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The n-of-1 randomized controlled trial: clinical usefulness

Article Abstract:

Randomized trials with control subjects are performed to test the efficacy of drugs used to treat various medical problems. However, there are a number of clinical situations in which decisions on the methods of treatment cannot be based on these studies. One such situation is that of a rare disorder for which there are not enough patients to do a randomized controlled trial. Another case is when certain patients do not meet the criteria of the trial, and extrapolation of the general results to them may not be appropriate. A method known as single case or single subject research, also called n=1, or n-of-1 randomized controlled trial, has been devised for examining the effects of medical intervention in individual patients with a broad spectrum of medical conditions. In each trial, at least three pairs of treatments are evaluated in each individual. The treatment pairs may be: administration of active drug and placebo; administration of high and low dose of the drug; and administration of first drug and alternate drug combinations. A referral service, based on three years of experience, was provided for clinicians for use of n-of-1 trials. The feasibility and effectiveness of n-of-1 randomized controlled trials were reviewed. Fifty out of 57 (88 percent) of the trials provided definite clinical or statistical conclusions. Clinicians who learned of the results actually changed their original plan of treatment based on the information provided by the n-of-1 analysis in 15 (39 percent) of the trials. A tutorial is available which teaches clinicians how to conduct their own n-of-1 trials. (Consumer Summary produced by Reliance Medical Information, Inc.)

Author: Guyatt, Gordon H., Jaeschke, Roman, Adachi, Jonathan D., Keller, Jana L., Rosenbloom, David, Newhouse, Michael T.
Publisher: American College of Physicians
Publication Name: Annals of Internal Medicine
Subject: Health
ISSN: 0003-4819
Year: 1990
Analysis, Statistics, Clinical trials, Medical research, Human experimentation in medicine, Human medical experimentation, Medicine, Experimental

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Incidence of and risk factors for ventilator-associated pneumonia in critically ill patients

Article Abstract:

It may be possible to prevent ventilator-associated pneumonia in critically ill patients. Researchers analyzed the risk factors for ventilator-associated pneumonia in 1,014 patients on a ventilator, of whom 177 developed ventilator-associated pneumonia. The risk of developing ventilator-associated pneumonia was highest during the first few days after the patients were placed on the ventilator and subsequently decreased. Burns, trauma, diseases of the heart, lungs or central nervous system, exposure to paralytic drugs and aspiration were risk factors for developing ventilator-associated pneumonia.

Author: Guyatt, Gordon H., Cook, Deborah J., Jaeschke, Roman Z., Brun-Buisson, Christian, Walter, Stephen D., Cook, Richard J., Griffith, Lauren E., Leasa, David
Publisher: American College of Physicians
Publication Name: Annals of Internal Medicine
Subject: Health
ISSN: 0003-4819
Year: 1998
Complications and side effects, Risk factors, Artificial respiration, Mechanical ventilation, Pneumonia, Critically ill

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Effect of HMGcoA reductase inhibitors on stroke: a meta-analysis of randomized, controlled trials

Article Abstract:

HMGcoA reductase inhibitors may reduce the incidence of stroke as well as coronary heart disease. These drugs are used to lower elevated blood cholesterol levels. Researchers analyzed 28 clinical trials of all cholesterol-lowering methods, including HMGcoA reductase inhibitors, diet and cholesterol-binding resins. HMGcoA reductase inhibitors reduced the risk of stroke by 24%, whereas other cholesterol-lowering methods had no effect. Death rates from coronary heart disease were also reduced by HMGcoA treatment.

Author: Guyatt, Gordon H., Bucher, Heiner C., Griffith, Lauren E.
Publisher: American College of Physicians
Publication Name: Annals of Internal Medicine
Subject: Health
ISSN: 0003-4819
Year: 1998
Prevention, Stroke (Disease), Stroke, Anticholesteremic agents

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Subjects list: Health aspects
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