Responsiveness and minimal clinically important difference of the EQ-5D-5L in cervical intraepithelial neoplasia: a long

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RESEARCH

Responsiveness and minimal clinically important difference of the EQ‑5D‑5L in cervical intraepithelial neoplasia: a longitudinal study Xin Hu1, Mingxia Jing1*  , Mei Zhang1, Ping Yang2 and Xiaolong Yan1

Abstract  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 minimal detectable change (MDC). Methods:  We conducted 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 EQ5D-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 the effect size (ES) and the 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  18  years; (3) Han ethnicity; (4) untreated before the baseline investigation; (5) the ability to express inner feelings clearly; (6) no severe comorbidities, mental illness, or cognitive impairment; and (7) willing to participate in this study. Exclusion criteria were (1) no CIN-related surgical treatment during hospitalization and (2) the establishment of invasive cervical cancer as the pathological diagnosis upon discharge. The baseline investigation was conducted through faceto-face interviews with patients when they were admitted, and the follow-up visit was performed one month after the surgery by telephone. The same investigator was responsible for both surveys. Investigators were postgraduates with a medical background and had been trained professionally.

Hu et al. Health Qual Life Outcomes

(2020) 18:324

Measurement Demographic and medical characteristics

Age, marital status, education level, body mass index (BMI), medical insurance, and household income were obtained through face-to-face interviews with patients. The disease duration, histopathological results, and surgical approach were collected through electronic medical records. EQ‑5D‑5L and Global Rating of Change Questionnaire (GRCQ)

The EQ-5D-5L consists of a short descriptive system and the E