Minimal clinically important difference of the Functional Living Index-Emesis in patients with gynecological malignant tumor: A post hoc analysis of a single-arm study

Aim: This study aimed to explore the impact of minimum clinically important difference (MCID) of the Functional Living Index-Emesis (FLIE) in patients with gynecologic malignancies. Method: This post hoc analysis included patients with gynecological malignant tumors in the Department of Oncology of our hospital between October 2020 and October 2021. Results: A total of 149 patients (aged 50.05 +/- 12.24 years) were included. Most of the patients were married (75.8%), lived in the city (60.4%), and had a history of motion sickness (75.8%). The degree of nausea (9.00 [0.00, 16.00] vs. 30.00 [16.00, 48.00], P < 0.001) and vomiting (9.00 [0.00, 16.00] vs. 30.00 [16.00, 48.00], P < 0.001) were significantly improved after treatment. Taking the options in the scale as the subjective anchor, the MCID of FLIE for nausea and vomiting were 28.5 and 29 in anchor-based analysis, respectively. In the distribution-based analysis, the MCID of FLIE for nausea and vomiting were 2.41, 6.04, and 9.66; and 2.31, 5.78, and 9.24 in effect size of 0.2, 0.5, and 0.8, respectively. Conclusion: The MCID of FLIE for nausea and vomiting in patients with gynecological malignant tumors was 28.5 and 29 in the anchor-based analysis, with higher specificity, and 6.04 and 5.78 in the distribution-based analysis, with higher sensitivity. The development of the MCID scale might be used to interpret the clinical significance of chemotherapy-induced nausea and vomiting in patients with gynecological malignancies and help to calculate the sample size for future clinical trials.