Trial Outcomes & Findings for Qualitative Analysis of Subject Experience of Nasal Polyps (NCT NCT03221192)
NCT ID: NCT03221192
Last Updated: 2019-05-29
Results Overview
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.
COMPLETED
27 participants
Up to 120 minutes
2019-05-29
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Qualitative Analysis of Subject Experience of Nasal Polyps
Baseline characteristics by cohort
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Age, Continuous
|
48.4 Years
n=93 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific islander
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population included all participants with severe, recurrent nasal polyps enrolled in the study
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Reported Primary Symptoms
Nasal congestion
|
27 Participants
|
|
Number of Participants Who Reported Primary Symptoms
Breathing difficulties
|
27 Participants
|
|
Number of Participants Who Reported Primary Symptoms
Post-nasal drip
|
25 Participants
|
|
Number of Participants Who Reported Primary Symptoms
Runny nose
|
24 Participants
|
|
Number of Participants Who Reported Primary Symptoms
Head/facial pressure
|
23 Participants
|
|
Number of Participants Who Reported Primary Symptoms
Loss of smell
|
23 Participants
|
|
Number of Participants Who Reported Primary Symptoms
Ear congestion
|
23 Participants
|
|
Number of Participants Who Reported Primary Symptoms
Headache
|
23 Participants
|
|
Number of Participants Who Reported Primary Symptoms
Loss of taste
|
22 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Reported Secondary Symptoms
Mucus catarrh
|
20 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Nose bleeds
|
20 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Nasal swelling
|
19 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Sneezing
|
18 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Nasal pressure
|
16 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Nasal pain
|
15 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Nasal tightness
|
13 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Visible polyps
|
6 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Nasal dryness
|
7 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Sinus blockage
|
18 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Sinus inflammation
|
17 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Sinus infections
|
16 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Wheezing
|
14 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Cough
|
19 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Distorted voice
|
17 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Dizziness
|
16 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Facial pain
|
13 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Facial swelling
|
9 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Watering eyes
|
4 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Visual disturbances
|
1 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Itchy eyes
|
2 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Red eyes
|
1 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Itching ears
|
1 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
General illness/infection
|
4 Participants
|
|
Number of Participants Who Reported Secondary Symptoms
Fever
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Nasal congestion: Worst, n=26
|
8 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Nasal congestion: most-frequent; n=27
|
9 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Nasal congestion: most bothersome; n=26
|
3 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Difficulty breathing: Worst, n=26
|
7 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Difficulty breathing: most-frequent, n=27
|
3 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Difficulty breathing: most bothersome, n=26
|
7 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Head/facial pressure: Worst, n=26
|
6 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Head/facial pressure: most-frequent, n=27
|
6 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Head/facial pressure: most bothersome, n=26
|
4 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Loss of smell/taste: Worst, n=26
|
3 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Loss of smell/taste: most frequent, n=27
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Loss of smell/taste: most bothersome, n=26
|
2 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Cough: Worst, n=26
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Cough: most-frequent, n=27
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Cough: most-bothersome, n=26
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Nasal discharge: Worst, n=26
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Nasal discharge: most-frequent, n=27
|
2 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Nasal discharge: most-bothersome, n=26
|
0 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Post-nasal drip: Worst, n=26
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Post-nasal drip: most-frequent, n=27
|
2 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Post-nasal drip: most-bothersome, n=26
|
5 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Dry mouth: Worst, n=26
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Dry mouth: most-frequent, n=27
|
0 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Dry mouth: most-bothersome, n=26
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Painful eyes: Worst, n=26
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Painful eyes: most-frequent, n=27
|
0 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Painful eyes: most-bothersome, n=26
|
0 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Earache: Worst, n=26
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Earache: most-frequent, n=27
|
0 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Earache: most-bothersome, n=26
|
0 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Runny nose: Worst, n=26
|
0 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Runny nose: most-frequent, n=27
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Runny nose: most-bothersome, n=26
|
3 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Sinus blockage: Worst, n=26
|
0 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Sinus blockage: most-frequent, n=27
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Sinus blockage: most-bothersome, n=26
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Sneezing: Worst, n=26
|
0 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Sneezing: most-frequent, n=27
|
1 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Sneezing: most-bothersome, n=26
|
0 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Sinus inflammation: Worst, n=26
|
0 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Sinus inflammation: most-frequent, n=27
|
0 Participants
|
|
Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
Sinus inflammation: most-bothersome, n=26
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Tiredness/fatigue
|
21 Participants
|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Blowing nose
|
19 Participants
|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Mouth breathing
|
14 Participants
|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Sports/exercise
|
14 Participants
|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Discomfort
|
7 Participants
|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Altered physical appearance
|
6 Participants
|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Mobility
|
4 Participants
|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Increased thirst
|
4 Participants
|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Reduced appetite/weight loss
|
2 Participants
|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Hearing loss
|
2 Participants
|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Spitting mucus
|
1 Participants
|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Smack lips
|
1 Participants
|
|
Number of Participants Reporting Proximal Impacts-Physical Impact
Passing out
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Proximal Impacts-Sleep Impact
Night-time awakenings
|
22 Participants
|
|
Number of Participants Reporting Proximal Impacts-Sleep Impact
Poor sleep quality
|
12 Participants
|
|
Number of Participants Reporting Proximal Impacts-Sleep Impact
Snoring
|
11 Participants
|
|
Number of Participants Reporting Proximal Impacts-Sleep Impact
Difficulty falling asleep
|
9 Participants
|
|
Number of Participants Reporting Proximal Impacts-Sleep Impact
Waking partner
|
2 Participants
|
|
Number of Participants Reporting Proximal Impacts-Sleep Impact
Bedsheet choice
|
1 Participants
|
|
Number of Participants Reporting Proximal Impacts-Sleep Impact
Comfortable sleep position
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Proximal Impacts-ADL Impact
ADLs affected
|
17 Participants
|
|
Number of Participants Reporting Proximal Impacts-ADL Impact
Always being prepared
|
8 Participants
|
|
Number of Participants Reporting Proximal Impacts-ADL Impact
Hygiene
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Annoyance/frustration
|
18 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Sadness
|
9 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Irritable/crabby
|
9 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Acceptance of nasal polyps
|
9 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Stressed
|
7 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Scared/worried
|
6 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Embarrased
|
6 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Loss of enjoyment
|
5 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Not understanding condition
|
2 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Wanting to be normal
|
2 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Isolated
|
1 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Worthless
|
1 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Not in control
|
1 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Suffering
|
1 Participants
|
|
Number of Participants Reporting Distal Impacts-emotional Impact
Not feeling themselves
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Distal Impacts-social Impact
Social activities affected
|
12 Participants
|
|
Number of Participants Reporting Distal Impacts-social Impact
Cancelling/avoiding social activities
|
12 Participants
|
|
Number of Participants Reporting Distal Impacts-social Impact
Stigma
|
7 Participants
|
|
Number of Participants Reporting Distal Impacts-social Impact
Lack of understanding from others
|
4 Participants
|
|
Number of Participants Reporting Distal Impacts-social Impact
Improve relationships with family
|
3 Participants
|
|
Number of Participants Reporting Distal Impacts-social Impact
Personal relationships affected
|
3 Participants
|
|
Number of Participants Reporting Distal Impacts-social Impact
Struggles to hold conversation
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Distal Impacts-work/School Impact
Time off work
|
17 Participants
|
|
Number of Participants Reporting Distal Impacts-work/School Impact
Affects activities at work
|
10 Participants
|
|
Number of Participants Reporting Distal Impacts-work/School Impact
Reduced productivity
|
5 Participants
|
|
Number of Participants Reporting Distal Impacts-work/School Impact
Inability to focus
|
5 Participants
|
|
Number of Participants Reporting Distal Impacts-work/School Impact
Taking breaks
|
4 Participants
|
|
Number of Participants Reporting Distal Impacts-work/School Impact
Symptom triggers in the workplace
|
3 Participants
|
|
Number of Participants Reporting Distal Impacts-work/School Impact
Loss of income
|
3 Participants
|
|
Number of Participants Reporting Distal Impacts-work/School Impact
Fatigue at work
|
3 Participants
|
|
Number of Participants Reporting Distal Impacts-work/School Impact
Reduced smell at work
|
3 Participants
|
|
Number of Participants Reporting Distal Impacts-work/School Impact
Blowing nose at work
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Distal Impacts-treatment Impact
Cost of treatment
|
7 Participants
|
|
Number of Participants Reporting Distal Impacts-treatment Impact
Short treatment efficacy
|
7 Participants
|
|
Number of Participants Reporting Distal Impacts-treatment Impact
Side effects of medication
|
5 Participants
|
|
Number of Participants Reporting Distal Impacts-treatment Impact
Lack of treatment efficacy
|
2 Participants
|
|
Number of Participants Reporting Distal Impacts-treatment Impact
Fear of taking medication
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population. Only those participants who were asked about treatment preferences were included.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=24 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Reported Symptoms to be Targeted by New Treatment
Nasal congestion
|
12 Participants
|
|
Number of Participants Who Reported Symptoms to be Targeted by New Treatment
Breathing difficulty
|
8 Participants
|
|
Number of Participants Who Reported Symptoms to be Targeted by New Treatment
Head/facial pressure
|
5 Participants
|
|
Number of Participants Who Reported Symptoms to be Targeted by New Treatment
Post-nasal drip
|
4 Participants
|
|
Number of Participants Who Reported Symptoms to be Targeted by New Treatment
Loss of taste
|
4 Participants
|
|
Number of Participants Who Reported Symptoms to be Targeted by New Treatment
Loss of smell
|
2 Participants
|
|
Number of Participants Who Reported Symptoms to be Targeted by New Treatment
Headache
|
2 Participants
|
|
Number of Participants Who Reported Symptoms to be Targeted by New Treatment
Ear pressure
|
1 Participants
|
|
Number of Participants Who Reported Symptoms to be Targeted by New Treatment
Dizziness
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population. Only those participants who were asked about treatment preferences were included.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=24 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participant Who Reported Impacts to be Targeted by New Treatment
Reduction in need for surgery & in polyp regrowth
|
6 Participants
|
|
Number of Participant Who Reported Impacts to be Targeted by New Treatment
Ability to do physical activity
|
3 Participants
|
|
Number of Participant Who Reported Impacts to be Targeted by New Treatment
Sleep disturbance
|
3 Participants
|
|
Number of Participant Who Reported Impacts to be Targeted by New Treatment
Less need for medications
|
2 Participants
|
|
Number of Participant Who Reported Impacts to be Targeted by New Treatment
Regain energy
|
1 Participants
|
|
Number of Participant Who Reported Impacts to be Targeted by New Treatment
Able to concentrate
|
1 Participants
|
|
Number of Participant Who Reported Impacts to be Targeted by New Treatment
Dry mouth
|
1 Participants
|
|
Number of Participant Who Reported Impacts to be Targeted by New Treatment
Able to blow nose
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population. Only those participants who discussed the factors were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=26 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Factors to be Considered for Surgery
Seriousness of surgery
|
3 Participants
|
|
Number of Participants Reporting Factors to be Considered for Surgery
Success of surgery
|
3 Participants
|
|
Number of Participants Reporting Factors to be Considered for Surgery
Unable to bear symptoms any longer
|
3 Participants
|
|
Number of Participants Reporting Factors to be Considered for Surgery
Confidence in doctor
|
3 Participants
|
|
Number of Participants Reporting Factors to be Considered for Surgery
Treatment failure
|
3 Participants
|
|
Number of Participants Reporting Factors to be Considered for Surgery
Simplicity of surgery
|
3 Participants
|
|
Number of Participants Reporting Factors to be Considered for Surgery
No alternative
|
2 Participants
|
|
Number of Participants Reporting Factors to be Considered for Surgery
Own research
|
1 Participants
|
|
Number of Participants Reporting Factors to be Considered for Surgery
Age
|
1 Participants
|
|
Number of Participants Reporting Factors to be Considered for Surgery
Pain/recovery
|
1 Participants
|
|
Number of Participants Reporting Factors to be Considered for Surgery
Risk of surgery
|
1 Participants
|
|
Number of Participants Reporting Factors to be Considered for Surgery
Risk of scarring
|
1 Participants
|
|
Number of Participants Reporting Factors to be Considered for Surgery
Life expectancy
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants With Ease of Decision to Have Surgery
Decision was easy
|
6 Participants
|
|
Number of Participants With Ease of Decision to Have Surgery
Decision was difficult
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Reported on the Positive or Negative Impacts of Surgery
Positive impact of surgery
|
21 Participants
|
|
Number of Participants Who Reported on the Positive or Negative Impacts of Surgery
Negative impact of surgery
|
23 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment
Overall symptoms
|
0 Participants
|
|
Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment
Facial pain/pressure
|
0 Participants
|
|
Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment
Loss of smell
|
0 Participants
|
|
Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment
Mucus in the throat
|
0 Participants
|
|
Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment
Nasal discharge
|
1 Participants
|
|
Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment
Nasal obstruction
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition
Overall symptoms
|
26 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition
Facial pain/pressure
|
25 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition
Loss of smell
|
24 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition
Mucus in the throat
|
25 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition
Nasal discharge
|
26 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition
Nasal obstruction
|
25 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population. Only those participants who provided general feedback were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=26 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Liked or Disliked VAS Assessments
VAS likes
|
17 Participants
|
|
Number of Participants Who Liked or Disliked VAS Assessments
VAS dislikes
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population. Only those participants who provided general feedback were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=26 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants With Difficulties Completing VAS Assessments
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: 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)
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Understood VAS Anchors
100=as bad as you can imagine; n=27
|
27 Participants
|
|
Number of Participants Who Understood VAS Anchors
0=none; n=24
|
23 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population. Only those participants who were asked about each item was analyzed (represented by n=X in category titles)
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Need to blow nose; n=25
|
0 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Nasal blockage; n=27
|
0 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Sneezing; n=26
|
1 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Runny nose; n=25
|
3 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Cough; n=26
|
0 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Post-nasal discharge; n=27
|
4 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Thick nasal discharge; n=26
|
2 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Ear fullness; n=27
|
1 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Dizziness; n=27
|
0 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Ear pain; n=23
|
0 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Facial pain/pressure; n=25
|
0 Participants
|
|
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
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Difficulty falling asleep; n=27
|
0 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Wake up at night; n=27
|
0 Participants
|
|
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
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Wake up tired; n=25
|
0 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Fatigue; n=24
|
0 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Reduced productivity; n=26
|
0 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Reduced concentration; n=26
|
0 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Frustration/restless/irritable; n=26
|
0 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Sad; n=26
|
1 Participants
|
|
Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
Embarrassed; n=26
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population. Only those participants who were asked about each item was analyzed (represented by n=X in category titles)
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Need to blow nose; n=27
|
25 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Nasal blockage; n=25
|
24 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Sneezing; n=25
|
20 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Runny nose; n=26
|
22 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Cough; n=25
|
19 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Post-nasal discharge; n=23
|
20 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Thick nasal discharge; n=23
|
20 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Ear fullness; n=27
|
21 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Dizziness; n=25
|
15 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Ear pain; n=26
|
16 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Facial pain/pressure; n=24
|
22 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Decreased sense of smell/taste; n=23
|
18 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Difficulty falling asleep; n=26
|
21 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Wake up at night; n=27
|
25 Participants
|
|
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
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Wake up tired; n=25
|
21 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Fatigue; n=27
|
22 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Reduced productivity; n=26
|
21 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Reduced concentration; n=25
|
21 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Frustration/restless/irritable; n=23
|
19 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Sad; n=26
|
15 Participants
|
|
Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
Embarrassed; n=26
|
16 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population. Only those participants who provided general feedback were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=24 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Liked or Disliked SNOT-22 Assessments
SNOT-22 likes
|
11 Participants
|
|
Number of Participants Who Liked or Disliked SNOT-22 Assessments
SNOT-22 dislikes
|
9 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population. Only those participants who were interviewed for ease of completion were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=20 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants With Difficulties Completing SNOT-22
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=27 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Understood SNOT-22 Response Options
|
27 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutesPopulation: All Enrolled Population. Only those participants who were asked about missing items were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=14 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Who Reported Missing SNOT-22 Items
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=10 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Symptom Variability-Application (App) Task
Within day variability
|
9 Participants
|
|
Number of Participants Reporting Symptom Variability-Application (App) Task
Between-day variability
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=10 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Primary Symptoms as Identified During App Task
Nasal congestion
|
8 Participants
|
|
Number of Participants Reporting Primary Symptoms as Identified During App Task
Difficulty breathing
|
8 Participants
|
|
Number of Participants Reporting Primary Symptoms as Identified During App Task
Head/facial pressure
|
7 Participants
|
|
Number of Participants Reporting Primary Symptoms as Identified During App Task
Post-nasal drip
|
6 Participants
|
|
Number of Participants Reporting Primary Symptoms as Identified During App Task
Runny nose
|
6 Participants
|
|
Number of Participants Reporting Primary Symptoms as Identified During App Task
Loss of smell
|
5 Participants
|
|
Number of Participants Reporting Primary Symptoms as Identified During App Task
Loss of taste
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=10 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Nasal swelling
|
3 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Nasal pain
|
3 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Sneezing
|
2 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Nasal dryness
|
2 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Nasal tightness
|
1 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Nasal itching
|
1 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Nasal burning
|
1 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Nasal scabs
|
1 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Sinus inflammation
|
1 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Sinus infection
|
1 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Throat pain
|
1 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Cough
|
2 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Distorted voice
|
3 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Face swelling
|
5 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Facial pain
|
3 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Dizziness
|
3 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Headache
|
4 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Ear pain
|
1 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Watering eyes
|
1 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Nasal tingling
|
1 Participants
|
|
Number of Participants Reporting Secondary Symptoms as Identified During App Task
Illness/infection
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=10 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Physical Impacts as Idenfied During the App Task
Blowing nose
|
5 Participants
|
|
Number of Participants Reporting Physical Impacts as Idenfied During the App Task
Breathing through mouth
|
5 Participants
|
|
Number of Participants Reporting Physical Impacts as Idenfied During the App Task
Dry throat/mouth
|
5 Participants
|
|
Number of Participants Reporting Physical Impacts as Idenfied During the App Task
Tiredness/fatigue
|
3 Participants
|
|
Number of Participants Reporting Physical Impacts as Idenfied During the App Task
Thirst
|
3 Participants
|
|
Number of Participants Reporting Physical Impacts as Idenfied During the App Task
Discomfort
|
3 Participants
|
|
Number of Participants Reporting Physical Impacts as Idenfied During the App Task
Physical activity difficulties
|
2 Participants
|
|
Number of Participants Reporting Physical Impacts as Idenfied During the App Task
Altered physical appearance
|
1 Participants
|
|
Number of Participants Reporting Physical Impacts as Idenfied During the App Task
Hearing loss
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=10 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Sleep Impacts as Identified During the App Task
Waking up at night
|
3 Participants
|
|
Number of Participants Reporting Sleep Impacts as Identified During the App Task
Difficulty finding comfortable sleep position
|
3 Participants
|
|
Number of Participants Reporting Sleep Impacts as Identified During the App Task
Difficulty falling asleep
|
2 Participants
|
|
Number of Participants Reporting Sleep Impacts as Identified During the App Task
General poor sleep quality
|
2 Participants
|
|
Number of Participants Reporting Sleep Impacts as Identified During the App Task
Snoring
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=10 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting ADL Impacts as Identified During the App Task
Restricts activities of daily living
|
3 Participants
|
|
Number of Participants Reporting ADL Impacts as Identified During the App Task
Unpredictably of condition
|
1 Participants
|
|
Number of Participants Reporting ADL Impacts as Identified During the App Task
Hygiene
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=10 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Emotional Impacts as Identified During the App Task
Embarrassment
|
4 Participants
|
|
Number of Participants Reporting Emotional Impacts as Identified During the App Task
Sadness
|
3 Participants
|
|
Number of Participants Reporting Emotional Impacts as Identified During the App Task
Anger
|
3 Participants
|
|
Number of Participants Reporting Emotional Impacts as Identified During the App Task
Irritable
|
3 Participants
|
|
Number of Participants Reporting Emotional Impacts as Identified During the App Task
Stressed
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=10 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Social Functioning Impacts as Identified During the App Task
Social isolation
|
1 Participants
|
|
Number of Participants Reporting Social Functioning Impacts as Identified During the App Task
Impacts personal relationships
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=10 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Work Impacts as Identified During the App Task
Certain work activities affected
|
2 Participants
|
|
Number of Participants Reporting Work Impacts as Identified During the App Task
Reduced productivity
|
1 Participants
|
|
Number of Participants Reporting Work Impacts as Identified During the App Task
Reduced concentration
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.
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.
Outcome measures
| Measure |
Interview Participants With Nasal Polyps
n=10 Participants
Participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled.
|
|---|---|
|
Number of Participants Reporting Treatment Impacts as Identified During the App Task
Side effects of medications
|
3 Participants
|
|
Number of Participants Reporting Treatment Impacts as Identified During the App Task
Lack of efficacy
|
2 Participants
|
|
Number of Participants Reporting Treatment Impacts as Identified During the App Task
Short efficacy
|
2 Participants
|
|
Number of Participants Reporting Treatment Impacts as Identified During the App Task
Overwhelming number of medications
|
2 Participants
|
|
Number of Participants Reporting Treatment Impacts as Identified During the App Task
Cost of medications
|
1 Participants
|
Adverse Events
Interview Participants With Nasal Polyps
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER