Clinically meaningful change in itch intensity scores: An evaluation in patients with chronic kidney disease–associated pruritus

Vernon, Margaret; Ständer, Sonja; Munera, Catherine; Spencer, Robert H.; Menzaghi, Frédérique

doi:10.1016/j.jaad.2020.06.991

Cited by 17 publications

(28 citation statements)

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“…The phase 2 dataset was used to assess psychometric validity. Pooled phase 3 trial data were used for confirmatory analyses and in an anchor-based analysis to verify the meaningful change threshold previously established with phase 2 data [ 13 ]. Eligibility criteria for patients in the phase 2 (N = 174) and phase 3 (N = 848) trials were similar to the content validity interviews, although patients were additionally required to self-report baseline pruritus severity of ≥ 4 on the WI-NRS (calculated as the average of the daily WI-NRS scores collected over a 7-day run-in period) [ 23 – 25 ].…”

Section: Methodsmentioning

confidence: 99%

“…The anchor-based methods and meaningful change threshold for the phase 2 cohort have been previously published [ 13 ]. The same anchor-based approach was used to define the point-change on the WI-NRS (change from baseline to end of treatment) that represented a clinically meaningful improvement to patients in the pooled phase 3 cohort.…”

Section: Methodsmentioning

confidence: 99%

“…Thus, the goal of the present study was to evaluate the content validity and psychometric properties of the WI-NRS in hemodialysis patients with CKD-aP based on qualitative interviewing and quantitative methodologies, as well as to confirm our earlier estimated meaningful change threshold [ 13 ] using anchor-based analyses and mixed methods exit interviews.…”

Section: Introductionmentioning

confidence: 93%

“…The Worst Itching Intensity NRS (WI-NRS) is a simple-to-use, single-item PRO [ 13 , 14 ]. Patients indicate the intensity of the worst itching they have experienced over the past 24 h by marking one of 11 numbers—from 0 to 10—that best describe the worst itching experiences (“0” labeled with the anchor phrase “no itching” and “10” labelled “worst itching imaginable”).…”

Section: Introductionmentioning

confidence: 99%

“…This WI-NRS has been validated for dermatologic conditions like psoriasis [ 15 , 16 ] and atopic dermatitis [ 14 ] but not for systemic pruritus like CKD-aP. We previously identified that a reduction of ≥ 3 points on the WI-NRS represented a clinically meaningful response to treatment with the selective kappa opioid receptor agonist difelikefalin in hemodialysis patients with moderate-to-severe pruritus [ 13 ]. However, gaps remain in our understanding of the measure’s content validity from patients’ perspectives as well as its other psychometric properties, including test–retest reliability and whether it mirrors other methods of measuring changes in itch (i.e., known-groups validity).…”

Section: Introductionmentioning

confidence: 99%

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Psychometric validation and meaningful change thresholds of the Worst Itching Intensity Numerical Rating Scale for assessing itch in patients with chronic kidney disease-associated pruritus

Vernon

Swett

Speck

et al. 2021

J Patient Rep Outcomes

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Background Chronic kidney disease-associated pruritus (CKD-aP) is characterized by persistent itch that often leads to substantially impaired quality of life. The Worst Itching Intensity Numerical Rating Scale (WI-NRS) is a single-item patient-reported outcome measure in which patients indicate the intensity of the worst itching they experienced over the past 24 h. Here, we evaluated the content validity and psychometric properties of the WI-NRS and confirmed the threshold of meaningful change in hemodialysis patients with moderate-to-severe CKD-aP. Methods Content validity interviews were conducted in 23 patients. Psychometric properties of the WI-NRS were assessed using data from one phase 2 (N = 174) and two phase 3 (N = 848) clinical trials investigating an anti-pruritic treatment. Anchor-based methods were used to confirm meaningful within-patient change score thresholds in the phase 3 trial patients and mixed-method exit interviews (N = 70) contributed further insight. Results Content validity interviews indicated patients considered the WI-NRS to be straightforward, comprehensive, and relevant. Test–retest reliability was strong in both trial cohorts (intraclass correlation coefficients > 0.75). Construct validity analyses indicated high correlation between the WI-NRS and other measures of itch. Anchor-based analyses showed a reduction of ≥ 3 points from baseline score represented an appropriate clinically meaningful within-patient change on the WI-NRS. In the exit interviews, all patients with a reduction ≥ 3 points considered the change meaningful. Conclusions The WI-NRS is a reliable, valid, and responsive measure of itch intensity for patients with moderate-to-severe CKD-aP. These results support its use to assess treatment efficacy and in clinical evaluation and management of pruritus in hemodialysis patients.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 93%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Psychometric validation and meaningful change thresholds of the Worst Itching Intensity Numerical Rating Scale for assessing itch in patients with chronic kidney disease-associated pruritus

Vernon

Swett

Speck

et al. 2021

J Patient Rep Outcomes

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Credibility and Generalization of the Minimally Important Difference Concept in Dermatology

et al. 2022

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ImportanceThe minimally important difference (MID) represents the point at which a difference in an outcome measure (eg, Dermatology Life Quality Index) is important enough that it warrants a change in treatment, and, to the authors’ knowledge, the robustness and limitations of MIDs have not been thoroughly evaluated in skin diseases. The MID is increasingly used in clinical trials to demonstrate that an intervention is worthwhile for patients; furthermore, MIDs also contribute to sample size calculations in clinical trials, influence treatment guidelines, and can guide clinicians to modify treatment.ObjectiveTo evaluate the credibility and generalization of MIDs for patient-reported outcome measures (PROMs) in skin disorders.Evidence ReviewA systematic search was conducted in PubMed and Embase for all original articles using the MID concept for skin disorders from inception to December 29, 2021. The credibility of MIDs obtained via an anchor-based approach (eg, global rating of change scale) was assessed with a previously developed credibility instrument. The validity of generalizing established MIDs to other patient groups was evaluated based on the diagnosis and the patient characteristics.FindingsA total of 126 articles were selected, and 84 different MIDs were identified for PROMs. A total of 13 of 84 MIDs (15.5%) for PROMs displayed acceptable credibility. The anchors used had varying capacity to assess minimal important changes from a patient’s perspective and were deemed inappropriate for this purpose in 52 of 84 cases (61.9%). Correlations between the anchors and PROMs were frequently not determined (39 of 84; 46.4%). The time interval for anchor questions assessing a change in the experienced disease burden was not optimal for 10 of 32 transition anchors (&gt;3 months), introducing potential recall bias. Previously reported MIDs were widely used to examine relevant changes in other study populations. However, the diagnosis and disease severity were different from the original MID population in 39 of 70 (55.7%) and 45 of 70 (64.3%) cases, respectively.Conclusions and RelevanceIn this scoping review, only a minority of MIDs for PROMs demonstrated sufficient credibility in dermatology. Inappropriate generalization of previously reported MIDs to patient populations with different disease characteristics was found to be a major concern. Furthermore, the study supported the use of multiple anchors and encouraged consistent reporting of the correlation between changes in the anchor and changes in the outcome measures.

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Difelikefalin in pruritus associated with chronic kidney disease: a profile of its use

Lamb

2022

Drugs Ther Perspect

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Clinically meaningful change in itch intensity scores: An evaluation in patients with chronic kidney disease–associated pruritus

Abstract: The importance of a full clinical examination: assessment of index lesions referred to a skin cancer clinic without a total body skin examination would miss one in three melanomas.

Cited by 17 publications

References 5 publications

Psychometric validation and meaningful change thresholds of the Worst Itching Intensity Numerical Rating Scale for assessing itch in patients with chronic kidney disease-associated pruritus

Psychometric validation and meaningful change thresholds of the Worst Itching Intensity Numerical Rating Scale for assessing itch in patients with chronic kidney disease-associated pruritus

Credibility and Generalization of the Minimally Important Difference Concept in Dermatology

Difelikefalin in pruritus associated with chronic kidney disease: a profile of its use

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