• Burns · Mar 2018

    Burn clinical trials: A systematic review of registration and publications.

    • Sarthak Sinha, Grace Yoon, Wisoo Shin, Jeff A Biernaskie, Duncan Nickerson, and Vincent A Gabriel.
    • Division of Physical Medicine and Rehabilitation, Departments of Clinical Neurosciences, Pediatrics and Surgery, Faculty of Medicine, University of Calgary, Alberta, Canada; Department of Comparative Biology & Experimental Medicine, Faculty of Veterinary Medicine, University of Calgary, Canada. Electronic address: sarthak.sinha@mail.utoronto.ca.
    • Burns. 2018 Mar 1; 44 (2): 263-271.

    BackgroundRandomized controlled clinical trials (CTs) are gold standard tools for assessing interventions. Although burn CTs have improved care, their status, publication frequency, and publication quality are not known.Objectives(1) Characterize burn CTs by analyzing location, completion status, temporal trend, and funding sources. (2) Assess quality of trial reporting.Data SourcesCT records were obtained from ClinicalTrials.gov and WHO's CT Registry (searched May 2017). Publications were obtained from PubMed, Google Scholar, OVID MEDLINE, and ClinicalTrials.gov (searched June 2017).Publication Appraisal23-item rubric adapted from CONSORT and ICH E3 guidelines.Results738 burn CTs were identified globally, of which majority were publically-funded (77%), ongoing (52%), and assessed behavioral, pharmacological, device-based, dietary-based, and biological/procedural interventions. Amongst the ended trials, 69 (28%) published their findings. Significantly fewer industry-funded trials published findings (14% vs 33% publically-funded). Quality of reporting was suboptimal, and most underreported categories were trial phase, severity, and sample size estimation.LimitationsIncomplete, outdated, and non-registered CTs which are difficult to track.ConclusionsBurn trials are proliferating in number, location, and interventions assessed. Only a small proportion are published and quality of reporting is suboptimal.Implications Of Key FindingsBurn researchers should aim to register and report on all clinical trials regardless of outcome. Superior a priori design can reduce precocious termination and mandatory reporting of data fields can improve quality of reporting. Systematic review registration number: CRD42017068549.Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.

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