• Pediatr Crit Care Me · Sep 2015

    Review

    Pilot Randomized Trials in Pediatric Critical Care: A Systematic Review.

    • Mark Duffett, Karen Choong, Lisa Hartling, Kusum Menon, Lehana Thabane, and Deborah J Cook.
    • 1Departments of Pediatrics and Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. 2Department of Pediatrics, Alberta Research Centre for Health Evidence, University of Alberta, Edmonton, AB, Canada. 3Departments of Pediatrics and Epidemiology and Community Medicine, University of Ottawa, Ottawa, ON, Canada. 4Departments of Clinical Epidemiology and Biostatistics, Pediatrics, and Anesthesia, McMaster University, Hamilton, ON, Canada. 5Departments of Clinical Epidemiology and Biostatistics, and Medicine, McMaster University, Hamilton, ON, Canada.
    • Pediatr Crit Care Me. 2015 Sep 1; 16 (7): e239-44.

    ObjectivesPilot trials are smaller randomized controlled trials conducted to inform the design and assess the feasibility of a large-scale trials. The objectives of this systematic review were to describe pilot trials in pediatric critical care, their conclusions about the clinical implications of the results, and the need for future research and to determine the frequency of large follow-up trials.Data SourcesThe Evidence in Pediatric Intensive Care database (http://epicc.mcmaster.ca), a comprehensive repository of published pediatric critical care randomized controlled trials and the World Health Organization's Clinical Trials Registry Platform.Study SelectionRandomized controlled trials described in the publication as "pilot," "feasibility," "proof-of-concept," "exploratory," "phase 2," "vanguard," or "preliminary."Data ExtractionPairs of reviewers screened studies for eligibility and abstracted data independently.Data SynthesisWe found 32 pilot trials (12.2% of all pediatric critical care randomized controlled trials) published before July 2014, varying in size from 6 to 165 children. Pilot trials were significantly smaller than those not described as pilots, but other key characteristics were not significantly different. The authors of 16 publications (48.4%) included explicit and specific conclusions about the design or feasibility of larger trials based on the results of the pilot trial. In 20 publications (64.5%), the authors made conclusions about clinical efficacy based on results of the pilot trial. Four of the 32 pilot trials (12.9%) led to larger trials, two of which have been published.ConclusionsPublished pilot trials in pediatric critical care often focus on clinical outcomes. They uncommonly report explicit feasibility outcomes, criteria for success, or rationale for the pilot sample size. These pilot trials infrequently lead to larger trials. Understanding and addressing the reasons for this are key to the success of pediatric critical care research.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…

What will the 'Medical Journal of You' look like?

Start your free 21 day trial now.

We guarantee your privacy. Your email address will not be shared.