Measuring the patient experience of chronic rhinosinusitis with nasal polyposis: qualitative development of a novel symptom diary.

chronic rhinosinusitis with nasal polyposis content validity instrument development patient-reported outcomes qualitative research

Journal

International forum of allergy & rhinology
ISSN: 2042-6984
Titre abrégé: Int Forum Allergy Rhinol
Pays: United States
ID NLM: 101550261

Informations de publication

Date de publication:
08 2022
Historique:
revised: 24 11 2021
received: 22 07 2021
accepted: 14 12 2021
pubmed: 19 12 2021
medline: 27 7 2022
entrez: 18 12 2021
Statut: ppublish

Résumé

This qualitative study assessed the experience of patients with chronic rhinosinusitis with nasal polyposis (NP) to inform the development of a novel symptom diary for clinical study use. Concept elicitation and cognitive interviews were conducted with patients who had a physician-verified diagnosis of NP and a history of intranasal corticosteroid use. Concepts were identified via open-ended and follow-up questions. Relative symptom/impact disturbance level was assessed using a scale of 0 (not at all disturbing) to 10 (extremely disturbing). Patients (n = 30) attributed numerous symptoms and impacts to NP; the most prevalent and disturbing were nasal congestion (identified by 100% of patients; average disturbance rating = 7.9), nasal blockage/obstruction (97%; 8.2), difficulty with sense of smell (97%; 7.6), facial pressure (90%; 6.2), postnasal drip (87%; 6.5), runny nose (87%; 6.2), facial pain (80%; 6.3), and headache (77%; 6.5). These symptoms, along with the impact of NP on sleep and daily activities, were included in the Nasal Polyposis Symptom Diary (NPSD). Cognitive interviews confirmed that patients understood the NPSD items and could select a response reflective of their experience at its worst over the past 24 hours using a four-point scale (none, mild, moderate, or severe). The most relevant and disturbing symptoms, according to patients with NP, were included in the NPSD. Interviews confirmed the suitability of NPSD in capturing the daily experience of patients. These findings support the content validity of the NPSD as a suitable tool for capturing NP symptoms and impacts.

Sections du résumé

BACKGROUND
This qualitative study assessed the experience of patients with chronic rhinosinusitis with nasal polyposis (NP) to inform the development of a novel symptom diary for clinical study use.
METHODS
Concept elicitation and cognitive interviews were conducted with patients who had a physician-verified diagnosis of NP and a history of intranasal corticosteroid use. Concepts were identified via open-ended and follow-up questions. Relative symptom/impact disturbance level was assessed using a scale of 0 (not at all disturbing) to 10 (extremely disturbing).
RESULTS
Patients (n = 30) attributed numerous symptoms and impacts to NP; the most prevalent and disturbing were nasal congestion (identified by 100% of patients; average disturbance rating = 7.9), nasal blockage/obstruction (97%; 8.2), difficulty with sense of smell (97%; 7.6), facial pressure (90%; 6.2), postnasal drip (87%; 6.5), runny nose (87%; 6.2), facial pain (80%; 6.3), and headache (77%; 6.5). These symptoms, along with the impact of NP on sleep and daily activities, were included in the Nasal Polyposis Symptom Diary (NPSD). Cognitive interviews confirmed that patients understood the NPSD items and could select a response reflective of their experience at its worst over the past 24 hours using a four-point scale (none, mild, moderate, or severe).
CONCLUSION
The most relevant and disturbing symptoms, according to patients with NP, were included in the NPSD. Interviews confirmed the suitability of NPSD in capturing the daily experience of patients. These findings support the content validity of the NPSD as a suitable tool for capturing NP symptoms and impacts.

Identifiants

pubmed: 34921526
doi: 10.1002/alr.22952
pmc: PMC9543166
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

996-1005

Informations de copyright

© 2021 The Authors. International Forum of Allergy & Rhinology published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngic Allergy and American Rhinologic Society.

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Auteurs

Sean O'Quinn (S)

AstraZeneca, Gaithersburg, MD, USA.

Vivian H Shih (VH)

AstraZeneca, Gaithersburg, MD, USA.

Ubaldo J Martin (UJ)

AstraZeneca, Gaithersburg, MD, USA.

Oren Meyers (O)

IQVIA Real World Solutions, Patient Centered Solutions, New York, NY, USA.

Patrick Crooks (P)

IQVIA Real World Solutions, Patient Centered Solutions, New York, NY, USA.

Julie Bailey (J)

IQVIA Real World Solutions, Patient Centered Solutions, New York, NY, USA.

Ashley F Slagle (AF)

Aspen Consulting, LLC, Steamboat Springs, CO, USA.

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Classifications MeSH