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.

Abstract

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. This post hoc analysis included patients with gynecological malignant tumors in the Department of Oncology of our hospital between October 2020 and October 2021. 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. 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.