Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo Nodularis
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...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2023-08-01
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| Series: | Dermatology and Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/s13555-023-00999-9 |
| _version_ | 1797669581135806464 |
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| author | Shawn G. Kwatra Danielle Rodriguez Carla Dias-Barbosa Ismail Budhiarso Fatoumata Fofana Margaret Vernon Sylvie Gabriel Christophe Piketty Jorge Puelles |
| author_facet | Shawn G. Kwatra Danielle Rodriguez Carla Dias-Barbosa Ismail Budhiarso Fatoumata Fofana Margaret Vernon Sylvie Gabriel Christophe Piketty Jorge Puelles |
| author_sort | Shawn G. Kwatra |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T20:46:29Z |
| format | Article |
| id | doaj.art-8668cff2f7af41c59c45275eeb2a3f45 |
| institution | Directory Open Access Journal |
| issn | 2193-8210 2190-9172 |
| language | English |
| last_indexed | 2024-03-11T20:46:29Z |
| publishDate | 2023-08-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Dermatology and Therapy |
| spelling | doaj.art-8668cff2f7af41c59c45275eeb2a3f452023-10-01T11:06:35ZengAdis, Springer HealthcareDermatology and Therapy2193-82102190-91722023-08-0113102403241610.1007/s13555-023-00999-9Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo NodularisShawn G. Kwatra0Danielle Rodriguez1Carla Dias-Barbosa2Ismail Budhiarso3Fatoumata Fofana4Margaret Vernon5Sylvie Gabriel6Christophe Piketty7Jorge Puelles8Department of Dermatology, Johns Hopkins University School of MedicineEvideraEvideraEvideraEvideraEvideraGaldermaGaldermaGaldermaAbstract 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.https://doi.org/10.1007/s13555-023-00999-9ItchNodular prurigoOutcome measurementPatientsPruritusQualitative research |
| spellingShingle | Shawn G. Kwatra Danielle Rodriguez Carla Dias-Barbosa Ismail Budhiarso Fatoumata Fofana Margaret Vernon Sylvie Gabriel Christophe Piketty Jorge Puelles Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo Nodularis Dermatology and Therapy Itch Nodular prurigo Outcome measurement Patients Pruritus Qualitative research |
| title | Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo Nodularis |
| title_full | Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo Nodularis |
| title_fullStr | Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo Nodularis |
| title_full_unstemmed | Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo Nodularis |
| title_short | Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo Nodularis |
| title_sort | validation of the peak pruritus numerical rating scale as a patient reported outcome measure in prurigo nodularis |
| topic | Itch Nodular prurigo Outcome measurement Patients Pruritus Qualitative research |
| url | https://doi.org/10.1007/s13555-023-00999-9 |
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