Department of Obstetrics and Gynecology, Central Finland Central Hospital, Keskussairaalantie 19, 40620, Jyväskylä, Finland.
University of Eastern Finland, Kuopio, Finland.
Int Urogynecol J. 2021 Dec;32(12):3169-3176. doi: 10.1007/s00192-020-04513-z. Epub 2020 Sep 2.
Patient-reported outcome measures are fundamental tools when assessing effectiveness of treatments. The challenge lies in the interpretation: which magnitude of change in score is meaningful for the patients? The minimal important difference (MID) is defined as the smallest difference in score that patients perceive as important. The Patient Acceptable Symptom State (PASS) represents the value of score beyond which patients consider themselves well. We aimed to determine the MID and PASS for Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) in pelvic organ prolapse (POP) surgery.
We used data from 2704 POP surgeries from a prospective, population-based cohort. MID was determined with three anchor-based and one distribution-based method. PASS was defined using two different methods. Medians of the estimates were identified.
The MID estimates with (1) mean change, (2) receiver-operating characteristic (ROC) curve, (3) 75th percentile, and (4) distribution-based method varied between 22.9-25.0 (median 24.2) points for PFDI-20 and 9.0-12.5 (median 11.3) for POPDI-6. The PASS cutoffs with (1) 75th percentile and (2) ROC curve method varied between 57.7-62.5 (median 60.0) for PFDI-20 and 16.7-17.7 (median 17.2) for POPDI-6.
A mean difference of 24 points in the PFDI-20 or 11 points in the POPDI-6 can be used as a clinically relevant difference between groups. Postoperative scores ≤ 60 for PFDI-20 and ≤ 17 for POPDI-6 signify acceptable symptom state.
患者报告的结局测量是评估治疗效果的基本工具。挑战在于解释：分数的变化幅度对患者有多大意义？最小有意义差异（MID）定义为患者认为重要的最小分数差异。患者可接受的症状状态（PASS）表示患者认为自己状态良好的分数值。我们旨在确定盆腔器官脱垂（POP）手术中盆腔底部不适量表 20 项（PFDI-20）和盆腔器官脱垂困扰量表 6 项（POPDI-6）的 MID 和 PASS。
我们使用了来自前瞻性、基于人群队列的 2704 例 POP 手术的数据。使用三种基于锚定的方法和一种基于分布的方法确定 MID。使用两种不同的方法定义 PASS。确定估计值的中位数。
PFDI-20 的 MID 估计值（1）平均变化、（2）接受者操作特征（ROC）曲线、（3）第 75 百分位数和（4）基于分布的方法分别为 22.9-25.0（中位数 24.2）点，POPDI-6 的 MID 估计值为 9.0-12.5（中位数 11.3）点。PFDI-20 的 PASS 截断值（1）第 75 百分位数和（2）ROC 曲线方法分别为 57.7-62.5（中位数 60.0）点，POPDI-6 的 PASS 截断值为 16.7-17.7（中位数 17.2）点。
PFDI-20 中 24 分或 POPDI-6 中 11 分的平均差异可作为组间的临床相关差异。PFDI-20 术后评分≤60 分和 POPDI-6 术后评分≤17 分表示可接受的症状状态。
