[Federal Register Volume 66, Number 37 (Friday, February 23, 2001)]
[Notices]
[Pages 11296-11297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4530]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Request for Planning Ideas for the Development of the Children's 
Health Outcomes Initiative

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

ACTION: Notice.

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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

[[Page 11297]]

20852, Phone: 301/594-5420, Email address: [email protected].
    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 [email protected].

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