StATS: 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
- A close look at therapeutic touch. Rosa L, Rosa E, Sarner L,
Barrett S. Jama 1998: 279(13); 1005-10.
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
TT practitioners say the therapy is based on a fluid energy field,
which is why a therapist constantly moves hands over the patient.
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
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.
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."
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
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.
- 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:
Issues involving concealed allocation
- Allocation concealment in randomised trials: defending against
deciphering. Schulz KF, Grimes DA. Lancet 2002: 359; 614-618.
- Statistics notes: Concealing treatment allocation in randomised
trials. Altman DG, Schulz KF. British Medical Journal 2001: 323(7310);
- 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.
- Randomised trials, human nature, and reporting guidelines. Schulz
KF. Lancet 1996: 348(9027); 596-8.
- Bias in treatment assignment in controlled clinical trials.
Chalmers TC, Celano P, Sacks HS, Smith H, Jr. N Engl J Med 1983: 309(22);
- 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.
- Amniotomy or oxytocin for induction of labor. Re-analysis of a
randomized controlled trial. Keirse MJ. Acta Obstet Gynecol Scand 1988:
- 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.
- 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.
- 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.
- 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);
- 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.
- Epidemiology faces its limits. Taubes G. Science 1995: 269(5221);
- Issues in Comparisons between Meta-analyses and Large Trials.
Ioannidis J, Cappelleri J, Lau J. Jama 2002: 279(14); 1089-93.
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.
- 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.
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);
- The publication of sponsored symposiums in medical journals. Bero
LA, Galbraith A, Rennie D. N Engl J Med 1992: 327(16); 1135-40.
- Why Review Articles on the Health Effects of Passive Smoking Reach
Different Conclusions. Barnes DE, Bero LA. JAMA 1998: 279(19);
- Editorials and Conflicts of Interest. Angell M, Kassirer JP. N
Engl J Med 1996: 335(14); 1055-1056.
- 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.
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);
- 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.
This page was written by
Steve Simon while working at Children's Mercy Hospital. Although I do not hold the copyright for this material, I am reproducing it here as a service, as it is no longer available on the Children's Mercy Hospital website. Need more
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