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Part ~ Assessment Program Profiles anc! Report Citations
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Part I: Assessment Program Profiles arid Report Citations This part has two major sections. Beginning on page 3 are profiles of 68 medical technology assessment programs, with citations of their approximately 3,200 complet- ed, ongoing, and planned assessments. The assessment program profiles are listed alphabetically by name of parent organization. Following the profiles, beginning on page 254, is a subject index to report citations, to be used for locating citations on particular subjects among the profiles. The index has approximately 1,900 subject terms. These terms are listed alphabetically, each followed by one or more relevant assessment report codes. Each code has a two letter prefix . .. . indicating an assessment program and a number indicating the report's placement in the list of citations at the end of the program's profile earlier in Part 1. A list of prefixes and their respective programs is shown on page 252, immediately preceding the subject index.
AMERICAN ACADEMY OF NEUROLOGY American Academy of Neurology Practice Committee 2221 University Overdue SE, Suite 335 Minneapolis, MN 55414 612-623-81 15 Contact: Richard P. Hames, Director, Division of Medical Services and Communica- tions; William H. Stuart M.D., 105 Collier Rd. NW, Suite 1030, Atlanta, GA 30309, 404-351-2270; or John P. Conomy M.D., Department of Neurology, Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, OH 44106, 216-444-5555. Overview: The American Academy of Neurology (AAN) is a 9,000-member medical specialty society founded in 1948. The Academy's major objectives are to stimulate the growth and development of the specialty of clinical neurology and clinical neurologists. The AAN Practice Committee assesses the clinical effectiveness of drugs, devices, and procedures involving the neurosciences. Purpose: To review and evaluate clinical, procedural, and technological requests for opinion received by the Academy. Primary iIItended users: Providers, generally; physicians; health/medical professional associations; third party payers; government regulators. Technologies: Medical or.surmr~71 brnr~l.q~.r~ it Fir vw, 5vvwv c, ~v~ww~ ~ MA ~ ~ V A~- Intervention: Treatment, diagnosis, rehabilitation. Stage: New, established or widespread practice, obsolete. Properties: Effectiveness; safety; efficacy; cost; service requirements; acceptance/adop- tion level; ethical, legal, social implications. Selection process: Individual practitioners in neurology and neurosurgery, medical organizations, and third party payers can request that an assessment be conducted. All requests must be in writing and sent to the Academy office. Requests are submitted to the Practice Committee for opinion and inclusion on the agenda. The Practice Commit- tee does not set assessment topic priorities. The Committee, acting as a group, assesses all questions submitted to it, although the Committee has rejected such complicated topics as organ transplantation. 3
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Methods: Group judgment, expert opinion. The Practice Committee receives reports from several subcommittees that are, in most cases, chaired by a Practice Committee member. The subcommittees consider the procedure/treatment question and exercise one of two options: 1) develop recommen- dation for full committee as to whether the treatment/procedure is established, investi- gational, unacceptable, or indeterminate (as defined in accordance with the American Medical Association (AMA) Diagnostic and Therapeutic Technology Assessment plan); or 2) defer recommendation pending further research/study by subcommittee members. At each of the four regularly scheduled meetings per year the Practice Committee reviews and acts on the recommendations of the subcommittees. Practice Committee actions are then submitted to the Academy Executive Board as information items. The following statement is incorporated into every response to a request for opinion: "This response is provided as a service of the American Academy of Neurology. It is based on current scientific and clinical information through (date of evaluation), and does not represent endorsement by the AAN of particular diagnostic and therapeutic procedures or treatment." When major questions or issues confront the Committee, such as the use of magnetic resonance imaging as a diagnostic procedure, a wider consensus is sought. Working with the Council of Medical Specialty Societies (CMSS), the AMA, and other organiza- tions, a consensus panel is convened and a position paper developed on the technology . . . In question. The turnaround time from selection of assessment topic to reporting of findings ranges from 1 week to 6 months. Assessors: The Practice Committee is composed of 16 members from across the country who represent the interests and concerns of the practitioner. Assessment reports include: Who sponsored/commissioned/ supported the assess- ment; stage of life-cycle of technology when assessed; recommendations for practice, future assessments, technology development, research. Dissemination: Assessment results are disseminated through the minutes of the Prac- tice Committee and through correspondence with other medical organizations and practitioners. The Academy office maintains a listing of Practice Committee decisions and responds to inquiries about procedures/treatment. The Council of Medical Spe- cialty Societies also distributes Practice Committee assessments. Budget: The assessment program is not budgeted as a separate activity. The approxi- mate cost per assessment is not known. Use: The Academy disseminates assessment results to its membership. Based on inquires received, third party payers rely on Practice Committee opinions in making reimbursement decisions. 4
AMERICAN ACADEMY OF NEUROLOGY Completed Reports AA1 American Academy of Neurology, Practice Com- mittee. Extracranial-intracranial bypass surgery for treatment or prevention of stroke. 1986 Feb. tExpert opinion, Group judgment] AA2 . Hyperbaric oxygen therapy for treatment of senility, multiple sclerosis, and cerebral edema. 1986 Feb. tExpert opinion, Group judgment] AA3 . Apheresis (therapeutic) in the treatment of Guillain-Barre Syndrome.1985 fun. LExpert opin- ion, Group judgment] AA4 . Apheresis in treatment of systemic lupus erythematosus. 1985 fun. tExpert opinion, Group judgment] AA5 . Percutaneous transluminal angioplasty (PTA). 1985 Feb. tExpert opinion, Group judgment] AA6 . Topographic mapping. 1985. Feb. LEx- pert opinion, Group judgment] AA7 . Apheresis in treatment of chronic relaps- ing polyneuropathy. 1984 Feb. LExpert opinion, Group judgment] AA8 . Autopsies on patients with slow virus dis- eases. 1984 Nov. [Expert opinion, Group judgments AA9 . EEG guidelines for epileptic mentally re- tarded.1984 Nov. [Expert opinion, Groupjudgment] AA10 . Electromyographic biofeedback in treat- ment of hyperactivity. 1984 Feb. [Expert opinion, Group judgment] AA11 . Electronystagmography. 1984 Jun. LEx- pert opinion, Group judgment] AA12 . Functional integration in the alleviation of chronic muscular pain and spasticity. 1984 Feb. LExpert opinion, Group judgment] AA13 . Nuclear magnetic resonance. 1984 Feb. fExpert opinion, Group judgment] AA14 . Sterotactic cingulatomy. 1984 Nov. LEx- pert opinion, Group judgment] AA15 . Amyotrophic lateral sclerosis injected modified neurotoxin for treatment. 1983 Feb. fEx- pert opinion, Group judgment] AA16 . Edinburgh Masker for stuttering. 1983 Jun. tExpert opinion, Group judgment] AA17 . Histamine desensitization for cluster headache. 1983 Jun. [Expert opinion, Group judg- ment] AA18 . Melodic intonation therapy for aphasia. tExpert opinion, Group judgment] AAl9 . Modified neurotoxin in the treatment of ALS. 1983 fun. fExpert opinion, Group judgment] AA20 . Plasmapheresis in treatment of multiple sclerosis. 1983 Feb. fExpert opinion, Group judg- ment] AA21 . Plasmapheresis in treatment of myasthe- nia gravis. 1983 Feb. fExpert opinion, Group judg- ment] AA22 . Somatosensory evoked response. 1983 Nov. tExpert opinion, Group judgment] AA23 . Trancutaneous electrical nerve stimula- tion for treatment of acute pain for ambulatory pa- tients. 1983 Nov. fExpert opinion, Group judgment] AA24 . Twenty-four hour EEG ambulatory monitoring. 1983 Jun. tExpert opinion, Group judg- ment] AA25 . Biofeedback for headaches. 1982 Jun. [Expert opinion, Group judgment] AA26 . Carotid infusion of BCNU for glioblas- toma multiforme. 1982 Jun. tExpert opinion, Group judgment] AA27 . Cerebellar stimulator implantation for cerebral palsy. 1982 Oct. tExpert opinion, Group judgment] AA28 . Cerebellar stimulator implantation.1982 Jun. LExpert opinion, Group judgment] AA29 . Cochleostomy with neurovascular trans- plant in treatment of Meniere's Disease. 1982 Oc- t.tExpert opinion, Group judgment] AA30 . EEG monitoring-ambulatory. 1982 Apr. fExpert opinion, Group judgment] AA31 . EEG monitoring during open-heart sur- gery and immediate post-operative period. 1982 Oct. LExpert opinion, Group judgment] AA32 . Negative pressure respirators for home use in chronic neuromuscular disease. 1982 Oct. LEx- pert opinion, Group judgment] AA33 . Spinal cord stimulation for treatment of cerebral palsy. 1982 Jun. tExpert opinion, Group judgment] AA34 . Taste and smell clinics. 1982 Jun. fEx- pert opinion, Group judgment] AA35 . Acupuncture.1981 Jul. [Expert opinion, Group judgment] AA36 . Apheresis for multiple sclerosis. 1981 ~ul. FExpert opinion, Group judgment] 5
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY AA37 . EEG interpretation and brain stem evoked response. 1981 Jul. fExpert opinion, Group judgment] AA38 . Electrical nerve stimulation of post-sur- gical pain. 1981 Apr. fExpert opinion, Group judg- ment] AA39 . Electrical stimulation for treatment of Bell's Palsy. 1981 Apr. tExpert opinion, Group judg- ment] AA40 . Electrical stimulation for treatment of facial nerve palsy.1981 May. [Expert opinion, Group judgment] AA41 . Histamine therapy for Men~tre's Dis- ease. 1981 Jul. LExpert opinion, Group judgment] AA42 . Prolotherapy.1981 Jul. Expert opinion, Group judgment] AA43 . Visual evoked potentials. 1981 Jul. tEx- pert opinion, Group judgment] American Academy of Ophthalmology Ophthalmic Procedures Assessment Program PO Box 7424 655 Beach Street San Francisco, CA 94120-7424 415-561-8500 AA44 . Biofeedback treatment for migraine headache. 1980 Apr. LExpert opinion, Group judg- ment] AA45 . Continuous EEG monitoring during surgery. 1980 Apr. tExpert opinion, Group judg- ment1 AA46 . Intracranial pressure monitors. 1980 Oct. FExpert opinion, Group judgment] AA47 . Neurosonology. 1980 Mar. FExpert opinion, Group judgment] AA48 . Spinal stimulation for multiple sclerosis. 1980 May. tExpert opinion, Group judgment] AA49 . Transfer factor treatment in multiple sclerosis. 1980 Apr. fExpert opinion, Group judg- ment] AA50 . Ultrasonic arteriography. 1980 May. fExpert opinion, Group judgment] Contact: Lea Gamble, Director Health Policy Research; or David L. Guyton, M.D., Chairman, Committee on Ophthalmic Procedures Assessment, Wilmer Ophthalmo- logical Institute, the Johns Hopkins Hospital, Baltimore, MD 21205, 301-955-8314. Overview: The American Academy of Ophthalmology (AAO) is a professional associa- tion composed of over 14,000 physicians trained in the specialty of ophthalmology. It offers a wide range of membership services including continuing education programs, public and professional information materials, and scientific meetings. The Ophthal- mic Procedures Assessment Program is the medical technology assessment program of the AAO. Purpose: To present state-of-the-science information about ophthalmic technologies that will help Academy members make informed decisions about patient care. Primary intended users: Physicians, third party payers, government regulators. Technologies: Medical or surgical procedure, drug, device. Ophthalmology-related orphan drugs and products, diagnostic and therapeutic de- vices, and medical and surgical procedures are assessed. Intervention: Treatment, diagnosis. 6
AMERICAN ACADEMY OF OPHTHALMOLOGY Stage: Nell', emerging, established or widespread practice. Sufficient information must be available in the scientific literature to develop assess- ments. Properties: Safety, effectiveness, efficacy. Comprehensive assessments usually follow this format: definition of terms, including development of technique or procedure, extent of current use; clinical implementa- tion, including indications for use, comparison to conventional methods, advantages/ disadvantages, patient population most likely to benefit, and effectiveness; safety; qualifications necessary to use technique; and current research and summary. Selection process: Academy members, public and private third party payers, and government agencies can request that assessments be conducted. Requests will also be accepted from other sources. Usually requests for assessments are written inquiries asking the Academy's position/opinion on a certain technology. Inquiries from individ- uals and private third party payers are frequently received over the telephone, but the AAO requires that a written request be submitted. The Committee on Ophthalmic Procedures Assessment sets priorities. Technologies to be assessed must be within the scope of ophthalmology, and sufficient scientific information on which to base a decision must be available. If new information is available that substantially changes . ~ . . . .. Information contained In an assessment, a reassessment of the technology will be . . . 1nltlatec A. Methods: Information syntheses, group judgment, expert opinion, epidemiological and other observational methods. The scientific literature in refereedjournals is reviewed and expert opinion and group judgment is sought in order to reach consensus. After a decision to evaluate a technol- ogy has been made, the following four steps are followed: 1) an expert is identified who develops a draft with references; 2) the draft is reviewed by other experts, generally AAO members, the Committee, staff, and legal counsel; 3) if substantial changes are needed, a revised draft is recirculated to all reviewers and, generally, a conference call is held to discuss differences in interpretation of findings in the literature; and 4) once a draft is acceptable to the reviewers, it is submitted to the Academy's Board of Directors for approval. For noncontroversial technologies, the average turnaround time from selection of assessment topic to reporting of findings is 6 to 9 months. For controversial technol- ogies the turnaround time can extend into years. Assessors: The Committee is composed of three Academy members, staffed by the Academy's Office of Health Policy Research, and assisted by the membership of the Academy. Academy members participate as reviewers, as in-depth consultants, or by preparing the original draft assessment. A total of 400 Academy members, covering 40 technical areas, have agreed to participate, in some capacity, in the assessment effort. These members participate voluntarily and without remuneration. When appropriate, experts from related fields are consulted. 7
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Assessment reports include: Who conducted the assessment; description of the tech- nology; properties assessed; sources of data/information; findings or conclusions; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles; development of the technol- ogy. Dissemination: Printed reports; journal articles; press conferences/news releases, TV/ radio broadcasts, video products. The Academy prints the assessment reports, and notices of completed assessments appear in the AAO membership newsletter. The assessments are published in the AAO's scientific journal, displayed at the AAO annual meeting, and are mailed to specific organizations and interested individuals. l he Academy's Order Department accepts telephone and written requests for assessment reports. Copies are provided free of charge. Budget: $7,500. Funding source: 100 percept sponsors/members dues, contributions. Use: Assessment reports are considered an educational service to the members and are provided in response to inquiries from the media, third party payers, and the public. Private and public third party payers use them to make policy decisions about coverage. Their purpose for requesting an assessment is generally stated. Related activities: At the 1986 AAO annual meeting, the Committee on Ophthalmic Procedures Assessment sponsored a special scientific session entitled, "Radial Kerato- tomy in Perspective." The purpose of this session was to have opthalmolog~sts repre- senting a range of opinions address key questions about the procedure. Completed Reports AB1 American Academy of Ophthalmology. Epikerato- phakia procedures for the correction of severe hyper- opia, myopia, and keratoconus. San Francisco, CA: American Academy of Ophthalmology, expected completion October 1987. "Information syntheses, Expert opinion] AB2 . Punctal occlusion for the dry eye. San Francisco, CA: American Academy of Ophthalmolo- gy, 1987. [Information syntheses, Expert opinions AB3 . Punctoplasty for siccakeratitis. San Fran- cisco, CA: American Academy of Ophthalmology, ex- pected completion June 1987. "Information synthe- ses, Expert opinions AB4 . Radial keratotomy for myopia. San Fran- cisco, CA: American Academy of Ophthalmology, ex- pected completion October, 1987. "Information syn- theses, Expert opinion] AB5 . Cataract surgery in the 1980's. San Fran- cisco, CA: American Academy of Ophthalmology, 1987. "Information syntheses, Expert opinion] 8 AB6 . Keratophakia and keratomileusis: safety and effectiveness. San Francisco, CA: American Academy of Ophthalmology, 1986. [Information syn- theses, Expert opinions AB7 . Thymoxamine: the need for orphan drug status. San Francisco, CA: American Academy of Ophthalmology, 1986. [Information syntheses, Ex . . pert opinions AB8 . Botulinum toxin therapy of eye muscle disorders: safety and effectiveness. San Francisco, CA: American Academy of Ophthalmology, 1984. [Information syntheses, Expert opinion] AB9 Committee on Ophthalmic Procedures Assess- ment. "American Academy of Ophthalmology] Car- bon dioxide laser surgery in head and neck surgery. San Francisco, CA: American Academy of Ophthal- mology, 1984. "Information syntheses, Expert opin- ion] AB10 . "American Academy of Ophthalmology] Cyanoacrylate tissue adhesive. San Francisco, CA: American Academy of Ophthalmology, 1984. tInfor- mation syntheses, Expert opinion]
AMERICAN ACADEMY OF OPHTHALMOLOGY AB11 . American Academy of Ophthalmology] Therapeutic contact lenses for recurrent corneal ero- sion. San Francisco, CA: American Academy of Oph- thalmology, 1984. Information syntheses, Expert . . Opmlon AB 12 Keltner ~L. fAmerican Academy of Ophthalmol- ogy] Academy recommendation: automated peri- metry. Ophthalmology 1984;91:51-56. [Information syntheses, Expert opinion] American Academy of Pediatrics 141 Northwest Point Boulevard PO Box 927 Elk Grove Village, IL 60009-0927 3 12-228-5005 Contact: lean Lockhart, M.D. AB13 Trokel S. "American Academy of Ophthalmolo- gy] Academy recommendation: ophthalmic neodym- ium YAG lasers: safety and effectiveness. Ophthal- mology 1984;91:539-42. Information syntheses, Ex . . pert opinion AB14 American Academy of Ophthalmology. Laser trabecular surgery for open-angle glaucoma. San Francisco, CA: American Academy of Ophthalmolo- gy, 1983. fInformation syntheses, Expert opinion] Overview: The American Academy of Pediatrics (AAP) is a professional association composed of pediatricians and pediatric medical and surgical subspecialists. The Acad- emy promotes optimal physical, mental, and social health for infants, children, adoles- cents, and young adults. It provides a range of services including advocacy for children and pediatrics, health systems delivery research, public information and education, continuing medical education, and analyses and review of child health policy issues. The Academy's technology assessment activities are an integral part of the information gathering and advisory functions of the numerous AAP Committees. Purpose: The AAP Committees keep abreast of developments in the field and advise the membership and Executive Board on topics within the committees' areas of exper- tise. Primary intended users: General public; physicians; health/medical professional asso- ciations; government regulators; public policy-makers, legislators; policy research or- ganizations; liability, malpractice insurers. Technologies: Drug, device, medical or surgical procedure, support system, organiza . ~ . . . tuna or administrative system. Intervention: Prevention, diagnosis, treatment, rehabilitation. Stage: Emerging, new, established or widespread practice. Properties: Safety; efficacy; effectiveness; service requirements; system impact; ethical, legal, social implications. Selection process: Topic suggestions can come from any source. Usually, assessment topics are suggested by committee members, AAP members, or through other organi- zational requests. The AAP accepts telephone and written requests and occasionally relies on formal contracts. For example, the Food and Drug Administration contracted 9
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY with the AAP for advice relative to infant formulas and drugs. AAP staff screen the requests and then the appropriate committee considers the question. Assessment topic priorities are set by the individual committee and the Academy. Methods: Information syntheses, expert opinion, group judgment. The assessment method varies from committee to committee and by issue, although all committees generally rely on a type of group judgment. For statements, committees usually proceed in the following manner: 1) general discussion of issue; 2) preparation of first draft by committee member; 3) extensive review and preparation of bibliogra- phy by same member (in some cases, this information is reviewed by outside consul- tants); 4) presentation of second draft and discussion by committee; and, 5) revision of draft, if necessary. All reports must be approved by the Executive Board of the AAP. The average turnaround time from selection of assessment topic to reporting of findings ranges from 4 months to 1 year. Assessors: AAP has committees in such areas as adolescence, bioethics, drugs, fetus and newborn, hospital care, infectious diseases, nutrition, radiology, and surgery. Each committee consists of experts in the topic area. Committees can also bring in consul- tants for additional expertise on particular reports. Dissemination: Printed reports; advisories to members/constituents; press confer- ences/news releases, TV/radio broadcasts. Committees issue reports with the assessment findings. For smaller scale projects a note is made in the minutes or a recommendation given to the AAP Executive Board. AAP Committee statements are published in Ped~atrics or information may appear in AAP News. Occasionally, letters are sent to government agencies such as the Environmental Protection Agency or the Consumer Product Safety Commission. Some reports are distributed directly to the AAP members, such as the Report of the Committee on Infectious Diseases (the "Red Book". Budget: Not provided. Related activities: The AAP publishes a quarterly newsletter, Child Health Financing Report, which contains the latest information about child health financing for privately insured children and those covered by Medicare. The Academy also sponsors an annual meeting, educational programs, and continuing education courses. Completed Reports AC1 American Academy of Pediatrics, Committee on Hospital Care. Emergency services. Pediatrics (To be published). AC2 , Committee on Hospital Care. Guidelines for air and ground transportation. Pediatrics (To be published). AC3 , Committee on Hospital Care. Quality as- surance of hospital care of children. Pediatrics (To be published). 10 AC4 , Committee on Practice and Ambulatory Medicine. Screening for vision problems. Pediatrics (To be published). AC5 , Committee on Accident and Poison Pre- vention. Revised first aid for the choking child. Pedi- atrics 1986 Jun. AC6 , Committee on Child Health Financing. Medicaid policy statement. Pediatrics 1986 May. AC7 , Committee on Disabilities. Screening for developmental disabilities. Pediatrics 1986 Sep.
AMERICAN ACADEMY OF PEDIATRICS AC8 , Committee on Disabilities. Transition of severely disabled children from hospital or chronic care facilities to the community. Pediatrics 1986 Sep. AC9 , Committee on Early Childhood, Adop- tion, and Dependent Care. Oral and dental aspects of child abuse and neglect. Pediatrics 1986 Sep. ACID , Committee on Nutrition. Prudent life- style for children: dietary fat and cholesterol. Pediat- rics 1986 Sep. AC11 , Committee on Practice and Ambulatory Medicine. Vision screening and eye examination in children. Pediatrics 1986 fun. AC12 , Committee on Research. Guidelines for the Pediatric Cancer Center and the role of such cen- ters in diagnosis and treatment. Pediatrics 1986 Jun. ACID , Committee on School Health. CPR train- ing in the school. AAP News 1986 Jan. AC14 , Committee on School Health. School attendance of children and adolescents with human T Iymphotropic virus III/lymphadenopathy-associated virus infection. Pediatrics 1986 Mar. ACID , Committee on School Health. School health examinations. AAP News 1986 Feb. ACID , Committee on Infectious Diseases. Pre- vention of hepatitis B virus infections. Pediatrics 1985 Feb. AC17 , Committee on Bioethics. Proposed guidelines on genetic engineering. Pediatrics 1985 Jun. AC18 , Committee on Disabilities. Assisting disa- bled children. Pediatrics 1985 Jun. ACl9 , Committee on Disabilities. Provision of related services for children with chronic disabilities. Pediatrics 1985 Apr. AC20 , Committee on Drugs. "Inactive" ingredi- ents in pharmaceutical products. Pediatrics 1985 Oct. AC21 , Committee on Drugs. Behavioral and cognitive effects of anticonvulsant therapy. Pediatrics 1985 Oct. AC22 , Committee on Drugs. Guidelines for the elective use or conscious use of sedation, deep seda- tion, and general anesthesia in pediatric patients. Pe- diatrics 1985 Aug. AC23 , Committee on Environmental Hazards. Smokeless tobacco-a carcinogenic hazard to chil- dren. Pediatrics 1985. AC24 , Committee on Fetus and Newborn. High risk newborn care. Pediatrics 1985 Jul. ACES , Committee on Fetus and Newborn. Home phototherapy. Pediatrics 1985 Soul. AC26 , Committee on Fetus and Newborn. Vita- min E and the prevention of retinopathy of prematu- rity. Pediatrics 1985 Aug. AC27 , Committee on Hospital Care. Child life programs for hospitalized children. Pediatrics 1985 Sep. AC28 , Committee on Hospital Care. Guidelines for pediatric intensive care units. Pediatrics 1983 Sep. AC29 , Committee on Infectious Diseases. lIe- mophilus type b polysaccharide vaccine. Pediatrics 1985 Aug. AC30 , Committee on Infectious Diseases. Rec- ommendations for using pneumococcal vaccine in children. Pediatrics 1985 Jun. AC31 , Committee on Infectious Diseases. Rec- ommendations for using pneumococcal vaccine in children. Pediatrics 1985 fun. AC32 , Committee on Nutrition. Nutritional needs of low-birth-weight infants. Pediatrics 1985 May. AC33 , Committee on Nutrition. Use of oral fluid therapy and posttreatment feeding following enteritis in children in a developed country. Pediatrics 1985 Feb. AC34 , Committee on Practice and Ambulatory Medicine. Computers in your practice. Pediatrics 1985 Jul. AC35 , Committee on Practice and Ambulatory Medicine. High risk newborn care. Pediatrics 1985 Jul. AC36 , Committee on School Health. Health education and schools. Pediatrics 1985 Jun. AC37 , Committee on Screening Genetics. Ma- ternal phenylketonuria. Pediatrics 1985 Aug. AC38 , Committee on Adolescence. A policy reference guide to the AAP's Council Committee and Executive Board statements. 1984. AC39 , Committee on Drugs. Ethanol in liquid preparations intended for children. 1984. AC40 , Committee on Drugs. Antimicrobial pro- phylaxis in pediatric surgical patients. Pediatrics 1984 Sep. AC41 , Committee on Infectious Diseases. Anti- microbial prophylaxis in pediatric surgical patients. Pediatrics 1984 Sep. 11
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY AC42 , Committee on Infectious Diseases. Per- tussis vaccine. Pediatrics 1984 Aug. AC43 , Committee on Nutrition. Imitation and substitute milks. Pediatrics 1984 Jun. AC44 , Committee on Research. Fetal research. Pediatrics 1984 Sep. AC45 , Committee on School Health. Adminis- tration of medication in school. Pediatrics 1984 Sep. AC46 , Committee on School Health. Alcohol abuse education in schools. Pediatrics 1984 Sep. AC47 , Committee on School Health. Guidelines for urgent care in schools. Pediatrics 1984 Jul. AC48 , Committee on School Health. Heat stress and school closings. Pediatrics 1984 Aug. AC49 , Committee on Sports Medicine. Health appraisal guidelines for day camps and residence camps. Pediatrics 1984 fun. AC50 , Committee on Nutrition. The use of whole cow's milk in infancy. Pediatrics 1983 Aug. AC51 , Committee on Adolescence. Rape and the adolescent. Pediatrics 1983 Nov. AC52 , Committee on Adolescence. The role of the pediatrician in substance abuse counseling. Pedi- atrics 1983 Aug. AC53 , Committee on Bioethics. Treatment of critically ill newborns. 1983. AC54 , Committee on Drugs. Growth hormone in treatment of children with short stature. 1983. AC55 , Committee on Drugs. "Look-alikes." Pe- diatrics 1983 Aug. AC56 , Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics 1983 Sep. AC57 , Committee on Drugs. Dimethyl sulfox- ide (DMSO). Pediatrics 1983 Tan. AC58 , Committee on Drugs. New therapy for severe cystic acne. Pediatrics 1983 Aug. AC59 , Committee on Drugs. Valproate terato- genicity. Pediatrics 1983 Jun. AC60 , Committee on Early Childhood, Adop- tion, and Dependent Care. Gonorrhea in prepubertal children. Pediatrics 1983 Apr. AC61 , Committee on Fetus and Newborn. Ben- zyl alcohol: toxic agent in neonatal units. Pediatrics 1983 Sep. 2 AC62 , Committee on Nutrition. Soy-protein formulas: recommendations for use in infant feeding. t19831 AC63 , Committee on Nutrition. Commentary on parenteral nutrition. Pediatrics 1983 Apr. AC64 , Committee on Nutrition. Toward a pru- dent diet for children. Pediatrics 1983 Jan. AC65 , Committee on Research. Reducing the toll of injuries in childhood requires support for a focused research effort. Pediatrics 1983 Nov. AC66 , Committee on Sports Medicine. Sports and the child with epilepsy. Pediatrics 1983 Dec. AC67 American Academy of Pediatrics, Committee on Fetus and Newborn. Criteria for early infant dis- charge and follow-up evaluation. Pediatrics 1982 Dec. AC68 , Committee on Disabilities. The Doman- Delacato treatment of neurologically handicapped children. Pediatrics 1982 Nov. AC69 , Committee on Drugs. Psychotropic drugs in pregnancy and lactation. Pediatrics 1982 Feb. AC70 , Committee on Drugs. Valproic acid: benef~ts and risks. Pediatrics 1982 Aug. AC71 , Committee on Hospital Care. Preoper- ative chest radiographs. Pediatrics 1983 May. AC72 , Committee on Infectious Diseases. Aspi- rin and Reye syndrome. Pediatrics 1982 Jun. AC73 , Committee on Nutrition. Promotion of breast feeding. 1982. AC74 , Committee on Research. Guidelines for health supervision of pediatric visits as recommended by the American Academy of Pediatrics Committee on Practice and Ambulatory Medicine. News and Comment 1982 May. AC75 , Committee on Screening Genetics. New issues in newborn screening for phenylketonuria and congenital hypothyroidism. Pediatrics 1982 Jan. AC76 , Committee on Sports Medicine. Risks in long distance running for children. Pediatrics 1982 Jun. AC77 , Committee on Nutrition. Nutritional as- pects of obesity in infancy and childhood. Pediatrics 1981 Dec. AC78 , Committee on Nutrition. Breast feeding and contraception. 1981 AC79 , Committee on Nutrition. Breast feeding and contraception. 1981.
AMERICAN ACADEMY OF PEDIATRICS AC80 , Committee on Nutrition. Plant fiber in- take in pediatric diet. 1981. AC81 , Committee on Nutrition. Sodium intake for infants in the U.S., 1981. AC82 , Committee on Nutrition. Nutrition and lactation. Pediatrics 1981 Sep. AC83 , Committee on Adolescence. Contracep- tion for the adolescent. Pediatrics 1980 Mar. AC84 , Committee on Drugs. Anticonvulsants and pregnancy. Pediatrics 1980 Feb. AC85 , Committee on Drugs. Medroxyproges- terone acetate (Depo-Provera). Pediatrics 1980 Mar. AC86 , Committee on Drugs. Naloxone use in newborns. Pediatrics 1980 Mar. AC87 , Committee on Nutrition. Vitamins and mineral supplement needs. 1980. AC88 , Committee on Nutrition. Encouraging breast-feeding. Pediatrics 1980 Mar. AC89 , Committee on Nutrition. Human milk banking. Pediatrics 1980 Apr. AC90 , Committee on Nutrition. On the feeding of supplemental foods to infants. Pediatrics 1980 J un. AC91 , Committee on Radiology. Comparison radiographs of extremities in childhood: recom- mended usage. Pediatrics 1980 Mar. AC92 , Committee on Radiology. Excretory orography for evaluation of enuresis. Pediatrics 1980 Mar. AC93 , Committee on Screening Genetics. Pre- natal diagnosis for pediatricians. Pediatrics 1980 Jun. AC94 , Committee on Adolescence. Pregnancy and abortion counseling. Pediatrics 1979 fun. AC95 , Committee on Disabilities. Current ap- proaches to evaluation and management of children with myelomeningocele. Pediatrics 1979 Apr. AC96 , Committee on Sports Medicine. Acci- dental hypothermia. Pediatrics 1979 fun. AC97 Committee on Drugs. Camphor: who needs it? Pediatrics 1978 Sep. AC98 , Committee on Drugs. Commentary on anthelmintics. Pediatrics 1978 Aug. AC99 , Committee on Drugs. Effect of medica- tion during labor and delivery on infant outcome. Pediatrics 1978 Sep. AC100 , Committee on Drugs. PUVA: a caution. Pediatrics 1978 Aug. AC101 , Committee on Drugs. Treatment of congenital hypothyroidism. Pediatrics 1978 Sep. AC102 , Committee on Drugs. Unapproved uses of approved drugs: the physician, the package insert, and the FDA. Pediatrics 1978 Aug. AC103 , Committee on Drugs. Use of codeine- and dextromethorphan-containing cough syrups in pediatrics. Pediatrics 1978 Tut. AC104 , Committee on Nutrition. Juice in ready-to-use bottles and nursing bottle caries. 1978. AC105 , Committee on Nutrition. Breast-feed- ing. Pediatrics 1978 Oct. AC106 , Committee on Radiology. Radiation of pregnant women. Pediatrics 1978 Jan. AC107 , Committee on Radiology. Water-solu- ble contrast material. Pediatrics 1978 {ul. AC108 , Committee on Nutrition. Nutritional aspects of vegetarianism, health foods and fad diets. Pediatrics 1977 Mar. AC109 , Committee on Screening Genetics. Screening school children for urologic disease. Pedi- atrics 1977 Aug. AC110 , Committee on Drugs. Adverse reac- tions to iodide therapy of asthma and other pulmo- nary diseases. Pediatrics 1976 Feb. ACl l l , Committee on Drugs. Generic prescrib- ing. Pediatrics 1976 Feb. AC112 , Committee on Nutrition. Commentary on breast-feeding and infant formulas, including pro- posed standards for formulas. Pediatrics 1976 Feb. AC113 , Committee on Bioethics. AAP code of ethics for the use of fetuses and fetal material for research. 1975 AC114 , Committee on Fetus and Newborn. Re- port of the Ad Hoc Task Force on Circumcision. Pediatrics 1975 Oct. AC115 , Committee on Disabilities. Early identi- fication of children with learning disabilities: the pre- school child. Pediatrics 1973 Nov. 13
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY American College of Cardiology/Amer~can Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures American College of Cardiology 91 ~ ~ Old Georgetown Road Bethesda, MD 20814 30 1-897-5400 American Heart Association National Center 7320 Greenville Avenue Dallas, TX 75231 2 14-373-6300 Contact: Charles Fisch, M.D., Chairman ACC/AHA Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures; David Feild, Associate Execu- tive Vice President, American College of Cardiology; or Kathryn A. Taubert, Ph.D., Science Consultant, American Heart Association 214-706-1455. Overview: The American College of Cardiology (ACC) is a professional medical society composed of physicians and scientists. Its mission is to ensure optimal care for persons with cardiovascular disease or the potential for developing cardiovascular disease and to contribute to the prevention of cardiovascular disease through educa- tional and socio-economic activities. The American Heart Association (AMA) is a voluntary health agency supported by public contributions and the donated time of volunteers. Its mission is to reduce premature death and disability from cardiovascular disease and stroke. The Task Force on the Assessment of Diagnostic and Therapeutic Cardiovascular Procedures is a technology assessment program jointly sponsored by the AHA and the ACC. Purpose: To define the role of noninvasive and invasive diagnostic and therapeutic procedures in the diagnosis and management of cardiovascular disease. Prunary intended users: Physicians. Technologies: Medical or surgical procedure. Specifically, diagnostic and therapeutic cardiovascular procedures are assessed. Intervention: Diagnosis, treatment. Stage: Established or widespread practice. Properties: Effectiveness, indications/contraindications. Selection process: Members of the American College of Cardiology or the American Heart Association can submit, in writing, requests for assessments to the Chairman of the ACC/AHA Task Force. The Task Force meets at least twice a year to discuss possible future assessments. Recommendations are forwarded to the officers of the 14
AMERICAN COLLEGE OF CARDIOLOGY/AMERICAN HEART ASSOCIATION American College of Cardiology and the American Heart Association. The possibility of updating published assessment reports is currently under discussion. Methods: Information syntheses, expert opinion, group judgment. As part of the assessment process a series of committee meetings are held. As the assessment report develops, information is shared, via mail, between Task Force mem- bers. The approximate turnaround time from selection of assessment topic to report- ing of findings is 18 months. Assessors: Task Force members are physicians who specialize in cardiovascular medi- cine. Assessment reports include: The purpose of the assessment, who sponsored/commis- sioned/supported the assessment, who conducted the assessment, description of the technology. Dissemination: Journal articles. Reports are published simultaneously in the Journal of the American College of Cardiology and Circulation. Copies of the assessment reports can be obtained by contacting the headquarters offices of the American College of Cardiology or the American Heart · . . Assoclatlon. -\ Budget: $25,000. The approximate direct costs per assessment ranges from $10,000 to $15,000. Volunteer time committed to this effort is significant and is not calculated in this amount. Funding source: 50 percent American College of Cardiology, 50 percent American Heart Association. Use: The Task Force assessment activities are described in Institute of Medicine, Committee on Evaluating Medical Technologies in Clinical Use. Assessing medical tech- nologaes. Washington, DC: National Academy Press, 1985. Related activities: Services available to ACC members include a government relations department that promotes cardiovascular issues, the Cardiology and Affiliates in Training newsletters, an endowments program, professional awards programs, and continuing education opportunities. The 14 Scientific Councils of the AHA generate state-of-the-art and position papers concerning specific areas of cardiovascular disease such as arteriosclerosis, cardiovascu- lar radiology, cardiovascular surgery, and thrombosis. The Association provides ap- proximately $50 million annually for scientific research and additional support for public education programs. The AHA advocates legislation for research and education in the field. Completed Reports AD1 O'Rourke RA, Chatterjee K, Dodge HT, et al. fAmerican College of Cardiology/American Heart Association Task Force on Assessment of Cardiovas- cular Procedures] Guidelines for clinical use of cardi- ac radionuclide imaging. ~ Am Coll Cardiol 1986 Dec;8:1471-83. EGroup judgment] AD2 Schlant RC, Blomqvist CG, Brandenburg RO, et al. [American College of Cardiology/American Heart Association Task Force on Assessment of Cardiovas- cular Procedures] Guidelines for exercise testing. J Am Coll Cardiol 1986;8:725-738. tGroup judgments 15
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY ADS Frye RL, Collins,,, DeSanctis RW, et al. [American College of Cardiology/American Heart Association Task Force on Assessment of Cardiovascular Proce- dures] Guidelines for permanent cardiac pacemaker implantation. ,i,,Am Coll Cardiol 1984;4:434-42. (Group judgments Ongoing Assessments AD4 American College of Cardiology/American Heart Association Task Force on Assessment of Cardiovas- cular Procedures. Guidelines for ambulatory electro- cardiographic monitoring. Ongoing. [Group judg- ment] ADS . Guidelines for clinical intracardiac elec trophysiologic studies. Ongoing. [Group judgment] ADO . Guidelines for coronary angiography. Ongoing. [Group judgment] AD7 . Guidelines for percutaneous transluminal coronary angioplasty (PICA). Ongoing. [Group judgments American College of Obstetricians and Gvnecolomsts Committee Opinions 600 Marylanct Avenue SW Washington, DC 20024 202-638-5577 Contact: Shirley A. Shelton, Associate Director, Division of Practice Activities; or the ACOG Resource Center. Overview: The American College of Obstetricians and Gynecologists (ACOG) is a not- for-profit, professional organization comprised of more than 26,000 physicians trained in the specialty of obstetrics and gynecology. The purpose of the organization is to promote and maintain high standards for women's health care by providing quality continuing education for its members and establishing patient care standards. ACOG is governed by an Executive Board composed of seven selected officers from the mem- bership and ten District representatives. The Committee Opinions program is one of two technology assessment programs sponsored by the College. Purpose: To provide members and other interested parties with state-of-the-art infor- mation on the clinical application of new technologies. Primary intended users: Physicians, third party payers, public policy-makers, legisla- tors. Technologies: Medical or surgical procedure, drug, device. The committees assess new devices, equipment, and other therapeutic modalities for the treatment of reproductive disorders in women. Intervention: Treatment, diagnosis. Stage: New, emerging, established or widespread practice. Technologies are assessed as they are being applied to clinical practice. Properties: Electiveness, safety, service requirements. 16
ACOG/COMMfFrEE OPINIONS Selection process: Within the ACOG structure, the Executive Board, Health Care Commission, or individual members can request that an assessment be conducted. The College also receives requests from third party carriers and government agencies. Only written requests are accepted. Assessment topic priorities are set by the Executive Board, Health Care Commission, and the committee to whom the request is referred. All existing opinions/statements are reviewed within 18 to 24 months from date of publication for relevance and accuracy. Methods: Information syntheses, expert opinion, group judgment. A subject is selected and referred to a committee. The committee elects a member to review the literature and draft a preliminary report citing literature references. The committee discusses the preliminary draft, achieves consensus on areas of controversy, and submits a revised report to an expert panel for review and comment. Information from reviewers is synthesized and a final report prepared for review by the Health Care Commission and Executive Board prior to publication. At any step along the way, when agreement is in doubt, the advice of further technical experts may be sought. The turnaround time from selection of the ~.cf>.c.cm~nt tonic to r`~'hlir~t;^rl ~f the findings ranges from 18 to 24 months. ~_ A ~ ^ ~ ~ .~. ~- 6_ ~ < .IL ~ Ad. ~ AL At_ C4. ~ l V 1 ~By 1 ~ 1 1 ~ Assessors: Committee members represent the academic and the clinical practice com- munities, are geographically dispersed, and reflect a wide range of practice settings. Panel experts are chosen because of their recognized authority in the chosen subject. The Health Care Commission and the Executive Board members are academicians, clinical practice generalists, and subspecialists. Assessment reports include: Description of the technology; sources of data/informa- tion; findings or conclusions; how the technology works, including theory, principles; whether the technology is experimental, investigational, or considered acceptable clini- cal practice. Dissemination: Advisories to memberslconstituents, printed reports. Assessments are published as committee opinions and are disseminated to the College membership as an insert in the monthly ACOG newsletter. The reports are available upon request to all other interested parties. Budget: $15,000. Currently, the assessment activity is considered part of the charge of the obstetric and gynecologic standing committees and is not identified separately within the committee budget. Therefore, the approximate cost per assessment is not known. Approximately $15,000 is allocated for printing and distribution of the reports to the membership. Funding source: 100 percent parent organization. Use: When appropriate, the report conclusions are conveyed in other documents prepared by the ACOG (such as educational resources) and used in responding to individuals and organizations requesting specific information. Third party carriers use the reports for insurance purposes and to determine if the technology is viewed as clinically applicable. Members use the reports to determine if the state-of-the-art of the technology is appropriate for application to their practices. The publications ACOG Standards for Obstetric-Gynecologic Services, Guidelines for Perinatal Care, and Precis, a compendium of current information in the specialty, reflect commit- tee opinions where applicable. New editions of these publications appear every 3 years. 17
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Related activities: The College produces a scientific, refereed journal that primarily reports research and the results of controlled clinical studies. These reports, along with those published in similarjournals, provide the data with which committees form their opinions. The College also issues Technical Bulletins (see separate profile on ACOG Committee on Technical Bulletins), conducts an annual scientific meeting with sympo- sia on new information in the specialty, and offers free-standing postgraduate courses on a variety of topics, many of which convey information on technologic advances and, where applicable, committee opinions. The College also provides a contraceptive slide rule for lay persons which spells out the risks/benef~ts, advantages/disadvantages, cost, and mortality rates for various forms of contraceptives . Completed Reports AE1 American College of Obstetricians and Gynecolo- gists, Committee Opinion. Clinical use of bromocrip- tine. Pending. [Information syntheses] AE2 . Teratogenicity of steroids. Pending. tIn- formation syntheses] AE3 . Ultrasonography in the monitoring of fol- licular growth. Pending. fInformation syntheses] AE4 . Hysteroscopy. Revised 1986 Jan. [Infor- mation syntheses] AE5 . The use of cryosurgery in the treatment of CIN. Revised 1986 Nov. LInformation syntheses] AE6 . Contraception for women in their later reproductive years. 1985 Dec. [Information synthe- ses] AE7 . Current role of electronic heart rate moni- toring in labor. Revised 1985 Jul. fInformation syn- theses] AE8 . Endometrial sampling. 1985 Jun. fInfor- mation syntheses] AE9 . Prophylactic use of antibiotics with ab- dominal hysterectomy. fInformation syntheses] American College of Obstetricians and Gynecologists Committee on Technical Bulledns 600 Maryland Avenue SW Washington, DC 20024 202-638-5577 AE10 . Anticonvulsants and pregnancy. Revised 1984 {ul. [Information syntheses] AEll . Carbon dioxide laser. Revised 1984 Apr. fInformation syntheses] AE12 . Fetoscopy. Revised 1984 Jul. ~Informa- tion syntheses] AE13 . Human in vitro fertilization and embryo placement. 1984 Apr. fInformation syntheses] AE14 . Microsurgery. 1984 Apr. fInformation syntheses] AE15 . Needle aspiration cytology in the evalua- tion of breast lesions. 1984 Tun. [Information synthe- ses] AE16 . Breast-feeding and contraception. 1981 May. LInformation syntheses] AE17 . ACOG statement on periodic cancer screening for women.1980 Jun. fInformation synthe- ses] AE18 . ACOG statement on mammography. 1979 Sep. fInformation syntheses] Contact: Rebecca Rinehart, Associate Director of Publications, Division of Education; or the ACOG Resource Center. 18
ACOG/COMMIPrEE ON TECHNICAL BULLETINS Overview: The American College of Obstetricians and Gynecologists (ACOG) is a not- for-profit, professional organization comprised of more than 26,000 physicians trained in the specialty of obstetrics and gynecology. The purpose of the organization is to promote and maintain high standards for women's health care by providing quality continuing education for its members and establishing patient care standards. ACOG is governed by an Executive Board composed of seven elected officers from the member- ship and ten District representatives. The Committee on Technical Bulletins is one of two technology assessment programs sponsored by the College. Pulpose: To provide practicing physicians with timely information on the latest proven techniques of clinical practice in the specialty. Primary intended users: Physicians. Technologies: Medical or surgical procedure, drug, device. The Committee assesses the management of specific reproductive disorders, treatment therapies, and the application of new technologies. Inte~vendon: Treatment, prevention, diagnosis. Stage: Established or widespread practice, new. Technologies are assessed when they are determined to have widespread applicability . . . . . In c Inca practice. Properties: Effectiveness, service requirements, acceptance/adoption level. Selection process: The Committee on Technical Bulletins is responsible for surveying current clinical knowledge to determine the need to address new topics or to update existing Bulletins. Topics can also be suggested by the Learning Resources and the Health Care Commissions, other standing committees, the Executive Board, and indi- vidual members. Requests for assessments are made by Committee consensus and are submitted in writing. Assessment topic priorities are set by the Committee in consulta- tion with the Learning Resources Commission. Technical Bulletins generally are reviewed for relevance and accuracy within 3 years from date of publication unless new information requires earlier attention. Methods: Expert opinion, group judgment. Once a topic is selected by the Committee on Technical Bulletins, an expert on the topic is chosen to prepare a manuscript. The Committee reviews the author's draft and achieves consensus on areas of disagreement between members and the author. A revised draft is submitted to the Learning Resources Commission. Information from the reviewers is synthesized, consensus is reached regarding any further unresolved matters, and a final report is prepared for review by the Executive Board prior to publication. The turnaround time from selection of the topic to the publication of findings averages between 18 to 24 months. 19
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Assessors: Committee members are geographically dispersed and are representatives of the academic and clinical practice communities. Authors are recognized authorities in the topics selected. The Learning Resources Commission and the Executive Board members are academicians, clinical practice generalists and subspecialists. Assessment reports include: Description of the technology; sources of data/informa- tion; findings or conclusions; how the technology works, including theory, principles. Dissemination: Printed reports, advisories to members/constituents. Assessments are published as Technical Bulletins and the results are disseminated to the College membership as an insert in the monthly ACOG newsletter. Requests for copies of the Technical Bulletins should be directed to the ACOG Distribution Center at the Washington, DC address. Budget: $95,000. The approximate cost per assessment is $5,000 exclusive of Commit- tee budget. Funding source: 100 percent parent organization. Use: The College uses the Technical Bulletins to keep members informed regarding accepted clinical management techniques. Insurers report that they have introduced the Bulletins as evidence in malpractice suits, by both plaintiffs and defendants. Trial lawyers have also used the Bulletins. The publications ACOG Standards for Obstetric-Gynecologic Services, Guidelines for Per7natal Care, and Prects, a compendium of current information in the specialty, reflect, where applicable, the findings of Technical Bulletins. New editions of these publications appear every 3-4 years. Program evaluation: The ACOG Division of Education periodically asks participants and members attending courses and annual meetings to evaluate the usefulness of educational offerings. Technical Bulletins consistently have been rated high by respon- dents. Related activities: ACOG produces a scientific, refereedjournal that primarily reports research and the results of controlled clinical studies. The College also issues committee opinions (see separate profile on ACOG Committee Opinions), conducts an annual scientific meeting with symposia on new information in the specialty, and offers free- standing postgraduate courses on a variety of topics, many of which convey informa- tion on technology advances. The College also provides a contraceptive slide rule for lay persons that spells out the risks/benef~ts, advantages/disadvantages, cost, and mortality rates for various forms of contraceptives. Completed Reports AF1 American College of Obstetricians and Gynecolo- gists, Committee on Technical Bulletins. Antimicrobi- al therapy for gynecologic infections. 1986 Oct. (Technical bulletin no. 971. fExpert opinion] AF: . Estrogen replacement therapy. 1986 fun. (Technical bulletin no. 931. [Expert opinion] 20 A173 . Management of diabetes mellitus in preg- nancy. 1986 May. (Technical bulletin no. 921. FExnert . . Opmlon -,- .---r- AF4 - . Management of isoimmunization in preg- nancy. 1986 Jan. (Technical bulletin no. 901. fExpert . . Opmlon
ACOG/COMMIPrEE ON TECHNICAL BULLETINS AF5 . Management of preeclampsia. 1986 Mar. (Technical Bulletin no. 911. [Expert opinion] AF6 . Management of the breech presentation. 1986 Aug. (Technical bulletin no. 951. tExpert opin- ion] AF7 . Genitourinary fistula. 1985 Tan. (Techni- cal bulletin no 831. LExpert opinion] AF8 . Gonorrhea and chlamydia infections. 1985 Nov. (Technical bulletin no. 891. fExpert opin- ion] AP9 . Management of endometriosis.1985 Mar. (Technical bulletin no. 851. fExpert opinion] AF10 . Blood component therapy. 1984 Jul. (Technical bulletin no. 781. fExpert opinion] AFll . Carcinoma of the endometrium. 1984 Mar. (Technical bulletin no. 751. LExpert opinion] AF12 _ . Carcinoma of the vulva.1984 Jun. (Tech- nical Bulletin no. 771. [Expert opinion] AF13 . Cervical cytology: evaluation and man- agement of abnormalities.1984 Oct. (Technical bulle- tin no. 81~. tExpert opinion] AF14 . Prevention of Rho(D) isoimmunization. 1984 Aug. (Technical bulletin no. 791. fExpert opin- ion] AF15 . Septic shock.1984 Mar. (Technical bulle- tin no. 751. LExpert opinion] AF16 . Hemorrhagic shock. 1984 Dec. (Techni- cal bulletin no. 82~. Expert opinion] AF17 . Automobile passenger restraints for chil- dren and pregnant women.1983 Dec. (Technical bul- letin no. 741. LExpert opinion] AF18 . Cancer of the ovary. 1983 Oct. (Techni- cal bulletin no. 731. fExpert opinion] AFl9 . Diagnosis and management of invasive cervical carcinomas. 1983 May. (Technical bulletin no. 691. [Expert opinion] AF20 . Dysmenorrhea. 1983 Mar. (Technical bulletin no. 681. tExpert opinion] AF21 . Epidemiology and diagnosis of breast disease.1983 Sep. (Technical bulletin no.71 ~. fExpert . . ~ opmlonJ AF22 . Osteoporosis.1983 Oct. (Technical bulle- tin no. 72~. fExpert oppinion] AF23 . Anesthesia for cesarean section. 1982 May. (Technical bulletin no. 65~. fExpert opinion] AF24 . Dysfunctional uterine bleeding. 1982 Sep. (Technical bulletin no. 661. fExpert opinion] AF25 . Immunization during pregnancy. 1982 May. (Technical bulletin no. 64~. fExpert opinion] AF26 . Prenatal detection of neural tube defects. 1982 Oct. (Technical bulletin no. 671. fExpert opin- ion] AF27 . Diagnostic ultrasound in obstetrics and gynecology. 1981 Oct. (Technical bulletin no. 631. fExpert opinion] AF28 . Neonatal metabolic diseases. 1981 ~an. (Technical bulletin no. 60~. [Expert opinion] AF29 . Rubella-a clinical update. 1981 Jul. (Technical bulletin no. 621. tExpert opinion] AF30 . Management of gestational trophoblastic neoplasia.1980 Dec. (Technical bulleltin no.59~. tEx . . ~ pert op~n~onJ AF31 . Pregnancy, work, and disability. 1980 May. (Technical bulletin no. 58~. tExpert opinion] AF32 . Cigarette smoking and pregnancy. 1979 Sep. (Technical bulletin no. 531. [Expert opinion] AF33 . Diagnosis and management of missed abortion and antepartum fetal death. 1979 Nov. (Technical bulletin no. 55~. LExpert opinion] AF34 . Methods of midtrimester abortion. 1979 Dec. (Technical bulletin no. 561. tExpert opinion] AF35 . Induction of labor. l 978 May. (Technical bulletin no. 491. fExpert opinion] AF36 . Sexually transmitted diseases (STD): oth- er than gonorrhea and syphilis. (Technical bulletin no. 511. 1978 Jul. [Expert opinion] AF37 . Classification and staging of malignant tumors in the female pelvis. 1977 Jun. (Technical bulletin no. 471. LExpert opinion] AF38 . Communication of sexual problems in office gynecology. 1977 Apr. (Technical bulletin no. 451. FExpert opinion] AF~ . Intrapartum fetal monitoring. 1977 Jan. ~ - - nical bulletin no. 441. tExpert opinion] A1740 . Prevention of hospital-acquired urinary tract infections in gynecology patients. 1977 May. (Technical bulletin no. 46~. fExpert opinion] AF41 . Fetal blood sampling. 1976 Oct. (Techni- cal bulletin no. 42~. FExpert opinion] AF42 . Oral contraception 1976 Jul. (Technical bulletin no. 41~. LExpert opinion] AF43 . Prevention of Tay-Sachs disease: carrier identification and genetic counseling. 1976 Jan. (Technical bulletin no. 341. LExpert opinion] ~1
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY AF44 . Urinary incontinence in the female. 1979 Feb. (Technical bulletin no. 36~. [Expert opinion] American College of Physicians Clinical Efficacy Assessment Project 4200 Pine Street Philadelphia, PA 19104 215-243-1200; 800-523-1546 Contact: Linda {ohnson White, Director; or John R. Ball, M.D. AF45 . Fetal heart rate monitoring. 1975 Jun. (Technical bulletin no. 32~. tExpert opinion] Overview: The American College of Physicians (ACP) is a national medical society with a membership of over 63,000 internists and related subspecialists. It works to uphold health care standards through its activities in continuing education, health policy analysis, quality assurance, and medical technology assessment. The Clinical Efficacy Assessment Project (CEAP) is an expansion of the College's participation in the Blue Cross and Blue Shield Association's Medical Necessity Project beginning in 1976, which identified outmoded tests in order to curtail reimbursement for unnecessary medical procedures. Recognizing the need for complete and accurate technology assessment on a continuing basis, the ACP expanded the program in 1981 with a 3-year grant from the John A. Hartford Foundation of New York City. In 1984, the CEAP became a fully funded activity of the College. Beginning in 1986, ACP has accepted contributions to the CEAP from interested individuals and organizations. PuIpose: To help physicians practice high-quality, more efficient, and cost-effective medicine. CEAP recommendations are intended to provide physicians with current information and guidelines regarding the use of tests, procedures, and therapies and the rationale for such recommendations founded on both the literature and broad- based expert opinion. Primary intended users: Providers, generally; physicians; other care givers; health/ medical professional associations; third party payers; government regulators; public policy-makers, legislators; policy research organizations. Technologies: Medical or surgical procedure, drug, device, organizational or administra- tive system. Inte~vendon: Du~gnos?s, prevention, treatment, rehabilitation. Stage: Establ~ ed or widespread practice, new, obsolete. Properties: Eff racy, safety, effectiveness, cost, service requirements. Selection process: The Clinical Efficacy Assessment Subcommittee identifies potential technologies for CEAP evaluations by reviewing policy needs, practitioner opinion, academic opinion, recent journal articles, and professional meetings focusing on emerging technologies. Recommendations and requests also are received from other ACP committees as well as outside organizations. In selecting technologies to be evalu- ated, the Clinical Efficacy Assessment Subcommittee examines the following attributes: 22
AMERICAN COLLEGE OF PHYSICIANS 1) degree of interest to practitioners of internal medicine, whether or not internists are directly responsible for its application; 2) potential for wide application, or prevalence of current usage; 3) potential for significant benefit if widely applied; and 4) potential for risk if widely applied, particularly in relation to potential benefit. The Subcommittee will consider requests from College members and others for reeval- uation of a statement if the request contains compelling documentation. Staff also solicit advice from the Council of Subspecialty Societies, the Council of Medical Socie- ties, and other experts as to the availability of new information on a technology. If substantive, new information is available, the Subcommittee will consider reassessment. Methods: Information syntheses, expert opinion, group judgment, cost analyses. Notice of a pending CEAP evaluation is published in Annals of Internal Medicine, ACP Observer, New England Journal of Medicine, and the International Journal of Technology Assessment in Health Care. The notices invite comments from interested parties. For special or major evaluations, other specialtyjournals may be asked to publish notices of CEAP evaluations. ACP staff, in consultation with the CEA Subcommittee, select the appropriate member societies of the Council of Subspecialty Societies (CSS) and Council of Medical Societies (CMS) to review the technology in question. These societies are asked to provide opinion and data on the safety, efficacy, effectiveness, and cost of the technology, as well as to identify other experts (proponents, opponents, and those who are neutral on the topic) to provide information on the technology. Consultants undertake a comprehensive review of the scientific literature. Assessments of other organizations are reviewed and, when possible and necessary, information regarding ongoing clinical trials is obtained. A synthesis of this information, the com- ments from persons responding to the published notices, and the opinions of the CSS/ CMS members and other experts form the scientific base of the CEAP evaluation. Consultants assess a technology by the method best suited to the topic. The methods include, but are not limited to, data synthesis, meta-analysis, clinical decision analysis, and consensus development. At times, a combination of methods is used. When possible, risk-benefit and cost-effectiveness analyses are performed. The approximate turnaround time from selection of assessment topic to reporting of findings is 9 months to 1 year. Assessors: Physicians trained in clinical epidemiology, statistics, economics, decision analysis, and technology assessment are commissioned to conduct CEAP evaluations. These physicians are selected from candidates suggested by the CEAP Subcommittee, members of the Technology Assessment Committee of the Society for Research and Education in Primary Care Internal Medicine (SREPCIM), and others. When the evaluation of a specific topic requires special expertise, the principal consultant is asked to collaborate with a qualified content expert in the assessment of the topic. Assessment reports include: Abstract; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life- cycle of technology when assessed; properties assessed; procedure used for the assess r ~ . / r . I' ~ r `, . ~ . /. r .. .' ~ meet; sources ot data/~ntormat~on; methods tor collecting data/~ntormat~on; methods for analyzing/synthesizing data/information; results; findings or conclusions; limita- tions of findings; implications of findings for practice; recommendations for practice, 23
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY future assessments, technology development, research; how the technology works, including theory, principles. CEAP statements have five components: 1) a general description of the technology, its uses, potential uses, and rationale; 2) an overview of the safety of the technology; 3) a review of the technology's efficacy; 4) information on its cost; and 5) appropriate conclusions and recommendations. Areas requiring further research also are summa- rized. Key points in the statement refer to the appropriate published literature and the effective date of the literature review is noted. A detailed and referenced background paper that supports and provides the rationale for the CEAP statement and recom- mendations also is developed. Wheren.s the CFAP ~t~t~m~nt fallows ~ ct~nHOr~ Armor .1 1 1 ~. ~ A^~_A.~ ^~ ~ ~ V ~ -~,~]L4~$ ~ VIA AAA~ one oacKgrouncl paper may be prepared in the style best suited to the analysis of the subject. Dissemination: CEAP statements become position papers of the American College of Physicians upon approval by the Board of Regents. The position and background papers are submitted to ACP Observer and to Annals of Internal Medicine for publication. If the Annals declines to publish the position paper, it is published in full in ACP Observer. If the Annals accepts the position paper for publication, an abstract will be published in ACP Observer. Thus, all College members and many others receive all CEAP statements through these publications. Background papers that are not pub- lished in Annals remain the property of their authors and may be submitted to other journals for publication. In addition, the International~ournalfor Technology Assessment in Health Care has been given permission to republish abstracts of all ACP position papers. Single copies of CEAP statements are available free of charge from the College. A three-ring binder Clinical Efficacy Reports, containing the full collection of CEAP state- ments is available from ACP. In 1987, ACP published the manual Common Diagnostic Tests: Use and Interpretation, available from the ACP publications department. The purpose of this manual is to help physicians determine when diagnostic tests are likely to make desirable differences in patient care. Based on a critical review of published articles, the manual provides recommendations for using selected tests in cardiopulmonary medicine, hematology, infectious diseases, oncology, and other diagnostic applications. The manual calls for additional research for tests for which the published literature is insufficient for making well founded recommendations. The manual chapters are derived from pa- pers commissioned by the Blue Cross and Blue Shield Association for its Medical Necessity Project. These were reviewed through the CEAP process, approved by the ACP, and published in the Annals of Internal Medicine. The appendices are texts of the Blue Cross and Blue Shield Medical Necessity guidelines. Budget: $150,000. If the total program budget is divided by the number of assessments per year, the cost is $10,000. Approximate consultant cost per assessment is $3,500. Funding sources: 95 percent parent organization; 5 percent foundations, other private grants. Use: CEAP statements are used by third party payers, training directors in residency programs, and as an educational service to college members as evidence of its commit- ment to quality care. 24
AMERICAN COLLEGE OF PHYSICIANS The establishment of the Association of Ambulatory Cardiac Catheters (AACC) was a direct result of a CEAP paper. The AACC is now organizing quality assurance activities with the objective of receiving iCAH accreditation for freestanding units. The CEAP endoscopy papers were cited in the 1985 presidential address to the American Gastro- enterology Association. CEAP is described in Institute of Medicine, Committee on Evaluating Medical Tech- nolog~es in Clinical Use. Assessing medical technologies. Washington, DC: National Acade- my Press, 1985. Program evaluation: As part of its grant award, the John A. Hartford Foundation stipulated and funded an evaluation of the CEAP. In 1983, the Blue Cross and Blue Shield Association conducted the evaluation which included a questionnaire that was sent to all major third party payers and government agencies. Recipients were asked about their knowledge of the CEAP, if the reports were relevant, and if the CEAP reports were used for educational and policy-setting purposes. Findings indicated that CEAP reports were used for educational and policy-setting purposes. The program was not modified as a result of the evaluation, but the mailing list was expanded. Completed Reports AG1 American College of Physicians, Clinical Efficacy Assessment Project. A comparative assessment of cor- onary artery bypass surgery and percutaneous trans- luminal coronary angioplasty. Expected completion 1988. "Information syntheses] AG2 . Allergy testing. Expected completion 1988. "Information synthesesJ AG3 . Chemical aversion therapy in the treat- ment of alcoholism, expected completion 1988. [In- formation syntheses] AG4 . Clinical ecology, expected completion 1988. "Information syntheses] AG5 . Exercise thallium scanning, expected completion 1988. [Information syntheses] AGO . How to study the carotid arteries, expect- ed completion 1988. [Information syntheses] AG7 . How to study the gallbladder, expected completion 1988. [Information syntheses] AGO . Intravenous pyelography, expected com- pletion 1988. [Information syntheses] AG9 . Laboratory evaluation of the patient after myocardial infarction, expected completion 1988. [Information syntheses] AGED . Preoperative pulmonary function tests, expected completion 1988. [Information syntheses] AGl l . Rehabilitation of the myocardial infarc- tion patient, expected completion 1988. [Information syntheses] AG12 . Bone mineral densitometry, 1987. [In- formation syntheses] AG13 . Magnetic resonance imaging of the brain and spine, 1987. "Information syntheses] AG14 . Methotrexate for rheumatoid arthritis, 1987. [Information syntheses] AG15 . Parenteral nutrition, 1987. [Information syntheses] AG16 . A comparative assessment of standard and computed tomography in the evaluation of neo- plasms of the chest. 1986. [Information syntheses] AG17 . Automated ambulatory blood pressure monitoring. Ann Intern Med 1986; 104:275-8. tInfor- mation syntheses] AG18 . Cardiokymography. ACP Observer 1986 Jan:8,10. [Information syntheses] AGl9 . Congestive heart failure and thoracente- sis, 1986. "Information syntheses] AG20 . Pneumococcal vaccine. Ann Intern Med 1986;104:118-120 AG21 . The diagnostic spinal tap. Ann Intern Med 1986;104:880-5,840-8. [Information syntheses] AG22 . Apheresis in chronic inflammatory de- myelinating polyneuropathy and in renal transplan- tation. Ann Inter Med 1985; 103:630-3. [Information syntheses] AG23 . Biofeedback for gastrointestinal disor- ders. Ann Intern Med 1985;103:291-3,240-44. [In- formation syntheses] ~5
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY AG24 . Biofeedback for headaches. Ann Intern Med 1985;102:128-31. [Information syntheses] AG25 . Biofeedback for hypertension. Ann In- tern Med 1985;102:709-15. "Information syntheses] AG26 . Biofeedback for neuromuscular disor- ders. Ann Intern Med 1985;102:854-8. [Information syntheses] AG27 . Colonoscopy: management of colorectal neoplasia. 1985. "Information syntheses] AG28 . Diagnostic thoracentesis and pleural bi- opsy. Ann Intern Med 1985;103:799-802. tInforma- tion syntheses] AG29 . Esophagogastroduodenoscopy (EGD). [Information syntheses] AG30 . Lithotripsy. Ann Intern Med 1985;103:626-9. [Information syntheses] AG31 . Screening for breast cancer. Ann Intern Med 1985; 103: 143-6,79-85. "Information syntheses] AG32 . The safety and efficacy of ambulatory cardiac catheterization in the hospital and free stand- ing setting. Ann Intern Med 1985: 103;294-8. tInfor- mation syntheses] AG33 . Thrombolysis for evolving myocardial infarction. Ann Intern Med 1985; 103:463-9. [Infor- mation syntheses] AG34 . Apheresis in chronic severe rheumatoid arthritis. 1984. [Information syntheses] AG35 . Clinical usefulness of hemoglobin A1C measurements. Ann Intern Med 1984; 101 :710-3. [Information syntheses] AG36 . Efficacy of endoscopic retrograde cho- langiopancreatography (ERCP) and endoscopic ret- rograde sphincterotomy (ERS). 1984. "Information syntheses! AG37 . Endocardial electrical stimulation. Ann Intern Med 1984; 100:452-4. [Information syntheses] AG38 . Endoscopic injection sclerotherapy. Ann Intern Med 1984;100:608-10. [Information synthe- ses] AG39 . Ergonovine provocative testing. Ann In- tern Med 1984; 100: 152-2. [Information syntheses] AG40 . Heparin infusion pumps. Ann Intern Med 1984;100:305-6. fInformation syntheses] AG41 . FIepatitis B vaccine. Ann Intern Med 1984; 100: 149-50. [Information syntheses] 26 AG42 . Radiologic methods to evaluate bone mineral content. Ann Intern Med 1984;100:108-11. "Information syntheses] AG43 . 13C and 14C glycocholate tests. 1983. [Information syntheses] AG44 . 13C and 14C glycocholate, H2 breath, 13C trioctanoin, and 14C triolein breath tests. 1983. tInformatton syntheses] AG45 . 14C xylose breath test. 1983. tInforma- tion syntheses! AG46 . Home blood glucose monitoring. Ann Intern Med 1983;99:272-4. "Information syntheses] AG47 . Hyperbaric oxygen therapy: acute, trau- matic peripheral ischemia. 1983. [Information syn- theseSl AG48 . Hyperbaric oxygen therapy: chronic vas- cular insufficiency. 1983. "Information syntheses] AG49 . Hyperbaric oxygen therapy: decubitus ulcers. 1983. [Information syntheses] AG50 . Hyperbaric oxygen therapy: senility. tIn- formation syntheses] AG51 . Lactulose H2 breath test. 1983. [Infor- mation syntheses] AG52 . Management of diabetes mellitus: com- puterized insulin infusion pumps. Ann Intern Med 1983;99::272-4. "Information syntheses] AG53 . Management of diabetes mellitus: exter- nal infusion pumps. Ann Intern Med 1983;99:272-4. "Information syntheses] AG54 . Management of diabetes mellitus: pan- creatic transplants. Ann Intern Med 1983-,99:272-4. "Information syntheses] AG55 . Percutaneous transluminal angioplasty: carotid, vertebral, and subclavian arteries. Ann Intern Med 1983;99:864-9. "Information syntheses] AG56 . Percutaneous transluminal angioplasty: coronary arteries. Ann Intern Med 1983;99:864-9. fInformation syntheses] AG57 . Percutaneous transluminal angioplasty: iliac, femoral, and popliteal arteries. Ann Intern Med 1983;99:864-9. "Information syntheses] AG58 . Percutaneous transluminal angioplasty: renal arteries. Ann Intern Med 1983;99:864-9. tIn- formation syntheses] AG59 . The dexamethasone suppression test. Ann Intern Med 1983;100:307-8. [Information syn- theses]
AMERICAN COLLEGE OF PHYSICIANS AG60 . The H2 breath test. 1983. [Information syntheses] AG61 . Antilymphocyte (ALG) and antithymo- cyte (ATG) globulin in renal transplantation. 1982. [Information syntheses. AG62_ . Bentonite flocculation test.1982. [Infor- mation syntheses] AG63 . DNA antibody test. 1982. [Information syntheses] AG64 . Immunotherapy of cancer.1982. [Infor- mation syntheses] AGG5 . Kunkel test (total serum gammaglobu- lin). 1982. tInformai'on syntheses] AG66 . Phonocardiography.1982. [Information syntheses] AG67 .24-hour sphygmomanometry.1981. [In- formation syntheses] AG68 .25 hydroxyvitamin D level.1981. tInfor- mation syntheses] AG69 . Cytotoxic food testing. 1981. tInforma- tion syntheses] AG70 . Gastric analysis by the capsule method (Heidelberg). 1981. "Information syntheses] AG71 . Human tumor cell drug sensitivity assay in the treatment of solid tumors. 1981. "Information syntheses] American College of Radiology Task Force on Breast Cancer ~89~ Preston White Drive Reston, VA 22091 703-648-8925 AG72 . Hyperbaric oxygen therapy: aciinomy- cosis. 1981. "Information syntheses] AG73 . Hyperbaric oxygen therapy: arthritis. 1981. "Information syntheses] AG74 . Hyperbaric oxygen therapy: osteomyeli- tis. 1981. "Information syntheses] AG75 . Intracutaneous titration. 1981. [Infor- mation syntheses] AG76 . Intravenous histamine therapy. 1981. [Information syntheses] AG77 . Management of histapenia.1981. [Infor- mation syntheses] AG78 . Radioallergosorbent technique (RAST). 1981. tInformanon syntheses] AG79 . Ultrasonic arter~ography, B mode.1981. "Information syntheses] AG80 . Ultrasonic arteriography, B-scan and Doppler ultrasound. 1981. [Information syntheses] AG81 . Hemodialysis for the treatment of schizophrenia. 1980. "Information syntheses] AG82 . Urine autoinflection. 1980. [Information syntheses] AG83 . Whole body hyperthermia for cancer patients. 1980. "Information syntheses] Contact: Marie Zinninger, M.S.N., Coordinator; Gerald Dodd, M.D., Chairman, Task Force on Breast Cancer. Overview: The American College of Radiology (AC R) serves radiologists with pro- grams addressing the practice of radiology and the delivery of comprehensive radio- logical health services. The purposes of the ACR are to advance the science of radiolo- gy, improve radiologic service to the patient, study the economic aspects of the practice of radiology, and encourage improved and continuing education for radiologists and allied professional fields. The ACR has more than 20,000 members and fellows in diagnostic and therapeutic radiology, radiologic physics, and related disciplines. ACR members participate in commissions and committees that prepare publications and conduct programs directed 27
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY to meeting member needs. These include quality assurance, practice and accreditation, management consulting, professional placement, self-evaluation, continuing educa- tion, manpower, practice management, and the development and conduct of special scientific courses needed in the field. The subject of this profile is the ACR Task Force on Breast Cancer. Purpose: To coordinate the activities of various ACR committees concerned with mammography and breast cancer. These include the Committee on Breast Cancer, Committee on Breast Imaging, Committee on Mammography Equipment, the Com- mittee on Mammography Accreditation of the Commission on Radiologic Practice, and the ACR/American Cancer Society Joint Committee on Mammography. Issues ad- dressed by the Task Force include education of radiologists and referring physicians, mammography policy statements and guidelines, mammography quality assurance, and liaison with other national medical organizations such as the American Cancer Society. Primary intended users: Physicians; patients; health/medical professional associations; . . . . vo untary assomat~ons, organizations. Technologies: Medical or surgical procedure, device. Intervention: Diagnosis, prevention. The major emphasis of the program is on early detection of breast cancer. Stage: Established or widespread practice. Properties: Safety; effectiveness; cost; ethical, legal, social implications. Selection process: ACR assessments are requested by such outside organizations as the Office of Health Technology Assessment, American Cancer Society (ACS), Blue Cross and Blue Shield Association, the Conference of Radiation Control Programs Directors, Inc., and other sources. In addition, they may be requested by ACR members and other physicians, and by the ACR committees cited above that work with the Task Force. Assessment priorities are normally set by the Task Force. Methods: Group judgment, information syntheses, expert opinion, cost analyses, epide- miological and other observational methods. Assessments are generally initiated by the Committee on Breast Cancer, Committee on Breast Imaging, Committee on Mammography Equipment, Committee on Mammog- raphy Accreditation, or ACR/ACS Joint Committee on Mammography, as appropri- ate. Reports are often drafted jointly by committee members and staff. When a consensus is reached at the committee level, it is forwarded to the Task Force for review and approval. The Task Force normally meets twice a year, though it may meet more often as needed. Upon Task Force approval, reports are submitted to the ACR Board of Chancellors for acceptance. The final endorsement comes at the ACR annual meeting where the ACR Council of approximately 175 physicians acts upon a resolution. Average turnaround time for assessments is approximately one year. As guidelines are based on current available information, they are to be revised as more is learned about the control of breast cancer. Thus, in 1986 the Task Force issued ~8
AMERICAN COLLEGE OF RADIOLOGY supplementary statements to the 1982 policy statement on mammography; these supplementary statements addressed the capabilities and limitations of mammography in the detection and diagnosis of breast cancer and performance guidelines for mam- mography. Assessors: The Task Force on Breast Cancer has 14 members. Of these, 12 are physicians and 2 are radiological physicists. There are 10-12 members on each of the committees; members are gynecologists, surgeons, radiation oncologists, internists, pathologists, family practitioners, and members of other or~ni7.~tiOn.c clash ~ the American Cancer Society and National Cancer Institute. C, ~_ ~ _ ~at,. ^~ Assessment reports include: Purpose of the assessment; relationship of the assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; sources of data/information; findings or conclusions; limitations of findings; implica- tions of findings for practice; recommendations for practice, future assessments, tech- nology development, research; how the technology works, including theory, principles. Dissemination: Printed reports; advisories to members/constituents; press conference/ news releases, TV radio broadcasts, video products; clearinghouses. Individual Task Force policy statements are available from the ACR at no charge. Policy statements also appear in the newsletter ACR Bulletin. The ACR Mammography Resource Kit includes the policy statements on mammography, as well as reprints of other organizations' statements on mammography, order forms for public service announcements, information about mammography training programs, mammogra- phy bibliography, audiovisual materials on mammography, protocol information for patients, and related educational and reference materials. The kit is available upon written request to ACR members at no charge and to others for $25. Use: Portions of ACR policy statements on mammography appear in publications of the National Cancer Institute, American Cancer Society, and other organizations. ACR policy statements on mammography help form the basis for recommended mammog- raphy guidelines issued by medical specialty organizations such as the American Col- lege of Obstetricians and Gynecologists and the American Academy of Family Physi- cians. ACR mammography guidelines are also cited in guidelines and suggested state regulations offered by the Conference of Radiation Control Program Directors, used by many state radiation control programs. ACR policy statements have been cited in assessments by the Blue Cross and Blue Shield Association, the Office of Health Technology Assessment, and other agencies. For example, ACR opinions have been used in the Blue Cross and Blue Shield Association Medical Necessity guidelines on bronchoscopy (1977), angiocardiography (1977), angiography (1977), diagnostic imaging (1984), and routine preoperative and general hospital admission chest x-rays (19871. ACR opinions have also been cited in the National Council on Radiation Protection and Measurements Report No. 85, Mammography: A User's Guide (1986~; State of New York Department of Health memorandum Quality Assurance Programs for Providers of Mam- mography Services (1987~; and the Food and Drug Administration Center for Devices and Radiological Health Mammographic Phantom Evaluation Project Report (1983~. 29
MEDICAL TECHNOLOGY ASSESSMENT DfRECTORY Articles written by Task Force members on topics related to mammography policy statements appear in the published periodical literature and in texts. Examples are the following: McClelland, R. Feig SA. Guidelines for mammography. In Feig SA, McClelland R. eds. Breast carcinoma: current diagnosis and treatment. New York: ACR and Masson, 1983:365- 69. Bird RE, McClelland R. How to initiate and operate a low-cost screening mammogra- phy center. Radiology 1986;161~21:43-47. Budget: The Task Force operations budget is approximately $26,000. This amount does not include the value of the time volunteered to the Task Force by the member radiologists, physicists, and other professionals; it also does not include costs for the other committees involved in generating statements. Related activities: The Task Force on Breast Cancer coordinates and cosponsors with the American College of Pathologists, ACS, and American SocietY for Therapeutic v , - ~ ~ ~ ~ ~ · · ~ ~ ~ ~ . Kacllology and oncology a olennlal Rational conference on breast cancer. 1 ne ARK and the ACS have a liaison committee to support the ACS Breast Cancer Detection Awareness Program to educate asymptomatic women and their physicians in the importance of breast cancer detection, including screening mammography. The ACR Mammography Accreditation Program, directed by the ACR Committee on Practice Accreditation and assisted by the Task Force on Breast Cancer, provides voluntary peer review and evaluation services of mammography facility staff qualifica- tions, equipment, quality control and quality assurance programs, image quality and breast dose. Facilities meeting the criteria of the Mammography Accreditation Pro- gram are given a 3-year accreditation, a certificate for each approved mammography unit, and a listing on the ACS referral list of approved mammographic centers. The Patterns of Care Study of cancer treatment, which has been supported by the National Cancer Institute and conducted by ACR since 1971, has conducted surveys of structure, process, and outcomes for a national sample of radiation treatment facilities. As part of the study, ACR assembled review committees of radiation therapists to reach consensus in the form of decision trees for the management of ten disease types in which radiation therapy is involved. The ACR Practice Accreditation Program in Radiation Oncology, which evolved from the Patterns of Care Study, provides a voluntary quality assurance service for radiation therapy facilities. This program in- volves individual facility visits modeled in order to provide feedback to radiation therapists on their practice relative to regional and national norms established through the Patterns of Care Study. Based on site visits by teams of selected ACR member surveyors, the ACR Practice Survey Program is a voluntary review and evaluation service offered to diagnostic , ~ , ~ ~ . ~ . . . ~ . . ~ , . . . . . radiologists in a variety of practice settings. Both accreditation and consultative surveys are available. Additional ACR publications related to technology assessment include the following. ACR policy statements on computed tomography, imaging center guidelines, magnetic resonance, and obstetrical/ultrasound examination guidelines. Acceptance testing protocols: a systematic approach to evaluation of radiology equipment. 1983. SO
AMERICAN COLLEGE OF RADIOLOGY Imaging equipment compendium: a comparative reference of equipment characteristics. 1983. 1985 update, supplement. List of MR sites. Planning guides for radiologic installations. Proceedings of the Eighth Conference on Computer Applications in Radiology. 1984. Completed Reports AH1 American College of Radiology, Task Force on Breast Cancer. Policy statement on oscillating grids for mammography equipment. Expected 1987. tGroup judgment] AH2 . Resolution no. 1: supplementary mam- mography statement. 1986 Sep. [Group judgment] AH3 . Resolution no. 2: mammography per formance guidelines. 1986 Sep. EGroup judgment] AH4 . Policy statement: breast cancer screening centers. 1985. EGroup judgment] AH5 . Policy statement on sonography for the detection and diagnosis of breast disease. 1984. (Group judgment] AH6 . Policy statement on thermography for the detection of breast cancer. 1 983 Sep 28. tGroup judg ment1 AH7 _ . Statement of the preservation of mammo- grams. 1983. [Group judgment] AH8 . Policy statement: guidelines for mam- mography. 1982 Sep 22. EGroup judgment] American Dental Association Council on Dental Materials, Instruments. and l~auinment 2 ~ ~ East Chicago Avenue Chicago, IL 6061 3 12-440-2507 Contact: Dr. P.L. Fan, Associate Secretary. -~7 - --~-r~ Overview: The American Dental Association (ADA) is a professional association that provides a variety of services to assist its members practice dentistry and deliver health care to the public. The ADA's objectives include encouraging the improvement of the public's health, promoting the art and science of dentistry, and representing the interests of the dental profession and the public that it serves. The Council on Dental Materials, Instruments, and Equipment is one of two technology assessment programs sponsored by the ADA; the other being the Council on Dental Therapeutics. The Council was established in 1966 to centralize the ADA's activities in the standardization and evaluation of dental materials, instruments, and equipment. This activity had been initiated by the Association in 1928 at the National Bureau of Standards. The Council performs its duties through its Specification Program, Evaluation Pro- grams (which include the Certification Program, the Acceptance Program and the Recognition Program), Complaint Report Program, and Status Report Program. This profile focuses on the Acceptance Program component. Additional information on other Council activities can be found in the Council's textbook, Dentists' Desk Reference: Materials, Instruments and Equipment. 31
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Purpose: To evaluate materials, instruments, and equipment for which evidence of safety and usefulness has been established by biological, laboratory, or clinical evalua- tions and for which physical standards or specifications do not exist. Primary intended users: General public, patients, health product manufacturers, dentists. Technologies: Device. The following are examples of product areas presently covered by the Council's Acceptance Program: alloys for cast dental restorative and prosthetic devices, autoclave sterilizers, composite resin materials for occlusal restorations, crown and bridge resins, electrosurgical devices; x-ray equipment, denture adherents, denture cleansers, endos- seous implants, glass ionomer cements, denture cleaning devices, nitrous oxide/oxygen sedation machines and devices, oral irrigating devices, orthodontic bracket attachment materials, powered oral hygiene devices, precision attachments, processing devices for radiographic film; scaling/stain removal devices, and visible radiation emitting devices. Intervention: Treatment, prevention, diagnosis. Stage: New, emerging, established or widespread practice. Properties: Effectiveness, safety, efficacy. Selection process: Commercial products are evaluated at the request of the manufac- turer or distributor, or at the Council's initiative. All submissions and other information are sent in writing to the Council. Only complete submissions will be accepted; partial submissions will be returned. Each submission must include a summary report cover- ing all information on safety and efficacy of the material, instrument, or item of equipment. Submissions normally include the following: name and use of item; patent number relating to product; composition, physical, and chemical properties of dental materials; materials used in construction and method of operation of a device; and evidence of safety and usefulness of the product based on in vitro, biological, and clinical evalua- tions. Evidence of safety and usefulness of the product may be in the form of published reports or unpublished information obtained from appropriate scientific studies using in vitro, biological, and clinical observations. Methods: Information syntheses, expert opinion, group judgment, bench testing. The Council evaluates the information available and arrives at a decision, classifying the product as "acceptable," "provisionally acceptable," or "unacceptable." Products classi- fied as "acceptable" usually retain that status for 3 years. Acceptance is renewable and may be reconsidered at any time. If there is a change in manufacturer or distributor of the product, the acceptance automatically expires. "Acceptable" products are listed in Dentists' Desk Reference: Materials, Instruments and Equipment. The manufacturer or distributor may use the Seal of Acceptance and the Council's authorized statement. "Provisionally acceptable" products consist of those that lack sufficient evidence to justify classification as "acceptable," but for which there is reasonable evidence of safety 32
ADA/CouNc~ ON DENTAL MATERIALS, INSTRUMENTS, AND EQUIPMENT and usefulness including clinical feasibility. The Council may authorize the use of a suitable statement to specifically define the area of usefulness. Products in this classifi- cation category are reviewed each year and ordinarily are not continued for more than 3 years. "Unacceptable" products are those that are obsolete, markedly inferior, useless, or dangerous to the health of the user. Dissemination: Acceptable products are listed in the ADA publication Dentists' Desk Reference: Materials, Instruments and Equipment and in the journal of the American Dental Association. See for example, Product listing: classified dental materials, instruments, and equipment. ~ Am Dent Assoc 1986 Dec.; 1 13: 1013-1015. Budget: Not available. Funding source: 100 percent parent organization. Evaluators and consultants donate their time. Use: The information is used by the ADA membership and the public. Related Activities: The Council's Certification Program evaluates products and classi- fies them as "certified" when they meet formal certification requirements. The results of the Certification Program are also published in the journal of the American Dental , . . Association. Completed Reports Al1 American Dental Association, Council on Dental Materials, Instruments and Equipment. Dentin bond- ing systems: an update. ~ Am Dent Assoc 1987; 114:91-95. AJ2 . Dental endosseous implants. I Am Dent Assoc 1986;113:949-950. AJ3 . Posterior composite resins. ~ Am Dent Assoc 1986;112:717-709. A}4 . Posterior composite resins: an update. Am Dent Assoc 1986; 113:950-952. AJ5 . The effects of blue light on the retina and the use of protective filtering glasses. ~ Am Dent As- soc 1986; 112:533-535. AM . Recent developments in materials and process for ceramic crowns. ~ Am Dent Assoc 1985; 110:548-549. AJ7 . Report on base metal alloys for crown and bridge applications: benefits and risks. I Am Dent Assoc 1985;111:479-483. AJ8 . Status report on professional scaling and stain-removal devices. ~ Am Dent Assoc 1985; 111 :801-802. AM . Visible light-cured composites and activat- ing units. ~ Am Dent Assoc 1985; 110: 100-103 AJ10 , Council on Dental Research, and Council on Dental Therapeutics. Hydroxylapatite, beta trical- cium phosphate, and autogenous and allogenic bone for filling periodontal defects, alveolar ridge augmen- tation, and pulp capping. ~ Am Dent Assoc 1984; 108:822-831. A}ll , Council on Dental Therapeutics. Patch tests for sensitivity to mercury or nickel. ~ Am Dent Assoc 1984;108:381. AJ12 . Classification system for cast alloys. J Am Dent Assoc 1984;109:766. AJ13 . Mouth protectors and sports team den- tists. J Am Dent Assoc 1984;109:84-87. A}14 . Recommendations in dental mercury hy- giene, 1984. J Am Dent Assoc 1984; 109:617-619. AJ15 . Recommendations in radiographic prac- tices, 1984. J Am Dent Assoc 1984; 109:764-765. AJ16 . Reported sensitivity to glass ionomer lut- ing cements. I Am Dent Assoc 1984;109:617-619. AJ17 . Resin dental bonding systems. I Am Dent Assoc 1984;108:240-241. AJ18 . Status report on enamel bonding of com- posites, preformed laminate, and laboratory fabricat- ed resin veneers. J Am Dent Assoc 1984; 109:762-764. 33
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY A}l9 . Denture cleansers. I Am Dent Assoc 1983; 106:77-79. AJ20 . Pit and fissure sealants. ~ Am Dent Assoc 1983;107:465. AJ21 . Safety of dental amalgam. ~ Am Dent Assoc 1983; 106:519-520. AJ22 . Status report on amalgamators. ~ Am Dent Assoc 1983; 107:639-640. A}23 . Status report on posterior composites. I Am Dent Asso 1983; 107:71-75. A}24 . Status report: the periodontal ligament injection. ~ Am Dent Assoc 1983; 106:222-224. AJ25 . Biological effects of nickel-containing dental alloys. J Am Dent Assoc 1982;104:501-505. AJ26 . Biological effects of radiation from dental radiography. J Am Dent Assoc 1982;105:275-281. AJ27 . High copper-content amalgam alloys. J Am Dent Assoc 1982; 105: 1077- 1080. AJ28 . Recommendations for radiographic darkrooms and darkroom practices. ~ Am Dent Assoc 1982; 104:636-637. AJ29 . State of the art and science of bonding in orthodontic treatment. ~ Am Dent Assoc 1982; 105:844-850. A}30 . Status report on beta titanium orthodon- tic wire. ~ Am Dent Assoc 1982;105:684-685. AJ31 . Status report on microf~lled composite restorative resins. J Am Dent Assoc 1982-105:488- 492. AJ32 . Status report on precious metal scrap. Am Dent Assoc 1982; 105: 1080-1081. AJ33 . Status report: dental visible light-curing units. ~ Am Dent Assoc 1982;104:505. American Dental Association Council on Dental Therapeutics 2 ~ ~ East Chicago Avenue Chicago, TE 6061 3 1 2-440-2523 Contact: Kenneth H. Burrell, Secretary. AJ34 . A status report on resilient denture base materials. I Am Dent Assoc 1981;103:450-451. AJ35 . ADA Council issues updated mercury hygiene measures recommended. ADA News 1981 Sep 7. AJ36 . Classification and definition of alloys used for casting substrates for porcelain veneering. Am Dent Assoc 1981; 103:755-757. AJ37 . Council update on "adhesion" and "adhe- sive" materials. I Am Dent Assoc 1981; 103:252-253. AJ38 . Current status of sterilization instru- ments, devices, and methods for the dental office. Am Dent Assoc 1981; 102 :683-689. AJ39 . How to improve shade matching in the dental operatory. ~ Am Dent Assoc 1981;102:209- 210. AJ40 . Porcelain-metal alloy compatibility: crite- ria and test methods. ~ Am Dent Assoc 1981; 102:71- 72. AJ41 . Recommendations in radiographic prac- tices. ~ Am Dent Assoc 1981; 103: 103- 104 AJ42 . The desirability of using radiopaque plas- tics in dentistry: a status report. J Am Dent Assoc 1981; 102:347-349. AJ43 . Council position on nitrous oxide scav- enging and monitoring devices. J Am Dent Assoc 1980; 101:62. A}44 . Council reevaluates position on dental endosseous implants. ~ Am Dent Assoc 1980; 100:247. AJ45 . Prevention of problems with removable partial dentures. J Am Dent Assoc 1980; 100:919-921. A}46 . Status report on low-gold-content alloys for fixed prostheses. J Am Dent Assoc 1980; 100:237- 240. Overview: The American Dental Association (ADA) is a professional association that provides a variety of services to assist the profession in delivering health care to the 34
ADA/COUNCIL ON DENTAL THERAPEUTICS public. The ADA's objectives include encouraging the improvements of the public's health, promoting the art and science of dentistry, and representing the interests of the members of the dental profession and the public that it serves. The Council on Dental Therapeutics is one of two technology assessment programs sponsored by the ADA; the other being the Council on Dental Materials, Instruments, and Equipment. The Council supplies reliable information and confers a seal of acceptance, provisional acceptance, and unacceptance on recently developed dental products. Purpose: To study, evaluate, and disseminate information on 1) the proper use of dental therapeutics, their adjuncts, and dental cosmetic agents offered to the public or profession; and 2) aspects of the dental practice environment related to the health of dentists, dental auxiliaries, and the public. Primary intended users: General public, patients, dentists. Technologies: Drug, medical or surgical procedure. Examples of technologies evaluated by the Council are: topical fluoride preparations, analgesics, antianxiety agents, anticholinergic drugs, antihistamines for control of aller- gic reactions, artificial salivas, astringents for gingival retraction, chemical disinfecting/ sterilizing agents, corticosteroids, fluoride dentrifices, fluoride mouthrinses, formocre- sol preparations, hand antiseptics, hemostatic agents, hypochlorite substances, inhala- tion anesthetics, local anesthetics, muscle relaxants, nutritional supplements, oral anti- septics, periodontal dressings, pharmaceutical aids, phenolic compounds, respiratory stimulants, root canal calcium chelating agents, sedatives and hypnotics, sterilizing agents, topical Protestants. vasoconstrictor.s once zinc ovirle nren~r~ti~nc _ _ _, ~- r r ~ . ~-. ~ A A V . Intervention: Prevention, diagnosis, and treatment. Stages: New, emerging, established or widespread practice. Properties: Safety, efficacy, effectiveness. The Council also considers if the products meet standards of acceptance with respect to composition, advertising, and labeling. Selection process: Commercial products are evaluated at the request of a manufactur- er or distributor, or at the Council's initiative. Any firm may submit appropriate products to the Council for the consideration of acceptance. Communications must be submitted in writing through the Secretary of the Council. The Manufacturers normally submit the following types of information: product name, composition, physical and chemical properties of product; evidence of safety and effectiveness; government regulations related to the product; and promotional . materla s. Methods: Information syntheses, expert opinion, group judgment, bench testing. The steps required for the review of products in the Council's acceptance program depend on several factors. For example, if a product is essentially the same as an existing accepted product and does not require chemical analysis by the Council's laboratory or review by consultants, the process will require fewer steps. 35
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY After consideration of a product has been completed, the Council classifies the product as "accepted," "provisionally accepted," or "unaccepted." Products are generally accept- ed for three years. Acceptance is renewable and may be reconsidered at any time. If there is a change in the product's manufacturer or distributor, the acceptance automat- ically expires. "Accepted" products include those for which there is adequate evidence of safety and effectiveness. They may use the Council's "Seal of Acceptance" and/or an authorized statement, unless otherwise provided. "Provisionally accepted" products include those for which there is reasonable evidence of safety and effectiveness, but which lack sufficient evidence of dental effectiveness to justify being accepted. These products meet other qualifications and standards established by the Council. "Unaccepted" products include those for which the Council has determined that there is no substan- tial evidence of effectiveness, or that a question of safety exists. . Dissemination: Accepted products are listed in Accepted Dental Therapeutics and may be described in suitable reports in the journal of the American Dental Association See for example, Product listing: accepted therapeutic products. ~ Am Dent Assoc 1986 Dec; 1 13: 1018-1023. When it is in the best interest of the public or the profession, the Council may submit reports on unaccepted products for publication in the journal of the American Dental Association. Budget: Not available. Funding source: 100 percent parent organization. Evaluators and consultants donate their time. Use: The information is used by the ADA membership and the public. Completed Reports AK1 American Dental Association, Council on Dental Therapeutics, Council on Dental Materials, Instru- ments, and Equipment. The use of root canal filling materials containing paraformaldehyde: a status re- port. T Am Dent Assoc 1987 Jan; 114:95. AK? . American Dental Association, Council on Dental Therapeutics. Acceptance of Promise with Fluoride and Sensodyne-F toothpastes for sensitive teeth.] Am Dent Assoc 1986; 113 :673-5. AK3 . Guidelines for acceptance of chemothera- peutic products for the control of supragingival den- tal plaque and gingivitis. T Am Dent Assoc 1986; 112:529-32. AK4 . Recommendations for evaluating agents for the reduction of dentinal hypersensitivity. T Am Dent Assoc 1986; 112:709-10. AK5 , Council on Prosthetic Services and Dental Laboratory Relations. Guidelines for infection control in the dental office and the commercial dental labora- tory. ~ Am Dent Assoc 1985; 110:969-72. AK6 . Acceptance of OMNI-II disinfectant for instruments and equipment. J Am Dent Assoc 1985; 110. 36 AK7 . Acceptance of Sensodyne toothpaste for sensitive teeth. J Am Dent Assoc 1985; 110. AK8 . Prevention of bacterial endocarditis: a committee report of the American Heart Association. ~ Am Dent Assoc 1985; 110. AK9 . Herpes simplex virus disease: implications for dentalpersonnel. Jam Dent Assoc 1984;108:381- 2. AK10 , Council on Dental Research and Council on Dental Therapeutics. Report of symposium: root surface caries. J Am Dent Assoc 1983; 106. AKl l American Dental Association. Report of the Pres- ident's Conference on the examination, diagnosis, and management of temporomandibular disorders. J Am Dent Assoc 1983; 106:75-7. AK12 American Dental Association, Council on Dental Therapeutics. Evaluation of Denquel Sensitive Teeth toothpaste. ~ Am Dent Assoc 1982;105. AK13 . Council accepts Aim with sodium mono- fluorophosphate. J Am Dent Assoc 1980;101:822. AK14 . Council accepts dilution claims for Spori- cidin. J Am Dent Assoc 1980; 100:918. AK15 _ . Office emergencies and emergency kits. J Am Dent Assoc 1980; 101.
AMERICAN DIABETES ASSOCIATION American Diabetes Association 1660 Duke Street Alexandria, VA 22314 703-549- 1500 Contact: Richard Kahn, Ph.D., Assistant Executive Vice President. Overview: The American Diabetes Association (ADA) is a not-for-profit membership association that promotes efforts to prevent and cure diabetes and works to improve the well-being of people with diabetes and their families. It provides professional education programs, patient information materials/programs, research grant awards, and public awareness about diabetes. ADA's technology assessment activities include sponsoring consensus conferences, developing position papers, and publishing review articles. Purpose: To provide health professionals and the public with accurate and comore- hensive information about technologies relevant to diabetes. Primary intended users: General public; people concerned about their health; pa- tients; providers, generally; physicians; other care givers; health product manufactur- ers; 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; reporters, writers, news media; information/computer industry; labs, blood banks; public policy-makers, legislators; policy research organizations. Technologies: Drug, device, medical or surgical procedure, support system, organiza- tional or administrative system. Intervention: Diagnosis, treatment, rehabilitation. Stage: New, established or widespread practice. Properties: Safety; efficacy; effectiveness; cost; cost-benefit; cost-effectiveness; service requirements; acceptance/adoption level; system impact; economic implications; ethi- cal, legal, social implications. Selection process: ADA board members and officers, professional members, and other agencies and institutions can request that an assessment be conducted. Written requests are submitted to the volunteer leadership or senior staff. The volunteer leadership sets the assessment topic priorities. Methods: Information syntheses, expert opinion, group judgment, cost analyses. The assessment process is conducted in committee meetings, symposia, and confer- ences. The approximate turnaround time from selection of assessment topic to report- ing of findings is 6 months. 37
MEDICAL ~CHNOL~Y ASSESSMENT DI~CTORY Assessors: The assessors have expertise in a wide variety of areas related to diabetes including medicine, nutrition, exercise, law, and public health. Assessment reports include: The purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who conducted the assessment; description of the technology; properties assessed; procedure used for the assessment; sources of dataJ information; methods for collecting dataJinformation; methods for analyzing/synthe- sizing dataJinformation; results; findings or conclusions; limitations of findings; impli- cations of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, prin- ciples; development of the technology; coverage/reimbursement status of the technol- ogy. Dissemination: Printed reports; journal articles; advisories to memberslconstituents; press conferences/news releases; TV/radio broadcasts, video products. The ADA accepts telephone and written requests for copies of assessment reports. Budget: $100,000. The approximate cost per assessment ranges from $1,000 to $50,000. Funding sources: 5 percent government grants/contracts; 15 percent founda- tions, other private grants; 80 percent sponsors/members dues, contributions. Use: The ADA uses the assessment reports and position statements as a guide for new program development and as an authoritative source of information. Reports are cited in government documents, newspaper articles, lay public magazines, and other publi- cations. Related activities: The ADA conducts an annual scientific session at which hundreds of original research reports are presented. The Association sponsors an annual post- graduate course, a research symposium, and other conferences intended to dissemi- nate new information or to provide a forum for discussing important topics related to diabetes. Completed Reports AL1 American Diabetes Association, Consensus Devel- opment Panel. Consensus statement on self-monitor- ing of blood glucose. Diabetes Care 1987;10:95-99. [Expert opinion, Group judgment] AL2 American Diabetes Association, Task Force of the Council on Nutrition Sciences and Metabolism. Posi tion statment on use of noncaloric sweeteners. 1987. [Expert opinion, Group judgment] AL3 American Diabetes Association. Nutritional recom- mendations and principles for individuals with diabe- tes mellitus. Diabetes Care 1987;10:126-132. tExpert opinion, Group judgment] 38 AL4 American Diabetes Association and the Centers for Disease Control, Task Force on Financing Quality Health Care for Persons with Diabetes. Third-party reimbursement for diabetes outpatient education. 1986. [Expert opinion, Group judgment] AL5 American Diabetes Association. Position statment on polydextrose.1986. [Expert opinion, Group judg- ment] AL6 . Bedside blood glucose monitoring in hos- pitals. Diabetes Care 1986;9:89. [Expert opinion, Group judgment]
AMERICAN DIABETES ASSOCIATION AL7 . Gestational diabetes mellitus. Diabetes Care 1986;9:430-431. LExpert opinion, Group judg- ment] AL8 . Continuous subcutaneous insulin infu- sion. Diabetes 1985 ;34:946. LExpert opinion, Group judgment] American Gastroenterolog~cal Association Patient Care Committee c/o John Balint, M.D. Chairman, Department of Medicine Albany Medical College 47 New ScotIanc! Avenue Albany, NY 12208 5 18-445-5376 Contact: John Balint, M.D. AL9 . Office guide to diagnosis and classification of diabetes mellitus and other categories of glucose intolerance. Diabetes Care 1981 ;4:335. LExpert opin- ion, Group judgment] AL10 Olefsky {M, Crapo P. fAmerican Diabetes Associ- ation] Fructose, xylitol, and sorbitol. Diabetes Care 1980;3:390-393. LExpert opinion, Group judgment] Overview: The American Gastroenterological Association (AGA) is a professional society for gastroenterologists concerned with patient care education, research, and public policy. Purpose: To evaluate the safety and efficacy of new diagnostic and treatment modal- ities in digestive diseases and to develop effective and affordable methodologies for data collection. Primary intended users: Patients; physicians; acute facility administrators; health product manufacturers; health/medical professional associations; third party payers; government regulators; biomedical researchers; public policy-makers, legislators. Technologies: Device, drug, medical or surgical procedure. Specifically, endoscopic instrumentation for diagnosis and treatment, new imaging technology, and nutritional support systems are assessed. Intervention: Treatment, diagnosis. Stage: New, emerging, established or widespread practice. Properties: Effectiveness, safety, cost-benefit, cost-effectiveness, acceptance/adoption level. Selection process: Anyone can request that an assessment be conducted. Generally, Committee members initiate a request, although the Committee will respond to re- quests from any organization. The Committee sets assessment topic priorities and decides on the most appropriate response to a request. Methods: Information syntheses, expert opinion, group judgment, epidemiological and other observational methods. 39
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Committee members conduct the assessment process and are assigned specific tasks to complete. Assessments are based largely on literature reviews, although, the Commit- tee wants to develop questionnaire methods for prospective evaluations. The turn- around time from selection of assessment topic to reporting of findings ranges from 6 months to 2 years. Assessors: The Patient Care Committee consists of practicing gastroenterologists, surgeons, endoscopists, and pediatric gastroenterologists. Assessment reports include: The purpose of the assessment; stage of life-cycle of technology when assessed; properties assessed; procedure used for the assessment; sources of dataJinformation; methods for collecting data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; and recom- mendations for practice, future assessments, technology development, research. Dissemination: Printed reports, journal articles. Assessment results are published in the journal Gastroenterology and are presented at AGA meetings. Copies of the assessments can be requested from the Patient Care Committee. Budget: Not available. The approximate cost per assessment is not known. In general, Committee members donate their time. Funding source: 100 percent parent organiza- tion. Related activities: The Patient Care Committee sponsors symposia at their annual meeting that are designed to help the practicing gastroenterologist evaluate and prop- erly use diagnostic and treatment modalities. Completed Reports Ongoing Assessments AM1 Sitzman JV, Pitt HA. "American Gastroenterologi-AM3 American Gastroenterological Association, Patient cat Association, Patient Care Committee] GuidelinesCare Committee. Diagnostic procedures in jaundice. Ongoing. for total parenteral nutrition. Gastroenterology 1987 (in press). AM2 Kreek M}, Balint {A. "American Gastroenterologi cal Association, Patient Care Committee] "Skinny needle" cholangiography: results of a pilot study of a voluntary prospective method for gathering risk data on new procedures. Gastroenterology 1980;78:598 604. "Information syntheses] 4o AM4 American Gastroenterological Association, Patient Care Committee. Diagnostic procedures in noncar- diac chest pain. Ongoing.
AMERICAN HOSPITAL ASSOCIATION American Hospital Association Hospital Technology Series Program Division of Clinical Services ant! Technology 840 North Lake Shore Drive Chicago, IL 6061 3 12-280-6084 Contact: Henry C. Alder, Director; Suzanna Pribyl, Manager, Technology Policy and Planning; or Susan A. Frankel, Manager, Marketing and Publications. Overview: The American Hospital Association (AMA) is a trade association that repre- sents member hospitals, providing advocacy, policy development, publications, data services, educational programs, and special projects. Its Hospital Technology Series Program, initiated in 1982, is a health care technology evaluation and information dissemination program for hospital administrators. Purpose: To assist hospital administrators in making prudent and informed manage- ment decisions regarding new and existing technologies to support clinical services . . . . P annlng actlvltles. Primary intended users: Providers, generally; acute facility administrators; long-term ~ . . . . . care tea lty aummlstrators. Technologies: Device, support system. The Program deals primarily with service implications of technological advances on the planning and delivery of clinical services from the hospital perspective. The Program generally does not evaluate procedures, although they are discussed insofar as they bear upon strategic equipment and service choices. Intervention: Diagnosis, treatment. Properties: Service requirements, system impact, efficacy, effectiveness, cost, cost-benefit, cost-effectiveness, acceptance/adoption level, economic implications. Evaluations also consider manufacturer issues, such as vendor stability, the capacity for technologies to be upgraded, and other compared attributes of competing technol- ogies. Although evaluations do not include brand name ratings, they sometimes pro- vide brand-specific information, such as cost and installation information and service support arrangements. Specifically, evaluations are most concerned with the following: 1) cost and organizational implications, 2) installation costs, 3) staffing and training requirements, 4) probable number of patients affected, 5) effects on other hospital resources, and 6) effectiveness (not patient outcomes, but effects on the use of hospital resources, such as inpatient versus outpatient stay and average length of stay). Selection process: Program staff select subjects for assessment after reviewing their importance to hospital management, especially their impact on costs. Technologies are reassessed based on new information and the perceived needs of hospitals. Reassess- ments follow the same format as the original assessments. 4
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Methods: Information syntheses, expert opinion, cost analyses. Evaluations consist of syntheses of the literature, focused interviews with manufactur- ers and users, and compilations of reported experience by users in such areas as negotiating purchase contracts and common mistakes made in implementation. The approximate turnaround time from selection of assessment tonic to reporting of findings is 6 months. - -r - ~ ~~~~o ~ Assessors: The evaluations are conducted or directed by staff of the Division of Clinical Services and Technology who have expertise in hospital and business administration, health care administration, and clinical engineering. Outside consultants with medical and scientific expertise are also employed. Assessment reports include: Who conducted the assessment; description of the tech- nology; properties assessed; results; findings or conclusions; implications of findings for practice; recommendations for practice, future assessments, technology develop- ment, research; how the technology works, including theory, principles; development of the technology; procurement/deployment information; regulatory agency approval status; coverage/reimbursement status of the technology. Dissemination: Printed reports, journal articles, advisories to members/constituents. ];'_ _ 1 ~ ~ __ 1 ~ 1 _ ~- 7 ~ ~ , . Evaluation ~lnalngs are reported in Guideline iceports issued approximately 4 times a year and disseminated to member hospitals. Selected Guideline Reports are summarized in Hospitals magazine. They may be obtained as part of a subscription to the AHA Hospital Technology Series or ordered separately for a nominal fee. In addition to Guideline Reports the AHA Hospital Technology Series includes the following: Executive Briefing; an overview of major developments affecting hospitals' use of tech- nology in the delivery of patient care; directed to hospitals' chief executive officers and distributed monthly. Technology Scanner; a collection of categorized summaries of articles relevant to hospital technology, drawn from more than 80 medical and technical journals. Directed to hospital administrators and distributed monthly. Special Reports; brief updates on current technological issues. Budget: $368,000. Funding sources: 100 percent sales of subscriptions and reports. Use: Approximately 1,700 hospitals subscribe to the Hospital Technology Series. Related activities: The AMA's Division of Clinical Services and Technology also pro- duces MediTrends, an environmental assessment of clinical services focusing on medical technology. Completed Reports AN1 American Hospital Association, Hospital Technol- ogy Series Program. Positron emission tomography. 1987. (Guideline report) [Information syntheses, Ex- pert opinion, Cost analyses] 42 AN2 . Radiation therapy planning. 1987. (Guideline report) [Information syntheses, Expert opinion, Cost analyses]
AMERICAN HOSPITAL ASSOCIATION AN3 . Topographic brain mapping. 1987. (Guideline report) fInformation syntheses, Expert opinion, Cost analyses] AN4 . Cine-CT: progress and opportunities. 1986. (Guideline report) FInformation syntheses, Ex- pert opinion, Cost analyses] AN5 . Implementing laser technology in the community hospital. 1986. (Guideline report) [Infor- mation syntheses, Expert opinion, Cost analyses] AND . Purchasing a satellite receiving earth ter- minal. 1986. (Guideline report) "Information synthe- ses, Expert opinion, Cost analyses] AN7 . Lithotripters. 1985. (Guideline report) fInformation syntheses, Expert opinion, Cost ana- lyses] AND . NMR issues for 1985 and beyond. l 985. (Guideline report) "Information syntheses, Expert opinion, Cost analyses] ANSI . Picture archiving and communication sys- tems. 1985. (Guideline report) "Information synthe- ses, Expert opinion, Cost analyses] AN10 . A medical device recall and reporting system. 1984. (Guideline report) [Information syn- theses, Expert opinion, Cost analyses] ANl l . Adult volume ventilators. 1984. (Guide- line report) [Information syntheses, Expert opinion, Cost analyses] AN12 . Bar coding technology applications in health care. 1984. (Guideline report) AN13 . Computerized tomographic scanners. 1984. (Guideline report) fInformation syntheses, Ex- pert opinion, Cost analyses] AN14 . Echocardiography. 1984. (Guideline re- port) "Information syntheses, Expert opinion, Cost analyses] AN15 . Equipment acquisition under prospec- tive payment. 1984. (Guideline report) "Information syntheses, Expert opinion, Cost analyses] AN16 . Microcomputers in hospitals. 1984. (Guideline report) [Information syntheses, Expert opinion, Cost analyses] AN17 _ . Trends in nuclear medicine. 1984. (Guideline report) fInformation syntheses, Expert opinion, Cost analyses] AN18 . Materials management information sys- tems. 1983. (Guideline report) fInformation synthe- ses, Expert opinion, Cost analysesJ ANl9 . Medicare technology assessment. 1983. (Guideline report) fInformation syntheses, Expert opinion, Cost analyses] AN20 . Nuclear magnetic resonance (NMR). 1983. (Guideline report) fInformation syntheses, Ex- pert opinion, Cost analyses] AN21 . Automated indirect blood pressure measurement devices. 1982. (Guideline report) fIn- formation syntheses, Expert opinion, Cost analyses] AN22 . Automated infusion devices. 1982. (Guideline report) fInformation syntheses, Expert opinion, Cost analyses] AN23 . Autotransfusion units. 1982. (Guideline report) fInformation syntheses, Expert opinion, Cost analysesJ AN24 . Buying and selling used medical equip- ment. 1982. (Guideline report) "Information synthe- ses, Expert opinion, Cost analyses] AN25 . Clinical laboratory information systems. 1982. (Guideline report) tInformaton syntheses, Ex- pert opinion, Cost analyses] AN26 . Computerized arrhythmia monitoring systems. 1982. (Guideline report) "Information syn- theses, Expert opinion, Cost analyses] AN27 . Digital subtraction angiography. 1982. (Guideline report) "Information syntheses, Expert opinion, Cost analyses] AN28 . Ethylene oxide sterilization. 1982. (Guideline report) fInformation synthesis, expert opinion, Cost analyses] AN29 . Evaluation methods for intensive care units. 1982. (Guideline report) fInformation synthe- ses, Expert opinion, Cost analyses] AN30 . Medicare technology assessment. 1982. (Guideline report) fInformation syntheses, Expert opinion, Cost analyses] AN31 . Medicare technology assessment. 1981. (Guideline report) fInformation syntheses, Expert opinion, Cost analyses] 43
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY American Medical Association Council on Scientific Affairs 535 North Dearborn Street Chicago, IL 60610 3 12-645-5335 Contact: William R. Hendee, Ph,D., Secretary; or Vicki Grosso, Council and Commit- tee Coordinator. Overview: The American Medical Association (AMA) is a professional association that provides a wide range of services and products to advance the field of medicine. The Council on Scientific Affairs was formed in 1976 by the AMA. Purpose: To provide accurate, balanced, and up-to-date information on medical tech- nology to the practicing medical community and to communicate the concerns and opinions of physicians to the health care community. Primary intended users: General public; people concerned about their health; pa- tients; providers, generally; physicians; acute facility administrators; long-term care facility administrators; other care givers; health product manufacturers; health/medi- cal professional associations; health industry associations; consumer associations; em- ployers; unions and other employee organizations; third party payers; government regulators; voluntary associations, organizations; biomedical researchers; public policy- makers, legislators. Technologies: Medical or surgical procedure, drug, device. Intervention: Diagnosis, treatment, prevention, rehabilitation. Stage: Emerging, new, established or widespread practice, obsolete. Properties: Safe0, effectiveness, efficacy. Selection process: Any responsible party may request an assessment. Requests are made to the Secretary or Council members. The members of the Council then set the . . . priorities tor assessment. Methods: Group judgment, information syntheses, expert opinion. Issues of importance to the practicing medical community are identified. Often expert panels are organized and charged with addressing pertinent issues. Reports are devel- oped by the panel and submitted to the Council for approval. In other cases, issues are analyzed by staff. Reports are developed and reviewed by three or four consultants. They are then submitted to the Council for approval. The approximate turnaround time from selection of assessment topic to reporting of findings is 6 to 12 months. Assessors: The Council has access to experts in all areas of medicine. Assessment reports include: Abstract; the purpose of the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; sources of data/information; results; findings or conclusions; limitations of findings; 44
AMA/COUNCIL ON SCIENTIFIC AFFAIRS implications of findings for practice; recommendations for practice, future assess- ments, technology development, research; how the technology works, including the- ory, principles; development of the technology. Dissemination: Printed reports; journal articles; advisories to members/constituents; press conferences/news releases, TV/radio broadcasts, video products. The reports are 20-25 pages in length with an initial synopsis. The results are dissemi- nated through the Journal of the American Medical Association JAMA) or the popular press. Copies of the assessment reports may be obtained from [AMA or by requesting reprints. Budget: $613,782. The cost per assessment varies. Funding source: 100 percent parent . . Organlzatlon. Use: The AMA uses the assessment reports as a source of information for physicians to incorporate in their decision-making processes. Completed Reports AO1 American Medical Association, Council on Scien- tific Affairs. Drugs and athletes- Progress Report. 1986. [Group judgment] AO2 _ . Glucocorticoid-induced osteonecrosis. 1986. tGroup judgment] AO3 . Herpes simplex and school children. 1986. tGroup judgment] AO4 . Lasers in medicine and surgery. iAMA 1986 Aug 15;256~7):900-907. tGroup judgment] AO5 . OTC diet preparations containing phen- ylpropanolamine (Resolution 100, I-85). 1986. [Group judgment] AO6 . Preventing death and disability from fires by the new rapid response automatic sprinklers and smoke detectors (Resolution 2, A-851. 1986. (Group judgment] AO7 _ . Safe use of radioactive materials in medi- cal practice (Resolution 66, A-851. 1986. tGroup judg- ment1 AO8 . Statement on liver transplantation. 1986. [Group judgment! AO9 . The Heimlich maneuver interim report (Resolution 52, I-85~. 1986. [Group judgment] AO10 . Use of immunosuppressants in organ transplantation. 1986. tGroup judgment] AO11 . AMA diagnostic and treatment guide- lines concerning child abuse and neglect. JAMA 1985 Aug 9;254~61:796-800. tGroup judgment] AO12 . Aspartame: review of safety issues. JAMA 1985 Jul 18;254:400-402. tGroup judgment] AO13 . Autopsies: interim report (Substitute Resolution 11, A-841. 1985. tGroup judgment! AO14 . Current status of therapeutic plasma- pheresis and related techniques. JAMA 1985 Feb 8;253:819-825. [Group judgmentJ AO15 . Dementia. 1985 tGroup judgment] AO16 . Drugs and athlete~ interim report. 1985. (Group judgment] AO17 . Guidelines for handling parenteral an- tineoplastics. JAMA 1985 Mar 15;253: 1590-1592. ~Group judgment1 AO18 . Guidelines for reporting estimates of probability of paternity. J-AMA -1985 Jun 14;253:3298. [Group judgment] AO19 . Harmful effects of UVA and UVB light. 1985. tGroup judgment] AO20 . SI units for clinical laboratory data. JAMA 1985 May 3;253:2553-2554. tGroup judg- ment] AO2 1 . Saccharin: review of safety issues. TAMA 1985 Nov 8;254~18~:2622-2624. tGroup judgment] AO22 . Scientific status of refreshing recollec- tion by the use of hypnosis. ~AMA 1985 Apr 5;253: 1918-1923. tGroup judgment] AO23 . The use of cardiac pacemakers in medi- cal practice..JAMA 1985 Oct 11;254 (14) 1952-1954. tGroup judgment] AO24 . Vitamin preparations as dietary supple- ments and as therapeutic agents. 1985. iGroup judg- ment] 45
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY AO25 . Xenografts: Review of the literature and current status. TAMA 1985 Dec 20;254~23~:3353. tGroup judgment; Information syntheses] AO26 . Caffeine labeling. JAMA 1984 Aug 10;252:803-806. tGroup judgment] AO27 . Chelation therapy. 1984. tGroup judg- ment] AO28 . Combined modality approaches to can- cer therapy. JAMA 1984 May 11;251:2398-2407. [Group judgment] AO29 . Early detection of breast cancer. JAMA 1984 Dec 7;252:3008-3011. tGroup judgment] AO30 . Nicotine chewing gum for cessation of smoking. 1984. [Group judgment] AO31 . Percutaneous transluminal angioplasty. MAMA 1984 Feb 10;251:764-768. tGroup judgments AO32 . Prescription Abuse Data Synthesis (PADS) Project and the AMA prescription drug abuse activity. 1984. tGroup judgment] AO33 . The acquired immunodeficiency syn- drome. JAMA 1984 Oct 19;252:2037-2043. (Group judgment] AO34 .A guide to the hospital management of · ~ r · . . .. Injuries arising trom exposure to or unto ring Ionizing radiation. 1983. tGroup judgment] AO35 . AMA's role in technology assessment (Resolution 131 (A-83~. 1983. tGroup judgment] AO36- . Calcium channel blocking agents. JAMA 1983 Nov 11 ;250:2522-2524. (Group judgment] AO37 . Choking: the Heimlich maneuver (ab- dominal thrust' vs. back blows. 1983. (Group judg- ment] AO38 . Cochlear implants. JAMA 1983 Jul 15;250:391-392. [Group judgment] AO39 . Dietary and pharmacologic therapy for the lipid risk factors. JAMA 1983 Oct 14;250:1873- 1879. tGroup judgment] AO40 . Effects of competition in medicine. JAMA 1983 Apr 8;249: 1864-1868. tGroup judg- ment] AO41 . Estrogen replacement in the meno- pause. JAMA 1983 Jan 21;249:359. tGroup judg- ment] AO42 . Exercise programs for the elderly.1983. [Group judgment] 46 AO43 . In-utero fetal surgery: (Resolution 73 (I- 81). JAMA 1983 Sep 16;250: 1443-1444. [Group judgment] AO44 . Maternal alcohol use. JAMA 1983 May 13;249:2517-2521. tGroup judgment] AO45 . Medical evaluations of healthy persons. JAMA 1983 Mar 25;249: 1626-1633. tGroup judg- ment1 AO46 . Methaqualone, abuse limits its useful- ness. JAMA 1 983 Dec 9; 250:3052. [Group judgments AO47 . Nonsmoking in hospitals. 1983. tGroup judgment] AO48 . Pharmaceutical dissolution of gallstones. JAMA 1983 Nov 4;250:2373-2374. tGroup judg ment] AO49 . Update on venereal disease. 1983. [Group judgment] AO50 . AMA involvement in prevention and treatment of child abuse and neglect (Substitute Reso- lution 75, A-81). 1982. [Group judgment] AO51 . Addition of thiamine to alcoholic bever- ages (Resolution 140, A-8 11. 1982. tGroup judgment] AO52 . Continuous ambulatory peritoneal dialy- sis. JAMA 1982 Nov 12;248:2340. tGroupjudgmentJ AO53 . Dimethyl sulfoxide. TAMA 1982 Sep 17;248:1369. tGroup judgment] AO54 . Drug abuse related to prescribing prac- tices. TAMA 1982 Feb 12;247:864. [GroupjudgmentJ AO55 . Genetic counseling and prevention of birth defects. JAMA 1982 Jul 9;248:221. tGroup judgment] AO56 . Health care needs of a homosexual pop- ulation. JAMA 1982 Aug 13;248:736. (Group judg- ment] AO57 . Infant formula marketing (Resolution 155, A-81). 1982. tGroup judgment] AO58 . Maternal serum a-fetoprotein monitor- ing. JAMA 1982 Mar 12;247:1478. tGroup judg- ment] AO59 . Pneumococcal, influenza and hepatitis-B vaccine (Resolution 75, A-82). 1982. tGroup judg- ment] AO60 . Acupuncture. 1981. EGroup judgment] AO61 . Electronic fetal monitoring. JAMA 1981 Nov 20;246:2370. tGroup judgment]
AMA/COUNCIL ON SCIENTIFIC AFFAIRS AO62 . Evalution of iridology. 1981. tGroup judgment] AO63 . Hypnotic drugs and treatment of insom- nia. JAMA 1981 Feb 20;245:749. tGroup judgment] AO64 . Indications and contraindications for ex- ercise testing. JAMA 1981 Aug 28;2a~6: 1015. tGroup judgment] AO65 . Marijuana, its health hazards and thera- peutic potentials. {AMA 1981 Oct 16;246: 1823. tGroup judgment] AO66 . Medical care for indigent and culturally displaced obstetrical patients and their newborns. Committee on Maternal and Child Health. JAMA 1981 Mar 20;245: 1159. tGroup judgment] AO67 . Organ donor recruitment. JAMA 1981 Nov 13;246:2157. tGroup judgments AO68 . Physician-supervised exercise programs in rehabilitation of patients with coronary heart dis- ease. JAMA 1981 Apr 10;245:1463. tGroup judg- ment] American Medical Association Diagnostic arid Therapeutic Technology Assessment 535 North Dearborn Street Chicago, IL 60610 3 12-645-4530 AO69 . Prescription of tranquilizers and antide- pressants for women (Board of Trustees report X, I- 80). 1981. [Group judgment] AO70 . Health care technology assessment- 1980. 1980. [Group judgment] AO71 . Hypoglycemic treatment, guidelines for the non-insulin-dependent diabetic. MAMA 1980 May 23-30;243:2078. tGroup judgment] AO72 . Importance of diagnostic computerized tomographic scanning. 1980. tGroup judgment] AO73 . Infant nutrition (Resolution III, I-78.) 1980. tGroup judgment] AO74 . Marijuana in the 80's. 1980. [Group judgment] AO75 . Progress in adoption of SI units. 1980. tGroup judgment] AO76 . The nutritive quality of processed foods: general policies for nutrient additions. 1980. tGroup judgment] Contact: William T. McGivney, Ph.D., Director; or Andrea L. Schneider, Program Administrator. Telex 910-221-0300. Overview: The American Medical Association (AMA) is a professional association that provides a wide range of services and products to advance the field of medicine. The Diagnostic and Therapeutic Technology Assessment program (DATTA) was estab- lished by the AMA in 1982. Purpose: To provide accurate, balanced, and up-to-date information on medical tech- nology to the practicing medical community; and to communicate the concerns and opinions of physicians to other constituents of the health care community. Primary intended users: General public; people concerned about their health; pa- tients; providers, generally; physicians; acute facility administrators; long-term care facility administrators; other care givers; health product manufacturers; health/medi- cal professional associations; health industry associations; consumer associations; em- ployers; unions and other employee organizations; third party payers; government regulators; voluntary associations, organizations; biomedical researchers; public policy- makers; legislators. 47
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Technologies: Medical or surgical procedure, drug, device. Intervention: Diagnosis, treatment, prevention, rehabilitation. Stage: New, emerging, established or widespread practice, obsolete. Properties: Safety, effectiveness, efficacy. Selection process: Any responsible party may request that an assessment be conducted. Written requests should be submitted to the Director. The DATTA Subcommittee, Director, and AMA Executive staff set assessment tonic priorities. The need to reassess the technologies is considered periodically. Methods: Expert opinion, information syntheses. 1~ A TT A ~1 ~· . 1 ~ - 1 ~ ~A ~ V V V V UA! IA formulates questions to examine the safety and effectiveness of a technology when applied for very specific indications. Individuals with expertise in the topic are selected from a reference panel and asked (by mail) to rate the safety and effectiveness of the technology as established, investigational, or unacceptable. Panelists are encour- aged to provide supporting data and relevant considerations. The evaluations of the panelists are collated, compiled, and synthesized with an extensive analysis of the biomedical literature. The approximate turnaround time from selection of topic to reporting of findings is 120 days. Assessors: DATTA is operated by AMA staff under direction of a subcommittee of the AMA Council on Scientific Affairs. Staff selects panelists for each assessment from a reference panel of 1,000 physicians appointed by the Council on Scientific Affairs. Panelists represent a broad spectrum of specialties and subspecialties. Assessment reports include: Description of the technology; stage of life-cycle of technology when assessed; properties assessed; sources of data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles. Dissemination: Printed reports; journal articles; advisories to members/constituents; press conferences/news releases, TV/radio broadcasts, video products. The assessment reports contain an initial synopsis and are usually 8 to 10 pages in length. DATTA results are usually published in the journal of the American Medical Association, disseminated in the popular press, and are distributed to certain individuals and organizations on a mailing list. Individual copies of DATTA reports may be obtained from the AMA. Subscriptions to the DATTA series, including new and past reports and the newsletter AMA Tech, are available from the AMA. Budget: $380,000. The approximate cost per assessment is $15 000. Funding source: 100 percent parent organization. a Use: The AMA uses the assessment reports as a source of information for physicians to use for decision-making purposes. They are also used by third party payers, group practices, specialty societies, individual patients, public policy-makers. Articles describ- ing the program include the following citations: 48
AMAIDIAGNOSTIC AND THERAPEUTIC TECHNOLOGY ASSESSMENT Institute of Medicine, Committee on Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. Monaco GP, Burke RL. Insurance as gatekeeper part two: policy obstacles in unprov- en methods litigation. Forum 1985;spring. Petitti DB. Competing technologies, implications for the cost and complexity of medical care. New Engl ~ Med 1986 Dec 4. Rose M, Leibenluft RF. Antitrust implications of medical technology assessment. New Engl J Med 1986.Jun 5. The following assessment reports of the Office of Health Technology Assessment (National Center for Health Services Research and Health Care Technology Assess- ment) reference DATTA statements: 1983 Anti-gastroesophageal reflex implantation Diathermy as a physical therapy modality Fully automated ambulatory blood pressure monitoring of hypertension 1984 Ambulatory electroencephalographic (EEGJ monitoring External open-loop pump for the subcutaneous infusion of insulin in diabetes Implantable pumpfor chronic Hepburn therapy S. treptokinase infusion for acute my ocardial infarc- tion Transplantation of the pancreas 1985 Apherests in the treatment of guillian-barre syndrome Extracorporeal shock wave lithotr~psy (ESWL) procedure for treatment of kidney stones Patient selection criteria for percutaneous transluminal coronary ang~oplasty of a stenotic lesion in a single coronary artery Percutaneous ultrasound procedures for the treatment of kidney stones Reassessment of cardiokymography (No longer valid) Transurethral ureteroscopic lithotrapsy procedures for the treatment of kidney stones Completed Reports API American Medical Association, Diagnostic and Therapeutic Technology Assessment. Ablation of ac- cessory pathways in Wolff-Parkinson-White Syn- drome. Mar 31, 1986. tExpert opinion, Information syntheses] APE . Angelchik antireflux prosthesis treatment of gastroesophageal reflex. JAMA 1986 Sep 12. tEx- pert opinion, Information syntheses] AP3 . Autologous bone marrow transplantation. }AMA 1986.Jul 4. tExpert opinion, Information syn- theses] AP4 . BCG immunotherapy in bladder cancer. Mar 31, 1986. tExpert opinion, Information synthe- ses] AP5 . Cardiac rehabilitation services. Jul 16, 1986.1iExpert opinion, Information syntheses] APO . Garren gastric bubble for morbid obesity. JAMA 1986 Dec 19. Expert opinion, Information syntheses] AP7 . Mammographic screening for breast can- cer. Oct 19, 1986. tExpert opinion, Information syn- theses] 49
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY AP8 . Microsurgical reconstruction for brachial plexus injury. Jul 16, 1986. tExpert opinion, Informa- tion syntheses] AP9 . Continuous arteriovenous hemofiltration (CAVH) for fluid removal. JAMA 1985 Mar 1. [Ex- pert opinion, Information syntheses] AP10 . Diagnostic intraoperative ultrasound. tAMA 1985 Jul 12. [Expert opinion, Information syntheses] APll . Endoscopic electrocoagulation for gas- trointestinal hemorrhage. JAMA 1985 May 11. [Ex- pert opinion, Information syntheses] AP12 . Endoscopic laser photocoagulation for gastrointestinal hemorrhage. JAMA 1985 May 11. [Expert opinion, Information syntheses] APES . Endoscopic thermal coagulation for gas- trointestinal hemorrhage. JAMA 1985 May 11. tEx- pert opinion, Information syntheses] AP14_ . Endoscopic topical therapy for gastroin- testinal hemorrhage. JAMA 1985 May 11. tExpert opinion, Information syntheses] APES . Enhanced computed tomography in head trauma. JAMA 1985 Dec 20. tExpert opinion, Information syntheses] AP16 . Non-invasive extracorporeal lithotripsy for disruption of kidney stones Update. Feb 15, 1985. tExpert opinion, Information syntheses] AP17 . Sperm penetration assay in identifying male infertility. JAMA 1985 Oct 11. [Expert opinion, Information syntheses] AP18 . Sterotactic cingulatomy treatment for psychiatric disorders. JAMA 1985 Nov 15. [Expert opinion, Information syntheses] APl9 . Apnea monitoring for 24-hour surveil- lance of newborns at risk for sudden infant death syndrome. JAMA 1984 Tan 27. tExpert opinion, In- formation syntheses] AP2O . Bone marrow transplantation in child- hood leukemia. JAMA 1984 Apr 27. [Expert opinion, Information syntheses] AP21 . Cardiokymography for (non-invasive) cardiological diagnosis. JAMA 1984 Feb 24. tExpert opinion, Information syntheses] AP22 . Diaphanography (transillumination of the the breast) for cancer screening. JAMA 1984 Apr 18. tExpert opinion, Information syntheses] AP23 . Endoscopic transurethral nephrolitho- tomy for disruption of kidney stones. JAMA 1984 Dec 21. [Expert opinion, Information syntheses] 5O AP24 . Gastric restrictive surgery for morbid obesity. JAMA 1984 {un 8. tExpert opinion, Informa- tion syntheses] AP25 . Hyperthermia treatment for cancer Update. Sep 17, 1984. ~Expert opinion, Information syntheses] AP26 . Implanted electrospinal stimulator for scoliosis. JAMA 1984 May 25. tExpert opinion, Infor- mation syntheses] AP27 . Percutaneous nephrolithotomy for kid- ney stone removal. JAMA 1984 Dec 2. tExpert opin- ion, Information syntheses] AP28 . 24-hour ambulatory EEG monitoring for diagnosing seizure disorders. JAMA 1983 Dec 23. tExpert opinion, Information syntheses] AP29 . Biofeedback for managing vascular and tension headaches. JAMA 1983 Nov 14. tExpert opinion, Information syntheses] AP30 . C02 laser for the treatment of gyneco- logic malignancies. JAMA 1983 Aug 5. [Expert opin- ion, Information systheses] AP31 . Chelation therapy (with EDTA) for ath- erosclerosis. ~AMA 1983 Aug 5. [Expert opinion, In- formation syntheses] AP32 . Cranial electrostimulation for treatment of anxiety and/or depression. {AMA 1984 Feb 24. tExpert opinion, Information syntheses] AP33 . Diathermy for treating musculoskeletal conditions. JAMA 1983.Jul 22-29. tExpert opinion, Information syntheses] AP34 . Implantable infusion pump for continu- ous drug therapy. JAMA 1983 Oct 14. tExpert opin- ion, Information syntheses] AP35 . Mandatory EKG prior to elective sur- gery. JAMA 1983 Jul 29. tExpert opinion, Informa- tion syntheses] AP36 . Quantitative EEG (fast Fourier trans- form analysis) operative monitoring of cerebrovascu- lar status. JAMA 1983 Jul 15. tExpert opinion, Infor- mation syntheses] AP37 . Radial keratotomy for the treatment of myopia. JAMA 1983 Jul 15. tExpert opinon, Infor- mation syntheses] AP38 . Thermography (electronic and liquid crystal) for diagnosing low-back pain. Ongoing. [Ex- pert opinion, Information synthesesJ
AMA/DRUG EVALUATIONS American Medical Association Drug Evaluations 535 North Dearborn Street Chicago, IL 60610 3 12-645-4560 (contact: Donald R. Bennett, M.D., Ph.D., Director; or Marilyn A. Mayo, Assistant to the Director. Telex 910-221-0300. Overview: The American Medical Association (AMA) is a professional association that provides many services and products to advance the field of medicine. The AMA Drug Evaluations section was established in 1971, however, the Department of Drugs has been a part of the AMA for 75 years. Every 2 to 3 years it publishes the reference book Drug Evaluations; the sixth edition was published in 1986. Purpose: To provide physicians and other health care professionals with up-to-date, objective information on the clinical use of drugs and to serve as a reference source for practical, comparative, evaluative information on drug therapy. Primary intended users: Providers, generally; physicians; health product manufactur- ers; health/medical professional associations; public policy-makers, legislators. Technologies: Drug. Intervention: Treatment. Stage: Emerging, new, established or widespread practice, obsolete. Properties: Safety, efficacy, effectiveness. Selection process: Assessment topics are identified primarily by AMA scientific staff review of current drug utilization. Occasionally, requests are received from physicians. The requests are submitted to the Director who sets priorities in consultation with the Drug Evaluations editor and scientific staff. Methods: Information syntheses, expert opinion. The staff of the AMA Department of Drugs prepares chapters based on the current scientific literature. The chapters are reviewed by consultants and the medical staffs of the appropriate pharmaceutical manufacturers. Following consensus revision, the chapters are reviewed by designees or members of the American Society for Clinical Pharmacology and Therapeutics (ASCPT). For the sixth edition, more than 500 distin- guished consultants contributed their comments to the draft versions. Thus, this publication is a joint scientific contribution to the field of applied therapeutics by the AMA, a large consultant body, and the ASCPT. The consultants have expertise in pharmacology and therapeutics. A new edition of Drug Evaluations is produced every 2 to 3 years. Assessors: AMA professional staff, medical staff of pharmaceutical manufacturers, and expert consultants in pharmacology and therapeutics participate in the assess- ments. 51
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Assessment reports include: Description of the technology; stage of life-cycle of technology when assessed; properties assessed; sources of data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works. including theory. orincinles. The text descrihe.s ~nnro~ri- mately 2,000 drugs. O ~ 1 1 ~rr~~-~ Dissem~nation: The text is sold by the AMA directly and by a commercial publisher. Budget: The cost of producing each text is $1,500,000; this averages $500 for each drug evaluation. Funding source: 100 percent parent organization. Use: Drug Evaluations provides physicians information on comparative drug therapy to improve their prescribing practices. There are numerous citations in the biomedical literature to this text. Completed Reports AQ1 American Medical Association. Drug evaluations. Philadelphia:Saunders, 1986. "Information synthe- ses, Expert opinion] American Society for Gastrointestinal Endoscopy Committee on Technology Assessment 13 Elm Street Manchester, MA 0 ~ 944 61 7-927-8330 Contact: William T. Maloney, Executive Director; or John H. Bond Tr., M.D., Chair- man, Veterans Administration Hospital, 54th St. and 48th Ave. South, Minneapolis, MN 55417,612-725-6767. Overview: The purposes of the American Society for Gastrointestinal Endoscopy (ASGE) are 1) to further knowledge of gastrointestinal disease through the use of endoscopic techniques in clinical practice and research; 2) to establish and maintain the highest standards of practices for the diagnostic and therapeutic use of gastrointestinal endoscopic methods; 3) to provide guidelines for training programs and to further the teaching of gastrointestinal endoscopy; 4) to assist all those involved with health care as it relates to gastrointestinal endoscopy; and 5) to facilitate development of improved instruments of gastrointestinal endoscopy. The Society has 3,840 members. Its activities include educational, audiovisual, scien- tific, and research programs, as well as publication of a bimonthly journal Gastrointesti- nal Endoscopy and guidelines and statements on training and practice. Various activities relating to technology assessment were organized under the direction of a five-member Committee on Technology Assessment in May 1986. The Society functions as an information source, and is capable of offering expert and consensus opinions and other assistance in matters that relate to gastrointestinal endoscopic technology. 52
AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY Purpose: To explore and define technology issues that apply to gastrointestinal endos- copy. Primary intended users: Providers, generally; physicians. Technologies: Device, medical or surgical procedure. Interest is focused primarily on the use in clinical practice of emerging and established gastrointestinal endoscopic procedures and other technical procedures that relate to endoscopy. The Society is also concerned with the development and assessment of new instruments and techniques as well as innovative uses of existing methods and instru- ments. ~ Intervention: Diagnosis, treatment. Stage: Emerging, new, established or widespread practice, obsolete. Existing and established endoscopic methods and related instruments are assessed. Emerging procedures and instruments are also assessed, especially those that appear likely to be adopted by large numbers of physicians who use endoscopy. Properties: Safety, efficacy, effectiveness, cost-effectiveness. Emphasis is on the correct use of endoscopic instruments and techniques with respect to accepted indications and contraindications, safety considerations, effectiveness, and cost-effectiveness, and on training in endoscopic procedures. Selection process: The ASGE Governing Board directs the activities of the Technology Assessment Committee. In some instances the Board directs that specific questions be reviewed while in other cases, committees may recommend areas for study that they consider important or controversial. The Society solicits the views of its members, usually by means of questionnaires and surveys, to identify problem areas. All ASGE statements on the use of endoscopic procedures are updated periodically, and out-of-date statements are withdrawn. Methods: Group judgment, information syntheses, expert opinion, cost analyses. The Society has several assessment procedures, including information gathering and syntheses. In this process, published information is reviewed, the opinions of expert consultants are solicited, and conclusions are formulated by a panel of experienced endoscopists. The ASGE conducts prospective studies of various problems pertaining to the use of endoscopy in which members submit data according to a protocol. One of the most useful has been the National ASGE Survey on Upper Gastrointestinal Bleeding (Silver- stein FE, et al. GastrointestEndosc 1981;27:73-103) which included the participation of 277 members. . A comprehensive review of a specific technology requires about 9 to 12 months, although this is highly variable and depends on the complexity of the problem. Assessors: Society members who participate in technology assessment have extensive , . . . . . clinical experience In endoscopy. They are usually acknowledged experts in specific 53
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY areas of endoscopy as well as established investigators who have made significant contributions to the field in its technical and clinical aspects. Assessment reports include: Description of the technology; properties assessed; pro- cedure used for the assessment; sources of dataJinformation; methods for collecting dataJinformation; methods for analyzing/synthesizing data/information; results; find- ings or conclusions; limitations of findings; implications of findings for practice; recom- mendations for practice, future assessments, technology development, research. Dissemination: Printed reports, journal articles. The conclusions that result from a review process may be formulated as a guideline statement with recommendations directed to Society members and the medical com- munity at large. Statements, recommendations, and reviews are usually published as pamphlets or monographs, which are available free from the Manchester office. Budget: Not provided. The approximate cost of an assessment. based on the number of meetings to generate a report, is $5,000 to $25,000. A complex review of a broad area or an intricate problem that requires considerable discussion might require great- er funding. Use: The ASGE uses the assessments to promote high standards of practice, patient care, and training in matters that pertain to endoscopy. Although the work of the ASGE as a professional society is primarily directed toward practicing physicians, it is also available to health care institutions, government agencies, certifying bodies, orga- nizations that regulate health care delivery, and virtually any organization with legiti- mate interests in health care. It is also available to the general public. It is the ASGE's impression that some of these groups have used its reports, but this usage is not tracked. Related activities: The results and conclusions of investigative work sponsored by the ASGE and relating, at times, to technology assessment are usually presented in open forums such as the plenary session of the Society and in the Society'sjournal, Gastrointes- tinal Endoscopy. Completed Reports AS1 Boyce HW. Treatment of esophageal stenosis. In: American Society for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an information resource manual. 1987. "Information syntheses, Expert opin- ion, Group judgment, Cost analyses] AS2 Fleischer DE. Esophageal cancer: laser treatment. In: American Society for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an information resource manual. 1987. "Information syntheses, Expert opin- ion, Group judgment, Cost analyses] 54 AS3 Jensen DM. Gastrointestinal angiomata: current diagnosis and treatment. In: American society for Gastrointestinal Endoscopy, Committee on Technol- ogy Assessment. Therapeutic gastrointestinal endos- copy: an information resource manual. 1987. tInfor- mation syntheses, Expert opinion, Group judgment, Cost analyses] AS4 Johnston TH. Ulcer hemorrhage heater probe treatment. In: American Society for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an informa- tion resource manual. 1987. [Information syntheses, Expert opinion, Group judgment, Cost analyses]
AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY AS5 Kozarek RA. Balloon dilation. In: American Socie- ty for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointesti- nal endoscopy: an information resource manual. 1987. "Information synthesis, Expert opinion, Group judgment, Cost analyses] AS6 Mellow MH. Endoscopic laser treatment of colon cancer. In: American Society for Gastrointestinal En- doscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an informa- tion resource manual. 1987. "Information syntheses, Expert opinion, Group judgment, Cost analyses] AS7 Overholt BE. Ulcer hemorrhage laser treatment. In: American Society for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an information resource manual. 1987. "Information syntheses, Expert opin- ion, Group judgment, Cost analyses] AS8 Papp JP. Control of upper gastrointestinal bleeding by monopolar electrocoagulation. In: American Soci- ety for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointesti- nal endoscopy: an information resource manual. 1987. "Information syntheses, Expert opinion, Group judgment, Cost analyses] AS9 Ponsky {L. Percutaneous endoscopic gastrostomy and jejunostomy. In: American Society for Gastroin- testinal Endoscopy, Committee on Technology As- sessment. Therapeutic gastrointestinal endoscopy: an information resource manual. 1987. [Information synthesis, Expert opinion, Group judgment, Cost an- alyses] AS10 Protell RL. Ulcer hemorrhage-bicap probe treat- ment. In: American Society for Gastrointestinal En- doscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an informa- tion resource manual. 1987. "Information sytheses, Expert opinion, Group judgment, Cost analyses] ASH Silvis SE. Endoscopic retrograde sphincterotomy (ERS,. In: American Society for Gastrointestinal En- doscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an informa- tion resource manual. 1987. "Information synthese- s;Expert opinion, Group judgment, Cost analyses] AS12 Sivak MV. Sclerotherapy of esophageal varices. In: American Society for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an information resource manual. 1987. "Information syntheses, Expert opin- ion, Group judgment, Cost analyses] AS13 Wayne JD. Colonoscopic polypectomy. In: Amer- ican Society for Gastrointestinal Endoscopy, Commit- tee on Technology Assessment. Therapeutic gastro- intestinal endoscopy: an information resource man- ual. 1987. "Information syntheses, Expert opinion, Group judgment, Cost analyses] AS14 Webb WA. Esophageal and gastric foreign bodies: endoscopic removal. In: American Society for Gastro- intestinal Endoscopy, Committee on Technology As- sessment. Therapeutic gastrointestinal endoscopy: an information resource manual. 1987. [Information syntheses, Expert opinion, Groupjudgment, Cost an- alyses] AS15 American Society for Gastrointestinal Endoscopy. Appropriate use of gastrointestinal endoscopy. 1986 Jun. AS16 . Flexible sigmoidoscopy. Revised 1986 Mar. AS17 . Standards of practice for gastrointestinal endoscopy. Revised 1986 Mar. AS18 . Statement of endoscopic training. Re- vised 1986 Mar. ASl9 . The role of colonoscopy in the manage- ment of patients with colonic polyps. Revised 1986 May. AS20 . The role of colonoscopy in the patients with inflammatory bowel diseases. Revised 1986 May. AS21 . The role of endoscopy in the manage- ment of esophagitis. Revised 1986 Mar. AS22 . The role of endoscopy in the manage- ment of the patient with peptic ulcer disease. Revised 1986 Mar. AS23 . The role of endoscopy in the manage- ment of upper gastrointestinal hemorrhage. Revised 1986 Mar. AS24 . The role of endoscopy in the patient with lower gastrointestinal bleeding. 1986 May. AS25 . The role of endoscopy in the surveillance of premalignant conditions of the upper gastrointesti- nal tract. Revised 1986 Mar. 55
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Battelle Memorial Institute Battelle Human Affairs Research Centers 4000 NE 4Ist Street Seattle, WA 98105 206-525-3130 Battelle Meclical Technology Assessment Program 2030 M Street NW Washington, DC 20036 202-785-8400 Contact: Roger W. Evans, Ph.D., Senior Research Scientist, Human Affairs Research Centers; Bryan R. Luce, Ph.D., Director, Medical Technology Assessment Program. Overview: The Battelle Memorial Institute is a nonprofit organization devoted to the advancement and use of science and technology. The Battelle Human Affairs Research Centers is a component of the Pacific Northwest Division of Battelle Memorial Insti- tute. Assessments of health care technologies are undertaken by the Health and Population Study Center in Seattle, and by the Medical Technoloy Assessment Pro- gram (MEDTAP) in Washington, DC. Pur Pose: To assess medical technologies. Primary intended uses: General public; patients; providers, generally; physicians; acute facility administrators; health product manufacturers; health/medical profes- sional associations; health industry associations; employers; third party payers; govern- ment regulators; reporters, writers, news media; public policy-makers, legislators. Technologies: Drug, device, medical or surgical procedure, support system, organiza- tional or administrative system. Intervention: Treatment, prevention, diagnosis, rehabilitation. Stage: New, emerging, established or widespread practice. Properties: Cost-effectiveness; effectiveness; cost; service requirements; acceptance/ adoption level; economic implications; ethical, legal, social implications; health status effects; reimbursement implications. Selection process: Anyone can request that an assessment be conducted; requests do not follow a specific format. All assessments are done through either a contract or grant. Generally the sponsor, whether it is industry or government, sets assessment . . . . topic priorities. Methods: Cost analyses, information syntheses, expert opinion, groupjudgment, model- ing, epidemiological or other observational methods, prospective economic clinical trials/studies, retrospective cost-effectiveness studies, quality of life questionnaires, cost of illness simulation techniques. 56
BATTELLE MEMORIAL INSTITUTE The assessment process varies depending upon the issue addressed. The turnaround time from selection of assessment topic to reporting of findings averages 1 year but ranges from 4 months to 3 years. Assessors: The assessors have expertise in conducting cost effectiveness research, quality of life~ealth status measurement, and prospective economic clinical studies. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment; sources of dataJinformation; methods for collecting data/information; methods for analyzing/synthesizing dataJinformation; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles; where technology is in use; regulatory agency approval status; coverage/reimbursement status of the tech nology. Dissemination: Printed reports, journal articles. Copies of assessments may be obtained by writing to: Battelle Human Affairs Research Centers or to Battelle MEDTAP. For the National Heart Transplantation Study and the National Kidney Dialysis and Kidney Transplantation Study, Battelle printed a total of some 80 Update Series reports on various aspects of these major studies. All are available from Battelle; some have been published in journals. Due to agreements with its clients, Battelle MEDTAP is unable to provide a complete list of ongoing assess- ments. Budget: $200,000. The cost per assessment ranges from $40,000 to $3,000,000. Fund- ing source: 100 percent private industry contracts. Use: Most assessments are used for health policy and reimbursement decisions or marketing purposes. The Battelle National Heart Transplant Study was particularly important in assisting the Health Care Financing Administration and the Secretary of the U.S. Department of Health and Human Services in formulating Medicare reim- bursement policy. Battelle's assessment activities are described in Institute of Medicine, Committee on Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washing- ton, DC: National Academy Press, 1985. Completed Reports BA1 Luce BR, Ellrodt AG, Camaeron JM, Reidinger M. tBattelle Medical Technology Assessment Program] Managing acute hypertension: cost considerations. Am I Emer Med 1986;6(supplement):31-34. tCost analyses1 BA2 Health Industry Manufacturers Association. tBat- telle Medical Technology Assessment Program] A guide to cost-effectiveness analysis for medical device and diagnostic manufacturers. Washington, D.C.: Health Industry Manufacturers Association, 1985. (HIMA Report Number B5-2, HIMA Research Re- port Series Number 3~. tCost analyses1 BA3 Battelle Human Affairs Research Centers. Nation- al Heart Transplantation Study, Final Report to the Health Care Financing Administration. 1984. BA4 Battelle Human Affairs Research Centers. Nation- al Kidney Dialysis and Kidney Transplantation Study, Final Report submitted to the Health Care Financing Administration. 1984. 57
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Ongoing Assessments BA5 Battelle Human Affairs Research Centers. Cost-ef- fectiveness of cyclosporine as primary immunosup- pressive therapy for kidney transplantation recipi- ents, sponsored by the Health Care Financing Ad . . . _ . mmlstratlon. ongoing. Blue Cross and Blue Shield Association Medical Necessity Program 676 North St. CIair Street, ~ Ith Floor Chicago, IL 6061 3 12-440-5577 BAG Battelle Medical Technology Assessment Pro- gram. Cost-effectiveness of the implantable cardiac defibrillator. Ongoing. Contact: Susan Gleeson, Executive Director, Technology Management Department; David Tennenbaum. Manager, Medical Necessity Program 312-440-6155. Overview: The Blue Cross and Blue Shield Association represents member Blue Cross and Blue Shield plans and advises them on health care insurance issues. As an associa- tion, it provides medical, financial, and administrative consultation and technical assis- tance to member plans. The identification of obsolete procedures by Blue Cross and Blue Shield plans began in 1975 with the California Blue Shield Medical Policy Committee. The Medical Necessity Program was begun in 1976 under the National Association of Blue Shield Plans (which merged in 1978 with the Blue Cross Association to form the Blue Cross and Blue Shield Association), representing one of the first national private initiatives to assess medical technology for coverage purposes. Since its inception, the Program has worked in cooperation with such organizations as the American College of Physicians, the Ameri- can College of Radiology, and the American College of Surgeons. As a result of its participation in the Medical Necessity Program, the American College of Physicians established the Clinical Efficacy Assessment Project. Purpose: To provide advice to member Blue Cross and Blue Shield plans on the clinically appropriate uses of existing medical technologies. Primary intended users: Physicians, medical policy staff, Blue Cross and Blue Shield plans. Technologies: Medical or surgical procedure, device. Intervention: Diagnosis, treatment, rehabilitation. Stage: Established or widespread practice, obsolete. Properties: Effectiveness, efficacy, medical necessity. Selection process: Blue Cross and Blue Shield plans submit requests for assessments to Program staff. The staff sets assessment topic priorities in consultation with a Medical Advisory Panel comprised of medical directors from selected Blue Cross and Blue Shield plans. Technologies are reassessed when an ongoing review of new clinical evidence suggests this is warranted. 58
BCBS/MEDICAL NECESSITY PROGRAM Methods: Information syntheses, expert opinion. The Program commissions experts on the respective assessment topics to develop comprehensive literature review articles. A Medical Necessity Program conference may be held where national medical organization representatives review the commissioned articles. Draft clinical guidelines based on the articles are also reviewed. Final guidelines are then developed by Program staff in consultation with the commissioned experts. Recently, several medical necessity topics have been assessed by the Clinical Efficacy Assessment Subcommittee of the American College of Physicians. The approximate turnaround time from selection of assessment topic to reporting of findings is 1 year. Assessors: Both external consultants and internal staff have medical, clinical, and research expertise including data analysis and interpretation. Assessment reports include: Who conducted the assessment; description of the tech- nology; properties assessed; results; findings or conclusions; recommendations for practice, future assessments, technology development, research. Dissemination: Advisories to memberslconstituents; printed reports; journal articles; press conferences/news releases, TV/radio broadcasts. The Association distributes Medical Necessity Program Guidelines to Blue Cross and Blue Shield plans. The plans generally publicize the Guidelines and distribute them to provid- ers in their service area. Guidelines can be obtained from the Association upon request. The literature review articles are published by the authors in medical peer-reviewed journals. Budget: $350,000. Funding source: 100 percent parent organization. Use: The literature review articles and Medical Necessity Guidelines constitute clinical advice to the plans, which use them in establishing their medical policies. Organizations such as the American College of Physicians have endorsed many Medical Necessity Program products. Guidelines are often used by health care institutions' utilization review and quality assurance programs. The Program is cited in the following documents: Government Accounting Office. OPM should promote medical necessity programsforfederal Employees' health insurance. 1980 Jut 29. Greenberg G and Derzon RA. Determining health insurance coverage of technolo~v: problems and options. Med Care 1 98 1; 1 9( 1 0~: 967-78. O OJ Institute of Medicine, Committee for Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. Lewin and Associates. A forward plan for Medicare coverage and technology assessment. 1986 Dec. Completed Reports BC1 Blue Cross and Blue Shield, Medical Necessity Program. Activated partial thromboplastin time and prothrombin time. 1987. fInformation syntheses] BC2 . Arterial blood gas analysis. 1987. tInfor- mation syntheses] BC3 . Biochemical profiles in ambulatory screening and preadmission testing of adults. 1987. [Information syntheses] 59
MEDICALI~CHNOLOGY ASSESSMENT DIRECTORY BC4 . Blood cultures. 1987. [Information syn- theses] BC5. . Blood urea nitrogen concentration and serum creatinine concentration. 1987. [Information syntheses] BC6 . Carcinoembryonic antigen. 1987. tInfor- mation syntheses] BC7 . Cardiac enzyme assays in the diagnosis of myocardial infarction. 1987. [Information syntheses] BC8 . Complete blood count and leukocyte dif- ferential count. 1987. [Information syntheses] BC9 . Erythrocyte sedimentation rate.1987. tIn- formation syntheses] BC10 . Routine preoperative and general hospi- tal admission chest x-rays.1987. [Information synthe- ses] BC11. . Routine preoperative and general hospi- tal admission electrocardiograms. 1987. [Information syntheses] BC12 . Serum electrolytes and serum osmolality. 1987. [Information syntheses] BC13 . Syphilis tests.1987. [Information synthe- ses] BC14 . Throat cultures and rapid test for diag- nosing group A streptococcal pharyngitis. 1987. [In- formation syntheses] BC15 . Urinalysis, urine culture, and other tests in the diagnosis of women with acute dysuria. 1987. "Information syntheses] BC16 . Anticoagulant therapy in the myocardial infarction patient. 1985. "Information syntheses] BC17. . Cardiac exercise stress test. 1985. tInfor- mation syntheses] BC18 . Cardiokymography. 1985. "Information syntheses] BC19. . Coronary angiography and cardiac cath- eterization. 1985. fInformation syntheses] BC20 . Doppler flow velocity study. 1985. [In- formation syntheses] BC21 . Echocardiogram. 1985. "Information syntheses] BC22 . Electrocardiogram. 1985. [Information syntheses] BC23 . Intensive cardiac care unit. 1985. tInfor mation syntheses] BC24 . Outpatient cardiac rehabilitation. 1985. "Information syntheses] 60 BC25 . Permanent cardiac pacemakers. 1985. [Information syntheses] BC26 . Serum lipoprotein evaluation. 1985. [In- formation syntheses] BC27 . Vectorcardiogram. 1985. [Information syntheses] BC28 .CT scan in the evaluation of headaches, cerebrovascular disease and dementia. 1984. tInfor- mation syntheses] BC29 . Chest x-ray examinations. 1984. [Infor- mation syntheses] BC30 . Diagnostic imaging in the evaluation of breast disease. 1984. "Information syntheses] BC31 . Head CT scan and ultrasound in the pediatric patient. 1984. [Information syntheses] BC32 . Outmoded radionuclide imaging proce- dures. 1984. [Information syntheses] BC33 . Radionuclide bone scan and x-ray of bones in the evaluation of bone metastases. 1984. [Information syntheses] BC34 . Radionuclide brain scan in the evaluation of adult intracranial disease. [Information syntheses] BC35 . Ultrasound and x-ray pelvimetry in ma- ternity care. 1984. [Information syntheses] BC36 . Upper gastrointestinal fluoroscopic study. 1984. "Information syntheses] BC37 . Routine admission testing medical ad- missions. 1983. [Information syntheses] BC38 . Routine admission testing surgical ad- missions. 1983. [Information synthesesJ BC39 . Diagnostic studies for respiratory pa- tients: arterial blood gas analysis. 1982. [Information syntheses] BC40. . Diagnostic studies for respiratory pa- tients: pulmonary function tests. 1982. "Information synthesesJ BC41 . Oxygen therapy. 1982. [Information syntheses] BC42 . Respiratory therapy: aerosol therapy. 1982. "Information syntheses] BC43 . Respiratory therapy: incentive spirome- try. 1982. [Information syntheses] BC44 . Respiratory therapy: intermittent posi- tive pressure breathing. 1982. [Information synthe- ses] BC45. . Respiratory therapy: postural drainage. 1982. "Information syntheses]
BCBS/TECHNOLOGY EVALUATION AND COVERAGE PROGRAM Blue Cross and Blue Shielc' Association Technology Evaluation and Coverage Program 676 North St. CIair, ~ Ith Floor Chicago, 1[1~ 606 3 1 2-440-5577 Contact: Susan Gleeson, Executive Director, Technology Management Department. Overview: The Blue Cross and Blue Shield Association represents member Blue Cross and Blue Shield plans and advises them on health care insurance issues. As a trade association, it provides medical, financial, and administrative consultation and technical assistance publications. Its Technology Evaluation and Coverage (TEC) Program was formally established in 1985, having evolved from activities originally begun under the National Association of Blue Shield Plans in the late 1960s. Purpose: To provide advice to member Blue Cross and Blue Shield plans to assist them in determining the eligibility for coverage of new and emerging technologies. Primary intended users: Blue Cross and Blue Shield plans. Technologies: Device, medical or surgical procedure, support system. Intervention: Treatment, diagnosis. Stage: New, emerging. Properties: Effectiveness, safety, efficacy, cost, cost-effectiveness, service requirements. In order to be recommended as eligible for coverage: (1) a technology must have final approval from the appropriate government regulatory agency, e.g., Food and Drug Administration; (2) scientific evidence must permit conclusions concerning the effect of the technology on health outcomes; (3) the technology must improve the net health outcome; (4) the technology must be as beneficial as any established alternative; and (5) the improvement must be attainable outside the investigational settings. Methods: Information syntheses, expert opinion, group judgment, cost analyses. TEC staff or commissioned experts review and synthesize the published literature. Responses to specific assessment criteria underlie and define the process. A Medical Advisory Panel appointed by the Association monitors the validity of the process and outcome. Approximate turnaround time from selection of assessment topic to reporting of findings is 3 to 6 months. Assessors: The Medical Advisory Panel includes seven physicians who are medical directors of Blue Cross and Blue Shield plans, as well as non-voting outside experts. Assessors have expertise in the medical, clinical, ethics, and research fields, including data analysis and interpretation. Assessment reports include: The purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; description of the technology; properties assessed; 61
MEDICAL I~CHNOLOGY ASSESSMENT DIRECTORY procedure used for the assessment; sources of data/information; findings or conclu- sions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technol- ogy works, including theory, principles. Dissemination: Advisories to memberslconstituents, printed reports. Advisory bulletins, newsletters, and reports are distributed to member plans. TEC evaluations are available only from the Blue Cross and Blue Shield Association and are normally made available only to member Blue Cross and Blue Shield plans. Budget: $600,000. Funding source: 100 percent parent organization. Use: The Association uses the reports only to provide advice to member plans. The coverage recommendations associated with each report, however, appear to be rapidly communicated among affected providers and other health insurance carriers. One example of outside use is the citation of the Association's document, Extracorporeal shock wave lithotrapsy: clinical assessments, utilization and cost projects, May 1985 in a publica- tion issued by the Congressional Office of Technology Assessment: Effects offederal policies on extracorporeal shock wave lithotrapsy, 1985. The Program is cited in the following documents: Greenberg G and Derzon RA. Determining health insurance coverage of technology: problems and options. Med Care 198 1; 1 9 ( 1 0) :96 7-7 8. Institute of Medicine, Committee for Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. Lewin and Associates. A forward planfor Medicare coverage and technology assessment. 1986 Dec. COmP1eted RePO~S BS1 Blue Cross and Blue Shield Association, Technol- ogy Evaluation and Coverage Program. Absorptio- metry, dual photon for osteoporosis monitoring. 1986. "Information syntheses] BS2 . Absorptiometry, single and dual photon. 1986. "Information syntheses] BS3 . Ambulatory uterine monitoring. 1986. "Information syntheses] BS4 . Angelchik antireflux prosthesis. 1986. tIn- formation syntheses] BS5 . Automated and semi-automated ambula- tory blood pressure monitoring. 1986. "Information syntheses] BS6 . Automatic im plan table cardioverter defi- brillator. 1986. "Information syntheses] BS7 . Bone marrow transplantation, allogeneic. 1986. "Information syntheses] BS8 . Bone marrow transplantation, autologous. 1986. "Information syntheses] 62 BS9 . Chorionic villi sampling. 1986. tInforma- tion syntheses] BS10 . Collagen implants. 1986. "Information syntheses] BS11 . Continuous arteriovenous hemofiltra- tion. 1986. (Information syntheses] BS12 . Continuous passive motion device. 1986. BS13 . Corneal endothelial cell microscopy. 1986. tInformatiaon syntheses] BS14 . Electrical bone growth stimulation. 1986. "Information synthesesJ BS15 . Electrical nerve stimulation (implantable spinal cord stimulator).1986. "Information syntheses] BS16 . Electrical nerve stimulation of the ear. 1986. "Information syntheses] BS17 . Epidural analgesia therapy. 1986. tInfor- mation syntheses]
BCBS/TECHNOLOGY EVALUATION AND COVERAGE PROGRAM BS18 . Epikeratophakia. 1986. "Information BS28 . Nasal continuous positive airway pres syntheses] BSl9 . Extracranial-intracranial artery bypass surgery. 1986. "Information syntheses] BS20 . Gastric bubble. 1986. "Information syn theses] BS21 . Home phototherapy for neonatal jaun dice. 1986. "Information syntheses] BS22 . Hyperthermia, local. 1986. "Information syntheses] BS23 . Implantable infusion pump. 1986. tIn formation syntheses] BS24 . In vitro fertilization. 1986. "Information syntheses] BS25 . Iontophoresis. 1986. "Information syn theses] BS26 . Isolated limb perfusion. 1986. tInforma i~on syntheses] BS27 . Lacate infusion for panic disorder.1986. "Information syntheses] Brandeis University Health Policy Center Organ Procurement Project 415 South Street Waltham, MA 02254 6 1 7-736-3900 sure. 1986. "Information syntheses] BS29 . Nd:YAG laser gastrointestinal bleed- ing. 1986. "Information syntheses] BS30 . Nd:YAG laser posterior capsulotomy. 1986. [Information synthesesJ BS31 . Nd:YAG laser tracheo-bronchial ob- struction. 1986. "Information syntheses] BS32 . Psoralens and ultraviolet A (PUVA). 1986. [Information syntheses] BS33 . SIDS (home apnea monitoring of sib- lings). 1986. "Information syntheses] BS34 . Signal averaged ECG. 1986. tInforma- tion syntheses] BS35 . Sperm penetration assay. 1986. tInfor- mation syntheses] BS36 . Videofluoroscopic evaluation in speech pathology. 1986. "Information syntheses] Contact: {effrey Prottas, Senior Research Associate; or Helen Levine Batten, Research Associate. Overview: The Brandeis University Health Policy Center studies, develops, and dem- onstrates aspects of national health policy. The Organ Procurement Project f~rst con- ducted an evaluation of the organ procurement system in 1983. Surveys of key medical professionals, donor families, and the general public were undertaken in 1984-1986. Currently, a study of the causes of failure to transplant organs and a reevaluation of the organ procurement system are in progress. Purpose: To improve the supply and distribution of cadaveric organs. Primary intended users: General public; health/medical professional associations; government regulators; public policy-makers, legislators. Technologies: Organizational or administrative system, support system. Intervention: Administration. 63
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Stage: Established or widespread practice, emerging, new. Properties: Service requirements; cost-effectiveness; economic implications; ethical, legal, . . . . sofa. . Imp canons. Methods: Epidemiological and other observational methods. Case studies, survey research, and cost-data analysis are the methods used to conduct assessments. The turnaround time from selection of assessment topic to reporting of findings varies. Assessors: The assessors have extensive experience and expertise in organ procure- ment and medical sociology. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment; sources of data/information; methods for collecting dataJinformation; methods for analyzing/synthesizing dataJinformation; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research. Dissemination: Printed reports, journal articles. Copies of assessment reports are available upon request. Budget: The budget and cost per assessment varies. Funding source: 100 percent parent organization. Use: The assessment reports are used to further the development of national health policy. Completed Reports BU1 Batten HL, Prottas ~M. fBrandeis University, Health Policy Center, Organ Procurement Project] Kind strangers: families of organ donors. Health Af- fairs, forthcoming. tEpidemiological and other obser- vational methods] BU2 Prottas {M, Batten HL. tBrandeis University, Health Policy Center, Organ Procurement Project] Attitudes and incentives in organ procurement: re- port to the Health Care Financing Administration. 1986 Apr. tEpidemiological and other observational methods] BUS Prottas iM. (Brandeis University, Health Policy Center, Organ Procurement Project] Organ procure- ment in Europe and the United States. Millbank Mem Fund Q 1985;63~1~:94-126. tEpidemiological and other observational methods] 64 BU4 Prottas iM. iBrandeis University, Health Policy Center, Organ Procurement Project] The structure and effectiveness of the U.S. procurement system. Inquiry 1985;22~4~365-376. [Epidemiological and other observational methods] BUS Prottas JM. IiBrandeis University, Health Policy Center, Organ Procurement ProjectJ Encouraging al- truisms: public attitudes and the marketing of organ donation. Milbank Mem Fund Q 1983;61:278-306. tEpidemiological and other observational methods] BUS Prottas JM. tBrandeis University, Health Policy Center, Organ Procurment Project] Obtaining re- placements: the organizational framework of organ procurement. .{ Health Polit Policy Law 1983;8~2~:235-250. [Epidemiological and other ob- servational methods] .
CALIFORNIA MEDICAL ASSOC"TION California Medical Association Medical Practice Opinion Program PO Box 7690 San Francisco, CA 94 ~ 20-7690 4 1 5-863-5522 Contact: Robert Sparacino, Manager, Department of Specialty Sections and Scientific Programs. Overview: The California Medical Association (C MA) is a not-for-profit, voluntary professional medical association whose members number almost 34,000. Its principal services include legislative advocacy, insurance programs, peer review, financial man- agement, continuing medical education, socio-economic research and reports, and administration of accreditation and licensing programs for hospitals. The Medical Practice Opinion Program began in 1972 and since its inception, approximately 350 opinions have been issued. Purpose: To provide CMA's members, its component medical societies, and other interested organizations with objective, authoritative, scientific opinion on questions of medical practice in California. The opinions offered are based on training, experience, and literature reviewed by specialists. The opinions are advisory only and are not intended to be interpreted as directives, instructions, or policy statements. Opinions are always subject to revision as dictated by new information. Primary intended users: General public; physicians; health/medical professional asso- ciations; health industry associations; unions and other employee organizations; third party payers; government regulators; voluntary associations, organizations. Technologies: Drug, device, medical or surgical procedure. Intervention: Diagnosis, treatment. Stage: New, emerging, established or widespread practice, obsolete. Properties: Acceptance/adoption level, safety, effectiveness, limitations of use. Selection process: CMA members, component medical societies, voluntary/profession- al medical associations, government agencies, third party payers or any other organiza- tion with a vital interest in a subject may pose a question for review. Requests must be submitted in writing and include background material that describes the technology in question. Staff, in collaboration with the chairmen of CMA's 24 advisory panels and the chairman of the Commission on Quality Care Review, set the assessment topic priorities. Topics are generally addressed in the order received. An issue that demands immediate attention is processed promptly. All opinions are reviewed annually by the appropriate advisory panels and the Com- mission on Quality Care Review. Some subjects warrant review within that annual interval. Methods: Group judgment, expert opinion, information syntheses. 65
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Following approval of the question by the appropriate advisory panel chairman, staff prepares a questionnaire with background material that typically includes policy or position statements from state/national organizations; testimonials from physicians who are known to be expert in the field; and a selection of recent, pertinent journal articles. Advisory panel members review the material and submit their opinions individually; these opinions are the foundation of the consensus opinion. Some questions involve more than one panel. Staff prepare the consensus opinion which is subject to the review and approval of the panel chairmen, the panel members and, finally, the Commission on Quality Care Review. Once approved, the opinion is sent to the original inquirer and then published in The Western.Journal of Medicine, the official scientific publication of California and eight other western state medical associations and five research societies. The approximate turnaround time from selection of assessment topic to reporting of findings is 4 months. Complex questions involving multiple panels usually take longer. Assessors: Officers of the state's principal specialty societies, California medical school department chairmen, and representatives of C MA's 24 specialty sections comprise the membership of each advisory panel, which includes an equal number of private practicing physicians and full-time medical school faculty physicians. Assessment reports include: The purpose of the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when as- sessed; properties assessed; implications of findings for practice; how the technology works, including theory, principles; regulatory agency approval status. Dissemination: Printed reports; journal articles; advisories to members/constituents. Copies of medical practice opinions can be obtained by calling or writing the CMA Department of Specialty Sections and Scientific Programs, in the Division of Scientific and Educational Activities. Budget: $15,000. Funding source: 100 percent sponsors/members dues, contributions. Use: The CMA provides the opinions to its members and component medical societies as a member service and will share them with persons or or~anization.s o~.sirle its immediate membership as a public service. 1 ~ Generally, health associations, government agencies, and insurance companies most frequently initiate CMA's review of new technologies. The opinions assist these organi- zations in formulating their own views on the scientific standing of new medical or surgical procedures. Program evaluation: Internal monitoring of the program is performed by the Com- mission on Quality Care Review and the Scientific Board's 24 advisory panels. Howev- er, no formal evaluation of the program has been conducted. Completed Reports CA1 California Medical Association, Medical Practice Opinion Program. Arthroscopic stapling of an unsta- ble shoulder. 1985 Sep. (Medical Practice Opinion #335) tGroup judgment] 66 CA2 . Diagnosis of obstructive sleep apnea in children. 1987 Feb. (Medical Practice Opinion #346) [Group judgment]
CALIFORNIA MEDICALASSOCIATION CA3 . Hubbard method of detoxification. 1987 Apr. (Medical Practice Opinion #347) [Group judg- ment] CA4 . Topographic brain mapping. 1987 Mar. (Medical Practice Opinion #345) [Group judgment] CA5 . Ambulatory monitoring of uterine activi- ty.1986 Jul. (Medical Practice Opinion #342) tGroup judgments CA6 . Contralateral breast surgery following mastectomy. 1986 Feb. (Medical Practice Opinion #338) tGroup judgment] CA7 . Epikeratophakia in children.. 1986 Dec. (Medical Practice Opinion #344) tGroup judgment! CAB . Gastric bubble for treatment of obesity. 1986 Aug. (Medical Practice Opinion #343) tGroup judgments CA9 . Hospital admission following rigid eso- phagoscopy. 1986 Jul. (Medical Practice Opinion #339) [Group judgment] CA10 . Sleep studies for obstructive sleep apnea. 1986 Feb. (Medical Practice Opinion #340) tGroup judgment] CAll . Vertebral artery surgery. 1986 Sep. (Medical Practice Opinion #341) [Group judgment] CA12 . Acoustic impedance testing in school screening. 1985 Sep. (Medical Practice Opinion #325) [Group judgment] CA13 . Anticholinergic drugs for nicotine addic- tion. 1985 May. (Medical Practice Opinion #322) tGroup judgment] CA14 . Assistant surgeon at cataract surgery. 1985 May. (Medical Practice Opinion #324) tGroup judgments CA15 . Assistant surgeon at elective abdominal tubal ligation. 1985 Nov. (Medical Practice Opinion #333) [Group judgment] CA16 . Chorionic villus biopsy.1985 Sep. (Medi- cal Practice Opinion #328) tGroup judgment] CA17 . Cytoxan therapy for multiple sclerosis. 1985 Oct. (Medical Practice Opinion #329) tGroup judgment] CA18 . Discography for cervical and lumbar dis- orders. 1985 Feb. (Medical Practice Opinion #317) tGroup judgmentJ CA19 . Early detection of lung cancer. l 985 Dec. (Medical Practice Opinion #337) [Group judgmentJ CA20 . Echocine for diagnosis of sinusitis. 1985 Jun. (Medical Practice Opinion #318) tGroup judg- ment] CA21 . Extracorporeal shock-wave lithotripsy. 1985 Sep. (Medical Practice Opinion #32) {Group judgment] CA22 . In vitro fertilization. 1985 Jun. (Medical Practice Opinion #278) [Group judgments CA23 . Indications for tonsillectomy. 1985 Dec. (Medical Practice Opinion #326) tGroup judgment] CA24 . Intraosseous pressure measurement. 1985 Oct. (Medical Practice Opinion #334) (Group judgment] CATS . Laser irradiation for pain of Charcot- Marie-Tooth disease. 1985 May. (Medical Practice Opinion #321) [Group judgment] CA26 . Laser therapy for planter warts. 1985 May. (Medical Practice Opinion #320) [Group judg- ment] CA27 . Magnetic resonance imaging. 1985 Sep. (Medical Practice Opinion #277) tGroup judgment] CATS . Microsurgery in the treatment of infertil- ity. 1985 Aug. (Medical Practice Opinion #308) [Group judgment] CA29 . Neurostimulation for urethral sphincter spasticity.1985 Dec. (Medical Practice Opinion #336) (Group judgment] CA30 . Permanent eyeliner.1985 Nov. (Medical Practice Opinion #332) tGroup judgment] CA31 . Radial keratotomy for myopia. 1985 Apr. (Medical Practice Opinion #244) EGroup judg- ment] CA32 . Reconsideration of percutaneous and transluminal coronary angioplasty.1985 Feb. tGroup judgments CA33 . Stereotactic heavy-ion irradiation for ar- teriovenous malformations. 1985 Sep. (Medical Prac- tice Opinion #316) (Group judgment] CA34 . Suction lipectomy. 1985 Dec. (Medical Practice Opinion #286) (Group judgment] CA35 . Transmission of disease via mouth to mouth resuscitation. 1985 June. (Medical Practice Opinion #323) tGroup judgment] CA36 . Treatment of rheumatoid arthritis with flagyl. 1985 Oct. (Medical Practice Opinion #330) tGroup judgment] 67
MEDICALI~CHNOLOGY ASSESSMENT DIRECTORY CA37 . Treatment of rheumatoid arthritis with sex hormones. 1985 Oct. (Medical Practice Opinion #331) tGroup judgment] CASE . YAG laser for posterior lens capsules. 1985 Apr. (Medical Practice Opinion #319) (Group judgment] CA39 . Assistant surgeon for arthroscopic pro- cedures. 1984 Apr. (Medical Practice Opinion #239) (Group judgment] CA40 . Assistant surgeon for septorhinoplasty. 1984 ~an. (Medical Practice Opinion #307) tGroup judgment] CA41 . Aversion therapy for alcoholism. 1984 Feb. (Medical Practice Opinion #311) [Group judg- ment] CA42 . Biochemical biopsy. 1984 Nov. (Medical Practice Opinion #285) tGroup judgments CA43 . Cardiac pacemakers.1984 Mar. (Medical Practice Opinion #291) tGroup judgment] CA44 . Computed tomography-multiplanar reconstruction. 1984 Nov. (Medical Practice Opinion #310) [Group judgment] CA45 . Cranial electrotherapy stimulation.1984 Nov. (Medical Practice Opinion #315) tGroup judg- ment] CA46 . Cytotoxic testing for food allergy. 1984 Feb. (Medical Practice Opinion #265) [Group judg- ment] CA47 . Heart-lung transplantation. 1984 Sep. (Medical Practice Opinion #309) (Group judgment] CA48 . Immunotherapy for melanoma. 1984 Feb. (Medical Practice Opinion #305) tGroup judg- mentJ CA49 . Immunotherapy for treatment of can- cer. 1984 {ul. (Medical Practice Opinion #204) tGroup judgment] CA50 . Intradermal provocative titration/diag- nosis of food allergy. 1984 Feb. (Medical Practice Opinion #293' tGroup judgment] CA51 . Kinetic therapy for lumbago. 1984 Nov. (Medical Practice Opinion #312) (Group judgment] CA52 . Radioallergosorbent test (RAST) 1984 Dec. (Medical Practice Opinion #255) tGroup judg- mentl CA53 . Rinkel serial intracutaneous titration/di- agnosis. 1984 Feb. (Medical Practice Opinion #295) tGroup judgmentJ 68 CA54 . Sublingual challenge technique/diagno- sis of food allergy. 1984 Feb. (Medical Practice Opin- ion #294) tGroup judgment] CA55 . Temporomandibular joint procedure. 1984 Feb. (Medical Practice Opinion #270) tGroup judgmentJ CA56 . Tuberculosis surveillance program for hospital employees. 1984 Oct. (Medical Practice Opinion #304) tGroup judgment] CA57 . Use of sclerosant injections for neck, back and lower extremity pain. (Medical Practice Opinion #313) tGroup judgment] CA58 . Video electroencephalographic monitor- ing. 1984 Nov. (Medical Practice Opinion #314) [Group judgment] CA59 . Barbiturate coma. 1983 Feb. (Medical Practice Opinion #280) tGroup judgment] CA60 . Bilio-pancreatic bypass surgery for obesi- ty. 1983 Mar. (Medical Practice Opinion #284) tGroup judgment] CA61 . Biofeedback. 1983 Aug. (Medical Prac- tice Opinion #240) tGroup judgment] CA62 . Collagen implant. 1983 Apr. (Medical Practice Opinion #283) tGroup judgment] CA63 . Computerized tomography for lumbar spine. Feb 1983. (Medical Practice Opinion #282) tGroup judgment] CA64 . Continuous passive motion for stiffening conditions. 1983 Mar. (Medical Practice Opinion #306) tGroup judgment] CA65 . Endothelial cell counts.1983 Sep. (Medi- cal Practice Opinion #303) tGroup judgment1 CA66 . Ericsson sex selection method.1983 Sep. (Medical Practice Opinion #298) (Group judgment] CA67 . Hyperbaric oxygen therapy. 1983 Sep. (Medical Practice Opinion #243) tGroup judgmentJ CA68 . Hyperthermia treatment for cancer. 1983 Oct. (Medical Practice Opinion #296) tGroup judgment] CA69 . Interferon for the treatment of cancer. 1983 Sep. (Medical Practice Opinion #299) tGroup judgment] CA70 . Interferon for the treatment of infec- tious diseases. 1983 Sep. (Medical Practice Opinion #300) tGroup judgment] CA71 . Intravenous streptokinase after myocar- dial infarction. 1983 June. (Medical Practice Opinion #287) tGroup judgment]
CALIFORNIA MEDICAL ASSOCIATION CA72 . Laser photoradiation therapy for carci- CA89 . Needleless insulin injection. 1982 Dec. noma. 1983 Feb. (Medical Practice Opinion #279) tGroup judgment] CA73 . Liver transplantation. 1983 Sep. (Medi cal Practice Opinion #297) tGroup judgment] CA74 . Nissen's fundoplication gastric reser voir reduction for morbid obesity. 1983 May. (Medi cal Practice Opinion #290) tGroup judgment] CA75 . Noninvasive muscle stimulators for pre vention of muscle atrophy.1983 Tut. (Medical Practice Opinion #292) tGroup judgment] CA76 . Palatopharyngoplasty for the treatment of snoring. 1983 Dec. (Medical Practice Opinion #301 ~ tGroup judgment! CA77 . Rectal mucosal replacement. 1983 Nov. (Medical Practice Opinion #288) tGroup judgment] CA78 . Stapedectomy for otosclerosis.1983 Sep. (Medical Practice Opinion #302) [Group judgment] CA79 . Thrombolytic therapy for pulmonary embolism. 1983 Feb. (Medical Practice Opinion #281) tGroup judgment] CA80 . Assistant surgeon for laser iridotomy. 1982 Jul. (Medical Practice Opinion #272) [Group judgments CA81 . Bone densitometry. 1982 Nov. (Medical Practice Opinion #254) tGroup judgment] CA82 . Challenge food testing for depression. 1982 Feb. (Medical Practice Opinion #257b) tGroup judgment] CA83 . Challenge food testing for respiratory disorders. 1982 Feb. (Medical Practice Opinion #257c) tGroup judgment] CA84 . Challenge food testing for rheumatoid arthritis.1982 Feb. (Medical Practice Opinion #257a) (Group judgment] CA85 . Constant blood pressure monitoring. 1982 Aug. (Medical Practice Opinion #275) tGroup judgment] CA86 . Human tumor stem cell assay. 1982 ~ul. (Medical Practice Opinion #273) tGroup judgment] CA87 . Intraarterial BCNU chemotherapy. 1982 Oct. (Medical Practice Opinion #276) tGroup judgment1 CA88 . Methylethylketone damage of the im mune system. 1982 Nov. (Medical Practice Opinion #261) (Group judgment] (Medical Practice Opinion #274) tGroup judgment] CA90 . Plasmapheresis for rheumatoid arthritis. 1982 Aug. (Medical Practice Opinion #263) tGroup judgment] CA91 . Plasmapheresis for six conditions. 1982 Sep. (Medical Practice Opinion #249) tGroup judg- ment1 CA92 . Sleep disorder therapy. l 982 Dec. (Medi- cal Practice Opinion #271) [Group judgment] CA93 . Thermography for spinal problems. 1982 Jul. (Medical Practice Opinion #269) tGroup judgment! CA94 . Transcutaneous electrical nerve stimula- tion. 1982 Jul. (Medical Practice Opinion #82) [Group judgment] CA95 . Viral and bacterial vaccines for arthritis. 1982 Jun. (Medical Practice Opinion #268) tGroup judgment] CA96 . Anesthesia by hypnosis. 1981 Aug. (Medical Practice Opinion #250) [Group judgment1 CA97 . Cochlear implant for deafness. 1981 Aug. (Medical Practice Opinion #178) tGroup judg- ment] CA98 . DMSO. 1981 Jan. (Medical Practice Opinion #248) [Group judgment1 CA99 . Esterine for treatment of rheumatoid arthritis. 1981 Dec. (Medical Practice Opinion #253) [Group judgment] CA100 . Heart transplants. 1981 Dec. (Medical Practice Opinion #252) [Group judgment] CA101 . High gastric bypass for morbid obesity. 1981 Feb. (Medical Practice Opinion #246) tGroup judgment] CA102 . Intermittent positive pressure breath- ing. 1981 Aug. (Medical Practice Opinion #259) tGroup judgment] CA103 . Paper radioallergosorbent test (PRAST) 1981 Aug. (Medical Practice Opinion #256) (Group judgment1 CA104 . Plasmapheresis treatment of multiple sclerosis. 1981 Dec. (Medical Practice Opinion #212) tGroup judgment] CA105 . Singer-Blom valve operation. 1981 ~ul. (Medical Practice Opinion #262) tGroup judgment] CA106 . Stat-tek glucose analyzer for diabetes. 1981 Aug. (Medical Practice Opinion #260) tGroup judgment] 69
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY CA107 . Clinical ecology. 1980 Dec. (Medical Practice Opinion #264) tGroup judgments CA108 . Injections of universal bacterial anti- ment] gen. 1980 Jan. (Medical Practice Opinion #210) tGroup judgment] CA109 . Microsurgical lumbar discectomy. 1980 Feb. (Medical Practice Opinion #238) [Group judg CBO (Centraal Begeleidingsorgaan voor de Intercollegiale Toetsing) National Organization for Quality Assurance in Hospitals Consensus Development Program PO Box 20064, ChurchillIaan ~ ~ 3502 LB Utrecht, The Netherlands (31-30) 96-06-47 Contact: Evert Reerink, M.D., Ph.D., Executive Director. Overview: CBO is an independent foundation established in 1979 by the National Specialists Organization in the Netherlands and the Dutch Association of Medical Directors of Hospitals. The Board of Trustees consists of representatives of those organizations, the National Hospital Association, the Society of Dutch Sick Funds, the Society of Private Insurance Companies, the Royal Netherlands Medical Association, and the Ministry of Welfare, Health and Culture. CBO is a World Health Organization Collaborating Center for Quality Assurance in Health Care. This profile describes the CBO consensus development program. Purpose: To develop statements that facilitate a uniform approach among hospital clinicians in dealing with patient problems of national concern. Primary intended users: Providers, generally; physicians; acute facility administrators; long-term care facility administrators. Technologies: Medical or surgical procedure. Intervention: Diagnosis, treatment, prevention, rehabilitation. Stage: Established or widespread practice. Properties: Safes, effectiveness, service requirements, acceptance/adoption level. Selection process: CBO selects the assessment topics from suggestions made by the hospitals. Topics may be reassessed when consensus statements are out of date, e.g., are 5 or more years old, or when the findings of consensus efforts are inconclusive. Blood transfusion therapy is the first topic to be reassessed. Methods: Group judgment, expert opinion. Panels consisting of 6 to 20 experts are given 6 to 18 months to produce a draft consensus report. The draft report contains 2- to 4-page papers individually authored by the panelists and a draft consensus statement consisting of as many as 30 numbered statements on the topic generated by the panelists. The report is put into a booklet and 7O
CBO/NATIONAL ORGANIZATION FOR QUALITY ASSURANCE IN HOSPITALS circulated to a larger group of health care workers interested in the topic. This larger group usually between 100 to 150 people, but sometimes more-convenes for a 1- day meeting to review the draft report with the panelists. Following this meeting, the panel completes a final consensus statement in narrative form. Assessors: Consensus panels are usually composed of physician specialists relevant to the topic (e.g., neurosurgeons, radiologists, and dermatologists); a few panels have included other types of personnel (e.g., laboratory technicians for blood transfusion therapy panel, nurses for treatment of bedsores panel, and epidemiologists for follow- up colorectal cancer panel). Assessment reports include: The first five assessment reports appeared in narrative form only. All subsequent statements have appeared first as draft statements in booklet form that include table of contents, list of participants, introductory paragraph, the short papers individually authored by the panelists, and the draft numbered consensus statements. The final statements are narratives distilled from the draft booklets. Final statements may reflect disagreements among panel members. Dissemination: The draft consensus statements in booklet form and the final state- ments are available from the CBO. The final statements are also published approxi- mately 1 year following their release in the Nederlands Tydschrtft voor Geneeskunde (Dutch Journal of Medicine). Only one report, on melanoma of the skin (1984) has been translated into English; all others are in Dutch. Budget: The entire CBO budget is approximately $900,000, some $135,000 of which is devoted to consensus activities. CBO is funded from levies applied to Dutch hospitals based on their number of beds. Use: CBO has attempted to gauge the impact of some consensus statements. CBO staff have worked with hospital quality assurance committees to determine whether consen- sus guidelines on melanoma of the skin and blood transfusion therapy have been incorporated into quality assurance criteria and practices. Related activities: CBO is devoted to enhancing quality assurance in Dutch hospitals. It assesses and works to improve the quality of procedures in specific hospitals, assists in setting criteria for quality assurance, and provides a second-opinion service. CBO also offers assistance to other organizations in assessing new technologies, developing infor- mation systems, and developing clinical protocols. Because of statutory limitations, CBO is not engaged in research. Completed Reports CB1 CBO (Centraal Begeleidingsorgaan voor de Inter- collegiale Toetsing) Consensus Development Pro- gram. Diagnosis of atopic syndrome. 1987. tDutch language only] Group judgment, Expert opinion] CB2 . Follow-up colorectal cancer.1987. [Dutch language only] [Group judgment, Expert opinion] CB3 . Hemophilia. 1987. tDutch language only] tGroup judgment, Expert opinion] CB4 . Hypercholesterolemia. 1987. [Dutch lan- guage only] tGroup judgment, Expert opinion] CB5 . Prevention of herpes neonatorum. 1987. tDutch language only] (Group judgment, Expert . . opinion CB6 . Suspect lymph nodules in the neck. 1987. tDutch language only] tGroup judgment, Expert . . ~ opinions 71
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY CB7 . Total hip prostheses.1987. fDutch lan- guage only] [Group judgment, Expert opinions CB8 . Diagnosis of deep venous thrombosis. 1986. tDutch language only] EGroup judgment, Ex . . pert opinion CB9 . Non-scrotal testis. 1986. [Dutch language only] [Group judgment, Expert opinion] CB10 . Treatment of bedsores. 1986. FDutch language only] tGroup judgment, Expert opinion] CBl l . Foot problems of diabetic patients. 1985. fDutch language only] (Group judgment, Expert . . opinion CB12 . Osteoporosis. 1985. EDutch language only] tGroup judgment, Expert opinion] CB13 . Prevention of bedsores. 1985. fDutch language only] Group judgment, Expert opinion] College of American Pathologists Surveys Program 5202 OIc! Orchard Road Skokie, 1I, 60077-1034 3 1 2-966-5700 CB14 . Solid solitary thyroid nodule. 1985. [Dutch language only] [Group judgment, Expert . . Oplmon CB15 . Melanoma of the skin. 1984. [Group judgment, Expert opinon] CB16 . Severe brain damage. 1984. fDutch lan- guage only] tGroup judgment, Expert opinion] CB17 . Thrombocytes transfusion policy. 1984. [Dutch language only1 EGroup judgment, Expert . . Opmlon CB18 . Mammography policy.1983. EDutch lan- guage only] (Group judgment, Expert opinion] CBl9 . Traumatic lesions of the back. 1983. tDutch language only] tGroup judgment, Expert . . Oplnlon CB20 . Blood transfusion therapy. 1982. FDutch language only] tGroup judgment, Expert opinion] Contact: William E. Williamson, Director Laboratory Improvement Programs. Overview: The College of American Pathologists is a professional association dedicat- ed to serving the needs of its members in the fields of pathology, medicine, and patient care. With over 10,000 members, its services include periodicals, educational programs, Professional Affairs Assistance, and other programs. The College's Surveys Program is an ongoing assessment of laboratory technology that provides subscribing laboratories with an evaluation of their own accuracy and preci- sion. This Program began with circulation of samples to assess the technology in limited areas of clinical chemistry and hematology. Over the past 25 years the program has grown to over 50 surveys, assessing the technology of virtually all areas of laboratory medicine. The program currently provides technology assessment information to over 12,000 participating laboratories in the United States and several foreign countries. Purpose: To assess laboratory technology and to provide individual subscribing labora- tories with these assessments as well as evaluations of their own accuracy and precision. Primary intended users: Labs, blood banks. Technologies: Device, medical or surgical procedure, support system. Laboratory methods, systems, and instrument performance are assessed. Intervention: Diagnosis, treatment. 72
COLLEGE OF AMERICAN PATHOLOGISTS Stage: Established or widespread practice, new, obsolete. Properties: Safety, effectiveness, acceptance/adoption level. The Program assesses the laboratories for safety and effectiveness with respect to accuracy and precision of results. Based on performance, assessments provide mecha- nisms for determining acceptance and level of technology. Selection process: Any medical laboratory may request that an assessment of its performance be conducted and compared with its peers. Since this is a voluntary program, laboratories need only to subscribe to the surveys in which they wish to participate. Assessment topics are determined and prioritized by CAP committees of experts in the laboratory discipline involved in the technology assessment. Methods: Bench testing. Unknown simulated patient samples (e.g., blood products, spinal fluid, urine) are sent quarterly to participating laboratories. Laboratories are given a certain amount of time to analyze samples for specified constituents and return data for computer analysis of performance. Selection of assessment topics (simulated patient sample content) is determined 18 months prior to the surveys. However, the actual turnaround time for the assessment process, from the standpoint of the participant, is approximately 8 weeks from receipt of samples for analysis to reporting of findings. Assessors: The expert committees that operate the various assessment programs are made up of pathologists and doctoral scientists with expertise in the given area of technology assessment. Assessment reports include: The assessment's intended audience; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; find- ings or conclusions; limitations of findings; where technology is in use. Dissemination: Printed reports, journal articles, advisories to members/constituents. Assessment products include CAP Surveys Program quarterly summary reports, CAP conference proceedings, articles in Archives of Pathology and Laboratory Medicine and the quarterly CAP newsletter, Summing Up. The summary reports are mailed to participat- ing laboratories listing their own results and summarizing the results of all participants. Generally, summary reports are available only to participants. Conference proceedings and Summing Up can be purchased from CAP. Selected studies are published in the . ·~ . soent~c literature. Budget: $15,000,000. Funding source: 85 percent sponsors/members dues, contribu- tions; 15 percent parent organization. Use: The CAP uses the assessments to monitor the state of the art. Members of the expert committees also use the assessments as the basis for articles in professional journals. 73
MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Scientific professionals may use the reports for the noncommercial purpose of scientific or educational advancement as defined in the CAP copyright. Generally permission is requested prior to publication. Government and regulatory agencies also use the results to establish compliance and regulatory requirements. Program evaluation: Various Federal agencies assess the Program to determine com- pliance with Federal Equivalency Requirements. The CAP evaluated the Surveys Program in 1981 as the result of a database conference it sponsored that was attended by representatives of clinical laboratories, the diagnostic industry, and government. The conferen