Evidence map›Paper›PMID 39704924›Full record

ArticleJournal of patient-reported outcomes2024

Chronic rhinosinusitis with nasal polyps (CRSwNP) symptom verbal response scales: content validity testing for use in adults with CRSwNP.

Tom Keeley, Nina Gaw, Waseem Ahmed, Rafael Alfonso-Cristancho, Ana R Sousa, Katie Forde, Rosie Sharp, Sophie Whyman, Adam Gater

Abstract read
In one paragraph

Article in Journal of patient-reported outcomes, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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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

2 citing papers in PubMed.

  1. Article
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4 · The record

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5 · Who and what money

Authors and funding

9 authors.

Tom KeeleyPatient Centered Outcomes, GSK, London, UK. tom.x.keeley@gsk.com.
Nina GawPatient Centered Outcomes, GSK, London, UK.
Waseem AhmedGlobal Data Generations, GSK, London, UK.
Rafael Alfonso-CristanchoGlobal Data Generations, GSK, Collegeville, PA, USA.
Ana R SousaClinical Sciences, Respiratory and Immunology Research Unit, GSK, London, UK.
Katie FordePatient-Centered Outcomes, Adelphi Values, Bollington, Cheshire, UK.
Rosie SharpPatient-Centered Outcomes, Adelphi Values, Bollington, Cheshire, UK.
Sophie WhymanPatient-Centered Outcomes, Adelphi Values, Bollington, Cheshire, UK.
Adam GaterPatient-Centered Outcomes, Adelphi Values, Bollington, Cheshire, UK.

Funding

GSK 218108
6 · The paper itself

Abstract

backgroundPRO measures of symptoms in clinical trials have historically utilized visual and numerical scales but verbal descriptors may make it easier for patients to clearly differentiate between response options. This study assessed content validity and meaningful change in five verbal response scales (VRSs) used to assess chronic rhinosinusitis with nasal polyp (CRSwNP) symptom severity. METHODOLOGY: This qualitative, semi-structured interview study recruited adults from the US, Germany, and China with confirmed moderate-to-severe CRSwNP. Interviews included a concept elicitation section, where participants were asked about their experience of living with CRSwNP including symptoms and health-related quality-of-life impacts, and a cognitive debriefing section, where participants were debriefed and participant understanding and real-life relevance of the CRSwNP symptom VRS content were assessed. Interview transcripts were qualitatively analyzed using thematic analysis methods.

resultsAmong the 24 participants interviewed, the most frequently reported CRSwNP symptoms were nasal obstruction, runny nose, mucus in the throat, loss of smell and facial pain/pressure. Participants demonstrated good understanding of the CRSwNP symptom VRS instructions, items, recall period, and response options. The five CRSwNP symptom VRS items were relevant to the majority of participants' experience of CRSwNP. At the item level, a one-category within-person improvement was the level most frequently reported by participants to be a meaningful change.

conclusionThe CRSwNP symptom VRSs assess relevant and bothersome symptoms experienced by patients with moderate-to-severe CRSwNP, supporting content validity of this measure. The findings of this study provided preliminary insights into meaningful change in the VRS. Further quantitative assessment of meaningful change is needed, and psychometric evaluation of the CRSwNP symptom VRSs will be required to evaluate their appropriateness for assessment of clinical trial endpoints in patients with CRSwNP.

Indexed as

Nasal PolypsQuality of LifeRhinitisSinusitisAdultAgedChinaChronic DiseaseFemaleGermanyHumansInterviews as TopicMaleMiddle AgedPatient Reported Outcome MeasuresQualitative ResearchChronic rhinosinusitisContent validityNasal polypsPatient-reported outcome measuresPsychometricsVerbal response scale

Identifiers

PMID39704924
PMCPMC11662121

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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.