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Child's Nervous System

Published in:

01-04-2007 | Review Paper

Designing randomized clinical trials in pediatric neurosurgery

Authors: Peter Kan, John R. W. Kestle

Published in: Child's Nervous System | Issue 4/2007

Abstract

Objectives

Randomized clinical trials provide the best evidence for making treatment decisions and their use in pediatric neurosurgery is increasing. In this paper, we review the basic principles of clinical trial design and discuss the unique challenges in trial design in pediatric neurosurgery.

Materials and methods

To illustrate the basic principles of trial design and highlight the special considerations in pediatric neurosurgery, examples from the Shunt Design Trial and Endoscopic Shunt Insertion Trial were used.

Conclusions

Each trial should answer one primary study question. Sample size estimates based on error rates and clinically important difference must be calculated. Allocation concealment, randomization, and blinding are critical to prevent selection and ascertainment bias. Standardization of the intervention is important to the result’s validity, and study centers/surgeons should be selected on the basis of the trial objective. The effects of dropouts, crossovers, and missing data should be handled with an intention-to-treat analysis. Sample selection, informed consent, and valid outcome measures are specific challenges in the pediatric population.

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Title: Designing randomized clinical trials in pediatric neurosurgery
Authors: Peter Kan
John R. W. Kestle
Publication date: 01-04-2007
Publisher: Springer-Verlag
Published in: Child's Nervous System / Issue 4/2007
Print ISSN: 0256-7040
Electronic ISSN: 1433-0350
DOI: https://doi.org/10.1007/s00381-006-0293-2

At a glance: The STEP trials

Springer Medicine

Designing randomized clinical trials in pediatric neurosurgery

Abstract

Objectives

Materials and methods

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Objectives

Materials and methods

Conclusions

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