(NeoReviews. 2001;2:E257-e266.)
© 2001 American Academy of Pediatrics
The Role of Follow-up in Randomized Controlled Trials
Linda L. Wright, MD*
*
Center for Research for Mothers and Children, National
Institute of Child Health and Human Development, National Institutes of
Health, Bethesda, MD.
 |
Objectives
|
|---|
After completing this article, readers should be able to:
- Describe useful tools for interpreting the randomized
controlled trial literature.
- Characterize the difference between a surrogate outcome and a
clinically meaningful outcome.
- Characterize the trend in the prevalence of neurodevelopmental
impairment in very low-birthweight infants.
- Describe the adverse effects that have been associated with
postnatal steroid use and why they were first reported in 1998.
- Justify neurodevelopment or death as the outcome of randomized
controlled trials of neonatal interventions.
- Describe the major methodologic problems in conducting such
trials.
|
Useful Tools
|
|---|
Dramatic increases in basic and translational research have increased the number of
therapies available to clinicians. Because randomized clinical trials are the
gold standard for evaluating the effect of treatment, there have been
parallel increases in the number of randomized controlled trials (RCTs) and
the refinement of methods for their design, conduct, analysis, and reporting.
For investigators designing a clinical trial, clinicians seeking an answer to
a specific clinical problem, and clinicians seeking to remain abreast of the
trial literature, efficient access to and use of the medical literature is a
major challenge. A number of tools have been developed for evaluating the
effectiveness of new therapies, including systems to rate the quality of
evidence, such as The United States Preventive Task Force’s rating
system (Table 1
).
(1)
View this table:
[in this window]
[in a new window]
|
Table 1. US Preventative Task Force’s Rating System
|
|
Another major advance is the development of standardized methods for
formal, systematic reviews of trials of an intervention (meta-analysis). The
Cochrane Collaboration, an organization committed to the preparation and
dissemination of systematic reviews of health care interventions, uses such
methods to identify high-quality trials and to obtain a summary estimate of
the overall treatment effect of a specific intervention in a defined
population on each outcome of interest. In addition to providing a typical
estimate of . . . [Full Text of this Article]
CiteULike 
Connotea 
Del.icio.us 
Digg 
Facebook 
Reddit 
Technorati 
Twitter What's this?
Copyright © 2001 by the American Academy of Pediatrics.
