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3
Obtaining Input to Identify
National Priorities for Comparative
Effectiveness Research
abstract: Stakeholder input was one of the express requirements of the
comparative effectiveness research priority study that Congress requested
from the Institute of Medicine (IOM) in the American Recovery and
Reinvestment Act of 00. The committee concluded that such input
should be invited and analyzed from direct communications to the IOM
from an in-person stakeholder meeting before the committee and from a
web-based questionnaire. Policy recommendations, general comments,
and opinions were provided in direct communication before, during, and
after the public meeting from the biomedical and health care communities
and patients and families. More than ,00 nominations representing a
diversity of research topics, respondents, and perspectives from the public
and private for-profit and not-for-profit sectors were submitted to the
web-based questionnaire.
INTRODuCTION
In response to the directive of the American Recovery and Reinvest-
ment Act (ARRA) of 2009 (P.L. 111-5) to consider input from stakehold-
ers,1 the committee focused on three mechanisms for obtaining input on
comparative effectiveness research (CER) from as wide an array as possible
of stakeholders including patients, families, and consumers. This chapter
1 American Recovery and Reinvestment Act of 00, P.L. 111-5, 111th Congress, 1st ses-
sion (February 17, 2009).
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INITIAL NATIONAL PRIORITIES FOR CER
describes the process of soliciting the inputs that informed the committee
in preparing its report.
INvITATIONS TO PROvIDE INPuT
More than 20,000 email announcements describing the Institute of
Medicine (IOM) study and inviting stakeholder input were sent out the first
week of March 2009. These announcements were directed to general lists
maintained by the IOM, composed of IOM members and other individuals
who signed up for the listserv because of an interest in the IOM and its
work. The lists include members of the media, policy makers, academics, re-
searchers, health care industry, physicians and other health care providers,
students, former Robert Wood Johnson Foundation Health Policy fellows,
and others in the public and private sectors interested in health policy, as
well as those on listservs to congressional staff and congressional agency
staff. Announcements were also sent specifically to seven categories of
stakeholders (Table 3-1) with broad constituencies; they were requested to
forward the announcement to their memberships. The committee concluded
that these organizations, and their memberships and constituencies, were
relevant to CER and could initiate further dissemination of the announce-
ments to similar individuals and groups thus providing an opportunity for
increased input to the committee. Invitations provided three distinct avenues
for submitting advice on national priorities for CER to the committee:
1. Direct correspondence with the IOM committee
2. Oral and written presentations at an open stakeholders’ meeting
scheduled at the National Academy of Sciences Building in Wash-
ington, DC
3. Submission of specific CER topics, as well as general comments on
the process of conducting CER via a web-based questionnaire
The committee’s goal was to receive the most extensive advice and
recommendations possible for national CER priorities from the widest
possible array of stakeholders within the time and resources available. In
the aggregate, useful advice and a list of national priorities emerged from
these three steps that related well to selection criteria and 32 research areas
as described below.
COMMuNICATIONS DIRECTLy TO THE COMMITTEE
The committee received approximately 90 emails and letters from a wide
variety of stakeholders that ranged from pharmaceutical manufacturers to
health profession associations, patient and consumer organizations, health
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OBTAINING INPUT TO IDENTIFY NATIONAL PRIORITIES
TAbLE 3-1 Solicited Stakeholder Groups (including, but not limited to
the examples shown)
Categories Stakeholder Groups
Consumers/Patient • AARP
Advocacy Groups • Center for Advancement of Health
• Consumers Union
• National Health Council
• National Minority Quality Forum
Federal Government • Agency for Healthcare Research and Quality
Agencies • Centers for Disease Control and Prevention
• Centers for Medicare & Medicaid Services
• Department of Veterans Affairs
• Food and Drug Administration
• National Institutes of Health
Health Care Providers and • American Academy of Family Physicians
Researchers • American Academy of Pediatrics
• American College of Physicians
• American Medical Association
• American Nurses Association
• American Psychological Association
• National Medical Association
Insurers • America’s Health Insurance Plans
• Blue Cross and Blue Shield Association
• CIGNA
Integrated Health Systems • Geisinger
• HealthPartners
• Kaiser Permanente
Manufacturers • Advanced Medical Technology Association
(including drugs, devices, and • Biotechnology Industry Organization
biotechnology) • Pharmaceutical Research and Manufacturers of
America
State Government Agencies • Association of State and Territorial Health
Officials
• National Governors Association
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INITIAL NATIONAL PRIORITIES FOR CER
services researchers, health plans, complementary and alternative medicine
providers, patient advocates, and individual patients and consumers. Many
of these made recommendations to include specific topics nominated as
research priorities, as well as suggestions about the general process. A sum-
mary of the general stakeholder recommendations follows:
transparency. Many stakeholders recommended using a systematic
•
and open process of setting priorities that would include patients
and consumers, and would avoid conflicts of interest.
research Design. Some stakeholders favored encouraging new
•
types of studies, adopting certain techniques to minimize research
bias, incorporating quality measures and patient preferences in
effectiveness studies, and focusing on real-world clinical situa-
tions rather than ideal conditions. Related suggestions called for
improving existing databases, making databases more accessible
to researchers, protecting patient privacy, and investing in health
information technology designed to produce a robust, scalable, and
open architecture capable of providing real-time data. They also
suggested that CER should take into account special populations
defined by such factors as race and ethnicity, gender, age, and so-
cioeconomic status.
translation and Dissemination. Many stakeholders addressed
•
issues of disseminating CER findings and converting them into
changes in health care practice. These suggestions included provid-
ing feedback to physicians, improving decision support for clini-
cians, encouraging physicians to use best practices and clinical
guidelines, conducting research on medical and surgical devices,
enhancing patient adherence to regimens, developing user-friendly
guides, testing alternative patient decision-making tools, and al-
lowing public comment periods for comparative effectiveness study
reports. Long-term issues that were addressed included revisiting re-
search results when new information becomes available, expanding
training programs for CER, and partnerships among professions.
economics. A number of stakeholders suggested expanding “cov-
•
erage with evidence development” (i.e., Medicare reimbursement
is conditioned on reporting results of use) to other payers in both
the public and private sectors. They also suggested including con-
sideration of the cost of an intervention as a secondary factor in
evaluation. Some correspondents urged that incentives for innova-
tion be preserved.
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OBTAINING INPUT TO IDENTIFY NATIONAL PRIORITIES
advocacy. Some stakeholders suggested advocating for specific
•
groups, providers, conditions, or organizations; the committee re-
viewed and acted on these suggestions as appropriate.
PRESENTATIONS AT AN OPEN MEETING OF STAKEHOLDERS
An open stakeholders meeting was held March 20, 2009 in the audito-
rium of the National Academy of Sciences Building on Constitution Avenue
in Washington, DC. Fifty-four speakers made 3-minute presentations (or 5-
minute presentations if the individual represented a large membership orga-
nization) to the committee and a large public audience with approximately
25 percent of the day reserved for the committee to address questions to
the presenters. Box 3-1 displays the list of speaker organizations and a full
agenda from the meeting is available in Appendix A. Written statements
from all 54 speakers were made publicly available on the committee website
and are provided as an electronic appendix at www.iom.edu/cerpriorities.
Word limits were not imposed on these written statements.2
Virtually all of the presenters addressed issues of public policy or
methodology involving CER, rather than proposing specific research top-
ics. Many presenters expressed support for CER in principle, while none
expressed direct opposition. The representative from America’s Health In-
surance Plans asserted that some health care interventions are used without
evidence or without recent reevaluation, and there is a need to know first,
what works, and second, what works best.
Many presenters, such as the representatives from the Biotechnology
Industry Organization and several physician societies, stated that evidence-
based medicine should guide CER, and that CER should be accurate and
rigorous. They emphasized that CER needs to be grounded in “real-world”
conditions and that the public will require evidence of this as investments in
CER increase. The representative from the Association of American Medi-
cal Colleges urged the committee to recommend investments in training
researchers, in data resources, and in other CER infrastructure.
Some presenters, such as the representatives from the National Medical
Association and the National Minority Quality Forum, expressed concern
that CER might be used to generalize approaches to therapy, in a so-called
one-size-fits-all approach to health care. Others, such as the representa-
tive from the National Health Council, strongly advocated for a patient-
2 Federal agencies listed in Table 3-1 did not make presentations before the committee. In-
stead, these agencies participated in the federal response to the CER mandate of ARRA under
the aegis of the Federal Coordinating Council on Comparative Effectiveness Research. This
council heard 3-minute presentations and/or received a written statement from stakeholders
over 3 hours on April 14, 2009, at a “public listening session” held in Washington, DC, and
on May 13, 2009, in Chicago, IL.
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INITIAL NATIONAL PRIORITIES FOR CER
BOX 3-1
Organizations Represented at the Stakeholder Meeting
• A Certified Nurse Midwife • Consumers Union
• Advanced Medical Technology • Developing Families Center
Association • Duke University Medical Center
• American Academy of Family • eHealth Initiative
Physicians • Focus on Therapeutic
• American Academy of Outcomes, Inc.
Pediatrics • Friends of Cancer Research
• American Association for • Frontier School of Midwifery &
Dental Research Family Nursing
• American Association of • Health Care Consultancy
Neurological Surgeons • HealthPartners Research
• American College of Cardiology Foundation
• American College of Clinical • International Society for
Pharmacy Pharmacoeconomics &
• American College of Occupation Outcomes Research
and Environmental Medicine • The Lewin Group
• American College of Surgeons • National Alliance for Hispanic
• American Heart Association Health
• American Medical Association • National Alliance on Mental
• American Nurses Association Illness
• American Psychiatric • National Health Council
Association • National Medical Association
• American Psychological • National Minority Quality Forum
Association • National Pharmaceutical
• American Society of Clinical Council
Oncology • Network for Regional
• America’s Health Insurance Healthcare Improvement
Plans • Oregon Health and Science
• Association of American University and Portland VA
Medical Colleges Medical Center
• Association of Clinical • Parkinson Pipeline Project
Research Organizations • Personalized Medicine
• Association of Schools of Coalition
Public Health • Pharmaceutical Research and
• Biotechnology Industry Manufacturers of America
Organization • Society for Cardiovascular
• Blue Cross and Blue Shield Angiography and Interventions
Association • The Society of Thoracic
• California Department of Public Surgeons
Health • United BioSource Corporation
• Center for Advancement of • United States Pharmacopeia
Health • University of Iowa
• Center for Science in the Public • Washington State Health Care
Interest Authority
• CIGNA
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OBTAINING INPUT TO IDENTIFY NATIONAL PRIORITIES
centered approach to health care delivery and CER. Still, others, such as
the presenter from the Lewin Group, offered a set of principles to guide
research, which included transparency, public input, a broad scope, careful
definitions of comparisons, support for personalized medicine, and evolu-
tion of innovation supported by explicit ground rules for review.
Speakers identified the inclusion of cost considerations in the outcomes
of CER as controversial. At least nine speakers expressly supported the in-
clusion of costs in the comparison of health interventions, and many more
advocated establishing the relative value of different interventions, services,
and care models by comparing costs to clinical benefits for two or more
alternatives. At least four others, however, recommended against the use
of cost comparisons for fear that the availability of drugs on formularies
or coverage decisions would be unduly influenced. One speaker suggested
that cost be taken into account only when the alternative interventions are
clinically equivalent. Another advocated a focus on enhancing value for
patients rather than minimizing costs.
Many groups spoke in favor of personalized or individualized care,
taking into consideration the varying concerns and clinical and genetic
diversity of patients. This concept was expressed in different ways, but
it reflected an overall concern that general research results should not be
applied in a way that overlooks the specific needs and preferences of indi-
vidual patients.
Strategic targeting of CER frequently arose as a topic of discussion.
Key topics for investigation identified by the speakers included diabetes,
coronary heart disease, chronic obstructive pulmonary disease, depression,
common spinal disorders, childhood asthma, obesity, early brain devel-
opment, family services and midwifery, oral health, minimally invasive
surgery, chronic disease in general, and complementary and alternative
medicine, among others. Specific modalities of health care delivery that
were proposed included behavioral health, medical homes, multi-profes-
sional teams, and expanded roles for non-physician health professionals.
Some also suggested starting with research that was “shovel-ready”—that
is, likely to be accomplished and yield results quickly. There was general
agreement that areas to be targeted included high-prevalence conditions,
services with high variation in use, conditions with major public health
consequences such as those involving health disparities, high-cost condi-
tions, conditions not covered by existing clinical guidelines, and research
directed at disease prevention. In addition, there was widespread agreement
that effectiveness must be assessed in racial and ethnic minorities to help
remedy health disparities.
A number of suggestions regarding research methods came from groups
such as the National Alliance on Mental Illness, the American Heart As-
sociation, Friends of Cancer Research, the Association of Clinical Research
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INITIAL NATIONAL PRIORITIES FOR CER
Organizations, and the Washington State Health Care Authority, among
others. They recommended improvements in defining the populations used
in randomized clinical trials, avoiding treatment and publication bias by
considering completed but unpublished studies, and collecting and storing
biospecimens. They also suggested the establishment of a process for timely
reconsideration of CER results.
Many presenters discussed sources of information, databases, and other
aspects of CER infrastructure. Some professional groups reported joining
together to help develop CER standards, registries, and procedures. Some
organizations, such as the Advanced Medical Technology Association and
Blue Cross and Blue Shield Association, indicated that they might be willing
to support projects materially. The American College of Surgeons and other
professional groups said their members would be supportive, participate in
studies, and likely to incorporate CER results into their practices.
Stakeholders at the meeting generally concluded that there was a need
for full transparency in the prioritization process. This encompasses the
ongoing participation of stakeholders, the avoidance or strict management
of potential conflicts of interest, and the establishment of rigorous scientific
standards and methods.
INPuT FROM A WEb-bASED QuESTIONNAIRE
At a very early stage, the committee concluded that substantial and
meaningful stakeholder input and specific recommendations for CER pri-
orities to the committee required a web-based questionnaire3 designed to
elicit such recommendations. As described earlier, announcement notices of
this questionnaire were circulated through a wide distribution of emails to
about 20,000 individuals and organizations, and through these organiza-
tions to their memberships. In addition, notice was disseminated through
the IOM website (www.iom.edu/cerpriorities). The questionnaire was open
for 3 weeks, from March 6 to March 27, 2009, which included 1 week
following the open stakeholders meeting. The questionnaire is available in
Appendix B.
Priority Topic Nominations
There were 1,758 respondents to the questionnaire and 2,606 nomina-
tions for CER topics. Initial review showed many duplicated entries and
3 The questionnaire was not requested by the federal sponsor nor was there time for ap-
proval by the Office of Management and Budget. This situation did not allow payment for the
questionnaire and associated analysis from federal funds, but because the committee concluded
it was essential, the IOM took the unusual step of supporting the costs associated with the
questionnaire from National Academies funds.
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OBTAINING INPUT TO IDENTIFY NATIONAL PRIORITIES
Web-based questionnaire
open to public
March 6-27, 2009
Received 2,606 nominated topics
for CER from 1,758 respondents
Initial screen of 2,606 nominated topics by
clinical review subcommittee (April 2-6)
335 1,268 1,003
Excluded due to Entered into Excluded due
nonresponsiveness round 1 of voting to verbatim duplication
FIGuRE 3-1 Stakeholder response to web-based questionnaire.
nonresponsive submissions.4 The initial entries were screened by staff to
identify unique submissions and were confirmed by two committee members
in independent review. Figure 3-1 shows the review and screening process of
the questionnaire submissions that resulted in the 1,268 topics that entered
the first round of voting. Table 3-2 displays the distribution of respon-
dents by self-identified stakeholder category. While approximately 75 per-
Figure 3-1
cent of respondents identified themselves as either providers or researchers
R01311
vector, editable
(which includes the following categories: Health Care Provider, Researcher,
Government—Research, Government—Programs, and Health Plan/Insurance
Carrier), there was also representation from other categories in the public
and private for-profit and not-for-profit sectors, and nearly 10 percent of
respondents identified themselves as patients, families, or consumers (which
includes the following categories: Patient/Family, Public/Consumer, and Em-
ployer). More than 300 respondents self-identified as members of more than
4 Nonresponsive submissions were either nonsense answers such as entering “aaaa” so that
the respondent could browse through the questionnaire without inserting answers, were not
complete responses, or were just general comments to the committee rather than topics for
CER.
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0 INITIAL NATIONAL PRIORITIES FOR CER
TAbLE 3-2 Respondents to the IOM Questionnaire by Stakeholder
Category
Number of
Self-Identified Stakeholder Categories Responders*
Health Care Provider 797
Researcher 416
Professional Association 229
Other 212
Nonprofit/Policy Institute 95
Patient/Family (including family caregiver) 77
Public/Consumer 76
Medical Administrator 40
Government—Research 39
Employer 26
Government—Programs (e.g., Medicare, Medicaid) 26
Manufacturer (Device) 17
Health Plan/Insurance Carrier 12
Manufacturer (Drug or Biologic) 11
Total 2,073
*315 respondents self-identified with more than one category.
one category. Although respondents were primarily from the biomedical
and health care communities, the committee concluded that a fair degree of
diversity of perspective was represented within those communities.
The questionnaire asked each respondent to submit up to three nomi-
nations for priority research topics. Respondents were further asked to
support each nominated topic with specific information, including data to
justify the importance of the proposed research, assignment of the topic to
a single primary research area, identification of appropriate study popu-
lations, specification of interventions being compared, and the proposed
study methodology. In an effort to be as broad and inclusive as possible,
the committee identified the primary research areas from the 17th edition
of Harrison’s Principles of Internal Medicine (Fauci et al., 2008). In addi-
tion, the committee added the following research areas to the questionnaire:
birth and developmental disorders, functional limitations and disabilities,
and pediatrics. Stakeholders pointed out during the public meeting on
March 20, 2009, that oral health had been omitted as a distinct category.
Therefore, the committee reassigned those nominated topics clearly belong-
ing in this category. The complete listing of named research area categories
totaled 32, with an additional category for “other.” The breakdown of the
questionnaire nominations by research area, study population, proposed
intervention, and study methodology appear in Tables 3-3 through 3-6. The
tables display results for the 1,268 topics that emerged after consolidating
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OBTAINING INPUT TO IDENTIFY NATIONAL PRIORITIES
TAbLE 3-3 Comparative Effectiveness Research Priorities Submitted by
Primary Area of Study
Category Number of Submissions
Alcoholism, Drug Dependency, and Overdose 31
Birth and Developmental Disorders 73
Cardiovascular and Peripheral Vascular Disease 50
Complementary and Alternative Medicine 19
Endocrinology and Metabolism Disorders 33
Eyes, Ears, Nose, and Throat Disorders 50
Functional Limitations and Disabilities 55
Gastrointestinal System Disorders 15
Genetics and Disease 11
Geriatrics 35
Health Care Delivery System* 156
Immune System, Connective Tissue, and Joint Disorders 12
Infectious Diseases 37
Kidney and Urinary Tract Disorders 23
Liver and Biliary Tract Disorders 0
Medical Aspects of Bioterrorism 2
Musculoskeletal Disorders 36
Neurologic Disorders 81
Nutrition (including obesity) 47
Oncology and Hematology 57
Oral Health 15
Other 3
Palliative and End-of-Life Care 20
Pancreatic Disorders 2
Pediatrics 89
Psychiatric Disorders 127
Racial and Ethnic Disparities 19
Regenerative Medicine 2
Respiratory Disease 29
Sexual Function and Reproductive Disorders 4
Skin Disorders 19
Trauma, Emergency Medicine, and Critical Care Medicine 79
Women’s Health 37
Total 1,268
NOTE: Secondary and comorbid conditions were also provided but not included in this
table.
*Although this category was described as “Safety and Quality of Health Care” in the web-
based questionnaire, the category was relabeled by the committee as “Health Care Delivery
System” to be more accurate.
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INITIAL NATIONAL PRIORITIES FOR CER
TAbLE 3-4 Comparative Effectiveness Research Priorities by Proposed
Population to be Studied
Population Count
Adults (excluding elderly) 120
Adults (including elderly) 381
Children/Adolescents Only 448
Elderly Only 193
Ethnic Subpopulations Only 72
Long-Term Care 124
Women 299
Men 242
Population at Large (general population) 336
Rare Diseases 25
Special Populations (e.g., pregnant women, low income, patients with 333
disabilities)
Total 2,573
NOTE: The total exceeds the total number of nominations because respondents were allowed
to select multiple populations.
TAbLE 3-5 Comparative Effectiveness Research Priorities by Proposed
Intervention
Comparators Count
Alternative Treatment 171
Behavioral Treatment 421
Devices 114
Pharmacological Treatment 306
Prevention 452
Procedures (including surgery) 136
Provider-Patient Relationships 304
Standard of Care 458
Systems of Care 508
Testing, Monitoring, and Evaluation 398
Treatment Pathways 305
Total 3,573
NOTE: The total exceeds the total number of nominations because respondents were allowed
to select multiple interventions.
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OBTAINING INPUT TO IDENTIFY NATIONAL PRIORITIES
TAbLE 3-6 Comparative Effectiveness Research Priorities by
Proposed Study Methodology
Methodology Count
Database Review 295
Prospective Observational Study 593
Randomized Clinical Trial 676
Systematic Review 253
Total 1,817
NOTE: The total exceeds the total number of nominations because respondents
were allowed to select multiple methodologies.
the 2,606 nominated topics to eliminate verbatim duplicates and nonre-
sponsive submissions, described in greater detail in Chapter 4.
Public Responses on Their Priority-Setting Process
In addition to making specific recommendations for comparative ef-
fectiveness priorities and providing supporting information, many of the
questionnaire respondents provided information on how they developed
their topic nominations, what were their principal priority-setting criteria,
and what new or enhanced infrastructure would be needed to sustain a
CER enterprise. Regarding the development of CER topics, the largest
number of respondents indicated that they nominated topics based on
professional experience, both clinical and classroom, and often of many
years’ duration. Many others developed topics based on literature reviews;
conferences attended (such as a National Institutes of Health [NIH] state-
of-the-science review); suggestions of specific organizations, such as NIH
or the Centers for Disease Control and Prevention (CDC); or their own
professional associations such as the American Medical Association, the
American Diabetes Association, or Blue Cross and Blue Shield Association.
Others reported consulting with colleagues and stakeholders, including a
hospital, health system, or consumer group. A small number reported using
personal experience to make their nominations, such as being the mother
of a deaf child.
The most common priority-setting criteria identified by the respondents
can be classified into three broad categories: patient need, quality of care,
and cost and reimbursement issues. Patient need was ranked as the top
criterion; 23 percent of respondents ranked it in first place, and 14 percent
ranked it in second place. Patient need referred primarily to disease burden,
including prevalence, morbidity, mortality, and family and social impact, as
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INITIAL NATIONAL PRIORITIES FOR CER
well as risk factors such as obesity and substance abuse. Conditions sup-
porting the use of this criterion included speech or hearing problems, autism
and traumatic brain injury, chronic diseases including HIV, cancer, asthma,
cardiovascular disease, birth outcomes, smoking and alcohol abuse, mental
health, and dental disease. The remaining specific criteria—decreasing vari-
ability in care, the potential to act on the information, and cost, all received
about 13 percent of the support from respondents.
With respect to quality of care-related criteria, many self-identified cli-
nicians said they sought better information for making clinical decisions in
order to deliver the best or evidence-based treatment, to reduce treatment
variation, and to promote quality of care for their patients, including safety
and improved outcomes. Clinicians sought better aids in making clinical
decisions; they expressed a need for help in delivering the best care when
there were many confusing alternatives.
Cost and reimbursement issues may reflect that research would lead
to cost management, better resource use, a decrease in societal costs, and
elimination of waste. Respondents stated that if research could lead to
deploying health care resources more effectively, costs would decrease. Oth-
ers thought CER might persuade payers to support or improve reimburse-
ment for particular services, such as integrative care, complementary and
alternative medicine, improved doctor-patient communication, caregiver
education, specific diagnostic services, and strategies to improve adherence
to treatment regimens, among others.
Other comments justifying priority nominations included closing in-
formation gaps, countering misinformation, addressing specific areas of
research deemed underfunded, assessing new service delivery models, im-
proving public interest, minimizing controversy, reducing disproportionate
impact on subpopulations, focusing on research that could deliver quick
results, that is low cost, and that is feasible to implement, focusing on psy-
chosocial and educational factors, including family dysfunction that affects
health outcomes, and developing new research methods.
In addition, 650 respondents answered the question about enhancing
CER infrastructure. Some called for either sufficient, high, or permanent
funding for CER, commenting that a public and business case needs to be
made to overcome the strong opposition to CER. Important attributes were
listed, such as a public-private partnership, methodological rigor, a focus
on outcomes, facilitating innovation in interventions and approaches, and
broad stakeholder involvement. Some respondents noted that CER is re-
lated to health reform or Food and Drug Administration reform, or changes
in state licensure of health professions. While some respondents recom-
mended privatizing or decentralizing CER or using existing resources, oth-
ers suggested that a CER program could be located within the Agency for
Healthcare Research and Quality, NIH, or the CDC. It was suggested that
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OBTAINING INPUT TO IDENTIFY NATIONAL PRIORITIES
funding be available to individually initiated, multicenter, or non-university-
based investigators. Simplification of participation in randomized controlled
clinical trials, or in institutional review board processes, and prohibition of
conflicts of interest were also recommended. Specific proposals were made
for openness, including a national conference, a national committee, local
research efforts, and scientific input. Identified needs included registries,
longitudinal studies, data availability and access provisions, development of
clinical guidelines, examination of subpopulations, reduction in disparities,
ways of widely disseminating results, and public and professional education
and communication of findings.
The committee was impressed by the value, breadth, and common
themes that characterized these inputs from stakeholders and the public.
While the committee concluded that many of the original topics nominated
by respondents to the web-based questionnaire were thoughtful and wor-
thy, as described in Chapter 4, some topics were edited to be broader and
more inclusive of multiple patient populations. In addition, the committee
nominated several topics to fill gaps in the portfolio. Through the selection
process described in Chapter 4, the topics nominated by the stakeholders,
the public, and the committee members were reduced to the final list of
100 national priority topics for CER listed in Chapter 5. The publically
nominated topics served as the basis for the majority (82 percent) of the
list, and the remaining 18 percent were nominated by the committee. These
responses also allayed committee concerns that the 3-week window for the
questionnaire that was necessary to meet the short turnaround time for this
report may have unduly limited public input. Furthermore, answers to ques-
tions on the questionnaire, and input from letters, e-mails, and stakeholder
presentations, informed the committee in several other ways—for example,
the suggestions on infrastructure were considered in drafting Chapter 6.
Learning from this experience, the committee concluded that an ongo-
ing process for citizens to express themselves and provide priorities for CER
would be worthwhile. See Chapter 4 for further discussion of how this
input could be collected. This process might also serve an educational role
by informing the public that CER is aimed to improve the quality of clinical
care delivered to patients not a sub rosa scheme to ration it.
REFERENCE
Fauci, A. S., E. Braunwald, D. L. Kasper, S. L. Hauser, D. L. Longo, J. L. Jameson, and J.
Loscalzo. 2008. Harrison’s principles of internal medicine, 17th edition Place Published:
McGraw-Hill Companies. http://www.accessmedicine.com/resourceTOC.aspx?resource
ID=4 (accessed May 21, 2009).
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