organization will measure members' use of the derivative products.
• Process by which the nominating organization will measure the impact of such use on clinical practice.

(b) Selection Criteria for Clinical and Behavioral Topics

Factors that will be considered in the selection of clinical and behavioral topics for AHRQ evidence report and technology assessment topics include: (1) High incidence or prevalence in the general population and in special populations, including women, racial and ethnic minorities, pediatric and elderly populations, and those of low socioeconomic status; (2) significance for the needs of the Medicare, Medicaid and other Federal health programs; (3) high costs associated with a condition, procedure, treatment, or technology, whether due to the number of people needing care, high unit cost of care, or high indirect costs; (4) controversy or uncertainty about the effectiveness or relative effectiveness of available clinical strategies or technologies; (5) impact potential for informing and improving patient or provider decision making; (6) impact potential for reducing clinically significant variations in the prevention, diagnosis, treatment, or management of a disease or condition, or in the use of a procedure or technology, or in the health outcomes achieved; (7) availability of scientific data to support the systematic review and analysis of the topic; (8) submission of nominating organization's plan to incorporate the report into its managerial or policy decision making, as defined above; (9) submission of nominating organization's plan to disseminate derivative products to its members; and (10) submission of nominating organization's plan to measure members' use of these products, and the resultant impact of these products on clinical practice.

Section B: Organization and Financing Topics

(a) Nomination Process for Organization and Financing Topics

Nominations of organization and financing topics for AHRQ evidence reports should focus on specific aspects of health care organization and finance. Topics should be carefully defined and circumscribed so that relevant databases may be searched, the evidence systematically reviewed, supplemental analyses performed, draft reports circulated for external peer review, and final evidence reports produced. Reports can be completed within six months if there is a small volume of literature for systematic review and analysis. Some evidence reports may require up to 12 months for completion due to the complexity of the topic and the volume of literature to be searched, abstracted, and analyzed. Topics selected will not duplicate current and widely available research syntheses, unless new evidence is available that suggests the need for revisions or updates.

For each topics, nominators should provide a rationale and supporting evidence on the importance and relevance of the topic. Nominators must also state their plans for use of the evidence report and indicate how the report could be used by public and private decision makers. Nomination information should include:

• Defined organizational/financial arrangement or structure impacting quality, outcomes, cost, access or use.
• Three to five focused questions to be answered.
• If appropriate, description of how the organizational/financial arrangement or structure is particularly relevant to delivery of care for specific vulnerable populations (e.g., children, persons with chronic disease) or certain communities (e.g., rural markets)
• Costs potentially affected by the organizational/financial arrangement, to the extent they can be quantified.
• Impact potential of the evidence report to decrease health care costs or to improve health status or outcomes.
• Availability of scientific and/or administrative data and bibliographies of studies on the topic.
• References to significant variation in delivery and financing patterns and/or results, and related controversies.
• Nominator's plan for use of an evidence report on this topic.
• Nominator's plan for measuring the impact of the report on organizational, financial, or delivery practices.

(b) Selection Criteria for Organization and Financing Topics

Factors that will be considered in the selection of topics related to the organization and financing of care include the following: (1) uncertainty about the impact of the subject organizational or financing strategy; (2) potential for the subject organizational or financing strategy or the proposed research synthesis to significantly impact aggregate health care costs; (3) policy-relevant to Medicare, Medicaid, and/or other Federal and State health programs; (4) relevant to vulnerable populations, including racial and ethnic minorities, and particular communities, such as rural markets; (5) available scientific data to support systematic review and analysis of the topic; (6) plans of the nominating organization to incorporate the report into its managerial or policy decision-making; and (7) plans by the nominating organization to measure the impact of the report on practice.

Dated: January 15, 2003.

Carolyn M. Clancy,

Acting Director.