Patient-Reported Outcome Measures of Quality of Life in People Affected by Diabetic Foot: A Psychometric Systematic Review.

OBJECTIVES: This psychometric systematic review aimed to identify the most suitable patient-reported outcome measures (PROMs) of quality of life (QoL) in people affected by diabetic foot. METHODS: We performed a literature search in MEDLINE (PubMed), CINAHL (EBSCOhost), and PsycINFO (EBSCOhost) databases from inception to February 1, 2022. We also searched gray literature databases. Eligible studies were full-text reports developing a QoL condition-specific PROM or assessing one or more of its measurement properties in people affected by diabetic foot. We assessed the methodological quality of included studies independently using the "Consensus-Based Standards for the Selection of Health Measurement Instruments Risk of Bias" checklist. The measurement properties were evaluated using specific criteria. We graded the quality of the evidence using a "Grading of Recommendations Assessment, Development and Evaluation" approach modified by Consensus-Based Standards for the Selection of Health Measurement Instruments. RESULTS: Forty-three reports (46 studies) providing information on the measurement properties of 10 different PROMs were included. We did not identify any instruments that could be recommended for use. We identified 2 PROMs that were not recommended for use and 8 that were potentially recommended but would require further investigation. Of these 8 PROMs, 4 had better evidence for content validity. CONCLUSIONS: Available PROMs to measure QoL in people affected by diabetic foot have limited evidence for their measurement properties. There is no fully suitable PROM. Pending further evidence, 4 PROMs could potentially be recommended for use.