How should minimally important change scores for the Patient-Oriented Eczema Measure be interpreted? A validation using varied methods

Howells, Laura; Ratib, Sonia; Chalmers, Joanne R; Bradshaw, Lucy; Kim, Thomas

doi:10.1111/bjd.16367

Cited by 28 publications

(49 citation statements)

References 22 publications

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“…These percentage values provide recommendations of how to interpret changes on an improvement in the CADIS and its domain scores (Table ). The suggested interpretation for the CADIS scores is in accordance with a previously published guide on change scores of the Patient‐Oriented Eczema Measure …”

Section: Discussionsupporting

confidence: 69%

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Evaluation of responsiveness and estimation of smallest detectable change and minimal important change scores for the Childhood Atopic Dermatitis Impact Scale

et al. 2019

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Summary Background The Childhood Atopic Dermatitis Impact Scale (CADIS) is an instrument to measure quality of life in young children affected by atopic dermatitis, and their parents. Objectives To evaluate the responsiveness (sensitivity to change), smallest detectable change (SDC) and minimal important change (MIC) of the CADIS. Methods Parents and primary caregivers of 300 young children completed the CADIS and a global rating of their child's skin condition at baseline and a 4‐week follow‐up. Kruskal–Wallis tests, Wilcoxon tests and effect sizes were used to assess responsiveness. The SDC can be seen as a change beyond measurement error. Anchor‐based and distribution‐based methods, and an integration of both methods were used to estimate the MIC. Results In total, 270 families provided data at baseline and 228 at follow‐up. The CADIS total change score and most of the domain scores had moderate‐to‐strong correlations with the skin change score. Patients were grouped according to the skin change score, which served as an anchor. Children whose parents noted an improvement of the skin showed lower CADIS scores at follow‐up (P < 0·001). For the SDC we obtained score changes of 1·34 points on the total score and < 1·0 points on each domain score. All detected MIC values passed the SDC cut‐off. Conclusions The CADIS is sensitive to change towards improvement of quality of life. A change > 12% on the total score or each domain score very likely represents a clinically important change. What's already known about this topic? Atopic dermatitis reduces the quality of life of affected children and their parents. The Childhood Atopic Dermatitis Impact Scale (CADIS) has been evaluated and translated into two further languages. What does this study add? Further validation of the responsiveness of the CADIS, and whether it is sensitive to change in patients whose condition had changed. Calculation of the smallest detectable change. What are the clinical implications of this work? Estimation of the minimal important change in CADIS provides benchmarks for clinical practice.

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Section: Discussionsupporting

confidence: 69%

“…If a change in CADIS scores is greater than the SDC, there is a 95% chance that the change in score is real and not just a random variation. Therefore, the MIC of the CADIS should be greater than the SDC to be useful and relevant …”

Section: Methodsmentioning

confidence: 99%

Evaluation of responsiveness and estimation of smallest detectable change and minimal important change scores for the Childhood Atopic Dermatitis Impact Scale

et al. 2019

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“…A systematic review that included studies looking at the measurement properties of POEM concluded that there was limited evidence for good internal consistency, moderate evidence for good construct validity, good responsiveness and good content validity, and unclear evidence of test–retest reliability and measurement error . Interpretation of POEM has been assessed in the form of the minimally important change and severity bandings . Pearson's correlation coefficients were used to assess the relationship between POEM (measuring patient‐reported symptoms) and the newly developed instrument.…”

Section: Methodsmentioning

confidence: 99%

Development and initial testing of a new instrument to measure the experience of eczema control in adults and children: Recap of atopic eczema ( RECAP )

et al. 2020

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Summary Background Eczema control has been identified as an important outcome by key stakeholders in eczema research (including patients, carers, healthcare professionals and researchers) but no validated instruments for the domain have been identified. Objectives To develop a measurement instrument to capture a patient's perspective of eczema control that is suitable for use in eczema clinical trials. Methods Best practice for the development of a patient‐reported outcome was followed. A mixed‐methods approach was used to develop and refine a conceptual framework, generate, refine and select items and to test the distribution and construct validity of the final scale. The mixed‐methods approach involved expert panel meetings (including patient representatives, healthcare professionals and methodologists), and data collection using a focus group, cognitive interviews and an online survey with people with eczema and caregivers. Multivariable linear regression was used in the item selection process. Results Fourteen expert panel members co‐produced the instrument, with input from people with eczema and caregivers via a focus group (n = 6), cognitive interviews (n = 13) and an online survey (n = 330). The resulting instrument, Recap of atopic eczema (RECAP), is a seven‐item questionnaire that captures eczema control via self or caregiver report. The development process aimed to ensure good content validity and feasibility. Initial testing suggested no floor or ceiling effects and good construct validity. Hypothesized correlation with the Patient‐Oriented Eczema Measure was confirmed [r(258) = 0·83, P < 0·001]. Conclusions RECAP has the potential to improve reporting of eczema control in research and clinical practice. Further exploration of measurement properties is required. Linked Comment: Pattinson and Bundy. Br J Dermatol 2020; 183:418–419. What's already known about this topic? Eczema control has been identified as an important outcome by key stakeholders in eczema research (including patients, carers, healthcare professionals and researchers). Qualitative studies suggest eczema control is a multifaceted and individual experience and no instrument has been identified that captures eczema control in this way. What does this study add? We have developed Recap of atopic eczema (RECAP), a seven‐item questionnaire to capture the experience of eczema control in all ages and eczema severities; there are two versions: a self‐reported version for adults and older children with eczema, and a caregiver‐reported version for younger children with eczema. Designed with input from people with eczema, caregivers and healthcare professionals to ensure good content validity. Initial testing of score distributions and construct validity suggests good measurement properties. What are the clinical implications of the work? The RECAP instrument is appropriate and feasible for measuring eczema control in clinical trials and may also be useful in routine practice.

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“…As we have four groups, we powered our sample size calculation to detect a clinically meaningful differences in six pairwise comparisons subsequent to a global test. We estimate that 416 participants (104 in each group) are required to detect a difference of 3.0 in POEM scores12 19 20 between any two groups with 90% power and a significance level of 0.05 (after adjustment for multiple pairwise comparisons). We assumed a SD of 5.5 (SD of 4.89 observed in feasibility trial21 to allow for greater variability in the data or smaller differences to be detected.…”

Section: Methods and Analysismentioning

confidence: 99%

Best emollients for eczema (BEE) – comparing four types of emollients in children with eczema: protocol for randomised trial and nested qualitative study

et al. 2019

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IntroductionAtopic dermatitis/eczema affects around 20% of children and is characterised by inflamed, dry, itchy skin. Guidelines recommend ‘leave-on’ emollients that are applied directly to the skin to add or trap moisture and used regularly, they can soothe, enhance the skin barrier and may prevent disease ‘flares’. However, the suitability of the many different emollients varies between people and there is little evidence to help prescribers and parents and carers decide which type to try first.Methods and analysisDesign: pragmatic, multicentre, individually randomised, parallel group superiority trial of four types of emollient (lotions, creams, gel or ointments).Setting: general practitioner surgeries in England.Participants: children aged over 6 months and less than 12 years with mild-to-severe eczema and no known sensitivity to study emollients.Interventions: study-approved lotion, cream, gel or ointment as the only leave-on emollient for 16 weeks, with directions to apply twice daily and as required. Other treatments, such as topical corticosteroids, used as standard care.Follow-up: 52 weeks.Primary outcome: validated patient-orientated eczema measure measured weekly for 16 weeks.Secondary outcomes: eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact).Sample size: 520 participants (130 per group).Analysis: intention-to-treat using linear mixed models for repeated measures.Nested qualitative study: audio-recording of sample of baseline appointments and up to 60 interviews with participants at 4 and 16 weeks, interviews to be transcribed and analysed thematically.Ethics and disseminationEthics approval granted by the NHS REC (South West - Central Bristol Research Ethics Committee 17/SW/0089). Findings will be presented at conferences, published in open-access peer-reviewed journals and the study website; and summaries shared with key stakeholders.Trial registration number ISRCTN84540529

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How should minimally important change scores for the Patient-Oriented Eczema Measure be interpreted? A validation using varied methods

Cited by 28 publications

References 22 publications

Evaluation of responsiveness and estimation of smallest detectable change and minimal important change scores for the Childhood Atopic Dermatitis Impact Scale

Evaluation of responsiveness and estimation of smallest detectable change and minimal important change scores for the Childhood Atopic Dermatitis Impact Scale

Development and initial testing of a new instrument to measure the experience of eczema control in adults and children: Recap of atopic eczema ( RECAP )

Best emollients for eczema (BEE) – comparing four types of emollients in children with eczema: protocol for randomised trial and nested qualitative study

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