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. 2023 Oct;13(10):2403-2416.
doi: 10.1007/s13555-023-00999-9. Epub 2023 Aug 24.

Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo Nodularis

Shawn G Kwatra  1 , Danielle Rodriguez  2 , Carla Dias-Barbosa  3 , Ismail Budhiarso  4 , Fatoumata Fofana  5 , Margaret Vernon  6 , Sylvie Gabriel  7 , Christophe Piketty  7 , Jorge Puelles  7
Affiliations

Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo Nodularis

Shawn G Kwatra et al. Dermatol Ther (Heidelb). 2023 Oct.

Abstract

Introduction: Validated patient report tools for quantifying patient experiences of itch in prurigo nodularis (PN) are limited. This study aimed to evaluate the validity of the 11-point peak pruritus numerical rating scale (PP NRS) as a single-item patient-reported outcome (PRO) measure for assessing itch severity in PN.

Methods: Content validity of the PP NRS was evaluated through qualitative interviews with adults with PN. The PP NRS was then psychometrically evaluated using data from a placebo-controlled trial of nemolizumab in adults with PN, during which patients completed the PP NRS daily. Meaningful within-patient change was estimated from the qualitative interviews and by anchor- and distribution-based analyses of trial data.

Results: The interview participants (N = 21) all understood the PP NRS and reported itch as their worst symptom overall. The PP NRS showed good test-retest reliability and demonstrated convergent validity and known-groups validity. PP NRS scores improved more in patients classified as "improved" on other clinical outcome measures than in those classified as "worsened/unchanged". Triangulation of the different estimates identified a 2- to 5-point decrease in PP NRS score as a meaningful within-patient change threshold.

Conclusion: The PP NRS is a content-valid and reliable PRO measure for quantifying itch severity in adults with PN in clinical trials.

Trial registration number: NCT03181503.

Keywords: Itch; Nodular prurigo; Outcome measurement; Patients; Pruritus; Qualitative research; Quality of life.

Plain language summary

Prurigo nodularis is a skin disease where the skin becomes inflamed and very itchy. Itching and scratching can ruin the lives of people with prurigo nodularis. For doctors to know how well treatments for prurigo nodularis are working, they need to be able measure how bad their patients’ itching is. Here we tested whether a tool called the peak pruritus numeric rating scale (PP NRS) can be used to reliably measure itching in patients with prurigo nodularis. The PP NRS asks patients to rate their itch “at the worst moment during the previous 24 h” on a scale from 0 (“no itch”) to 10 (“worst itch imaginable”). We interviewed 21 patients with prurigo nodularis. Overall, itch was their worst symptom. They were able to use the PP NRS with few or no problems. To further explore whether the PP NRS can be used by patients with prurigo nodularis, we also obtained data from a clinical study. In this clinical study, patients with prurigo nodularis received a drug that might one day be used to treat their disease. They completed the PP NRS daily during the time they received the drug. When we analyzed the data from the clinical study, we found that the PP NRS has the properties a tool like this needs to be useful. We also concluded that a decrease of 2–5 points on the PP NRS scale would be a meaningful improvement in itching for patients with prurigo nodularis.

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Conflict of interest statement

Shawn G. Kwatra has received grants from Galderma, Incyte, Pfizer, and Sanofi, and consulting fees from AbbVie, Arcutis Biotherapeutics, Castle Biosciences, Celldex Therapeutics, Galderma, Incyte, Johnson & Johnson, Leo Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, and Sanofi. He has served on the Board of Directors of the Skin of Color Society. He was paid by Galderma for work relating to this study. Danielle Rodriguez, Carla Dias-Barbosa, Ismail Budhiarso, Fatoumata Fofana, and Margaret Vernon are employees of Evidera, which was paid by Galderma for work relating to this study. Sylvie Gabriel, Christophe Piketty, and Jorge Puelles are employees of Galderma, which funded this study and is currently sponsoring the development of nemolizumab for the treatment of prurigo nodularis.

References

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