Reporting of cross-over clinical trials of analgesic treatments for chronic pain: Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks systematic review and recommendations

Jennifer S. Gewandter*, Michael P. McDermott, Andrew McKeown, Kim Hoang, Katarzyna Iwan, Sarah Kralovic, Daniel Rothstein, Ian Gilron, Nathaniel P. Katz, Srinivasa N. Raja, Stephen Senn, Shannon M. Smith, Dennis C. Turk, Robert H. Dworkin

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

8 Citations (Scopus)

Abstract

Cross-over trials are typically more efficient than parallel group trials in that the sample size required to yield a desired power is substantially smaller. It is important, however, to consider some issues specific to cross-over trials when designing and reporting them, and when evaluating the published results of such trials. This systematic review evaluated the quality of reporting and its evolution over time in articles of cross-over clinical trials of pharmacologic treatments for chronic pain published between 1993 and 2013. Seventy-six (61%) articles reported a within-subject primary analysis, or if no primary analysis was identified, reported at least 1 within-subject analysis, which is required to achieve the gain in power associated with the cross-over design. For 39 (31%) articles, it was unclear whether analyses conducted were within-subject or between-group. Only 36 (29%) articles reported a method to accommodate missing data (eg, last observation carried forward, n529), and of those, just 14 included subjects in the analysis who provided data from only 1 period. Of the articles that identified a within-subject primary analysis, 21 (51%) provided sufficient information for the results to be included in a metaanalysis (ie, estimates of the within-subject treatment effect and variability). These results and others presented in this article demonstrate deficiencies in reporting of cross-over trials for analgesic treatments. Clearer reporting in future trials could improve readers' ability to critically evaluate the results, use these data inmeta-analyses, and plan future trials. Recommendations for proper reporting of cross-over trials that apply to any condition are provided.

Original languageEnglish
Pages (from-to)2544-2551
Number of pages8
JournalPain
Volume157
Issue number11
DOIs
Publication statusPublished - 19 Aug 2016

Keywords

  • Chronic pain
  • Clinical trial reporting
  • Cross-over trials

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