title: Development and validation of a composite score based on clinically meaningful events for the opioid-related symptom distress scale.
abstract: OBJECTIVE
  To develop and validate a composite score based on clinically meaningful events (CMEs) for the opioid-related symptom distress scale (OR-SDS) that would be appropriate for use in postoperative clinical trials.
  
  
  METHODS
  Secondary analysis of data from 2 multi-site Phase III randomized clinical safety trials: a general surgery trial (N = 1,050) and a coronary artery bypass graft surgery trial (N = 1,636). Validating measures include daily opioid consumption and physician and patient global evaluations of study medication. We empirically defined CMEs for each symptom, using factor analysis and an area under the receiver-operating characteristic analysis of the severity and frequency items of the OR-SDS. Construct validity was examined by testing hypotheses of relationships between composite CME scores and opioid consumption and physician and patient evaluations of study medication.
  
  
  RESULTS
  Hypotheses supporting the construct validity of the CME-based composite score were confirmed. Significant associations were found between higher numbers of CMEs with greater opioid consumption and lower likelihood of a positive evaluation of the study medication.
  
  
  CONCLUSIONS
  The OR-SDS CME-based composite score demonstrates evidence of construct validity and appears appropriate for use in evaluating patients' opioid-related side effect burden in future postoperative clinical trials.
authors.affiliation: Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Room 633, Baltimore, MD 21205, USA. kchan@jhsph.edu
authors.forename: Kitty S
authors.initials: KS
authors.lastname: Chan
authors.forename: Wen-Hung
authors.initials: WH
authors.lastname: Chen
authors.forename: T J
authors.initials: TJ
authors.lastname: Gan
authors.forename: Ray
authors.initials: R
authors.lastname: Hsieh
authors.forename: Connie
authors.initials: C
authors.lastname: Chen
authors.forename: Mani
authors.initials: M
authors.lastname: Lakshminarayanan
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
mesh_terms: D000368:Aged; D000701:Analgesics, Opioid / Q000009:adverse effects*; D001026:Coronary Artery Bypass; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy*; D011184:Postoperative Period; D016032:Randomized Controlled Trials as Topic
chemical_list: D000701:Analgesics, Opioid