Randomized trials, observational registries, and the foundations of evidence-based medicine

American Journal of Cardiology

Volumn 113, Issue 8, 2014, Pages 1436-1441

  Diamond, George A ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BAYES THEOREM; CLINICAL EFFECTIVENESS; EVIDENCE BASED MEDICINE; HIGH RISK PATIENT; HUMAN; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROBABILITY; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK FACTOR; RISK REDUCTION; SAMPLE SIZE;

CARDIOVASCULAR DISEASES; EVIDENCE-BASED MEDICINE; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES;

EID: 84897448640     PISSN: 00029149     EISSN: 18791913     Source Type: Journal    
DOI: 10.1016/j.amjcard.2014.01.420     Document Type: Editorial

References (37)

1. 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 JAMA 290 2003 1624 1632
2. R. Califf Simple principles of clinical trials remain powerful JAMA 293 2005 489 491
3. D. Schwartz, and J. Lellouch Explanatory and pragmatic attitudes in therapeutical trials J Chron Dis 20 1967 637 648
4. K. Benson, and A.J. Hartz A comparison of observational studies and randomized, controlled trials N Engl J Med 342 2000 1878 1886
5. J. Concato, N. Shah, and R.I. Horwitz Randomized, controlled trials, observational studies, and the hierarchy of research designs N Engl J Med 342 2000 1887 1892
6. S.J. Pocock, and D.R. Elbourne Randomized trials or observational tribulations N Engl J Med 342 2000 1907 1909
7. A.J. Kirtane, A. Gupta, S. Iyengar, J.W. Moses, M.B. Leon, R. Applegate, B. Brodie, E. Hannan, K. Harjai, L.O. Jensen, S.J. Park, R. Perry, M. Racz, F. Saia, J.V. Tu, R. Waksman, A.J. Lansky, R. Mehran, and G.W. Stone Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies Circulation 119 2009 3198 3206
8. M.A. Hernan, S. Hernandez-Diaz, and J.M. Robins Randomized trials analyzed as observational studies Ann Intern Med 159 2013 560 562
9. M.S. Lauer, and R.B. D'Agostino The randomized registry trial - the next disruptive technology in clinical research? N Engl J Med 369 2013 1579 1581
10. S. Sen, J.E. Davies, I.S. Malik, R.A. Foale, G.W. Mikhail, N. Hadjiloizou, A. Hughes, J. Mayet, and D.P. Francis Why does primary angioplasty not work in registries? Quantifying the susceptibility of real-world comparative effectiveness data to allocation bias Circ Cardiovasc Qual Outcomes 5 2012 759 766
11. J.P.A. Ioannidis Why most published research findings are false PLos Med 2 2005 696 701
12. W.J. Sutherland, D. Spiegelhalter, and M. Burgman Twenty tips for interpreting scientific claims Nature 503 2013 335 337
13. R.A. Fisher The Design of Experiments (4th ed.) 1947 Oliver and Boyd Edinburgh
14. C. Howson, and P. Urbach Scientific Reasoning: The Bayesian Approach 1989 Open Court La Salle, Illinois
15. E.T. Jaynes Probability Theory: The Logic of Science 2003 Cambridge University Press Cambridge
16. P.M. Ridker, E. Danielson, F.A. Fonseca, J. Genest, A.M. Gotto Jr., J.J. Kastelein, W. Koenig, P. Libby, A.J. Lorenzatti, J.G. MacFadyen, B.G. Nordestgaard, J. Shepherd, J.T. Willerson, and R.J. Glynn Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein N Engl J Med 359 2008 2195 2207
17. W.E. Boden, R.A. O'Rourke, K.K. Teo, P.M. Hartigan, D.J. Maron, W.J. Kostuk, M. Knudtson, M. Dada, P. Casperson, C.L. Harris, B.R. Chaitman, L. Shaw, G. Gosselin, S. Nawaz, L.M. Title, G. Gau, A.S. Blaustein, D.C. Booth, E.R. Bates, J.A. Spertus, D.S. Berman, G.B. Mancini, W.S. Weintraub COURAGE Trial Research Group Optimal medical therapy with or without PCI for stable coronary disease N Engl J Med 356 2007 1503 1516
18. P.J. Davis, and H. Hersh The Mathematical Experience 1981 Houghton Mifflin Boston 167
19. J. Bertrand Calcul des Probabilites 1907 Gauthier-Villars Paris 4 5
20. A.R. Feinstein Clinical Epidemiology. The Architecture of Clinical Research 1985 W. B. Saunders Philadelphia
21. M.S. Lauer Risk stratification for sudden cardiac death: a puzzle beyond p values J Am Coll Cardiol 56 2010 1484 1485
22. F.I. Marcus, D.A. Bluemke, H. Calkins, and V.L. Sorrell Cardiac magnetic resonance for risk stratification of patients with frequent premature ventricular contractions J Am Coll Cardiol 57 2011 1636 1637
23. G.A. Diamond, and S. Kaul By desperate appliance relieved? On the clinical relevance of risk stratification to therapeutic decision-making Am J Cardiol 109 2012 919 923
24. A. Tversky, and D. Kahneman Belief in the law of small numbers Psychol Bull 2 1971 105 110
25. G.A. Diamond Reverend Bayes' silent majority. An alternative factor affecting sensitivity and specificity of exercise electrocardiography Am J Cardiol 57 1986 1175 1180
26. M.R. Patel, E.D. Peterson, D. Dai, J.M. Brennan, R.F. Redberg, H.V. Anderson, R.G. Brindis, and P.S. Douglas Low diagnostic yield of elective coronary angiography N Engl J Med 362 2010 886 895
27. G.A. Diamond, and S. Kaul Low diagnostic yield of elective coronary angiography N Engl J Med 363 2010 93
28. S. Kaul, and G.A. Diamond Trial and error: how to avoid commonly encountered limitations of published clinical trials J Am Coll Cardiol 55 2010 415 427
29. G.A. Diamond, and S. Kaul Bayesian classification of clinical practice guidelines Arch Intern Med 169 2009 1431 1435
30. J.P.T. Higgens, and D.J. Spiegelhalter Being sceptical about meta-analysis: a Bayesian perspective on magnesium trials in myocardial infarction Int J Epidemiol 31 2002 96 104
31. J.S. Ross, and H.M. Krumholz Ushering in a new era of open science through data sharing JAMA 309 2013 1355 1356
32. R.M. Califf, J. McCall, and R.A. Harrington Assessing research results in the medical literature: trust but verify JAMA Intern Med 173 2013 1053 1055
33. G.A. Diamond, and S. Kaul Forbidden fruit. On the analysis of total events in randomized clinical trials Am J Cardiol 111 2013 1530 1536
34. G.A. Diamond, and S. Kaul What the tortoise said to Achilles Am J Cardiol 106 2010 593 595
35. National Academy of Sciences. Institute of Medicine Report on Clinical Practice Guidelines We Can Trust (accessed on September 22, 2013, at http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx).
36. G.H. Gibbons, S.B. Shurin, G.A. Mensah, and M.S. Lauer Refocusing the agenda on cardiovascular guidelines: an announcement from the National Heart, Lung, and Blood Institute Circulation 2013 10.1161/circulationaha.113.004587
37. G.H. Gibbons, J.G. Harold, M. Jessup, R.M. Robertson, and W.J. Oetgen Next steps in developing clinical practice guidelines for prevention J Am Coll Cardiol 2013 10.1016/j.jacc.2013.08.004