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Ten research studies that anyone teaching EBM should be familiar with (January 17, 2005) Category: Teaching resources

When I get a chance, I want to write a paper with a title along the lines of "Ten research studies that anyone teaching EBM should be familiar with". These would be studies that are

  • well known in the research community;
  • actual research studies (as opposed to editorials); and
  • illustrative of important issues in EBM.

One of the studies would be

This is a very simple study that was originally performed as a science fair experiment by a fourth grade student, Emily Rosa. I describe the experiment in an earlier weblog entry.

Interesting is the criticisms of this study, such as the following:

Some proponents now insist that the “intentionality” of the practitioner is essential for TT to work. Healing takes place, in other words, only when the person performing the technique sincerely intends to heal a patient. If that's true, conducting a placebo-controlled study is virtually impossible, which means the only evidence for efficacy will remain largely anecdotal: compelling to advocates but unconvincing to skeptics. www.hippocrates.com/archive/March2000/03departments/03integrative.html

TT practitioners say the therapy is based on a fluid energy field, which is why a therapist constantly moves hands over the patient. www.nurseweek.com/features/98-6/touch.html

Dolores Krieger, co-founder of TT criticized the study. "It's poor in terms of design and methodology." She said that someone other than the designer should have conducted the test, and that the 21 test subjects were too few and unrepresentative. She said that the validity of TT has been established in many doctoral dissertations and "innumerable" clinical studies. Referring to the study, she said "It's a cute idea, but it's not valid. The way her subjects sat is foreign to TT, and our hands are moving, not stationary. You don't just walk into a room and perform--it's a whole process." www.religioustolerance.org/ther_tou2.htm

Proponents of touch therapy argue that Emily's study does not disprove the value of the procedure. Dr. Delores Krieger, an emeritus professor of nursing at New York University, and the developer of touch therapy, thought it was an April Fool's joke when she first heard about the study. She and other practitioners argue that the study means nothing because the technique relies on more than just touch to sense the human energy field. Practitioners also use the senses of intuition and sight. hermes.hhp.ufl.edu/keepingfit/ARTICLE/TOUCH.HTM

It is the JAMA-reported study itself that is less than honest. In her response to JAMA, Cynthia Poznanski Hutchinson, DNSc, RN, CHTP/I, Research Coordinator for Healing Touch International, delineates the study's problems. Among them, that TT involves five factors-and that the ability to sense the client's energy field, the least important of the factors, is the only one JAMA investigated. As Hutchinson writes: "The critical variables of practitioner compassion and holding the intentionality for the highest good of the recipient was not part of the study. In the study setting, no healing was sought. Their method was biased, unnatural and fragmented. The five steps of TT in clinical practice is done as a process and as a whole." www.seniorworld.com/articles/a19980618161408.html

A couple of defenses of the Rosa et al study are also worth reading:

A discussion of the findings of this paper and the criticisms will help illustrate why proponents of alternative medicine will often find themselves at odds with proponents of evidence based medicine.

Here are some of the other articles that I might want to highlight in the top ten list. I will try to describe some of these articles in future weblog entries.

Issues involving placebos:

  • Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. Hrobjartsson A, Gotzsche PC. N Engl J Med 2001: 344(21); 1594-602. [Medline] [Abstract] [Full text] [PDF]
  • A controlled trial of arthroscopic surgery for osteoarthritis of the knee. Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. N Engl J Med 2002: 347(2); 81-8. [Medline]

Issues involving concealed allocation

  • Allocation concealment in randomised trials: defending against deciphering. Schulz KF, Grimes DA. Lancet 2002: 359; 614-618. [Medline] [Abstract]
  • Statistics notes: Concealing treatment allocation in randomised trials. Altman DG, Schulz KF. British Medical Journal 2001: 323(7310); 446-7.
  • Empirical evidence of bias dimensions of methodological quality associated with estimates of treatment effects in controlled trials. Schulz K, Chalmers I, Hayes R, Altman D. JAMA 1995: 273(5); 408-12. [Medline]
  • Randomised trials, human nature, and reporting guidelines. Schulz KF. Lancet 1996: 348(9027); 596-8. [Medline]
  • Bias in treatment assignment in controlled clinical trials. Chalmers TC, Celano P, Sacks HS, Smith H, Jr. N Engl J Med 1983: 309(22); 1358-61. [Medline]
  • Comparing like with like: some historical milestones in the evolution of methods to create unbiased comparison groups in therapeutic experiments. Chalmers I. Int J Epidemiol 2001: 30(5); 1156-64. [Medline]
  • Amniotomy or oxytocin for induction of labor. Re-analysis of a randomized controlled trial. Keirse MJ. Acta Obstet Gynecol Scand 1988: 67(8); 731-5.
  • Subversion of Allocation in a Randomised Controlled Trial. Kennedy A, Grant A. Control Clinical Trials 1997: 18(suppl 3); S77-78.
  • The unpredictability paradox: review of empirical comparisons of randomised and non-randomised clinical trials. Kunz R, Oxman AD. British Medical Journal 1998: 317(7167); 1185-1190. [Medline] [Abstract] [Full text] [PDF]
  • Randomization in the Canadian National Breast Screening Study: a review for evidence of subversion. Bailar JC, 3rd, MacMahon B. Cmaj 1997: 156(2); 193-9. [Medline] [Abstract] [PDF]
  • Assessing Allocation Concealment and Blinding in Randomised Controlled Trials: Why bother? Schulz K. Evid Based Nurs 2001: 4; 4 - 6.

Issues involving the hierarchy of evidence

  • The disappearance of Reye's syndrome--a public health triumph. Monto AS. N Engl J Med 1999: 340(18); 1423-4. [Medline]
  • Randomized Trial of Estrogen Plus Progestin for Secondary Prevention of Coronary Heart Disease in Postmenopausal Women. Hulley S, Grady D, Bush T, Furberg C, Herrington D, Riggs B, Vittinghoff E. JAMA 1998: 280(7); 605-613.
  • Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs. Concato J, Shah N, Horwitz RI. The New England Journal of Medicine 2000: 342(25); 1887-1892. [Medline]
  • Epidemiology faces its limits. Taubes G. Science 1995: 269(5221); 164-9.
  • Issues in Comparisons between Meta-analyses and Large Trials. Ioannidis J, Cappelleri J, Lau J. Jama 2002: 279(14); 1089-93. [Medline]

Issues involving publication bias

  • What contributions do languages other than English make on the results of meta-analysis? Moher D, Pham, Klassen T, Schulz K, Berlin J, Jadad A, Liberati A. Journal of Clinical Epidemiology 2000: 53(9); 964-972.
  • Multiple Publication of reports of Drug Trials. Gotzsche P. Eur J Clin Pharmacol 1989: 36; 429-432. [Medline]
  • The existence of publication bias and risk factors for its occurrence. Dickersin K. Jama 1990: 263(10); 1385-9.
  • Underreporting research is scientific misconduct. Chalmers I. Jama 1990: 263(10); 1405-8. [Medline]

Issues involving conflict of interest

  • Conflict of interest in the debate over calcium-channel antagonists. Stelfox HT, Chua G, O. Rourke K, Detsky AS. N Engl J Med 1998: 338(2); 101-6. [Medline]
  • The publication of sponsored symposiums in medical journals. Bero LA, Galbraith A, Rennie D. N Engl J Med 1992: 327(16); 1135-40. [Medline] [Abstract]
  • Why Review Articles on the Health Effects of Passive Smoking Reach Different Conclusions. Barnes DE, Bero LA. JAMA 1998: 279(19); 1566-1570. [Medline] [Abstract]
  • Editorials and Conflicts of Interest. Angell M, Kassirer JP. N Engl J Med 1996: 335(14); 1055-1056. [Medline] [Full text]
  • Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Jama 2003: 290(7); 921-8. [Medline] [Abstract]

Other interesting studies

  • A Randomized, Controlled Trial of the Effects of Remote, Intercessory Prayer on Outcomes in Patients Admitted to the Coronary Care Unit. Harris WS, Gowda M, Kolb JW, Strychacz CP, Vacek JL, Jones PG, Forker A, O’Keefe JH, McCallister BD. Archives of Internal Medicine 1999: 159(19); 2273-2278. [Medline]
  • Final report on the aspirin component of the ongoing Physicians' Health Study. Physicians' Health Study Research Group. N Engl J Med 1989: 321(3); 129-35. [Medline]

This webpage was written by Steve Simon and was last modified on 07/08/2008.