Advertisement

Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting

  • Nikolaos Pandis
    Correspondence
    Corresponding author. Department of Orthodontics and Dentofacial Orthopedics, School of Dental Medicine/Medical Faculty, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Tel.: +41 31 632 25 92; fax: +41 31 632 98 69.
    Affiliations
    American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO), Department of Orthodontics, University of Washington, D-569 HSC, Box 357446, Seattle, WA 98195-7446, US

    Department of Orthodontics and Dentofacial Orthopedics, School of Dental Medicine/Medical Faculty, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland
    Search for articles by this author
  • Larissa Shamseer
    Affiliations
    Clinical Epidemiology Program, Ottawa Hospital Research Institute, 725 Parkdale Ave. Ottawa, ON K1Y 4E9, Canada

    Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON K1H 8M5, Canada
    Search for articles by this author
  • Vincent G. Kokich
    Affiliations
    American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO), Department of Orthodontics, University of Washington, D-569 HSC, Box 357446, Seattle, WA 98195-7446, US
    Search for articles by this author
  • Padhraig S. Fleming
    Affiliations
    American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO), Department of Orthodontics, University of Washington, D-569 HSC, Box 357446, Seattle, WA 98195-7446, US

    Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Turner St., London E1 2 AD, UK
    Search for articles by this author
  • David Moher
    Affiliations
    Clinical Epidemiology Program, Ottawa Hospital Research Institute, 725 Parkdale Ave. Ottawa, ON K1Y 4E9, Canada

    Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON K1H 8M5, Canada
    Search for articles by this author

      Abstract

      Objective

      To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials.

      Study Design and Setting

      The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009.

      Results

      Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011–2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable.

      Conclusion

      Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Clinical Epidemiology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Schulz K.F.
        • Altman D.G.
        • Moher D.
        • CONSORT Group
        CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.
        J Clin Epidemiol. 2010; 63: 834-840
        • Turner L.
        • Shamseer L.
        • Altman D.G.
        • Schulz K.F.
        • Moher D.
        Does use of the CONSORT statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review.
        Syst Rev. 2012; 1: 60
        • Jokstad A.
        • Esposito M.
        • Coulthard P.
        • Worthington H.V.
        The reporting of randomized controlled trials in prosthodontics.
        Int J Prosth. 2002; 15: 230-242
        • Dumbrigue H.B.
        • Jones J.S.
        • Esquivel J.F.
        Control of bias in randomized controlled trials published in prosthodontic journals.
        J Prosth Dent. 2001; 86: 592-596
        • Montenegro R.
        • Needleman I.
        • Moles D.
        • Tonetti M.
        Quality of RCTs in periodontology: a systematic review.
        J Dent Res. 2002; 81: 866-870
        • Harrison J.E.
        Clinical trials in orthodontics II: assessment of the quality of reporting of clinical trials published in three orthodontic journals between 1989 and 1998.
        J Orthod. 2003; 30: 309-315
        • Devereaux P.J.
        • Manns B.J.
        • Ghali W.A.
        • Quan H.
        • Guyatt G.H.
        The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist.
        Control Clin Trials. 2002; 23: 380-388
        • Pandis N.
        • Polychronopoulou A.
        • Eliades T.
        An assessment of quality characteristics of randomised control trials published in dental journals.
        J Dent. 2010; 38: 713-721
        • Mills E.
        • Wu P.
        • Gagnier J.
        • Heels-Ansdell D.
        • Montori V.M.
        An analysis of general medical and specialist journals that endorse CONSORT found that reporting was not enforced consistently.
        J Clin Epi. 2005; 58: 662-667
        • Dechartres A.
        • Charles P.
        • Hopewell S.
        • Ravaud P.
        • Altman D.G.
        Reviews assessing the quality or the reporting of randomized controlled trials are increasing over time but raised questions about how quality is assessed.
        J Clin Epi. 2011; 64: 136-144
        • Dwan K.
        • Gamble C.
        • Williamson P.R.
        • Kirkham J.J.
        • for the Reporting Bias Group
        Systematic review of the empirical evidence of study publication bias and outcome reporting bias: an updated review.
        PLoS ONE. 2013; 8: e66844
        • Turpin D.L.
        CONSORT and QUOROM guidelines for reporting randomized clinical trials and systematic reviews.
        Am J Orthod Dentofacial Orthop. 2005; 128: 681-685