StATS: Classic references in evidence based medicine (May 16, 2007)

A couple of weeks ago, a regular correspondent (PG) on the Evidence Based Health email discussion group asked about what were the essential readings in Evidence Based Medicine (EBM). These are articles beyond simple tutorials that are aimed at those who want more specifics about EBM. The articles that this person suggested are quite good.

  1. A comparison of results of meta-analyses of randomized control trials and recommendations of clinical experts. Treatments for myocardial infarction. E. M. Antman, J. Lau, B. Kupelnick, F. Mosteller, T. C. Chalmers. Jama 1992: 268(2); 240-8.
  2. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. An-Wen Chan, Asbjorn Hrobjartsson, Mette T Haahr, Peter C Gotzsche, Douglas G Altman. JAMA 2004: 291(20); 2457-65. [Medline] [Abstract] [Full text] [PDF]
  3. What is the evidence that postgraduate teaching in evidence based medicine changes anything? A systematic review. A. Coomarasamy, K. S. Khan. Bmj 2004: 329(7473); 1017. [Medline] [Abstract] [Full text] [PDF]
  4. When are randomised trials unnecessary? Picking signal from noise. P. Glasziou, I. Chalmers, M. Rawlins, P. McCulloch. Bmj 2007: 334(7589); 349-51. [Medline] [Abstract]
  5. Practitioners of evidence based care. Not all clinicians need to appraise evidence from scratch but all need some skills. G. H. Guyatt, M. O. Meade, R. Z. Jaeschke, D. J. Cook, R. B. Haynes. Bmj 2000: 320(7240); 954-5. [Medline] [Full text] [PDF]
  6. Of studies, syntheses, synopses, summaries, and systems: the "5S" evolution of information services for evidence-based healthcare decisions. R. B. Haynes. Evid Based Med 2006: 11(6); 162-4. [Medline] [Abstract]
  7. The GATE frame: critical appraisal with pictures. R. Jackson, S. Ameratunga, J. Broad, J. Connor, A. Lethaby, G. Robb, S. Wells, P. Glasziou, C. Heneghan. Evid Based Med 2006: 11(2); 35-8. [Medline] [Abstract] [Full text] [PDF]
  8. The medical review article revisited: has the science improved? F. A. McAlister, H. D. Clark, C. van Walraven, S. E. Straus, F. M. Lawson, D. Moher, C. D. Mulrow. Ann Intern Med 1999: 131(12); 947-51. [Medline] [PDF]
  9. What do evidence-based secondary journals tell us about the publication of clinically important articles in primary healthcare journals? K. A. McKibbon, N. L. Wilczynski, R. B. Haynes. BMC Med 2004: 2; 33. [Medline] [Abstract] [Full text] [PDF]
  10. Finding and applying evidence during clinical rounds: the "evidence cart". D. L. Sackett, S. E. Straus. Jama 1998: 280(15); 1336-8. [Medline] [Abstract] [Full text] [PDF]
  11. Empirical evidence of bias dimensions of methodological quality associated with estimates of treatment effects in controlled trials. Kenneth F Schulz, I Chalmers, RJ Hayes, DG Altman. JAMA 1995: 273(5); 408-12. [Medline]
  12. Teaching evidence-based medicine skills can change practice in a community hospital. S. E. Straus, C. Ball, N. Balcombe, J. Sheldon, F. A. McAlister. J Gen Intern Med 2005: 20(4); 340-3. [Medline] [Abstract] [Full text] [PDF]
  13. Evidence-based medicine: a commentary on common criticisms. S. E. Straus, F. A. McAlister. Cmaj 2000: 163(7); 837-41. [Medline] [Abstract] [Full text] [PDF]

Here are some additional articles that may be helpful. They are organized in a variety of topics.

Blinding

  1. "Double blind, you are the weakest link- good-bye!" Devereaux PJ, Bhandari M, Montori VM, Manns BJ, Ghali WA, Guyatt GH. ACP Journal Club 2002: 136; A11-A12.
  2. Blinding in randomised trials: hiding who got what. Schulz KF, Grimes D. Lancet 2002: 359(9307); 696-700. [Medline]
  3. Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology. Schulz KF, Grimes DA, Altman DG, Hayes RJ. BMJ 1996: 312(7033); 742-744. [Medline] [Abstract] [Full text]

Challenges to the research hierarchy.

  1. A comparison of observational studies and randomized, controlled trials. K. Benson, A. J. Hartz. New England Journal of Medicine 2000: 342(25); 1878-86. [Medline]
  2. Observational Versus Experimental Studies: What's the Evidence for a Hierarchy? J. Concato. NeuroRx 2004: 1(3); 341-347. [Medline] [Abstract] [Full text] [PDF]
  3. Why we need observational studies to evaluate the effectiveness of health care. N. Black. British Medical Journal 1996: 312(7040); 1215-8. [Medline] [Full text]
  4. Any casualties in the clash of randomised and observational evidence? J. P. Ioannidis, A. B. Haidich, J. Lau. British Medical Journal 2001: 322(7291); 879-80. [Medline] [Full text] [PDF]
  5. Acting on imperfect evidence: How much regret are we ready to accept? Djulbegovic B, Frohlich A, Bennett CL. J Clin Oncol 2005: 23(28); 6822-5. [Medline] [Full text] [PDF]

Clinical importance

  1. Measurement of fatigue. determining minimally important clinical differences. Schwartz AL, Meek PM, Nail LM, Fargo J, Lundquist M, Donofrio M, Grainger M, Throckmorton T, Mateo M. J Clin Epidemiol 2002: 55(3); 239-44. [Medline]
  2. Is it clinically significant? Erill S. Lancet 2002: 359(9318); 1708.
  3. Clinically significant changes in pain along the visual analog scale. Bird SB, Dickson EW. Ann Emerg Med 2001: 38(6); 639-43. [Medline]
  4. The visual analog scale for pain: clinical significance in postoperative patients. Bodian CA, Freedman G, Hossain S, Eisenkraft JB, Beilin Y. Anesthesiology 2001: 95; 1356-61. [Medline]
  5. How well is the clinical importance of study results reported? An assessment of randomized controlled trials. Chan KB, Man-Son-Hing M, Molnar FJ, Laupacis A. Cmaj 2001: 165(9); 1197-202. [Abstract] [Full text] [PDF]

Criticisms of evidence based medicine

  1. A philosophical analysis of the evidence-based medicine debate. SR Sehon, DE Stanley. BMC Health Serv Res 2003: 3(1); 14. [Medline] [Abstract] [Full text] [PDF]
  2. Deconstructing the evidence-based discourse in health sciences: truth, power and fascism. Dave Holmes, Stuart J. Murray, Amelie Perron, Genevieve Rail. International Journal of Evidence-Based Healthcare 2006: 4(3); 180. [Abstract] [Full text] [PDF]
  3. Problems in the "evidence" of "evidence-based medicine". A. R. Feinstein, R. I. Horwitz. Am J Med 1997: 103(6); 529-35. [Medline]
  4. The double-blind, randomized, placebo-controlled trial: gold standard or golden calf? T. J. Kaptchuk. J Clin Epidemiol 2001: 54(6); 541-9. [Medline]
  5. The growth of a lie and the end of "conventional" medicine. Mastrangelo D, Lore C. Med Sci Monit 2005: 11(12); SR27-31. [Medline] [Abstract] [PDF]

Excessive exclusions

  1. Including elderly people in clinical trials. Avorn J. BMJ 1997: 315(7115); 1033-1034. [Full text]
  2. Clinical trials should be designed to include elderly people. Bene J, Liston R. BMJ 1998: 316(7148); 1905a-. [Full text]
  3. Exclusion of elderly people from clinical research: a descriptive study of published reports. Bugeja G, Kumar A, Banerjee AK. British Medical Journal 1997: 315(7115); 1059. [Full text]
  4. The exclusion of the elderly and women from clinical trials in acute myocardial infarction. Gurwitz JH, Col NF, Avorn J. Jama 1992: 268(11); 1417-22. [Medline]
  5. Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute. Harris DJ, Douglas PS. N Engl J Med 2000: 343(7); 475-80. [Medline]
  6. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. Lee PY, Alexander KP, Hammill BG, Pasquali SK, Peterson ED. Jama 2001: 286(6); 708-13. [Medline] [Abstract] [Full text] [PDF]
  7. Why Are There So Few Papers on Elderly Patients in Thorax? Mamun M. Thorax 1998: 53; 233. [Full text]
  8. The limited spectrum of patients studied in exercise test research. Analyzing the tip of the iceberg. Philbrick JT, Horwitz RI, Feinstein AR, Langou RA, Chandler JP. Jama 1982: 248(19); 2467-70. [Medline]
  9. Unjustified exclusion of elderly people from studies submitted to research ethics committee for approval: descriptive study. Bayer A, Tadd W. British Medical Journal 2000: 321(7267); 992-3. [Medline] [Full text] [PDF]
  10. Estimation of gender bias in clinical trials. Meinert CL, Gilpin AK. Stat Med 2001: 20(8); 1153-64. [Medline] [Abstract]
  11. Gender bias in clinical trials: do double standards still apply? Ramasubbu K, Gurm H, Litaker D. J Womens Health Gend Based Med 2001: 10(8); 757-64. [Medline] [Abstract]
  12. The fallacy of enrolling only high-risk subjects in cancer prevention trials: is there a "free lunch"? S. G. Baker, B. S. Kramer, D. Corle. BMC Med Res Methodol 2004: 4(1); 24. [Medline] [Abstract] [Full text] [PDF]

How good is the quality of evidence in the published literature?

  1. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. A. C. Plint, D. Moher, A. Morrison, K. Schulz, D. G. Altman, C. Hill, I. Gaboury. Med J Aust 2006: 185(5); 263-267. [Medline]
  2. Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals. C. Hewitt, S. Hahn, D. J. Torgerson, J. Watson, J. M. Bland. Bmj 2005; [Medline] [Full text] [PDF]
  3. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. J. Pildal, A. W. Chan, A. Hrobjartsson, E. Forfang, D. G. Altman, P. C. Gotzsche. Bmj 2005; [Medline] [Abstract] [Full text] [PDF]
  4. Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials. Fergusson D, Glass KC, Waring D, Shapiro S. Bmj 2004: 328(7437); 432. [Medline] [Abstract] [Full text] [PDF]

Incorporation of qualitative evidence in a systematic review

  1. Qualitative research in systematic reviews has established a place for itself. M. Dixon-Woods, R. Fitzpatrick. British Medical Journal 2001: 323(7316); 765-6. [Medline] [Full text] [PDF]
  2. Qualitative research and evidence based medicine. J. Green, N. Britten. British Medical Journal 1998: 316(7139); 1230-2. [Medline] [Full text] [PDF]
  3. Ethnography and health care. J Savage. BMJ 2000: 321(7273); 1400-2. [Medline] [Full text] [PDF]

Individualizing/particularizing.

  1. Applying the results of trials and systematic reviews to individual patients. P. Glasziou, G. H. Guyatt, A. L. Dans, L. F. Dans, S. Straus, D. L. Sackett. ACP Journal Club 1998: 129(3); A15-6. [Medline]
  2. An evidence based approach to individualising treatment. P. P. Glasziou, L. M. Irwig. British Medical Journal 1995: 311(7016); 1356-9. [Medline] [Full text]

Influence of drug companies on research

  1. Funding source, trial outcome and reporting quality: are they related? Results of a pilot study. Tammy Clifford, Nicholas Barrowman, David Moher. BMC Health Services Research 2002: 2(1); 18. [Medline] [Abstract] [Full text] [PDF]
  2. Sponsorship, Authorship and Accountability. F Davidoff, CD DeAngelis, JM Drazen, J Hoey, L Hojgaard, R Horton, S Kotzin, MG Nicholls, M Nylenna. MJA 2001: 175(6); 294-296. [Medline] [Full text]
  3. Source of funding and outcome of clinical trials. R. A. Davidson. J Gen Intern Med 1986: 1(3); 155-8. [Medline]
  4. Evaluation of conflict of interest in economic analyses of new drugs used in oncology. M Friedberg, B Saffran, TJ Stinson. JAMA 1999: 282(15); 1453-1457. [Medline] [Abstract] [Full text] [PDF]
  5. Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ. LL Kjaergard, B Als-Nieslen. BMJ 2002: 325; 249 - 252. [Medline] [Abstract] [Full text] [PDF]

Intention to treat analysis

  1. What is meant by intention to treat analysis? Survey of published randomised controlled trials. Hollis S, Campbell F. British Medical Journal 1999: 319(7211); 670-674. [Medline] [Abstract] [Full text] [PDF]
  2. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. Fergusson D, Aaron SD, Guyatt G, Hebert P. Bmj 2002: 325(7365); 652-4. [Medline] [Full text] [PDF]

Important developments in research design.

  1. Need for expertise based randomised controlled trials. P. J. Devereaux, M. Bhandari, M. Clarke, V. M. Montori, D. J. Cook, S. Yusuf, D. L. Sackett, C. S. Cina, S. D. Walter, B. Haynes, H. J. Schunemann, G. R. Norman, G. H. Guyatt. Bmj 2005: 330(7482); 88. [Medline] [Full text] [PDF]
  2. The paired availability design for historical controls. S. G. Baker, K. S. Lindeman, B. S. Kramer. BMC Med Res Methodol 2001: 1(1); 9. [Medline] [Abstract] [Full text] [PDF]
  3. The method of minimization for allocation to clinical trials. a review. NW Scott, GC McPherson, CR Ramsay, MK Campbell. Control Clin Trials 2002: 23(6); 662-74. [Medline]
  4. Dynamic balanced randomization for clinical trials. DF Signorini, O Leung, RJ Simes, E Beller, VJ Gebski, T Callaghan. Stat Med 1993: 12(24); 2343-50. [Medline]
  5. Understanding controlled trials: What are pragmatic trials? Martin Roland, David J Torgerson. BMJ 1998: 316(7127); 285-. [Full text]

More sophisticated appraisal of the evidence

  1. Assessing the quality of research. P. Glasziou, J. Vandenbroucke, I. Chalmers. Bmj 2004: 328(7430); 39-41. [Medline] [Full text] [PDF]
  2. A systematic review of the content of critical appraisal tools. P. Katrak, A. E. Bialocerkowski, N. Massy-Westropp, S. Kumar, K. A. Grimmer. BMC Med Res Methodol 2004: 4(1); 22. [Medline] [Abstract] [Full text] [PDF]

More sophisticated searching strategies

  1. Optimal search strategies for retrieving systematic reviews from Medline: analytical survey. V. M. Montori, N. L. Wilczynski, D. Morgan, R. B. Haynes. Bmj 2005: 330(7482); 68. [Medline] [Abstract] [Full text] [PDF]
  2. Optimal search strategies for retrieving scientifically strong studies of treatment from Medline: analytical survey. Haynes RB, McKibbon KA, Wilczynski NL, Walter SD, Werre SR. Bmj 2005: 330(7501); 1179. [Medline] [Abstract] [Full text] [PDF]

Practical issues in implementing EBM

  1. Do short courses in evidence based medicine improve knowledge and skills? Validation of Berlin questionnaire and before and after study of courses in evidence based medicine. L. Fritsche, T. Greenhalgh, Y. Falck-Ytter, H. H. Neumayer, R. Kunz. Bmj 2002: 325(7376); 1338-41. [Medline] [Abstract] [Full text] [PDF]
  2. From best evidence to best practice: effective implementation of change in patients' care. R. Grol, J. Grimshaw. Lancet 2003: 362(9391); 1225-30. [Medline]
  3. Implementing evidence based medicine in general practice: audit and qualitative study of antithrombotic treatment for atrial fibrillation. Alistair Howitt, D Armstrong. British Medical Journal 1999: 318(7194); 1324-1327. [Medline] [Abstract] [Full text] [PDF]
  4. Barriers and bridges to evidence based clinical practice. B. Haynes, A. Haines. British Medical Journal 1998: 317(7153); 273-6. [Medline] [Full text] [PDF]
  5. How much effort is needed to keep up with the literature relevant for primary care? Alper BS, Hand JA, Elliott SG, Kinkade S, Hauan MJ, Onion DK, Sklar BM. J Med Libr Assoc 2004: 92(4); 429-37. [Medline] [Abstract] [Full text] [PDF]
  6. Incorporating quality of evidence into decision analytic modeling. Braithwaite RS, Roberts MS, Justice AC. Ann Intern Med 2007: 146(2); 133-41. [Medline] [Abstract]
  7. Methodological and statistical techniques: what do residents really need to know about statistics? Reed JF, 3rd, Salen P, Bagher P. J Med Syst 2003: 27(3); 233-8. [Medline]
  8. Alternative medicine: a "mirror image" for scientific reasoning in conventional medicine. Vandenbroucke J, de Craen A. Ann Intern Med 2001: 135(7); 507-13. [Abstract] [PDF]

Publication bias

  1. Review of randomised controlled trials of traditional chinese medicine. Jin-Ling Tang, SY Zhan, E Ernst. BMJ 1999: 319(7203); 160-61. [Medline] [Full text] [PDF]

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