Evidence based? Caveat emptor!

Health Affairs

Volumn 24, Issue 1, 2005, Pages 80-92

  Steinberg, Earl P ^a,b   Luce, Bryan R ^c  

^a Resolution Health Inc   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c UNITED BIOSOURCE CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DECISION MAKING; DRUG MARKETING; EVALUATION; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE; HEALTH CARE DELIVERY; HEALTH CARE POLICY; HEALTH CARE QUALITY; HEALTH INSURANCE; HUMAN; MEDICAL PRACTICE; PRACTICE GUIDELINE; REVIEW;

EVIDENCE-BASED MEDICINE; HEALTH SERVICES; INSURANCE COVERAGE; MARKETING; QUALITY OF HEALTH CARE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 12844280150     PISSN: 02782715     EISSN: None     Source Type: Journal    
DOI: 10.1377/hlthaff.24.1.80     Document Type: Review

References (35)

1. The term first appeared in G.H. Guyatt, "Evidence-based Medicine," ACP Journal Club 114, no. 2 (1991): A-16. A more substantial paper on the topic appeared shortly thereafter: Evidence-Based Medicine Working Group, "Evidence-based Medicine: A New Approach to Teaching the Practice of Medicine," Journal of the American Medical Association 268, no. 17 (1992): 2420-2425. For at least the prior decade, however, David Eddy and others had been championing efforts to develop evidence-based guidelines and to base insurance coverage decisions on critical appraisal of published evidence.
2. The term first appeared in G.H. Guyatt, "Evidence-based Medicine," ACP Journal Club 114, no. 2 (1991): A-16. A more substantial paper on the topic appeared shortly thereafter: Evidence-Based Medicine Working Group, "Evidence-based Medicine: A New Approach to Teaching the Practice of Medicine," Journal of the American Medical Association 268, no. 17 (1992): 2420-2425. For at least the prior decade, however, David Eddy and others had been championing efforts to develop evidence-based guidelines and to base insurance coverage decisions on critical appraisal of published evidence.
3. Council on Health Care Technology, Institute of Medicine, Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Resources (Washington: National Academies Press, 1988); and Council on Health Care Technology and Divisions of Health Sciences Policy and Health Promotion and Disease Prevention, Assessing Medical Technologies (Washington: National Academies Press, October 1985).
4. Council on Health Care Technology, Institute of Medicine, Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Resources (Washington: National Academies Press, 1988); and Council on Health Care Technology and Divisions of Health Sciences Policy and Health Promotion and Disease Prevention, Assessing Medical Technologies (Washington: National Academies Press, October 1985).
5. The term "meta-analysis" began to be used to describe quantitative approaches to synthesizing evidence from multiple randomized controlled trials. See, for example, K.A. L'Abbe, A.S. Detsky, and K. O'Rourke, "Meta-Analysis in Clinical Research," Annals of Internal Medicine 107, no. 2 (1987): 224-233.
6. K.N. Lohr and T.S. Carey, "Assessing 'Best Evidence': Issues in Grading the Quality of Studies for Systematic Reviews," Joint Commission Journal on Quality Improvement 25, no. 9 (1999): 470-479.
7. S. West et al., Systems to Rate the Strength of Scientific Evidence, Evidence Report, Technology Assessment no. 47, Pub. no. 02-E016 (Rockville, Md.: Agency for Healthcare Research and Quality, 2002).
8. K.N. Lohr, "Rating the Strength of Scientific Evidence: Relevance for Quality Improvement Programs," International Journal for Quality in Health Care 16, no. 1 (2004): 9-18.
9. See, for example, S.H. Woolf et al., "Assessing the Clinical Effectiveness of Preventive Maneuvers: Analytic Principles and Systematic Methods in Reviewing Evidence and Developing Clinical Practice Recommendations," Journal of Clinical Epidemiology 43, no. 9 (1990): 891-905; R.P. Harris et al., "Current Methods of the U.S. Preventive Services Task Force: A Review of the Process," American Journal of Preventive Medicine 20, no. 3S (2001): 21-35; and Canadian Task Force on Preventive Health Care, "CTFPHC History/Methodology," 5 August 2003, www.ctfphc.org/ctfphc&methods.htm (14 October 2004).
10. See, for example, S.H. Woolf et al., "Assessing the Clinical Effectiveness of Preventive Maneuvers: Analytic Principles and Systematic Methods in Reviewing Evidence and Developing Clinical Practice Recommendations," Journal of Clinical Epidemiology 43, no. 9 (1990): 891-905; R.P. Harris et al., "Current Methods of the U.S. Preventive Services Task Force: A Review of the Process," American Journal of Preventive Medicine 20, no. 3S (2001): 21-35; and Canadian Task Force on Preventive Health Care, "CTFPHC History/Methodology," 5 August 2003, www.ctfphc.org/ctfphc&methods.htm (14 October 2004).
11. See, for example, S.H. Woolf et al., "Assessing the Clinical Effectiveness of Preventive Maneuvers: Analytic Principles and Systematic Methods in Reviewing Evidence and Developing Clinical Practice Recommendations," Journal of Clinical Epidemiology 43, no. 9 (1990): 891-905; R.P. Harris et al., "Current Methods of the U.S. Preventive Services Task Force: A Review of the Process," American Journal of Preventive Medicine 20, no. 3S (2001): 21-35; and Canadian Task Force on Preventive Health Care, "CTFPHC History/Methodology," 5 August 2003, www.ctfphc.org/ctfphc&methods.htm (14 October 2004).
12. E.P. Steinberg et al., "Methods Used to Evaluate the Quality of Evidence Underlying the National Kidney Foundation-Dialysis Outcomes Quality initiative Clinical Practice Guidelines: Description, Findings, and Implications," American Journal of Kidney Diseases 36, no. 1 (2000): 1-11.
13. See D.M. Eddy, A Manual for Assessing Health Practices and Designing Practice Policies: The Explicit Approach (Philadelphia: American College of Physicians, 1992), for a good overview of the topic.
14. See D.M. Eddy, "Investigational Treatments: How Strict Should We Be?" Journal of the American Medical Association 278, no. 3 (1997): 179-185; and C.D. Mulrow and K.N. Lohr, "Proof and Policy from Medical Research Evidence," Journal of Health Politics, Policy and Law 26, no. 2 (2001): 249-266.
15. See D.M. Eddy, "Investigational Treatments: How Strict Should We Be?" Journal of the American Medical Association 278, no. 3 (1997): 179-185; and C.D. Mulrow and K.N. Lohr, "Proof and Policy from Medical Research Evidence," Journal of Health Politics, Policy and Law 26, no. 2 (2001): 249-266.
16. West et al., Systems to Rate the Strength of Scientific Evidence.
17. Lohr, "Rating the Strength of Scientific Evidence."
18. See ibid.; and Eddy, "Investigational Treatments."
19. See ibid.; and Eddy, "Investigational Treatments."
20. See Steinberg et al., "Methods Used to Evaluate the Quality of Evidence";
21. and GRADE Working Group, "Grading Quality of Evidence and Strength of Recommendations," British Medical Journal 328, no. 7454 (2004): 1490-1494.
22. National Kidney Foundation, "DOQI Clinical Practice Guidelines for Hemodialysis Adequacy and Peritoneal Dialysis Adequacy," American Journal of Kidney Diseases 30, Supp. 2 (1997): S1-S136.
23. M.M. Millenson, Beyond the Managed Care Backlash: Medicine in the Information Age, PPI Policy Report no. 1 (Washington: Progressive Policy Institute, 1997); and J.W. Williamson, Assessing and Improving Health Care Outcomes: The Health Accounting Approach to Quality Assurance (Cambridge, Md.: Ballinger Publishing Co., 1978).
24. M.M. Millenson, Beyond the Managed Care Backlash: Medicine in the Information Age, PPI Policy Report no. 1 (Washington: Progressive Policy Institute, 1997); and J.W. Williamson, Assessing and Improving Health Care Outcomes: The Health Accounting Approach to Quality Assurance (Cambridge, Md.: Ballinger Publishing Co., 1978).
25. M.J. Field and K.N. Lohr, eds., Guidelines for Clinical Practice: From Development to Use (Washington: National Academies Press, 1992).
26. J.A. Knottnerus and G.J. Dinant, "Medicine based Evidence, a Prerequisite for Evidence based Medicine," British Medical Journal 315, no. 7116 (1997): 1109-1110.
27. K.N. Lohr, K. Eleazer, and J. Mauskopf, "Health Policy Issues and Applications for Evidence-based Medicine and Clinical Practice Guidelines," Health Policy 46 (1998): 1-19.
28. See S.R. Tunis, D.B. Stryer, and C.M. Clancy, "Practical Clinical Trials: Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy," Journal of the American Medical Association 290, no. 12 (2003): 1624-1632.
29. D.N. Juurlink et al., "Rates of Hyperkalemia after Publication of the Randomized Aldactone Evaluation Study," New England Journal of Medicine 351, no. 6 (2004): 543-551.
30. J.J.V. McMurray and E. O'Meara, "Treatment of Heart Failure with Spironolactone - Trial and Tribulation," New England Journal of Medicine 351, no. 6 (2004): 526-528.
31. Eddy, "Investigational Treatments."
32. I b i d.
33. See BlueCross BlueShield Association, "TEC Assessments," 2004, www.bcbs.com/tec/tecprocess.html (14 October 2004).
34. A. Schneider, "Tennessee's New 'Medically Necessary' Standard: Uncovering the Insured?" Pub. no. 7139, 30 July 2004, www.kff.org/medicaid/ 7139.cfm (14 October 2004).
35. See L.C. Walter et al., "Pitfalls of Converting Practice Guidelines into Quality Measure: Lessons Learned from a VA Performance Measure," Journal of the American Medical Association 291, no. 20 (2004): 2466-2470.