title: Assay sensitivity and study features in neuropathic pain trials: an ACTTION meta-analysis.
abstract: OBJECTIVE
  Our objective was to identify patient, study, and site factors associated with assay sensitivity in placebo-controlled neuropathic pain trials.
  
  
  METHODS
  We examined the associations between study characteristics and standardized effect size (SES) in a database of 200 publicly available randomized clinical trials of pharmacologic treatments for neuropathic pain.
  
  
  RESULTS
  There was considerable heterogeneity in the SESs among the examined trials. Univariate meta-regression analyses indicated that larger SESs were significantly associated with trials that had 1) greater minimum baseline pain inclusion criteria, 2) greater mean subject age, 3) a larger percentage of Caucasian subjects, and 4) a smaller total number of subjects. In a multiple meta-regression analysis, the associations between SES and minimum baseline pain inclusion criterion and age remained significant.
  
  
  CONCLUSIONS
  Our analyses have examined potentially modifiable correlates of study SES and shown that a minimum pain inclusion criterion of 40 or above on a 0 to 100 scale is associated with a larger SES. These data provide a foundation for investigating strategies to improve assay sensitivity and thereby decrease the likelihood of falsely negative outcomes in clinical trials of efficacious treatments for neuropathic pain.
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. robert_dworkin@urmc.rochester.edu
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.forename: Sarah
authors.initials: S
authors.lastname: Peirce-Sandner
authors.forename: Hua
authors.initials: H
authors.lastname: He
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.forename: John T
authors.initials: JT
authors.lastname: Farrar
authors.forename: Nathaniel P
authors.initials: NP
authors.lastname: Katz
authors.forename: Allison H
authors.initials: AH
authors.lastname: Lin
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
authors.forename: Michael C
authors.initials: MC
authors.lastname: Rowbotham
mesh_terms: D000367:Age Factors; D002986:Clinical Trials as Topic; D006801:Humans; D009437:Neuralgia / Q000175:diagnosis / Q000628:therapy*; D012107:Research Design; D012680:Sensitivity and Specificity; D016896:Treatment Outcome