Evidence map›Paper›PMID 38130916›Full record

ArticleOTO open

Patient-Reported Outcome Measures for Severe Recurrent Bilateral Nasal Polyps: Psychometric Evaluation and Content Validity.

Adam Gater, Chloe Tolley, Rebecca Williams-Hall, Claire Trennery, Helena Bradley, Mirko V Sikirica, Linda Nelsen, Ana R Sousa, Daniel J Bratton, Robert Chan and 1 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in OTO open. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 27% 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.

NCT01362244 phase2completednot on this map

A Randomised, Double-Blind, Placebo Controlled, Multi-Center Study To Investigate The Use Of Mepolizumab (Sb-240563) In Reducing The Need For Surgery In Subjects With Severe Bilateral Nasal Polyposis

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2014Enrolled109ConditionsNasal PolypsArmsMepolizumab, Placebo, Run In Medication
NCT03221192 completednot on this map

Qualitative Research to Characterize the Patient Experience of Nasal Polyps

TypeobservationalSponsorGlaxoSmithKlineRan2017 to 2018Enrolled27ConditionsNasal PolypsArmsVAS questionnaire, SNOT-22 questionnaire, Data capture app
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

11 authors at 4 institutions in 3 countries.

Adam GaterPatient-Centered Outcomes, Adelphi Values Bollington Cheshire UK.
Chloe TolleyPatient-Centered Outcomes, Adelphi Values Bollington Cheshire UK.
Rebecca Williams-HallPatient-Centered Outcomes, Adelphi Values Bollington Cheshire UK.
Claire TrenneryPatient-Centered Outcomes, Adelphi Values Bollington Cheshire UK.
Helena BradleyPatient-Centered Outcomes, Adelphi Values Bollington Cheshire UK.
Mirko V SikiricaValue Evidence and Outcomes, GSK Philadelphia Pennsylvania USA.
Linda NelsenValue Evidence and Outcomes, GSK Philadelphia Pennsylvania USA.
Ana R SousaClinical Sciences, Respiratory, GSK Brentford Middlesex UK.
Daniel J BrattonClinical Statistics, GSK Brentford Middlesex UK.
Robert ChanClinical Sciences, Respiratory, GSK Brentford Middlesex UK.
Robyn von MaltzahnPatient Centered Outcomes, Value Evidence and Outcomes, GSK Brentford Middlesex UK.ORCID https://orcid.org/0000-0001-9058-8108
Adelphi Group (United Kingdom) · GBGlaxoSmithKline (Germany) · DEGlaxoSmithKline (United States) · USPatient-Centered Outcomes Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To date, no patient-reported outcome measures have been specifically developed to assess pharmacological treatment effect in participants with severe chronic rhinosinusitis (CRS) with recurrent bilateral nasal polyps (NP). These studies aimed to assess (1) the psychometric properties and (2) content validity of Visual Analogue Scales (VAS) assessing NP symptom severity. Study Design: (1) Retrospective psychometric validation study using clinical trial data and (2) cross-sectional qualitative patient interview study. Setting: (1) Multicentre trial; (2) real-world. Methods: (1) Psychometric validation was performed using data from a randomized, double-blind, placebo-controlled, Phase II study (NCT01362244) investigating the effect of mepolizumab in 105 participants with severe, recurrent bilateral NP currently needing polypectomy surgery. (2) Content validity was explored through cognitive debriefing interviews in 27 adults with severe CRS with recurrent bilateral NP who had received NP surgery in the past 10 years (NCT03221192). Results: (1) Acceptable reliability, validity, and responsiveness were shown for individual VAS items, although the loss of smell VAS item performed poorly in several analyses, suggesting further evaluation of this item is needed. (2) All individual VAS items were well understood, considered relevant and were consistently interpreted by most participants, providing evidence for their content validity. Conclusion: These findings support the use of symptom VAS measures to evaluate disease experience and treatment effect in clinical trials of participants with severe CRS with recurrent bilateral NP.

Indexed as

chronic rhinosinusitisdisease severityquality of lifevisual analogue scale

Identifiers

PMID38130916
PMCPMC10733778
OpenAlexW4390071393

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.