Comparing PROMIS-29 to SF-12 in Evaluating Quality of Life in Patients with Diabetes-Related Foot Disease

BACKGROUND: With the increasing prevalence of diabetes mellitus (DM), DM-related foot disease (DFD) is an underappreciated problem with far-reaching consequences. Understanding the impact of DFD on clinical outcomes and patient-reported quality of life (QOL) is an important step for improving patient care. Historically, the 12-item Short Form (SF-12) has been commonly used to evaluate QOL in this population. However, with recent innovations in survey methods such as in the Patient-Reported Outcomes Measurement Information System (PROMIS) and computer adaptive testing (CAT), these emerging surveys should be evaluated and compared to the legacy surveys for effectiveness in measuring patient QOL. OBJECTIVE: The aim of this research was to describe patient-reported quality of life in those with and without DFD using the SF-12 and the PROMIS-29. METHODS: All patients included in the study were treated in a foot and ankle clinic in a tertiary care hospital and completed both the SF-12 and the PROMIS surveys. Patients who did not complete both surveys during the same clinic visit were not included. Patient-reported QOL was compared statistically between those with and without DFD. RESULTS: One-hundred fifty patients were included in the study. Seventy-two (48%) had DFD. Between groups, those with DFD were younger, more often male, and had poorer DM-related parameters. Patient responses on the SF-12 and PROMIS surveys correlated significantly on most parameters including SF-12 mental component summary (MCS-12) and PROMIS Depression and Anxiety subscales as well as SF-12 physical component summary (PCS-12) and PROMIS physical function. However, when evaluating ceiling and floor effects, the PROMIS survey was found to have a longer ceiling effect in patients with DFD than the SF-12. CONCLUSION: The PROMIS survey correlates well with the legacy standard, SF-12, for patient-reported QOL in those with and without DFD. In addition, the PROMIS survey may be less sensitive to ceiling effects correlated with the effects of DFD on physical and mental health, potentially being a more effective tool than SF-12 for long-term monitoring of patient QOL. In addition, the technologic advance of CAT in surveys, the patient burden of repeated survey evaluation may be diminished.