title: Single-day pain assessments as clinical outcomes: not so fast.
abstract: BACKGROUND
  Pain diaries are important tools for clinical trials and optimal assay sensitivity of outcomes derived from these diaries is a worthwhile goal. Jensen and colleagues recently reported results suggesting that single-day diary-based outcomes could possibly be as psychometrically sound as outcomes based on taking the average of many diaries.
  
  
  METHODS
  In this paper, we attempted to replicate those results with several diary data sets.
  
  
  CONCLUSIONS
  We come to a different conclusion than that advanced by Jensen and colleagues and conclude that their results were unusual in that very high test-retest reliability among days was found. With our 4 diary data sets we find that aggregating multiple diaries yields more reliable outcomes and improved sensitivity. We suggest that using single-day diaries will often lead to underpowered studies and that pretesting is advised before adopting single-day diaries. We also suggest that other researchers replicate these findings within their diary-based clinical trials.
authors.affiliation: *Department of Psychiatry and Behavioral Science, Stony Brook University, Stony Brook, NY †ERT Inc., Pittsburgh, PA.
authors.forename: Arthur A
authors.initials: AA
authors.lastname: Stone
authors.forename: Stefan
authors.initials: S
authors.lastname: Schneider
authors.forename: Joan E
authors.initials: JE
authors.lastname: Broderick
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Schwartz
mesh_terms: D001943:Breast Neoplasms / Q000188:drug therapy / Q000503:physiopathology; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008499:Medical Records; D064887:Observational Studies as Topic; D010003:Osteoarthritis / Q000503:physiopathology; D010146:Pain / Q000175:diagnosis / Q000503:physiopathology; D010147:Pain Measurement / Q000379:methods*; D011594:Psychometrics; D015203:Reproducibility of Results; D012216:Rheumatic Diseases / Q000503:physiopathology; D012680:Sensitivity and Specificity; D013997:Time Factors