Process for Determining Need for Updates of Clinical Practice Guidelines

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Health Care Policy and Research

Process for Determining Need for Updates of Clinical Practice

Guidelines

The Agency for Health Care Policy and Research (AHCPR) announces a

process for determining when updates are needed of AHCPR-supported

clinical practice guidelines. The process consists of obtaining

information about new scientific evidence or new technologies,

soliciting opinions from the public, and convening a public meeting to

receive relevant information. Comments on the process are invited.

Background

The Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239)

added a new Title IX to the Public Health Service Act (the Act), which

established the Agency for Health Care Policy and Research (AHCPR) to

enhance the quality, appropriateness, and effectiveness of health care

services, and access to such services. (See 42 U.S.C. 299-299c-6 and

1320b-12.) The Agency for Health Care Policy and Research

Reauthorization Act of 1992 (Pub. L. 102-410), enacted on October 13,

1992, extended the authorization of AHCPR and amended certain

provisions related to the development of clinical practice guidelines.

In keeping with its legislative mandates, AHCPR, through the Office of

the Forum for Quality and Effectiveness in Health Care (Forum),

arranges for the development, periodic review, and updating of

clinically relevant guidelines that may be used by physicians, other

health care practitioners, educators, and consumers to assist in

determining how diseases, disorders, and other health conditions can

most effectively and appropriately be prevented, diagnosed, treated,

and clinically managed. The AHCPR also supports development, periodic

review, and updating of medical review criteria, standards of quality,

and performance measures, based on the guidelines.

Section 912 of the Act (42 U.S.C. 299b-1(b)), as amended by Public

Law 102-410, requires that the guidelines:

1. Be based on the best available research and professional

judgment;

2. Be presented in formats appropriate for use by physicians, other

health care practitioners, medical educators, medical review

organizations, and consumers;

3. Be presented in treatment-specific or condition specific forms

appropriate for use in clinical practice, educational programs, and

reviewing quality and appropriateness of medical care;

4. Include information on the risks and benefits of alternative

strategies for prevention, diagnosis, treatment, and management of the

particular health condition(s); and

5. Include information on the costs of alternative strategies for

prevention, diagnosis, treatment, and management of the particular

health condition(s), where cost information is available and reliable.

Section 913 of the Act (42 U.S.C. 299b-2) describes two mechanisms

through which AHCPR may arrange for development of guidelines:

1. Panels of qualified private sector experts and health care

consumers may be established; and

2. Contracts may be awarded to public and private nonprofit

organizations. Guideline contractors are assisted by panels of private

sector experts and health care consumers approved by AHCPR.

Section 914(a) of the Act (42 U.S.C. 299b-3(a)), as amended by

Public Law 102-410, identifies factors to be considered in establishing

priorities for guideline topics, including the extent to which the

guidelines would:

1. Improve methods for disease prevention;

2. Improve methods of diagnosis, treatment, and clinical management

for the benefit of a significant number of individuals;

3. Reduce clinically significant variations among clinicians in the

particular services and procedures utilized in making diagnoses and

providing treatments; and

4. Reduce clinically significant variations in the outcomes of

health care services and procedures.

Also, in accordance with Title IX of the PHS Act and section 1142

of the Social Security Act, the AHCPR Administrator is to assure that

the needs and priorities of the Medicare program are reflected

appropriately in the priorities for development of guidelines.

Clinical Practice Guidelines Released and Under Development

The following AHCPR-supported guidelines have been released and

disseminated widely:

1. Acute Pain Management: Operative or Medical Procedures and Trauma

2. Urinary Incontinence in Adults

3. Pressure Ulcers in Adults: Prediction and Prevention

4. Cataract in Adults: Management of Functional Impairment

5. Depression in Primary Care: Volume I: Detection and Diagnosis, and

Volume II: Treatment of Major Depression

6. Sickle Cell Disease: Screening, Diagnosis, Management, and

Counseling in Newborns and Infants

7. Evaluation and Management of Early HIV Infection

8. Benign Prostatic Hyperplasia: Diagnosis and Treatment

9. Management of Cancer Pain

10. Unstable Angina: Diagnosis and Management

The following AHCPR-supported guidelines are under development:

1. Treatment of Pressure Ulcers in Adults

2. Acute Low Back Problems in Adults

3. Quality Determinants of Mammography

4. Recognition and Initial Assessment of Alzheimer's and Related

Dementias

5. Diagnosis and Treatment of Anxiety and Panic Disorders

6. Smoking Prevention and Cessation

7. Otitis Media with Effusion in Young Children

8. Heart Failure: Evaluation and Care of Patients with Left

Ventricular Systolic Dysfunction

9. Post Stroke Rehabilitation

10. Cardiac Rehabilitation

The following guidelines are currently being reviewed and updated

by private sector panels of experts and consumers.

1. Urinary Incontinence in Adults

2. Acute Pain Management: Operative or Medical Procedures and Trauma

Process for Determining Need for Guideline Updates

Information regarding the need for a guideline update will be

obtained from several sources.

1. Not later than 24 months following the release of an AHCPR-

supported guideline, the Office of the Forum will arrange for a survey

of subsequently published scientific literature in the topic areas

addressed by the guideline. The purpose of this survey is to determine

the volume of new scientific evidence, its quality, and the likelihood

that such information would cause a change in the guideline's

recommendations.

2. The AHCPR is required by section 914(a) (42 U.S.C. 299b-3(a)) to

publish annually in the Federal Register a list of guideline topics

under consideration for development. This annual notice will also

include a listing of those guidelines which have been published by

AHCPR and for which updates are being contemplated. Comments will be

solicited from the public regarding the availability of new scientific

evidence or new technologies that may warrant the updating of a

clinical practice guideline.

3. Other information relevant to the updating of guidelines may be

obtained from evaluation studies conducted to examine the

implementation or effects of the guidelines; from development and use

of guideline-derived medical review criteria, performance measures, and

standards of quality; or from other related activities.

4. When sufficient data are obtained from the above sources to

indicate that a guideline update may be needed, a public meeting to

address the need for and timing of an update will be convened. This

meeting will provide an opportunity for interested parties to

contribute relevant information and comments, including new scientific

evidence not available at the time the guideline was written.

The Office of the Forum will review all the information and

scientific evidence obtained in steps 1 through 4 above. When the need

for a guideline update has been established, the Forum will recommend

the update and the timing of the update to the AHCPR Administrator.

Following administrative approval, and as allowed by available

resources, AHCPR will arrange for the development of the guideline

update by a panel of private sector experts and consumers or a

contractor assisted by such a panel.

Request for Comments

Written comments on the process are invited. The AHCPR will not

respond to individual comments, but will consider all comments in

determining future modifications to the guideline update process.

Comments, in writing, should be submitted by June 24, 1994, to: Linda

K. Demlo, Ph.D., Director, Office of Program Development, AHCPR, suite

603, 2101 East Jefferson Street, Rockville, Maryland 20852. All

comments will be available for public inspection at the Office of

Program Development, telephone (301) 594-1457, weekdays between 8:30

a.m. and 5 p.m.

For Additional Information

Additional information on the guideline development process is

contained in the AHCPR Program Note, ``Clinical Practice Guideline

Development,'' dated August 1993. This document describes AHCPR's

activities with respect to clinical practice guidelines, including the

process and criteria for selecting panels. This document may be

obtained from the AHCPR Publications Clearinghouse, P.O. Box 8547,

Silver Spring, MD 20907; or call Toll-Free: 1-800-358-9295.

Also, information may be obtained by contacting Carole Hudgings,

Ph.D., Acting Director, Office of the Forum for Quality and

Effectiveness in Health Care, Agency for Health Care Policy and

Research, Willco Building, 6000 Executive Blvd, suite 310, Rockville,

MD. 20852.

Dated: April 18, 1994.

J. Jarrett Clinton,

Administrator.

[FR Doc. 94-9950 Filed 4-22-94; 8:45 am]

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