Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Agency for Healthcare Research and Quality

# AGENCY:

Agency for Healthcare Research and Quality (AHRQ), DHHS.

# ACTION:

Notice.

# SUMMARY:

AHRQ is exploring the feasibility of leading a significant research initiative (Initiative) that will examine the relationships between care management processes (including health systems and clinical care) and children's health outcomes to produce information that can be incorporated into practice and policy. Consistent with research previously funded by AHRQ, outcomes are defined as important dimensions of health attributable to health care, including health perceptions, ability to function, and satisfaction with care. Interventions of interest are broadly defined to include both clinical interventions, organizational characteristics and strategies, and the intersection or combination of both. The purpose of this announcement is to solicit broad input from clinical and social scientists, researchers, clinicians, health systems leaders and others regarding priorities for focusing the Initiative. Recommendations received will be compiled and discussed at an expert meeting convened to discuss the initiative and plan a possible research strategy. This request for suggestions and the expert meeting are preparatory steps of the Initiative, which may lead to a study (or family of studies) commencing in FY 2002.

## Nature of Recommendations

AHRQ requests written suggestions as to the priority issues in children's health care that the Initiative should address. Issues should be considered priorities because their impact has not been adequately studied in other research or because their impact can only be evaluated in a large study such as this. Supporting rationale and suggestions for research strategies should be included. Suggestions should address one or more of the following categories:
      -  Age of population to be studied:                          Child health includes the health care needs of infants, preschoolers, school-age children, and adolescents. Since their needs vary, should the Initiative focus on a particular group or the entire spectrum?                    
      -  General population or priority populations to be studied:                          Should the Initiative focus exclusively on the needs of priority populations (as defined by AHRQ: racial and ethnic minorities, low-income populations, people living in rural areas and inner-city, and people living with chronic illnesses and/or disabilities), the needs of children insured through public programs, or the general pediatric population?                    
      -  General health or tracer conditions to be studied:                          One approach used to assess care management in adult populations has involved the use of selected “tracer” or sentinel conditions (                         e.g.,                          diabetes) to derive inferences about overall health system performance. (Kessner DM, Kalk CE, Singer J. Assessing health quality—the case for tracers. The New England Journal of Medicine. 1973;288(4): 189-194.) This strategy may or may not be suitable for children. AHRQ seeks input on the question: Should general health or tracer conditions be used to evaluate the health care organization's impact on child health status? If tracer conditions should be the focus, which conditions (physical, mental or behavioral) should be examined? Examples of experience from research or clinical improvement programs would be particularly helpful.                    
      -  Structures of the health care system to be studied:                          What organizational and delivery components of typical child health care settings and characteristics should be examined for their impact on children's health outcomes? Beyond the evolution of managed care arrangements, there is far less understood about practice settings likely to influence the content of care.                    
      -  Clinical processes of care:                          An important challenge for this Initiative is establishing priorities for clinical conditions or interventions to be assessed. When assessing clinical processes of care, should the focusing theme be “tracer” conditions (                         e.g.,                          acute or chronic medical conditions, behavior problems, risk factors for adult disease, etc.) and the clinical processes that effect theses conditions, or should the focusing theme be generic clinical processes (                         e.g.,                          anticipatory guidance, specialty care, pediatric rehabilitation, etc.) and their impact on broader health outcomes, or should it be a combination of the two? Criteria for selecting priority topics would also be most welcomed. For example, conditions for which current evidence is exceeded by increasing need (                         e.g.,                          obesity) are of particular interest, as are clinical processes that are broadly applied but for which there is little evidence (                         e.g.,                          anticipatory guidance), as well as conditions relevant to children with special health care needs, such as rehabilitative services.                    
      -  Outcomes to be measured:                          What might be the most salient child health outcomes, long and short term, for which it would be important to elucidate the relationship with the structures and processes of health care under study?                    
      -  Methodologic issues:                          There are a number of study designs that are potentially suitable for this effort, including a multi-center study with a single protocol and coordinating center; centers of excellence with specific themes; a follow-back component added to an existing data collection effort; or focused individual projects that include common outcome measures and design features but allow local flexibility. Comments on the relative advantages or disadvantages to these approaches, or other designs, are also most welcomed.                    
      - Other issues in child health care that do not fit into the categories above.

# DATES:

Submit comments on or before March 26, 2001.

# ADDRESSES:

                        Submissions should be brief (no more than three pages per recommendation) and may be in the form of a letter or e-mail, preferably with an electronic file in a standard word processing format on 3                        1/2                         floppy disk or as an attachment. Responses to this request should be submitted to: Howard Bauchner, MD, Scholar in Residence, Agency for Healthcare Research and Quality, 6010 Executive Boulevard, Suite 201, Rockville, MD                               ( print page 11297)                            20852, Phone: 301/594-5420, Email address: HBauchne@AHRQ.gov.                    

In order to facilitate the handling of submissions, please include full information about the person submitting the recommendation: (a) Name, (b) title, (c) organization, (d) mailing address, (e) telephone number, and (f) e-mail address. Please do not use acronyms. Electronic submissions are encouraged to HBauchne@AHRQ.gov.

# FOR FURTHER INFORMATION CONTACT:

Howard Bauchner (301) 594-5420. All responses will be available for public inspection at AHRQ's Center for Outcomes and Effectiveness Research weekdays between 8:30 a.m. and 5 p.m. Arrangements for reviewing the submissions may be made by calling (301) 594-5420.

# SUPPLEMENTARY INFORMATION:

## Background

Under authorization of Title IX of the Public Health Service Act (42 U.S.C. 299-299c-7) as amended by Public Law 106-129 (1999), the Agency for Healthcare Research and Quality (formerly the Agency for Health Care Policy and Research) 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; promotion of improvements in clinical and health systems practices including the prevention of diseases and other health conditions; and improvements in the organization, financing and delivery of health care services. Section 1142 of the Social Security Act (42 USC 1320b-12) enhances and elaborates on AHRQ's program of outcomes and effectiveness research which constitutes a major portion of AHRQ's health services research agenda.

This Initiative would combine AHRQ's commitment to health services research on one of its priority populations: children, and two of its strategic goals: to support improvements in health outcomes and identify strategies to improve access, foster appropriate use, and reduce unnecessary expenditures.

## Priority Populations

AHRQ has made a commitment to focus its health services research on certain priority populations: racial and ethnic minorities, women, children, the elderly, low-income populations, people living in rural areas and inner-city, and people living with chronic illnesses and/or disabilities. These are all groups for whom public policy struggles to find effective solutions to improve health care. Health services research has consistently documented the persistent, and at times great, disparities in health status and access to appropriate health care services for certain groups, notably racial and ethnic minorities and low income families and children. Despite the dramatic changes occurring in the organization and financing of children's health services, the knowledge base for guiding these changes or assessing their impact is less well developed than that for adults. Health care issues that exist for people with chronic illnesses and disabilities also require attention. Health services research should do a better job of bringing science-based information to bear on these disparities so that the health of these groups is enhanced.

## Strategic Goals

AHRQ has enunciated three strategic goals which will contribute to improving the quality of health care for all Americans. These goals are to (1) support improvements in health outcomes; (2) strengthen quality measurement and improvement; and (3) identify strategies to improve access, foster appropriate use, and reduce unnecessary expenditures. This Initiative would focus on the first and third.

### (1) Support Improvements in Health Outcomes

The field of health outcomes research studies the end results of the structure and processes of health care on the health and well-being of patients and populations. (Institute of Medicine, 1996.) A unique characteristic of this research is the incorporation of the consumer's or patient's perspective in the assessment of effectiveness. Policymakers in the public and private sectors are also concerned with the end results of their investments in health care, whether at the individual, community, or population level.

A high priority for AHRQ's outcomes research will be conditions that are common, expensive, and/or for which significant variations in subpopulations, practice or opportunities for improvement have been demonstrated. Also of importance for research will be the type of delivery system or processes by which care is provided and their effects on outcomes, as well as, research on clinical preventive services that lead to the prevention of premature death and disability in the United States.

                    The outcomes and effectiveness research program grew out of the awareness of significant unexplained variations in clinical practice and the inadequacy of scientific evidence to support many common treatments and procedures. Outcomes and effectiveness research encompasses three main areas of emphasis for the prevention, diagnosis, treatment, and management of illness: (1) Determination of the clinical interventions that are most effective, cost effective, and appropriate; (2) development of methods and data to advance effectiveness research; and (3) dissemination and evaluation of the impact of research findings on clinical practice and outcomes. Other distinctive characteristics of outcomes and effectiveness research include its multi-disciplinary nature; use of a variety of research designs (                    *e.g.,*                     observational studies, prospective trials, databases studies) and analytical methods (                    *e.g.,*                     decision analysis, utility analysis, and cost-effectiveness analysis); incorporation of both objective and subjective measures of outcomes; and emphasis on policy relevance.                

### (3) Identify Strategies To Improve Access, Foster Appropriate Use, and Reduce Unnecessary Expenditures.

Adequate access to health care services continues to be a challenge for many Americans. This is particularly so for the poor, the uninsured, members of minority groups, rural residents, and other vulnerable populations. In addition, the changing organization and financing of care has raised new questions about access to a range of health services, including emergency and specialty care. At the same time, examples of inappropriate use of care, including overutilization and misuse of services, continue to be documented.

The increasing portion of our Nation's resources devoted to health care expenditures remains a concern, with some indicators suggesting that the rate of increase may accelerate once again. The continued growth in public spending for Medicare and Medicaid, in particular, raises important questions about the care delivered to the elderly, poor, and people with disabilities. Together, these factors require concerted attention to the determinants of access, use, and expenditures as well as effective strategies to improve access, contain costs, and assure appropriate and timely use of effective services.

Dated: February 15, 2001.

John M. Eisenberg,

Director.

[FR Doc. 01-4530  Filed 2-22-01; 8:45 am]

BILLING CODE 4160-90-M