• Neurology · Nov 2015

    Review

    Registration status and outcome reporting of trials published in core headache medicine journals.

    • Melissa L Rayhill, Roni Sharon, Rebecca Burch, and Elizabeth Loder.
    • From the John R. Graham Headache Center (M.L.R., R.S.), Department of Neurology (R.B.), and Division of Headache and Pain, Department of Neurology (E.L.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA. melissa.raskopf@gmail.com.
    • Neurology. 2015 Nov 17; 85 (20): 1789-94.

    ObjectivesTo evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals.MethodsWe identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications.ResultsThe journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness.ConclusionsOnly about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue.© 2015 American Academy of Neurology.

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