Evidence map›Paper›PMID 34608623›Full record

Trial reportThe British journal of dermatology2022

Psychometric validation and responder definition of the sleep disturbance numerical rating scale in moderate-to-severe atopic dermatitis.

J Puelles, F Fofana, D Rodriguez, J I Silverberg, A Wollenberg, C Dias Barbosa, M Vernon, R Chavda, S Gabriel, C Piketty

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The British journal of dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Rapid improvement of itch with nemolizumab in atopic dermatitis and prurigo nodularis phase 3 studies.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Trial
  3. Trial
  4. Nemolizumab efficacy in prurigo nodularis: onset of action on itch and sleep disturbances.Journal of the European Academy of Dermatology and Venereology : JEADV · 2022
    Trial
  5. Article
  6. Review
  7. The effects of tetrahydrocannabinol and cannabidiol on sleep in cancer patients.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. AtopyRegAmerican journal of clinical dermatology · 2024
    Observational
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

10 authors at 5 institutions in 4 countries.

J PuellesGalderma, La Tour-de-Peilz, Switzerland.
F FofanaEvidera, Bennekom Born, the Netherlands.ORCID 0000-0003-3051-0098
D RodriguezEvidera, Seattle, WA, USA.ORCID 0000-0002-1135-6999
J I SilverbergDepartment of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.ORCID 0000-0003-3686-7805
A WollenbergDepartment of Dermatology and Allergology, Ludwig-Maximilians-Universität, Munich, Germany.ORCID 0000-0003-0177-8722
C Dias BarbosaEvidera, Ivry-sur-Seine, France.ORCID 0000-0003-4701-8825
M VernonEvidera, Bethesda, MD, USA.
R ChavdaGalderma, La Tour-de-Peilz, Switzerland.ORCID 0000-0002-1959-1563
S GabrielGalderma, La Tour-de-Peilz, Switzerland.
C PikettyGalderma, La Tour-de-Peilz, Switzerland.
Galderma (Switzerland) · CHIthaka Harbors · USGeorge Washington University · USInstitut Polytechnique des Sciences Avancées · FRLudwig-Maximilians-Universität München · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSleep disturbance (SD) is an important part of the burden of atopic dermatitis (AD), but patient-reported outcomes that are easy to understand and interpret in the target population have been lacking. A daily, single-item, self-reported SD 11-point numerical rating scale (NRS) was recently developed to assess SD for patients with moderate-to-severe AD, but its psychometric properties have not yet been described.

objectivesTo assess the psychometric properties of the SD NRS in patients with moderate-to-severe AD.

methodsThe psychometric properties of the SD NRS were assessed using data from a phase IIb clinical trial in 218 adults with moderate-to-severe AD.

resultsTest-retest reliability of the SD NRS was substantial to almost perfect (interclass correlation 0·66-1·00) in participants who had stable SD or stable pruritus scores over 1 week. Baseline correlations were moderate to large (r > 0·30) between SD NRS and pruritus or sleep loss scores, but were small (r = -0·11 to 0·17) between SD NRS and EQ-5D-3L index and visual analogue scores, Hospital Anxiety and Depression Scale, Scoring Atopic Dermatitis, and Investigator's Global Assessment. The SD NRS could discriminate groups of participants in the expected direction according to different quality-of-life scores but not according to different clinician-reported disease severity scores. SD NRS scores significantly decreased as sleep loss, itch and quality-of-life scores improved. Analysis of meaningful change suggested a 2-5-point improvement as the initial range of responder definition in the SD NRS score.

conclusionsThe SD NRS is a reliable, valid and responsive measure of SD in adults with moderate-to-severe AD.

Indexed as

Dermatitis, AtopicAdultHumansPsychometricsQuality of LifeReproducibility of ResultsSeverity of Illness IndexSleep

Identifiers

PMID34608623
PMCPMC9299666
OpenAlexW3202424224

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.