Background: With the widespread clinical application of the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L), whether the questionnaire scores are responsive to changes in patients’ health and how much changes in questionnaire scores represent patients’ real health changes require consideration. Consequently, we assessed responsiveness and estimated the minimal clinically important difference (MCID) of the EQ-5D-5L in surgically treated patients with cervical intraepithelial neoplasia (CIN) to determine the relationship between MCID and minimum detectable change (MDC).Methods: This was a longitudinal, observational study. Participants were patients with CIN from the gynecology inpatient department of a grade-A tertiary hospital in Shihezi, Xinjiang, China. Participants completed the EQ-5D-5L and the Global Rating of Change Questionnaire (GRCQ) at baseline and one month post-surgery. The Wilcoxon signed-rank test was used to compare EQ-5D-5L scores pre- and post-treatment. We calculated effect size (ES) and standardized response mean (SRM) to quantitatively assess responsiveness. Distribution-based, anchor-based, and instrument-defined methods were used to estimate MCID. MCID to MDC ratios at individual- and group-levels were also calculated.Results: Fifty patients with CIN completed the follow-up investigation (mean age 44.76 ± 8.72 years; mean follow-up time 32.28 ± 1.43 days). The index value and EQ visual analogue scale (EQ VAS) of the EQ-5D-5L improved by 0.025 and 6.92 (all p < 0.05) at follow-up as compared to baseline, respectively. ES and SRM of the index value were 0.47 and 0.42, respectively, indicating small responsiveness; while ES and SRM of EQ VAS were 0.50 and 0.49, respectively, indicating small to moderate responsiveness. The average (range) of MCIDs for index value and EQ VAS were 0.039 (0.023–0.064) and 5.35 (3.12–6.99), respectively, which can only be used for determining whether patients have experienced clinically meaningful health improvements at the group level. Conclusions: The EQ-5D-5L has only small to moderate responsiveness in post-surgical patients with CIN, and the MCIDs developed in this study can be used for group-level health assessment. However, further study is needed concerning health changes at the individual level. Keywords Responsiveness; MCID; EQ-5D-5L; CIN; MDC
Background: With the application of the EQ-5D-5L in clinic, whether the questionnaire scores can responsive to changes in patients' health and how much changes in questionnaire scores represents the real health change are gradually concerned. So the aims of the study were to assess the responsiveness and estimate MCID of the EQ-5D-5L in surgically treated CIN patients, and to analyze the relationship between MCID and MDC.Methods: This is a longitudinal observational study. Participants were CIN patients from the gynecology inpatient department of a Grade-A Tertiary Hospital in Shihezi, Xinjiang, China, which completed the EQ-5D-5L and the GRCQ at baseline and 1 month after the surgery. Wilcoxon signed-rank test was used to compare scores of the EQ-5D-5L before and after treatment. We calculated ES and SRM to assess the responsiveness quantitatively. Distribution-based, anchor-based and instrument-defined methods were used to estimate MCID. And ratios of MCID to MDC at individual and group levels were calculated. Results: 50 CIN patients completed follow-up investigate with mean (SD): age 44.76 (8.72) years; follow-up time 32.28 (1.43) days. The UI and EQ VAS of the EQ-5D-5L improved by 0.025 and 6.92 (all p <0.05) at follow-up compared baseline, respectively. ES and SRM of UI were 0.47 and 0.42, indicating small responsiveness, while ES and SRM of EQ VAS were 0.50 and 0.49, indicating small to medium responsiveness. The average (range) of MCIDs for UI and EQ VAS were 0.039 (0.023, 0.064) and 5.35 (3.12, 6.99), which can only be used for determing whether patients have experienced clinically meaningful improvement in health at group level. Conclusion: The EQ-5D-5L has only small responsiveness in patients with CIN after surgery, and MCIDs developed in this study can be used for health assessment at group level. Further study is needed on MCID that can be used at individual level. Keywords Responsiveness; MCID; EQ-5D-5L; CIN; MDC
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