title: A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation.
abstract: BACKGROUND
  Anticoagulation can reduce quality of life, and different models of anticoagulation management might have different impacts on satisfaction with this component of medical care. Yet, to our knowledge, there are no scales measuring quality of life and satisfaction with anticoagulation that can be generalized across different models of anticoagulation management. We describe the development and preliminary validation of such an instrument - the Duke Anticoagulation Satisfaction Scale (DASS).
  
  
  METHODS
  The DASS is a 25-item scale addressing the (a) negative impacts of anticoagulation (limitations, hassles and burdens); and (b) positive impacts of anticoagulation (confidence, reassurance, satisfaction). Each item has 7 possible responses. The DASS was administered to 262 patients currently receiving oral anticoagulation. Scales measuring generic quality of life, satisfaction with medical care, and tendency to provide socially desirable responses were also administered. Statistical analysis included assessment of item variability, internal consistency (Cronbach's alpha), scale structure (factor analysis), and correlations between the DASS and demographic variables, clinical characteristics, and scores on the above scales. A follow-up study of 105 additional patients assessed test-retest reliability.
  
  
  RESULTS
  220 subjects answered all items. Ceiling and floor effects were modest, and 25 of the 27 proposed items grouped into 2 factors (positive impacts, negative impacts, this latter factor being potentially subdivided into limitations versus hassles and burdens). Each factor had a high degree of internal consistency (Cronbach's alpha 0.78-0.91). The limitations and hassles factors consistently correlated with the SF-36 scales measuring generic quality of life, while the positive psychological impact scale correlated with age and time on anticoagulation. The intra-class correlation coefficient for test-retest reliability was 0.80.
  
  
  CONCLUSIONS
  The DASS has demonstrated reasonable psychometric properties to date. Further validation is ongoing. To the degree that dissatisfaction with anticoagulation leads to decreased adherence, poorer INR control, and poor clinical outcomes, the DASS has the potential to help identify reasons for dissatisfaction (and positive satisfaction), and thus help to develop interventions to break this cycle. As an instrument designed to be applicable across multiple models of anticoagulation management, the DASS could be crucial in the scientific comparison between those models of care.
authors.affiliation: Department of Biometry and Bioinformatics, Duke University Medical Center, Wachovia Plaza, Suite 220, 2200 West Main Street, Durham, NC 27705, USA. samsa001@mc.duke.edu
authors.forename: Greg
authors.initials: G
authors.lastname: Samsa
authors.forename: David B
authors.initials: DB
authors.lastname: Matchar
authors.forename: Rowena J
authors.initials: RJ
authors.lastname: Dolor
authors.forename: Ingela
authors.initials: I
authors.lastname: Wiklund
authors.forename: Ewa
authors.initials: E
authors.lastname: Hedner
authors.forename: Gail
authors.initials: G
authors.lastname: Wygant
authors.forename: Ole
authors.initials: O
authors.lastname: Hauch
authors.forename: Cheryl Beadle
authors.initials: CB
authors.lastname: Marple
authors.forename: Roger
authors.initials: R
authors.lastname: Edwards
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D017281:Cost of Illness; D005260:Female; D017144:Focus Groups; D006403:Hematologic Tests / Q000706:statistics & numerical data; D006801:Humans; D008134:Long-Term Care / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D010045:Outpatients / Q000523:psychology*; D010349:Patient Compliance / Q000523:psychology; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D011594:Psychometrics / Q000295:instrumentation* / Q000379:methods; D011788:Quality of Life / Q000523:psychology*; D018434:Sickness Impact Profile; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D014859:Warfarin