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Pain. 2014 Mar;155(3):461-6. doi: 10.1016/j.pain.2013.11.009. Epub 2013 Nov 23.

Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations.

Author information

1
Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: jennifer_gewandter@urmc.rochester.edu.
2
Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
3
United States Food and Drug Administration, Silver Spring, MD, USA.
4
School of Professional Psychology, Pacific University, Hillsboro, OR, USA.
5
Analgesic Solutions, Natick, MA, USA; Tufts University, Boston, MA, USA.
6
Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
7
Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.

Abstract

Performing multiple analyses in clinical trials can inflate the probability of a type I error, or the chance of falsely concluding a significant effect of the treatment. Strategies to minimize type I error probability include prespecification of primary analyses and statistical adjustment for multiple comparisons, when applicable. The objective of this study was to assess the quality of primary analysis reporting and frequency of multiplicity adjustment in 3 major pain journals (ie, European Journal of Pain, Journal of Pain, and PAIN®). A total of 161 randomized controlled trials investigating noninvasive pharmacological treatments or interventional treatments for pain, published between 2006 and 2012, were included. Only 52% of trials identified a primary analysis, and only 10% of trials reported prespecification of that analysis. Among the 33 articles that identified a primary analysis with multiple testing, 15 (45%) adjusted for multiplicity; of those 15, only 2 (13%) reported prespecification of the adjustment methodology. Trials in clinical pain conditions and industry-sponsored trials identified a primary analysis more often than trials in experimental pain models and non-industry-sponsored trials, respectively. The results of this systematic review demonstrate deficiencies in the reporting and possibly the execution of primary analyses in published analgesic trials. These deficiencies can be rectified by changes in, or better enforcement of, journal policies pertaining to requirements for the reporting of analyses of clinical trial data.

KEYWORDS:

Multiplicity; Primary analysis reporting; Systematic review

PMID:
24275257
DOI:
10.1016/j.pain.2013.11.009
[Indexed for MEDLINE]

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