[Federal Register Volume 61, Number 103 (Tuesday, May 28, 1996)]
[Notices]
[Pages 26519-26520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13195]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Health Care Policy and Research
Nominations of Outcomes and Effectiveness Research Priority
Topics
The Agency for Health Care Policy and Research (AHCPR) is inviting
suggestions for priority topics for research related to prevention,
diagnosis, treatment and/or management of common diseases and clinical
conditions. These suggestions will be considered in AHCPR's plans for
future research on the outcomes and effectiveness of health care
services. The process AHCPR will employ in establishing priorities and
selecting topics for outcomes/effectiveness research is described
below.
Background
AHCPR is charged under Title IX of the Public Health Service Act
(42 U.S.C. 299-299c-6) with enhancing the quality, appropriateness, and
effectiveness of health care services and access to such services.
AHCPR accomplishes these goals through scientific research that
promotes improvements in clinical practice (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 U.S.C. 1320b-12) enhances and
elaborates on AHCPR's program of outcomes and effectiveness research.
Outcomes of care and effectiveness research constitutes a major portion
of AHCPR's health services research agenda.
Outcomes and Effectiveness Research Program
The outcomes and effectiveness research program grew out of
awareness of significant unexplained variations in clinical (medical,
nursing, and allied health) 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 multidisciplinary nature; use of a variety of
research designs (e.g., observational studies, prospective trails,
database 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.
To date, AHCPR's outcomes and effectiveness research has focused on
conditions that meet the following criteria:
High incidence or prevalence in the general population or
in major population subgroups, as defined by age, gender, or ethnicity;
Controversy or uncertainty about the effectiveness and
relative effectiveness of available clinical strategies;
High cost, whether due to the number of people needing
care, high unit cost of care, or high indirect costs;
Needs, of the Medicare and Medicaid programs; and
Data available, or readily developed.
In addition, all outcomes and effectiveness research is expected to
be:
Generalizable: Outcomes and effectiveness research is
concerned with the outcomes that can be expected in typical patients,
receiving care in typical clinical situations, not with outcomes that
can be achieved only in selected patients and in controlled clinical
situations. Thus, critical features of all outcomes and effectiveness
research projects are that the questions have broad applicability and
the research designs support wide generalizability of findings.
Pragmatic: Outcomes and effectiveness research projects
address questions that have high clinical and policy significance and
are designed with attention to the eventual implementation of findings.
They strengthen the science base in ways that can directly contribute
to improved patient outcomes and decisionmanking processes (including
practice guidelines), and to a more equitable and cost-effective health
care system. The usefulness of outcomes and effectiveness research
stems, in part, from the requirement that the clinical problems and
practices addressed are common and costly, and from attention to the
realities of clinical practice.
Patient-Centered: Outcomes and effectiveness research
evaluates health care in terms of outcomes that emphasize the patient's
experience and perspective. In addition to survival, morbidity, and
complications, outcomes and effectiveness studies consider patient-
reported symptom relief, functional capacity, quality of life,
satisfaction with care, and economic burden. Demographic, social and
cultural characteristics, as well as personal preferences, are
important independent variables.
Multidisciplinary: Outcomes and effectiveness research
requires theoretical and practical understanding of a wide range of
clinical and non-clinical variables that determine the structure,
processes, and outcomes of health care. Studies typically involve teams
of researchers who bring together the knowledge and methodological
expertise of both the clinical and social sciences, plus understanding
of the perspectives of patients, providers, and policymakers.
Since 1989, AHCPR has supported significant advances in medical
effectiveness research, especially through the set of special projects
known as Patient Outcomes Research Teams (PORTs). PORTs are large-
scale, 5-year studies designed to determine ``what works best'' in
clinical treatment for common diseases and conditions. PORTs have
succeeded in (1) documenting the scientific basis for many common
clinical practices, (2) demonstrating the relative benefits of
different interventions, and (3) identifying areas for further
research. The following clinical conditions addressed by the AHCPR PORT
program meet the criteria of being common, costly, and feasible to
study:
Acute Myocardial Infarction
Ischemic Heart Disease
Low Back Pain
Total Knee Replacement
Hip Fracture and Osteoarthritis
Low Birth Weight Prevention
Cataract
Community-Acquired Pneumonia
Childbirth
Schizophrenia
Stroke Prevention
Type II Diabetes
Biliary Tract Disease
Prostrate Disease
In July 1993, AHCPR introduced a new generation of PORT research,
known as PORT II. A program announcement inviting applications for PORT
IIs was published in the May 13, 1994 ``NIH Guide for Grant and
[[Page 26520]]
Contracts,'' Vol. 23, No. 18. Like the original PORTs, PORT IIs are
pragmatic, methodologically sophisticated, multidisciplinary projects
that focus on patient outcomes for common clinical problems. They
differ from the original PORTs by their individualized research
strategies and are also distinguished by their expected impact on
clinical practice, patient outcomes, and health care policy. PORT IIs
focus on the establishment of direct linkages between practice and
outcomes and on research methods that facilitate direct comparisons of
two or more distinct clinical strategies. Clinical conditions addressed
to date by the AHCPR PORT II program include:
Localized Breast Cancer
Cardiac Arrhythmia
End-stage Renal Disease
Depression
Prostate Disease
Infant Dehydration
Cataract: Preoperative Testing
Pelvic Inflammatory Disease
In addition to PORTs and PORT IIs, AHCPR has funded approximately
130 other outcomes and effectiveness research clinical studies. For
clinical subjects as diverse as AIDS, dental disease, emergency
medicine, and cancer, these studies document patterns of practice,
describe the natural history of diseases, synthesize the evidence for
various clinical strategies, or answer relatively discrete
effectiveness questions. Major ongoing program areas focus on
pharmaceutical therapy, minority health, and primary care.
AHCPR Process for Determining Priority Topics
Topic selection for the original PORT projects was guided by work
of the Institute of Medicine (IOM) which was described in the 1990 IOM
publication entitled ``National Priorities for the Assessment of
Clinical Conditions and Medical Technologies.'' A new process to
identify priorities for future outcomes research was discussed at a
November, 1995 expert panel meeting. During this meeting, the AHCPR
conferred with health services and effectiveness experts, representing
multiple disciplines, specialties, and institutions. Alternative
approaches for prioritizing topic areas and identification of
populations whose major health conditions have not yet been adequately
addressed (e.g., young children, the very elderly, women, and ethnic
minorities) were considered.
Based on the IOM work and expert discussions, AHCPR has initiated a
three stage process for identifying topics:
1. Develop a preliminary list of priority topics and reasons for
importance, representing the views of health care providers, insurers,
medical and health specialty societies, consumers, and the general
public;
2. Convene an expert panel to review and assess the preliminary
research priorities and suggested criteria; and
3. Identify which topic areas can be most appropriately addressed
using outcomes and effectiveness research methods.
This Notice initiates the first step, that is, a solicitation of
topics from health care providers, insurers, health-related societies,
consumers, and the public. Written suggestions for research topics that
fit within the parameters of AHCPR's outcomes and effectiveness
research program are invited.
For each suggestion, the nominee should provide a clear rationale
and supporting evidence for the topic's importance and clinical
relevance. Responses should be submitted by July 29, 1996 to: Carolyn
Clancy, M.D., Acting Director, Center for Outcomes and Effectiveness
Research, Agency for Health Care Policy and Research, Suite 605, 2101
East Jefferson Street, Rockville, Maryland 20852. All responses will be
available for public inspection at the Center for Outcomes and
Effectiveness Research, Telephone (301) 594-1485, weekdays between 8:30
a.m. and 5 p.m. The AHCPR will not reply to individual responses, but
will consider all submissions in developing the research priorities.
For further information on the outcomes and effectiveness research
program, contact: Carolyn Clancy, M.D., Acting Director, Center for
Outcomes and Effectiveness Research, Agency for Health Care Policy and
Research, Suite 605, 2101 East Jefferson Street, Rockville, Maryland
20852; Telephone (301) 594-1485.
Dated: May 16, 1996.
Clifton R. Gaus,
Administrator.
[FR Doc. 96-13195 Filed 5-24-96; 8:45 am]
BILLING CODE 4160-90-M
