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Recommendations for
Program Structure
PURPOSE AND SCOPE OF THE PROGRAM
Scope of Topics as Defined by Program Purpose
The stated purpose of the NIH COP should be expanded to in-
clude issues related to the management of clinical conditions in
addition to the evaluation of specific biomedical technologies.
According to the OMAR pamphlet "Guidelines for the Selection
and Management of Consensus Development Conferences,', the NIH
consensus development conferences are organized to "produce Con-
sensus Statements on important and controversial topics in medi-
cine.t' However, He current OMAR guidelines proceed to describe
a more restrictive purpose for the NTH CDP:
The purpose of a Consensus Development Conference is to evaluate the avail-
able scientific information on a biomedical technology and to produce a Con-
sensus Statement that advances understanding of the technology or issue in
question ....
In practice, NTH consensus development conferences have addressed
the management of clinical conditions, as well as biomedical tech-
nologies. Examples of clinical conditions that have been addressed
by NTH consensus development conferences include osteoporosis
9
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10
CONSENSUS DEVELOPMENT AT THE NIH
(1984), neurofibromatosis (1987), and urinary incontinence (1988~.~
Accordingly, it would be appropriate to include reference to man-
agement of clinical conditions in the program's statement of pur-
pose.
Scope of Inquiry as Defined by Program Purpose
The scope of inquiry of the NIH CDP should be expanded. The
program should seek to ensure that relevant economic, social, and
ethical aspects of assessing biomedical technologies and manage-
ment of clinical problems are appropriately addressed as part of the
consensus process. OMAR should commit the necessary resources
to identify and, where appropriate, evaluate these aspects. Specifi-
cally, OMAR should do one or more of the following for each con-
ference topic: expand or modify the structure of consensus develop-
ment conferences (i.e., planning committee and conference pane]
membership, questions, speakers, and consensus statement) to ad-
dress these aspects of assessment; convene a second pane! to ad-
d~ress the relevant economic, social, and' ethical issues and prepare
a statement to be issued in conjunction with the consensus statement
on the biomedical aspects of a topic; anal request another appropri-
ate organization to prepare a statement that addresses these aspects
and to issue that statement in conjunction with the NIH CDP con-
sensus statement.
The scope of inquiry of the NIH CDP should reflect its role in
technology assessments and the intent that the program should have
an impact on health care practice. As a prominent program of health
technology assessment, the NTH CDP has the potential to influence
decisions about clinical practice, health technology acquisition and
use, insurance coverage and reimbursement, product development,
MA complete list of conference topics is provided in Appendix B.
The committee's definition of technology assessment is consistent with the defi-
nition outlined by IOM; that is, medical technology assessment is "any process of
examining and reporting properties of a medical technology used in health care,
such as safety, efficacy, feasibility, and indications for use, cost, and cost-effective-
ness, as well as social, economic, and ethical consequences, whether intended or
unintended" (IOM, 1985~.
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RECOMMENDATIONS FOR PROGRAM SIRUCI URE
11
and public health policies. As noted in the recent RAND Corpora-
tion study of the program's impact on medical practice,
The COP is more than an assessment program. It is also a communication
program to the professional community and the public. It aims to disseminate
the results to health care professionals (as well as researchers) throughout the
county in order to improve the state of professional practice. The expecta-
tion is that once physicians and other relevant health care professional person-
nel know the expert consensus about a particular medical procedure, device,
or condition, they will change their practice to conform to the consensually
validated recommendation. Increasing public knowledge about the technol-
ogy under review will help to encourage this change (Kanouse et al., 1989)
(emphasis added).
This recommendation regarding the scope of inquiry of the NIH
CDP recognizes the overarching mission of NIH.
Through the conduct, support and promotion of biomedical research, NIH
seeks to improve the health of the American people by: increasing the under-
standing of the processes underlying human heals, disability, and disease;
advancing knowledge concerning the health effects of interactions between
man and the environment; developing methods of preventing, detecting, diag-
nosing, and Beating disease; and disseminating research results for critical
review and ultimately for medical application (NIH, 1989~.
Assessment of technology and related health practices has the poten-
tial to affect people's health by influencing their health habits, health
care providers' actions, and resource allocation within the health
care system. But, evaluation of safety and efficacy provides only
part of the information needed by health care professionals, patients,
third-party payers, and other decision makers. To be effective in
improving health care practice, health technology assessments must
also address relevant economic, social, and ethical consequences,
such as cost, access, and quality of life.
By limiting its explicit attention to matters pertaining to evalu-
ation of safety and efficacy, the NIH CDP does not adequately meet
the needs of health care professionals, patients, policymakers, third-
party payers, industry, and members of the general public who look
to NTH consensus statements for authoritative guidance. If NTH is
to undertake consensus development, it must seek to ensure that
applicable economic, social, and ethical issues are addressed in or-
der to provide useful information about a technology to interested
parties and decision makers, even if such analyses extend beyond
the core mission of NTH.
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12
CONSENSUS DEVELOPME~JI AT THE NIT
Expanding the structure of the NTH consensus development con-
ferences to address relevant economic, social, and ethical aspects
has the advantage of providing explicit attention to these aspects. It
is important that such matters as cost, accessibility, equity, societal
norms, and legal implications be considered in a shared context with
technologic performance, safety, efficacy, and other strictly biomedi-
cal issues in order to deal explicitly with me trade-offs among these
that are raised in research settings as wed as clinical practice.
However, within the current time constraints allotted for confer-
ences, expansion of scope may become too burdensome to produce
useful results. Therefore, it may be necessary for OMAR to con-
vene a second pane} to produce a statement, or to have a statement
prepared by an outside organization, in order to address these as-
pects adequately. Such a supplemental effort could be performed
concurrent with or subsequent to the consensus development confer-
ence on issues of safety and efficacy. In some instances, certain
salient economic, social, and ethical issues may not become evident
until consensus on the strictly biomedical issues has been achieved.
In those cases, OMAR could provide for a second pane} to address
such issues. Convening a second panel or contracting with another
organization would require additional coordination by OMAR, and,
if conducted in a sequential rather than parallel manner, would add
time to the consensus development process.
In particular, it may be appropriate for NTH to coordinate a two-
stage or other complementary process with the Agency for Health
Care Policy and Research (AHCPR). As provided in Section 904 of
P.~. 101-239 (U.S. Congress, 1989), AHCPR `'shall conduct alla
support specific assessments of health care technologies" and in so
doing "shall consider the safety, efficacy, and effectiveness, and, as
appropriate, the cost-effectiveness, legal, social and ethical implica-
tions, and appropriate uses of such technologies, including consid-
eration of geographic factors." Alternatively, other organizations in
government or the private sector could be requested to provide assis-
tance to NTH in addressing relevant economic, social, arid ethical
issues.
Program Purpose
OMAR should expand the purpose of the NIH COP to acknowI-
edge explicitly that the ultimate goal of the program is to change
behavior toward appropriate use of health practices and technology.
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RECOMMENDATIONS FOR PROGRAM S7RUCIURE
13
A clear and accurate statement of purpose is essential to me suc-
cess of the COP. A clearly stated purpose provides guidance to
conference planners and participants and assists users of conference
findings by delineating what is to be addressed by a conference, the
intended target of the resulting information, and the reason for gen-
erating this information. Such a statement of purpose should define
the program scope by identifying the appropriate range of topics and
extent of inquiry to be addressed.
The current purpose of the NIH CDP as described in OMAR's
guidelines is
to evaluate the available scientific inflation 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) rsic] (OMAR, NIH, 1988~.
The statement of purpose should be expanded to encompass be-
haviorally oriented program objectives. This will assist NTH in de-
veloping, conducting, disseminating, and evaluating the CDP. Clearly
stating that the purpose of the NTH CDP is to influence behavior
regarding the appropriate use of medical interventions will establish
a focused program goal or standard toward which the program can
be managed and against which its impact can be measured. Specif~-
cally, the statement of purpose should explicitly note the program
objectives to promote me timely incorporation of beneficial medical
innovations into clinical practice, encourage the abandonment of
obsolete technologies in favor of ones that are more efficacious or
safe, discourage the adoption of technologies that have little value,
and inform public policy choices that encourage or discourage the
use of certain medical technologies (Kanouse et al., 1989~. Each of
these objectives seeks to influence behavior in order to improve
health care practices, but is not given due weight in the current NTH
CDP statement of purpose.
Objectives of Individual Consensus Development Conferences
The objectives of each consensus development conference should
be clearly stated as part of the planning process (including topic
selection), the conference itself, and the consensus statement. To
aid in delineating objectives for a particular conference, OMAR
should consider developing a topology that identifies various poten-
tial conference objectives and the audiences that the conference might
serve.
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14
CONSENSUS DEVELOPMENT AT THE NIH
In fulfilling the mission of the NIH CDP, an individual consensus
development conference can meet one or more objectives for one or
more audiences. The objectives of an individual conference might
include education, policy-making, resolution of controversial issues,
or examination of specific clinical practices. The audience for the
resulting consensus statement might include researchers, clinicians,
third-party payers, health care administrators, professional organiza-
tion representatives, consumers (patients), or the general public. Such
variation in objectives and audiences among consensus development
conferences is necessary and appropriate given the diversity of top-
ics to be addressed. Explicit acknowledgment of objectives and
intended audiences will assist in conference planning, conduct, and
dissemination efforts.
ORGANIZATIONAL ISSUES
OMAR is part of the Office of the Director of NIH, where it
reports to the Associate Director for Disease Prevention. OMAR is
the focal point in NIH for technology assessment and transfer. The
aim of OMAR's activities is to facilitate the transfer of NTH-sup-
ported biomedical research results into clinical applications and to
evaluate these research findings for safety and efficacy. In addition
to the CDP, OMAR coordinates NIH medical and scientific review
of Medicare coverage issues,3 conducts research and evaluation stud-
ies of NTH technology assessment and transfer efforts, and serves as
liaison between NIH and health professionals and the general public
(IOM, 19X51. As a result, OMAR has a varied constituency that
includes the BIDs of NTH, biomedical researchers, health care pro-
viders, professional societies, voluntary organizations, private in-
dustry, state and local governments, other federal agencies, con-
sumer groups, and the general public (OMAR, NIH, undated).
Location of OMAR within NIH
Organizational support for the NIH CDP should be strengthened
at the highest levels of NIH. Specifically, OMAR's reporting rela-
31~ese issues are referred to NIH and other Public Health Service agencies (e.g.,
the Food and Drug Administration) from the Health Care Financing Administration
primarily via the Office of Health Technology Assessment (OHTA). OHTA was
formerly part of National Center for Health Services Research and is retained in the
Agency for Health Care Policy and Research.
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RECOMMENDATIONS FOR PROGRAM STRUCTURE
15
tionship to the director of NIH should be reevaluated with respect to
the CDP. Further, OMAR should be an equal partner with the BIDs
in setting the agenda of the CDP.
Given NIH's traditional focus on biomedical research, some ob-
servers may regard technology assessment and transfer as subordi-
nate or marginal concerns of NTH. Nevertheless, the functions of
technology assessment and transfer are essential to the mission of
NIH. In order to have an impact on the health of the public, the
knowledge gained through the efforts of NTH and other scientific
programs must be transmitted to health care providers and others in
the health care system. Successful accomplishment of technology
assessment and transfer requires that the needs of the intended audi-
ences of these activities are represented and understood. Thus, the
scope of the CDP—especially as reflected in the selection of con-
sensus development topics and the drafting of conference questions—
must be responsive to health care providers and others in the health
care system. These needs should be reflected in the CDP, but may
not, in all instances, be consonant with the particular priorities of
the respective BIDs of NTH. Furthermore, OMAR's role in technol-
ogy assessment and transfer, in particular, as coordinator of the CDP,
offers opportunities for NIH to gain the insights of representatives
of the broader health care system that may be useful to the agency in
formulating its research agenda and related policies.
To ensure that the functions of technology assessment and trans-
fer remain integral aspects of NTH activity and that OMAR is able to
adequately represent the concerns of those outside of NTH in the
CDP, OMAR's organizational role should be strengthened. There
appears to be no particular advantage to the current placement of
OMAR in the Office of Disease Prevention; indeed, this may have
the potential, or give the appearance, of skewing the emphasis of the
program. Stronger organizational support would be best achieved
through a closer, perhaps direct, reporting relationship between the
directors of NTH and OMAR. Further, OMAR should be an equal
partner with the BIDs in setting the agenda of the CDP.
OMAR Advisory Council
An external advisory council should be established to assist OMAR
in setting its agenda, including provision of oversight to the NIH
CDP and guidance in consensus development conference topic se-
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16
CONSENSUS DEV~U)PME~ AT THE NIT
lection. The council should be broadly constituted so that the views
of health care professionals, provider organizations, industry, re-
searchers, thirdl-party payers, and the general public can be heard(.
In order to be effective in technology assessment and transfer,
OMAR must have an understanding of the perspectives and priori-
ties of the broader health care system. Currendy, there is no stand-
ing means for providing OMAR with the views of its constituencies
outside NIH. Formalizing OMAR's link to the venous segments of
the health care system would benefit the CDP and may prove useful
for OMAR's other technology assessment and transfer activities as
well.
PROGRAM EVALUATION
OMAR should develop an explicit ongoing research effort to de-
termine ways to improve the NIH CDP and to monitor the impact of
the program.
This report constitutes just one step in a continuing process of
improvement of the NTH CDP in particular and of the methodology
of consensus development in general. OMAR should experiment
with new techniques (see the recommendations in the section Devel-
opment of Consensus and Group Dynamics in Chapter 3 of this
report) to improve its program and to provide guidance to other
consensus development efforts. As noted in Chapter ~ of this report,
dissemination of CDP findings is as essential an element in the proc-
ess as the other program components addressed here are, given the
intent to use consensus statements to influence health care practice.
Thus, OMAR should build on its efforts to improve dissemination
by engaging in further analysis of this area. In addition, evaluation
by OMAR and outside organizations of the impact of the NIH CDP
should receive high priority and should be performed on an ongoing
basis.
FINANCIAL SUPPORT
OMAR should revise its budget expectations for consensus dlevel-
opment conferences in light of the recommendations of this report,
which likely would require additional resources. If N H is unable to
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RECOMMENDATIONS FOR PROGRAM SIRUCrURE
17
increase the funding available to OMAR for the consensus develop-
ment conferences accordingly, then OMAR should reduce the num-
ber of conferences it sponsors to have adequate funding for each
conference held.
A number of the committee's recommendations will result in an
increase in the amount of money spent per conference and in admin-
istrative costs for OMAR (e.g., pertaining to the broader scope of
the program, use of a professional facilitator, establishment of an
OMAR advisory council, meta-analysis, decision modeling, and
ongoing evaluation). Given the importance of the NTH CDP and the
au~or~ty attributed to it, OMAR should focus on the quality, rather
than the quantity, of its consensus development conferences. It is
more important to conduct fewer conferences that address the full
range of issues required by decision makers than to conduct a greater
number of conferences that do not provide decision makers with
adequate information to change behavior.
Representative terms from entire chapter:
development conferences
