caa a22 4500 463180402 CHVBK 20180406164837.0 cr unu---uuuuu 170326e20070401xx s 000 0 eng 10.1007/s00381-006-0293-2 doi (NATIONALLICENCE)springer-10.1007/s00381-006-0293-2 Designing randomized clinical trials in pediatric neurosurgery [Elektronische Daten] [Peter Kan, John Kestle] 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. Springer-Verlag, 2007 Designs nationallicence Randomized clinical trials nationallicence Surgical trials nationallicence Pediatric neurosurgery nationallicence Kan Peter Department of Neurosurgery, Primary Children's Medical Center, University of Utah, 100 N. Medical Drive, 84113, Salt Lake, UT, USA aut Kestle John Department of Neurosurgery, Primary Children's Medical Center, University of Utah, 100 N. Medical Drive, 84113, Salt Lake, UT, USA aut Child's Nervous System Springer-Verlag 23/4(2007-04-01), 385-390 0256-7040 23:4<385 2007 23 381 https://doi.org/10.1007/s00381-006-0293-2 text/html Onlinezugriff via DOI 1 review-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s00381-006-0293-2 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Kan Peter Department of Neurosurgery, Primary Children's Medical Center, University of Utah, 100 N. Medical Drive, 84113, Salt Lake, UT, USA aut NATIONALLICENCE 700 1- Kestle John Department of Neurosurgery, Primary Children's Medical Center, University of Utah, 100 N. Medical Drive, 84113, Salt Lake, UT, USA aut NATIONALLICENCE 773 0- Child's Nervous System Springer-Verlag 23/4(2007-04-01), 385-390 0256-7040 23:4<385 2007 23 381 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer