PMID- 37553232 OWN - NLM STAT- MEDLINE DCOM- 20231106 LR - 20231106 IS - 1447-0756 (Electronic) IS - 1341-8076 (Linking) VI - 49 IP - 11 DP - 2023 Nov TI - 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. PG - 2711-2716 LID - 10.1111/jog.15769 [doi] AB - 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. CI - (c) 2023 Japan Society of Obstetrics and Gynecology. FAU - Fan, Tingting AU - Fan T AUID- ORCID: 0000-0002-0296-9515 AD - Oncology Department, Affiliated People's Hospital of Jiangsu University, Zhenjiang, China. FAU - Luo, Caifeng AU - Luo C AD - Department of Nursing, Medical College of Jiangsu University, Zhenjiang, China. LA - eng PT - Journal Article DEP - 20230808 PL - Australia TA - J Obstet Gynaecol Res JT - The journal of obstetrics and gynaecology research JID - 9612761 RN - 0 (Antiemetics) RN - 0 (Antineoplastic Agents) SB - IM MH - Humans MH - Female MH - Vomiting/chemically induced MH - *Antiemetics MH - *Antineoplastic Agents/therapeutic use MH - Minimal Clinically Important Difference MH - Quality of Life MH - Nausea/chemically induced MH - *Genital Neoplasms, Female/complications/drug therapy OTO - NOTNLM OT - CINV OT - FLIE OT - chemotherapy OT - gynecological malignancies OT - post hoc analysis EDAT- 2023/08/09 01:05 MHDA- 2023/11/06 06:43 CRDT- 2023/08/08 21:23 PHST- 2023/01/16 00:00 [received] PHST- 2023/07/26 00:00 [accepted] PHST- 2023/11/06 06:43 [medline] PHST- 2023/08/09 01:05 [pubmed] PHST- 2023/08/08 21:23 [entrez] AID - 10.1111/jog.15769 [doi] PST - ppublish SO - J Obstet Gynaecol Res. 2023 Nov;49(11):2711-2716. doi: 10.1111/jog.15769. Epub 2023 Aug 8.