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Randomized Clinical Trials in Pediatric Hydrocephalus

  • Evan J. Joyce
  • Jay Riva-Cambrin
  • John R. W. Kestle
Chapter

Abstract

Among the options for research design for clinical investigators are case series (mostly retrospective), cohort studies (retrospective or prospective), case control studies, and randomized controlled trials. Analysis of data from prospective registries [1] using matching and/or propensity scores [2] has also gained popularity. Although nonexperimental design studies are frequently reported, randomized controlled trials have been considered the gold standard for the assessment of treatment efficacy, and the pros and cons have been extensively discussed in the literature [3, 4]. Randomized clinical trials of surgical procedures have some unique study design challenges and methods to address them. The most important attribute of randomized clinical trials, which is unique to that study design, is that randomization balances unknown confounders. Known confounders are also balanced, but this can be done with other research designs. Because it is not always possible to predict confounders in clinical research, randomization is the only method that has the ability to balance the unknown confounding factors.

Keywords

Hydrocephalus Clinical trial Shunt Third ventriculostomy Randomized Shunt failure Shunt infection 

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Evan J. Joyce
    • 1
  • Jay Riva-Cambrin
    • 2
  • John R. W. Kestle
    • 3
  1. 1.University of Utah, Department of Neurological SurgerySalt Lake CityUSA
  2. 2.Alberta Children’s Hospital, Department of Clinical NeurosciencesCalgaryCanada
  3. 3.Primary Children’s Hospital, University of Utah, Department of NeurosurgerySalt Lake CityUSA

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