title: Outcomes in acute pain trials: systematic review of what was reported?
abstract: Single-dose clinical trial methods for evaluating analgesics have been used successfully for over 50 years. The aims of this review were to examine which pain measurement scales have been used in high quality acute pain trials, to investigate other common measurements or characteristics, to confirm that different scales used by standard methods give the same estimate of analgesic effect, to investigate remedication methodologies and the potential of 'time to remedication' as a standard outcome. Published reports of randomised, double blind, placebo-controlled trials, investigating at least 20 adult patients (10 patients per treatment arm) experiencing moderate or severe pain using at least one standard pain intensity or pain relief scale were sought. Key design features, outputs and outcomes were catalogued for each report. The main outcomes reported were misleading, detailing only the mean values of data with a demonstrably skewed distribution. After 50 years, the reporting of results from acute pain trials warrants a fresh look. Possible improvements include reporting the number of patients with certain levels of pain relief, or the actual number (percentage) of patients with a certain level of pain relief at a certain time, or more useful information on remedication from trials of at least 12 h duration. Most useful would be all three. Further exploration would only be possible from analysis at the individual patient level.
authors.affiliation: Pain Research and Nuffield Department of Anaesthetics, University of Oxford, Oxford Radcliffe Hospital, The Churchill, Headington, Oxford OX3 7LJ, UK.
authors.forename: Jodie
authors.initials: J
authors.lastname: Barden
authors.forename: Jayne E
authors.initials: JE
authors.lastname: Edwards
authors.forename: Lorna
authors.initials: L
authors.lastname: Mason
authors.forename: Henry J
authors.initials: HJ
authors.lastname: McQuay
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Moore
mesh_terms: D000700:Analgesics / Q000008:administration & dosage*; D006801:Humans; D010146:Pain / Q000188:drug therapy* / Q000523:psychology; D010147:Pain Measurement / Q000379:methods* / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D015203:Reproducibility of Results; D012107:Research Design; D055502:Secondary Prevention; D011795:Surveys and Questionnaires / Q000592:standards; D016896:Treatment Outcome
chemical_list: D000700:Analgesics