A Systematic Review of Patient Reported Outcome Measures (PROMs) for Patients with Chronic Limb Threatening Ischemia
Goodney, P., Shah, S., Hu, Y. D., Suckow, B., Kinlay, S., Armstrong, D. G., Geraghty, P., Patterson, M., Menard, M., Patel, M. R., and Conte, M. S.
Chronic limb-threatening ischemia (CLTI) causes significant morbidity with profound negative effects on health-related quality of life. As the prevalence of peripheral artery disease and diabetes continue to rise in our aging population, the public health impact of CLTI has escalated. Patient-reported outcome measures (PROMs) have become common and important measures for clinical evaluation in both clinical care and research. PROMs are important for measurement of clinical effectiveness, cost effectiveness, and for shared decision making on treatment options. However, the PROMs used to describe the experience of patients with CLTI are heterogeneous, incomplete, and lack specific applicability to the underlying disease processes and diverse populations. For example, certain PROMs exist for patients with extremity wounds, while other PROMs exist for patients with pain, while still others exist for patients with vascular disease. Despite this multiplicity of tools, no single PROM encompasses all of the components necessary to describe the experiences of patients with CLTI. This significant unmet need is evident from both published reports and contemporary large-scale clinical trials in the field. In this systematic review, we review the current use of PROMs for patients with CLTI in clinical practice and in research trials and highlight the gaps which need to be addressed to develop a unifying PROM instrument for CLTI.