Evidence map›Paper›PMID 39847130›Full record

ReviewJournal of patient-reported outcomes2025

Patient-centered outcomes for clinical trials in chronic rhinosinusitis with or without nasal polyps and allergic fungal rhinosinusitis.

Brittany Klooster, Kaitlin Chatterton, Nazifa Ibrahim, Madison C Bernstein, Alan L Shields, Veleka Allen

Abstract readReview
In one paragraph

Review in Journal of patient-reported outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Review
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.

Brittany KloosterAdelphi Values, 1 Lincoln Street, Suite 2900, Boston, MA, 02111, USA. Brittany.Klooster@adelphivalues.com.ORCID http://orcid.org/0000-0002-2018-8982
Kaitlin ChattertonAdelphi Values, 1 Lincoln Street, Suite 2900, Boston, MA, 02111, USA.
Nazifa IbrahimAdelphi Values, 1 Lincoln Street, Suite 2900, Boston, MA, 02111, USA.
Madison C BernsteinAdelphi Values, 1 Lincoln Street, Suite 2900, Boston, MA, 02111, USA.
Alan L ShieldsAdelphi Values, 1 Lincoln Street, Suite 2900, Boston, MA, 02111, USA.
Veleka AllenSanofi US Services, Inc., Bridgewater, NJ, USA.

Funding

Sanofi Sanofi
6 · The paper itself

Abstract

backgroundChronic rhinosinusitis (inclusive of subtypes with nasal polyps [CRSwNP], without nasal polyps [CRSsNP], and allergic fungal rhinosinusitis [AFRS]) causes inflammation of the nose mucosa and paranasal sinuses. Unfortunately, evidence supporting use of clinical outcome assessments (COAs) in regulated clinical trials to assess key measurement concepts of these conditions is limited.

objectiveTo identify key disease-related symptoms and impacts, potential outcomes of interest for new treatments, and COAs available to measure those outcomes among adult and adolescent individuals living with CRSwNP, CRSsNP, and AFRS.

methodsLiterature, clinical trial, and product label reviews were conducted to identify symptoms, impacts, and COAs used to assess CRSwNP, CRSsNP, and AFRS patient experiences in clinical trials. The disease related concepts identified in the literature were mapped to selected COAs to determine conceptual coverage of each COA.

resultsTwenty-five articles, twenty-five clinical trial records, and four product labels were included in the review. Across conditions, nasal obstruction, nasal discharge, and altered smell were the most frequently identified symptoms. The most frequently identified impacts of CRSwNP and CRSsNP were on emotional functioning and sleep, and adopting new behaviors for AFRS. Findings for key symptoms and impacts in adolescents were limited. More than 20 COAs used in these conditions were identified, and 14 COAs (e.g., Sinonasal Outcome Test [SNOT-22]) were evaluated for conceptual coverage of the concepts identified in the literature.

conclusionResults specify several symptom and impact outcomes, that if improved, would reflect treatment benefit for patients living with CRSwNP, CRSsNP, and/or AFRS. Several COAs demonstrated coverage of key measurement concepts and warrant further evaluation for use in clinical trials.

Indexed as

MycosesNasal PolypsPatient Reported Outcome MeasuresRhinitisRhinitis, AllergicSinusitisAdolescentAllergic Fungal SinusitisChronic DiseaseClinical Trials as TopicHumansRhinosinusitis

Identifiers

PMID39847130
PMCPMC11757837

What OpenQuestion holds

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LicenceCC BY
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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.