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Nasal polyposis is a chronic inflammatory disease of the nose and sinuses. GlaxoSmithKline (GSK) is embarking on a clinical program to assess treatment of severe, recurrent nasal polyps with an anti-interleukin-5 (anti-IL5) (mepolizumab). Subject specific symptomatic endpoints will form the basis for the assessment of treatment benefit of nasal polyp therapies. However, there is a lack of published qualitative data regarding nasal polyps to understand the symptoms or health-related quality of life (HRQoL) impacts. This cross-sectional qualitative study aims to address this unmet gap by conducting semi-structured combined concept elicitation (CE) and cognitive debriefing (CD) telephone interviews and real-time data capture. The combined CE and CD interviews (each 90 minutes in duration) will investigate the subject experience of nasal polyps, and the relevance and understanding of existing patient-reported outcomes (PRO) instruments. The real-time data capture conducted over a 10 day period, will investigate the subject experience of the symptoms, HRQoL impacts and treatment of nasal polyps and any day-to-day variability that exists in these experiences in 'real time'. Twenty adult subjects in the United States (US), and 10 adult subjects in Germany with severe, recurrent nasal polyps will participate in the CE and CD interviews section of the study and of these, 10 subjects from US will also complete real-time data capture app task.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects participating in CE and CD interviews | Twenty adult subjects from the US and 10 adult subjects from Germany with severe recurrent nasal polyps who have received nasal polyp surgery in the past 10 years prior to screening will be asked to participate in CE and CD interviews |
| |
| Subjects participating in interview and real-time data capture | Ten subjects from the US with severe recurrent nasal polyps who are participating in CE and CD interviews will be asked to complete the real-time data capture app task. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAS questionnaire | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Reported Primary Symptoms | During the CE section of the interview, participants were asked a series of broad open-ended questions designed to encourage them to talk openly and as spontaneously as possible about their experience of having nasal polyps. In addition, participants were asked more focused questions designed to probe on issues that they may not have mentioned during the course of the interview spontaneously or concepts/statements that required additional clarification. The interviews were transcribed/translated verbatim and qualitative analysis was conducted using Atlas Ti. The symptoms which were most frequently reported spontaneously and were also reported to either be the most frequent, bothersome or worst were categorized as primary symptoms. Number of participants who reported each of the primary symptom is presented. | Up to 120 minutes |
| Number of Participants Who Reported Secondary Symptoms | During the CE section of the interview, participants were asked a series of broad open-ended questions designed to encourage them to talk openly and as spontaneously as possible about their experience of having nasal polyps. In addition, participants were asked more focused questions designed to probe on issues that they may not have mentioned during the course of the interview spontaneously or concepts/statements that required additional clarification. The interviews were transcribed/translated verbatim and qualitative analysis was conducted using Atlas Ti. The symptoms that were reported by fewer participants and less frequently mentioned spontaneously by participants during the interviews were classified as secondary symptoms. Number of participants who reported each of the secondary symptoms is reported. | Up to 120 minutes |
| Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms | Following spontaneous and probed discussions regarding symptoms during CE interviews, participants were asked to comment on what they each considered to be their 'worst' symptom, their 'most frequent' symptom and their 'most bothersome' symptom. The interviews were transcribed/translated verbatim and qualitative analysis was conducted using Atlas Ti. The number of participants with worst, most-frequent and most-bothersome symptoms are presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Symptom Variability-Application (App) Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Participants completed a number of tasks across 10 days, which explored how nasal polyp symptoms and impacts varied across a full day (within day variability) or assess the day to day variability (between day variability). Number of participants reporting within day and between-day symptom variability is reported. |
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Inclusion Criteria:
For real-time data capture:
Exclusion Criteria:
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Twenty adult subjects in the US, and 10 adult subjects in Germany with severe, recurrent nasal polyps who have undergone nasal polyp surgery in the past 10 years prior to screening will be included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Boston | Massachusetts | 02210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38130916 | Derived | Gater A, Tolley C, Williams-Hall R, Trennery C, Bradley H, Sikirica MV, Nelsen L, Sousa AR, Bratton DJ, Chan R, von Maltzahn R. Patient-Reported Outcome Measures for Severe Recurrent Bilateral Nasal Polyps: Psychometric Evaluation and Content Validity. OTO Open. 2023 Dec 21;7(4):e84. doi: 10.1002/oto2.84. eCollection 2023 Oct-Dec. | |
| 32389229 |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All Enrolled Population included all participants with severe, recurrent nasal polyps enrolled in the study | Posted | Count of Participants | Participants | Up to 120 minutes |
|
Up to 10 days
AEs and SAEs were observed in All Enrolled Population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 30, 2017 | May 23, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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|
| SNOT-22 questionnaire | Other | 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. |
|
| Data capture app | Other | 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. |
|
| Up to 120 minutes |
| Number of Participants Reporting Proximal Impacts-Physical Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Proximal impacts were defined as those reported to be the direct impact of the symptoms of nasal polyps and included; physical impacts, sleep impacts and impacts on activities of daily living (ADL). The number of participants with physical impacts are reported. | Up to 120 minutes |
| Number of Participants Reporting Proximal Impacts-Sleep Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Proximal impacts were defined as those reported to be the direct impact of the symptoms of nasal polyps and included; physical impacts, sleep impacts and impacts on ADL. The number of participants with sleep impacts are reported. | Up to 120 minutes |
| Number of Participants Reporting Proximal Impacts-ADL Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Proximal impacts were defined as those reported to be the direct impact of the symptoms of nasal polyps and included; physical impacts, sleep impacts and impacts on ADL. The number of participants with ADL impacts are reported. | Up to 120 minutes |
| Number of Participants Reporting Distal Impacts-emotional Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Distal impacts were those reported to be impacts of the condition as a whole and included; emotional, social, work/school and treatment impacts. The number of participants with emotional impacts are reported. | Up to 120 minutes |
| Number of Participants Reporting Distal Impacts-social Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Distal impacts were those reported to be impacts of the condition as a whole and included; emotional, social, work/school and treatment impacts. The number of participants with social impacts are reported. | Up to 120 minutes |
| Number of Participants Reporting Distal Impacts-work/School Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Distal impacts were those reported to be impacts of the condition as a whole and included; emotional, social, work/school and treatment impacts. The number of participants with work/school impacts are reported. | Up to 120 minutes |
| Number of Participants Reporting Distal Impacts-treatment Impact | The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Distal impacts were those reported to be impacts of the condition as a whole and included; emotional, social, work/school and treatment impacts. The number of participants with treatment impacts are reported. | Up to 120 minutes |
| Number of Participants Who Reported Symptoms to be Targeted by New Treatment | During CE interviews, participants were asked about the changes they would like to see from a new treatment for nasal polyps and which symptoms would be most meaningful for the treatment to target. The number of participants with their reported symptoms to be targeted by new treatment is presented. | Up to 120 minutes |
| Number of Participant Who Reported Impacts to be Targeted by New Treatment | During CE interviews, participants were asked about the changes they would like to see from a new treatment for nasal polyps and which impacts would be most meaningful for the treatment to target. The number of participants with corresponding impacts to be targeted by new treatment is presented. | Up to 120 minutes |
| Number of Participants Reporting Factors to be Considered for Surgery | During CE interviews, participants were asked about experiences of their surgery in past. The number of participants with the corresponding factors to be considered for surgery is presented. | Up to 120 minutes |
| Number of Participants With Ease of Decision to Have Surgery | During CE interviews, participants were asked about experiences of their surgery in past. The number of participants with ease of decision to have surgery is presented. | Up to 120 minutes |
| Number of Participants Who Reported on the Positive or Negative Impacts of Surgery | During CE interviews, participants were asked about experiences of their surgery in past. The number of participants who reported on the positive or negative impacts of surgery is presented. | Up to 120 minutes |
| Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment | Participants were required to complete six VAS assessments (overall symptom VAS and single item VAS) as a part of the CD interview. The participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 centimeter (cm) or 100 millimeter (mm) whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants were asked to speak aloud their thoughts as they read the instructions and completed the questions. After completion of each think-aloud exercise, participants were also probed upon their understanding of the instrument items. Number of participants who did not understand the VAS assessments is reported. | Up to 120 minutes |
| Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition | Participants were required to complete six VAS assessments (overall symptom VAS and single item VAS) as a part of the CD interview. The participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 cm or 100 mm whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants were asked to speak aloud their thoughts as they read the instructions and completed the questions. After completion of each think-aloud exercise, participants were also probed about the relevance of VAS items. Relevance was determined based on participants personal descriptions and related discussion of their experience of each symptom or impact during CD interview. It was also determined via the rating of a given symptom/impact on each measure as greater than a score of zero. Number of participants who reported the symptoms assessed by VAS to be relevant are presented. | Up to 120 minutes |
| Number of Participants Who Liked or Disliked VAS Assessments | Participants were required to complete six VAS assessments (overall symptom VAS and single item VAS) as a part of the CD interview. The participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 cm or 100 mm whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants provided a general feedback on completing the six VAS assessments which included relevance of symptoms to their condition, ease of completion and interpretation of the scale. The number of participants who provided general feedback for VAS assessments in terms of likes or dislikes for VAS assessment is presented. | Up to 120 minutes |
| Number of Participants With Difficulties Completing VAS Assessments | Participants were required to complete six VAS assessments (overall symptom VAS and single item VAS) as a part of the CD interview. The participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 cm or 100 mm whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants provided a general feedback on completing the six VAS assessments which included relevance of symptoms to their condition, ease of completion and interpretation of the scale. The number of participants with difficulties completing VAS assessment is presented. | Up to 120 minutes |
| Number of Participants Who Understood VAS Anchors | Participants completed the VAS assessment as a part of the CD interview. Participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 cm or 100 mm whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants were asked about their understanding of the response continuum for VAS assessment. Number of participants who understood the VAS anchors (100 as bad as you can imagine and 0 none) is presented. | Up to 120 minutes |
| Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22 | Participants completed SNOT-22 assessment as a part of the CD interview. The SNOT-22 contains 22 nose, sinus, and general health-related quality of life (HRQoL) items and is used to measure HRQoL associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Number of participants who did not understand the items of SNOT-22 is presented. | Up to 120 minutes |
| Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition | Participants were required to complete SNOT-22 assessment as a part of the CD interview. The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Number of participants who reported the symptoms assessed by SNOT-22 to be relevant to their condition are presented. | Up to 120 minutes |
| Number of Participants Who Liked or Disliked SNOT-22 Assessments | The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Participants provided a general feedback on completing the SNOT-22 which included relevance of symptoms to their condition, ease of completion and interpretation of the scale. Number of participants who liked or disliked the SNOT-22 is presented. | Up to 120 minutes |
| Number of Participants With Difficulties Completing SNOT-22 | Participants provided a general feedback on completing the SNOT-22 during the CD interview. The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Number of participants with difficulties completing SNOT-22 assessment is presented. | Up to 120 minutes |
| Number of Participants Who Understood SNOT-22 Response Options | Participants completed SNOT-22 as a part of the CD interview. The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Participants were asked about their understanding of each of the six options (no problem, mild or slight problem, very mild problem, moderate problem, severe problem, as bad as it can be) included in SNOT-22. Number of participants who understood each of the six SNOT-22 response options is presented. | Up to 120 minutes |
| Number of Participants Who Reported Missing SNOT-22 Items | Participants completed SNOT-22 as a part of the CD interview. The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Participants were asked if they felt any items were missing from SNOT-22. Number of participants who reported missing items in SNOT-22 is presented. | Up to 120 minutes |
| Up to 10 days |
| Number of Participants Reporting Primary Symptoms as Identified During App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting primary symptoms as identified during app task is reported. | Up to 10 days |
| Number of Participants Reporting Secondary Symptoms as Identified During App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting secondary symptoms as identified during app task is reported. | Up to 10 days |
| Number of Participants Reporting Physical Impacts as Idenfied During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants with physical impacts as identified during app task is reported. | Up to 10 days |
| Number of Participants Reporting Sleep Impacts as Identified During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting sleep impacts as identified during app task is reported. | Up to 10 days |
| Number of Participants Reporting ADL Impacts as Identified During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting ADL impacts as identified during app task is reported. | Up to 10 days |
| Number of Participants Reporting Emotional Impacts as Identified During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting emotional impacts as identified during app task is reported. | Up to 10 days |
| Number of Participants Reporting Social Functioning Impacts as Identified During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting social functioning impacts as identified during app task is reported. | Up to 10 days |
| Number of Participants Reporting Work Impacts as Identified During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting work impacts as identified during app task is reported. | Up to 10 days |
| Number of Participants Reporting Treatment Impacts as Identified During the App Task | Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting treatment impacts as identified during app task is reported. | Up to 10 days |
| Hall R, Trennery C, Chan R, Gater A, Bradley H, Sikirica MV, von Maltzahn R, Sousa AR, Nelsen LM. Understanding the Patient Experience of Severe, Recurrent, Bilateral Nasal Polyps: A Qualitative Interview Study in the United States and Germany. Value Health. 2020 May;23(5):632-641. doi: 10.1016/j.jval.2019.11.005. Epub 2020 Mar 11. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 |
| 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. |
|
|
| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
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| 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. | All Enrolled Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles). | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
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| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
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|
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| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
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|
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| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
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| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
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| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
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| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
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| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
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|
|
| 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. | All Enrolled Population. Only those participants who were asked about treatment preferences were included. | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population. Only those participants who were asked about treatment preferences were included. | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population. Only those participants who discussed the factors were included in the analysis. | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population. Only those participants who provided general feedback were included in the analysis. | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population. Only those participants who provided general feedback were included in the analysis. | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | 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) | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population. Only those participants who were asked about each item was analyzed (represented by n=X in category titles) | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population. Only those participants who were asked about each item was analyzed (represented by n=X in category titles) | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population. Only those participants who provided general feedback were included in the analysis. | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population. Only those participants who were interviewed for ease of completion were included in the analysis. | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population. Only those participants who were asked about missing items were included in the analysis. | Posted | Count of Participants | Participants | Up to 120 minutes |
|
|
|
| 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. | All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis. | Posted | Count of Participants | Participants | Up to 10 days |
|
|
|
| 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. | All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis. | Posted | Count of Participants | Participants | Up to 10 days |
|
|
|
| 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. | All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis. | Posted | Count of Participants | Participants | Up to 10 days |
|
|
|
| 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. | All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis. | Posted | Count of Participants | Participants | Up to 10 days |
|
|
|
| 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. | All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis. | Posted | Count of Participants | Participants | Up to 10 days |
|
|
|
| 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. | All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis. | Posted | Count of Participants | Participants | Up to 10 days |
|
|
|
| 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. | All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis. | Posted | Count of Participants | Participants | Up to 10 days |
|
|
|
| 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. | All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis. | Posted | Count of Participants | Participants | Up to 10 days |
|
|
|
| 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. | All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis. | Posted | Count of Participants | Participants | Up to 10 days |
|
|
|
| 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. | All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis. | Posted | Count of Participants | Participants | Up to 10 days |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Sneezing |
|
| Nasal pressure |
|
| Nasal pain |
|
| Nasal tightness |
|
| Visible polyps |
|
| Nasal dryness |
|
| Sinus blockage |
|
| Sinus inflammation |
|
| Sinus infections |
|
| Wheezing |
|
| Cough |
|
| Distorted voice |
|
| Dizziness |
|
| Facial pain |
|
| Facial swelling |
|
| Watering eyes |
|
| Visual disturbances |
|
| Itchy eyes |
|
| Red eyes |
|
| Itching ears |
|
| General illness/infection |
|
| Fever |
|
|
| Nasal congestion: most bothersome; n=26 |
|
|
| Difficulty breathing: Worst, n=26 |
|
|
| Difficulty breathing: most-frequent, n=27 |
|
|
| Difficulty breathing: most bothersome, n=26 |
|
|
| Head/facial pressure: Worst, n=26 |
|
|
| Head/facial pressure: most-frequent, n=27 |
|
|
| Head/facial pressure: most bothersome, n=26 |
|
|
| Loss of smell/taste: Worst, n=26 |
|
|
| Loss of smell/taste: most frequent, n=27 |
|
|
| Loss of smell/taste: most bothersome, n=26 |
|
|
| Cough: Worst, n=26 |
|
|
| Cough: most-frequent, n=27 |
|
|
| Cough: most-bothersome, n=26 |
|
|
| Nasal discharge: Worst, n=26 |
|
|
| Nasal discharge: most-frequent, n=27 |
|
|
| Nasal discharge: most-bothersome, n=26 |
|
|
| Post-nasal drip: Worst, n=26 |
|
|
| Post-nasal drip: most-frequent, n=27 |
|
|
| Post-nasal drip: most-bothersome, n=26 |
|
|
| Dry mouth: Worst, n=26 |
|
|
| Dry mouth: most-frequent, n=27 |
|
|
| Dry mouth: most-bothersome, n=26 |
|
|
| Painful eyes: Worst, n=26 |
|
|
| Painful eyes: most-frequent, n=27 |
|
|
| Painful eyes: most-bothersome, n=26 |
|
|
| Earache: Worst, n=26 |
|
|
| Earache: most-frequent, n=27 |
|
|
| Earache: most-bothersome, n=26 |
|
|
| Runny nose: Worst, n=26 |
|
|
| Runny nose: most-frequent, n=27 |
|
|
| Runny nose: most-bothersome, n=26 |
|
|
| Sinus blockage: Worst, n=26 |
|
|
| Sinus blockage: most-frequent, n=27 |
|
|
| Sinus blockage: most-bothersome, n=26 |
|
|
| Sneezing: Worst, n=26 |
|
|
| Sneezing: most-frequent, n=27 |
|
|
| Sneezing: most-bothersome, n=26 |
|
|
| Sinus inflammation: Worst, n=26 |
|
|
| Sinus inflammation: most-frequent, n=27 |
|
|
| Sinus inflammation: most-bothersome, n=26 |
|
|
| Title | Measurements |
|---|---|
|
| Sports/exercise |
|
| Discomfort |
|
| Altered physical appearance |
|
| Mobility |
|
| Increased thirst |
|
| Reduced appetite/weight loss |
|
| Hearing loss |
|
| Spitting mucus |
|
| Smack lips |
|
| Passing out |
|
| Title | Measurements |
|---|---|
|
| Difficulty falling asleep |
|
| Waking partner |
|
| Bedsheet choice |
|
| Comfortable sleep position |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Acceptance of nasal polyps |
|
| Stressed |
|
| Scared/worried |
|
| Embarrased |
|
| Loss of enjoyment |
|
| Not understanding condition |
|
| Wanting to be normal |
|
| Isolated |
|
| Worthless |
|
| Not in control |
|
| Suffering |
|
| Not feeling themselves |
|
| Title | Measurements |
|---|---|
|
| Lack of understanding from others |
|
| Improve relationships with family |
|
| Personal relationships affected |
|
| Struggles to hold conversation |
|
| Title | Measurements |
|---|---|
|
| Inability to focus |
|
| Taking breaks |
|
| Symptom triggers in the workplace |
|
| Loss of income |
|
| Fatigue at work |
|
| Reduced smell at work |
|
| Blowing nose at work |
|
| Title | Measurements |
|---|---|
|
| Lack of treatment efficacy |
|
| Fear of taking medication |
|
| Title | Measurements |
|---|---|
|
| Post-nasal drip |
|
| Loss of taste |
|
| Loss of smell |
|
| Headache |
|
| Ear pressure |
|
| Dizziness |
|
| Title | Measurements |
|---|---|
|
| Less need for medications |
|
| Regain energy |
|
| Able to concentrate |
|
| Dry mouth |
|
| Able to blow nose |
|
| Title | Measurements |
|---|---|
|
| Confidence in doctor |
|
| Treatment failure |
|
| Simplicity of surgery |
|
| No alternative |
|
| Own research |
|
| Age |
|
| Pain/recovery |
|
| Risk of surgery |
|
| Risk of scarring |
|
| Life expectancy |
|
| Title | Measurements |
|---|---|
|
| Mucus in the throat |
|
| Nasal discharge |
|
| Nasal obstruction |
|
| Title | Measurements |
|---|---|
|
| Mucus in the throat |
|
| Nasal discharge |
|
| Nasal obstruction |
|
|
|
| Sneezing; n=26 |
|
|
| Runny nose; n=25 |
|
|
| Cough; n=26 |
|
|
| Post-nasal discharge; n=27 |
|
|
| Thick nasal discharge; n=26 |
|
|
| Ear fullness; n=27 |
|
|
| Dizziness; n=27 |
|
|
| Ear pain; n=23 |
|
|
| Facial pain/pressure; n=25 |
|
|
| Decreased sense of smell/taste; n=27 |
|
|
| Difficulty falling asleep; n=27 |
|
|
| Wake up at night; n=27 |
|
|
| Lack of good night's sleep; n=24 |
|
|
| Wake up tired; n=25 |
|
|
| Fatigue; n=24 |
|
|
| Reduced productivity; n=26 |
|
|
| Reduced concentration; n=26 |
|
|
| Frustration/restless/irritable; n=26 |
|
|
| Sad; n=26 |
|
|
| Embarrassed; n=26 |
|
|
|
| Sneezing; n=25 |
|
|
| Runny nose; n=26 |
|
|
| Cough; n=25 |
|
|
| Post-nasal discharge; n=23 |
|
|
| Thick nasal discharge; n=23 |
|
|
| Ear fullness; n=27 |
|
|
| Dizziness; n=25 |
|
|
| Ear pain; n=26 |
|
|
| Facial pain/pressure; n=24 |
|
|
| Decreased sense of smell/taste; n=23 |
|
|
| Difficulty falling asleep; n=26 |
|
|
| Wake up at night; n=27 |
|
|
| Lack of good night's sleep; n=22 |
|
|
| Wake up tired; n=25 |
|
|
| Fatigue; n=27 |
|
|
| Reduced productivity; n=26 |
|
|
| Reduced concentration; n=25 |
|
|
| Frustration/restless/irritable; n=23 |
|
|
| Sad; n=26 |
|
|
| Embarrassed; n=26 |
|
|
| Title | Measurements |
|---|---|
|
| Post-nasal drip |
|
| Runny nose |
|
| Loss of smell |
|
| Loss of taste |
|
| Title | Measurements |
|---|---|
|
| Nasal dryness |
|
| Nasal tightness |
|
| Nasal itching |
|
| Nasal burning |
|
| Nasal scabs |
|
| Sinus inflammation |
|
| Sinus infection |
|
| Throat pain |
|
| Cough |
|
| Distorted voice |
|
| Face swelling |
|
| Facial pain |
|
| Dizziness |
|
| Headache |
|
| Ear pain |
|
| Watering eyes |
|
| Nasal tingling |
|
| Illness/infection |
|
| Title | Measurements |
|---|---|
|
| Tiredness/fatigue |
|
| Thirst |
|
| Discomfort |
|
| Physical activity difficulties |
|
| Altered physical appearance |
|
| Hearing loss |
|
| Title | Measurements |
|---|---|
|
| General poor sleep quality |
|
| Snoring |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Irritable |
|
| Stressed |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Overwhelming number of medications |
|
| Cost of medications |
|