Determining the minimal important change of the recap of atopic eczema (RECAP) instrument in clinical trials

Arabella Baker (Corresponding / Lead Author), Beth Stuart, Laura Howells, Eleanor Mitchell, Kim Thomas

    Research output: Contribution to journalArticlepeer-review

    Abstract

    Background:
    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.

    Objectives:
    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.

    Methods: 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.

    Results: 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.

    Conclusions: 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.
    Original languageEnglish
    JournalSkin Health and Disease
    Volume4
    Issue number6
    DOIs
    Publication statusPublished (VoR) - 26 Oct 2024

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