Determining the minimal important change of the recap of atopic eczema (RECAP) instrument in clinical trials
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 m...
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| Format: | Article |
| Language: | English |
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Wiley
2024-12-01
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| Series: | Skin Health and Disease |
| Online Access: | https://doi.org/10.1002/ski2.470 |
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| author | Arabella Baker Beth Stuart Laura Howells Eleanor J. Mitchell Kim S. Thomas |
| author_facet | Arabella Baker Beth Stuart Laura Howells Eleanor J. Mitchell Kim S. Thomas |
| author_sort | Arabella Baker |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a5ecbe07278a45418a464323f6f0529a |
| institution | Kabale University |
| issn | 2690-442X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | Skin Health and Disease |
| spelling | doaj-art-a5ecbe07278a45418a464323f6f0529a2024-12-02T04:03:51ZengWileySkin Health and Disease2690-442X2024-12-0146n/an/a10.1002/ski2.470Determining the minimal important change of the recap of atopic eczema (RECAP) instrument in clinical trialsArabella Baker0Beth Stuart1Laura Howells2Eleanor J. Mitchell3Kim S. Thomas4Centre of Evidence Based Dermatology School of Medicine University of Nottingham Nottingham UKPragmatic Clinical Trials Unit Queen Mary University of London London UKCentre of Evidence Based Dermatology School of Medicine University of Nottingham Nottingham UKNottingham Clinical Trials Unit University of Nottingham Nottingham UKCentre of Evidence Based Dermatology School of Medicine University of Nottingham Nottingham UKAbstract 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.https://doi.org/10.1002/ski2.470 |
| spellingShingle | Arabella Baker Beth Stuart Laura Howells Eleanor J. Mitchell Kim S. Thomas Determining the minimal important change of the recap of atopic eczema (RECAP) instrument in clinical trials Skin Health and Disease |
| title | Determining the minimal important change of the recap of atopic eczema (RECAP) instrument in clinical trials |
| title_full | Determining the minimal important change of the recap of atopic eczema (RECAP) instrument in clinical trials |
| title_fullStr | Determining the minimal important change of the recap of atopic eczema (RECAP) instrument in clinical trials |
| title_full_unstemmed | Determining the minimal important change of the recap of atopic eczema (RECAP) instrument in clinical trials |
| title_short | Determining the minimal important change of the recap of atopic eczema (RECAP) instrument in clinical trials |
| title_sort | determining the minimal important change of the recap of atopic eczema recap instrument in clinical trials |
| url | https://doi.org/10.1002/ski2.470 |
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