Evidence map›Paper›PMID 36333616›Full record

ArticleDermatology and therapy2022

Determining Severity Strata for Three Atopic Dermatitis Patient-Reported Outcome Questionnaires: Defining Severity Score Ranges for the Worst Pruritus Numerical Rating Scale and the Atopic Dermatitis Symptom and Impact Scales (ADerm-SS and ADerm-IS).

Jonathan I Silverberg, Eric L Simpson, Brian M Calimlim, Leighann Litcher-Kelly, Xiaoran Li, Xiaowu Sun, Yael A Leshem

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03568318 (A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.7field-weighted citation impact, top 16% 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.

NCT03568318 phase3active not recruitingnot on this map

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

TypeinterventionalSponsorAbbVieRan2018 to 2030Enrolled1,533ConditionsAtopic DermatitisArmsPlacebo, Upadacitinib, Topical corticosteroids (TCS)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
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  4. Article
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

7 authors at 5 institutions in 2 countries.

Jonathan I SilverbergDepartment of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Eric L SimpsonDepartment of Dermatology, Oregon Health & Science University, Portland, OR, USA.
Brian M CalimlimHealth Economics and Outcomes Research (HEOR), AbbVie, Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA. brian.calimlim@abbvie.com.
Leighann Litcher-KellyPatient-Centered Outcomes, Adelphi Values, Boston, MA, USA.
Xiaoran LiPatient-Centered Outcomes, Adelphi Values, Boston, MA, USA.
Xiaowu SunPatient-Centered Outcomes, Adelphi Values, Boston, MA, USA.
Yael A LeshemDivision of Dermatology, Rabin Medical Center, Petah Tikva, Israel.
Adelphi Laboratory Center · USAbbVie (United States) · USGeorge Washington University · USOregon Health & Science University · USRabin Medical Center · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThree patient-reported outcome (PRO) questionnaires-Worst Pruritus Numerical Rating Scale (WP-NRS), Atopic Dermatitis Symptom Scale (ADerm-SS), and Atopic Dermatitis Impact Scale (ADerm-IS)-were developed to assess the symptoms and impacts of atopic dermatitis (AD). Severity strata for these PROs are needed to aid in their interpretation.

methodsUsing data from a global, randomized, double-blind, placebo-controlled, phase 3 clinical trial (NCT03568318) of patients with moderate-severe AD (age ≥ 12 years), equipercentile linking analyses were conducted to define severity strata applying the Patient Global Impression of Severity as an anchor. Analyses were conducted separately for adults and adolescents, and then harmonized between the two age groups.

resultsThe sample included 769 adults and 113 adolescents. For the WP-NRS, 0 was associated with absent, 1-2 with minimal, 3 with mild, 4-7 with moderate, and 8-10 with severe. For the ADerm-SS Skin Pain, 0 was associated with absent, 1 with minimal, 2 with mild, 3-6 with moderate, and 7-10 with severe. For ADerm-SS 7-Item Total Symptom Score (TSS-7), 0-1 was associated with absent, 2-11 with minimal, 12-22 with mild, 23-47 with moderate, and 48-70 with severe. For ADerm-IS Sleep, 0 was associated with absent, 1-3 with minimal, 4-6 with mild, 7-20 with moderate, and 21-30 with severe. For ADerm-IS Daily Activities, 0 was associated with absent, 1-2 with minimal, 3-7 with mild, 8-25 with moderate, and 26-40 with severe. For ADerm-IS Emotional State, 0 was associated with absent, 1-2 with minimal, 3-8 with mild, 9-22 with moderate, and 23-30 with severe.

conclusionsThese severity strata provide score interpretations of the WP-NRS, ADerm-SS, and ADerm-IS, translating these scores to simple and intuitive outcomes, which can inform clinical studies and clinical practice. TRIAL REGISTRATION NUMBER: NCT03568318.

Indexed as

ADerm-ISADerm-SSAtopic dermatitisPatient-reported outcomesPruritusSeverity strataSkin painSleep

Identifiers

PMID36333616
PMCPMC9674812
OpenAlexW4308256457

What OpenQuestion holds

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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.