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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? 659

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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