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Clinical Trials.  

Edward H. Livingston

in AMA Manual of Style: A Guide for Authors and Editors (11th edn)

Print Publication Year: 
Feb 2020
Published Online: 
Feb 2020
DOI: 
10.1093/jama/9780190246556.003.0019.021.0003
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section
The International Committee of Medical Journal Editors (ICMJE) defines a clinical trial as “any research project that prospectively assigns human participants to intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome.”6 All clinical trials must be registered at an appropriate online public registry. Interventions include but are not limited to drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, process-of-care changes, and the like....

Cluster Trials.  

Edward H. Livingston

in AMA Manual of Style: A Guide for Authors and Editors (11th edn)

Print Publication Year: 
Feb 2020
Published Online: 
Feb 2020
DOI: 
10.1093/jama/9780190246556.003.0019.022.0011
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section
Cluster randomization is undertaken when performance of the intervention risks contamination of the control group. Imagine a multifaceted intervention that involves sedation protocols and measures of arousal levels and readiness for weaning from a mechanical ventilator in a trial of extubation.25 In this scenario, intensive care unit (ICU) personnel performing these functions may be influenced by the effectiveness of the interventions and consciously or unconsciously use them on patients assigned to the control group. In cases such as this, it is best to perform the intervention in one ICU and apply the control intervention in a separate ICU. Instead of randomizing individual patients to intervention or control groups, ICUs are randomized. Each ICU is considered a cluster of patients....

Crossover Trials.  

Edward H. Livingston

in AMA Manual of Style: A Guide for Authors and Editors (11th edn)

Print Publication Year: 
Feb 2020
Published Online: 
Feb 2020
DOI: 
10.1093/jama/9780190246556.003.0019.022.0009
Item type: 
section
In a crossover trial, participants receive more than 1 of the treatments under investigation, usually in a randomly determined sequence and with a prespecified amount of time (a washout period ) between sequential treatments. The participants and the investigators are generally blinded to the treatment assignment (double-blinded). This experimental design is often used for evaluating drug treatments. Each participant serves as his or her own control, thereby eliminating variability when comparing treatment effects and reducing the sample size needed to detect a statistically ...

Equivalence Trials and Noninferiority Trials.  

Edward H. Livingston

in AMA Manual of Style: A Guide for Authors and Editors (11th edn)

Print Publication Year: 
Feb 2020
Published Online: 
Feb 2020
DOI: 
10.1093/jama/9780190246556.003.0019.022.0010
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section
It is sometimes desirable to compare a treatment or intervention that is already known to be effective with a treatment or intervention that is less expensive or has other advantages (eg, easier administration such as oral dosing).20 In these cases, it would be unethical to expose participants to an inactive ...

Nonrandomized Trials.  

Edward H. Livingston

in AMA Manual of Style: A Guide for Authors and Editors (11th edn)

Print Publication Year: 
Feb 2020
Published Online: 
Feb 2020
DOI: 
10.1093/jama/9780190246556.003.0019.022.0012
Item type: 
section
A nonrandomized trial prospectively assigns groups or populations to study the efficacy or effectiveness of an intervention but the assignment to the intervention occurs through self-selection or administrator selection rather than through randomization. Control groups can be historical, concurrent, or both. This design is sometimes called a quasi-experimental design. Reports of these trials should follow the Transparent Reporting of Evaluations With Nonrandomized Designs (TREND) reporting guideline (...

Parallel-Design, Double-blind Trials.  

Edward H. Livingston

in AMA Manual of Style: A Guide for Authors and Editors (11th edn)

Print Publication Year: 
Feb 2020
Published Online: 
Feb 2020
DOI: 
10.1093/jama/9780190246556.003.0019.022.0008
Item type: 
section
In parallel-design, double-blind trials, participants are assigned to only 1 treatment group of the study. These trials are generally designed to assess whether 1 or more treatments are more effective than the others. Participants and those administering the intervention should all be unaware of which intervention individual participants are receiving (double-blinding). Ideally, those rating the outcomes should also be blinded to treatment assignment (triple-blinding). Blinded parallel-design trials are often the optimal design to compare 2 or more types of drugs or other therapy because known and unknown potentially confounding factors should be randomly distributed between intervention and control groups. Reports of these types of trials should follow the CONSORT reporting guideline (...

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