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OCR for page 137
Profile of the Consensus Development
Program in the United States:
The National Institutes of Health Office
of Medical Applications of Research
Sharon R. Baratz
NATIONAL CONTEXT
Throughout the 1970s, the acceleration of technological innova-
tion in medicine, accompanied by rising costs and increased con-
ce~ns for the quality of care, generated extensive interest in tech-
nology assessment. Following the initiation of the Consensus De-
velopment Program in 1977, the Office of Medical Applications of
Research (OMAR) was formally established in the Office of the Di-
rector of the National Institutes of Health (NIH) in 1978. OMAR is
the focal point for activities to improve the assessment and transla-
tion of results from NIH-supported biomedical research into knowI-
edge that can be applied safely and effectively in the practice of
medicine and public health. OMAR is part of NIH, the primary
government-sponsored biomedical research facility in the United
States.
The principal vehicle for OMAR's efforts in me systematic as-
sessment of biomedical technologies is the Consensus Development
Program. Each consensus development conference is cosponsored
by OMAR and one or more of the NIH bureaus, institutes, or divi-
sions (BIDs). Other federal agencies with biomedical components
*The author acknowledges Jerry Elliott of OMAR, NIH, for reviewing the manu-
script.
137
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138
CONSENSUS DEVELOPMENT
may participate in the sponsorship of particular conferences, de-
pending on the topic (OMAR, NIH, 19X81. The approximate cost
per assessment for the OMAR conferences is $116,000 (Elliott, 19891.
The purpose of the conference is to "evaluate the available scientific
information on a biomedical technology and to produce a consensus
statement that advances understanding of the technology or issue in
question (assessment) and that will be useful to health professionals
and the public at large (transfer)" (OMAR, NIH, 1988~.
The three main goals of the consensus development program are
to:
· provide a setting for the evaluation and review of the scientific
soundness of health technologies for a particular clinical condition
or for a particular health-related technology, with emphasis on safety
and efficacy
· aid in the diffusion of knowledge of advances in biomedical
technology, through dissemination of the findings from the consen-
sus development process to physicians and consumers
· to facilitate the diffusion, adoption, and appropriate use of tech-
nologies found to be sound.
SCOPE OF THE PROGRAM
A broad variety of technologies have been topics of consensus
development conferences, including medical and dental drugs, de-
vices, procedures, facilities, and support systems used in prevention,
diagnosis, and treatment. Conferences tend to focus on a technol-
ogy, for example, electroconvuisive therapy (1985) and magnetic
resonance imaging (1987), or on a particular clinical problem and
the alternative technologies applied for prevention, diagnosis, treat-
ment, or rehabilitation of these, for example, travelers' diarrhea (1985)
and adult urinary incontinence (1988~.
Although the consensus development program was to have origi-
naDy focused on emerging technologies, most of the conferences
have addressed technologies already in clinical use, especially new
or widely used technologies. This is largely because evaluative
information regarding many emerging technologies is insufficient
for the level of validity sought for consensus development confer-
ences and because many technologies already in widespread use have
OCR for page 139
UNITED SIATESNA770NALINSI771JTES OF HEALTH
139
not been carefully scrutinized for safety and efficacy (Perry and
Kalberer, 1980~. The Consensus Development Program at OMAR is
primarily concerned with the safety, efficacy, and clinical applica-
tion of technologies. Conferences do not usually directly address
social, ethical, legal, economic, or political issues surrounding tech-
nologies.
For the most part, the BIDs of NIH suggest consensus topics to
OMAR for consideration. Topics are considered from other sources,
including other Public Health Service agencies such as the Food and
Drug Administration, the U.S. Congress, or organizations outside of
government (Goodman, 1988~. The following criteria are currently
in use by OMAR for the selection of conference topics.
· The subject under consideration should have public health im-
portance. The topic should affect or have broad application to a
significant number of people.
· There should be controversy surrounding biomedical/scientific
aspects of the topic that would be clarified by the consensus ap-
proach or a gap between current knowledge and practice that a con-
ference might help to narrow.
· The topic must have an adequately defined and available base
of scientific information to answer the previously posed questions
and to resolve the controversies insofar as possible.
· The topic should be amenable to clarification on technical
grounds, and the outcome should not depend mainly on the impres-
sions or value judgments of panelists.
Additional elements desirable for positive consideration of a consen-
sus topic include health care cost impact, preventive impact, and
public interest (OMAR, NIH, 1988~. The topic selection process
may take from two months to a year or more.
FORMAT AND CONDUCT OF THE PROCESS
Once a topic is chosen, a senior OMAR staff person works with a
designated BID coordinator and other BID staff to organize the con-
ference. OMAR's focus is on the consensus development process
while the initiating BID's contribution concerns the scientific infor-
mation required for the conference topic (Elliott, 1989~. A planning
committee of OMAR staff, BID staff, the conference chairperson,
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140
CONSENSUS DEVELOPME:NT
and outside experts (who are not federal employees) begin to organ-
ize the conference. The program planning committee has four major
functions:
I. to draft consensus questions (usually four to six questions)
2. to draft the conference program
3. to recommend conference speakers
4. to recommend consensus panel members (OMAR, NIH, 198X).
The chairperson of the consensus development conference is se-
lected for his or her stature as a distinguished physician or scientist
and for personal skills in chairing the open symposium portion of
the conference and in leading the consensus panel. The size of the
panels has varied from g to 16 individuals; most have had l0 to 12
members. OMAR seeks balanced representation from various sec-
tors of professional and community life. The planning committee
usually decides upon the appropriate areas of expertise needed for
panelists of a particular conference. OMAR holds that all panelists,
including the chair, should have no vested interest in the assessment
topic and should be able to weigh evidence and to collaborate.
According to OMAR, panels should include individuals involved in
research in the field; health professionals who are users of the tech-
nology; methodologists or evaluators such as epidemiologists or
biostatisticians; and public representatives such as ethicists, law-
yers, theologians, economists, public interest groups or voluntary
health association representatives, consumers, and patients. Panel-
ists should be residents of the United States and should not be fed-
eral employees, to avoid the appearance of undue federal influence
(OMAR, NIH, 1988~. The planning committee also selects speakers
on the basis of their expertise and their ability to present evidence
on the safety, efficacy, effectiveness, and service requirements, as
appropriate, of the technology in question (Goodman, 19881. OMAR
recommends that the planning committee suggest speakers to pre-
sent opposing data and interpretations where controversy exists
(OMAR, NIH, 1988~.
The planning and implementation of a consensus development
conference usually involves 12-14 months of work after topic selec-
tion. Observers have noted that the consensus development confer-
ence borrows aspects from the scientific meeting, the judicial pro-
cess, and the town meeting (Iacoby and Rose, 1986; Mullan and
Jacoby, 1985~. Consensus development conferences are open meet-
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UNITED SIATE:5 NATIONAL INSrl71~ES OF HEALTH
141
ings to which members of the public and the medical community are
invited. The conference begins on a Sunday night with a closed
session of the conference panel. During this session, panelists meet
with OMAR staff to clarify questions about the consensus develop-
ment conference. Several months before the conference, panelists
divide into subcommittees to focus on particular consensus ques-
tions so that different pane! members are responsible for writing
specific portions of the consensus statement. All panelists remain
responsible for the statement as a whole and are to follow all presen-
tations and deliberations in the consensus development process.
Panelists may meet as subcommittees on Sunday night. The follow-
ing one and a half days are devoted to the plenary session for the
expert presentations (15-30 minutes each, interspersed with open
discussions involving speakers, panelists, and questions from the
audience).
In the evenings, the panel convenes to draft consensus answers to
the predetermined questions, considering the expert opinions of the
conference speakers and other views expressed at the meeting. The
panelists and chairperson for each conference decide on the rules
for consensus in the executive sessions. The consensus view of the
pane} is not necessarily that of all panelists. If a pane} cannot achieve
full agreement on a particular point, the consensus statement may
identify opposing or alternative opinions and/or majority-minority
viewpoints. Few conferences have produced minority statements.
The chair reads the consensus statement to the audience on the
morning of the third day for further comment and discussion among
the pane} and audience. The pane} may choose to revise the state-
ment based on comments received during this session. The confer-
ence concludes with a press conference.
z
DOCUMENTATION AND USE OF EVIDENCE IN
CONSENSUS DEVELOPMENT
Panelists receive abstracts of the speakers' presentations at least
one month in advance of the actual conference date, to prepare them
for the consensus development conference. Speakers are also asked
to bring photocopies of their slides to the consensus development
conference for panelists. The BID coordinator is responsible for the
supply of overview articles and other supplemental materials for the
panelists prior to the consensus development conference. The BID
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142
CONSENSUS DEVELOPMENT
coordinator meets with staff of We National Library of Medicine in
order to direct and detail the strategy for preconference information
retrieval. Panelists receive a copy of this literature search approxi-
mately three months prior to the actual conference. Speakers and
members of the audience receive conference matenals, including
speakers" presentation summaries, a conference agenda, and logisti-
cal information, at the first public meeting of the panel. The con-
sensus statement's validity rests in part upon Me scientific evidence
presented to the pane} for decision making.
In general, the evidence presented prior to and during the confer-
ence is not formally weighted for integration in the consensus devel-
opment process. A few conferences have employed decision-assist
models to help the pane} explore the implications of the data pre-
sented by speakers. The extent of the panelists t dependence upon
such models in decision making has varied among the conferences
(lacoby and Pauker, 1986~. Decision analysis may be used to pro-
vide a mode} of the sequence of potential strategies and outcomes
for the questions at hand. The data available are used to structure
the pathways in terms of probable occurrence and to compute utili-
ties for the alternative outcomes. Strategies may be tested under
different assumptions of risk and utility values. The decision-assist
models are intended to `'help structure complex alternatives in a
rational way [and to allow] the incorporation of expertise and infor-
mation from a variety of expert consultants without abdicating the
decision to any one of them" (McNeil and Pauker, 1984~.
There are no explicit rules for the consideration of evidence by
the panel. The panels for each conference decide upon the definition
of consensus. The chairperson directs and leads the discussion and
consideration of evidence in a format acceptable to the panel.
The final product of the consensus development process is the
consensus statement. Consensus statements do not cite articles used
as evidence. Each consensus statement contains a list of the mem-
bers of the program planning committee, the expert speakers, and
the panelists.
DISSEMINATION AND IMPACT
The OMAR Director of Communications and the BID Informa-
tion Officer develop a plan to announce the conference arid to dis-
seminate the consensus statements. Conferences usually receive
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UNITED SIATESNATlONAL INSrlTl~ES OF HEALTH
143
considerable attention from the medical media and general media at
the time of their occurrence. The plan may include a combination of
the following.
· The consensus statement is printed by OMAR and distributed
routinely to a variety of federal health agencies, health care organi-
zations, and the directors of continuing education of American Hos-
pital Association membership hospitals. Additionally, the consensus
statement is sent to targeted individuals and organizations specified
in the infonnation dissemination plan.
· The Journal of the American Medical Association routinely
publishes most of the consensus statements. Consensus statements
are also published by specialty journals in the topic area.
· OMAR places notices in numerous professional journals to
announce future conferences as well as the availability of consensus
statements.
· The publication of the consensus statement along with selected
papers from a CDC [consensus development conference] as a sym-
posium is also a possibility. Proceedings of several conferences have
been published in this manner either as supplements to specialty
journals or as a monograph.
· Summary videotapes and audiotapes of the conference may also
be prepared and distributed.
.
A summary of the statement is also prepared and sent to appro-
priate specialty journals (OMAN NIT 1988).
Two consensus development conferences, on prostate cancer (1987)
and urinary incontinence (1989~9 were televised live via satellite
throughout the nation.
The consensus development program at NIH has undergone for-
mal evaluation. The process continues to evolve in an attempt to
improve health care practices in the United States. The procedures
for conference planning, formulation of questions, and report dis-
semination have become more standardized, as have the formats for
conducting the conferences and the final consensus statements.
Winkler et al. (1986) studied the dissemination of consensus de-
velopment conference information in the popular press and concluded
that the reports of the NTH conferences appear to be factual and
balanced. Direct mailing seems to augment the success of informa-
tion transfer to targeted groups. A variety of sources is needed to
inform practitioners and the public (lacoby and Clark, 19861.
OCR for page 144
144
CONSENSUS DEVELOPMENT
OMAR conducted a survey to measure me effectiveness of two
conferences (computed tomography scan of the brain, 1981; hip-
joint replacement, 1982), as evidenced by the extent to which physi-
cians were aware of the conferences and the conclusions reached at
each one. The surveys determined that awareness varied greatly
among different specialties. The study concluded that there was
much room for improvement in information dissemination and that
it would be fruitful to examine physicians' information-seeking hab-
its, such as examining the role of opinion leaders, so as to better
design strategies that more effectively disseminate conference re-
sults (Iacoby, 1983~.
In another study by the RAND Corporation to evaluate the assess-
ment program, Kanouse et al. (1987) investigated the impact of the
consensus development conferences on physician awareness and
behavior. They found that efforts to reach the practicing community
can be improved. The consensus development program is more
successful at reaching specialists than generalists. In addition, phy-
sicians who frequently participate in continuing medical education
are more likely to have heard of consensus development conference
recommendations. The physicians surveyed knew more about the
content of specific consensus findings than about the program as a
whole and the consensus development conference process. The
physicians found information on clinical practice, in summary form
accompanied by evidence, to be most useful.
The group from the RAND Corporation also investigated medical
records in the state of Washington to determine whether the quality
of care improved with respect to 12 recommendations by four con-
sensus development conference panels. The results indicated that
the conferences did not affect clinical practice in the manner in-
tended. In some instances, physicians had adopted the consensus
recommendations on patterns of care before the conference or no
change was shown in comparisons of patterns before and after the
conference or other constraints determined clinicians' practices, such
as a lack of available resources (Kosecoff et al., 1987~.
In early 1990, the Institute of Medicine (IOM) completed an evalu-
ation of the NTH Consensus Development Program, conducted at the
request of NIH. Although not charged with evaluating the program's
dissemination activities and impact, the IOM did address program
purpose and scope, role and placement of the program within NIH,
aspects of the consensus development process, and financial support
for the program (Institute of Medicine, 1990~.
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UNITED STATES NATIONAL INSIlTUTES OF HEALTH
REFERENCES
145
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Representative terms from entire chapter:
development conference
