Deficiencies in reporting of statistical methodology in recent randomized trials of nonpharmacologic pain treatments: ACTTION systematic review

Abstract

Objective: The 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 design: Systematic 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.

Setting: Systematic review.

Results: Sixty-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.

Conclusion: This 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.

Keywords: Clinical trials; Missing data; Multiplicity; Nonpharmacologic trials; Prespecification; Reporting.