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Evidence-Based Practice
Lecture c
This material (Comp2_Unit5c) was developed by Oregon Health and Science University, funded by the Department of Health
and Human Services, Office of the National Coordinator for Health Information Technology under Award Number
IU24OC000015.
Evidence-Based Practice
Learning Objectives
Define the key tenets of evidence-based medicine (EBM) and its
role in the culture of health care (Lectures a, b)
Construct answerable clinical questions and critically appraise
evidence answering them (Lecture b)
Apply EBM for intervention studies, including the phrasing of
answerable questions, finding evidence to answer them, and
applying them to given clinical situations (Lecture c)
Understand EBM applied to the other key clinical questions of
diagnosis, harm, and prognosis (Lectures d, e)
Discuss the benefits and limitations to summarizing evidence
(Lecture f)
Describe how to implement EBM in clinical settings through clinical
practice guidelines and decision analysis (Lecture g)
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Health IT Workforce Curriculum
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The Culture of Healthcare
Evidence-Based Practice
Lecture c
Using EBM To Assess Questions
About Interventions
Questions concerning benefit of a clinical
intervention to treat or prevent disease
Can include drug therapy, diet therapy,
surgery, alternative medicine, etc.
Best evidence comes from a randomized
controlled trial (RCT) or meta-analysis of
RCTs
Patients similar in all regards with
exception of intervention applied
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Health IT Workforce Curriculum
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The Culture of Healthcare
Evidence-Based Practice
Lecture c
Why Are RCTs The Best Evidence
For Interventions?
Reduction in bias
Vitamin C to prevent the common cold (Douglas,
Chalker, & Treacy, 2000)
Womens Health Initiative (Anonymous, 2002)
Emphasis on clinical end-points and patient-
oriented outcomes
Cardiac Arrhythmia Suppression Trial (Epstein, et al.,
1993)
New treatments are not necessarily better
In radiation oncology, trials of new treatments are as
likely as not to be successful (Soares, et al., 2005)
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Health IT Workforce Curriculum
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The Culture of Healthcare
Evidence-Based Practice
Lecture c
Other Issues For RCTs
Quality of study inversely related to magnitude of
treatment effect (Moher, et al., 1998)
Lower-quality (e.g., non-RCT) studies more
likely to be later overturned (Ioannidis, 2005)
But well-designed observational studies may be
just as good (Benson & Hartz, 2000)
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Health IT Workforce Curriculum
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The Culture of Healthcare
Evidence-Based Practice
Lecture c
History Of RCTs
James Lind, British naval doctor and
surgeon (1717-1794) demonstrated that
lemons and oranges improved health of
sailors with scurvy over those who did not
receive them (Lindemann, 1999)
First true RCT performed in UK in 1940s,
demonstrating superiority of streptomycin
over placebo for tuberculosis (Anonymous,
1948)
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The Culture of Healthcare
Evidence-Based Practice
Lecture c
How Do We Critically Appraise An
Intervention Study?
Remember the questions to be asked of
any study
Are the results valid?
What are the results?
Can the results be applied to patient
care?
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The Culture of Healthcare
Evidence-Based Practice
Lecture c
Questions To Ask About A Study
On Intervention
Are the results valid?
Did experimental and control groups begin the
study with a similar prognosis?
Were patients randomized?
Was randomization concealed (blinded or
masked)?
Were patients analyzed in the groups to which they
were randomized?
Were patients in treatment and control groups
similar with respect to known prognosis?
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Evidence-Based Practice
Lecture c
A Study On An Intervention
(continued)
Are the results valid? (continued)
Did experimental and control groups
retain a similar prognosis after the study
started?
Were patients aware of group allocation?
Were clinicians aware of group allocation?
Were assessors aware of group allocation?
Was follow-up complete?
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The Culture of Healthcare
Evidence-Based Practice
Lecture c
A Study On An Intervention
(continued)
What are the results?
How large was the treatment effect?
What was the relative risk reduction?
What was the absolute risk reduction?
How precise was the estimate of treatment effect?
Were the confidence intervals or p-values stated?
Can the results be applied to patient care?
Were the study patients similar to my patient?
Were all clinically important outcomes considered?
Are the likely treatment benefits worth the potential
harm and costs?
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Health IT Workforce Curriculum
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The Culture of Healthcare
Evidence-Based Practice
Lecture c
Examples Of RCTs
Womens Health Initiative (WHI)
Previous non-RCT studies suggested women who
used postmenopausal hormone replacement therapy
(HRT) at any time had lower mortality overall and
from heart disease
In general, RCTs and observational studies had
yielded conflicting results
WHI study was RCT that settled the issue
(Anonymous, 2002; Lowe, 2002), showing no
benefit and possible harm from increased risk
of breast cancer and cardiovascular disease
Observational studies found to be confounded by
non-similarities between users and non-users
(Humphrey, Chan, & Sox, 2002)
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Health IT Workforce Curriculum
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The Culture of Healthcare
Evidence-Based Practice
Lecture c
Examples of RCTs
(continued)
Eradication of H. pylori to prevent
recurrence of gastric cancer (Fukase, et
al., 2008)
H. pylori is bacteria associated with peptic
ulcer disease
When eradicated with antibiotics in
patients with cancer of stomach,
recurrence of cancer is less likely to occur
Relative risk reduction = 66%
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The Culture of Healthcare
Evidence-Based Practice
Lecture c
Evidence-Based Practice
Summary Lecture c
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The Culture of Healthcare
Evidence-Based Practice
Lecture c
Most common type of question in EBM is about
intervention, sometimes called treatment or
therapy
Best evidence for intervention is the RCT, or a
systematic review of multiple RCTs on a given
topic
Evidence-Based Practice
References Lecture c
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Evidence-Based Practice
Lecture c
References
Anonymous. (1948). Streptomycin treatment of pulmonary tuberculosis. British Medical Journal, 30, 769-782.
Anonymous. (2002). Risks and benefits of estrogen plus progestin in healthy postmenopausal women - principal results
from the Women's Health Initiative randomized controlled trial. Journal of the American Medical Association, 288,
321-333.
Benson, K., & Hartz, A. (2000). A comparison of observational studies and randomized, controlled trials. New England
Journal of Medicine, 342, 1878-1886.
Douglas, R., Chalker, E., & Treacy, B. (2000). Vitamin C for preventing and treating the common cold. Cochrane
Database of Systematic Reviews, 2, CD000980.
Epstein, A., Hallstrom, A., Rogers, W., Liebson, P., Seals, A., Anderson, J., . . . Wyse, D. (1993). Mortality following
ventricular arrhythmia suppression by encainide, flecainide, and moricizine after myocardial infarction. The original
design concept of the Cardiac Arrhythmia Suppression Trial (CAST). Journal of the American Medical Association,
270, 2451-2455.
Fukase, K., Kato, M., Kikuchi, S., Inoue, K., Uemura, N., Okamoto, S., . . . Asaka, M. (2008). Effect of eradication of
Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric
cancer: an open-label, randomised controlled trial. Lancet, 372, 392-397.
Humphrey, L., Chan, B., & Sox, H. (2002). Postmenopausal hormone replacement therapy and the primary prevention
of cardiovascular disease. Annals of Internal Medicine, 137, 273-284.
Ioannidis, J. (2005). Contradicted and initially stronger effects in highly cited clinical research. Journal of the American
Medical Association, 294, 218-228.
Lindemann, M. (1999). Medicine and Society in Early Modern Europe. Cambridge, England: Cambridge University
Press.
Evidence-Based Practice
References Lecture c
(continued)
Lowe, J. (2002). Estrogen plus progestin increased coronary heart disease and breast cancer events in
postmenopausal women. ACP Journal Club, 137, 41.
Moher, D., Pham, B., Jones, A., Cook, D., Jadad, A., Moher, M., . . . Klassen, T. (1998). Does quality of reports of
randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet, 352, 609-613.
Soares, H., Kumar, A., Daniels, S., Swann, S., Cantor, A., Hozo, I., . . . Djulbegovic, B. (2005). Evaluation of new
treatments in radiation oncology: are they better than standard treatments? Journal of the American Medical
Association, 293, 970-978.
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Health IT Workforce Curriculum
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The Culture of Healthcare
Evidence-Based Practice
Lecture c