Evidence map›Paper›PMID 26833304›Full record

Trial reportAdvances in therapy2016

Assessing Changes in Chronic Spontaneous/Idiopathic Urticaria: Comparisons of Patient-Reported Outcomes Using Latent Growth Modeling.

Donald E Stull, Doreen McBride, Katherine Houghton, Andrew Y Finlay, Ari Gnanasakthy, Maria-Magdalena Balp

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 9% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Omalizumab substantially improves dermatology-related quality of life in patients with chronic spontaneous urticaria.Journal of the European Academy of Dermatology and Venereology : JEADV · 2017
    Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. 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

6 authors at 3 institutions in 3 countries.

Donald E StullRTI Health Solutions, Research Triangle Park, NC, USA. dstull@rti.org.
Doreen McBrideRTI Health Solutions, Didsbury, Manchester, UK. dmcbride@rti.org.
Katherine HoughtonRTI Health Solutions, Research Triangle Park, NC, USA.
Andrew Y FinlayCardiff University School of Medicine, Cardiff, UK.
Ari GnanasakthyRTI Health Solutions, Research Triangle Park, NC, USA.
Maria-Magdalena BalpNovartis Pharma AG, GMA and HEOR, Basel, Switzerland.
RTI Health Solutions · USCardiff University · GBNovartis (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAssessing the consequences of chronic spontaneous/idiopathic urticaria (CSU) requires the evaluation of health-related quality of life (HRQoL) associated with the severity of CSU signs and symptoms. It is important to understand how signs, symptoms, and HRQoL change over time in CSU. Evidence is lacking on how closely changes in signs and symptoms of CSU are related to changes in HRQoL. The objective of this study was to assess the correlation between changes in patient-reported outcome measures (PROMs) of signs and symptoms, dermatologic quality of life (QoL), and urticaria-specific QoL.

methodsLatent growth models (LGMs) were applied to longitudinal data from three randomized, Phase 3 clinical trials investigating the efficacy and safety of omalizumab in CSU.

resultsA near-perfect association between changes in signs and symptoms and changes in dermatologic and urticaria-specific QoLs was identified in each clinical trial when using LGMs (correlation coefficient range 0.88-0.92).

conclusionEvidence showed that changes in signs and symptoms are closely related to changes in HRQoL. However, analyses were performed on clinical trial results of an extremely effective treatment; a less effective treatment with much smaller changes over time may not show such close correlations. Results suggest that any of these PROMs may be used to understand changes in CSU.

Indexed as

Patient Outcome AssessmentQuality of LifeAdolescentAdultAgedChildChronic DiseaseHumansLongitudinal StudiesMiddle AgedOmalizumabSeverity of Illness IndexTreatment OutcomeUrticariaYoung AdultOmalizumabCorrelationHealth-related quality of lifeLatent growth modelQuality of lifeUrticaria

Identifiers

PMID26833304
PMCPMC4769726
OpenAlexW2262690280

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.