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Institute of Medicine (US) Council on Health Care Technology; Goodman C, editor. Medical Technology Assessment Directory: A Pilot Reference To Organizations, Assessments, and Information Resources. Washington (DC): National Academies Press (US); 1988.

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Medical Technology Assessment Directory: A Pilot Reference To Organizations, Assessments, and Information Resources.

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National Heart, Lung, and Blood Institute

National Heart, Blood Vessel, Lung, and Blood Program

Office of Program Planning and Evaluation

National Institutes of Health

Building 31, Room 5A-11

9000 Rockville Pike

Bethesda, MD 20892

301-496-3620

Contact: Carl A. Roth, Ph.D, J.D., Chief, Program Analysis and Evaluation Branch.

Overview: The National Institutes of Health (NIH) is the principal biomedical research agency of the Federal government. NIH is composed of 12 bureaus and institutes and six research and support divisions. The National Heart, Lung, and Blood Institute (NHLBI) is the second largest in terms of funding. It was established in 1948 as the National Heart Institute. With a growing awareness of national health problems, it was redesignated the National Heart and Lung Institute in 1969 and in 1976 was redesignated the National Heart, Lung, and Blood Institute.

Purpose: To serve the overriding strategy of the Institute's national program. This strategy is represented by the biomedical research and clinical applications spectrum in which the products of research flow from basic research and clinical research to applied research and development and practical health care.

Primary intended users: General public; people concerned about their health; patients; providers, generally; physicians; health product manufacturers; health/medical professional associations; health industry associations; consumer associations; employers; unions and other employee organizations; voluntary associations, organizations; biomedical researchers; reporters, writers, news media; labs, blood banks.

Technologies: Medical or surgical procedure, drug, device, support system.

NHLBI also devotes considerable attention to the roles of smoking, diet, and other aspects of lifestyle and the environment in heart and vascular diseases, lung diseases, and blood diseases.

Intervention: Treatment, prevention, diagnosis.

Stage: New, emerging, established or widespread practice, obsolete.

According to the Institute, emerging technologies are those under development that appear likely to be used in the practice of medicine within 4 years. New technologies are those that may have passed the stage of clinical trials but are not yet widely disseminated, or those that are moving into general use without benefit of clinical trials. The last group are those established technologies that are currently undergoing or likely to undergo major changes in use or costs as a result of new research findings, or for which serious concerns have been raised concerning safety and effectiveness.

Properties: Effectiveness; safety; efficacy; ethical, legal, social implications.

The principal concerns of NHLBI assessment activities are safety and efficacy. The planning and conduct of research reported by NHLBI, particularly clinical trials, are subject to detailed review of ethical considerations. The Institute does conduct some cost studies, such as in-house studies to demonstrate the cost-effectiveness of its clinical trials. It must also evaluate the cost-effectiveness of the Federal investment in the National Heart, Blood Vessel, Lung, and Blood Program, and make recommendations regarding future resource allocations.

Selection process: Large-scale clinical trials are usually initiated by Institute staff, advisory groups, and other biomedical scientists and health care researchers. The smaller, grant-supported clinical trials are usually initiated by investigators who apply for grants. Consensus development conferences are initiated by the Institute, Office of Medical Applications of Research (OMAR), other government agencies, or the public.

If the concept of a large-scale clinical trial is approved by the Institute, a request for proposal (RFP) or request for application (RFA) is prepared and advertised. The RFP or RFA defines the program requirements and describes the criteria by which the proposals will be evaluated. Consensus development conferences may be requested by the Institute, OMAR, other government agencies, and the public.

Institute Advisory Groups, Institute staff, and the National Heart, Lung, and Blood Advisory Council all set assessment topic priorities throughout the processes of concept development and initiation of assessments.

The NHLBI reassesses technologies in light of new scientific evidence of efficacy or of long-term adverse effects not apparent in short-term studies, and gives suggested new uses for established technologies.

Methods: Clinical trials, information syntheses, expert opinion, group judgment, epidemiological and other observational methods, bench testing.

If NHLBI makes a commitment to conduct a trial, subject recruitment and clinical intervention begin. Generally subjects are not recruited simultaneously, and thus the recruitment and intervention activities proceed together.

Once the trial is under way, it is managed by a complex of committees composed of the investigators, advisors, and Institute staff. Often, the central organizational element of the trial is a steering committee that provides overall scientific direction for the study at the operational level. Various subcommittees appointed by the steering committee are responsible for reviewing such matters as patient adherence, quality control, nonfatal events, natural history, mortality classification, bibliography, and editorial review. An assembly of investigators representing all of the clinical and logistical coordinating centers reports to the steering committee. A policy data-monitoring board which does not include any of the trial investigators acts in a senior advisory capacity to the NHLBI on policy matters throughout the trial's duration. It periodically reviews study results and evaluates the study treatments for beneficial and adverse effects, and consults on such major policy decisions as trial safety and termination, changes in protocol, measurement procedures, and publication.

Analysis continues during the trial. By the time the trial is ended, much of the analysis concerning the major question may already have been completed. However, only in rare cases such as those in which a trial is not double-blind and the trends are extraordinary, might the findings of a trial be published during its course.

The duration of clinical trials supported by NHLBI has ranged from 2 to 18 years (including patient follow-up), averaging about 6.6 years, although interim assessments and other reports are made during the longer trials. Consensus conferences, state-of-the-art conferences, and workshops generally take about 1 year to plan.

Assessors: NHLBI technology assessment activities entail the participation of the full complement of biomedical research and health care delivery personnel. Various advisory groups also include representatives of other professions. As noted above, members of the National Heart, Lung, and Blood Advisory Council include scientists and others who are lay community members with a demonstrated interest in health areas relevant to the program area of the Institute. The study sections that review proposals are composed of nonfederal scientists selected for their competence in the particular scientific areas for which a study section has review responsibilities.

Assessment reports include: Abstract; 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 sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of lifecycle of technology when assessed; properties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research.

Dissemination: Journal articles; printed reports; press conferences/news releases, TV/ radio broadcasts, video products.

NHLBI promotes and disseminates assessment findings through workshops; information centers; and prevention, education, and control programs. The Institute also disseminates information through professional societies, educational programs such as the National High Blood Pressure Education Program, clearinghouses such as the High Blood Pressure Information Center, interactions with industry representatives, and activities of the Institute's Office of Prevention, Education, and Control.

Copies of assessments are available in the open scientific literature. Many special reports can be obtained from the Communications and Public Information Branch, NHLBI, NIH, Building 31 Room 4A-31, 9000 Rockville Pike, Bethesda, MD 20892.

Budget: $29,000,000. The cost of large scale clinical trials ranges between $1.6 million and $142.3 million. Funding source: 100 percent parent organization.

Use: The NHLBI uses the assessment reports for planning and evaluation. The NIH and NHLBI conducted an evaluation of the impact of clinical trials on medical practice. The study evaluated the relationship between the dissemination of the clinical trial results and subsequent physician knowledge and medical practice. The two trials, both supported by NHLBI, were the Coronary Drug Project (CDP) reported in 1976 and the Aspirin Myocardial Infarction Study (AMIS) which was completed in 1979 with results disseminated in 1980. Following AMIS, there was a small increase in the number of physicians who said aspirin was of unproven benefit for post-myocardial infarction use, but most physicians still heavily prescribed aspirin.

NHLBI assessment activities are described in Institute of Medicine, Committee on Evaluating Medical Technologies. Assessing medical technologies . Washington, DC: National Academy Press, 1985.

Program evaluations: NHLBI has sponsored several evaluations of its assessment program and clinical trials. Listed below are the evaluation project names followed by citations to published documents about the evaluation or its findings.

1. Evaluation of Clinical Trial Coordinating Center Model Project. The University of Maryland conducted this study from June 1976 to June 1979.

The following reports were submitted to the NHLBI.

I. Study design and methods

II. RFPs for coordination centers: a content evaluation

III. The contract process for selecting coordination centers

V. Terminology

VI. Phases of a multicenter clinical trial

X. Management of coordinating centers

XIV. Enhancement of methodological research in the field of clinical trials

XVI. CCMP manuscripts presented at the Annual Symposia on Coordinating Clinical Trials

2. Evaluation of the Impact of Clinical Trials on Medical Practice. Market Facts, Inc. conducted this study from September 1978 to January 1982.

Markets Facts, Inc. The impact of clinical trials on physician knowledge and practice. 1982 Mar.

3. Evaluation of the Impact of Adenine on Blood Banking. JRB Associates conducted this study from June 1979 to June 1983.

Cummings PD, Cerveny RP, Wallace EL, et al. Impact of adenine on blood banking. 1983 Jul.

4. Evaluation of Regimen Compliance in Long-term Clinical Trials. The University of Maryland conducted this study from June 1979 to September 1984.

Howard J, Whittemore AS, Hoover J J, Panos M, and the Aspirin Myocardial Infarction Study Research Group. How blind was the patient blind in AMIS? Clin Pharmacol Ther 1982;32:543-553.

Mattson ME, Friedman LM. Issues in medication adherence assessment in clinical trials of the National Heart, Lung, and Blood Institute. Controlled Clin Trials 1984;5:488-496.

Mattson ME, Curb JD, McArdle R, and the AMIS and BHAT Research Groups. Participation in a clinical trial: the patients' point of view. Controlled Clin Trials 1985;6:156-167.

Byington AP, Curb JD, Mattson ME for the Beta-Blocker Heart Attack Trial Research Group. Assessment of Double-Blindness at the conclusion of the Beta-Blocker Heart Attack Trial. JAMA 1985;253:1733-1736.

5. Assessment of the Impact of the Hypertension Detection and Follow-up Program (HDFP). NHLBI Staff conducted this study from January 1981 to October 1982.

National Heart, Lung, and Blood Institute. Conference on the implications of the Hypertension Detection and Follow-up Program, November 30, 1982.

6. Evaluation of the Impact of the Coronary Primary Prevention Trial: Baseline Measurement of Practice Before Release of Clinical Trial Results. National Capitol Systems conducted this study from July 1983 to June 1984.

National Capitol Systems, Inc. Determination of medical practice regarding coronary heart disease risk factors: baseline measurements of practice before release of results of the Coronary Primary Prevention Trial. final report. 1984 Apr.

7. Evaluation of the Impact of the Coronary Primary Prevention Trial (CPPT) on Clinical Practice: Measurement of Practice after Release of Clinical Trial Results. National Capitol Systems conducted this study from October 1985 to October 1986. The findings have not yet been published.

8. Evaluation of the Impact of the Coronary Primary Prevention Trial (CPPT) on Public Attitudes, Knowledge, and Behavior Regarding Serum Cholesterol and Other Risk Factors for Coronary Heart Disease. This study was conducted by the Food and Drug Administration and NHLBI staff from January 1984 to September 1985. The findings have not yet been published.

Completed Reports

NH1 Curb JD, Borhani NO, Blaszkowski TP, et al. [National Heart, Lung, and Blood Institute] Patient perceived side effects to antihypertensive drugs. J Community Health, accepted for publication.

NH2 Beta-Blocker Heart Attack Study Group. [______] The Beta-Blocker Heart Attack Trial: cooperative trial-preliminary report. JAMA 1986;246:2073-2074.

NH3 Friedman LM, Byington RP, Capone RJ, et al. for the Beta-Blocker Heart Attack Trial Research Group. [______] Effect of propranolol in patients with myocardial infarction and ventricular arrhythmia. J Am Coil Cardiol 1986;7:1-8.

NH4 Hulley SB, Feigal DW, Ireland CC, et al. [______] The Systolic Hypertension in the Elderly Program (SHEP): the first three months. 1986. J Am Ger Soc 1986;34:101-105.

NH5 Muller JE, Turi ZG, Store PH, et al. and the MILIS Study Group. [______] Digoxin therapy and mortality after myocardial infarction. Experience in the MILIS Study. N Eng J Med 1986;314:265-271.

NH6 Wheelan K, Mukharji J, Rude RE, et al. and the MILIS Study Group. [______] Sudden death and its relation to QT-internal prolongation after acute myocardial infarction: two year follow-up. Am J Cardiol 1986;57:745-750.

NH7 Buchwald H, Fitch L, Varco RL. [______] Ileal bypass for hyperlipidemia. World J Surg 1985:9;850-859.

NH8 Buchwald H, Fitch L, Varco RL. [______] Partial ileal bypass; hypercholesterolemia; atherosclerosis. In: Nyhus LM, Nelson RL, (eds): Blackwell Scientific Publ Inc, Boston, MA, 1985, in press.

NH9 Buchwald H, Fitch L, Varco RL. [______] Surgical intervention in atherosclerosis: partial ileal bypass and the Program of Surgical Control of the Hyperlipidemias (POSCH). Int Encyclo Pharm Therapy, 1985 (in press).

NH10 Buchwald H. [______] Partial ileal bypass: a surgical approach to cholesterol lowering. In: Perspectives in lipid disorders. New York: McGraw-Hill Publishing Co., 1985:Vol 3.

NH11 Byington R, Goldstein S, for the BHAT Research Group. [______] Association of digitalis therapy with mortality in survivors of acute myocardial infarction: observation in the Beta-Blocker Heart Attack Trial. J Am Coil Cardiol 1985;6:976-982.

NH12 Byington RP, Curb DJ, Mattson ME for the Beta-Blocker Heart Attack Trial Research Group. [______] Assessment of double-blindness at the conclusion of the Beta-Blocker Heart Attack Trial. JAMA 1985;253(12): 1733-1766.

NH13 Collaborative Group on Antenatal Steroid Therapy. [______] Prevention of respiratory distress syndrome: effect of antenatal dexamethasone administration. Hospital and follow-up studies. 1985 [NIH Publication No. 85-2695]

NH14 Curb DJ, Borhani NO, et al. [______] Long-term surveillance for adverse effects of antihypertensive drugs. JAMA 1985;253:3263-3268.

NH15 Cutler JA, Neaton JD, Hulley SB et al. [______] Coronary heart disease and all-cause mortality in the Multiple Risk Factor Intervention Trial: subgroup findings and comparisons with other trials. Prev Med 1985;14:293-311.

NH16 Gersh BJ, Kronmal RA, Schaff HV, et al. [______] Comparison of coronary artery bypass surgery and medical therapy in patients 65 years of age or older. a nonrandomized study from the Coronary Artery Surgery Study (CASS) registry. N Engl J Med 1985;313:217-224.

NH17 Grimm RH, Neaton JD, McDonald M, et al for the Multiple Risk Factor Intervention Trial Research Group. [______] Beneficial effects from systematic dosage reduction of the diuretic chlorthalidone: a randomized study within a clinical trial. Am Heart J 1985; 109:858-864.

NH18 Grimm RH, Neaton JD, McDonald M, et al. [______] Beneficial effects from systematic dosage reduction of the diuretic, chlorthalidone: a randomized study within a clinical trial. Am Heart J 1985;109:858-864.

NH19 Hennekens C, Eberlein K. [______] A randomized trial of aspirin and beta-carotene among U.S. physicians. Prev Med 1985: Appendix VI.

NH20 Hillis LD, Borer J, Braunwald E, et al. [______] High dose intravenous streptokinase for acute myocardial infarction: preliminary results of a multicenter trial. J Am Coil Cardiol 1985;6:957-962.

NH21 Hulley SB, Furberg CD, Gurland BJ, et al for the SHEP Research Group. [______] The Systolic Hypertension in the Elderly Program (SHEP): antihypertensive efficacy of chlorthalidone. Am J Cardiol 1985;56:913-920.

NH22 Hypertension Detection and Follow-up Program Cooperative Group. [______] Five-year findings of the Hypertension Detection and Follow-up Program. Prevention and reversal of left ventricular hypertrophy with antihypertensive drug therapy. Hypertension 1985;7:105-112.

NH23 Hypertension Detection and Follow-up Program Cooperative Research Group. [______] Mortality findings for stepped-care and referred-care participants in the Hypertension Detection and Follow-up Program, stratified by other risk factors. Prev Med 1985;14:312-335.

NH24 Karnegis JN, Matts JP, Tuna N and the POSCH Group. [______] Development and evolution of electrocardiographic Minnesota Q-Qs codes in patients with acute myocardial infarction. Am Heart J 1985; 110:452-459.

NH25 Karnegis JN, Matts JP, Tuna N, et al and the POSCH Group. [______] Quantitative assessment of left ventricular function after myocardial infarction using the Minnesota Q-Qs codes for resting electrocardiograms. Cathet Cardiovasc Diagn 1985; 11:393-400.

NH26 Kuller L, Farrier N, Borhani N, et al. [______] Relationship of diuretic therapy and serum magnesium levels among participants in the Multiple Risk Factor Intervention Trial. Am J Epidemiol 1985; 122:1045-1059.

NH27 Langford HG, Blaufox MD, Oberman A, et al. [______] Dietary therapy slows the return of hypertension after stopping prolonged medication. JAMA 1985;5:657-664.

NH28 Long JM. [______] Discovery and confirmation of causal relationships in a large medical record database: a POSCH experiment. Society for Clinical Trials, Annual Conference, 1985.

NH29 Long, JM. [______] The POSCH secondary intervention trial. Proc Int Cong Prev Cardiology, Moscow, 1985.

NH30 Mattson M, Curb JD, McArdle R and the AMIS and BHAT Research Group. [______] Participation in a clinical trial: the patient's point of view. Controlled Clin Trial 1985;6:156-167.

NH31 Morganroth J, Lichstein E, Byington R. [______] Beta-Blocker Heart Attack Trial: impact of propranolol therapy on ventricular arrhythmias. Prev Med 1985; 14:346-357.

NH32 Multiple Risk Factor Intervention Trial Research Group. [______] Baseline rest electrocardiographic abnormalities, antihypertensive treatment, and mortality in the Multiple Risk Factor Intervention Trial. Am J Cardiol 1985;55:1-15.

NH33 Multiple Risk Factor Intervention Trial Research Group. [______] Exercise electrocardiogram and coronary heart disease mortality in the Multiple Risk Factor Intervention Trial. Am J Cardiol 1985;55:16-24.

NH34 Passamani E, David B, Gillespie MJ, et al. [______] A randomized trial of coronary artery bypass surgery: survival of patients with a low ejection fraction. N Engl J Med 1985;312:1655-1671.

NH35 Rifkind BM. [______] The Lipid Research Clinics Coronary Primary Prevention Trial. Heartbeat 1985;1:7-8.

NH36 Shekelle RB, Gale M, Norusis M for the Aspirin Myocardial Infarction Study Research Group. [______] Type A score (Jenkins activity survey) and risk of recurrent coronary heart disease in the Aspirin Myocardial Infarction Study. Am J Cardiol 1985;56:221-225.

NH37 TIMI Study Group. [______] Special report. The Thrombolysis in Myocardial Infarction (TIMI) Trial. Phase I findings. N Engl J Med 1985;312:932-936.

NH38 Brensike JF, Levy RI, Kelsey SF, et al. [______] Effects of therapy with cholestyramine on progression of coronary arteriosclerosis: results of the NHLBI Type II Coronary Intervention Study. Circulation 1984:69;313-324.

NH39 Byington RP for the Beta-Blocker Heart Attack Trial Research Group. [______] Beta-Blocker Heart Attack Trial—design, methods and baseline results. Controlled Clin Trials 1984;4:382-437.

NH40 CASS Principal Investigators and Their Associates. [______] Coronary Artery Surgery Study (CASS): a randomized trial of coronary artery bypass surgery: myocardial infarction and mortality in the randomized trial. N Engl J Med 1984;310:750-758.

NH41 Collaborative Group on Antenatal Steroid Therapy. [______] Effects of antenatal dexamethasone administration in the infant: long-term follow-up. J Pediatr 1984; 104:259-267.

NH42 Connett JE, Stamler J. [______] Responses of Black and white males to the special intervention program of the Multiple Risk Factor Intervention Trial. Am Heart J 1984;108(3):839-849.

NH43 Croft CH, Rude RE, Lewis SE, et al. [______] Comparison of left ventricular function and infarct size in patients with and without positive technetium-99m pyrophosphate myocardial scintigrams after myocardial infarction: analysis of 357 patients. Am J Cardiol 1984;53:421-428.

NH44 DeMets DL, Hardy R, Friedman LM, et al. [______] Statistical aspects of early termination in the Beta-Blocker Heart Attack Trial. Controlled Clin Trials 1984;5:362-372.

NH45 Furberg CD, Hawkins CM, Lichstein E for the Beta-Blocker Heart Attack Study Group. [______] Effect of propranolol in postinfarction patients with mechanical or electrical complications. Circulation 1984;69:761-765.

NH46 Goldstein S, Friedman L, Hutchinson, R et al and the Aspirin Myocardial Infarction Study Research Group. [______] Timing, mechanism and clinical setting of witnessed deaths in postmyocardial infarction patients. J Am Coll Cardiol 1984;3:1111-1117.

NH47 Hypertension Detection and Follow-up Program Cooperative Group. [______] Five-year findings of the Hypertension Detection and Follow-up Program: mortality by race-sex and blood pressure level: a further analysis. J Community Health 1984;9:314-327.

NH48 Hypertension Detection and Follow-up Program Cooperative Research Group. [______] The effect of antihypertensive drug treatment on mortality in the presence of testing electrocardiographic abnormalities at baseline: the HDFP experience. Circulation 1984;70:996-1003.

NH49 Hypertension Detection and Follow-up Program. [______] Effect of stepped-care treatment on the incidence of myocardial infarction of the Hypertension Detection and Follow-up Program. Hypertention 1984;6(Suppl 1).

NH50 Langford HG, Blaufox MD, Oberman A, et al. [______] Effect of weight loss on the return of hypertension after withdrawal of prolonged antihypertensive therapy. In: Nutritional Prevention of Cardiovascular Disease. 1984:311-315.

NH51 Langford HG, Oberman A, Borhani NO, et al. [______] Black-white comparison of indices of coronary heart disease and myocardial infarction in the stepped-care cohort of the Hypertension Detection and Follow-Up Program. Am Heart J 1984; 108(3):797-801.

NH52 Langford HG, Schlundt D, Levine K. [______] Sodium restriction in hypertension. Compr Ther 1984;10:6-11.

NH53 Lasser N, Grandits G, Caggiula A, et al. [______] Effects of antihypertensive therapy on plasma lipids and lipoproteins in the Multiple Risk Factor Intervention Trial. Am J Med 1984;76:52-66.

NH54 Levy RI, Brensike JF, Epstein SF, et al. [______] The influence of changes in lipid values induced by cholestyramine and diet on progression of coronary artery disease: results of the NHLBI Type II Coronary Intervention Study. Circulation 1984;69:325-337.

NH55 Lipid Research Clinics Program. [______] The Lipid Research Clinics Coronary Primary Prevention Trial results. I. Reduction in incidence of coronary heart disease. JAMA 1984;251:351-364.

NH56 Lipid Research Clinics Program. [______] The Lipid Research Clinics Coronary Primary Prevention Trial results. II. The relationship of reduction in incidence of coronary heart disease to cholesterol-lowering. JAMA 1984;251:365-374.

NH57 Muller JE (ed), Braunwald E, Mock MB, et al. (assoc. eds). [______] ______ Multicenter Investigation of the Limitation of Infarct Size (MILIS). Design and methods of the clinical trial. An investigation of beta-blockade and myaluronidase for treatment of acute myocardial infarction. Am Heart Assoc Monograph 1984;100:1-134.

NH58 Rifkind BM. [______] The Lipid Research Clinics Coronary Primary Prevention Trial: results and implication. Am J Cardiol 1984;54:30C-34C.

NH59 Roberts R, Croft C, Gold HK, et al. and the MILIS Study Group. [______] Effect of propranolol on myocardial-infarct size in a randomized blinded multicenter trial. N Eng J Med 1984;311:218-225.

NH60 Shekelle R. [______] Diuretic treatment of hypertension and changes in plasma lipids over six years in the Multiple Risk Factor Intervention Trial. In: Paolette R et al. (eds). Endpoints for cardiovascular drug studies. New York: Raven, 1984:216.

NH61 Wing R, Caggiula A, Nowalk M, et al. [______] Dietary approaches to the reduction of blood pressure: the independence of weight and sodium/potassium interventions. Prev Med 1984;13:233-234.

NH62 Beta-Blocker Heart Attack Trial Research Group. [______] A randomized trial of propranolol in patients with acute myocardial infarction. II. Morbidity results. JAMA 1983;250:2814-2819.

NH63 Buchwald H, Moore RB, Rucker Rd, et al. [______] Clinical angiographic regression of atheroscerosis after partial ileal bypass. Artherosclerosis 1983;46:117.

NH64 CASS Principal Investigators and Their Associates. [______] Coronary Artery Surgery Study (CASS): a randomized trial of coronary artery bypass surgery: quality of life in patients randomly assigned to treatment groups. Circulation 1983;68:951-960.

NH65 CASS Principal Investigators and Their Associates. [______] Coronary Artery Surgery Study (CASS): randomized trial of coronary artery bypass surgery: survival data. Circulation 1983;68:939-950.

NH66 CASS Principal Investigators and Their Associates. [______] Coronary Artery Surgery Study (CASS): a randomized trial of coronary artery bypass surgery: comparability of entry characteristics and survival in randomized patients and nonrandomized patients meeting randomization criteria. J Am Coil Card 1983;3:114-128.

NH67 Davis KB, Chatman BR, Killip T, et al. [______] Effect of coronary bypass surgery on operative mortality and survival patterns in subsets of patients with left main coronary artery disease. In: Hammermeister KE, ed. Coronary bypass surgery. New York: Praeger Scientific, 1983:99-127.

NH68 Davis KB, Kennedy JW, Berger RL, et al. [______] Operative mortality in the CASS registry. In: Hammermeister KE ed. Coronary bypass surgery. New York: Praeger Scientific, 1983:99-127.

NH69 Frommer PL, Fisher LD, Moek MB, et al. [______] The Coronary Artery Surgery Study: a randomized trial in the context of the registry. In: Hammermeister KE, ed. Coronary bypass surgery. New York: Praeger Scientific, 1983:57-82.

NH70 Furberg CD, Byington RP for the BHAT Research Group. [______] What do subgroup analyses reveal about differential response to beta-blocker therapy? The Beta-Blocker Heart Attack Trial experience. Proceedings of the Workshop on Implications of Recent Beta-Blocker Trials for Post-Myocardial Infarction Patients. Circulation 1983;67(Supplement I):I-98.

NH71 Gersh B J, Kronmal RA, Frye RL, et al. [______] Coronary arteriography and coronary artery bypass surgery: morbidity and mortality in patients ages 65 years or older: a report from the Coronary Artery Surgery Study. Circulation 1983;67:483-490.

NH72 Goldstein, S. [______] Propranolol therapy in patients with acute myocardial infarction: the Beta-Blocker Heart Attack Trial. Circulation 1983;67(Suppl 1):53-57.

NH73 Hardy RJ, Hawkins CM. [______] The impact of selected indices of anti-hypertensive treatment on all-cause mortality. Am J Epidemiol 1983;117:566-574.

NH74 Heaton RK, Grant I, McSweeny J, et al. [______] Psychologic effects of continuous and nocturnal oxygen therapy in hypoxemic chronic obstructive pulmonary disease. Arch Intern Med 1983;143:1941-1947.

NH75 Holmes DR, Vliestra RE, Fisher LD, et al. [______] Follow-up of patients from the Coronary Artery Surgery Study (CASS) potentially suitable for percutaneous transluminal coronary angioplasty. Am Heart J 1983; 106:981-988.

NH76 Hughes GH, Schnaper HW. [______] The Systolic Hypertension in the Elderly Program. Int J Mental Health 1983;11:76-97.

NH77 Intermittent Positive Pressure Breathing Trial Group. [______] Intermittent positive pressure breathing therapy of chronic obstructive pulmonary disease—a clinical trial. Ann Intern Med 1983;99:612-620.

NH78 Keogh BA, Bernardo J, Hunninghake GW, et al. [______] Effect of intermittent high dose parenteral corticosteroids on the alveolitis of idiopathic pulmonary fibrosis. Am Rev Respir Dis 1983;127:18-27.

NH79 Lichstein E, Morganroth J, Harrest R, et al. [______] Effect of propranolol on ventricular arrhythmia: the Beta-Blocker Heart Attack Trial Experience. Circulation 1983;67(Suppl 1):5-10.

NH80 Ryan TJ, Bailey KR, McCabe CH, et al. [______] The effects of digitalis on survival in high-risk patients with coronary artery disease: the Coronary Artery Surgery Study (CASS). Circulation 1983;67:735-742.

NH81 Smith WM. [______] Isolated systolic hypertension in the elderly. In: Mild hypertension. New York: Raven Press, 1983.

NH82 Wassertheil-Smoller S, Langford HG, Blaaufox MD, et al. [______] Diuretics and salt-restriction in blood pressure control. In: Winick M ed. Nutrition and drugs. New York: John Wiley and Sons Inc, 1983:175-189.

NH83 Brensike JF, Kelsey SF, Passamani ER, et al. [______] National Heart, Lung, and Blood Institute Type II Coronary Intervention Study: design, methods, and baseline characteristics. Controlled Clin Trials 1982:3;91-111.

NH84 Buchwald H, Fitch L, Moore RL. [______] Overview of clinical trials of lipid intervention for athero-sclerotic cardiovascular disease. Controlled Clin Trials 1982;3:271-283.

NH85 Buchwald H, Moore RB, Matts JP, et al. [______] The Program on the Surgical Control of the Hyperlipidemias: a status report. Surgery 1982;92:654.

NH86 Buchwald H, Moore RB, Varco RL. [______] Surgery in the therapy of atherosclerosis: partial ileal bypass. In: Arteriosclerosis: clinical evaluation and therapy. MTP Press Limited, International Medical Publication, 1982.

NH87 Buchwald H, Rucker RD Jr, Moore RB, et al. [______] Regression of atherosclerosis by surgical cholesterol reduction. In: Noseda CI, et al. eds. Lipoproteins and coronary atherosclerosis. Elsevier Biomedical Press, 1982:417.

NH88 Curb JD, Hardy RJ, Labarthe DR, et al. [______] Reserpine and breast cancer in the Hypertension Detection and Follow-up Program. Hypertension 1982;4(2):307-311.

NH89 Fisher LD, Lundberg ED, McBride R, et al. [______] The design of a database management system, C2, for research use in the Coronary Artery Surgery Study (CASS). In: Proceedings of the Fifteenth Hawaii International Conference on Systems Sciences, 1982, Volume II, Software, Hardware, Decision Support Systems, Special Topics. North Hollywood, CA: Western Periodicals Co., 1982.

NH90 Hymowitz N. [______] The Multiple Risk Factor Intervention Trial: a four year evaluation. Int J Ment Health 1982; 11:44-67.

NH91 Hypertension Detection and Follow-up Program Cooperative Group. [______] Five-year findings of the Hypertension Detection and Follow-Up Program. III. Reductions in stroke incidence among persons with high blood pressure. JAMA 1982;247:633-638.

NH92 Hypertension Detection and Follow-up Program Cooperative Group. [______] The effect of treatment on mortality in ''mild'' hypertension: results of the Hypertension Detection and Follow-up Program. N Engl J Med 1982;307:976-980.

NH93 Lipid Research Clinics Program. [______] Recruitment for clinical trials: the Lipid Research Clinics Coronary Primary Prevention Trial experience. Its implications for future trials. (AHA Monograph No. 93) Circulation 1982;66:IVl-IV78.

NH94 Long JM, Brasshear JR, Matts JP, et al. [______] The evolution of a large clinical database. Proceedings of Medcomp 1982;82:224-229.

NH95 Lundberg ED, McBride R, Rawson TE, et al. [______] A data base management system developed for the Coronary Artery Surgery Study (CASS) and other clinical studies. In: Riddle K, Thurber P, Keen P, et al. eds. Proc of the 15th Hawaii Internat Conf on Systems Sciences, 1982, Vol II, Software, Hardware, Decision Support Systems, Special Topics, North Hollywood, CA: Western Periodicals Co, 1982:484-500.

NH96 Mock MB, Ringvist I, Fisher LD, et al. [______] Survival of medically treated patients in the Coronary Artery Surgery Study (CASS) registry. Circulation 1982;66:562-568.

NH97 Multiple Risk Factor Intervention Trial Research Group. [______] Multiple Risk Factor Intervention Trial: risk factor changes and mortality results. JAMA 1982;248:1465-1477.

NH98 Ockene J, Hymowitz N, Sexton M, Broste S. [______] Comparison of patterns of smoking behavior change among smokers in the Multiple Risk Factor Intervention Trial (MRFIT). Prev Med 1982;11:621-638.

NH99 Shulman N, Cutter G, Daugherty R, et al. [______] Correlates of attendance and compliance in the Hypertension Detection and Follow-Up Program. Controlled Clin Trials 1982;3:13-27.

NH100 Smith EO, Curp JD, Hardy RJ, et al. [______] Clinic attendance in the Hypertension Detection and Follow-Up Program.' Hypertension 1982;4:710-715.

NH101 Vlietstra RE, Kronmal RA, Frye RL, et al. [______] Factors affecting the extent and severity of coronary artery disease in patients enrolled in the Coronary Artery Surgery Study. Arteriosclerosis 1982;2:208-215.

NH102 Wassertheil-Smoller S, Langford HG, Blaufox MD et al. [______] Rate of hypertension return after withdrawal of prolonged antihypertensive therapy. Clin Sci 1982;63(Suppl 8):4235-4255.

NH103 Benfari R, Sherwin R. [______] The Multiple Risk Factor Intervention Trial after 4 years: a summing-up. Prey Med 1981; 10:544-546.

NH104 Berger RL, Davis KB, Kaiser GC, et al. [______] Preservation of the myocardium during coronary artery bypass grafting. Circulation 1981;64 (Supplement II):1161-1166.

NH105 Beta-Blocker Heart Attack Trial Research Group. [______] A randomized trial of propranolol in patients with acute myocardial infarction. 1. Mortality results. JAMA 1982;247:1707-1713.

NH106 Beta-Blocker Heart Attack Trial Research Group. [______] Beta-Blocker heart attack trial—e-sign features. Controlled Clin Trials 1981;2:275-285.

NH107 Caggiula A, Christakis G, Farrand M, et al. [______] The Multiple Risk Factor Intervention Trial (MRFIT). IV. Intervention on blood lipids. Prev Med 1981;10:443-475.

NH108 Chaitman BR, Bourassa MG, Davis K, et al. [______] Angiographic prevalance of high-risk coronary artery disease patient subjects (CASS). Circulation 1981;64:360-367.

NH109 Chaitman BR, Fisher LD, Bourassa MG, et al. [______] Effect of coronary bypass surgery on survival patterns in subsets of patients with left main coronary artery disease. Report of the collaborative study in Coronary Artery Surgery (CASS). Am J Cardiol 1981;48:765-777.

NH110 Cohen J, Grimm R Jr, Swith W. [______] Multiple Risk Factor Intervention Trial (MRFIT). VI. Intervention on blood pressure. Prev Med 1981;10:501-518.

NH111 Collaborative Group on Antenatal Steroid Therapy. [______] Effect of antenatal dexamethasone administration on the prevention of respiratory distress syndrome. Am J Obstet Gynecol 1981;141:276-287.

NH112 Coronary Drug Project Research Group. [______] Implications of findings in the Coronary Drug Project for secondary prevention trials in coronary heart disease. Circulation 1981;63:1342-1350.

NH113 Fisher LD, Kennedy JW, Chaitman BR, et al. [______] Diagnostic quantification of CASS (Coronary Artery Surgery Study) clinical and exercise test results in determining presence and extent of coronary artery disease: a multivariate approach. Circulation 1981 ;63:987-1000.

NH114 Hodgkin JE and Zorn EG. [______] Intermittent positive pressure breathing (IPPB) in the outpatient management of chronic obstructive pulmonary disease (COPD): description of the NIH clinical trial. Respir Care 1981;26:1095-1104.

NH115 Howard JM, DeMets D, and the BHAT Research Group. [______] How informed is informed consent? The BHAT experience. Controlled Clin Trials 1981;2:287-303.

NH116 Hughes G, Hymowitz N, Ockene J, et al. [______] The Multiple Risk Factor Intervention Trial (MRFIT). V. Intervention on smoking. Prey Med 1981;10:476-500.

NH117 Kennedy JW, Kaiser GC, Fisher LD, et al. [______] Clinical and angiographic predictors of operative mortality from the collaborative study in Coronary Artery Surgery (CASS). Circulation 1981;63;793-802.

NH118 Neaton J, Broste S, Cohen L, et al. [______] The Multiple Risk Factor Intervention Trial (MRFIT). VII. A comparison of risk factor changes between the two study groups. Prey Med 1981;10:519-543.

NH119 Principal Investigators of CASS and Their Associates. [______] National Heart, Lung, and Blood Institute Coronary Artery Surgery Study. Circulation 1981;63 (AHA Monograph No. 79):11-181.

NH120 Strauss RG, Connett JE, Gale RP, et al. [______] A controlled trial of prophylactic granulocyte transfusions during initial induction chemotherapy for acute myelogenous leukemia. N Eng J Med 1981;305:597-603.

NH121 Winston DJ, Ho WG, Gale RP. [______] Prophylactic granulocyte transfusions during chemotherapy of acute nonlymphocytic leukemia. Ann Intern Med 1981;94:616-622.

NH122 Zukel PO, Schnaper H. [______] The Multiple Risk Factor Intervention Trial (MRFIT). I. Historical perspectives. Prev Med 1981; 10:387-401.

NH123 Aspirin Myocardial Infarction Research Group. [______] Aspirin Myocardial Infarction Study: design, methods and baseline results. DHEW Pub. No. (NIH) 80-2106, 1980.

NH124 Aspirin Myocardial Infarction Research Group. [______] A randomized controlled trial of aspirin in persons recovered from myocardial infarction. JAMA 1980;243:661-669.

NH125 Aspirin Myocardial Infarction Study Research Group. [______] The Aspirin Myocardial Infarction Study: final results. Circulation 1980;60(Suppl V)V79-V84.

NH126 Beta-Blocker Heart Attack Trial Study Group. [______] Beta-Blocker Heart Attack Trial Study protocol. DHHS Pub No. (NIH) 81-2209, 1980.

NH127 Borhani NO. [______] Clinical ramifications of the Hypertension Detection and Follow-Up Program: SC yields lower mortality and morbidity. Symposia Reporter 1980;4(2):16.

NH128 Coronary Drug Research Group. [______] Aspirin in coronary heart disease. Circulation 1980;62(Suppl V):V59-V62.

NH129 Coronary Drug Research Project Group. [______] Influence of adherence to treatment and response of cholesterol on mortality in the Coronary Drug Project. N Eng J Med 1980;303:1038-1041.

NH130 Cowan L, Detels R, Farbar M, et al. [______] Residential mobility and long-term hypertension. J Community Health 1980;5:159-166.

NH131 Cutter G, Heyden S, Kasteler J, et al. [______] Mortality surveillance in collaborative trials. Am J Public Health 1980;70:394-400.

NH132 Farrand ME, Majonnier L, (for the MRFIT Group). [______] Nutrition in the Multiple Risk Factor Intervention Trial (MRFIT). J Am Dietetic Assn 1980;76:347-351.

NH133 Gosselin AJ, Fisher L, Judkins MP, et al. [______] An estimate of the number of possible candidates from the CASS registry. Proceedings of the workshop on percutaneous transluminal coronary angioplasty June 15-16, 1979, March 1980:89-100. (U.S. Department of Health, Education and Welfare, NIH Publication No. 80-2030).

NH134 Kennedy JW, Kaiser GC, Fisher LD, et al. [______] Multivariate discriminant analysis of the clinical and angiographic predictors of operative mortality from the Collaborative Study in Coronary Artery Surgery (CASS). J Thorac Cardiovasc Surg 1980;80:876.

NH135 Knopp RH. [______] Test of the lipid hypothesis: the Coronary Primary Prevention Trial (CPPT) of the Lipid Research Clinics Program. In: Gotto AM, Jr., ed. Proceedings of the Fifth International Symposium on Atherosclerosis. Springer-Verlag 1980:509-512.

NH136 Kuller L, Neaton J, Caggiula A, et al (for the MRFIT Group). [______] Primary prevention of heart attacks: the Multiple Risk Factor Intervention Trial. Am J Epidemiol 1980;112:185-199.

NH137 Langford HG. [______] Clinical ramifications of the Hypertension Detection and Follow-Up Program: HDFP methodology and results: overview. Symposia Reporter 1980;4(2):3-6.

NH138 Long JM, Brashear JR, Matts JP, et al. [______] The POSCH Information Management System: experience with alternative approaches. J Med Systems 1980;4:355-366.

NH139 Lusher JM, Shapiro SS, Palascak JE, et al. [______] Efficiency of prothrombin-complex concentrates in hemophiliacs with antibodies to Factor VIII. N Eng J Med 1980;303:421.

NH140 Moore RB, Buchwald H, Varco RL, and the Participants in the Program on the Surgical Control of the Hyperlipidemias. [______] The effect of partial ileal bypass on plasma lipoproteins. Circulation 1980;62:469-476.

NH141 Nocturnal Oxygen Therapy Trial Group. [______] Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Ann Intern Med 1980;93:391-398.

NH142 Nocturnal Oxygen Therapy Trial Study Group. [______] Is 12-hour oxygen as effective as 24-hour oxygen in advanced chronic obstructive pulmonary disease with hypoxemia? (The Nocturnal Oxygen Therapy Trial—NOT-F). Chest 1980;78:419-420.

NH143 Remmell PS, Benfari RC (for the MRFIT Group). [______] Assessing dietary adherence in the Multiple Risk Factor Intervention Trial (MRFIT). II. Food record rating as an indicator of compliance. J Am Dietetic Assn 1980;76:357-360.

NH144 Remmell PS, Gorder DD, Hall Y, et al (for the MRFIT Group). [______] Assessing dietary adherence in the Multiple Risk Factor Intervention Trial (MRFIT). I. Use of a dietary monitoring tool. J Am Dietetic Assn 1980;76:351-356.

NH145 Rifkind B, Goor R. [______] Lipid Research Clinics Coronary Primary Prevention Trial. In: Fumagalli R, Kritchevsky D, Paoletti R, eds. Drugs affecting lipid metabolism. Elsevier, North Holland Biomedical Press, 1980:151-157.

NH146 Russell RO, Wayne JB, Kronenfeld J, et al. [______] Surgical versus medical therapy for treatment of unstable angina: changes in work status and family income. Am J Cardiology 1980;45:134-140.

NH147 Stamler J, Borhani NO. [______] Interview: HDFP mortality and morbidity. Hypertension Report 1980;1(1):12-14.

NH148 Stamler J. [______] Clinical ramifications of the Hypertension Detection and Follow-Up Program: benefits of treatment outweigh risks. Symposia Reporter 1980;4(2):12-14.

NH149 Szmuness W, Stevens CE, Harley EJ, et al. [______] Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in high-risk population in the United States. N Eng J Med 1980;303:833-841.

NH150 Unstable Angina Pectoris Study Group. [______] Unstable Angina Pectoris Study National Cooperative Study Group to compare medical and surgical therapy. III. Results in patients with S-T segment elevation during pain. Am J Cardiology 1980;45:819-824.

NH151 Hypertension Detection and Follow-Up Program Cooperative Group. [______] Five year findings of the Hypertension Detection and Follow-Up Program. I. Reduction in mortality of persons with high blood pressure including mild hypertension. JAMA 1979;242:2562-2571.

NH152 Hypertension Detection and Follow-Up Program Cooperative Group. [______] Five-year findings of the Hypertension Detection and Follow-Up Program: II. Mortality by race-sex and age. JAMA 1979;242:2572-2577.

NH153 Unstable Angina Pectoris Study Group. [______] Unstable Angina Pectoris National Cooperative Study Group to compare medical and surgical therapy. II. In-hospital experience and initial follow-up results in patients with one, two and three vessel disease. Am J Cardiol 1978;42:839-848.

NH154 Williams DO, Passamani ER, et al. [______] Intravenous recombinant tissue-type plasminogen activator in patients with acute myocardial infarction: a report from the NHLBI Thrombolysis in Myocardial Infarction Trial. Circulation 1986;73:338-346.

Copyright © 1988 by the National Academy of Sciences.
Bookshelf ID: NBK218529

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