Evidence map›Paper›PMID 38363461›Full record

ArticleAdvances in therapy2024

Assessing Itch Severity: Content Validity and Psychometric Properties of a Patient-Reported Pruritus Numeric Rating Scale in Atopic Dermatitis.

Alissa Rams, Jessica Baldasaro, Laurine Bunod, Laure Delbecque, Sara Strzok, Juliette Meunier, Hany ElMaraghy, Luna Sun, Evangeline Pierce

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03443024 (A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
9.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03443024 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorEli Lilly and CompanyRan2018 to 2019Enrolled280ConditionsAtopic DermatitisArmsLebrikizumab, Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 17 citations in OpenAlex.

  1. Mixed-Methods to Define Meaningful Change using Exit Interviewand Clinical Trial Data in Patients with Tenosynovial Giant Cell Tumor (TGCT).Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026
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  4. "Reading level is just one component": best practices for cognitive debriefing patient-reported outcome instruments with pediatric populations.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Alissa RamsModus Outcomes, a THREAD Company, Cambridge, MA, USA.
Jessica BaldasaroModus Outcomes, a THREAD Company, Cambridge, MA, USA.
Laurine BunodModus Outcomes, a THREAD Company, Lyon, France.
Laure DelbecqueEli Lilly and Company, Indianapolis, IN, USA.
Sara StrzokModus Outcomes, a THREAD Company, Cambridge, MA, USA. sara.strzok@modusoutcomes.com.ORCID 0000-0002-2640-7090
Juliette MeunierModus Outcomes, a THREAD Company, Lyon, France.ORCID 0000-0001-5372-5804
Hany ElMaraghyEli Lilly and Company, Indianapolis, IN, USA.
Luna SunEli Lilly and Company, Indianapolis, IN, USA.
Evangeline PierceEli Lilly and Company, Indianapolis, IN, USA.
Eli Lilly (United States) · USModus Health · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPruritus, or itch, is a key symptom of atopic dermatitis (AD); as such, mitigating itch is an important outcome of AD treatment. This study explored the content validity and measurement properties of the Pruritus Numeric Rating Scale (Pruritus NRS), a novel single-item scale for assessing itch severity in clinical trials of AD treatments.

methodsIn this mixed-methods study, qualitative interviews were conducted with 21 people with moderate-to-severe AD (n = 15 adult, n = 6 adolescent) to develop a conceptual model of the patient experience in AD and explore the content validity of the Pruritus NRS. Data collected daily from adults with moderate-to-severe AD enrolled in a phase 2b study (NCT03443024) were used to assess the Pruritus NRS' psychometric performance, including reliability, construct validity, and responsiveness. Meaningful within-patient change (MWPC) thresholds were also determined using anchor-based methods.

resultsQualitative findings highlighted the importance of itch in AD, including severity, persistence, frequency, and daily life interference. Patient debriefing of the Pruritus NRS indicated that the scale was relevant, appropriate, and interpreted as intended. Trial data supported overall good psychometric properties. MWPC was defined as a 3-point improvement in Pruritus NRS score, a finding supported by qualitative data.

conclusionsThe Pruritus NRS provides a valid and reliable patient-reported measure of itching severity in patients with moderate-to-severe AD, and can detect change, indicating it is fit-for-purpose to evaluate the efficacy of AD treatments in this population.

trial registrationClinicalTrials.gov identifier, NCT03443024.

Indexed as

Dermatitis, AtopicAdolescentAdultHumansPatient Reported Outcome MeasuresPruritusPsychometricsQuality of LifeReproducibility of ResultsSeverity of Illness IndexAtopic dermatitisItchMixed-methods researchPatient-reported outcomePruritusRating scale

Identifiers

PMID38363461
PMCPMC10960880
OpenAlexW4391881497

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.