title: Assay sensitivity of pain intensity versus pain relief in acute pain clinical trials: ACTTION systematic review and meta-analysis.
abstract: The magnitude of the effect size of an analgesic intervention can be influenced by several factors, including research design. A key design component is the choice of the primary endpoint. The purpose of this meta-analysis was to compare the assay sensitivity of 2 efficacy paradigms: pain intensity (calculated using summed pain intensity difference [SPID]) and pain relief (calculated using total pain relief [TOTPAR]). A systematic review of the literature was performed to identify acute pain studies that calculated both SPIDs and TOTPARs within the same study. Studies were included in this review if they were randomized, double-blind, placebo-controlled investigations involving medications for postsurgical acute pain and if enough data were provided to calculate TOTPAR and SPID standardized effect sizes. Based on a meta-analysis of 45 studies, the mean standardized effect size for TOTPAR (1.13) was .11 higher than that for SPID (1.02; P = .01). Mixed-effects meta-regression analyses found no significant associations between the TOTPAR - SPID difference in standardized effect size and trial design characteristics. Results from this review suggest that for acute pain studies, utilizing TOTPAR to assess pain relief may be more sensitive to treatment effects than utilizing SPID to assess pain intensity.
  
  
  CONCLUSIONS
  The results of this meta-analysis suggest that TOTPAR may be more sensitive to treatment effects than SPIDs are in analgesic trials examining acute pain. We found that standardized effect sizes were higher for TOTPAR compared to SPIDs.
authors.affiliation: Lotus Clinical Research, Huntington Hospital, Department of Anesthesiology, Pasadena, California. Electronic address: neil@lotuscr.com.
authors.forename: Neil
authors.initials: N
authors.lastname: Singla
authors.affiliation: School of Professional Psychology, Pacific University, Hillsboro, Oregon.
authors.forename: Matthew
authors.initials: M
authors.lastname: Hunsinger
authors.affiliation: Lotus Clinical Research, Huntington Hospital, Department of Anesthesiology, Pasadena, California.
authors.forename: Phoebe D
authors.initials: PD
authors.lastname: Chang
authors.affiliation: Department of Biostatistics and Computational Biology, University of Rochester, Rochester, New York.
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.affiliation: Department of Biostatistics and Computational Biology, University of Rochester, Rochester, New York.
authors.forename: Amit K
authors.initials: AK
authors.lastname: Chowdhry
authors.affiliation: Desjardins Associates, LLC, Maplewood, New Jersey.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Desjardins
authors.affiliation: Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington.
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.affiliation: Department of Anesthesiology, University of Rochester, Rochester, New York.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
mesh_terms: D016206:Databases, Bibliographic / Q000706:statistics & numerical data; D006801:Humans; D010146:Pain / Q000503:physiopathology* / Q000523:psychology*; D059408:Pain Management; D010147:Pain Measurement; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
keywords: Acute pain; methodology; pain intensity; pain relief; postoperative pain; summed pain intensity difference; total pain relief