Establishing clinical thresholds for PROMs in foot and ankle surgery enhancing interpretability of SEFAS and EQ-5D: a national register study

Interpreting patient-reported outcomes (PROMs) is enhanced by establishing clinical threshold values. This study determined the minimal important change (MIC), patient acceptable symptom state (PASS), treatment failure (TF) thresholds and responsiveness for the Self-reported Foot and Ankle Score (SEFAS) and the EuroQol 5 Dimensions (EQ-5D) in patients from the Swedish National Foot and Ankle Register (Swefoot). A cohort of 139 randomly selected patients (mean age 55, SD:13; 60% women) from Swefoot (2021- 2024) was analyzed. MIC, PASS and TF thresholds were estimated using anchor-based adjusted predictive modelling with logistic regression. Responsiveness was evaluated using effect size (ES), calculated as the mean change divided by the preoperative standard deviation. Results For forefoot disorders, SEFAS thresholds were: MIC 7.2, PASS 36.3 and TF 30.7. For ankle/hindfoot disorders, corresponding thresholds were: MIC 8.8, PASS 33.7 and TF 32.5. EQ-5D thresholds for forefoot disorders were: MIC 0.09, PASS 0.67 and TF 0.70; for ankle/hindfoot disorders: MIC 0.16, PASS 0.77 and TF 0.76. SEFAS responsiveness was 1.31 for forefoot and 1.64 for ankle/hindfoot; EQ-5D responsiveness was 0.69 and 0.97, respectively. Conclusion: The established thresholds enhance the interpretability and clinical utility of SEFAS and EQ-5D in patients undergoing foot and ankle surgery. III