Introduction to Regulatory

Course Content

References and Suggested Readings on Health Technology Assessment (HTA)

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Course Overview

1 Introduction

2 Safety & Effectiveness

3 Regulatory Pathways

4 Clinical Trials

5 Quality Systems

6 Intl Regulation

Glossary

Summary

 

 

 

 

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Origins and Evolution of Technology Assessment

  1. Arnstein, S. A. "Technology Assessment: Opportunities and Obstacles." IEEE Transactions on Systems, Man, and Cybernetics SMC-7 (1977): 571-82.
  2. Brooks H., and R. Bowers. "The Assessment of Technology." Science 222, no. 2 (1970): 13-20.
  3. Coates, J. F. "Technology Assessment: the Benefits ... the Costs ... the Consequences." The Futurist December (1971): 225-31.
  4. National Academy of Engineering, Committee on Public Engineering Policy. A Study of Technology Assessment. Washington, DC: U.S. Government Printing Office, 1969.
  5. National Research Council, Committee on the Life Sciences and Social Policy. Assessing Biomedical Technologies: An Inquiry into the Nature of the Process. Washington, DC: National Academy of Sciences, 1975.
  6. Porter, A. L. "Technology Assessment." Impact Assessment 13, no. 2 (1995): 135-51.
  7. Rettig, R. A. Health Care in Transition: Technology Assessment in the Private Sector. Santa Monica, Ca.: RAND, 1997.
  8. U.S. Congress, Office of Technology Assessment. Technology Assessment in Business and Government. Summary and Analysis. Washington, DC: U.S. Government Printing Office, 1977.
  9. U.S. Congress, Office of Technology Assessment. Assessing the Efficacy and Safety of Medical Technologies. Washington, DC: U.S. Government Printing Office, 1978.
  10. U.S. Congress, Office of Technology Assessment. Development of Medical Technology: Opportunities for Assessment. Washington, DC: U.S. Government Printing Office, 1976.
  11. U.S. Congress, House of Representatives. Committee on Science and Astronautics. Technology Assessment. Statement of Emilio Q. Daddario, Chairman, Subcommittee on Science Research and Development. 90th Cong., 1st sess., Washington, DC, 1967.

Overview of HTA

  1. Banta, H. D., and B. R. Luce. Health Care Technology and its Assessment: An International Perspective. New York: Oxford University Press, 1993.
  2. Cochrane, A. L. Effectiveness and Efficiency: Random Reflections on Health Services. London: Nuffield Provincial Hospitals Trust, 1972.
  3. Eddy, D. M. A Manual for Assessing Health Practices & Designing Practice Policies: The Explicit Approach. Philadelphia: American College of Physicians, 1992.
  4. Feeny, D., G. Guyatt, and P. Tugwell, eds. Health Care Technology: Effectiveness, Efficiency, and Public Policy. Montreal: Institute for Research on Public Policy, 1986.
  5. Franklin C. "Basic Concepts and Fundamental Issues in Technology Assessment." Intensive Care Medicine 19, no. 2 (1993): 117-21.
  6. Frazier, H. S., and F. Mosteller, eds. Medicine Worth Paying For: Assessing Medical Innovations. Cambridge, Mass.: Harvard University Press, 1995.
  7. Goodman, C. "It's Time to Rethink Health Care Technology Assessment." International Journal of Technology Assessment in Health Care. 8, no. 2 (1992): 335-58.
  8. Hendee, W.R. "Technology Assessment in Medicine: Methods, Status and Trends." Medical Progress Through Technology 17, no. 2 (1991): 69-75.
  9. Institute of Medicine. Assessing Medical Technologies. Washington, DC: National Academy Press, 1985.
  10. "Joint Report of the Council on Scientific Affairs and the Council on Medical Service. Technology Assessment in Medicine." Archives of Internal Medicine 152, no. 1 (1992): 46-50.
  11. Littenberg, B. "Technology Assessment in Medicine." Academic Medicine 67, no. 7 (1992): 424-8.
  12. Luce, B. R., and A. Elixhauser, eds. Standards for Socioeconomic Evaluation of Health Care Products and Services. New York: Springer-Verlag, 1990.
  13. Porter, A. L., F. A. Rossini, S. R. Carpenter, and A. T. Roper. A Guidebook for Technology Assessment and Impact Analysis. New York: North Holland, 1980.
  14. Power, E. J., S. R. Tunis, and J. L. Wagner. "Technology Assessment and Public Health." Annual Review of Public Health 15, (1994): 561-79.
  15. Szczepura, A., Kankaanp䤬 J., eds. Assessment of Health Care Technologies: Case Studies, Key Concepts and Strategic Issues. New York: John Wiley & Sons, 1996.
  16. U.S. Congress, Office of Technology Assessment. Strategies for Medical Technology Assessment. Washington, DC: U.S. Government Printing Office,1982.
  17. U.S. Congress, Office of Technology Assessment. Identifying Health Technologies That Work: Searching for Evidence. OTA-H-608. Washington, DC: U.S. Government Printing Office, 1994.
  18. U.S. Congress, Office of Technology Assessment. Health Care Technology Assessment and Its Assessment in Eight Countries. OTA-BP-H-140. Washington, DC: U.S. Government Printing Office, 1995.

Priority Setting

  1. Donaldson, M. S., and H. C. Sox, Jr., eds. Setting Priorities for Health Technology Assessment: A Model Process. Washington, DC: National Academy Press, 1992.
  2. Eddy, D. M. "Selecting Technologies for Assessment." International Journal of Technology Assessment in Health Care 5, no. 4 (1989): 485-501.
  3. Hadorn, D. C. "The Problem of Discrimination in Health Care Priority Setting." Journal of the American Medical Association 268, no. 11 (1992): 1454-9.
  4. Lara, M. E., and C. Goodman, eds. National Priorities for the Assessment of Clinical Conditions and Medical Technologies: Report of a Pilot Study. Washington, DC: National Academy Press, 1990.
  5. Phelps, C. E., and S. T. Parente. "Priority Setting in Medical Technology and Medical Practice Assessment." Medical Care 28, no. 8 (1990): 703-23.
  6. Phelps, C. E., and C. Mooney. "Correction and Update on 'Priority Setting in Medical Technology Assessment.'" Medical Care 30, no. 8 (1992): 744-51.

Randomized Controlled Trials

  1. Buring, J. E., M. A. Jonas, and C. H. Hennekens. "Large and Simple Randomized Trials." In Tools for Evaluating Health Technologies: Five Background Papers, U.S. Congress, Office of Technology Assessment. BP-H-142. Washington, DC: U.S. Government Printing Office, 1995: 67-91.
  2. Chalmers, T. C., P. Celano, H. S. Sacks, and H. Smith, Jr. "Bias in Treatment Assignment in Controlled Clinical Trials." New England Journal of Medicine 309, (1983): 1358-61.
  3. Ellenberg, S. S. "Do Large, Simple Trials Have a Place in the Evaluation of AIDS Therapies?" Oncology 6, no. 4 (1992): 55-9, 63.
  4. Freiman, J. A., T. C. Chalmers, H. Smith, Jr., and R. R. Kuebler. "The Importance of Beta, the Type II Error and Sample Size in the Design and Interpretation of the Randomized Controlled Trial. Survey of 71 "Negative" Trials." New England Journal of Medicine 299, no. 13 (1978): 690-4.
  5. Gurwitz, J. H., N. F. Col, and J. Avorn. "The Exclusion of the Elderly and Women From Clinical Trials in Acute Myocardial Infarction." Journal of the American Medical Association 268, no. 11 (1992): 1417-22.
  6. Kraemer, H. C., and J. P. Pruyn. "The Evaluation of Different Approaches to Randomized Clinical Trials." Archives of General Psychiatry 47, no. 12 (1990): 1163-9.
  7. Lubsen, J., and J. G. Tijssen. "Large Trials With Simple Protocols: Indications and Contraindications." Controlled Clinical Trials 10, suppl. 4 (1989): 151S-60S.
  8. Merigan, T. C. "You Can Teach an Old Dog New Tricks: How AIDS Trials are Pioneering New Strategies." New England Journal of Medicine 323, no. 19 (1990): 1341-3.
  9. Merkatz, R. B., R. Temple, S. Sobel, K. Feiden, and D. Kessler. "Women in Clinical Trials of New Drugs: A Change in Food and Drug Administration Policy." New England Journal of Medicine 329, no. 4 (1993): 292-6.
  10. Peto, R., R. Collins, and R. Gray. "Large-Scale Randomized Evidence: Large, Simple Trials and Overviews of Trials." Journal of Clinical Epidemiology 48, no. 1 (1995): 23-40.
  11. Pocock, S. J., M. D. Hughes, and R. J. Lee. "Statistical Problems in the Reporting of Clinical Trials." New England Journal of Medicine 317, no. 7 (1987): 426-32.
  12. Spilker, B. Guide to Clinical Trials. New York: Raven Press, 1991.
  13. Yusuf, S., P. Held, K. K. Teo, and E. R. Toretsky. "Selection of Patients for Randomized Controlled Trials: Implications of Wide or Narrow Eligibility Criteria." Statistics in Medicine 9, no. 1-2 (1990): 73-83.

HTA of Diagnostic and Screening Technologies

  1. Begg, C.B. "Biases in the Assessment of Diagnostic Tests." Statistics in Medicine 6, no. 4 (1987): 411-23.
  2. Boyko, E. J. "Ruling Out or Ruling In Disease With the Most Sensitive or Specific Diagnostic Test: Short Cut or Wrong Turn?" Medical Decision Making 14, no. 2 (1994): 175-9.
  3. Canadian Task Force on the Periodic Health Examination. "The Periodic Health Examination: 2. 1987 Update." Canadian Medical Association Journal 138, no. 7 (1988): 617-26.
  4. Eddy, D. M. "Screening for Cervical Cancer." Annals of Internal Medicine 113, no. 3 (1990): 214-26.
  5. Goin, J. E., and G. A. Hermann. "The Clinical Efficacy of Diagnostic Imaging Evaluation Studies: Problems, Paradigms, and Prescription." Investigative Radiology 26, no. 5 (1991): 507-11.
  6. Kassirer, J. P. "Our Stubborn Quest for Diagnostic Certainty. A Cause of Excessive Testing." New England Journal of Medicine 321, no. 18 (1989): 1272-3.
  7. Littenberg, B., A. M. Garber, and H. C. Sox, Jr. "Screening for Hypertension." Annals of Internal Medicine 112, no. 3 (1990): 192-202.
  8. Mushlin, A. I., C. Mooney, V. Grow, and C. E. Phelps. "The Value of Diagnostic Information to Patients With Suspected Multiple Sclerosis." Archives of Neurology 51, no. 1 (1994): 67-72.
  9. Riegelman, R. K., and R. P. Hirsch, eds. Studying a Study and Testing a Test. How to Read the Medical Literature. Second Edition. Boston: Little, Brown, 1989.
  10. Royal, H. D. "Technology Assessment: Scientific Challenges." AJR. American Journal of Roentgenology 163, no. 3 (1994): 503-7.
  11. Showstack, J. A., S. A. Schroeder, and H. R. Steinberg. "Evaluating the Costs and Benefits of a Diagnostic Technology." Medical Care 9, no. 5 (1981): 498-509.
  12. Sox, H., S. Stern, D. Owens, and H. L. Abrams. Assessment of Diagnostic Technology in Health Care: Rationale, Methods, Problems, and Directions. Institute of Medicine. Washington, DC: National Academy Press, 1989.
  13. Thornbury, J. R. "Clinical Efficacy of Diagnostic Imaging: Love It or Leave It." AJR. American Journal of Roentgenology 162, no. 1 (1994): 1-8.
  14. Thornbury, J. R., and D. G. Fryback. "Technology Assessment -- An American View." European Journal of Radiology 14, no. 2 (1992): 147-56.
  15. U.S. Preventive Services Task Force. Guide to Clinical Preventive Services: An Assessment of the Effectiveness of 169 Interventions. Baltimore: Williams & Wilkins, 1989.
  16. Wells, P. N., J. A. Garrett, and P. C. Jackson. "Assessment Criteria for Diagnostic Imaging Technologies." Medical Progress Through Technology 17, no. 2 (1991): 93-101.

Evidence in HTA

  1. Bailar, J. C. and F. Mosteller, eds. Medical Uses of Statistics. Boston, MA: NEJM Books, 1992.
  2. Canadian Task Force on the Periodic Health Examination. The Periodic Health Examination: 2. 1987 Update. Canadian Medical Association Journal 138, no. 7 (1988): 617-26.
  3. Chalmers, I. "Under-Reporting Research is Scientific Misconduct." Journal of the American Medical Association 263, no. 10 (1990): 1405-8.
  4. Chalmers, T. C., C. S. Frank, and D. Reitman. "Minimizing the Three Stages of Publication Bias." Journal of the American Medical Association 263, no. 10 (1990): 1392-5.
  5. Chalmers, T. C., H. Smith, Jr., B. Blackburn, B. Silverman, B. Schroeder, D. Reitman, and A. Ambroz. "A Method for Assessing the Quality of a Randomized Are the Results of the Study Valid?" Journal of the American Medical Association 270, no. 21 (1993): 2598-601.
  6. Guyatt, G. H., D. L. Sackett, and D. J. Cook. "Users' Guides to the Medical Literature. II. How to Use an Article About a Therapy or Prevention. B. What Were the Results and Will They Help Me in Caring for My Patients?" Journal of the American Medical Association 271, no. 1 (1994): 59-63.
  7. Hirsh, J., and B. Haynes. "Transforming Evidence Into Practice: Evidence-based Consensus." Annals of Internal Medicine 118, suppl. 2 (1993): A16-7.
  8. Jaeschke, R., G. Guyatt, and D. L. Sackett. "Users' Guides to the Medical Literature. III. How to Use an Article About a Diagnostic Test. A. Are the Results of the Study Valid?" Journal of the American Medical Association 271, no. 5 (1994): 389-91.
  9. Jaeschke, R., G. H. Guyatt, and D. L. Sackett. "Users' Guides to the Medical Literature. III. How to Use an Article About a Diagnostic Test. B. What Are the Results and Will They Help Me in Caring for My Patients?" Journal of the American Medical Association 271, no. 9 (1994): 703-7.
  10. Laupacis, A., C. D. Naylor, and D. L. Sackett. "How Should the Results of Clinical Trials be Presented to Clinicians?" Annals of Internal Medicine 116, suppl. 3 (1992): A12-4.
  11. Laupacis, A., D. L. Sackett, and R. S. Roberts. "An Assessment of Clinically Useful Measures of the Consequences of Treatment." New England Journal of Medicine 318, no. 26 (1988): 1728-33.
  12. Lomas, J., G. Anderson, M. Enkin, E. Vayda, R. Roberts, and B. MacKinnon. "The Role of Evidence in the Consensus Process: Results from a Canadian Experience." Journal of the American Medical Association 259, no. 20 (1988): 3001-5.
  13. Naylor, C. D., E. Chen, B. Strauss. "Measured Enthusiasm: Does the Method of Reporting Trial Results Alter Perceptions of Therapeutic Effectiveness?" Annals of Internal Medicine 117, no. 11 (1992): 916-21.
  14. Oxman, A. D., D. J. Cook, and G. H. Guyatt. "Users' Guides to the Medical Literature. VI. How to use an Overview. Evidence-Based Medicine Working Group." Journal of the American Medical Association 272, no. 17 (1994): 1367-71.
  15. Oxman, A. D., D. L. Sackett, and G. H. Guyatt. "Users' Guides to the Medical Literature. I. How to Get Started." Journal of the American Medical Association 270, no. 17 (1993): 2093-5.
  16. Sackett DL, Richardson WS, Rosenberg W, Haynes RB. Evidence-Based Medicine. New York: Churchill Livingstone, 1997.
  17. Temple, R. "Problems in the Use of Large Data Sets to Assess Effectiveness." International Journal of Technology Assessment in Health Care 6, no. 2 (1990): 211-9.

Cost-Effectiveness and Related Economic Analyses

  1. Bloom, B. S. "Costs, Benefits and Unintended Gastrointestinal Side Effects of Pharmaceutical Therapy." Pharmacoeconomics 1, no. 3 (1992): 175-81.
  2. Doubilet, P., M. C. Weinstein, and B. J. McNeil. "Use and Misuse of the Term "Cost Effective" in Medicine." New England Journal of Medicine 314, no. 4 (1986): 253-6.
  3. Drummond, M. F. "Economic Evaluation and the Rational Diffusion and Use of Health Technology." Health Policy 7, no. 3 (1987): 309-24.
  4. Drummond, M. F. "Allocating Resources." International Journal of Technology Assessment in Health Care 6, no. 1 (1990): 77-92.
  5. Drummond, M. F., and L. Davies. "Economic Analysis Alongside Clinical Trials: Revisiting the Methodological Issues." International Journal of Technology Assessment in Health Care 7, no. 4 (1991): 561-73.
  6. Eddy, D. M. "Clinical Decision Making: From Theory to Practice. Cost-effectiveness Analysis. Is It Up to the Task?" Journal of the American Medical Association 267, no. 24 (1992): 3342-8.
  7. Eisenberg, J. M. "Clinical Economics: A Guide to the Economic Analysis of Clinical Practices." Journal of the American Medical Association 262, no. 20 (1989): 2879-86.
  8. Gagnon, J. P. "A Primer on Pharmacoeconomics." Managed Care Medicine February (1995): 11-8.
  9. Garber, A. M. "Can Technology Assessment Control Health Spending?" Health Affairs 13, no. 3 (1994): 115-26.
  10. Geweke, J., and B. A. Weisbrod. "Clinical Evaluation vs. Economic Evaluation: The Case of a New Drug." Medical Care 20, no. 8 (1982): 821-30.
  11. Laupacis, A., D. Feeny, A. S. Detsky, and P. X. Tugwell. "How Attractive Does a New Technology Have to be to Warrant Adoption and Utilization? Tentative guidelines for using clinical and economic evaluations." Canadian Medical Association Journal 146, no. 4 (1992): 473-81.
  12. Maynard, A. "The Design of Future Cost-benefit Studies." American Heart Journal 119, no. 3 pt. 2 (1990): 761-5.
  13. Pauker, S. G., J. P. Kassirer. "Therapeutic Decision Making: A Cost-Benefit Analysis." New England Journal of Medicine 293, no. 5 (1975): 229-34.
  14. Poe, N. R., and R. I. Griffiths. "Clinical-Economic Trials." In Tools for Evaluating Health Technologies: Five Background Papers. U.S. Congress, Office of Technology Assessment, 125-49. BP-H-142. Washington, DC: U.S. Government Printing Office, 1995.
  15. Russell, L. B. "Opportunity Costs in Modern Medicine." Health Affairs 11, no. 2 (1992): 162-9.
  16. Warner, K. E., and B. R. Luce. Cost-Benefit and Cost-Effectiveness Analysis in Health Care. Ann Arbor, MI: Health Administration Press, 1982.
  17. Weinstein, M. C. "Principles of Cost-effective Resource Allocation in Health Care Organizations." International Journal of Technology Assessment in Health Care 6, no. 1 (1990): 93-103.
  18. Weisbrod, B. A. "A Guide to Benefit-Cost Analysis, As Seen Through a Controlled Experiment in Treating the Mentally Ill." Journal of Health Politics, Policy and Law 7, no. 4 (1983): 808-45.

Meta-Analysis

  1. Chalmers, T. C. "Problems Induced by Meta-analysis." Statistics in Medicine 10, no. 6 (1991): 971-80.
  2. Chalmers, T. C., and J. Lau. "Meta-analytic Stimulus for Changes in Clinical Trials." Statistical Methods in Medical Research 2, no. 2 (1993): 161-72.
  3. Cook, D. J., G. H. Guyatt, G. Ryan, J. Clifton, L. Buckingman, A. Willan, W. McIlroy, and A. D. Oxman. "Should Unpublished Data be Included in Meta-Analyses? Current Convictions and Controversies." Journal of the American Medical Association 269, no. 21 (1993): 2749-53.
  4. Cook, T. D., H. Cooper, D. S. Cordray, H. Hartmann, L. V. Hedges, R. J. Light, T. A. Louis, and F. Mosteller. Meta-Analysis for Explanation: A Casebook. New York: Russell Sage Foundation, 1992.
  5. Detsky, A. S., C. D. Naylor, K. O'Rourke, A. J. McGeer, and K. A. L'Abb鮊"Incorporating Variations in the Quality of Individual Randomized Trials into Meta-analysis." Journal of Clinical Epidemiology 45, no. 3 (1992): 255-65.
  6. Dickersin, K., and J. A. Berlin. "Meta-analysis: State-of-the-Science." Epidemiologic Reviews 14, (1992): 154-76.
  7. Eddy, D. M. A Manual for Assessing Health Practices & Designing Practice Policies: The Explicit Approach. Philadelphia: American College of Physicians, 1992.
  8. Eddy, D. M., V. Hasselblad, and R. Shachter. "A Bayesian Method for Synthesizing Evidence: The Confidence Profile Method." International Journal of Technology Assessment in Health Care 6, no. 1 (1990): 31-55.
  9. Hasselblad, V., and D. C. McCrory. "Meta-Analytic Tools for Medical Decision Making: A Practical Guide." Medical Decision Making 15, no. 1 (1995): 81-96.
  10. Hedges, L. V., and S. M. Rowley. "Combining Estimates Across Studies: Meta-analysis of Research." In Clinical Practice Guideline Development: Methodology Perspectives, edited by K. A. McCormick, S. R. Moore and R. A. Siegel, 15-25. Rockville, MD: Agency for Health Care Policy Research, 1994.
  11. Jones, D. R. "Meta-analysis of Observational Epidemiological Studies: A Review." Journal of the Royal Society of Medicine 85, no. 3 (1992): 165-8.
  12. L'Abb鬠K. A., A. S. Detsky, and K. O'Rourke. "Meta-analysis in Clinical Research." Annals of Internal Medicine 107, no. 2 (1987): 224-33.
  13. Laird, N. M., and F. Mosteller. "Some Statistical Methods for Combining Experimental Results." International Journal of Technology Assessment in Health Care 6, no. 1 (1990): 5-30.
  14. Lau, J., E. M. Antman, J. Jiminez-Silva, B. Kupelnick, F. Mosteller, and T. C. Chalmers. "Cumulative Meta-analysis of Therapeutic Trials for Myocardial Infarction." New England Journal of Medicine 327, no. 4 (1992): 248-54.
  15. Longnecker, M. P. "Meta-analysis." In Tools for Evaluating Health Technologies: Five Background Papers. U.S. Congress, Office of Technology Assessment, 93-123. BP-H-142. Washington, DC: U.S. Government Printing Office, 1995.
  16. Petitti, D. B. Meta-analysis, Decision Analysis, and Cost-Effectiveness Analysis. Methods for Quantitative Synthesis in Medicine. New York: Oxford University Press, 1994.
  17. Sacks, H. S., J. Berrier, D. Reitman, V. A. Ancona-Berk, and T. C. Chalmers. "Meta-analysis of Randomized Controlled Trials." New England Journal of Medicine 316, no. 8 (1987): 450-5.
  18. Spector, T.D., and S. G. Thompson. "The Potential and Limitations of Meta-analysis." Journal of Epidemiology and Community Health 45, no. 2 (1991): 89-92.
  19. Thacker, S. B. "Meta-analysis: A Quantitative Approach to Research Integration." Journal of the American Medical Association 259, no. 11 (1988): 1685-9.
  20. U.S. General Accounting Office. Cross Design Synthesis: A New Strategy for Medical Effectiveness Research. Gaithersburg, MD, 1992.
  21. Wilson, A., and D. A. Henry. "Meta-Analysis. Part 2: Assessing the Quality of Published Meta-Analyses." Medical Journal of Australia 156, no. 3 (1992): 173-87.

Decision Analysis

  1. Eckman, M. H., H. J. Levine, and S. G. Pauker. "Decision Analytic and Cost-effectiveness Issues Concerning Anticoagulant Prophylaxis in Heart Disease." Chest 102, suppl. 4 (1992): 538-49S.
  2. Fleming, C., J.H. Wasson, P. C. Albertsen, M. J. Barry, and J. E. Wennberg. "A Decision Analysis of Alternative Treatment Strategies for Clinically Localized Prostate Cancer." Journal of the American Medical Association 269, no. 20 (1993): 2650-8.
  3. Hagen, M. D. "Decision Analysis: A Review." Family Medicine 24, no. 5 (1992): 349-54.
  4. McNeil, B. J., and S. G. Pauker. "Decision Analysis for Public Health: Principles and Illustrations." Annual Review of Public Health 5, (1984): 135-61.
  5. Pauker, S. G., and J. P. Kassirer. "Medical Progress: Decision Analysis." New England Journal of Medicine 316, no. 5 (1987): 250-8.
  6. Thornton, J. G., R. J. Lilford, and N. Johnston. "Decision Analysis in Medicine." BMJ 304, no. 6834 (1992): 1099-103.
  7. Zalkind, D. L., and R. H. Shachtman. "A Decision Analysis Approach to the Swine Influenza Vaccination Decision for an Individual." Medical Care 18, no. 1 (1980): 59-72.

Consensus Development

  1. Andreasen, P. B. "Consensus Conferences in Different Countries: Aims and Perspectives." International Journal of Technology Assessment in Health Care 4, no. 2 (1988): 305-8.
  2. Eddy, D. M. "Clinical Policies and the Quality of Clinical Practice." New England Journal of Medicine 307, no. 6 (1982): 343-7.
  3. Fink, A., J. Kosecoff, M. Chassin, and R. H. Brook. "Consensus Methods: Characteristics and Guidelines for Use." American Journal of Public Health 74, no. 9 (1984): 979-83.
  4. Goodman, C., and S. R. Baratz, eds. Improving Consensus Development for Health Technology Assessment: An International Perspective. Washington, DC: National Academy Press, 1990.
  5. Greer, A. L. "The Two Cultures of Biomedicine: Can There be a Consensus?" Journal of the American Medical Association 258, no. 19 (1987): 2739-40.
  6. Institute of Medicine. Consensus Development at the NIH: Improving the Program. Washington, DC: National Academy Press, 1990.
  7. Kosecoff, J., D. E. Kanouse, W. H. Rogers, L. McCloskey, C. M. Winslow, and R. H. Brook. "Effects of the National Institutes of Health Consensus Development Program on Physician Practice." Journal of the American Medical Association 258, no. 19 (1987): 2708-13.
  8. Lomas, J., G. Anderson, M. Enkin, E. Vayda, R. Roberts, and B. MacKinnon. "The Role of Evidence in the Consensus Process: Results from a Canadian Experience." Journal of the American Medical Association 259, no. 20 (1988): 3001-5.
  9. Perry, S. "The NIH Consensus Development Program a Decade Later." New England Journal of Medicine 317, no. 8 (1987): 485-488.
  10. Veatch, R. M. "Consensus of Expertise: The Role of Consensus of Experts in Formulating Public Policy and Estimating Facts." Journal of Medicine and Philosophy 16, no. 4 (1991): 427-45.
  11. Wortman, P. M., A. Vinokur, and L. Sechrest. "Do Consensus Conferences Work? A Process Evaluation of the NIH Consensus Development Program." Journal of Health Politics, Policy and Law 13, no. 3 (1988): 469-98.

Health-Related Quality of Life Measures

  1. Aaronson, N. K. "Methodologic Issues in Assessing the Quality of Life of Cancer Patients." Cancer 67, suppl. 3 (1991): S844-50.
  2. "Advances in Health Status Assessment: Proceedings of a Conference." Medical Care 30, suppl. 5 (1992): MS1-MS293.
  3. "Advances in Health Status Assessment: Conference Proceedings." Medical Care 27, suppl. 3 (1989): S1-S294.
  4. Bell, M. J., C. Bombardier, and P. Tugwell. "Measurement of Functional Status, Quality of Life, and Utility in Rheumatoid Arthritis." Arthritis and Rheumatism 33, no. 4 (1990): 591-601.
  5. EuroQol© Group. "EuroQol© -- A New Facility for the Measurement of Health Related Quality of Life." Health Policy 16, no. 3 (1990): 199-208.
  6. Fitzpatrick, R., A. Fletcher, S. Gore, D. Jones, D. Spiegelhalter, and D. Cox. "Quality of Life Measures in Health Care. I: Applications and Issues in Assessment." BMJ 305, no. 6861 (1992): 1074-7.
  7. Fletcher, A., S. Gore, D. Jones, R. Fitzpatrick, D. Spiegelhalter, and D. Cox. "Quality of Life Measures in Health Care. II: Design, Analysis, and Interpretation." BMJ 305, no. 6862 (1992): 1145-8.
  8. Gill, T. M., and A. R. Feinstein. "A Critical Appraisal of the Quality of Quality-of-life Measurements." Journal of the American Medical Association 272, no. 8 (1994): 619-26.
  9. Guyatt, G. H., D. H. Geeny, and D. L. Patrick. "Measuring Health-related Quality of Life." Annals of Internal Medicine 118, no. 8 (1993): 622-9.
  10. Mason JM. Cost-per QALY league tables: their roles in pharmacoeconomic analysis. Pharmacoeconomics 1994;5:472-81.
  11. Mehrez, A., and A. Gafni. "Healthy-years Equivalents Versus Quality-adjusted Life Years: In Pursuit of Progress." Medical Decision Making 13, no. 4 (1993): 287-92.
  12. Mosteller, F., and J. Falotico-Taylor, eds. Quality of Life and Technology Assessment. Washington, DC: National Academy Press, 1989.
  13. Nord, E. "Methods for Quality Adjustment of Life Years." Social Science and Medicine 34, no. 5 (1992): 559-69.
  14. Patrick, D. L., and P. Erickson. Health Status and Health Policy. Quality of Life in Health Care Evaluation and Resource Allocation. New York: Oxford University Press, 1993.
  15. "Proceedings of the International Conference on the Measurement of Quality of Life as an Outcome in Clinical Trials." Controlled Clinical Trials 12, suppl. 4 (1991): 79S-280S.
  16. Revicki, D. A., M. Rothman, and B. Luce. "Health-Related Quality of Life Assessment and the Pharmaceutical Industry." Pharmacoeconomics 1, no. 6 (1992): 394-408.
  17. Spiegelhalter, D., S. Gore, R. Fitzpatrick, A. E. Fletcher, D. R. Jones, and D. R. Cox. "Quality of Life Measures in Health Care. III: Resource Allocation." BMJ 305, no. 6863 (1992): 1205-9.
  18. Walker, S.R., and R. M. Rosser, eds. Quality of Life Assessment: Key Issues for the 1990s. Dordrecht: Kluwer, 1993.
  19. Ware, J. E., Jr. "The Status of Health Assessment 1994." Annual Review of Public Health 15, (1995): 327-54.
  20. Williams, A. "Is the QALY a Technical Solution to a Political Problem? Of Course Not." International Journal of Health Services 21, no. 2 (1991): 365-9.

 

Ethical, Legal, Social, and Political Issues

  1. Anderson, G. F., M. A. Hall, and E. P. Steinberg. "Medical Technology Assessment and Practice Guidelines: Their Day in Court." American Journal of Public Health 83, no. 11 (1993): 1635-9.
  2. Banta, H. D., and P. B. Andreasen. "The Political Dimension in Health Care Technology Assessment Programs." International Journal of Technology Assessment in Health Care 6, no. 1 (1990): 115-23.
  3. Baum, M., K. Zilka, and J. Houghton. "Ethics of Clinical Research: Lessons for the Future." BMJ 299, no. 6693 (1989): 251-3.
  4. Beauchamp, T. L., and J. F. Childress. Principles of Biomedical Ethics. 4th ed. New York: Oxford University Press, 1993.
  5. Diamond, G. A. "The Importance of Subjective Values to Medical Technology." Journal of Invasive Cardiology 5, no. 1 (1993): 17-22.
  6. Ferguson, J. H., M. Dubinsky, and P. J. Kirsch. "Court-ordered Reimbursement for Unproven Medical Technology." Journal of the American Medical Association 269, no. 16 (1993): 2116-21.
  7. Gillon, R., ed. Medical Technology, Social and Health Care Issues. New York: John Wiley, 1994.
  8. Gold, J. A., M. J. Zaremski, E. R. Lev, and D. H. Shefrin. "Daubert v. Merrell Dow. The Supreme Court Tackles Scientific Evidence in the Courtroom." Journal of the American Medical Association 270, no. 24 (1993): 2964-7.
  9. Lantos, J. "Ethics, Randomization, and Technology Assessment." Cancer 74, suppl. 9 (1994): 2653-6.
  10. Marsden, C. "An Ethical Assessment of Intensive Care." International Journal of Technology Assessment in Health Care 8, no. 3 (1992): 408-18.
  11. Passamani, E. "Clinical Trials: Are They Ethical?" New England Journal of Medicine 324, no. 22 (1991): 1589-92.
  12. Sibbald, W. J., and K. J. Inman. "Problems in Assessing the Technology of Critical Care Medicine." International Journal of Technology Assessment in Health Care 8, no. 3 (1992): 419-43.
  13. Tangri, S. S., and T. E. Levin. "New Medical Technologies: Economic, Ethical, and Political Considerations for Policy." Journal of Social Issues 49, no. 2 (1993): 1-211.

HTA and Quality of Care

  1. Brook, R. H. "Using Scientific Information to Improve Quality of Health Care." Annals of the New York Academy of Sciences 703, (1993): 74-84.
  2. Donabedian, A. "Quality Assessment and Assurance: Unity of Purpose, Diversity of Means." Inquiry 25, no. 1 (1988): 173-92.
  3. Donabedian, A. "The Quality of Care: How Can It be Assessed?" Journal of the American Medical Association 260, no. 12 (1988): 1743-8.
  4. Lohr, K. N., ed. Medicare: A Strategy for Quality Assurance. Volume I. Institute of Medicine. Washington, DC: National Academy Press, 1990.
  5. Lohr K. N., and R. A. Rettig, eds. Quality of Care and Technology Assessment. Report of a Forum of the Council on Health Care Technology. Washington, DC: National Academy Press, 1988.

Effectiveness/Outcomes Research and HTA

  1. Brook, R. H., and K. N. Lohr. "Efficacy, Effectiveness, Variations, and Quality: Boundary-crossing Research." Medical Care 23, no. 5 (1985): 710-22.
  2. Ellwood, P. M. "Outcomes Management: A Technology of Patient Experience." New England Journal of Medicine 318, no. 23 (1988): 1549-56.
  3. Fuchs, V. R., and A. M. Garber. "The New Technology Assessment." New England Journal of Medicine 323, no. 10 (1990): 673-7.
  4. Neuhauser, D. "Ernest Amory Codman, M.D., and End Results of Medical Care." International Journal of Technology Assessment in Health Care 6, no. 2 (1990): 307-25.
  5. Roper, W. L., W. Winkenwerder, G. M. Hackbarth, and H. Krakauer. "Effectiveness in Health Care: An Initiative to Evaluate and Improve Medical Practice." New England Journal of Medicine 319, no. 18 (1988): 1197-202.
  6. Schwartz, J. S., and N. Lurie. "Assessment of Medical Outcomes: New Opportunities for Achieving a Long Sought-after Objective." International Journal of Technology Assessment in Health Care 6, no. 2 (1990): 333-9.
  7. U.S. Congress, Office of Technology Assessment. Identifying Health Technologies That Work: Searching for Evidence. OTA-H-608. Washington, DC: U.S. Government Printing Office, 1994.

Searching the HTA Literature

  1. Antczak-Bouckoms, A., E. Burdick, S. Klawansky, and F. Mosteller. "Using Medical Registries and Data Sets for Technology Assessment." International Journal of Technology Assessment in Health Care 7, no. 2 (1991): 123-8.
  2. Auston, I., M. A. Cahn, and C. R. Selden. "Literature Search Methods for the Development of Clinical Practice Guidelines." In Clinical Practice Guideline Development: Methodology Perspectives, editied by K. A. McCormick, S. R. Moore, and R. A. Siegel, 123-7. Rockville MD: Agency for Health Care Policy Research, 1994.
  3. Chalmers, I. The Cochrane Collaboration: Preparing, Maintaining, and Disseminating Systematic Reviews of the Effects of Health Care." Annals of the New York Academy of Sciences 703, (1993): 156-63.
  4. Chalmers, T. C., P. Hewett, D. Reitman, and H. S. Sacks. "Selection and Evaluation of Empirical Research in Technology Assessment." International Journal of Technology Assessment in Health Care 5, no. 4 (1989): 521-36.
  5. Dickersin, K., P. Hewitt, L. Mutch, I. Chalmers, and T. C. Chalmers. "Comparison of MEDLINE Searching With a Perinatal Trials Database." Controlled Clinical Trials 6 no. 4 (1985): 306-17.
  6. Goodman, C., ed. Medical Technology Assessment Directory. Washington, DC: National Academy Press, 1988.
  7. Goodman, C. Literature Searching and Evidence Interpretation for Assessing Health Care Practices. Stockholm: Swedish Council on Technology Assessment in Health Care, 1993.
  8. Jadad, A. R., and H. J. McQuay. "A High-yield Strategy to Identify Randomized Controlled Trials for Systematic Reviews." Online Journal of Current Clinical Trials 1993. Doc. No. 33.
  9. Larson, E., and R. Sattertwhite. "Searching the Literature: A Professional Imperative." American Journal of Infection Control 17, no. 6 (1989): 359-64.
  10. Ludbrook, J. "How to Find the Surgical Articles You Are Looking For." Australian and New Zealand Journal of Surgery 61, no. 4 (1991): 251-3.
  11. Marcaccio, K. Y., ed. Gale Directory of Databases. Volume 1: Online Databases. London: Gale Research International (Detroit, Washington, DC: Gale Research), 1993.
  12. Marcaccio, K. Y., ed. Gale Directory of Databases. Volume 2: CD-ROM, Diskette, Magnetic Tape, Handheld, and Batch Access Database Products. London: Gale Research International (Detroit, Washington, DC: Gale Research), 1993.
  13. Orenstein, R. M., ed. Fulltext Sources Online. Needham, MA: BiblioData, 1993.
    U.S. Department of Health and Human Services, National Library of Medicine. The Basics of Searching MEDLINE. Bethesda, Md., 1989, PB89-146179.
 
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