Measures of health-related quality of life in diabetes-related foot disease: a systematic review.

Aims/hypothesis: Patient-reported outcome measures (PROMs) are increasingly used as key performance indicators in chronic illness. We sought to review the value of these tools in assessing health-related quality of life (HRQOL) in patients with diabetes-related foot disease and identify the impact of each foot problem on life quality.

Methods: A systematic review of literature on HRQOL PROMs in diabetes-related foot disease was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. The quality of eligible studies was evaluated within pre-existing criteria.

Results: 53 studies written between 1995 and 2010 met the inclusion criteria. A variety of HRQOL PROMs were used. Disease-specific tools were better than generic at quantifying temporal changes in life quality and showed greater sensitivity to ulcer/neuropathic severity. No studies have simultaneously evaluated disease-specific tools. Generic and utility HRQOL PROMs are frequently used as secondary outcome measures in randomised trials and cost-utility analysis. HRQOL is depressed in diabetes, further impaired by the presence of foot disease. Ulcer healing is associated with improvements in HRQOL. Patients with active ulceration report poorer HRQOL than those whom have undergone successful minor lower extremity amputation (LEA) but there is a paucity of quality data on HRQOL outcomes for diabetes-related LEA.

Conclusions/interpretation: No one PROM was identified as a 'gold standard' for assessing HRQOL in diabetes-related foot disease. Specific areas for further development include the most valid HRQOL PROM with disease-specific content; HRQOL outcomes in minor and major amputations and the role of HRQOL tools in routine clinical care.