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Appendix C
Survey of Organizations with an Ongoing
Meclical Technology Assessment Program
645
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APPENDICES
Name of person
completing survey
Telephone: _
The purpose of this survey is to compile a directory
of organizations with an ongoing program of medical
technology assessment. For purposes of this survey:
an organization may be a professional, trade, or other
association, university or other not-for-profit entity, gov-
ernment agency, or for-profit corporation
an ongoing program is a structure or process within the
organization, if not the entire organization, that assesses
medical technologies and generates assessment reports
a medical technology assessment is any study or inquiry
the objective of which is to provide information regarding
the effects of a technology designed to maintain or
improve health or be used as part of an intervention for
such purpose, whether or not the study evaluates the
effects
Survey of Organizations With an Ongoing
Medical Technology Assessment Program
an assessment may be made by any one or a combination
of methods, e.g., panel of experts, information synthe-
sis, empirical study
the report of results may be published by the organi-
zation/program, in a journal, or other vehicle. How-
ever, for the organization/program to be eligible for
inclusion in this survey, the report must be available
to others outside of the organization.
This survey is not for organizations that: may have
conducted medical technology assessments but do not
have any ongoing program; catalog, index, or evaluate
assessments but do not produce them; conduct assess-
ments but do not make results available to anyone outside
of the organization. Information on these types of activ-
ities may be incorporated into the directory using other
collection instruments.
If your organization contains two or more programs that
qualify for inclusion, please complete a separate survey
form for each one. Additional copies, and information,
may be obtained from Pamela Simerly on 202/334-2319.
_ ,
-of........
Instructions for Completing the Survey
This survey consists of four parts.
· Part I asks you to describe your organization.
· Part II consists of categorized checklists that ask
you to select one or more response categories to describe
your program.
· Part III is a series of open-ended questions that ask
you to describe your program in a brief narrative format.
· Part IV requests listings of completed, ongoing, and
planned assessment reports.
If an item is not applicable, please note "NA" (rather
than leaving the answer space blank).
In completing this survey, if more convenient, you may
type answers on separate sheets and append them to the
survey form. If you do append sheets, be sure that you
have keyed them to the question, responded to all survey
items, and completed structured items on the survey
form.
Please provide a current example of a medical technology
assessment report published by your program. By pro-
viding the report you are consenting to its reproduction in
,
647
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MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY
the directory as a sample assessment, if the IOM chooses
to include it. If you produce different types of assessment
reports, please append a current example of each type;
key the report to the type of assessment.
If your organization has two or more assessment programs,
please complete a separate survey form for each one (Parts
II, III, and IV).
If your program conducts two or more types of medical
technology assessment, please complete a separate survey
form for each one (Parts II, III, and IV).
ran ~ _
. . .
floes your organization have two or more assessment
programs?
yes (If yes, please list the separate programs
below, and complete a separate survey
form for each one. You may copy survey
formats or request additional copies from
Pamela Simerly, 202/334-2319.)
no
List of programs (only if your organization has two or
more distinct programs that assess medical technol-
ogy).
1.
2.
3.
4.
Does your program conduct two or more types of assess-
ment that differ materially with respect to purpose, subject
selection, method of assessment, or assessment process
or methods? Check one:
yes (If yes, please list the separate types of
assessment below and complete a separate
survey form for each one. You may copy
survey formats or request additional copies
from Pamela Simerly, 202/334-2319.)
no (A "no" response implies that your program
and its assessments are uniform with respect
to purpose, subject selection, method of
assessment, and assessment process, even
though some slight variation may occur to
suit individual assessments.)
List separate types of assessment (only if your program
conducts two or more types).
1.
4.
To the extent possible, please provide publication titles and citations in Index Medicus style. Examples follow:
Journal
1. Standard Journal Article (List all authors when six or less; when
seven or more, list only first three and add et al.)
Soter NA, Wasserman SI, Austen KF. Cold urticaria: release into
the circulation of histamine and eosinophil chemotactic factor of
anaphylaxis during cold challenge. N Engl J Med 1976;294:687-
90.
2. Corporate Author
The Committee on Enzymes of the Scandinavian Society for
Clinical Chemistry and Clinical Physiology. Recommended method
for the determination of gammaglutamyltransferase in blood. Send
J Clin Lab Invest 1976;36:1 19-25.
Anonymous. Epidemiology for primary health care. Int J Epidemiol
1976;5:224-5.
Books and Other Monographs
3. Personal Author(s)
Osler AG. Complement: mechanisms and functions. Englewood
Cliffs: Prentice-Hall. 1976.
4. Corporate Author
American Medical Association Department of Drugs. AMA drug
evaluations. 3rd ed. Littleton: Publishing Sciences Group, 1977.
5. Editor. Compiler, Chairman as Author
Rhodes AJ, Van Rooyen CD, comps. Textbook of virology: for
648
students and practitioners of medicine and other health sciences.
5th ed. Baltimore: Williams & Wilkins, 1968.
6. Chapter in Book
Weinstein L, Swartz MN. Pathogenic properties of invading mi-
crooreanisms. In: Sodeman WA Jr Sodeman WA ~1~ P~tholnair
physiology: mechanisms of disease. Philadelphia: WE Sauders,
1974:457-72.
7. Agency Publication
National Center for Health Statistics. Acute conditions: incidence
and associated disability, United States July 1968-June 1969.
Rockville, Md.: National Center for Health Statistics, 1972. (Vital
and health statistics. Series 10: Data from the National Health
Survey, no. 69) (DHEW publication no. (HSM)72-1036).
Other Articles
8. Newspaper Article
Shaffer RA. Advances in chemistry are starting to unlock mysteries
of the brain: discoveries could help cure alcoholism and insomnia,
explain mental illness. How the messengers work. Wall Street
Journal 1977 Aug 12:1(col. 1). 10(col. 1).
9. Magazine Article
Roucche B. Annals of medicine: the Santa Claus culture. The New
Yorker 1971 Sep 4:66-81.
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APPENDICES
Part I. Description of Parent Organization
Please complete a separate survey form for each program/ Program:
type of assessment conducted. For each, please specify
the program/type of assessment covered by this survey Type of assessment:
format.
A. For the parent organization to the assessment program, please describe the following.
1. Nadine, address, telephone
Name:
Address:
Telephone:
2. What is the organization's purpose?
3. Who are its sponsors, owners, stockholders?
4. What products or services does the organization provide?
B. Which of the following categories best describes your organization?
Circle one number.
Government agency
1. federal
2. state/local
3. international
Not-for-profit
4. university
5. research institute
6. foundation
Other, specify:
Association
7. professional
8. trade/industry
9. labor union
For-profit corporation
10. business
649
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MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY
Part II. Type of Assessment Program
Please complete a separate survey form for each program/ Program:
type of assessment conducted. For each, please specify
the program/type of assessment covered by this survey Type of assessment:
format.
A. Who are the primary intended users of your assess-
ments? Check all that apply.
General public
People concerned about their health
Patients
Providers, generally
Physicians
Acute facility administrators
Long-term care facility administrators 3.
Other care givers
Health product (drugs, devices, equipment)
manufacturers
Health/medical professional associations
Health industry associations
Consumer associations
Employers
Unions and other employee organizations
Third party payers
Government regulators
Voluntary associations, organizations
Biomedical researchers
Financial analysts, consultants
Reporters, writers, news media
Information/computer industry
Labs, blood banks, etc.
Public policy-makers, legislators
Policy research organizations
Lawyers
Liability, malpractice insurers
Other, specify:
B. Which of the following technologies does your pro-
gram assess? Check all that apply. Circle the one
assessed most often.
Drug: any chemical or biological substance
that may be applied to, ingested by, or injected
in order to prevent, treat, or diagnose disease
or other medical conditions. Included are bio-
logicals such as vaccines and blood products,
medicinals and botanicals, and pharmaceutical
preparations.
2. Device: any physical item, excluding drugs,
used in medical care. Included are diagnostic
650
and therapeutic equipment, prostheses, sur-
gical and medical instruments and supplies,
dental equipment and supplies, ophthalmic
goods, and in vitro diagnostic products-re-
agents, instruments, and systems used in the
collection, preparation, and examination of
specimens taken from the human body to
determine the state of a patient's health.
Medical or surgical procedure: a practice of a
health care provider that generally involves a
combination, often quite complex, of special
skills or abilities with drugs, devices, or both.
In some cases, the drugs or devices involved
are not predominant factors in a procedure.
Instead, the technique of the provider perform-
ing the procedure is most important, such as
in the performance of a surgical procedure
facilitated by the use of scalpels, clamps, and
drugs against infection. Psychotherapy or pre-
scription of a special diet are examples of
procedures which may not involve drugs or
devices.
4. Support system: a system that provides the
environment for and otherwise facilitates the
provision of health care, but is not the focal
technology in a medical regimen, surgical pro-
cedure, or other form of health care. Examples
are laboratory and radiology services, medical
information systems, blood banking services,
hospital infection control programs, food serv-
ices, laundry, hospital facilities, and physical
plant. Many of these are often referred to as
ancillary services.
5. Organizational or administrative system: used
in management and administration to ensure
that health care is delivered effectively. In-
cluded are alternative delivery modes or set-
tings (e.g., health maintenance organizations
(HMOs), area-wide emergency care systems,
and home health delivery), and payment sys-
tems (e.g., prospective payment using diag-
nosis-related groups).
6. Other, specify:
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APPENDICES
C. Which of the following phases of technological inter-
vention does your program normally assess? Check
all that apply. Circle the one assessed most often.
1. Prevention: designed to prevent a disease from
occurring, reduce the risk of its occurrence,
or promote health and welfare.
2. Diagnosis: designed to identify an individual at
high-risk (of a disease) or who has the disease
(whether or not clinical signs and symptoms
are present).
3. Treatment: designed to restore. maintain or
improve health status, encompassing cure tot
an acute disease), care (of a chronic disease),
or avoidance of further deterioration (of a
degenerative process).
,
. , ~
4. Rehabilitation: designed to restore, maintain,
or improve a person's ability to function with-
out necessarily affecting health status.
5. Other, specify:
D. At what stages in the life-cycle of technologies do
you carry out your assessments? Check all that apply.
Circle the one assessed most often.
1. Emerging: in the applied research or devel-
opment stage, at about the time of initial clinical
testing; once the prototype has been built
(device) or described (procedure) but prior to
the point were the technology can be readily
used by practitioners other than its developers.
2. New: initial use of the defined by practitioners
other than its developers but not in widespread
use; the beginnings of diffusion.
3. Established or widespread practice: when prac-
titioners generally consider the technology to
be accepted or standard practice.
Obsolete: when one or more other technologies
(or using no technology) have superseded the
technology as established practice, but it con-
tinues to be used by some practitioners.
Other, specify:
E. What properties (or attributes) of a technology do
you assess? Check all that apply. Circle the one
usually emphasized.
1. Safety: a judgment of the acceptability of risk
in a specified situation, e.g., for a given medical
problem, by a provider with specified training,
at a specified type of facility.
Efficacy: health benefit for a specified popu-
lation with a given medical problem under
ideal conditions of use (i.e., a special case or
effectiveness).
3. Effectiveness: the health benefit for a specified
population with a given medical problem under
average conditions of use.
. . ~
4.
Cost: of using the technology for an individual
application (e.g., direct and indirectloverhead
costs) including charges or prices.
5. Cost-benefit: the costs of a technological ap-
plication compared to the resultant benefits,
with both costs and benefits expressed in the
same (usually monetary) units.
6. Cost-effectiveness: the costs of a technological
application compared to the resultant benefits,
with cost and benefits/effectiveness not ex-
pressed by the same unit. Costs are usually
expressed in monetary units, but benefits/
effectiveness are ordinarily expressed in such
terms as lives saved, disability avoided, qual-
ity-adjusted life years or other similar meas-
ures.
Service requirements: for using the technology
in practice, such as its placement and distri-
bution within a health care system, organiza-
tional arrangements within a facility, need for
technologists or staff training.
8. Acceptance/adoption level: actual/projected level
of a technology's acceptability among provid-
ers, extent of diffusion/use, stage in lifecycle,
etc.
9. System impact: beyond clinical effectiveness,
the actual/projected impact on medical practice
patterns, health care delivery organization/
systems.
10. Economic implications: the cost of the tech-
nology in the aggregate, and its impact on
factor prices, medical costs, alternative uses
of national or industrial resources, etc.
11. Ethical, legal, social implications: of using the
technology, including, e.g., its impact on moral
values, challenges to legal principals, and ef-
fects on society.
651
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MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY
12. Other, specify:
F. Which of the following broad categories of assessment
methods do you employ to conduct an assessment?
Check all that apply. Circle the one relied on primarily.
Information syntheses: summarizing, integrat-
ing, and interpreting findings reported in the
literature. May include unstructured literature
reviews as well as various systematic and
quantitative procedures such as meta-analysis.
Expert opinion: consultation with individual
experts who may be involved in drafting,
editing, reviewing assessments but who do not
interact as a group.
Group judgment: a process in which a group
of experts interact in assessing a technology
and formulate findings by vote or other process
of reaching general agreement. It is necessary
that group members have the opportunity to
interact in formulating and reviewing each
other's and the group's observations and find-
ings.
4. Modeling: use of simulations or models to test
or evaluate proposed interventions, often un-
dertaken when evaluation of the actual inter-
vention would be impractical.
7.
652
5. Cost analyses: analyses, including cost-benefit
and eost-effeetiveness analyses, that identify,
measure, and compare both the benefits and
costs of medical technologies. Analyses may
vary in terms of perspective (i.e., the parties
to whom the benefits and costs accrue) and
the choice and valuation of the benefits and
costs considered.
6. Epidemiological and other observational meth-
ods: excludes the more rigorous experimental
design studies such as randomized clinical
trials. Included are such studies known as
quasi-experiments, including those with his-
torieal cohorts, series, ease studies, cohort
studies, natural experiments, descriptive sur-
veys and certain cross-sectional, ease control,
and longitudinal methods.
Clinical trials: prospective clinical experiments
designed to test the safety and efficacy of a
technology in which people are assigned to
experimental or control groups and outcomes
are compared. Includes randomized controlled
clinical trials, in which people are randomly
assigned to experimental and control groups.
8. Bench testing in the laboratory; non-elinieal,
in vitro testing, experiments, or related obser-
vations.
G. Which of the following itemsltopies are included/
addressed in most or all of your assessment reports?
Check all that apply.
The assessment's intended audience
The purpose of the assessment (i.e., why it
was conducted)
Relationship of this assessment to prior or
concurrent assessments of the technology or
other technologies intended for similar pur-
poses
Who sponsored/commissioned/supported the
assessment
Who conducted the assessment (including,
e.g., identity of subcontractors or support
agencies, assessors' types of expertise)
7. Description of the technology (including, e.g.,
intended purpose, target patients/populations,
indieations/eontraindieations, competing teeh-
nologies for the same type intervention)
8. Stage of life-eyele of technology when assessed
9. Properties assessed (e.g., safety, effectiveness,
effieaey, service arrangements, economic, eth-
ical, legal, social implications)
10. Procedure used for the assessment
Sources of data/information (e.g., patient groups
studied, types of experts surveyed)
12. Methods for collecting data/information
13. Methods for analyzing/synthesizing dataJinfor-
mation
14. Results (quantitative and/or qualitative)
15. Findings or conclusions
16. Limitations of findings
17. Implications of findings for practice
18. Recommendations for practice, future assess-
ments, technology development, research
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APPENDICES
19. How much the assessment cost
20. How the technology works, including theory,
principles
21. Development of the technology (including,
e.g., its development, evolution, prospects for
further development)
22. Procurement/deployment information (e.g.,
manufacturer name, how to order, cost, avail-
ability, delivery, installation, staffing/training
requirements, quality control procedures,
maintenance)
Where technology is in use
24. Regulatory agency approval status (e.g., status
of premarketing approval or 510(k) application,
supplemental approvals, regulatory agency
product identification/docket numbers, certif-
icate-of-need status)
25. Coverage/reimbursement status of the tech-
nology (e.g., which payers cover the technol-
ogy and how much is paid for it, diagnosis-
related group status)
26. Product recall history, liability actions
-27. Other, specify:
H. How do you disseminate technology assessment re
sults? Check all that apply. Circle the one relied on
. .
prlmar1 Y.
Printed reports (excluding journal articles)
2. Journal articles
3.
5.
Clearinghouses; data/citation bases; on-line
services; specify which:
6. Other, specify:
I. What is your assessment program's approximate
annual budget (excluding value of in-kind services)?
What percentage of the budget is met by each of the
following sources?
Approximate annual budget: U.S. $
Sources (total = equal 100%;
figures may be approximate) Percent
Parent organization (for programs that
are part of government agencies, this
line would likely be 100%)
%
Government grants/contracts %
Foundations, other private grants %
Sponsors/members dues, contributions %
Sales of assessments, consultant serv-
ices, etc.
Other (specify source, percentage)
Advisories to members/constituents
4. Press conferences/news releases, TV/radio
broadcasts, video products
Total
100%
%
%
%
653
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MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY
Part III. Description of Assessment Program
Please complete a separate survey form for each program/ Program:
type of assessment conducted. For each, please specify
the program/type of assessment covered by this survey Type of assessment:
format.
This section of the survey is for brief narrative descrip-
tions of selected aspects of your assessment program.
These descriptions will enable a better understanding of
your program than can be conveyed alone by the cate-
gorical checklists in the previous section. Many of the
selected aspects below are accompanied by questions
and other items that may be used as guides to your
descriptions. Some of these may not be applicable to
your program; if so, simply indicate "NA."
A. Identification and access
Program name:
Type of assessment:
Director:
The descriptions for this section need not be detailed. It
is sufficient to complete the items in the space provided.
You may use more words if appropriate, but please try
not to exceed 250 words per item. Should you require
extra space for your answers or the requested citations,
please append extra sheets, keying your answers to the
item in the survey.
Contact person and title:
Address:
Telephone:
Telex:
Telefax:
Other access information (e.g., alternative contact persons, publications office, special inquiries)
B. Program origin/chronology
654
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APPENDICES
C. What is the purpose of the assessment program?
D. What Apes of technologies are assessed?
E. During what stages of their life-cycles are technologies assessed?
F. What properties or attributes of technologies are assessed?
G. Selection process for assessment topic
Who can request that an assessment be conducted?
655
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MEDICAE TEC~OEOGY ASSESSMENT DIRECTORY
2. How are requests for assessment made?
3. How and by whom are assessment topic priorities set?
4. What, if any, provisions are made for reassessing technologies?
H. Assessment process
1. What methods are used to conduct assessments?
2. How is the assessment process conducted?
656
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APPENDICES
3. What are areas of expertise of the assessors?
4. What is the approximate (e.g., average or range aft turnaround time from selection of assessment topic to
reporting of findings?
S. What is the approximate cost per assessment?
I. Assessment products and dissemination
What are the types of assessment products?
2. How are assessment results disseminated?
657
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MEDICAL TEC~OLOGY ASSESSMENT DIRECTORY
3. How does one acquire copies of your assessments?
J. Use of assessments
1. How does the parent organization use the program's assessment reports?
2. Who else uses the reports and for what purposes? How do you know?
3. Please describe briefly any documented instances of use of your assessment reports and their impact, citing any
pertinent published documents.
4. Please list any citations in the published literature (journal articles and other publicly available documents) to
the program.
658
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APPENDICES
5. Please list any citations in the published literature to individual assessment reports from your program.
K. Assessment program evaluations. Please briefly describe below any evaluations that have been made of your assessment
program. If more than one evaluation has been conducted, please provide information separately for each one.
1. What was the purpose of the evaluation? Who requested that it be conducted? Who funded it?
2. How was it conducted?
3. Who conducted it?
4. During what period (starting and ending dates) was it conducted?
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MEDICAL TEC~OLOGY ASSESSMENT DIRECTORY
SWhat were the findings?
6. How were the findings used to modify the assessment program?
7. Please list citations to published documents about the evaluation or its findings.
L. Related Activities. If appropriate, please describe (in 250 words or less) activities other than, but related to, technology
assessment with which your program is involved. These activities could include conferences, symposia, newsletters,
special panels or committees, etc.
660
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APPENDICES
Part IV. Listing of Assessment Reports
Please complete a separate survey form for each program/ Program:
type of assessment conducted. For each, please specify
the program/type of assessment covered by this survey Type of assessment:
format.
This section asks you to append lists of citations for
the assessment reports that your program has completed,
has in progress, and is planning; and to note the primary
assessment method(s) used for each. When appending
these lists, please key them to the appropriate section.
To indicate the primary assessment method used to
produce each report, please complete the following steps.
1. Check below the method you usually rely on for con
ducting assessments. If you generally use two or more
methods for conducting each assessment, you may
check the corresponding methods listed (although we
would prefer you check only one-the method pri
marily relied upon for producing the assessment).
Definitions of methods may be found in Part II of the
survey (Question F).
2. For assessment reports produced using a method other
than that indicated in step 1 above, as your usual
method for assessing a technology, indicate the method
used in the particular case by writing (in parenthesis
following the report title) the letter (from the following
list) corresponding to the assessment method actually
used. Thus, you have only to indicate exceptions to
your usual method for conducting assessments.
If you have never deviated from your usual method for
conducting an assessment, which you described in step 1
above, then you would have nothing to add after any of
your assessment report titles.
General category of assessment method
A. Information syntheses
B. Expert opinion
C. Group judgment
D. Modeling
E. Cost analyses
F. Epidemiological and other observational
methods
G. Clinical trials
H. Bench testing
A. Completed reports. Please append a list of all medical
technology assessment reports that your program has
published from its inception to the present.
If your reports are only published elsewhere, e.g., in
a journal, please provide the citation. If you publish
the report and permit collateral journal publication,
listing your publication is sufficient, although you
may list both together if you choose.
If you already have a list of publications or journal
citations, please check that it is current, and that it
specifies clearly the technologies assessed.
To the extent possible, provide publication titles and
citations in Index Medicus style. (See page 2 of the
instructions for examples.) Please provide at mini-
mum the report title, date of publication, other
citation information such as volume, number, and
publisher where appropriate; and primary assessment
method(s) as described above.
We would appreciate receiving an abstract of each
assessment, if available. We are not asking that you
create abstracts if none are available presently, unless
you want to do so.
B. List of ongoing assessments. Please append a list of all
medical technology assessments that your program is
conducting presently or are in the process of being
published and their expected publication dates.
To the extent possible, provide (anticipated) publi-
cation titles and citations in Index Medicus style.
Please provide where possible the (anticipated) report
title, date of publication, other citation information
such as volume, number, and publisher where ap-
propriate; and primary assessment method(s) as de-
scribed above.
If you already have a list of anticipated reports,
please check that it is current, and that it specifies
clearly the technologies being assessed.
66
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MEDICAL TEC~OLOGY ASSESSMENT DIRECTORY
C. List of planned assessments. Please append a list of
any medical technology assessments that your program
is planning to conduct within the next three years. A
planned study is one that is not being conducted
presently, but that you have identified as needed and
have or will set aside resources to conduct it, whether
or not a starting date has been set.
To the extent possible, provide (planned) publication
titles and citations in Index Medicus style. Please
provide where possible the (planned) report title, date
of publication, other citation information such as
volume, number, and publisher where appropriate;
and primary assessment method(s) as described above.
If you already have a list of planned reports, please
check that it is current, and that it specifies clearly
the technologies to be assessed.
Other information, comments. Please provide below any other information you think is relevant to the purpose of this
survey or any comments you may have about the survey. Thank you very much for completing it.
662
Representative terms from entire chapter:
assessment reports
