Nasal Polyps
Conditions
Keywords
Real-time data capture, Concept elicitation, Nasal polyps, Cognitive debriefing, Patient-reported outcomes, HRQoL
Brief summary
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.
Interventions
OTHERVAS questionnaire
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.
OTHERSNOT-22 questionnaire
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.
OTHERData capture app
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.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Missing SNOT-22 Items | Up to 120 minutes | 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. |
| Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment | Up to 120 minutes | 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. |
| Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition | Up to 120 minutes | 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. |
| Number of Participants Who Liked or Disliked VAS Assessments | Up to 120 minutes | 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. |
| Number of Participants With Difficulties Completing VAS Assessments | Up to 120 minutes | 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. |
| Number of Participants Who Understood VAS Anchors | Up to 120 minutes | 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. |
| Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Up to 120 minutes | 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. |
| Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Up to 120 minutes | 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. |
| Number of Participants Who Liked or Disliked SNOT-22 Assessments | Up to 120 minutes | 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. |
| Number of Participants With Difficulties Completing SNOT-22 | Up to 120 minutes | 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. |
| Number of Participants Who Understood SNOT-22 Response Options | Up to 120 minutes | 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. |
| Number of Participants Who Reported Primary Symptoms | Up to 120 minutes | 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. |
| Number of Participants Who Reported Secondary Symptoms | Up to 120 minutes | 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. |
| Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Up to 120 minutes | 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. |
| Number of Participants Reporting Proximal Impacts-Physical Impact | Up to 120 minutes | 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. |
| Number of Participants Reporting Proximal Impacts-Sleep Impact | Up to 120 minutes | 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. |
| Number of Participants Reporting Proximal Impacts-ADL Impact | Up to 120 minutes | 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. |
| Number of Participants Reporting Distal Impacts-emotional Impact | Up to 120 minutes | 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. |
| Number of Participants Reporting Distal Impacts-social Impact | Up to 120 minutes | 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. |
| Number of Participants Reporting Distal Impacts-work/School Impact | Up to 120 minutes | 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. |
| Number of Participants Reporting Distal Impacts-treatment Impact | Up to 120 minutes | 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. |
| Number of Participants Who Reported Symptoms to be Targeted by New Treatment | Up to 120 minutes | 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. |
| Number of Participant Who Reported Impacts to be Targeted by New Treatment | Up to 120 minutes | 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. |
| Number of Participants Reporting Factors to be Considered for Surgery | Up to 120 minutes | 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. |
| Number of Participants With Ease of Decision to Have Surgery | Up to 120 minutes | 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. |
| Number of Participants Who Reported on the Positive or Negative Impacts of Surgery | Up to 120 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Primary Symptoms as Identified During App Task | Up to 10 days | 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. |
| Number of Participants Reporting Secondary Symptoms as Identified During App Task | Up to 10 days | 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. |
| Number of Participants Reporting Physical Impacts as Idenfied During the App Task | Up to 10 days | 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. |
| Number of Participants Reporting Sleep Impacts as Identified During the App Task | Up to 10 days | 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. |
| Number of Participants Reporting ADL Impacts as Identified During the App Task | Up to 10 days | 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. |
| Number of Participants Reporting Emotional Impacts as Identified During the App Task | Up to 10 days | 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. |
| Number of Participants Reporting Social Functioning Impacts as Identified During the App Task | Up to 10 days | 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. |
| Number of Participants Reporting Work Impacts as Identified During the App Task | Up to 10 days | 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. |
| Number of Participants Reporting Treatment Impacts as Identified During the App Task | Up to 10 days | 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. |
| Number of Participants Reporting Symptom Variability-Application (App) Task | Up to 10 days | 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. |
Countries
United States
Participant flow
Recruitment details
This was a cross-sectional qualitative study to characterize the participants experience of nasal polyps. Participants were identified via partner recruitment agencies for participation in the Concept Elicitation (CE) or Cognitive Debriefing (CD) interview.
Pre-assignment details
A total of 27 participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled in the study. The study was conducted in the United States and Germany.
Participants by arm
| Arm | Count |
|---|---|
| Interview Participants With Nasal Polyps Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Interview Participants With Nasal Polyps |
|---|---|
| Age, Continuous | 48.4 Years |
| Race/Ethnicity, Customized Asian/Pacific islander | 1 Participants |
| Race/Ethnicity, Customized Black/African American | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants |
| Race/Ethnicity, Customized White | 19 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Annoyance/frustration | 18 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Sadness | 9 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Irritable/crabby | 9 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Acceptance of nasal polyps | 9 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Stressed | 7 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Scared/worried | 6 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Embarrased | 6 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Loss of enjoyment | 5 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Not understanding condition | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Wanting to be normal | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Isolated | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Worthless | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Not in control | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Suffering | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-emotional Impact | Not feeling themselves | 1 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-social Impact | Social activities affected | 12 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-social Impact | Cancelling/avoiding social activities | 12 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-social Impact | Stigma | 7 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-social Impact | Lack of understanding from others | 4 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-social Impact | Improve relationships with family | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-social Impact | Personal relationships affected | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-social Impact | Struggles to hold conversation | 2 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-treatment Impact | Cost of treatment | 7 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-treatment Impact | Short treatment efficacy | 7 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-treatment Impact | Side effects of medication | 5 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-treatment Impact | Lack of treatment efficacy | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-treatment Impact | Fear of taking medication | 2 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-work/School Impact | Time off work | 17 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-work/School Impact | Affects activities at work | 10 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-work/School Impact | Reduced productivity | 5 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-work/School Impact | Inability to focus | 5 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-work/School Impact | Taking breaks | 4 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-work/School Impact | Symptom triggers in the workplace | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-work/School Impact | Loss of income | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-work/School Impact | Fatigue at work | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-work/School Impact | Reduced smell at work | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Distal Impacts-work/School Impact | Blowing nose at work | 3 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population. Only those participants who discussed the factors were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | Seriousness of surgery | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | Success of surgery | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | Unable to bear symptoms any longer | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | Confidence in doctor | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | Treatment failure | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | Simplicity of surgery | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | No alternative | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | Own research | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | Age | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | Pain/recovery | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | Risk of surgery | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | Risk of scarring | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Factors to be Considered for Surgery | Life expectancy | 1 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-ADL Impact | ADLs affected | 17 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-ADL Impact | Always being prepared | 8 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-ADL Impact | Hygiene | 4 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Tiredness/fatigue | 21 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Blowing nose | 19 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Mouth breathing | 14 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Sports/exercise | 14 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Discomfort | 7 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Altered physical appearance | 6 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Mobility | 4 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Increased thirst | 4 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Reduced appetite/weight loss | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Hearing loss | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Spitting mucus | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Smack lips | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Physical Impact | Passing out | 1 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Sleep Impact | Night-time awakenings | 22 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Sleep Impact | Poor sleep quality | 12 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Sleep Impact | Snoring | 11 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Sleep Impact | Difficulty falling asleep | 9 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Sleep Impact | Waking partner | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Sleep Impact | Bedsheet choice | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Proximal Impacts-Sleep Impact | Comfortable sleep position | 1 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population. Only those participants who were asked about each item was analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Need to blow nose; n=25 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Nasal blockage; n=27 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Sneezing; n=26 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Runny nose; n=25 | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Cough; n=26 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Post-nasal discharge; n=27 | 4 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Thick nasal discharge; n=26 | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Ear fullness; n=27 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Dizziness; n=27 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Ear pain; n=23 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Facial pain/pressure; n=25 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Decreased sense of smell/taste; n=27 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Difficulty falling asleep; n=27 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Wake up at night; n=27 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Lack of good night's sleep; n=24 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Wake up tired; n=25 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Fatigue; n=24 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Reduced productivity; n=26 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Reduced concentration; n=26 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Frustration/restless/irritable; n=26 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Sad; n=26 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Embarrassed; n=26 | 1 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment | Facial pain/pressure | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment | Overall symptoms | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment | Loss of smell | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment | Mucus in the throat | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment | Nasal discharge | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment | Nasal obstruction | 0 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population. Only those participants who provided general feedback were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Liked or Disliked SNOT-22 Assessments | SNOT-22 likes | 11 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Liked or Disliked SNOT-22 Assessments | SNOT-22 dislikes | 9 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population. Only those participants who provided general feedback were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Liked or Disliked VAS Assessments | VAS likes | 17 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Liked or Disliked VAS Assessments | VAS dislikes | 2 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population. Only those participants who were asked about missing items were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Missing SNOT-22 Items | 5 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Reported on the Positive or Negative Impacts of Surgery | Positive impact of surgery | 21 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported on the Positive or Negative Impacts of Surgery | Negative impact of surgery | 23 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population included all participants with severe, recurrent nasal polyps enrolled in the study
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Primary Symptoms | Breathing difficulties | 27 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Primary Symptoms | Nasal congestion | 27 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Primary Symptoms | Post-nasal drip | 25 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Primary Symptoms | Runny nose | 24 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Primary Symptoms | Head/facial pressure | 23 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Primary Symptoms | Loss of smell | 23 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Primary Symptoms | Ear congestion | 23 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Primary Symptoms | Headache | 23 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Primary Symptoms | Loss of taste | 22 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Mucus catarrh | 20 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Nose bleeds | 20 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Nasal swelling | 19 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Sneezing | 18 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Nasal pressure | 16 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Nasal pain | 15 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Nasal tightness | 13 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Visible polyps | 6 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Nasal dryness | 7 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Sinus blockage | 18 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Sinus inflammation | 17 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Sinus infections | 16 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Wheezing | 14 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Cough | 19 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Distorted voice | 17 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Dizziness | 16 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Facial pain | 13 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Facial swelling | 9 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Watering eyes | 4 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Visual disturbances | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Itchy eyes | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Red eyes | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Itching ears | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | General illness/infection | 4 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Secondary Symptoms | Fever | 1 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population. Only those participants who were asked about each item was analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Need to blow nose; n=27 | 25 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Nasal blockage; n=25 | 24 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Sneezing; n=25 | 20 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Runny nose; n=26 | 22 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Cough; n=25 | 19 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Post-nasal discharge; n=23 | 20 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Thick nasal discharge; n=23 | 20 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Ear fullness; n=27 | 21 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Dizziness; n=25 | 15 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Ear pain; n=26 | 16 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Facial pain/pressure; n=24 | 22 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Decreased sense of smell/taste; n=23 | 18 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Difficulty falling asleep; n=26 | 21 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Wake up at night; n=27 | 25 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Lack of good night's sleep; n=22 | 19 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Wake up tired; n=25 | 21 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Fatigue; n=27 | 22 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Reduced productivity; n=26 | 21 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Reduced concentration; n=25 | 21 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Frustration/restless/irritable; n=23 | 19 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Sad; n=26 | 15 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Embarrassed; n=26 | 16 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition | Overall symptoms | 26 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition | Facial pain/pressure | 25 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition | Loss of smell | 24 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition | Mucus in the throat | 25 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition | Nasal discharge | 26 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition | Nasal obstruction | 25 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population. Only those participants who were asked about treatment preferences were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms to be Targeted by New Treatment | Nasal congestion | 12 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms to be Targeted by New Treatment | Breathing difficulty | 8 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms to be Targeted by New Treatment | Head/facial pressure | 5 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms to be Targeted by New Treatment | Post-nasal drip | 4 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms to be Targeted by New Treatment | Loss of taste | 4 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms to be Targeted by New Treatment | Loss of smell | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms to be Targeted by New Treatment | Headache | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms to be Targeted by New Treatment | Ear pressure | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Symptoms to be Targeted by New Treatment | Dizziness | 1 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Nasal congestion: Worst, n=26 | 8 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Nasal congestion: most-frequent; n=27 | 9 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Nasal congestion: most bothersome; n=26 | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Difficulty breathing: Worst, n=26 | 7 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Difficulty breathing: most-frequent, n=27 | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Difficulty breathing: most bothersome, n=26 | 7 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Head/facial pressure: Worst, n=26 | 6 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Head/facial pressure: most-frequent, n=27 | 6 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Head/facial pressure: most bothersome, n=26 | 4 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Loss of smell/taste: Worst, n=26 | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Loss of smell/taste: most frequent, n=27 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Loss of smell/taste: most bothersome, n=26 | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Cough: Worst, n=26 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Cough: most-frequent, n=27 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Cough: most-bothersome, n=26 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Nasal discharge: Worst, n=26 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Nasal discharge: most-frequent, n=27 | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Nasal discharge: most-bothersome, n=26 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Post-nasal drip: Worst, n=26 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Post-nasal drip: most-frequent, n=27 | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Post-nasal drip: most-bothersome, n=26 | 5 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Dry mouth: Worst, n=26 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Dry mouth: most-frequent, n=27 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Dry mouth: most-bothersome, n=26 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Painful eyes: Worst, n=26 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Painful eyes: most-frequent, n=27 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Painful eyes: most-bothersome, n=26 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Earache: Worst, n=26 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Earache: most-frequent, n=27 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Earache: most-bothersome, n=26 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Runny nose: Worst, n=26 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Runny nose: most-frequent, n=27 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Runny nose: most-bothersome, n=26 | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Sinus blockage: Worst, n=26 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Sinus blockage: most-frequent, n=27 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Sinus blockage: most-bothersome, n=26 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Sneezing: Worst, n=26 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Sneezing: most-frequent, n=27 | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Sneezing: most-bothersome, n=26 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Sinus inflammation: Worst, n=26 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Sinus inflammation: most-frequent, n=27 | 0 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Sinus inflammation: most-bothersome, n=26 | 1 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Understood SNOT-22 Response Options | 27 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population. Only those participants with data available at the specified time points were included in the analysis (indicated by n=X in category titles)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Who Understood VAS Anchors | 100=as bad as you can imagine; n=27 | 27 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Who Understood VAS Anchors | 0=none; n=24 | 23 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population. Only those participants who were interviewed for ease of completion were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants With Difficulties Completing SNOT-22 | 3 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population. Only those participants who provided general feedback were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants With Difficulties Completing VAS Assessments | 7 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants With Ease of Decision to Have Surgery | Decision was difficult | 6 Participants |
| Interview Participants With Nasal Polyps | Number of Participants With Ease of Decision to Have Surgery | Decision was easy | 6 Participants |
Primary
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.
Time frame: Up to 120 minutes
Population: All Enrolled Population. Only those participants who were asked about treatment preferences were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participant Who Reported Impacts to be Targeted by New Treatment | Reduction in need for surgery & in polyp regrowth | 6 Participants |
| Interview Participants With Nasal Polyps | Number of Participant Who Reported Impacts to be Targeted by New Treatment | Ability to do physical activity | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participant Who Reported Impacts to be Targeted by New Treatment | Sleep disturbance | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participant Who Reported Impacts to be Targeted by New Treatment | Less need for medications | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participant Who Reported Impacts to be Targeted by New Treatment | Regain energy | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participant Who Reported Impacts to be Targeted by New Treatment | Able to concentrate | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participant Who Reported Impacts to be Targeted by New Treatment | Dry mouth | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participant Who Reported Impacts to be Targeted by New Treatment | Able to blow nose | 1 Participants |
Secondary
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.
Time frame: Up to 10 days
Population: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting ADL Impacts as Identified During the App Task | Restricts activities of daily living | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting ADL Impacts as Identified During the App Task | Unpredictably of condition | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting ADL Impacts as Identified During the App Task | Hygiene | 1 Participants |
Secondary
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.
Time frame: Up to 10 days
Population: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Emotional Impacts as Identified During the App Task | Embarrassment | 4 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Emotional Impacts as Identified During the App Task | Sadness | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Emotional Impacts as Identified During the App Task | Anger | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Emotional Impacts as Identified During the App Task | Irritable | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Emotional Impacts as Identified During the App Task | Stressed | 1 Participants |
Secondary
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.
Time frame: Up to 10 days
Population: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Physical Impacts as Idenfied During the App Task | Blowing nose | 5 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Physical Impacts as Idenfied During the App Task | Breathing through mouth | 5 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Physical Impacts as Idenfied During the App Task | Dry throat/mouth | 5 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Physical Impacts as Idenfied During the App Task | Tiredness/fatigue | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Physical Impacts as Idenfied During the App Task | Thirst | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Physical Impacts as Idenfied During the App Task | Discomfort | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Physical Impacts as Idenfied During the App Task | Physical activity difficulties | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Physical Impacts as Idenfied During the App Task | Altered physical appearance | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Physical Impacts as Idenfied During the App Task | Hearing loss | 1 Participants |
Secondary
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.
Time frame: Up to 10 days
Population: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Primary Symptoms as Identified During App Task | Nasal congestion | 8 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Primary Symptoms as Identified During App Task | Difficulty breathing | 8 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Primary Symptoms as Identified During App Task | Head/facial pressure | 7 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Primary Symptoms as Identified During App Task | Post-nasal drip | 6 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Primary Symptoms as Identified During App Task | Runny nose | 6 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Primary Symptoms as Identified During App Task | Loss of smell | 5 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Primary Symptoms as Identified During App Task | Loss of taste | 4 Participants |
Secondary
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.
Time frame: Up to 10 days
Population: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Nasal swelling | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Nasal pain | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Sneezing | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Nasal dryness | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Nasal tightness | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Nasal itching | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Nasal burning | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Nasal scabs | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Sinus inflammation | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Sinus infection | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Throat pain | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Cough | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Distorted voice | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Face swelling | 5 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Facial pain | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Dizziness | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Headache | 4 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Ear pain | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Watering eyes | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Nasal tingling | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Secondary Symptoms as Identified During App Task | Illness/infection | 1 Participants |
Secondary
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.
Time frame: Up to 10 days
Population: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Sleep Impacts as Identified During the App Task | Waking up at night | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Sleep Impacts as Identified During the App Task | Difficulty finding comfortable sleep position | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Sleep Impacts as Identified During the App Task | Difficulty falling asleep | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Sleep Impacts as Identified During the App Task | General poor sleep quality | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Sleep Impacts as Identified During the App Task | Snoring | 1 Participants |
Secondary
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.
Time frame: Up to 10 days
Population: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Social Functioning Impacts as Identified During the App Task | Social isolation | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Social Functioning Impacts as Identified During the App Task | Impacts personal relationships | 1 Participants |
Secondary
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.
Time frame: Up to 10 days
Population: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Symptom Variability-Application (App) Task | Within day variability | 9 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Symptom Variability-Application (App) Task | Between-day variability | 7 Participants |
Secondary
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.
Time frame: Up to 10 days
Population: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Treatment Impacts as Identified During the App Task | Side effects of medications | 3 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Treatment Impacts as Identified During the App Task | Lack of efficacy | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Treatment Impacts as Identified During the App Task | Short efficacy | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Treatment Impacts as Identified During the App Task | Overwhelming number of medications | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Treatment Impacts as Identified During the App Task | Cost of medications | 1 Participants |
Secondary
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.
Time frame: Up to 10 days
Population: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interview Participants With Nasal Polyps | Number of Participants Reporting Work Impacts as Identified During the App Task | Certain work activities affected | 2 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Work Impacts as Identified During the App Task | Reduced productivity | 1 Participants |
| Interview Participants With Nasal Polyps | Number of Participants Reporting Work Impacts as Identified During the App Task | Reduced concentration | 1 Participants |