Determining the Minimal Important Change of the Recap of Atopic Eczema (RECAP) Instrument in Clinical Trials

Baker, Arabella and Stuart, Beth and Howells, Laura and Mitchell, Eleanor J. and Thomas, Kim S. (2024) Determining the Minimal Important Change of the Recap of Atopic Eczema (RECAP) Instrument in Clinical Trials. Skin Health and Disease, 4 (6). ISSN 2690-442X

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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.

Item Type: Article
Identification Number: 10.1002/ski2.470
Dates:
Date
Event
11 October 2024
Accepted
26 October 2024
Published Online
Subjects: CAH02 - subjects allied to medicine > CAH02-04 - nursing and midwifery > CAH02-04-01 - nursing (non-specific)
Divisions: Faculty of Health, Education and Life Sciences > College of Nursing and Midwifery
Depositing User: Gemma Tonks
Date Deposited: 14 Jan 2025 10:49
Last Modified: 14 Jan 2025 10:49
URI: https://www.open-access.bcu.ac.uk/id/eprint/16075

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