Patient-assessed health outcome measures for diabetes: a structured review.

AIMS: To identify available disease-specific measures of health-related quality of life (HRQL) for diabetes and to review evidence for the reliability, validity and responsiveness of instruments. METHODS: Systematic searches were used to identify instruments. Instruments were assessed against predefined inclusion and exclusion criteria. Letters were sent to authors requesting details of further instrument evaluation. Information relating to instrument content, patients, reliability, validity and responsiveness to change was extracted from published papers. RESULTS: The search produced 252 references. Nine instruments met the inclusion criteria: Appraisal of Diabetes Scale (ADS), Audit of Diabetes-Dependent Quality of Life (ADDQoL), Diabetes Health Profile (DHP-1, DHP-18), Diabetes Impact Measurement Scales (DIMS), Diabetes Quality of Life Measure (DQOL), Diabetes-Specific Quality of Life Scale (DSQOLS), Questionnaire on Stress in Diabetic Patients-Revised (QSD-R), Diabetes-39 (D-39) and Well-being Enquiry for Diabetics (WED). The shortest instrument (ADS) has seven items and the longest (WED) has 50 items. The ADS and ADDQoL are single-index measures. The seven multidimensional instruments have dimensions covering psychological well-being and social functioning but vary in the remainder of their content. The DHP-1 and DSQOLS are specific to Type 1 diabetes patients. The DHP-18 is specific to Type 2 diabetes patients. The DIMS and DQOL have weaker evidence for reliability and internal construct validity. Patients contributed to the content of the ADDQoL, DHP-1/18, DQOL, DSQOLS, D-39, QSD-R and WED. The authors of the ADDQoL, DHP-1/18, DQOL, DSQOLS gave explicit consideration to content validity. The construct validity of instruments was assessed through comparisons with instruments measuring related constructs and clinical and sociodemographic variables. None of the instruments has been formally assessed for responsiveness to changes in health. CONCLUSIONS: Five of the diabetes-specific instruments have good evidence for reliability and internal and external construct validity: the ADDQoL, DHP-1/18, DSQOLS, D-39 and QSD-R. Instrument content should be assessed for relevance before application. The instruments should be evaluated concurrently for validity and responsiveness to important changes in health.