Worst itch numerical rating scale for prurigo nodularis: a psychometric evaluation
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Worst itch numerical rating scale for prurigo nodularis: a psychometric evaluation. / Ständer, S; Zeidler, C; Pereira, M; Szepietowski, J C; McLeod, L; Qin, S; Williams, N; Sciascia, T; Augustin, M.
in: J EUR ACAD DERMATOL, Jahrgang 36, Nr. 4, 04.2022, S. 573-581.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Worst itch numerical rating scale for prurigo nodularis: a psychometric evaluation
AU - Ständer, S
AU - Zeidler, C
AU - Pereira, M
AU - Szepietowski, J C
AU - McLeod, L
AU - Qin, S
AU - Williams, N
AU - Sciascia, T
AU - Augustin, M
N1 - © 2021 European Academy of Dermatology and Venereology.
PY - 2022/4
Y1 - 2022/4
N2 - BACKGROUND: Study TR03 evaluated the safety and efficacy of nalbuphine ER for prurigo nodularis (PN; NCT02174419).OBJECTIVE: We conducted supplementary analyses to assess the psychometric properties of the Worst Itch Numeric Rating Scale (WI-NRS), the TR03 primary endpoint.METHODS: Study TR03 was a double-blind, placebo-controlled, phase 2 trial in PN patients with documented scores ≥5 on the WI-NRS (0 [no itch]-10 [worst itch imaginable]) on ≥5 of 7 days before baseline. Using TR03 data, the WI-NRS's psychometric properties, including reliability, validity and ability to detect change, were evaluated. A responder threshold was estimated to facilitate interpretation of WI-NRS score changes.RESULTS: Amongst 62 treated patients, improvements in mean [SD] (median) WI-NRS scores were observed between baseline (8.2 [1.21] (8.1)) and week 10 (5.8 [2.43] (6.0)). The WI-NRS had an intraclass correlation coefficient of 0.96 (95% confidence interval, 0.93-0.98) in 42 patients who had stable Itch verbal rating scale (VRS) scores from week 9-10, supporting strong test-retest reliability. Construct validity was supported, with strong correlations at week 10 with Average Itch NRS (r = 0.87) and Itch VRS single-day/weekly mean scores (r = 0.81/0.89) and moderate correlations with ItchyQoL™ total/domain scores (r = 0.41-0.43). The WI-NRS discriminated between predefined severity subgroups based on the Itch VRS and detected changes in itching severity (effect-size estimate: -2.05; standardized response mean: -1.21). An anchor-based threshold based on a two-category improvement in the single-day Itch VRS suggests a responder threshold of ≥3.8 points (~40% improvement).CONCLUSIONS: The WI-NRS demonstrates good measurement properties, supporting its use in evaluating treatment change in PN.
AB - BACKGROUND: Study TR03 evaluated the safety and efficacy of nalbuphine ER for prurigo nodularis (PN; NCT02174419).OBJECTIVE: We conducted supplementary analyses to assess the psychometric properties of the Worst Itch Numeric Rating Scale (WI-NRS), the TR03 primary endpoint.METHODS: Study TR03 was a double-blind, placebo-controlled, phase 2 trial in PN patients with documented scores ≥5 on the WI-NRS (0 [no itch]-10 [worst itch imaginable]) on ≥5 of 7 days before baseline. Using TR03 data, the WI-NRS's psychometric properties, including reliability, validity and ability to detect change, were evaluated. A responder threshold was estimated to facilitate interpretation of WI-NRS score changes.RESULTS: Amongst 62 treated patients, improvements in mean [SD] (median) WI-NRS scores were observed between baseline (8.2 [1.21] (8.1)) and week 10 (5.8 [2.43] (6.0)). The WI-NRS had an intraclass correlation coefficient of 0.96 (95% confidence interval, 0.93-0.98) in 42 patients who had stable Itch verbal rating scale (VRS) scores from week 9-10, supporting strong test-retest reliability. Construct validity was supported, with strong correlations at week 10 with Average Itch NRS (r = 0.87) and Itch VRS single-day/weekly mean scores (r = 0.81/0.89) and moderate correlations with ItchyQoL™ total/domain scores (r = 0.41-0.43). The WI-NRS discriminated between predefined severity subgroups based on the Itch VRS and detected changes in itching severity (effect-size estimate: -2.05; standardized response mean: -1.21). An anchor-based threshold based on a two-category improvement in the single-day Itch VRS suggests a responder threshold of ≥3.8 points (~40% improvement).CONCLUSIONS: The WI-NRS demonstrates good measurement properties, supporting its use in evaluating treatment change in PN.
KW - Double-Blind Method
KW - Humans
KW - Prurigo/diagnosis
KW - Pruritus/diagnosis
KW - Psychometrics
KW - Reproducibility of Results
KW - Severity of Illness Index
U2 - 10.1111/jdv.17870
DO - 10.1111/jdv.17870
M3 - SCORING: Journal article
C2 - 34908192
VL - 36
SP - 573
EP - 581
JO - J EUR ACAD DERMATOL
JF - J EUR ACAD DERMATOL
SN - 0926-9959
IS - 4
ER -