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
Preview |
Text
skinhd_4_6_e470.pdf - Published Version Available under License Creative Commons Attribution. Download (597kB) |
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 |
Actions (login required)
![]() |
View Item |