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Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955–2013

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  • Humam Saltaji
  • Susan Armijo-Olivo
  • Greta G Cummings
  • Maryam Amin
  • Carlos Flores-Mir

Abstract

Objectives: To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. Methods: We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. Results: Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955–2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P

Suggested Citation

  • Humam Saltaji & Susan Armijo-Olivo & Greta G Cummings & Maryam Amin & Carlos Flores-Mir, 2017. "Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955–2013," PLOS ONE, Public Library of Science, vol. 12(12), pages 1-25, December.
    • Handle: RePEc:plo:pone00:0190089
    DOI: 10.1371/journal.pone.0190089
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    References listed on IDEAS

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    1. Denise Thomson & Lisa Hartling & Eyal Cohen & Ben Vandermeer & Lisa Tjosvold & Terry P Klassen, 2010. "Controlled Trials in Children: Quantity, Methodological Quality and Descriptive Characteristics of Pediatric Controlled Trials Published 1948-2006," PLOS ONE, Public Library of Science, vol. 5(9), pages 1-9, September.
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