Qualitative Analysis of Subject Experience of Nasal Polyps

Study Overview
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Brief Summary
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Nasal polyposis is a chronic inflammatory disease of the nose and sinuses. GlaxoSmithKline (GSK) is embarking on a clinical program to assess treatment of severe, recurrent nasal polyps with an anti-interleukin-5 (anti-IL5) (mepolizumab). Subject specific symptomatic endpoints will form the basis for the assessment of treatment benefit of nasal polyp therapies. However, there is a lack of published qualitative data regarding nasal polyps to understand the symptoms or health-related quality of life (HRQoL) impacts. This cross-sectional qualitative study aims to address this unmet gap by conducting semi-structured combined concept elicitation (CE) and cognitive debriefing (CD) telephone interviews and real-time data capture. The combined CE and CD interviews (each 90 minutes in duration) will investigate the subject experience of nasal polyps, and the relevance and understanding of existing patient-reported outcomes (PRO) instruments. The real-time data capture conducted over a 10 day period, will investigate the subject experience of the symptoms, HRQoL impacts and treatment of nasal polyps and any day-to-day variability that exists in these experiences in 'real time'. Twenty adult subjects in the United States (US), and 10 adult subjects in Germany with severe, recurrent nasal polyps will participate in the CE and CD interviews section of the study and of these, 10 subjects from US will also complete real-time data capture app task.

Official Title
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Qualitative Research to Characterize the Patient Experience of Nasal Polyps

Conditions
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Nasal Polyps

Intervention / Treatment
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* Other: VAS questionnaire
* Other: SNOT-22 questionnaire
* Other: Data capture app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a clinical diagnosis of bilateral nasal polyps as diagnosed by endoscopy or CT scan. Subject is aged 18 or over. Subject has severe nasal polyps symptoms defined as a subject-reported nasal obstruction VAS score of >5. Subject had at least one previous surgery in the past ten years for the removal of nasal polyps. Surgery in this case is defined as any procedure involving instruments with resulting incision and removal of polyp tissue from the nasal cavity (polypectomy). Subject is currently an eligible candidate for polypectomy defined by an overall subject-reported VAS symptom score of >7 and an endoscopic bilateral nasal polyp score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity). Subject has symptoms consistent with chronic rhinosinusitis. Subject is currently receiving intranasal corticosteroids for the management of their nasal polyps. Subject is willing to participate in the study and provide informed consent. Subject is an English speaker and is able to read, write and fully understand the English language. Subject is willing to and able to attend and participate in a 90-minute interview to discuss their experiences of nasal polyps and obtain their feedback on several symptom/impact questionnaires. For real-time data capture: Subject owns/or has access to either a smartphone [iPhone Operating System (iOS) or android] or tablet which has video, audio/microphone and photographic capabilities and access to either the Apple app store or Google play store to download the app. Subject is willing and able to take part in the real-time data application task and respond to a series of questions/tasks fielded to them via the application over the course of 10 days and is willing to respond to some brief questions following the real-time data capture task about their experience of using the app and completing the tasks, either during their interview or in a 5-10 minute telephone call following completion of the task. Subject would feel comfortable recording short videos of themselves and providing audio commentary in response to questions/tasks. Exclusion Criteria: Subject has a diagnosis of cystic fibrosis. Subject has a diagnosis of eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young's, Kartagener's or dyskinetic ciliary syndromes). Subject has a diagnosis of antrochoanal polyps. Subject has a diagnosis of nasal septal deviation occluding one nostril. Subject has had acute sinusitis or upper respiratory tract infection in the last two week. Subject has ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis). Subject has had an asthma exacerbation requiring admission to hospital in the last four weeks. Subject is currently or has previously taken part in a clinical trial for nasal polyps. Subject is unwilling or unable to comply with the requirements of the study or has a physical or mental condition or learning difficulties that, in the opinion of the physician, may affect the subject's ability to participate in the study, the responses he/she might provide or their ability to provide consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects participating in CE and CD interviews<br>Twenty adult subjects from the US and 10 adult subjects from Germany with severe recurrent nasal polyps who have received nasal polyp surgery in the past 10 years prior to screening will be asked to participate in CE and CD interviews | Other: VAS questionnaire<br>* VAS questionnaire is a PRO tool in which subjects will be asked to evaluate overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 centimeter (cm) or 100 millimeter (mm) whereby 0 represents 'no symptom' and '10 or 100 represents 'as bad as you can imagine', Scores of 0-3 (or 0-30) are defined as mild disease, >3-7 (or >30-70) as moderate disease and >7-10 (or >70-100) as severe disease.<br>Other: SNOT-22 questionnaire<br>* SNOT-22 is a PRO tool to measure HRQoL associated with rhinosinusitis with or without nasal polyps. It contains 22 nose, sinus, and general HRQoL items and subjects will be required to score the experience on a 6-point scale ranging from 0 (no problem) to 5 (Problem as bad as it can be) and identify the five most important items affecting their health.<br>|
| Subjects participating in interview and real-time data capture<br>Ten subjects from the US with severe recurrent nasal polyps who are participating in CE and CD interviews will be asked to complete the real-time data capture app task. | Other: VAS questionnaire<br>* VAS questionnaire is a PRO tool in which subjects will be asked to evaluate overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 centimeter (cm) or 100 millimeter (mm) whereby 0 represents 'no symptom' and '10 or 100 represents 'as bad as you can imagine', Scores of 0-3 (or 0-30) are defined as mild disease, >3-7 (or >30-70) as moderate disease and >7-10 (or >70-100) as severe disease.<br>Other: SNOT-22 questionnaire<br>* SNOT-22 is a PRO tool to measure HRQoL associated with rhinosinusitis with or without nasal polyps. It contains 22 nose, sinus, and general HRQoL items and subjects will be required to score the experience on a 6-point scale ranging from 0 (no problem) to 5 (Problem as bad as it can be) and identify the five most important items affecting their health.<br>Other: Data capture app<br>* Real time data capture app is a smart-phone or web-based application which will allow the subjects to communicate about their experience of nasal polyps in real-time as they go about their daily lives via varying video, audio, photographic and text responses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Reported Primary Symptoms | During the CE section of the interview, participants were asked a series of broad open-ended questions designed to encourage them to talk openly and as spontaneously as possible about their experience of having nasal polyps. In addition, participants were asked more focused questions designed to probe on issues that they may not have mentioned during the course of the interview spontaneously or concepts/statements that required additional clarification. The interviews were transcribed/translated verbatim and qualitative analysis was conducted using Atlas Ti. The symptoms which were most frequently reported spontaneously and were also reported to either be the most frequent, bothersome or worst were categorized as primary symptoms. Number of participants who reported each of the primary symptom is presented. | Up to 120 minutes | 
| Number of Participants Who Reported Secondary Symptoms | During the CE section of the interview, participants were asked a series of broad open-ended questions designed to encourage them to talk openly and as spontaneously as possible about their experience of having nasal polyps. In addition, participants were asked more focused questions designed to probe on issues that they may not have mentioned during the course of the interview spontaneously or concepts/statements that required additional clarification. The interviews were transcribed/translated verbatim and qualitative analysis was conducted using Atlas Ti. The symptoms that were reported by fewer participants and less frequently mentioned spontaneously by participants during the interviews were classified as secondary symptoms. Number of participants who reported each of the secondary symptoms is reported. | Up to 120 minutes | 
| Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Following spontaneous and probed discussions regarding symptoms during CE interviews, participants were asked to comment on what they each considered to be their 'worst' symptom, their 'most frequent' symptom and their 'most bothersome' symptom. The interviews were transcribed/translated verbatim and qualitative analysis was conducted using Atlas Ti. The number of participants with worst, most-frequent and most-bothersome symptoms are presented. | Up to 120 minutes | 
| Number of Participants Reporting Proximal Impacts-Physical Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Proximal impacts were defined as those reported to be the direct impact of the symptoms of nasal polyps and included; physical impacts, sleep impacts and impacts on activities of daily living (ADL). The number of participants with physical impacts are reported. | Up to 120 minutes | 
| Number of Participants Reporting Proximal Impacts-Sleep Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Proximal impacts were defined as those reported to be the direct impact of the symptoms of nasal polyps and included; physical impacts, sleep impacts and impacts on ADL. The number of participants with sleep impacts are reported. | Up to 120 minutes | 
| Number of Participants Reporting Proximal Impacts-ADL Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Proximal impacts were defined as those reported to be the direct impact of the symptoms of nasal polyps and included; physical impacts, sleep impacts and impacts on ADL. The number of participants with ADL impacts are reported. | Up to 120 minutes | 
| Number of Participants Reporting Distal Impacts-emotional Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Distal impacts were those reported to be impacts of the condition as a whole and included; emotional, social, work/school and treatment impacts. The number of participants with emotional impacts are reported. | Up to 120 minutes | 
| Number of Participants Reporting Distal Impacts-social Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Distal impacts were those reported to be impacts of the condition as a whole and included; emotional, social, work/school and treatment impacts. The number of participants with social impacts are reported. | Up to 120 minutes | 
| Number of Participants Reporting Distal Impacts-work/School Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Distal impacts were those reported to be impacts of the condition as a whole and included; emotional, social, work/school and treatment impacts. The number of participants with work/school impacts are reported. | Up to 120 minutes | 
| Number of Participants Reporting Distal Impacts-treatment Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Distal impacts were those reported to be impacts of the condition as a whole and included; emotional, social, work/school and treatment impacts. The number of participants with treatment impacts are reported. | Up to 120 minutes | 
| Number of Participants Who Reported Symptoms to be Targeted by New Treatment | During CE interviews, participants were asked about the changes they would like to see from a new treatment for nasal polyps and which symptoms would be most meaningful for the treatment to target. The number of participants with their reported symptoms to be targeted by new treatment is presented. | Up to 120 minutes | 
| Number of Participant Who Reported Impacts to be Targeted by New Treatment | During CE interviews, participants were asked about the changes they would like to see from a new treatment for nasal polyps and which impacts would be most meaningful for the treatment to target. The number of participants with corresponding impacts to be targeted by new treatment is presented. | Up to 120 minutes | 
| Number of Participants Reporting Factors to be Considered for Surgery | During CE interviews, participants were asked about experiences of their surgery in past. The number of participants with the corresponding factors to be considered for surgery is presented. | Up to 120 minutes | 
| Number of Participants With Ease of Decision to Have Surgery | During CE interviews, participants were asked about experiences of their surgery in past. The number of participants with ease of decision to have surgery is presented. | Up to 120 minutes | 
| Number of Participants Who Reported on the Positive or Negative Impacts of Surgery | During CE interviews, participants were asked about experiences of their surgery in past. The number of participants who reported on the positive or negative impacts of surgery is presented. | Up to 120 minutes | 
| Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment | Participants were required to complete six VAS assessments (overall symptom VAS and single item VAS) as a part of the CD interview. The participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 centimeter (cm) or 100 millimeter (mm) whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants were asked to speak aloud their thoughts as they read the instructions and completed the questions. After completion of each think-aloud exercise, participants were also probed upon their understanding of the instrument items. Number of participants who did not understand the VAS assessments is reported. | Up to 120 minutes | 
| Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition | Participants were required to complete six VAS assessments (overall symptom VAS and single item VAS) as a part of the CD interview. The participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 cm or 100 mm whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants were asked to speak aloud their thoughts as they read the instructions and completed the questions. After completion of each think-aloud exercise, participants were also probed about the relevance of VAS items. Relevance was determined based on participants personal descriptions and related discussion of their experience of each symptom or impact during CD interview. It was also determined via the rating of a given symptom/impact on each measure as greater than a score of zero. Number of participants who reported the symptoms assessed by VAS to be relevant are presented. | Up to 120 minutes | 
| Number of Participants Who Liked or Disliked VAS Assessments | Participants were required to complete six VAS assessments (overall symptom VAS and single item VAS) as a part of the CD interview. The participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 cm or 100 mm whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants provided a general feedback on completing the six VAS assessments which included relevance of symptoms to their condition, ease of completion and interpretation of the scale. The number of participants who provided general feedback for VAS assessments in terms of likes or dislikes for VAS assessment is presented. | Up to 120 minutes | 
| Number of Participants With Difficulties Completing VAS Assessments | Participants were required to complete six VAS assessments (overall symptom VAS and single item VAS) as a part of the CD interview. The participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 cm or 100 mm whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants provided a general feedback on completing the six VAS assessments which included relevance of symptoms to their condition, ease of completion and interpretation of the scale. The number of participants with difficulties completing VAS assessment is presented. | Up to 120 minutes | 
| Number of Participants Who Understood VAS Anchors | Participants completed the VAS assessment as a part of the CD interview. Participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 cm or 100 mm whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants were asked about their understanding of the response continuum for VAS assessment. Number of participants who understood the VAS anchors (100 as bad as you can imagine and 0 none) is presented. | Up to 120 minutes | 
| Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Participants completed SNOT-22 assessment as a part of the CD interview. The SNOT-22 contains 22 nose, sinus, and general health-related quality of life (HRQoL) items and is used to measure HRQoL associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Number of participants who did not understand the items of SNOT-22 is presented. | Up to 120 minutes | 
| Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Participants were required to complete SNOT-22 assessment as a part of the CD interview. The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Number of participants who reported the symptoms assessed by SNOT-22 to be relevant to their condition are presented. | Up to 120 minutes | 
| Number of Participants Who Liked or Disliked SNOT-22 Assessments | The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Participants provided a general feedback on completing the SNOT-22 which included relevance of symptoms to their condition, ease of completion and interpretation of the scale. Number of participants who liked or disliked the SNOT-22 is presented. | Up to 120 minutes | 
| Number of Participants With Difficulties Completing SNOT-22 | Participants provided a general feedback on completing the SNOT-22 during the CD interview. The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Number of participants with difficulties completing SNOT-22 assessment is presented. | Up to 120 minutes | 
| Number of Participants Who Understood SNOT-22 Response Options | Participants completed SNOT-22 as a part of the CD interview. The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Participants were asked about their understanding of each of the six options (no problem, mild or slight problem, very mild problem, moderate problem, severe problem, as bad as it can be) included in SNOT-22. Number of participants who understood each of the six SNOT-22 response options is presented. | Up to 120 minutes | 
| Number of Participants Who Reported Missing SNOT-22 Items | Participants completed SNOT-22 as a part of the CD interview. The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Participants were asked if they felt any items were missing from SNOT-22. Number of participants who reported missing items in SNOT-22 is presented. | Up to 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Symptom Variability-Application (App) Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Participants completed a number of tasks across 10 days, which explored how nasal polyp symptoms and impacts varied across a full day (within day variability) or assess the day to day variability (between day variability). Number of participants reporting within day and between-day symptom variability is reported. | Up to 10 days | 
| Number of Participants Reporting Primary Symptoms as Identified During App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting primary symptoms as identified during app task is reported. | Up to 10 days | 
| Number of Participants Reporting Secondary Symptoms as Identified During App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting secondary symptoms as identified during app task is reported. | Up to 10 days | 
| Number of Participants Reporting Physical Impacts as Idenfied During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants with physical impacts as identified during app task is reported. | Up to 10 days | 
| Number of Participants Reporting Sleep Impacts as Identified During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting sleep impacts as identified during app task is reported. | Up to 10 days | 
| Number of Participants Reporting ADL Impacts as Identified During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting ADL impacts as identified during app task is reported. | Up to 10 days | 
| Number of Participants Reporting Emotional Impacts as Identified During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting emotional impacts as identified during app task is reported. | Up to 10 days | 
| Number of Participants Reporting Social Functioning Impacts as Identified During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting social functioning impacts as identified during app task is reported. | Up to 10 days | 
| Number of Participants Reporting Work Impacts as Identified During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting work impacts as identified during app task is reported. | Up to 10 days | 
| Number of Participants Reporting Treatment Impacts as Identified During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting treatment impacts as identified during app task is reported. | Up to 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real-time data capture, Concept elicitation, Nasal polyps, Cognitive debriefing, Patient-reported outcomes, HRQoL