Validation of ‘ItchApp©’ in Poland and in the <scp>USA</scp>: multicentre validation study of an electronical diary for the assessment of pruritus

Schnitzler, C.; Rosen, Jordan; Szepietowski, Jacek C.; Reich, Adam; Yosipovitch, Gil; Reszke, Radomir; Nattkemper, Leigh; Osada, Nani; Pihan, David; Ständer, Sonja; Zeidler, Claudia

doi:10.1111/jdv.15300

Cited by 9 publications

(4 citation statements)

References 18 publications

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“…In another psychometric analysis, an ICC of 0.78 was noted for WI-NRS in patients with PN . Consistently, excellent reliability (ICC, 0.99) for WI-NRS has also been demonstrated in patients with chronic prurigo . Furthermore, the results of this study were in line with the ICC values reported for other PROs in patients with chronic itch (ICC between 0.74 and 0.87) …”

Section: Discussionsupporting

confidence: 89%

Worst Itch Numeric Rating Scale for Prurigo Nodularis

Kwatra,

Yosipovitch,

Kim

et al. 2024

JAMA Dermatol

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ImportancePrurigo nodularis (PN) is a debilitating skin disease characterized by the hallmark symptom of chronic itch; the intensity of itch in PN was assessed using the Worst Itch Numeric Rating Scale (WI-NRS) to evaluate the primary efficacy end point of 2 recent phase 3 studies of dupilumab treatment for PN.ObjectiveTo validate the psychometric properties and to determine the clinically meaningful improvement threshold for WI-NRS in patients with moderate to severe PN.Design, Setting, and ParticipantsIn this secondary analysis of the PRIME and PRIME2 trials, content validity of WI-NRS was assessed through in-depth patient interviews. Psychometric assessments used pooled data from masked, intention-to-treat (ITT) patients with PN from randomized, double-masked, and placebo-controlled studies. Psychometric assessments included test-retest reliability, construct validity, known-groups validity, and sensitivity to change in adult patients with moderate-to-severe PN. Thresholds for meaningful within-patient improvement in the WI-NRS score were determined using anchor and distribution-based approaches. Data were analyzed after completion of each study, December 2019 to November 2021 for PRIME and January 2020 to August 2021 for PRIME2.ExposuresDupilumab (300 mg) or placebo subcutaneously every 2 weeks for 24 weeks.Main outcomes and measuresWI-NRS score at specified time points up to 24 weeks after randomization.ResultsA total of 20 patients were included across the 2 studies (mean [SD] age, 49.3 [17.2] years; 11 female [55%]); 311 patients were included in the pooled intention-to-treat analysis (mean [SD] age, 49.5 [16.1] years; 203 female [65.3%]). The WI-NRS questions (20 of 20 patients), recall period (19 of 20 patients), and response scale (20 of 20 patients) were easy to understand and relevant for patients with PN. Adequate test-retest reliability was observed between screening and baseline (intraclass correlation coefficient = 0.72, using Patient Global Impression of Severity [PGIS] to define stable patients). Convergent and discriminant validity was supported by moderate to strong correlations (absolute r range = 0.34-0.73) with other conceptually related measures and weaker correlations (absolute r range = 0.06-0.32) with less-related measures, respectively. WI-NRS was sensitive to change, as demonstrated by differences in change from baseline among groups (per PGIS change and PGI of Change [PGIC]). Using anchor-based approach with PGIS and PGIC, the clinically meaningful improvement threshold was 4 points (range, 3.0-4.5), which was also supported by distribution-based methods.Conclusion and RelevanceThis study found that WI-NRS may be a fit-for-purpose instrument to support efficacy end points measuring the intensity of itching in adults with PN.Trial RegistrationNCT04183335 (PRIME) and NCT04202679 (PRIME2)

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Section: Discussionsupporting

confidence: 89%

Worst Itch Numeric Rating Scale for Prurigo Nodularis

Kwatra,

Yosipovitch,

Kim

et al. 2024

JAMA Dermatol

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“…The “ItchApp©” is like an e-Diary for the assessment of pruritus and has been validated in English, Polish, and German. [ 24 ]…”

Section: Classificationmentioning

confidence: 99%

Use of mobile applications in dermatology

Kaliyadan

Ashique²

2020

Indian J Dermatol

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Smartphones and applications related to the same are ubiquitous now. As dermatologists, we have a wide array of smartphone apps at our disposal which we can use to improve our practice in all aspects—clinical, academic, research, and administrative. This article provides an overview of available apps, tips on using apps—both general and specific for dermatology, as well as discusses the scientific validity of some of these apps and the future of smartphone apps in the context of dermatology.

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“…WI‐NRS does not attempt to take into account itch duration or the variability that is often experienced throughout the day and night by patients with chronic itch. The 24‐h average itch NRS (AI‐NRS) attempts to integrate the peaks and valleys of itch severity throughout a 24‐h period into a singular score 5. Our study aims to determine correlations between WI‐NRS and AI‐NRS and to determine the influence of itch duration on these measures.…”

Section: Worst Itch Nrs Average Itch Nrs Mean ± Sd Difference From ≥ mentioning

confidence: 99%