• J Am Dent Assoc · Apr 2015

    Review

    Reporting of adverse events and statistical details of efficacy estimates in randomized clinical trials of pain in temporomandibular disorders: Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks systematic review.

    • Jennifer S Gewandter, Shannon M Smith, Andrew McKeown, Kenessa Edwards, Aastha Narula, Joseph R Pawlowski, Daniel Rothstein, Paul J Desjardins, Samuel F Dworkin, Robert A Gross, Richard Ohrbach, Bob A Rappaport, Barry J Sessle, Dennis C Turk, and Robert H Dworkin.
    • J Am Dent Assoc. 2015 Apr 1; 146 (4): 246-54.e6.

    BackgroundStatistical methods and adverse events (that is, harms) data affect the accuracy of conclusions about the risk-to-benefit ratio of treatments for temporomandibular disorders (TMDs). The authors reviewed the quality of reporting in TMD clinical trials to highlight practices that are in need of improvement.Types Of Studies ReviewedThe authors included articles published between 1969 and May 31, 2013, in which the investigators reported randomized clinical trials of TMD treatments with pain as a principal outcome variable. Investigators in trials of nonpharmacologic and noninvasive treatments were required to at least mask the participants and assessors; all others were required to be double masked.ResultsNinety articles qualified for this review: 39 published between 1971 and 2005 (older articles) and 51 published between 2006 and 2013 (newer articles). Specification of primary outcome analyses, methods to accommodate missing data, and adverse event collection methods and rates were generally poor. In some cases, there was apparent improvement from the older to the newer cohort; however, reporting of these methodological details remained inadequate even in the newer articles.Practical ImplicationsThis review is designed to alert authors, reviewers, editors, and readers of TMD clinical trials to these issues and improve reporting quality in the future.Copyright © 2015 American Dental Association. Published by Elsevier Inc. All rights reserved.

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