Baker Arabella, Stuart Beth, Howells Laura, Mitchell Eleanor J, Thomas Kim S
Centre of Evidence Based Dermatology School of Medicine University of Nottingham Nottingham UK.
College of Nursing and Midwifery Birmingham City University Birmingham UK.
Skin Health Dis. 2024 Oct 26;4(6):e470. doi: 10.1002/ski2.470. eCollection 2024 Dec.
The Recap of atopic eczema (RECAP) is a patient-reported instrument designed to assess eczema control. There is a lack of evidence on the interpretability of change scores in clinical trials.
To calculate the smallest detectable change (SDC) in RECAP and estimate the minimal important change (MIC) for RECAP using various calculation methods in three eczema clinical trial datasets.
In this study, four anchor-based methods (within-person score change, between-patient score change, predictive modelling, receiver operating characteristic curve) and a distribution-based method (effect size) was used to determine the MIC of RECAP. The trial datasets involved children (0-12 years), young people (13-25 years) and adults (>25 years) with all eczema severities.
A total of 698 participants were included in this study. The SDC was between 1.74 and 1.80. For the anchor-based methods, the patient global assessment anchor provided MIC values ranging from 2.35 to 3.94 and the patient oriented eczema measure anchor yielded values between 1.11 and 3.62. The MIC for the distribution-based method ranged from 2.66 to 3.06, respectively.
The interpretability of RECAP was improved by establishing MIC values and the following thresholds are suggested for interpreting changes in RECAP scores: <2.0 points is possibly a measurement error; 2.0-2.9 points denotes a small improvement that may be clinically relevant; 3.0-3.9 points indicates an improvement that is likely to be clinically important and ≥4.0 points is highly likely to represent a clinically important change.
特应性皮炎回顾性评估（RECAP）是一种患者报告的用于评估湿疹控制情况的工具。目前缺乏关于临床试验中变化分数可解释性的证据。
在三个湿疹临床试验数据集中，使用多种计算方法计算RECAP的最小可检测变化（SDC），并估计RECAP的最小重要变化（MIC）。
在本研究中，采用四种基于锚定的方法（个体内分数变化、患者间分数变化、预测模型、受试者操作特征曲线）和一种基于分布的方法（效应量）来确定RECAP的MIC。试验数据集涉及所有严重程度的儿童（0至12岁）、年轻人（13至25岁）和成年人（>25岁）。
本研究共纳入698名参与者。SDC在1.74至1.80之间。对于基于锚定的方法，患者整体评估锚定得出的MIC值在2.35至3.94之间，患者导向性湿疹测量锚定得出的值在1.11至3.62之间。基于分布的方法得出的MIC分别在2.66至3.06之间。
通过建立MIC值提高了RECAP的可解释性，建议使用以下阈值来解释RECAP分数的变化：<2.0分可能是测量误差；2.0 - 2.9分表示可能具有临床相关性的小改善；3.0 - 3.9分表明可能具有临床重要性的改善，≥4.0分极有可能代表具有临床重要性的变化。
