A landmark for popperian epidemiology: Refutation of the randomised Aldactone evaluation study

Journal of Epidemiology and Community Health

Volumn 59, Issue 11, 2005, Pages 1000-1006

  Koch, Elard ^a,b   Otarola, Alvaro ^a,b   Kirschbaum, Aida ^a  

^a UNIVERSITY OF CHILE   (Chile)

^b PONTIFICIA UNIVERSIDAD CATÓLICA DE CHILE   (Chile)

Author keywords

[No Author keywords available]

Indexed keywords

DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; PLACEBO; SPIRONOLACTONE;

EPIDEMIOLOGICAL PHENOMENA;

CARDIOVASCULAR DISEASE; CHRONIC DISEASE; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; EVIDENCE BASED MEDICINE; HEART FAILURE; HOSPITALIZATION; HUMAN; HYPERKALEMIA; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MORTALITY; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; REVIEW; TREATMENT OUTCOME;

ALDOSTERONE ANTAGONISTS; EPIDEMIOLOGIC METHODS; HEART FAILURE, CONGESTIVE; LOGIC; PHILOSOPHY, MEDICAL; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; SPIRONOLACTONE;

EID: 27344441994     PISSN: 0143005X     EISSN: None     Source Type: Journal    
DOI: 10.1136/jech.2004.031633     Document Type: Review

References (68)

1. Buck C. Popper's philosophy for epidemiologist's. Int J Epidemiol 1975;4:159-68.
2. MaClure M. Popperian refutation in epidemiology. Am J Epidemiol 1985;121:343-50.
3. Weed D. On the logic of causal inference. Am J Epidemiol 1986;123:965-79.
4. Senn SJ. Falsificationism and the clinical trials. Staf Med 1991;10:1679-92.
5. Renton A. Epidemiology and causation: a realist view. J Epidemiol Community Health 1994;48:79-85.
6. Poole C. Induction does not exist in epidemiology, either. In: Rothman KJ, ed. Causal inference. Chestnut Hill, MA: ERI, 1988.
7. Banegas JR, Rodriguez F, Del Rey Calero J. Popper and the problem of induction in epidemiology. Rev Esp Salud Publica 2000;74:327-39.
8. Jacobsen M. Against popperized epidemiology. Int J Epidemiol 1976;5:9-11.
9. Karhausen L. The poverty of popperian epidemiology. Int J Epidemiol 1995;24:869-74.
10. Pearce NE. Crawford-Brown DJ. Critical discussion in epidemiology: problems with the Popperian approach. J Clin Epidemiol 1989;42:177-84.
11. Cole SR. Atheoretical science. A response to the poverty of Popperian epidemiology. Int J Epidemiol 1996;25:899-900.
12. Greenland S. Induction versus Popper: substance versus semantics. Int J Epidemiol 1998;27:543-8.
13. Susser M. What is a cause and how do we know one? A grammar for pragmatic epidemiology. Am J Epidemiol 1991;133:635-48.
14. Rothman KJ. Epidemiology. An introduction. New York: Oxford University Press, 2002.
15. Goodman SN. Toward evidence-based medical statistics. 1: The P value fallacy. Ann Intern Med 1999;130:995-1004.
16. Greenland S. Probability logic and probabilistic induction. Epidemiology 1998;9:322-32.
17. Poole C. Positivized epidemiology and the model of sufficient and component causes. Int J Epidemiol 2001;30:707-9.
18. Weed D. Theory and practice in epidemiology. Ann NY Acad Sci 2001;954:52-62.
19. Juurlink DN, Mamdani M, Pharm D, et al. Rates of hyperkalemia after publication of the randomized aldactone evaluation study. N Engl J Med 2004;351:543-51.
20. Pitt B, Zannad F, Remme WJ, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med 1999;341:709-17.
21. Shahar E. A Popperian perspective of the term 'evidence-based medicine'. J Eval Clin Pract 1997;3:109-16.
22. Suppe F. The structure of scientific theories. Urbana, IL: University of Illinois Press, 1977.
23. Popper KR. The logic of scientific discovery. London: Hutchinson, 1997.
24. Popper KR. Conjectures and refutations: the growth of scientific knowledge. London: Routledge, 1992.
25. Hume D. An inquiry concerning human understanding. Oxford: Oxford University Press, 1974.
26. Popper KR. The poverty of historicism. London: Routledge, 1961.
27. Popper KR. Replies to my critics. In: Schilpp PA, ed. The philosophy of Karl Popper. Illinois: Open Court, 1974.
28. Maclure M. Karl Popper and his unending quest: an epidemiologic interpretation. Epidemiology 1995;6:331-4.
29. Haynes RB, Devereaux PJ, Guyatt GH. Clinical expertise in the area of evidence- based medicine and patient choice. Evid Based Med 2002;7:36-8.
30. Sackett DL, Richardson WS, Rosemberg W, et al. Evidence-based medicine: how to practice and teach EBM. Edinburgh: Churchill Livingstone, 2000.
31. Guyatt GH, Sackett DL, Cook DJ, et al. for the Evidence Based Medicine Working Group. How to use an article about therapy or prevention. JAMA 1993;270:2598-601.
32. Sehon SR, Stanley DE. A philosophical analysis of evidence-based medicine debate. BMC Health Serv Res 2003;3:14.
33. Cook DJ, Mulrow CD, Haynes RB. Systematic reviews: synthesis of best evidence for clinical decisions. Ann Intern Med 1997;126:376-80.
34. Tonelli MR. In defense of expert opinion. Acad Med 1999;74:1187-92.
35. Charlton BG. Fundamental deficiencies in the megatrial methodology. Curr Control Trials Cardiovasc Med 2001;2:2-7.
36. Ghali WA, Cornuz J. Early uptake of research finding after fast-track publication. Lancet 2000;355:579-80.
37. Benson K, Hartz AJ. A comparison of observational studies and randomized controlled trials. N Engl J Med 2000;342:1878-86.
38. Cohen AM, Stavri PZ, Hersh WR. A categorization and analysis of the criticisms of Evidence-Based Medicine. Int J Med Inform 2004;73:35-43.
39. MaClure M. Taxonomic axes of epidemiology study designs: a refutationist perspective. J Clin Epidemiol 1991;44:1045-53.
40. Naylor CD. Grey zones of clinical practice: some limits to evidence based medicine. Lancet 1995;345:840-2.
41. Kulbertus H. Study of the month. The RALES study (randomized aldactone evaluation study). Rev Med Liege 1999;54:770-2.
42. Majumdar SR, McAlister FA, Soumerai S. Synergy between publication and promotion: comparing adoption of new evidence in Canada and the United States. Am J Med 2003;115:467-72.
43. Bozkurt B, Agoston I, Knowlton A. Complications of inappropriate use of spironolactone in heart failure: when an old medicine spirals out of new guidelines. J Am Coll Cardiol 2003;41:211-14.
44. Masoudi FA, Havranek EP, Wolfe P, et al. Most hospitalized older persons do not meet the enrolment criteria for clinical trials in heart failure. Am Heart J 2003;146:250-7.
45. Tang WH, Francis GS. Spironolactone in chronic heart failure: all's well that ends well. J Am Coll Cardiol 2003;41:215-16.
46. MacMurray J, O'Meara E. Treatment of heart failure with spironolactone. Trial and tribulations. N Engl J Med 2004;351:526-8.
47. Goldfarb DS. Hyperkalemia after publication of RALES. N Engl J Med 2004;351:2448-50.
48. Antiseri D. Philosophers, physicists and physicians in defense of the unity of the scientific method. Clin Ter 1998;149:429-33.
49. Lakatos I. The methodology of scientific research programmes. London: Cambridge University Press, 1978.
50. Miller D. Critical rationalism: a restatement and defense. Chicago: Open Court, 1994.
51. Watkins J. Popperian ideas on progress and rationality in science. The Critical Rationalist. 1997;2:1-11. (http://www.eeng.dcu.ie/~tkpw/tcr/volume-02/ number-02/v02n02.pdf).
52. Pearce N. The ecological fallacy strikes backs. J Epidemiol Community Health 2000;54:326-7.
53. Salmon W. The pragmatic justification of induction. In: Swinburne R, ed. The justification of induction. Oxford: Oxford University Press, 1974.
54. Maclure M. On the logic and practice of epidemiology. Am J Epidemiol 1987;126:554.
55. Weed D. An epidemiological application of Popper's method. J Epidemiol Community Health 1985;39:277-85.
56. Maclure M. Multivariate refutation of aetiological hypotheses in non-experimental epidemiology. Int J Epidemiol 1990;19:782-7.
57. Maclure M. Demonstration of deductive meta-analysis: ethanol intake and risk of myocardial infarction. Epidemiol Rev 1993;15:328-51.
58. Maclure M. Inventing the AIDS virus hypothesis: an illustration of scientific vs unscientific induction. Epidemiology 1998;9:467-473.
59. Malavasi A, Realdi G. Logical structure of the problem oriented clinical record. A combined Popper-Bayes approach. Ann Ital Med Int 2002;17:21-30.
60. Boissel JP. Note on the epistemology of clinical pharmacology: comparison with the approach of Karl Popper. Therapie 1999;54:67-73.
61. Holmberg L, Baum M, Adami HO. On the scientific inference from clinical trials. J Eval Clin Pract 1999;5:157-62.
62. de Dombal FT. Epidemiology of Crohn's disease of the colon. Ann Gastroenterol Hepatol (Paris) 1985;21:191-200.
63. Ayres JR. The problem of true knowledge in epidemiology. Rev Saude Publica 1992;26:206-14.
64. Havlicek J. Popper's critical rationalism and the biomedical sciences. Cas Lek Cesk 1993;132:641-4.
65. Hogel J, Gaus W. The procedure of new drug application and the philosophy of critical rationalism or the limits of quality assurance with good clinical practice. Control Clin Trials 1999;20:511-18.
66. Allmark P. Popper and nursing theory. Nurs Philos 2003;4:4-16.
67. Hyams KC. The investigation or chronic fatigue syndrome: a case-study of the limitations of inductive inferences and non-falsifiable hypotheses in medical research. Med Hypotheses 2003;60:760-6.
68. Rothwell PM. External validity of randomised controlled trials: "To whom do the results of this trial apply?". Lancet 2005;365:82-93.