• Jordan D Dworkin, Andrew McKeown, John T Farrar, Ian Gilron, Matthew Hunsinger, Robert D Kerns, Michael P McDermott, Bob A Rappaport, Dennis C Turk, Robert H Dworkin, and Jennifer S Gewandter.
• Department of Biostatistics and Epidemiology, University of Pennsylvania, 423 Guardian Dr., Philadelphia, PA 19104, USA.
• J Clin Epidemiol. 2016 Apr 1; 72: 56-65.

ObjectiveThe goal of this study was to assess the quality of reporting of statistical methods in randomized clinical trials (RCTs), including identification of primary analyses, missing data accommodation, and multiplicity adjustment, in studies of nonpharmacologic, noninterventional pain treatments (e.g., physical therapy, cognitive behavioral therapy, acupuncture, and massage).Study DesignSystematic review of 101 articles reporting RCTs of pain treatments that were published between January 2006 and June 2013 in the European Journal of Pain, the Journal of Pain, and Pain.SettingSystematic review.ResultsSixty-two percent of studies identified a primary outcome variable, 46% identified a primary analysis, and of those with multiple primary analyses, only 21% adjusted for multiplicity. Slightly over half (55%) of studies reported using at least one method to accommodate missing data. Only four studies reported prespecifying at least one of these four study methods.ConclusionThis review identified deficiencies in the reporting of primary analyses and methods to adjust for multiplicity and accommodate missing data in articles disseminating results of nonpharmacologic, noninterventional trials. Investigators should be encouraged to indicate whether their analyses were prespecified and to clearly and completely report statistical methods in clinical trial publications to maximize the interpretability of trial results.Copyright © 2016 Elsevier Inc. All rights reserved.

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