Validation of two generic patient-reported outcome measures in patients with type 2 diabetes.
BACKGROUND
Prior to using a generic patient-reported outcome measure (PRO), the measure should be validated within the target population. The purpose of the current study was to validate two generic measures in patients with type 2 diabetes.


METHODS
Patients with type 2 diabetes in Scotland and England completed two generic measures: EQ-5D and Psychological General Well-Being Index (PGWB). Two diabetes-specific measures were administered: ADS and DSC-R. Analyses assessed reliability and validity.


RESULTS
There were 130 participants (53 Scotland; 77 England; 64% male; mean age = 55.7 years). Responses on the EQ-5D and PGWB reflected moderate impairment consistent with previous diabetes samples: mean EQ-5D Index score, 0.75; EQ-5D VAS, 68.8; PGWB global score, 67.9. All scales of the PGWB demonstrated good internal consistency reliability (Cronbach's alpha = 0.77 to 0.97). The EQ-5D and PGWB demonstrated convergent validity through significant correlations with the ADS (r = 0.48 to 0.61), DSC-R scales (r = 0.33 to 0.81 except ophthalmology subscale), and Body Mass Index (r = 0.15 to 0.38). The EQ-5D and PGWB discriminated between groups of patients known to differ in diabetes-related characteristics (e.g., history of hypoglycemia).


CONCLUSIONS
Results support the use of the EQ-5D and PGWB among patients with type 2 diabetes, possibly in combination with condition-specific measures.
Matza
Louis S
LS
Center for Health Outcomes Research at United BioSource Corporation, Bethesda, MD, USA. louis.matza@unitedbiosource.com
Boye
Kristina S
KS
Yurgin
Nicole
N
D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000503:physiopathology / Q000523:psychology* / Q000628:therapy; D004739:England; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011594:Psychometrics / Q000295:instrumentation*; D011788:Quality of Life; D012606:Scotland; D018434:Sickness Impact Profile; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires