Qualitative interviews with patients with Nasal Polypsis
Research type
Research Study
Full title
Qualitative interviews with patients with nasal polyposis / nasal polyps (NP)
IRAS ID
247254
Contact name
Sean O'Quinn
Contact email
Sponsor organisation
AstraZeneca
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
This non-interventional qualitative research study will involve telephone interviews with up to N=20 US adult patients and up to N=15 UK adult patients. All patients will have a confirmed diagnosis of nasal polyposis / nasal polyps (NP). In addition to US central IRB approval, UK Research ethics committee (EC) approval will also be obtained.
The purpose of the study is to explore patients’ experiences with NP. Specifically, the study will focus on understanding patients’ symptoms and the impact of these symptoms on patients’ daily life. Proposed research is retrospective, e.g., patients will discuss their experience with NP to date. The overall goal of this study is to explore and document the concepts that are relevant and important to patients with NP in order to inform the development of new treatments for NP. To do this, combined concept elicitation and cognitive interviews will be conducted with the following specific objectives:
• To explore the experience of patients with NP
• To determine words and phrases patients use to describe NP
• To determine the impact of NP on patient overall health and functioning
• To document the frequency, severity, duration and precipitating factors for symptoms and impacts elicited
• To use the findings to contribute to the development of a disease conceptual framework of the patient experience
• To assess the performance and content validity of a nasal polyp symptom diary (NPSD)Interaction with patients will consist of a single one-on-one interview session conducted by phone. Interviews will last for approximately 75-90 minutes and will be moderated by an IQVIA consultant. The interview will be based on a discussion guide and related “worksheets” of symptoms and impacts of NP.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0261
Date of REC Opinion
31 Aug 2018
REC opinion
Further Information Favourable Opinion