title: Psychometric evaluation of the Sinonasal Outcome Test-16 and activity impairment assessment in acute bacterial sinusitis.
abstract: OBJECTIVE
  To validate the Sinonasal Outcome Test-16 and Activity Impairment Assessment in patients with acute bacterial sinusitis.
  
  
  METHODS
  Data were used from a phase III clinical trial designed to evaluate the efficacy and safety of moxifloxacin 400 mg once daily for 5 consecutive days in the treatment of acute bacterial sinusitis. The psychometric properties and factor structure of the 2 measures were assessed.
  
  
  METHODS
  Participants were given the measures to self-complete using either a telephone voice response system or a paper-and-pencil format.
  
  
  METHODS
  Three hundred seventy-four patients with acute bacterial sinusitis were used in the analysis. Patients received either a placebo or 400 mg moxifloxacin once daily. Patients were then reviewed at test of cure and follow-up. All analyses were conducted on a combined sample of placebo and active treatment patients.
  
  
  RESULTS
  The Sinonasal Outcome Test-16 was associated with minimal missing data at baseline but a higher proportion by test of cure. There was no evidence of floor or ceiling effects and no significant skew. The Activity Impairment Assessment also had low missing data at baseline and no obvious floor or ceiling effects, but the data were not normally distributed. Both measures had good internal consistency. Convergent and divergent validity as well as sensitivity and the minimally important difference are also reported.
  
  
  CONCLUSIONS
  The measures both have good psychometric properties and are suitable for use with patients with acute bacterial sinusitis. Both instruments are sensitive. The minimal important difference estimates for the Sinonasal Outcome Test-16 are quite high but are similar to estimates reported previously.
authors.affiliation: Oxford Outcomes, an ICON plc Company, Oxford, UK. nuz.quadri@oxfordoutcomes.com
authors.forename: Nuz
authors.initials: N
authors.lastname: Quadri
authors.forename: Andrew
authors.initials: A
authors.lastname: Lloyd
authors.forename: Karen N
authors.initials: KN
authors.lastname: Keating
authors.forename: Beenish
authors.initials: B
authors.lastname: Nafees
authors.forename: Jay
authors.initials: J
authors.lastname: Piccirillo
authors.forename: Diane
authors.initials: D
authors.lastname: Wild
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001372:Aza Compounds / Q000627:therapeutic use; D001424:Bacterial Infections / Q000188:drug therapy* / Q000503:physiopathology*; D015331:Cohort Studies; D004185:Disability Evaluation; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D017063:Outcome Assessment, Health Care; D011594:Psychometrics; D011804:Quinolines / Q000627:therapeutic use; D020127:Recovery of Function / Q000502:physiology; D015203:Reproducibility of Results; D057566:Self Report; D012852:Sinusitis / Q000188:drug therapy* / Q000382:microbiology / Q000503:physiopathology*
chemical_list: D000900:Anti-Bacterial Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D000077266:Moxifloxacin
keywords: Activity Impairment Assessment; Sinonasal Outcome Test-16; acute bacterial sinusitis; psychometric analyses