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Pain. 2014 Sep;155(9):1871-7. doi: 10.1016/j.pain.2014.06.018. Epub 2014 Jun 30.

Reporting of missing data and methods used to accommodate them in recent analgesic clinical trials: ACTTION systematic review and recommendations.

Author information

  • 1Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: Jennifer_gewandter@urmc.rochester.edu.
  • 2Departments of Biostatistics and Computational Biology and Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
  • 3Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
  • 4School of Professional Psychology, Pacific University, Hillsboro, OR, USA.
  • 5Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA.
  • 6Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.

Abstract

Missing data in clinical trials can bias estimates of treatment effects. Statisticians and government agencies recommend making every effort to minimize missing data. Although statistical methods are available to accommodate missing data, their validity depends on often untestable assumptions about why the data are missing. The objective of this study was to assess the frequency with which randomized clinical trials published in 3 major pain journals (ie, European Journal of Pain, Journal of Pain, and Pain) reported strategies to prevent missing data, the number of participants who completed the study (ie, completers), and statistical methods to accommodate missing data. A total of 161 randomized clinical trials investigating treatments for pain, published between 2006 and 2012, were included. Approximately two-thirds of the trials reported at least 1 method that could potentially minimize missing data, the most common being allowance of concomitant medications. Only 61% of the articles explicitly reported the number of patients who were randomized and completed the trial. Although only 14 articles reported that all randomized participants completed the study, fewer than 50% of the articles reported a statistical method to accommodate missing data. Last observation carried forward imputation was used most commonly (42%). Thirteen articles reported more than 1 method to accommodate missing data; however, the majority of methods, including last observation carried forward, were not methods currently recommended by statisticians. Authors, reviewers, and editors should prioritize proper reporting of missing data and appropriate use of methods to accommodate them so as to improve the deficiencies identified in this systematic review.

KEYWORDS:

ACTTION; Missing data; Systematic review

PMID:
24993384
DOI:
10.1016/j.pain.2014.06.018
[PubMed - indexed for MEDLINE]
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