title: Quantifying clinical change: discrepancies between patients' and providers' perspectives.
abstract: Interpreting the clinical significance of changes in patient-reported outcomes (PROs) is critically important. The most commonly used approach is to anchor mean changes on PRO scores against a global assessment of change. Whether the assessor of global change should be patients or their physicians is unknown. We compared patients' and physicians' assessments of change over time to examine which was more aligned with patients' changes in PRO measures.
  
  
  
  A total of 459 chronic heart failure patients aged >30 years were enrolled from 13 US centers. Data were obtained by medical record abstraction, physical assessments, and patient interviews at a baseline clinic visit and 6 weeks later. Health status was measured with the disease-specific Kansas City Cardiomyopathy Questionnaire (KCCQ), and both patients and physicians completed a validated 15-level global assessment of change, ranging from large deterioration to large improvement.
  
  
  
  There was substantial variation between physicians/patients' global assessment of clinical change (weighted kappa = 0.36, 95 % CI 0.28, 0.43). Overall, physician assessments were more strongly correlated with change on the KCCQ summary score than were patients' assessments (physician R = 0.37, patient R = 0.29).
  
  
  
  There was substantial variation between patients' and physicians' global assessment of 6-week change in heart failure status. Physician assessments of the importance of clinical changes were more strongly associated with changes in all domains of patient-reported health status, as assessed by the KCCQ, and may provide a more consistent method for defining the clinical importance of changes in patients' health status.
authors.affiliation: Center for Outcomes Research and Evaluation (CORE), Yale-New Haven Hospital, New Haven, CT, USA.|Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
authors.forename: Rachel P
authors.initials: RP
authors.lastname: Dreyer
authors.affiliation: School of Medicine, Biomedical and Health Informatics, University of Missouri - Kansas City, Kansas City, MO, USA.|Saint Luke's Mid America Heart Institute, University of Missouri - Kansas City, 4401 Wornall Road, Kansas City, MO, 64111, USA.
authors.forename: Philip G
authors.initials: PG
authors.lastname: Jones
authors.affiliation: Department of Pediatrics, Children's Hospital and Medical Center, Omaha, NE, USA.
authors.forename: Shelby
authors.initials: S
authors.lastname: Kutty
authors.affiliation: School of Medicine, Biomedical and Health Informatics, University of Missouri - Kansas City, Kansas City, MO, USA. spertusj@umkc.edu.|Saint Luke's Mid America Heart Institute, University of Missouri - Kansas City, 4401 Wornall Road, Kansas City, MO, 64111, USA. spertusj@umkc.edu.
authors.forename: John A
authors.initials: JA
authors.lastname: Spertus
mesh_terms: D000368:Aged; D005260:Female; D006304:Health Status; D006333:Heart Failure / Q000503:physiopathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D011795:Surveys and Questionnaires
keywords: Clinical change; Heart failure; Kansas City Cardiomyopathy Questionnaire; Patient-reported outcome measures