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.
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 language | English |
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Journal | Skin Health and Disease |
Volume | 4 |
Issue number | 6 |
DOIs | |
Publication status | Published (VoR) - 26 Oct 2024 |