Federal Register / Vol. 61, No. 103 / Tuesday, May 28, 1996 / Notices 26519

Board of Governors of the Federal Reserve

System, May 21, 1996.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 96–13229 Filed 5–24–96; 8:45 am]

BILLING CODE 6210–01–F

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 nonclinical 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
26520 Federal Register / Vol. 61, No. 103 / Tuesday, May 28, 1996 / Notices

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

Centers for Disease Control and

Prevention

[ANNOUNCEMENT 648]

National Institute for Occupational

Safety and Health; Fatality Surveillance

and Field Investigations at the State

Level Using the NIOSH Fatality

Assessment and Control Evaluation

(FACE) Model

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for cooperative agreements to

build State capacity for conducting

traumatic occupational fatality

surveillance, investigation, and

intervention activities through the

National Institute for Occupational

Safety and Health (NIOSH) Fatality

Assessment and Control Evaluation

(FACE) Model.

The CDC is committed to achieving

the health promotion and disease

prevention objectives of Healthy People

2000, a national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority areas of

Occupational Safety and Health, and

Surveillance and Data Systems. (To

order a copy of Healthy People 2000, see

the section Where to Obtain Additional

Information.)

Authority

This program is authorized under

section 20(a) of the Occupational Safety

and Health Act of 1970 (29 U.S.C.

669(a)) and sections 301 (42 U.S.C. 241)

and 317 (42 U.S.C. 247b) of the Public

Health Service Act, as amended.

Smoke-Free Workplace

The CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the nonuse of

all tobacco products, and Public Law

103–227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicants

Eligible applicants are State

Departments of Health, Departments of

Labor, Departments of Industry, etc.,

located within any State or territory of

the United States. Program activities,

however, may not be carried out by

departmental divisions that are

responsible for enforcement of

occupational safety and health

standards. Awards will be limited to