Qualitative Research to Characterize the Patient Experience of Nasal Polyps
Conditions: Nasal Polyps
Sponsor: GlaxoSmithKline

 
CGI-501 E010 
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HEALTH OUTCOMES STUDY PROTOCOL - QUALITATIVE RESEARCH 
 
 
UNIQUE IDENTIFIER 
HO-16-17264 
 
FULL TITLE 
Qualitative research to characterize the patient 
experience of nasal polyps 
ABBREVIATED TITLE 
Qualitative research to categorize nasal polyps  
FINAL PROTOCOL 
APPROVED 
DD-MMM-YYYY  
(Enter date of Senior Line Manager approval signature)  
SPONSORSHIP 
Sponsored or Supported  
DIVISION 
Pharma  
BUSINESS UNIT 
Research & Development 
DEPARTMENT 
VEO 
STUDY ACCOUNTABLE 
PERSON 
 
CONTRIBUTING AUTHORS 
 (GSK), 
 (GSK), 
 
(Adelphi Values), 
 (Adelphi Values) and 
 (Adelphi Values)  
 
ASSET ID 
SB240563 
GSK ASSET 
Mepolizumab 
INDICATION 
Nasal Polyps  
 
 
REVISION CHRONOLOGY:   
Version Date   
Document 
Type 
Change(s) since last version 
14/02/2017 
Original 
(V1_0) 
n/a 
13/04/2017 
V2_0 
Comments from client incorporated 
02/05/2017 
V3_0 
Protocol transferred in GSK template as per 
client request 
PPD
PPD
PPD
PPD
PPD
PPD
Oct 30, 2017

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10/05/2017 
V4_0 
Client comments on update template 
addressed for client internal review 
committee 
25/05/2917 
V5_0 
Comments from client internal review 
committee addressed  
12/06/2017 
V6_0 
Version approved by client internal review 
committee and version submitted to IRB  
30/10/2017 
V7_0 
 Errors with study quotas corrected and 
study quotas broadened to allow for 
smoother recruitment.  
 New exclusion criteria added to ensure 
that the criteria was aligned with that 
of the client’s clinical trial. 
 Interview length extended to 120 mins 
and incentive increased to $200 to 
ensure that all concepts could be 
covered in interviews.  
 
 
 
Description: Qualitative research to categorize nasal polyps  
 
 
Unique Identifier: HO-16-17264 
 
 
SPONSOR SIGNATORY 
 
 
     
 
 
 
 
 
 
 
         DD-MMM-YYYY 
Enter Sponsor Signatory’s name 
Senior Line Manager 
Enter title, e.g. Therapy Area Head, Senior Group 
Leader, or Medical Director 
 
 
 
Date 
 
 
 
 
 

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Only include this section if the study uses study sites to collect data. 
 
Description: Abbreviated Title 
 
Unique Identifier: trackHO / eTrack ID 
 
 
Investigator Protocol Agreement Page 
 
• 
I confirm agreement to conduct the study in compliance with the protocol. 
• 
I acknowledge that I am responsible for overall study conduct. I agree to 
personally conduct or supervise the described clinical study. 
• 
I agree to ensure that all associates, colleagues and employees assisting in the 
conduct of the study are informed about their obligations. Mechanisms are in 
place to ensure that site staff receives the appropriate information throughout the 
study. 
 
 
Investigator Name:  
_________________________________ 
 
 
 
 
 
 
 
 
 
  
Investigator Signature 
 
Date (DD-MMM-
YYYY) 
 
 
 
 

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 PROTOCOL SYNOPSIS  
 
Unique Identifier 
HO-16-17264
Abbreviated Title  
Qualitative research to categorize nasal polyps  
GSK Product 
Mepolizumab 
Rationale 
GlaxoSmithKline (GSK) is embarking on a clinical program to 
assess treatment of severe, recurrent nasal polyps with an anti-
interleukin-5 (anti-IL5) (mepolizumab). Patient symptomatic 
endpoints will form the basis for the assessment of treatment 
benefit of nasal polyp therapies. Currently, there is a lack of 
published qualitative data regarding nasal polyps to understand 
the symptoms (specific symptoms, duration, frequency, 
severity) or health-related quality of life (HRQoL) impacts for 
patients, as well as the patient decision-making process in 
electing for surgery and their pre- and post-surgical experience 
to treat nasal polyps. In line with regulatory requirements,1,2 the 
patient experience of nasal polyps will need to be characterized. 
Additionally, there is a requirement to evaluate existing 
symptomatic endpoints with respect to relevance and 
comprehensiveness within this population to inform GSK’s 
clinical outcome assessment (COA) strategy for this trial.   
To address this unmet need GSK would like to conduct a 
qualitative research study with adult patients with nasal polyps 
to explore the disease experience from the patient perspective 
and to debrief existing symptomatic PROs (including overall and 
single item VAS’s and the SNOT-22), via patient interviews and 
real-time data capture. This protocol details the methods and 
procedures that will be used in the conduct of this study.  
Objectives  
(Primary, Secondary)  
Primary 
To explore the symptom, impact and surgery experience of 
patients with severe, recurrent nasal polyps and obtain patient 
feedback regarding the adequacy of the SNOT-22 and GSK 
VAS assessments (in terms of relevance and 
comprehensiveness) in assessing disease experience in nasal 
polyps. 
Secondary 
Combined concept elicitation (CE) and cognitive debriefing 
(CD) interviews 
Concept elicitation objectives: 

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To identify through open-ended questioning the concepts that 
are important to patients with severe, recurrent, nasal polyps, 
who have been treated with surgery and the language they use 
to describe their disease experience. The main areas of 
exploration will be the symptoms with particular attention paid to 
the frequency, severity, duration and bother of each symptom, 
patients’ surgical decision-making and surgical/treatment 
experience and the functional and HRQoL impact experienced 
by patients. 
Cognitive debriefing objectives:  
To cognitively test and explore the content and face validity of 
existing PRO instruments (single item VAS and SNOT-22) via 
assessment of the relevance and appropriateness of the items 
included in the instruments and the participants’ ability to read, 
and consistently understand the instrument item wording, 
instructions, response option and recall period. 
Real-time data capture app 
To explore the patient 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’ using 
smartphone/tablet app based technology. 
Study Design 
This is a cross-sectional qualitative study comprising the 
conduct of semi-structured combined CE and CD telephone 
interviews (each 120 minutes in duration) with US (n=20) and 
German (n=10) adults with severe, recurrent nasal polyps. The 
combined CE and CD interviews aim to investigate the patient 
experience of nasal polyps, and the relevance and 
understanding of existing PRO instruments (e.g. VAS and 
SNOT-22).In addition to the interview, the study includes a real-
time data capture task conducted with 10 of the 20 US 
participants over a 10-day period using smartphone/tablet app-
based technology. Five of the ten participants (50%) will take 
part in the app task prior to their interview and the remaining 
five participants (50%) will take part in the app task following 
their interview.  
This study will be conducted by Adelphi Values, an independent 
research agency specializing in health outcomes research, on 
behalf of GSK.   
Study Population and 
Sampling Methods  
A sample of 20 US-English speaking patients and 10 German 
patients will be recruited, giving a collective sample of 30 
patients. Recruitment will be facilitated by third-party vendors in 

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both US and Germany (MedQuest Global in US and Zeste in 
Germany). A purposive approach to sampling using recruitment 
quotas outlined in section 3.2.2 in Table 1 and Table 2 will be 
employed to ensure that patients with a broad range of 
demographic and clinical characteristics are recruited.  
 
Inclusion criteria 
To participate in the interview aspect of this study, patients must 
meet the following criteria: 
 
 Participant has a clinical diagnosis of bilateral nasal polyps 
as diagnosed by endoscopy or CT scan; 
 Participant is aged 18 or over; 
 Participant has severe nasal polyps symptoms defined as an 
patient-reported nasal obstruction VAS score of >5 (see 
Appendix 1); 
 Participant has had at least one previous surgery in the 
past ten years for the removal of nasal polyps. Surgery in 
this case is defined as any procedure involving instruments 
with resulting incision and removal of polyp tissue from the 
nasal cavity (polypectomy); 
 Participant is currently an eligible candidate for polypectomy 
defined by: 
An overall patient-reported VAS symptom score of 
>7.(Appendix 2), AND 
An endoscopic bilateral nasal polyp score of at least 5 out of a 
maximum score of 8 (with a minimum score of 2 in each nasal 
cavity). ( 
Appendix 3); 
 Participant has symptoms consistent with chronic 
rhinosinusitis; 
 Participant is currently receiving intranasal corticosteroids for 
the management of their nasal polyps; 
 Participant is willing to participate in the study and provide 
informed consent; 
 Participant is an English speaker and is able to read, write 
and fully understand the English language; 
 Participant is willing to and able to attend and participate in a 
120-minute interview to discuss their experiences of nasal 
polyps and obtain their feedback on several symptom/impact 
questionnaires. 
In addition to meeting the interview criteria, those participants 
invited to take part in the real-time data capture will also be 
required to meet the following criteria: 
 Participant owns/or has access to either a smartphone (iOS 

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or android) or tablet which has video, audio/microphone and 
photographic capabilities and access to either the Apple app 
store or google play store to download the app; 
  Participant is willing and able to take part in the real-time 
data application task and respond to a series of 
questions/tasks fielded to them via the application over the 
course of 10 days; 
AND 
Is willing to respond to some brief questions following the 
real-time data capture task about their experience of using 
the app and completing the tasks, either during their 
interview or in a 5-10 minute telephone call following 
completion of the task.  
 Participant has stated that they would feel comfortable 
recording short videos of themselves and providing audio 
commentary in response to questions/tasks. 
 
Exclusion criteria 
Patients will not be eligible to participate in the study if they 
meet any of the following criteria: 
 
 Participant has received oral or injectable systemic 
corticosteroids in the last 4 weeks (28 days) for the 
management of their nasal polyps 
 Participant has a diagnosis of cystic fibrosis; 
 Participant has a diagnosis of eosinophilic granulomatosis 
with polyangitis (also known as Churg Strauss syndrome), 
Young’s, Kartagener’s or dyskinetic ciliary syndromes; 
 Participant has a diagnosis of antrochoanal polyps; 
 Participant has a diagnosis of nasal septal deviation 
occluding one nostril; 
 Participant has had acute sinusitis or upper respiratory tract 
infection in the last two weeks; 
 Participant has ongoing rhinitis medicamentosa (rebound or 
chemical induced rhinitis); 
 Participant has had an asthma exacerbation requiring 
admission to hospital in the last four weeks; 
 Participant is currently or has previously taken part in a 
clinical trial for nasal polyps; 
 Participant is unwilling or unable to comply with the 
requirements of the study or has a physical or mental 
condition or learning difficulties that, in the opinion of the 
physician, may affect the participant’s ability to participate in 
the study, the responses he/she might provide or their ability 
to provide consent. 

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Data Source  
This study will consist of combined concept elicitation and 
cognitive debriefing interviews, which will last for 120 minutes in 
total. All participants (20 participants from the US and 10 
participants from Germany) will all complete these interviews. 
Ten of the 20 US participants (50%) will also complete a 10-day 
real-time data capture app task and provide feedback about 
their experience of completing this task.  
 
No endpoints are specified or feature as part of this study. 
Data Analysis 
Methods 
Descriptive socio-demographic and clinical characteristics 
Socio-demographic and clinical characteristics for participant 
collected from the demographics form and CRF respectively will 
be summarized using descriptive statistics (e.g. n vales, means, 
ranges, percentages etc. where relevant). 
Analysis of interviews 
All interviews will be audio-recorded, and along with audio real-
time data capture app task responses, transcribed/translated 
verbatim. Transcripts will be analyzed using thematic analysis 
methods and qualitatively coded using Atlas.Ti software. The 
Adelphi Values project team will create the initial code list, and 
each transcript would be assessed and participant comments 
that pertain to the main research questions would be highlighted 
The code list will be updated iteratively during the coding 
process. The CE interview data will be analyzed in accordance 
with the principle of conceptual saturation as fully outlined in 
section 4.  
 
Descriptive statistics for the SNOT-22 and visual analogue 
scales 
The data collected from the SNOT-22 and visual analogue 
scales during the CD interview will be scored by Adelphi Values 
and summarized using descriptive statistics (e.g., n values, 
mean scores, ranges and percentages). Information relating to 
the distribution of responses will be summarized in addition to 
any missing data. The data will be presented in tabular or 
graphical format, whichever is deemed most appropriate at the 
time of reporting the findings. 
Real-time data capture analysis 

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Responses to the real-time data capture data will be collected 
using a variety of methodologies (e.g., video, audio, text and 
photographic responses with captions). For audio responses 
these will be transcribed. 
 
Participants’ responses to questions/tasks in the real-time data 
capture activity and post-activity questions administered via 
telephone will be analyzed in the same way using Atlas.Ti for 
the qualitative interviews as outlined above. Video, free text 
photographic and transcribed audio responses will be entered 
into Atlas Ti and assigned codes in the same manner as the 
verbatim interview transcripts to tag/code what their content 
conveys. For any questions/tasks fielded to participants as part 
of the app with multiple choice or numerical responses options, 
descriptive analysis of these items will be performed and 
reported (e.g. mean item score, ranges etc.). 
 
The interview and app task results will be used to inform the 
further development of a conceptual model for nasal polyps, 
previously constructed based on literature review activity only. 
The qualitative analysis will also be used help summarize the 
content validity of the reviewed PRO instruments and their 
suitability for use with patients with nasal polyps. 
Sample Size and 
Power 
Where the goal of qualitative research is to provide 
comprehensive understanding of complex phenomena (e.g. the 
holistic experience disease from the patient/caregiver 
perspective), it is recommended that sample sizes are 
determined based on the concept of ‘conceptual saturation’ 
where no new concepts are identified with repeated data 
collection. Past research and experience suggests that 
conceptual saturation can typically be achieved in as few as 12 
individual interviews in a relatively homogenous population.3,4   
Taking the above into account, a total of 20 participants from 
the US and a total of 10 from Germany will be interviewed (total 
sample= 30).  
Limitations 
As the study has been designed using best practice 
methodology advocated by the Food and Drug Administration 
for exploratory qualitative studies used to support clinical 
measurement strategies, the foreseen risk/limitations of the 
study are minimal but include the following: 

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 Selection of participants: potential bias is always 
possible when selecting interviewees; however, as 
outlined in sections 3.2.1 and 3.2.2 eligibility criteria and 
recruitment quotas will be employed to ensure the 
participant sample is as diverse and representative as 
possible given the overall study size (n=30). 
 Generalizability of data: The participant sample (n=30) 
is relatively small as the planned research is primarily 
exploratory in nature. The sample size is typical of 
qualitative studies conducted in this context. 
Nevertheless, the findings obtained from the participant 
interviews cannot be extrapolated or generalized to the 
wider population with nasal polyps; however, they will be 
relevant to GSK target nasal polyp population for their 
planned Phase III clinical trial. 
 Real-time data capture: The eligibility criteria for the 
real-time data capture task and information included 
within the consent form (Appendix 5) will aim to ensure 
that those participants who take part in this activity are 
willing to take part over a period of ten days and that they 
would feel comfortable in providing responses using a 
variety of methods including video, audio, photographic 
and/or free text responses. As this methodology is 
exploratory and ethnographic in nature the quality of 
completion and the comprehensiveness of participant 
responses cannot be guaranteed. This said however, the 
participants will be contactable both via the app and also 
via email and/or telephone during the completion of the 
app task and as such the project researchers will 
endeavor to encourage the completion of all task in as 
thorough manner as possible (e.g. provide reminders to 
participants to complete their task or probes/examples if 
they are unsure of how to respond to a task/question). 
 Conceptual saturation: Whilst conceptual saturation 
can typically be achieved in a sample of 12 in a relatively 
homogenous population, a potential limitation of the 
study is that conceptual saturation is not achieved across 
the 20 interviews. Should conceptual saturation not be 
achieved, discussion will be held with GSK to determine 
whether additional interviews should be conducted in 

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order to achieve saturation. 
 
 
 

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TABLE OF CONTENTS 
1 
INTRODUCTION/BACKGROUND ............................................................................................. 15 
2 
OBJECTIVES ............................................................................................................................ 16 
2.1 
Primary ............................................................................................................................... 16 
2.2 
Secondary .......................................................................................................................... 16 
Combined concept elicitation (CE) and cognitive debriefing (CD) interviews: ........................... 16 
Real-time data capture application: ........................................................................................... 17 
3 
RESEARCH METHODOLOGY ................................................................................................. 17 
3.1 
Study Design ...................................................................................................................... 17 
Combined CE and CD interviews (120 minutes) ....................................................................... 18 
Real-time data capture application (10 days) ............................................................................ 18 
3.2 
Study Population ................................................................................................................ 19 
3.2.1 
Eligibility Criteria ......................................................................................................... 20 
3.2.1.1 
Inclusion Criteria ..................................................................................................... 20 
Inclusion criteria for real-time data capture ............................................................................. 22 
3.2.1.2 
Exclusion Criteria .................................................................................................... 22 
3.2.2 
Sampling ..................................................................................................................... 23 
3.3 
Data Source / Data Collection ............................................................................................ 25 
Concept elicitation (55 minutes) ................................................................................................ 25 
Cognitive debriefing (60 minutes) .............................................................................................. 25 
Real-time data capture .............................................................................................................. 26 
3.3.1 
Endpoints .................................................................................................................... 27 
3.3.1.1 
Primary Endpoint .................................................................................................... 27 
3.3.1.2 
Secondary Endpoint(s)............................................................................................ 27 
3.4 
Sample Size / Power Calculations ..................................................................................... 27 
3.5 
Hypotheses ........................................................................................................................ 27 
4 
DATA ANALYSIS CONSIDERATIONS ..................................................................................... 28 
Descriptive socio-demographic and clinical characteristics ........................................................... 28 
Analysis of interviews .................................................................................................................... 28 
Real-time data capture analysis .................................................................................................... 29 
Reporting ....................................................................................................................................... 30 
5 
LIMITATIONS ............................................................................................................................ 30 
6 
STUDY CONDUCT, MANAGEMENT & ETHICS....................................................................... 31 
6.1 
Ethics Committee/IRB Approval ......................................................................................... 31 
6.2 
Informed Consent ............................................................................................................... 31 
6.3 
Data Protection .................................................................................................................. 32 

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6.4 
Personally Identifiable Information (PII).............................................................................. 32 
6.5 
Adverse Event (AE), Pregnancy Exposure, and Incident Reporting ................................... 33 
7 
EXTERNAL INVOLVEMENT ..................................................................................................... 33 
7.1 
Third Party Supplier............................................................................................................ 33 
MedQuest Global .............................................................................................................................. 33 
Zeste Research ................................................................................................................................. 33 
7.2 
External Expert/Health Care Professionals (Consultants & Research PIs) ........................ 34 
8 
REFERENCES .......................................................................................................................... 34 
9 
APPENDICES ........................................................................................................................... 35 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ABBREVIATIONS  
 
AE 
Adverse Event 
AV 
Adelphi Values 
CD 
Cognitive Debriefing 
CE 
Concept Elicitation  
COA 
Clinical Outcomes Assessment  
CRF 
Case Report Form 
ENT 
Ear, Nose and Throat 
GSK 
GlaxoSmithKline 
HRQoL 
Health-Related Quality of Life 
ICF 
Information Consent Form 
PRO 
Patient-Reported Outcome  
SNOT 
Sino-Nasal Outcomes Test 
US 
United States 
VAS 
Visual Analogue Scales 
 
 
 

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1 
INTRODUCTION/BACKGROUND  
Nasal polyps is considered to be a subgroup of chronic rhinosinusitis and is defined as 
a chronic inflammatory disease of the nose and sinuses.5 Nasal polyps is characterized 
by the presence of two or more of the following symptoms: watery rhinorrhea from the 
nose (anterior), postnasal drainage (posterior), nasal obstruction and a temporary or in 
extreme cases permanent decreased sense of smell (anosmia).6 The standard of care 
for patients with severe nasal polyps includes intranasal steroids, oral corticosteroids 
and surgery. However, there are currently no established criteria for surgery; candidacy 
for surgery is considered on the basis of level of nasal obstruction, symptom severity, 
impacts to the patient and the perceived risks/benefits of surgery. 
 
The patient experience of nasal polyps is typically assessed via clinical interview and 
review of clinical history and the use of existing patient-reported outcome instruments 
(PROs). PRO instruments used with patients with nasal polyps typically include single 
item visual analogue scales (VAS), whereby patients are asked to evaluate overall 
symptom severity, or the severity of individual symptoms of nasal polyps along a 
continuum, typically of 10cm or 100 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.5 Historically, these items have not been developed based on patient 
characterization and therefore there is a need to understand the appropriateness of 
these measures for use within this population. The Sino-Nasal Outcomes Test (SNOT-
22) is also used frequently within clinical research and as a clinical trial endpoint to 
measure health-related quality of life associated with rhinosinusitis with or without nasal 
polyps. The SNOT-22, a derivative of the SNOT-20, is a modification of the 31-Item 
Rhinosinusitis Outcome Measure (RSOM), containing 22 nose, sinus, and general 
health-related quality of life (HRQoL) items. Within the SNOT-22 patients are required to 
indicate the level of 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) and also identify the five most important items affecting their health.7 Existing 
evidence supports the psychometric validity of the SNOT-22 among patients with 
rhinosinusitis; with evidence of high reliability and sensitivity to clinical change.8 
Preliminary searches, however, suggest that evidence regarding the content validity of 
the SNOT-22 may be lacking.  
 
GlaxoSmithKline (GSK) is embarking on a clinical program to assess treatment of 
severe, recurrent nasal polyps with an anti-interleukin-5 (anti-IL5) (mepolizumab). 
Patient symptomatic endpoints will form the basis for the assessment of treatment 
benefit of nasal polyp therapies. Currently, there is a lack of published qualitative data 
regarding nasal polyps to understand the symptoms (specific symptoms, duration, 

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frequency, severity) or health-related quality of life (HRQoL) impacts for patients, as well 
as the patient decision-making process in electing for surgery and their pre- and post-
surgical experience to treat nasal polyps. In line with regulatory requirements,1,2 the 
patient experience of nasal polyps will need to be characterized. Additionally, as 
described above, there is a requirement to evaluate existing symptomatic endpoints 
with respect to relevance and comprehensiveness within this population to inform 
GSK’s clinical outcome assessment (COA) strategy for this trial.   
 
To address this unmet need GSK would like to conduct a qualitative research study with 
adult patients with nasal polyps to explore the disease experience from the patient 
perspective and to debrief existing symptomatic PROs (including overall and single item 
VAS’s and the SNOT-22), via patient interviews and real-time data capture. This 
protocol details the methods and procedures that will be used in the conduct of this 
study.  
2 
OBJECTIVES  
2.1 Primary 
To explore the symptom, impact and surgery experience of patients with severe, 
recurrent nasal polyps and obtain patient feedback regarding the adequacy of the 
SNOT-22 and GSK VAS assessments (in terms of relevance and comprehensiveness) 
in assessing disease experience in nasal polyps. 
2.2 Secondary  
Combined concept elicitation (CE) and cognitive debriefing (CD) interviews:  
To identify through open-ended questioning the concepts that are important to 
patients with severe, recurrent, nasal polyps, who have been treated with surgery 
and the language they use to describe their disease experience. The main areas 
of exploration will be the symptoms with particular attention paid to the frequency, 
severity, duration and bother of each symptom, patients’ surgical decision-making 
and surgical/treatment experience and the functional and HRQoL impact 
experienced by patients. 
 
To cognitively test and explore the content and face validity of existing PRO 
instruments (single item VAS and SNOT-22) via assessment of the relevance and 
appropriateness of the items included in the instruments and the participants’ 
ability to read, and consistently understand the instrument item wording, 
instructions, response option and recall period. The CD interviews will: 

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 Explore participants’ ability to read and consistently understand the item 
wording, instructions, response options and recall period of the overall and 
single item VAS and SNOT-22.  
• 
Explore the relevance and appropriateness of all of the items covered by 
the instruments based on the symptom experience of patients with nasal 
polyps.  
• 
Verify if the key concepts identified in the concept elicitation phase of the 
study are adequately assessed by the PRO instruments (confirmation of 
face validity) and if any gaps exist, provide recommendations for how these 
could be addressed. 
 Explore what level of change in symptoms and/or impacts the patients 
might consider meaningful.  (E.g. what level of change they might consider 
noticeable and important in response to treatment, and how changes on the 
item scores might relate to changes in their experience in their symptoms 
and/or functional impacts.  
Real-time data capture application:  
To supplement the CE section of the interviews with additional data regarding the 
patient experience of nasal polyps in ‘real time’ using smartphone/tablet app 
based technology. Real-time data capture uses a smart-phone or web-based 
application allowing the patient 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.  
Real-time data capture will be used to field a series of questions/tasks to patients 
with nasal polyps to: 
 Explore the patient 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’. 
Note: This is a low-interventional study – participants will not be asked to change 
their treatment as part of this study. 
3 
RESEARCH METHODOLOGY 
3.1 Study Design  
This is a cross-sectional qualitative study comprising the conduct of semi-structured 
combined CE and CD telephone interviews (each 120 minutes in duration) conducted in 
with US and German adults with severe, recurrent nasal polyps. In addition to the 
interview, the study includes a real-time data capture task conducted with US participant 
only over a 10-day period using smartphone/tablet app-based technology. The 
combined CE and CD interviews aim to investigate the patient experience of nasal 

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polyps, and the relevance and understanding of existing PRO instruments (e.g. VAS 
and SNOT-22). 
 
A total of 20 adult participants from the US with severe, recurrent, nasal polyps, who 
have received nasal polyp removal surgery in the past 10 years, will participate in the 
study as well as 10 patients of the same characteristic in Germany. In qualitative 
research, sample size estimation is based on projections of the number of participants 
needed to reach conceptual saturation (i.e., the point in the data collection process after 
which no new information is elicited). Past evidence in the literature suggests that 
conceptual saturation can be achieved in as few as 12 individual interviews in a 
relatively homogenous population.7,8 As such, it is anticipated that conceptual saturation 
will be achieved within 20 interviews.  
 
This study comprises two qualitative research activities outlined in the sections below: 
combined CE and CD qualitative interviews and real-time data capture. 
Combined CE and CD interviews (120 minutes) 
Twenty participants for the US and 10 from Germany (total sample= 30 participants) will 
be invited to part in combined CE and CD interviews. The CE component of the 
interview will explore participants’ experience of living with severe, recurrent nasal 
polyps with particular focus on participants’ symptoms, impacts and treatment/surgical 
experiences relating to their condition and the terminology used to describe their 
experiences. Following CE, participants will complete the CD component of the 
interview. Participants will complete the existing PRO instruments (overall symptom 
VAS, single item VAS and SNOT-22) as part of a ‘think aloud’ process in which they will 
be asked to speak aloud their thoughts as they read the instructions and complete the 
questions. Participants will also be probed upon their experience of completing the 
instruments/items and the relevance and participant understanding of the instrument 
items, instructions, recall period and response options. Further details regarding the 
conduct of the combined CE and CD interviews are provided in section 3.3. 
Real-time data capture application (10 days) 
All 20 US patients will be invited to take part in an app-based real world data capture 
activity. It is anticipated that of the 20 interview participants, a sub-set of ten will meet 
the inclusion criteria for this task. Therefore, the first ten patients to meet the criteria will 
make up the sample for this task. Five of the ten participants (50%) will take part in the 
app task prior to their interview and the remaining five participants (50%) will take part in 
the app task following their interview. Using this methodology, identified participants will 
be asked to download an app to their smartphone or tablet. Data capture will be 
conducted over a 10 day period and during this time participants will receive a series of 
questions/tasks via the application that they can response to in real-time, designed to 

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explore the experience of nasal polyps. The task will aim to explore the patient 
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’. Participants will be 
able to provide responses to the questions/tasks fielded to them using a variety of 
methodologies including video, audio, text and photographic responses with captions. 
Further details regarding conduct of the real-time data application component are 
provided in section 3.3. 
3.2 Study Population 
Twenty adult participants in the US, and 10 participants in Germany with severe, 
recurrent nasal polyps who have received nasal polyp surgery in the past 10 years prior 
to screening will take part in this study. Of these 30 participants, 10 of the 20 US 
participants (50%) will also complete the real-time data capture app task. The real-time 
data capture app task will not be conducted in Germany. 
 
MedQuest Global, a recruitment agency, will assist in recruiting participants from a 
minimum of two geographically diverse sites in the US (e.g., East Coast, West Coast, 
Southern states). Zeste, a recruitment agency in Germany will assist with the 
recruitment of the German sample across 1-2 sites. Both agencies will recruit 
participants using the same methodology outlined below. 
 
Participants will be recruited through a combination of primary care physicians/general 
practitioners and ear, nose and throat (ENT) specialists. Physicians will identify suitable 
participants for the study using the case report form (CRF) (Appendix 4). Participants 
identified by their physician will be provided with two copies of the information and 
consent form (ICF) to read and sign to indicate informed consent/assent if they wish to 
participate in the study (Appendix 5) – one for the participant to keep and one that the 
recruitment agency will send to AV. Participants will be given the opportunity to consider 
the information provided in the ICF and to ask the recruitment agencies/recruiting 
physician or AV any questions about the ICF before providing their informed consent. If 
the participant verbally agrees to take part and also signs the ICF, they will be informed 
that their name and contact information will be passed to the respective recruitment 
agencies in each country who will contact them to screen them into the study and 
collect demographic information about each participant (Appendix 6), ensuring study 
quotas are met for obtaining a representative sample as outlined in section 3.2.2. No 
information will be passed to the recruitment agencies until verbal and informed consent 
has been obtained from the participant.  After informed consent has been obtained, the 
participant’s physician will release the CRF data to the respective recruitment agencies 
in each country (Appendix 4); confirming that the participant meets the study inclusion 
requirements, and providing additional information about the participant’s clinical 
condition and medical history. MedQuest Global will be responsible for ensuring that 

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any US participant who opts in to take part in the real-time data capture activities meets 
the criteria as outlined in section 0. 
 
If the participant meets the criteria for inclusion in the study section 3.2.1.1 the recruiter 
will organize enrolment into the app task (where applicable) and schedule a time for the 
participant to attend the 120-minute interview visit. Of the 10 US participants who elect 
to take part in the app task five will complete the app task prior to their scheduled 
interview, and the remaining five will complete the app task after their interview. For the 
five US participants who complete the app task prior to their interview they will be asked 
about their experience of completing the app task at the end of the interview. For the 
five US participants who complete the app task after their interview, a separate a brief 
telephone call (approximately 5-10 minutes) will be scheduled with the participant to ask 
them brief questions about their experience. The questions relating to the participant 
experience of completing the app task are provided in Appendix 7. 
 
In terms of compensating participants for their involvement in the study the following 
compensation structure will be employed: 
 
Payments to participants for their participation 
US participants will receive $200 upon completion of the 120-minute interview. Those 
participants who also complete real-time data capture will receive an additional payment 
of $200. German participants will each receive €200 following completion of the 
interview. All payments will be paid via bank transfer or amazon voucher.  
3.2.1 Eligibility Criteria  
Participants eligible for enrolment in the study must meet the following inclusion and 
exclusion criteria, which are broadly reflective of GSK’s clinical trial population. 
3.2.1.1 Inclusion Criteria 
Participants will be required to meet the following inclusion criteria to be eligible for 
inclusion in the study.  
1. Participant has a clinical diagnosis of bilateral nasal polyps as diagnosed by 
endoscopy or CT scan;  
2. Participant is aged 18 or over; 
3. Participant has severe nasal polyps symptoms defined as a patient-reported  
nasal obstruction VAS score of >5 (Appendix 1); 
4. Participant has had at least one previous surgery in the past ten years for the 
removal of nasal polyps. Surgery in this case is defined as any procedure 
involving instruments with resulting incision and removal of polyp tissue from the 
nasal cavity (polypectomy);  

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5. Participant is currently an eligible candidate for polypectomy defined by: 
a) An overall patient-reported VAS symptom score of >7.(Appendix 2), AND 
 An endoscopic bilateral nasal polyp score of at least 5 out of a maximum score of 8 
(with a minimum score of 2 in each nasal cavity). ( 
 

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b) Appendix 3); 
6. Participant has symptoms consistent with chronic rhinosinusitis;  
7. Participant is currently received intranasal corticosteroids for the management of 
their nasal polyps; 
8. Participant is willing to participate in the study and provide informed consent; 
9. Participant is an English speaker and is able to read, write and fully understand 
the English language; 
10. Participant is willing to and able to attend and participate in a 120-minute 
interview to discuss their experiences of nasal polyps and obtain their feedback 
on several symptom/impact questionnaires. 
Inclusion criteria for real-time data capture  
In addition to meeting the standard inclusion criteria outlined in section 3.2.1.1, those 
participants invited to take part in the real-time data capture will also be required to 
meet the following criteria: 
1. Participant owns/or has access to either a smartphone (iOS or android) or tablet 
which has video, audio/microphone and photographic capabilities and access to 
either the Apple app store or google play store to download the app; 
2.  Participant is willing and able to take part in the real-time data application task 
and respond to a series of questions/tasks fielded to them via the application 
over the course of 10 days; 
 
Is willing to respond to some brief questions following the real-time data capture 
task about their experience of using the app and completing the tasks, either 
during their interview or in a 5-10 minute telephone call following completion of 
the task 
3. Participant would feel comfortable recording short videos of themselves and 
providing audio commentary in response to questions/tasks. 
3.2.1.2 Exclusion Criteria 
Any participant presenting with any of the following will not be included in the study. 
1. Participant has received oral or injectable systemic corticosteroids in the last 4 
weeks (28 days) for the management of their nasal polyps 
2. Participant has a diagnosis of cystic fibrosis; 
AND 

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3. Participant has a diagnosis of eosinophilic granulomatosis with polyangiitis (also 
known as Churg Strauss syndrome), Young’s, Kartagener’s or dyskinetic ciliary 
syndromes); 
4. Participant has a diagnosis of antrochoanal polyps; 
5. Participant has a diagnosis of nasal septal deviation occluding one nostril; 
6. Participant has had acute sinusitis or upper respiratory tract infection in the last 
two week; 
7. Participant has ongoing rhinitis medicamentosa (rebound or chemical induced 
rhinitis); 
8. Participant has had an asthma exacerbation requiring admission to hospital in 
the last four weeks; 
9. Participant is currently or has previously taken part in a clinical trial for nasal 
polyps; 
10. Participant is unwilling or unable to comply with the requirements of the study or 
has a physical or mental condition or learning difficulties that, in the opinion of the 
physician, may affect the participant’s ability to participate in the study, the 
responses he/she might provide or their ability to provide consent.  
3.2.2 Sampling  
 
Twenty adult participants in the US, and 10 participants in Germany with severe, 
recurrent nasal polyps who have received nasal polyp surgery in the past 10 years prior 
to screening will take part in this study. Of these 30 participants, 10 of the 20 US 
participants (50%) will also complete the real-time data capture app task. The real-time 
data capture app task will not be conducted in Germany. 
 
In addition to meeting the inclusion/exclusion criteria outlined in section 3.2.1, AV will 
employ a purposive approach to sampling to ensure patients with a range of 
demographic, educational and clinical characteristics are recruited. To achieve 
representation of demographics and clinical characteristics within the sample, sampling 
quotas will be employed. Overall sampling quotas for the US are detailed in Table 1 and 
for Germany outlined in Table 2. German demographic data is not collected in regards 
to ethnicity and race separately, and thus, the quotas have been adjusted to fit the norm 
in Germany. Quotas may be relaxed if recruitment proves challenging. The clinical and 
demographic information to support the achievement of these quotas will be captured 
using the clinician-completed case report form (CRF) and patient-completed 
demographic form. 
 

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Table 1: Quotas for US participants (n=20) 
 
Participant characteristics 
Adults 
 
18-45 
46+ 
Total 
Age 
≥6
≥6 
≥12
Gender 
Male  
≥2
≥2 
≥6
Female 
≥2
≥2 
≥6
Ethnicity 
Hispanic or Latino (of any race)
≥6
Non-Hispanic or Latino
≥6
Race 
White  
≥4
 
Black/African American
≥4
Multi-racial 
≥2
Other race/ethnicities
 
Asian or Pacific Islander 
 
Native American or Alaska native 
 
North African or Middle Eastern 
 
Other (specified by participant)
≥2
Education 
Some high school
≥3
College or higher
≥3
Polypectomy 
surgery 
In past 2 years 
≥6
In past 3-10 
≥6
 
Table 2: Quotas for German participants (n=10)* 
Participant characteristics 
Adults 
 
18-45 
46+ 
Total 
Age 
≥3
≥3 
≥6
Gender 
Male  
≥2
≥2 
≥4
Female 
≥2
≥2 
≥4
Race 
White  Caucasian
 
≥4
 
Non-Caucasian 
 
≥2
Education 
Some high school (German equivalent)
 
≥3
College or higher (German equivalent)
 
≥3
Polypectomy 
surgery 
In past 2 years 
 
≥3
In past 3-10 
 
≥3

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*Note that German quotas have no ethnicity category as this is not typically collected in German. 
The race category is also simplified in line which what is typically expected in Germany. 
 
3.3 Data Source / Data Collection 
All recruited participants will take part in a 120-minute telephone interview.  A semi-
structured interview guide will be used to guide the conduct of the CE interview section 
and CD interview section and will ensure that all topics of interest are discussed 
(Appendix 7). The interview guide is designed to be used as a guide, not as a script to 
be read verbatim. The interviewer will therefore be flexible in the order of questioning, 
following the lead of the participant and asking appropriate questions when topics of 
interest arise. All interviews will be audio recorded and transcribed verbatim for the 
purpose of analysis. Any identifiable information (e.g. participant or doctor’s names) will 
be removed from the transcripts such that they are fully anonymized. 
Concept elicitation (55 minutes) 
During the CE section of the interview participants will be 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 and how it affects their life. In 
addition to speaking open-endedly about their experiences, participants will be asked 
more focused questions designed to probe on issues that they may not have mentioned 
during the course of the interview or concepts/statements that require additional 
clarification. Asking probe questions in a dynamic and ‘as required’ fashion information 
will be important for ensuring all study objectives are met and all study questions and 
topics of interest are explored, thus supporting the identification of the concepts that are 
most important to patients and the terminology they use to describe their experiences.  
Cognitive debriefing (60 minutes) 
During the CD section of the interview participants will be asked to complete the PRO 
instruments using a ‘think aloud’ process in which they will be asked to speak aloud 
their thoughts as they read the instructions, item and complete the questions. After 
completion of each ‘think aloud’ exercise, participants will take part in in-depth CD 
centered on their experience of completing the instruments, with particular focus on the 
relevance and understanding of the items, instructions, response options and recall 
period. In addition, the participants will be encouraged to discuss what level of change 
in their symptoms would they consider meaningful and important and how this would 
relate to changes on the items scores. 
 
The questionnaires (Appendix 8) that will be used in the cognitive debriefing task will be 
sent to participants in the mail in advance of their interview by the recruitment agency. 
Participants will not be required to complete these until instructed to during the 
interview. Following the interview, participants will be asked to send the questionnaires 

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back to the recruitment agency using a stamped addressed envelope which will be 
supplied to them. 
Real-time data capture  
All 20 US patients will be invited to take part in an app-based real world data capture 
activity. It is anticipated that of the 20 interview participants, a sub-set of ten will meet 
the inclusion criteria for this task. Five of the ten participants (50%) will take part in the 
app task prior to their interview and the remaining five participants (50%) will take part in 
the app task following their interview. Eligible participants will receive instruction and 
supporting documentation on how to download and access the application via their 
smartphone or tablet. Participants will be required to take part in the real-time data 
capture exercise over the course of 10 days and during this time a series of 
approximately 10 questions/tasks will be fielded to participants via the application to 
explore the experience of the symptoms, HRQoL impacts and treatment of nasal polyps 
and any day-to-day variability that exists these experiences in ‘real time’. Some 
questions/tasks may be issued daily over the 10 days and others may be issued once. 
Examples of the types of questions that might be asked to participants via the 
application are documented in Appendix 9. Each task will take no longer than 5-10 
minutes to complete and participants will be able to provide responses to the 
questions/tasks fielded to them using a variety of methodologies including video, audio, 
text and photographic responses. 
 
Once recorded, the participants can submit their responses via Wi-Fi or 3/4G and they 
will become immediately viewable on a response dashboard for the study researchers 
to track and analyses. The AV research team would be able to interact with participants 
via the dashboard (e.g. add new tasks, send reminders to complete a task), monitor 
compliance and review and run reports on received responses to questions/tasks. All 
data from the dashboard would be downloaded and stored by Adelphi Values. As part of 
this process any video or photographic data whereby the participant’s face was visible 
would be blurred/redacted. 
 
Germany participants will not be invited to take part in the real-time data capture app 
task. 
 
For those participants who elect to take part in the app task and complete this activity 
prior to their interview, participants will also be asked a series of general questions at 
the end of their interview about their experience of the app and completing the 
tasks/questions over the 10-day period. For those participants who take part in the app 
task after their interview the same questions included in the interview about the app task 
will be asked during a separate brief telephone call (approximately 5-10 minutes) 
conducted upon completion of the app task. 

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Adelphi Values’ qualitative interviewers who are experienced in conducting interviews 
with adult participants will conduct the interviews. Each interviewer will participate in a 
comprehensive briefing meeting to ensure that they are fully familiar with the interview 
guide and can anticipate difficulties that may arise during the interview.  The AV project 
team will also be responsible for the content and management of the real-time data 
capture application.  
3.3.1 Endpoints  
As this study is a low-interventional, qualitative interview study, there are no formal 
endpoints. Data from the interviews will be used to supplement a provisional conceptual 
model that has been developed from a review of qualitative literature of nasal polyps, 
exploring the symptoms and quality of life impacts of nasal polyps. Patients will be 
asked to complete the SNOT-22 questionnaire and overall and single item VAS 
assessment during the interview; however this is purely for cognitive debriefing 
purposes to explore the relevance and patients understand of the content of the 
assessments. 
3.3.1.1 Primary Endpoint  
Not applicable  
3.3.1.2 Secondary Endpoint(s) 
Not applicable  
3.4 Sample Size / Power Calculations 
Where the goal of qualitative research is to provide comprehensive understanding of 
complex phenomena (e.g. the holistic experience disease from the patient/caregiver 
perspective), it is recommended that sample sizes are determined based on the 
concept of ‘conceptual saturation’ where no new concepts are identified with repeated 
data collection. Past research and experience suggests that conceptual saturation can 
typically be achieved in as few as 12 individual interviews in a relatively homogenous 
population.3,4   
Taking the above into account, a total of 20 participants from the US and a total of 10 
from Germany will be interviewed (total sample= 30).  
3.5 Hypotheses  
As this qualitative research study is exploratory in nature no formal hypotheses are 
required. 

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4 
DATA ANALYSIS CONSIDERATIONS  
Descriptive socio-demographic and clinical characteristics 
Socio-demographic and clinical characteristics for participant collected from the 
demographics form and CRF respectively will be summarized. Ratio data (e.g., age) will 
be summarized using totals (n values), means, min/max (range) statistics and where 
relevant standard deviations and medians. Similarly, categorical data (e.g., gender, 
ethnicity, race, education levels) will be summarized using totals (n values) and 
percentages to represent the sample in each sub-category. Descriptive data will be 
summarized in tabular format. 
Analysis of interviews 
All interviews will be audio-record and transcribed/translated verbatim. All identifiable 
information (e.g. participants’, interviewer’s and doctors’ names) will be removed from 
the transcripts to make them anonymous and all participants will be assigned a unique 
participants identification code (ID). 
 
Qualitative analysis of verbatim transcripts for the semi-structured interviews will be 
conducted using thematic analysis methods (CE interview data) and framework analysis 
(CD interview data).  All interview data will be audio-recorded, transcribed and entered 
into ATLAS.Ti, a software package which is designed to facilitate the storage, coding, 
and analysis of qualitative data.  This program allows the researcher to code data at 
different levels of analysis and search for coded data using Boolean operators. ATLAS. 
Ti software allows traditional qualitative analysis of transcripts, but facilitates an easier 
break-down and management of qualitative data into groups and assign ‘codes’. Each 
transcript would be assessed and participant comments that pertain to the main 
research questions would be highlighted.  Axial coding enables the relationship between 
concepts to be explored. 
 
The AV project leader will review the analysis of the first two interviews with the project 
researcher and create a coding scheme to be used throughout the analysis process 
(each highlighted statement will eventually be coded). After analyzing each 
transcription, the coded statements are then moved into their relevant domains. A list of 
participant statements would be generated for each domain, all of which will contain a 
prefix comprising the participant’s designated ID number and the corresponding 
transcript page from which the statement was derived. Of note, whilst the frequency of 
participants mentioning a particular issue may be reported, quantitative analysis of this 
data would not occur, since that is not the purpose of qualitative research and the 
sample sizes are too small to utilize the data meaningfully in a quantitative or statistical 
fashion. 
 

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In assessing the adequacy of the qualitative research to explore the patients’ 
experience of nasal polyps, Adelphi Values will assess whether conceptual saturation 
has been obtained for the CE component of the qualitative interviews (i.e. that a point 
has been reached at which no substantially new themes or descriptions of the concept 
and no new terms are being introduced by patients). Assessment of conceptual 
saturation is important to ensure that all concepts of importance to participant have 
been elicited in the interviews and is a key means of justifying the adequacy of sample 
sizes used in qualitative research studies. If saturation has not been reached, additional 
concepts important to patients may not have been captured. The process for 
determining saturation involves comparison of sets of transcripts to identify any 
consistency or inconsistencies in the pattern elicited concepts and themes. This 
typically involves comparison of the findings from sets of consecutive interviews. 
Specifically, for this sample of 30 participants (20 in the US and 10 in Germany), five 
sets of six interviews will be compared. If new concepts and themes are emerging in the 
final set of interviews then this suggests that conceptual saturation has not been 
achieved and further interviews may be necessary and would be discussed with GSK. 
 
Descriptive statistics for the SNOT-22 and visual analogue scales 
The SNOT-22 and VAS assessments completed as part of the CD interviews will be 
scored by Adelphi Values using the instrument scoring instructions. For the collected 
VAS assessments the research team will measure the vertical line bisection and record 
the corresponding score which will be factored into the instrument scoring. Instrument 
total scores and items scores and data from the VAS (ratio data) will be summarized 
using totals (n values), means and min/max statistics. At the item level the distribution of 
participant responses (categorical data) will be summarized using totals (n values) and 
percentages to represent the proportion of the sample selecting each response option. 
Any missing data at the item level will be summarized using total (n values) and 
percentages. Where relevant, data will be presented in tabular or graphical format, 
whichever is deemed most appropriate based on the content at the time of reporting of 
findings. 
Real-time data capture analysis 
Responses to the real-time data capture data will be collected using a variety of 
methodologies (e.g., video, audio, text and photographic responses with captions). For 
audio responses these will be transcribed.  
 
Participants responses to questions/tasks in the real-time data capture activity will be 
analyzed in the same way using Atlas.Ti for the qualitative interviews as outlined above. 
Video, free text photographic and transcribed audio responses will be entered into 
Atlas.Ti and assigned codes in the same manner as the verbatim transcripts to tag/code 

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what their content conveys. For any questions/tasks fielded to participants as part of the 
app with multiple choice or numerical responses options, descriptive analysis of these 
items will be performed and reported (e.g. mean item score, ranges etc.). For those 
participants who complete the app task after their interview, they will answer a series of 
questions via telephone about their experience of this activity. This data would also be 
audio-recorded, transcribed verbatim and analyzed in the same way as the interview 
and app task data. 
 
The interview and app task results will be used to inform the further development of a 
conceptual model for nasal polyps, previously constructed based on literature review 
activity only. The qualitative analysis will also be used help summarize the content 
validity of the reviewed PRO instruments and their suitability for use with patients with 
nasal polyps. 
Reporting 
Adelphi Values will prepare a single report, detailing the findings from the CE and CD 
interviews and real-time data capture. Within the report, anonymized patient quotes will 
be reported. Findings from the study may also be published in peer-reviewed journals. 
Again, however, only anonymized information will be reported. 
5 
LIMITATIONS 
As the study has been designed using best practice methodology advocated by the 
Food and Drug Administration for exploratory qualitative studies used to support clinical 
measurement strategies, the foreseen risk/limitations of the study are minimal but 
include the following: 
 Selection of participants: potential bias is always possible when selecting 
interviewees; however, as outlined in sections 3.2.1 and 3.2.2 eligibility criteria 
and recruitment quotas will be employed to ensure the participant sample is as 
diverse and representative as possible given the overall study size (n=30). 
 Generalizability of data: The participant sample (n=30) is relatively small as the 
planned research is primarily exploratory in nature. The sample size is typical of 
qualitative studies conducted in this context. Nevertheless, the findings obtained 
from the participant interviews cannot be extrapolated or generalized to the wider 
population with nasal polyps; however, they will be relevant to GSK target nasal 
polyp population for their planned Phase III clinical trial. 
 Real-time data capture: The eligibility criteria for the real-time data capture task 
and information included within the consent form (Appendix 5) will aim to ensure 
that those participants who take part in this activity are willing to take part over a 
period of ten days and that they would feel comfortable in providing responses 
using a variety of methods including video, audio, photographic and/or free text 

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responses. As this methodology is exploratory and ethnographic in nature the 
quality of completion and the comprehensiveness of participant responses 
cannot be guaranteed. This said however, the participants will be contactable 
both via the app and also via email and/or telephone during the completion of the 
app task and as such the project researchers will endeavor to encourage the 
completion of all task in as thorough manner as possible (e.g. provide reminders 
to participants to complete their task or probes/examples if they are unsure of 
how to respond to a task/question). 
 Conceptual saturation: As outlined in section 4 the CE component of the 
interviews will be analyzed according to the principles of conceptual saturation to 
assess that all concepts of importance have been elicited. Whilst conceptual 
saturation can typically be achieved in a sample of 12 in a relatively homogenous 
population, a potential limitation of the study is that conceptual saturation is not 
achieved across the 30 interviews. Should conceptual saturation not be 
achieved, discussions will be held with GSK to determine whether additional 
interviews should be conducted in order to achieve saturation. 
6 
STUDY CONDUCT, MANAGEMENT & ETHICS 
6.1 Ethics Committee/IRB Approval  
This study will be submitted to an independent ethical review board in the US for review 
and approval prior to any study related activities and fieldwork being conducted. The 
German component of this study will be submitted for ethical approval to the Freibruger 
Ethik-Komission International (FEKI) board in Germany. 
6.2 Informed Consent 
Each participant will be given full oral and written information about the nature, purpose, 
possible risk and benefit of the study.  The participant will be given the opportunity to 
ask questions and allowed time to consider the information provided. Participants will 
also be notified of their right to discontinue their participation in the study at any time.  
The participant’s signed and dated informed consent will be obtained using the 
information and consent form (ICF) (Appendix 5) before any medical information is 
accessed (i.e. before completion of the CRF, Appendix 4), before the participant is 
contacted by the recruitment agencies, and before they are asked to perform any study 
related activities. The participant will be provided with the ICF (Appendix 5), be allowed 
to read it, and given the opportunity to ask the study investigator or recruitment 
agencies any questions. Copies of the ICF will be signed by the recruitment agencies 
and the participant, with the participant given one copy to take away for their records.  

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6.3 Data Protection 
The ICF (Appendix 5) explains that the transcribed data will be stored in a computer 
database in a folder that is password protected for 15 years by Adelphi Values. 
Confidentiality of this data will be maintained in accordance with HIPAA legislation.  The 
database will be de-identified; participants will be assigned a participant ID number in 
place of their name and any identifiable data will be made anonymous – such as place 
names, family members, etc.  If participants participate in the app task, for some 
questions/tasks they will have the option to submit video, picture, audio and text 
responses. In these situations all visible faces will be blurred/redacted following analysis 
and prior to storage, to ensure anonymity. 
 
The ICF also explains that for data verification purposes, authorized representatives of 
GSK, AV, a regulatory authority or an IRB may require direct access to parts of the 
hospital or practice records relevant to the study including participants’ medical history.  
The ICF further explains that in the event that a medical emergency should occur at the 
time of interview, the interviewer is permitted to break confidentiality and pass 
information onto persons such as medical personnel, in order for the participant to 
receive medical treatment. 
 
With regard to the real-time data app task, the ICF also explains that if participants 
choose to participate in the app task, for some questions/tasks they will have the option 
to submit video, photograph, audio and text responses. If they choose to take part in the 
app task and choose to submit videos of themselves or pictures, full anonymity of the 
data cannot be guaranteed if their face is visible in the recordings and images that are 
uploaded to Adelphi Values. If they consent to participate in the real-time data app task 
they agree that full anonymity of the data cannot be guaranteed. However, any data 
submitted via the real-time data capture task will not be shared with any individuals 
outside of the project team. For each app question/task they will have the option of how 
they respond (e.g. video, audio, photograph/text). Full anonymity and confidentiality can 
be guaranteed for any data files, written documents or reports that are produced about 
the data collected. 
6.4 Personally Identifiable Information (PII) 
Participant data will be handled in accordance to the data protection information 
provided in section 6.3. All participant data (study forms, transcripts and responses to 
the real-time data task) will be de-identified and participants will be assigned a 
participant ID number. This ID number will be used to label the electronica data files and 
documents relevant to each participant and will be used to reference participant data in 
the reporting of the study findings (e.g. study reports, presentations, publications). 

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6.5 Adverse Event (AE), Pregnancy Exposure, and Incident Reporting 
As this is a low-interventional study that does not involve an investigational product the 
occurrence of adverse events is anticipated to be none to extremely low. Adverse event 
reporting will be managed in line with the study-specific pharmacovigilance plan (sPVP) 
that will be completed and filed internally at GSK. If a participant mentions during the 
interview any adverse event (AE) or product complaint, whether it is considered serious 
or not, experienced whilst taking a product produced by GSK, this must be reported to 
the pharmacovigilance department at GSK. The interviewer will complete an adverse 
event monitoring report form (Error! Reference source not found.) at the end of the 
interview that will capture information regarding the reportable event and the GSK 
product involved and the role of the person reporting the event. As part of this process 
the interviewer will seek the participant’s permission to include their contract details and 
the contact details of their physician on the form; however, should a participant not 
choose to include their contact details on the AE form, they will be informed that the AE 
still has to be reported, but will be done so anonymously. Any completed forms will be 
sent to the designated contact at GSK within 24 hours of awareness of the adverse 
event or adverse drug reaction.  
7 
EXTERNAL INVOLVEMENT 
7.1 Third Party Supplier 
 
Supplier 
Address 
Staff contact details 
Adelphi Values 
(Company conducting 
the study) 
Adelphi Mill 
Grimshaw Lane 
Bollington 
Macclesfield 
SK10 5JB 
 
Senior Lead: 
 
 
Project Lead: 
 
 
Researcher: 
 
Project administrator: 
 
 
 
MedQuest Global 
(Recruiter) 
MedQuest Global  
30460 Cartagena Place, 
Castaic, CA 91384 
Zeste Germany 
(Recruiter) 
Zeste Research 
Stockheimerstrasse 
297647 Willmars, 
Germany  
Transperfect 
Transperfect 
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(Transcription 
agency) 
Three Park Avenue 
39th Floor 
New York, NY 10016 
 
LumiGlobal 
(App vendor) 
LumiGlobal 
Lumi USA 
510 First Avenue North 
Suite 222 
Minneapolis 
USA 
MN 55403 
7.2 External Expert/Health Care Professionals (Consultants & Research PIs)  
Not applicable  
8 
REFERENCES  
 
1. 
US Food and Drug Administration. Guidance for industry: patient-reported 
outcome measures: use in medical product development to support labeling 
claims. 2009. 
2. 
European Medicines Agency Comittee for Medicinal Products for Human Use. 
Reflection paper on the regulatory guidance for the use of health-related quality 
of life (HRQL) measures in the evaluation of medicinal products. 2005. 
3. 
Francis JJ, Johnston M, Robertson C, et al. What is an adequate sample size? 
Operationalising data saturation for theory-based interview studies. Psychology 
and Health. 2010;25(10):1229-1245. 
4. 
Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment 
with data saturation and variability. Field methods. 2006;18(1):59-82. 
5. 
Fokkens W, Lund V, Bachert C, et al. EAACI position paper on rhinosinusitis and 
nasal polyps executive summary. Allergy. 2005;60(5):583-601. 
6. 
Meltzer EO, Hamilos DL, Hadley JA, et al. Rhinosinusitis: Developing guidance 
for clinical trials. Journal of Allergy and Clinical Immunology. 2006;118(5):S17-
S61. 
7. 
Piccirillo JF, Merritt MG, Richards ML. Psychometric and clinimetric validity of the 
20-item Sino-Nasal Outcome Test (SNOT-20). Otolaryngology--Head and Neck 
Surgery. 2002;126(1):41-47. 
8. 
Hopkins C, Gillett S, Slack R, Lund V, Browne J. Psychometric validity of the 22‐
item Sinonasal Outcome Test. Clinical otolaryngology. 2009;34(5):447-454. 
 
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9 
APPENDICES  
 
Appendix 1: Patient-reported nasal obstruction VAS  
 
The following question should be completed by the participant. Recruited participants 
are required to have an overall symptom score of >50. 
 
Please rate your nasal obstruction at its worst over the previous 24 hours. 
 
 
 
 
 
0 
 
 
 
 
 
 
 
 
100 
None  
 
 
 
 
 
 
 
As bad 
as you 
can 
imagine

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Appendix 2: Patient-reported overall symptom VAS 
The following question should be completed by the participant. Recruited participants 
are required to have an overall symptom score of >70. 
 
Please rate your nasal polyps symptoms at their worst over the previous 24 
hours. 
 
 
 
 
 
 
 
0 
 
 
 
 
 
 
 
 
100 
None  
 
 
 
 
 
 
 
As bad 
as you 
can 
imagine

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Appendix 3: Clinician-reported endoscopic nasal polyp scoring 
 
 
Recruited patients should have an endoscopic bilateral nasal polyp score of at least 5 out of a 
maximum score of 8 (with a minimum score of 2 in each nasal cavity) to be eligible for 
participation in the study.  
Clinicians will be asked to provide confirmation of each nasal cavity rating as part of the case report 
form. 
Polyp Score 
Polyp size 
0 
No polyps 
1 
Small polyps in the middle meatus not reaching below the inferior border of the 
middle concha 
2 
Polyps reaching below the lower border of the middle turbinate 
3 
Large polyps reaching the lower border of the inferior turbinate or polyps 
medial to the middle concha 
4 
Large polyps causing almost complete congestion/obstruction of the inferior 
meatus 
 
 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
 
CGI-501 E010 
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Appendix 4: Case Report Form 
 
PARTICIPANT CASE REPORT FORM (CRF) 
TO BE COMPLETED BY THE RECRUITING PHYSICIAN 
(Please complete a separate form for each patient recruited to the study) 
Physician Details 
 
Name (printed): 
__________________________________________ 
 
 
Date of form completion:  
/__/__/ 
/__/__/ 
/__/__/ 
 
 
 
 Month 
 
     Day 
 
    Year 
 
What is your job title/field of specialty?  
Please specify:  ________________________________________________ 
Please sign here:    
________________________________________________ 
 
INCLUSION CRITERIA
 
Yes 
No 
1. Participant has received oral or injectable systemic corticosteroids in the last 
4 weeks (28 days) for the management of their nasal polyps 
1 
2 
2. Participant has a clinical diagnosis of bilateral nasal polyps as diagnosed 
by endoscopy or CT scan.  
1 
2 
3. Participant is aged 18 or over. 
1 
2 
4. Participant has severe nasal polyp symptoms as defined as a patient-
reported nasal obstruction Visual Analogue Score (VAS) of >5 (Please ask 
patient to complete Appendix 1 of this protocol).  
1 
2 
5. Participant has had at least one previous surgery in the past ten years for 
the removal of nasal polyps. Surgery in this case is defined as any 
procedure involving instruments with resulting incision and removal of polyp 
tissue from the nasal cavity (polypectomy).  
1 
2 
6. Participant is currently an eligible candidate for polypectomy defined by: 
c) An overall patient‐reported VAS symptom score of >7 (Appendix 2 of this 
protocol).  
AND 
d)  An endoscopic bilateral nasal polyp score of at least 5 out of a 
maximum score of 8 (with a minimum score of 2 in each nasal cavity) ( 
1 
2 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
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INCLUSION CRITERIA
 
Yes 
No 
e) Appendix 3 of this protocol).  
7. Participant has symptoms consistent with chronic rhinosinusitis.  
1 
2 
8. Participant is currently receiving intranasal corticosteroids for management 
of their nasal polyps.  
1 
2 
8. Participant is willing to participate in the study and provide informed consent. 
1 
2 
9. Participant is an English speaker and is able to read, write and fully 
understand the English language.  
1 
2 
10. Participant is willing to and able to attend and participate in a 120-minute 
interview to discuss their experiences of nasal polyps and give feedback on 
several symptom/impact questionnaires.   
1 
2 
 
 If ONE of the above answers is NO, the patient CANNOT be included in the study 
 
Yes 
No 
1. Participant has a diagnosis of cystic fibrosis.   
1 
2 
2. Participant has a diagnosis of eosinophilic granulomatosis with polyangitis 
(also known as Churg Strauss syndrome), Young’s, Kartagener’s or 
dyskinetic ciliary syndromes).  
1 
2 
3. Participant has a diagnosis of antrochoanal polyps.   
1 
2 
4. Participant has a diagnosis of nasal septal deviation occluding one nostril.  
1 
2 
5. Participant has acute sinusitis or upper respiratory tract infection or has had 
had acute sinusitis or upper respiratory tract infection in the last two weeks.  
1 
2 
6. Participant has ongoing rhinitis medicamentosa (rebound or chemical 
induced rhinitis). 
1 
2 
7. Participant has had an asthma exacerbation requiring admission to hospital 
in the past four weeks. 
1 
2 
8. Participant is currently or has previously taken part in a clinical trial for nasal 
polyps.  
1 
2 
9. Participant is unwilling or unable to comply with the requirements of the study or 
has a physical or mental condition or learning difficulties that, in the opinion of the 
physician,  may  affect  the  participant’s  ability  to  participate  in  the  study,  the 
1 
2 
EXCLUSION CRITERIA

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
 
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Yes 
No 
responses he/she might provide or their ability to provide consent.  
 If ONE of the above answers is YES, the patient CANNOT be included in the study 
 If all inclusion criteria are YES and all exclusion criteria are NO please include the participant in the study 
 
 
1. When was the participant first diagnosed with bilateral nasal polyps? 
________/________ (month, year) 
 
2. Please specify which methods were used to support the participant’s diagnosis with nasal 
polyps:  
Endoscopy 
 
 
 
1 
CT scan  
 
 
 
2 
Nasoscope investigation   
3 
MRI scan  
 
 
 
4 
Other diagnosis tool (please state) 
5
 
__________________________________________________________________________ 
3. Please indicate which of the following symptoms the participant experienced with their nasal polyps 
(tick as many as apply): 
Nasal blockage/obstruction/congestion 
 
 
1 
Nasal discharge (anterior) 
 
 
 
2 
Post nasal drip (anterior discharge) 
 
 
3 
Facial pain 
 
 
 
 
 
4 
Facial pressure   
 
 
 
 
5 
Reduction or loss of smell 
 
 
 
6 
Reduction or loss of taste 
 
 
 
7 
Sleep apnea 
 
 
 
 
 
8 
Snoring  
 
 
 
 
 
9 
Other symptom type (please state) 
 
 
10 
__________________________________________________________________________ 
4. Please  indicate  the  number  of  surgeries  the  patient  has  received  to  remove  their  nasal 
(polypectomy), the date of surgery and the extent of the surgery received. 
 
INFORMATION ABOUT THE PARTICIPANT’S NASAL POLYPS 

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Surgery Number 
Date of surgery (MM/DD/YYYY) 
Type of nasal polyp surgery 
(e.g. polypectomy, functional 
endoscopic sinus surgery with 
polypectomy or balloon 
sinuplasty with polypectomy 
etc.)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5. Please  indicate  what  treatments  (drug  and  non‐drug  treatments)  the  participant  is  currently 
receiving (or has previously received) for their nasal polyps. 
 
 
Current medications 
Past medications  
Treatments 
(for medications, generic 
or trade name is 
acceptable) 
 
Please specify type and 
dose 
Medication in 
current use? 
() 
Medication start 
date 
(MM/DD/YYYY) 
Medication 
NOT in 
current use, 
BUT used in 
the past? 
()  
 
Medication start 
date 
(MM/DD/YYYY)  
Medication end 
date 
(MM/DD/YYYY) 
Nasal corticosteroids  
(e.g., Fluctisone, 
Budesonide, Flunisolide, 
Mometasone etc.) 
 
 
 
 
 
 
 
 
 
 
 
 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
 
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Current medications 
Past medications  
Treatments 
(for medications, generic 
or trade name is 
acceptable) 
 
Please specify type and 
dose 
Medication in 
current use? 
() 
Medication start 
date 
(MM/DD/YYYY) 
Medication 
NOT in 
current use, 
BUT used in 
the past? 
()  
 
Medication start 
date 
(MM/DD/YYYY)  
Medication end 
date 
(MM/DD/YYYY) 
Oral corticosteroids 
(e.g., Prednisone) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Injectable 
corticosteroids 
(e.g., Prednisone) 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Current medications 
Past medications  
Treatments 
(for medications, generic 
or trade name is 
acceptable) 
 
Please specify type and 
dose 
Medication in 
current use? 
() 
Medication start 
date 
(MM/DD/YYYY) 
Medication 
NOT in 
current use, 
BUT used in 
the past? 
()  
 
Medication start 
date 
(MM/DD/YYYY)  
Medication end 
date 
(MM/DD/YYYY) 
Other treatment type 
(please specify) 
 
 
 
 
 
 
 
 
 
 
 
6. Please indicate which surgical nasal treatments (which did not include the removal of polyps) that 
the patient has previously received.  
 
Other nasal and/or 
sinus surgery (Non‐
polyp removal 
surgeries) 
Dates of previous surgeries (please list all dates if the surgery has been performed 
more than once) 
(e.g., balloon sinuplasty 
without polypectomy, 
nasal stent insertion) 
 
 
 
 
 
 
 
 
 
 

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7. Does the participant currently have any chronic diseases or conditions in addition to bilateral nasal 
polyps? 
1 
Yes 
 
0 
No 
 
If YES, please indicate the disease(s) or condition(s) below. For each comorbidity, please indicate the 
category of the chronic disease or condition the participant has and the specific diagnosis. 
Chronic Disease/Condition
Please specify diagnosis 
1  Cardiovascular 
 
 
2  Urological/Nephrological 
 
3  Dermatological 
 
4  Endocrinological/Nutritional  
 
5  Gastroenterological  
 
6  Gynecological 
 
7  Psychiatric 
 
8  Stomatological (diseases of the mouth) 
 
9  Ophthalmological 
 
10  Hematological 
 
11  Pneumological/Pulmonary 
 
12 Rheumatological  
 
13 Neurological 
 
14 Allergy 
 
15 Otorhinolaryngological (ear, nose, throat) 
 
16  Other (e.g. obesity) 
 
 
GENERAL HEALTH STATUS INFORMATION 

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8. Is the participant currently taking treatment(s) for any other disease or condition?  
       1 Yes 
 
       0 No 
 
9. If yes, please give the name of the condition and the treatment received. 
Disease or Condition 
Treatment
1 
 
2 
 
 
3   
 
4    
 
5 
 
6   
 
 
10. How would you rate the participant’s general health? 
Excellent 
 
 
1 
Very Good 
 
 
2 
Good 
 
 
 
3 
Fair 
 
 
 
4 
Poor 
 
 
 
5 
Once you have a participant who has agreed to participate in the study and who meets the 
selection criteria, please send a signed copy of this form 
to MedQuest by fax 
 for the attention of: 
 
 
Should you have any questions, please contact 
 on 
 
 
 
THANK YOU FOR COMPLETING THIS FORM 
 
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Appendix 5: Information and consent form 
 
 
INFORMED CONSENT FORM AND HIPAA AUTHORIZATION 
 
Name of Research Study:  
Qualitative research to characterize the patient 
experience of nasal polyps 
 
Study #:  
GK7818A 
 
Sponsor:  
GlaxoSmithKline 
 
Study Doctor Name:  
 
 
Research Site Address(es):  Adelphi Values 
 
290 Congress Street 
 
7th Floor 
 
Boston, MA 
 
02210 
 
Daytime telephone number(s): 
 
 
24-hour contact number(s): 
 
 
You should keep a copy of this form. If you have any questions or problems during the 
study, call the phone number(s) above. 
 
What is the purpose of this form? 
The purpose of this form is to help you decide if you want to be in the research study. 
It is up to you to decide if you want to take part in this study.  You should take part in 
this study only if you want to.  
 
Before you decide if you want to take part in this research study, it is important that you 
read the information below.  
 
This form may use words you do not understand.  Please ask the person who gave you 
this form to explain any words or procedures that you do not clearly understand.  
 
If you sign this form, it means that you agree to take part in this study.  This form 
describes what the study is about and what will happen.  It also tells you about the risks 
and benefits of the study.   
 
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You can change your mind about taking part in this study at any time.  You may leave 
the study at any time, even if you have signed this form.  You do not have to give a 
reason. 
 
Please ask any questions you have. 
 
You may talk with your family, friends, and your doctor to help you make your decision.  
You can take as much time as you like to make this decision. 
 
The sponsor (Glaxo SmithKline) is paying for this research study and the research will 
be carried out by Adelphi Values (a health research company). Your study doctor will be 
paid by the sponsor. 
 
When deciding to take part in a research study you should know: 
 
 The main goal of medical care is to help you. 
 The main goal of a research study is to gain information to help patients in the 
future.  
 Being in this study does not replace your regular medical care.  
 
Why is this study being done? 
The purpose of this research study is to learn more about the experiences of individuals 
living with nasal polyps, and how having nasal polyps affects individuals in their daily 
life. 
 
To do this, we would like to conduct interviews with individuals with nasal polyps to 
understand their experience of nasal polyps. As part of this interview, we would also like 
you to complete a number of questionnaires about your experience of nasal polyps and 
give your opinion on whether they are easy to understand and complete, and relevant to 
your experience of nasal polyps. As an optional activity, we would also like a sub-set of 
ten individuals with nasal polyps to complete a series of activities via a free app 
downloaded to their smartphone or tablet. 
 
This study will involve approximately 20 subjects from the United States and 10 subjects 
from Germany.  
 
What will I need to do as part of the study?  
You are invited to take part in the following research activities: 
 
1. Nasal polyp interview: Participants will take part in a 120-minute telephone 
interview about their experience of living with nasal polyps. During the first half of 
the interview you will be asked to discuss the symptoms of nasal polyps that you 
experience, how they affect you, and your experience of any treatment/surgery 
you have received. 

 
 
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For the second half of the interview, participants will be asked to complete a 
number of questionnaires about their experience of nasal polyps. You will be 
asked about the relevance of the questionnaires to your experience of nasal 
polyps and your ability to understand and complete the questionnaires.  
 
2. (OPTIONAL) App task: Participants will be invited to download a free application 
(app) to their personal smartphone or tablet. Participants will be asked to 
complete approximately 10 questions/tasks via the app over a 10-day period. 
The questions/tasks will explore the participants’ experience of the symptoms, 
impacts and treatments of nasal polyps and any day-to-day changes that the 
participant experiences, in ‘real time’ as participants go about their daily lives. 
Participants will be required to complete some questions/tasks once during the 
10 days and other questions/tasks will need to be completed daily. Each task will 
take no longer than 5-10 minutes to complete and participants will be able to 
provide video, audio, text, multiple choice and photographic responses to the 
questions/tasks. Participants will also be asked to complete a 5-10 minute phone 
call following completion of the app task to provide feedback about their 
experiences of completing the app task.  
 
SUBJECTS WHO AGREE TO TAKE PART IN THIS RESEARCH STUDY ARE 
REQUIRED TO TAKE PART IN ACTIVITY 1 BUT ACTIVITY 2 IS OPTIONAL 
 
What are the study procedures?  
Before you decide whether to be in this study, you should think about how the study 
activities will affect your schedule. If you agree to be in this study, you will need to sign 
this form before you take part in any study activities.  
 
If your doctor thinks you are suitable for this study, he or she will ask you to read this 
form and sign 2 copies of it – one for you to keep and one which will be kept by the 
company doing the research (Adelphi Values). If you sign this form and would like to 
take part, then your name will be passed to a recruitment agency – MedQuest Global 
Marketing Research. Your clinician will complete a short form about your nasal polyps 
and associated medical history and provide this to the recruitment agency. The 
recruitment agency will contact you to collect some background information from you 
such as your age, gender, race, and ethnicity and schedule the interview at a time that 
is convenient for you. The recruitment agency will also ask you if you would like to 
participate in the optional app task, and explore if you are a suitable to take part in this 
activity. 
 
Interview procedure: Interviews will be conducted by a trained Adelphi Values 
researcher by telephone. The interviews will be audio-recorded. If you do not consent to 
the interview being audio-recorded, then you cannot take part in the study as it is 
essential that we have an accurate record of the interviews. 

 
 
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The questionnaires you will provide feedback on during the interview will be sent to you 
in the mail in advance of your interview by the recruitment agency. You will not be 
required to complete these until instructed to during the interview. Following your 
interview you will be asked to send the questionnaires back to the recruitment agency 
using a stamped addressed envelope which will be supplied to you. 
 
(OPTIONAL) app task procedure: If you have opted to participate in the app task, 
some participants will be asked to complete this before their interview and other 
participants will be asked to complete it after their interview. You will be provided with 
instructions from the recruitment agency or Adelphi Values on how download the free 
app, create a username and password login, work the app and complete the tasks over 
the 10-day period. The app is free to download/install however costs may be incurred if 
you download or upload any information from the app using your data allowance. We 
recommend using WiFi or enabling the ‘WiFi only’ mode in settings on your device to 
submit your responses as this uses the internet and not your data allowance. This will 
be further explained in the instructions, should you take part in the app task. Some 
questions/tasks may need to be completed on the same day and others may be 
completed at any time over the 10-day period. Participants will be required to complete 
some questions/tasks once during the 10 days and other questions/tasks will need to be 
completed daily. 
 
Questions may be multiple choice questions or free text answer questions such as: 
 
“Please rate the severity of your nasal polyp symptoms today using the 0-100 
scale below” 
   
Tasks may require video, audio or photographic responses such as: 
 
“Record a short audio, video or written response telling us about your symptoms 
today and how they have affected you.”  
 
You will receive messages on your smartphone/tablet when you have a new 
question/task to complete, and will be told how long you have to complete this task. For 
most tasks you will have one day to complete them at a time of your choosing but the 
completion time for other tasks may vary. Your responses will be submitted 
automatically via Wi-Fi or 3/4G and they will become immediately available to study 
researchers. The researchers will be able to track your responses and interact with you 
via the app over the course of the 10 days if you need help or have any questions. 
Following completing of the app task, you will be asked about your experiences of using 
the app and completing the tasks. If you were selected to complete the app task 
following you interview, you will be contacted by telephone and asked about your 
experiences, this will take 5-10 minutes. If you were selected to complete the app task 

 
 
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prior to interview, you will be asked about your experience of the app task during your 
interview.     
 
If you choose to take part in the app task, your responses to questions/task will need to 
be visible to members of Adelphi Values (the company conducting this research on 
behalf of the study sponsor) and the study sponsor (Glaxo SmithKline) and will be 
included in study reports and presentations to the study sponsor. Please note that any 
data submitted will not be used outside of this study or published online for example on 
Facebook or video sharing websites such as YouTube. 
 
How will my information be protected? 
All information that you provide will be kept strictly confidential. Your name and contact 
information will remain with Adelphi Values and will only be accessible to the research 
staff.  
 
The audio-recording of the interviews and any audio or video responses to the optional 
app task will be transcribed (typed up word for word). All information collected during 
this study will be will be assigned a unique ID number. Any identifiable information 
including names and addresses that are reported in the interviews will be removed 
during the transcribing and analysis process.  All information collected during this study 
(e.g. paperwork, data files and reports produced about the data) will be used for the 
purpose of this study only and will be kept confidential and anonymized. If information 
about this study is published, your name will not be given.   
 
If you choose to participate in the app task, please note that for some questions/tasks 
you will have the option to submit video, picture, audio and text responses. If you 
choose to take part in the app task and choose to submit videos of yourself or pictures, 
anonymity of the data cannot be guaranteed if your face is visible in the recordings and 
images that are uploaded. If you consent to participate in the real-time data app task 
you agree that full anonymity of the data cannot be guaranteed. This data however will 
still be labelled and stored with your unique ID number. For each app question/task you 
will have the option of how you respond (e.g. video, audio, photograph/text).  
 
Your interview transcripts, app task responses, audio recordings and study paperwork 
will be stored on Adelphi Values’ computer system in a folder that is password protected 
so only the research staff will have access to it. It will be archived in this way for 15 
years by Adelphi Values. Prior to the storage of any video/photographic app-task 
responses, any data whereby your face is visible will be blurred so that this data is 
anonymized..  
 
The U.S. Food and Drug Administration (FDA), Copernicus Group Independent Review 
Board (IRB), GlaxoSmithKline, and other federal and regulatory agencies as required 
may sometimes request to look at the study information of those who participate in the 
study. By signing this consent form, you are authorizing such access. A court of law 

 
 
Approved:   
 
GK7818A v7_0 
Page 51 of 131 
Effective: 20 Jan 2017 
could order medical records shown to other people, but that is unlikely. Therefore, 
should this scenario occur, full confidentiality cannot be guaranteed.  
 
Adverse event reporting: As part of Adelphi Values’ agreement with the study sponsor 
(GlaxoSmithKline), if during the interviews you mention a bad effect/problem that you 
have experienced while using a product made by GlaxoSmithKline, Adelphi Values 
must report this back to them. This is so they can monitor and learn more about the 
safety of their medicines. By consenting to take part in this study you agree to such 
information being passed on to the sponsor anonymously. You will be identified only by 
a study participant number. 
 
What are the risks or discomforts of the study? 
There is no risk of physical harm directly related to completing an interview as part of 
this study. There is the potential risk of loss of confidentiality should you opt to take part 
in the video task as part of the app task which is explained in the section: ‘How will my 
information be protected?’  
 
Are there any benefits?  
You will have no direct medical benefit from your participation in this study. Participation 
in the study will contribute to information about the experience of nasal polyps, the 
suitability of the reviewed questionnaires for use in clinical trials and may benefit others 
in the future. 
 
Will I be paid to take part?  
You will receive $200 upon completion of the 120-minute interview. If you chose to take 
part in the optional app task, you will receive an additional payment of $200.  
Payments will be paid by electronic bank transfer or amazon voucher.  
 
Are there any costs? 
You will not incur any costs to take part in this study. If you take part in the optional app 
task, you may incur data usage charges when downloading/uploading data. We 
recommend setting your device to ‘WiFi only’ if you are concerned about using your 
mobile data allowance. Submitting your responses by WiFi will be free of charge and 
not use your data allowance. 
 
What are the alternatives? 
You do not have to take part in this research study. 
 
What if I am hurt or get sick in the study? 
If you are hurt or get sick during the study, you should call your doctor. Neither 
GlaxoSmithKline nor Adelphi Values have a program in place to provide other 
compensation in the event of an injury. Since this is a telephone interview, there is no 
risk of injury. No risks are associated with the app-task; however, it is expected that 
participants will be sensible when completing and submitting tasks required and that 

 
 
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these are done in a safe environment, thus reducing any possibility of risk. Participating 
in this study does not restrict your right to seek legal assistance. You do not waive any 
legal rights by signing this Subject Information and Consent Form and HIPAA 
Authorization. 
 
Do I have to take part in the study? 
Taking part in this study is your choice.  There will not be any penalty or loss of benefits 
to you if you decide not to take part or if you leave the study early.  
 
Could I be withdrawn from the study? 
Your doctor or the study sponsor, may withdraw you from the study without your 
consent for the following reasons: 
 if you do not follow the study procedures as instructed, 
 if the study is canceled by the FDA or the sponsor.  
 
The sponsor, the FDA or the IRB may decide to stop the study at any time.   
You may leave the study at any time. 
 
Who can answer my questions about this research? 
If you have questions, concerns, or complaints, or think this research has hurt you or 
made you sick, talk to the research team at the phone number listed above on the first 
page. 
 
Please call Copernicus Group IRB at 
 (toll free) if: 
 
 You want to talk to someone about the study other than the study staff; 
 You cannot reach the research team; 
 
You have questions about your rights as a research subject. 
PPD

Informed Consent Form  
and HIPAA Authorization Template 
 
 
 
 
 
GK7818A v2_0 
Page 53 of 131 
15th May 2017 
SUBJECT’S STATEMENT OF CONSENT 
 
Qualitative research to characterize the patient experience of nasal polyps 
 
Please indicate by ticking () the activities you consent to taking part in. 
Please note that the app task is optional.  
 
 
1. I would like to take part in the 120-minute nasal polyp interview to talk 
about my experience of nasal polyps and provide feedback on a 
number of questionnaires that assess my experience of nasal polyps.  
 
2. (OPTIONAL) In addition to the interview I would also like to take part 
in the 10-day app task about my experience of nasal polyps and 
answer some questions about my experience of taking part in this 
activity. I confirm I have access to a smartphone or tablet to take part 
in this activity. 
 
 
I consent to take part in the research study. This study and the information in this 
consent form have been explained to me. I have read all pages of this form. I have had 
an opportunity to ask questions and they have been answered to my satisfaction. I have 
been told that I have not given up any legal rights. I will receive a copy of this signed 
and dated consent form. 
 
I voluntarily agree to take part in this research study. 
 
 
 
 
Printed Name of Subject 
 
 
 
 
Signature of Subject 
Date 
 
 
The information about the study was described to the subject in language he/she 
understood. 
 
 
 
 
Printed Name of Person Obtaining Consent  
 
 
 
 
Signature of Person Obtaining Consent 
 
 
 
 
Date 
 

Informed Consent Form  
and HIPAA Authorization Template 
 
 
 
 
 
GK7818A v2_0 
Page 54 of 131 
15th May 2017 
 
 
 
 
 
HIPAA AUTHORIZATION 
 
Federal regulations give you certain rights related to your health 
information.  These include the right to know who will receive the 
information and how it will be used.  The study doctor must obtain your 
authorization (permission) to use or release any health information that 
might identify you. 
 
 
What information may be used and shared? 
The study doctor and study staff will use and share your health information 
as part of this research study. This may include your name, address, 
telephone number or other facts that could identify the health information 
as yours.   
 
Examples of the information that may be used are: 
 Medical records (from any doctor, hospital or other healthcare 
provider) 
 Information created or collected during the research.  This could 
include your medical history, and dates or results from any physical 
exams, laboratory tests or other tests. 
 
 
Who will receive information about you? 
The study doctor and study staff will share your personal health information 
with: 
 the sponsor, including persons or companies working for or with the 
sponsor 
 Copernicus Group Independent Review Board  
 the U.S. Food and Drug Administration (FDA) 
 Department of Health and Human Services (DHHS) agencies 
 other regulatory agencies  
 
 
Why will this information be used and/or given to others? 
The sponsor and the groups above will use your health information: 
 to complete this research 

Informed Consent Form  
and HIPAA Authorization Template 
 
 
 
 
 
GK7818A v2_0 
Page 55 of 131 
15th May 2017 
 to evaluate the results of the study 
 to check that the study is being done properly 
 to obtain marketing approval for new products resulting from this 
research 
 
Is my health information protected after it has been given to 
others? 
Your health information may be further shared by the groups above. If 
shared by them, the information will no longer be covered by this 
Authorization.  These groups are committed to keeping your health 
information confidential.  
 
 
What if I decide not to allow the use of my health information? 
You do not have to sign this form.  If you do not sign this form, you cannot 
take part in this research study.  
 
 
May I withdraw or revoke (cancel) my permission? 
YES.  You may withdraw your permission to use and disclose your health 
information at any time.  You can do this by sending written notice to the 
study doctor.  If you withdraw your permission, you will not be able to 
continue being in the research study. 
 
 
What happens if I want to withdraw my authorization? 
Information that has already been gathered may still be used and given to 
others.  If you withdraw your permission, no new health information will be 
gathered unless you have a side effect related to the study.   
 
If you withdraw from the study but do not withdraw your Authorization, new 
health information may be collected until this study ends.   
 
 
Will my authorization expire? 
If you do not withdraw this Authorization, it will remain in effect. 
 
If the research site is located in 
  
 or 
 this authorization will expire on 31 Dec 2060. 
 
There is no expiration of this authorization except for research conducted in 
the states listed above. 
 
PPD
PPD

Informed Consent Form  
and HIPAA Authorization Template 
 
 
 
 
 
GK7818A v2_0 
Page 56 of 131 
15th May 2017 
 
May I review or copy the information obtained or created about 
me? 
YES. You have the right to review and copy your health information.  
However, your access to this information may be delayed until the study is 
complete. 
 
Your decision to withdraw your Authorization or not to participate will not 
involve any penalty or loss of access to treatment or other benefits to which 
you are entitled.   
 
 
 
 
 
AUTHORIZATION 
By signing this form, I allow the use or disclosure of my health information.  
I will receive a signed and dated copy of this Authorization. 
 
 
 
 
Printed Name of Subject 
 
 
 
 
Signature of Subject 
Date 
 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
 
 
 
 
 
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Appendix 6: Patient Demographic Form 
 
 
DEMOGRAPHICS FORM 
This form is to be completed by the recruitment agency 
(Please complete a separate form for each participant recruited) 
Please ask the participant which activities they would like to take part in: 
 
60‐minute interview ONLY 
 
 
 
 
 
1 
 
60‐minute interview AND 10‐day app activity and follow‐up call  
to provide feedback *   
 
 
 
 
 
2 
 
 
 
If the participant does not want to participate in the app task, please skip straight to the demographic 
questions section below.  
*If the participant DOES want to take part in the app task, please ensure that they meet the following 
inclusion criteria 
ACTIVITIES  
INCLUSION CRITERIA FOR APP TASK 
YES 
NO 
4. Participant  owns/or  has  access  to  either  a  smartphone  (iOS  or  android)  or 
tablet which has video, audio/microphone and photographic capabilities  and 
access to either the Apple app store or google play store to download 
the app; 
1 
1 
5. Participant is willing and able to take part in the real‐time data application task 
and respond to a series of questions/tasks fielded to them via the application 
over the course of 10 days.  
AND 
Is  willing  to  respond  to  some  brief  questions  following  the  real‐time  data 
capture task about their experience of using the app and completing the tasks, 
either  during  their  interview  or  in  a  5‐10  minute  telephone  call  following 
completion of the task 
1 
2 
6. Participant has stated that they would feel comfortable recording short videos 
of themselves and providing audio commentary in response to questions/tasks. 
1 
2 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
 
 
 
 
 
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 If ONE of the above answers is NO, the patient CANNOT be included in the app task aspect of the 
study.  
 
Please complete the following questions for all participant irrespective of which research activities they 
would like to take part in. 
1. 
How old are you? |__|__| years 
 
 
2. 
What is your gender? 
 
Male 
 
1 
 
Female   
2 
 
3. 
How long have you have you been experiencing symptoms of nasal polyps? 
____________years____________ months 
 
4. 
At what age were you first diagnosed with nasal polyps by a physician? 
____________ years___________months 
 
5. 
Who diagnosed your nasal polyps? 
Ear, nose and throat (ENT) specialist 
 
 
 
 
1 
GP/Family doctor 
 
 
 
 
 
 
2 
Other (please specify)______________________________ 
 
3 
 
6. What is your ethnicity? (please check which applies) 
Hispanic or Latino (of any race) 
 
1 
Non‐Hispanic or Latino 
 
 
2 
 
7. What is your race? (please check one box only) 
White  
 
 
 
 
 
 
 
1 
Black/African American 
 
 
 
 
 
2 
DEMOGRAPHICS QUESTIONS 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
 
 
 
 
 
GK7818A v2_0 
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Asian or Pacific Islander 
 
 
 
 
 
3 
Native American or Alaska native 
 
 
 
 
4 
North African or Middle Eastern 
 
 
 
 
5 
Multi‐racial  
 
 
 
 
 
 
6  
(Please specify)___________________________ 
Other  
 
 
 
 
 
 
 
7 
(Please specify)___________________________ 
 
 
8. What is your highest level of education? 
Grade school 
 
 
 
 
 
 
1 
Some high school 
 
 
 
 
 
 
2 
High school diploma or GED  
 
 
 
 
3 
Some years of college 
 
 
 
 
 
4 
Certificate program  
 
 
 
 
 
5 
College or university degree (2 or 4 year)  
 
 
 
6 
Graduate or professional degree 
 
 
 
 
7 
Other (please specify) ______________________________   
8 
 
9. 
What is your current living status? (please check all that apply) 
Living alone 
 
 
 
 
 
 
1 
Living with husband/wife/partner 
 
 
 
2 
Living with parents 
 
 
 
 
 
3 
Living with your children 
 
 
 
 
4 
Living with other family members 
 
 
 
5 
Living with your friends  
 
 
 
 
6 
Other (please specify)___________________________   
 
7 
 
10. How would you describe your work status  (Please check all that apply) 
 
Working full‐time   
 
 
 
 
 
 
1 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
 
 
 
 
 
GK7818A v2_0 
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Working part‐time  
 
 
 
 
 
 
2 
Retired 
 
 
 
 
 
 
 
 
3 
Unemployed 
 
 
 
 
 
 
 
4 
Student 
 
 
 
 
 
 
 
 
5 
Other (please specify) _______________________________ 
 
6 
 
11. What is your approximate annual income? 
Under $25,000 
 
 
 
 
1 
$25,000 to $50,000  
 
 
 
2 
$50,000 to $75,000 
 
 
 
3 
$75,000 to $100,000 
 
 
 
4 
More than $100,000 
 
 
 
5 
Prefer not to answer 
 
 
 
6 
 
12. How would you rate your health in general? 
Excellent 
 
 
 
 
 
1 
Very Good   
 
 
 
 
2 
Good 
 
 
 
 
 
3 
Fair  
 
 
 
 
 
4 
Poor 
 
 
 
 
 
5 
 
 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
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Recruitment Quotas 
In addition to meeting the inclusion/exclusion criteria please ensure the following quotas are met by the 
sample: 
 
Participant characteristics 
Adults 
 
18-45 
46+ 
Total 
Age 
 
≥6
≥6
≥12 
Gender 
Male  
≥2
≥2
≥6 
Female 
≥2
≥2
≥6 
Ethnicity 
Hispanic or Latino (of any race)
≥6 
Non-Hispanic or Latino
≥6 
Race 
White  
≥4 
 
Black/African American
≥4 
Multi-racial 
≥2 
Other race/ethnicities
 
Asian or Pacific Islander 
 
Native American or Alaska 
native 
 
North African or Middle 
Eastern 
 
Other (specified by 
participant) 
≥2 
Education 
Some high school 
≥3 
College or higher 
≥3 
Polypectomy 
surgery 
In past 2 years 
≥6 
In past 3-10 
≥6 
 
Recruiter: If the participant meets the inclusion criteria for the study and is appropriate based on the 
sample quotas above please schedule the participant for an interview. 
 
 
Appendix 7: Combined concept elicitation and cognitive debriefing patient 
interview guide 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
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1.    Interview objectives and overview 
[Note to interviewer]: 
The overall objective of this interview is to explore patients’ experience of severe, recurrent nasal polyps 
via the conduct of concept elicitation interviews and to obtain feedback from patients on a series of 
patient‐reported outcome (PRO) instruments designed to assess the symptom and impact experience of 
nasal polyps via the conduct of cognitive debriefing interviews. 
The concept elicitation phase will facilitate the identification of concepts of disease experience that are 
important to adult patients with nasal polyps and the language they use to talk about the concepts and 
describe those concepts. The main areas of exploration will be the symptoms experienced by patients. In 
particular we are interested in the intensity, frequency and duration of each symptom, how bothersome 
or intrusive each symptom is to each patient, and whether/ how the collective symptom experience of 
nasal polyps has any impact on the patient’s quality of life.  
The cognitive debriefing phase will assess a number of PROs including the following: 
Sino‐Nasal Outcome Test (SNOT‐22); 
Visual analogue scales (VAS) proposed for use in GSK phase III trial:  
Nasal obstruction VAS; 
Nasal discharge VAS; 
Throat mucus VAS; 
Loss of smell VAS; 
Facial pain VAS; 
Overall VAS symptom score. 
The relevance and appropriateness of the each of the items covered by each instrument will be assessed 
during the cognitive debriefing interview, as will patients’ ability to read and consistently understand the 
item  wording,  instructions,  response  options  and  recall  period  of  each  instrument.  The  cognitive 
debriefing phase will also investigate how patients define a meaningful change in score, for each item of 
each instrument. 
 Aim of the concept elicitation phase 
Explore the symptoms experienced by adults with nasal polyps, with particular attention paid to the 
frequency, intensity, duration of each symptom and how bothersome it is.  
Explore the language used by adult nasal polyp patients to describe their disease experience.  
Explore how each symptom (individually and collectively) affects the patients’ quality of life.  
 Aim of the cognitive debriefing phase 
 
Evaluate the relevance of the PRO instruments to nasal polyp patients.  

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
GK7818A v3_0 
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 
Evaluate the patients’ ability to read and consistently understand the content of the collection of 
PRO instruments, such as the item wording, instructions, response options and recall period. 
 
Investigate  how  patients  define  a  meaningful  change  in  score,  for  each  item  of  each  of  the 
instruments.  
(PRO instruments include: SNOT‐22, Nasal obstruction VAS, Nasal discharge VAS, Throat mucus VAS, Loss 
of smell VAS, Facial pain/pressure VAS and an overall severity of condition VAS scale).  
 Overview of the interview process 
The interview should be conducted as follows: 
1. Introduction to the study: Introduce Adelphi Values to the patient. Explain the objectives and 
the process of the interview. 
2. Consent:  Ensure  the  patients’  written  informed  consent  to  participate  has  been  obtained 
prior to beginning the interview. Also obtain the patients’ verbal consent for the interview to 
be audio‐recorded. 
3. Interview:  In  the  interviews  you  should  ask  the  patient  questions  in  an  open‐ended 
exploratory manner. Lead the patient as little as possible in this part of the interview. 
The interview is divided into the following sections: 
1. Introduction to the study (5 minutes) 
2. Experience of nasal polyps  (55 minutes) 
3. Cognitive debriefing of the collection of PRO instruments (60 minutes) 
In total, the interview should take approximately 120 minutes.  

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
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2. Role of the interviewer and instructions 
The role of the interviewer before the interview:  
1. 
Check that the patient’s clinician has completed the CRF and screener and that the patient meets the 
inclusion and exclusion criteria. 
2. 
Check  the  patient  has  provided  written  informed  consent  and  provided  verbal  consent  for  the 
interview to be audio‐recorded. 
The role of the interviewer during the interview 
 
Digital Audio recording.  Ensure that the comments of the patient throughout the interview are 
clearly recorded on the audio‐recording.  Audio recordings will be transcribed verbatim.  Check the 
volume settings and positioning of the audio recorder to ensure the clarity of the audio recording 
prior to the interview making sure recordings are clearly audible. Check that the audio recorder has 
enough battery power for the duration of the interview. Avoid rustling papers near the recorder or 
jostling the recorder during the interview as this will lead to inaudible responses.  
The role of the interviewer is to inquire and support: 
Do not give your own point of view 
Be patient and accept silence during open‐ended questioning to make sure the patient has time to 
think about her/his response 
Help the patient stick to the topics intended in the guide (but not necessarily in the order presented 
in the guide) 
Help the patient avoid repeating himself or herself 
Help the patient cross‐reference and make connections that they would not do spontaneously 
Ask the patient to clarify any comments that you are not certain you understood and for the benefit 
of the recording 
Ask  the  patient  to  explain  any  vague  reference  or  comment  that  is  pertinent  to  the  research 
question 
Most importantly: avoid biasing or leading the patient 
As  much  as  possible  your  questions  should  be  open‐ended  and  general  rather  than  specific  –  use 
suggested probes to follow‐up on topics of interest if not adequately discussed in response to the open 
questions. 
It is very important that you do not lead the patient with your questions or remarks.  Ask all questions 
in as open‐ended a manner as possible; take care not to bias the patient’s response one way or the 
other.  Below for most questions, we have provided a number of possible probes that should help the 
patient explain his or her thinking when s/he is talking about the topics of interest.  These probes are 

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optional and do not have to be asked if, when asked the initial question, the patient provides a fully 
elaborated response and addresses the topics noted in the probes.  The probes are only provided for use 
when the patient finds it difficult to answer your questions, if s/he is reluctant to speak at length about 
experiences or if key topics of interest have not been elicited spontaneously.  You may have to invent 
your own probes or reword the probes indicated in the interview guide; this is fine.  As a fully trained 
and experienced interviewer we rely on your judgment as to when more information is required from 
the patient and for you to probe as appropriate. 
POSSIBLE NON‐LEADING PROBES MIGHT INCLUDE: 
 
Can you describe exactly how that feels? 
 
Tell me more about that. 
 
How does that affect you? 
 
Can you talk more about ___________? 
 
How often does that happen? 
 
How long does that last? 
 
Is there anything that makes it better or worse? 
During the interview, it is not essential for you to ask the questions in exactly the way that they are 
written in this guide and for some interviewees it may be necessary for you to reword questions as a 
means to enable open‐discussion. If you reword a question; however, you should be sure to avoid 
biasing the patient’s response.  If a topic has been covered sufficiently in an earlier part of the discussion 
it is not necessary to go over it again later if this topic comes up later in the interview guide. 
If the patient directs any questions to you that are of a medical nature, please explain that you are not a 
medical professional and that the patient should direct any medical queries to his or her doctor or nurse. 
Using the interview guide 
Throughout this guide we have coded the questions and instructions so that it is clear which questions 
are required and which are probes and do not necessarily need to be asked. The code is as follows: 
Blue font 
These are instructions to you  
 
These are statements that you are to read aloud word‐for‐word  
1. 
Questions prefixed by a specific number must be posed to all patients 
  
All probes are bulleted  – these do not need to be used specifically but are included to 
assist you in drawing further information from the patients 
Adverse event reporting 
If the respondent mentions an adverse event experienced while taking a product made by the sponsor 
company, or a product you suspect is a product made by the sponsor company ,whether it is considered 
serious (see definitions below) or not, you should make a note of it and at the end of the interview go 
through the ‘Adverse Event Form’. At this time please state the following to the patient: 

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“During the interview you mentioned a problem that you experienced while taking 
[product name]. The sponsor of this research needs to collect information about their 
products  in  order  to  continue  making  them  as  safe  and  effective  as  possible.  Every 
report  they  receive  contains  potentially  useful  information.  I  would  like  to  spend  a 
couple of minutes with you now to collect some more details. Is that OK with you?” 
If yes “Thank you. The information you provide will be sent to the study sponsor, who 
may wish to contact your doctor for further information. If you agree to provide your 
doctor’s name, this will not be linked in any way to your other responses given during 
the interview. Are you happy to provide the name of your doctor?” 
(If the respondent subsequently says no, then go to the ‘If no’ section) 
If  no  “OK  that’s  fine.  However,  as  the  information  you  were  given  about  this  study 
explained,  we  do  have  to  report  this  problem  to  the  sponsor.  This  will  be  done 
anonymously, and none of your personal details will be shared with them.” 
You should complete the ‘Adverse Event Form’ with as much detail as you can retrieve.  
Remember, an Adverse Event must be reported when the following are present: 
PREP – Patient, Reporter, Event, Product 
1. A Patient or group of patients 
 
Identifiers  such  as  age,  age  group,  birth  date,  gender,  role,  profession  should  be 
collected if available, if not the event should still be reported.   
2. An identifiable Reporting source 
 
Information that identifies the reporter, establishing knowledge of the reportable event 
in an identifiable consumer. 
 
A reporter can be a patient, doctor, patient’s parent, friend, colleague or caregiver.   
3. An adverse Event 
 
Description of at least one event or product complaint.   
4. A suspect Product 
 
This must be one of the products being marketed by the company that we are doing 
research for. 
Remember: The event need not have a causal relationship with the treatment or usage. 
An adverse event is: 
“Any untoward medical occurrence in a patient administered a sponsor medicinal product and which 
does not necessarily have to have a causal relationship with this treatment. An adverse event can be 
any  unfavorable  and  unintended  sign  (e.g.  an  abnormal  laboratory  finding),  symptom,  or  disease 
temporally associated with the use of a medicinal product, whether or not considered related to the 
medicinal product.” 

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An  adverse  event  can  also  be  revealed  through  follow  up  on  a  product  complaint  (PC).  For  these 
purposes a PC is a complaint specific to the product itself, or packaging, as opposed to its effect on the 
patient.  Examples  include  damaged  or  missing  tablets;  wrong  strength  or  color  of  tablets;  damaged 
packaging;  a  label  that  cannot  be  read;  a  liquid  that  should  be  clear  but  is  cloudy  or  contains 
unexpected  particles;  a  bent  needle,  a  broken  syringe;  a  missing  patient  information  leaflet  or  the 
identification of a potentially counterfeit medicine.  
Cases where a woman is pregnant or breastfeeding while taking a company’s medicine also need to be 
collected even if no AE is specifically cited. In these instances, it is important to capture whether or not 
there were any complications during the pregnancy or any congenital abnormalities occurring in the 
baby.   
A serious adverse event (which should be reported to the FDA) is any undesirable experience associated 
with the use of a medical product in a patient when the patient outcome is:  
Death 
Report  if  you  suspect  that  the  death  was  an  outcome  of  the  adverse  event,  and  include  the  date  if 
known.  
 
Life‐threatening 
Report if suspected that the patient was at substantial risk of dying at the time of the adverse event, or 
use or continued use of the device or other medical product might have resulted in the death of the 
patient. 
 
Hospitalization (initial or prolonged) 
Report if admission to the hospital or prolongation of hospitalization was a result of the adverse event. 
Emergency room visits that do not result in admission to the hospital should be evaluated for one of the 
other serious outcomes (E.g., life‐threatening; required intervention to prevent permanent impairment 
or damage; other serious medically important event). 
 
Disability or permanent damage 
Report if the adverse event resulted in a substantial disruption of a person's ability to conduct normal 
life  functions,  i.e.,  the  adverse  event  resulted  in  a  significant,  persistent  or  permanent  change, 
impairment,  damage  or  disruption  in  the  patient's  body  function/structure,  physical  activities  and/or 
quality of life. 
 
Congenital anomaly/birth defect 
Report if you suspect that exposure to a medical product prior to conception or during pregnancy may 
have resulted in an adverse outcome in the child. 
 
Required intervention to prevent permanent impairment or damage (devices) 
Report  if  you  believe  that  medical  or  surgical  intervention  was  necessary  to  preclude  permanent 
impairment  of  a  body  function,  or  prevent  permanent  damage  to  a  body  structure,  either  situation 
suspected to be due to the use of a medical product. 
 
Other serious (important medical events) 
Report when the event does not fit the other outcomes, but the event may jeopardize the patient and 
may  require  medical  or  surgical  intervention  (treatment)  to  prevent  one  of  the  other  outcomes. 

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Examples include allergic bronchospasm (a serious problem with breathing) requiring treatment in an 
emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in 
hospitalization.  The  development  of  drug  dependence  or  drug  abuse  would  also  be  examples  of 
important medical events. 
 
 

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3. Interview introduction (5 minutes) 
This interview should last approximately 120 minutes.  
INTRODUCE YOURSELF AS WORKING FOR ADELPHI VALUES  
 “My  name  is_________  and  I  work  for  a  company  called  Adelphi  Values.  Adelphi  Values  is  a 
research  company  which  works  with  pharmaceutical  companies  to  develop  questionnaires  for 
use in clinical studies to assess the impact of health conditions on people’s lives. GlaxoSmithKline, 
the sponsor of this study, would like to explore individuals’ experience of nasal polyps to find out 
more about the symptoms experienced and how the condition affects their lives.” 
EXPLAIN THE AIM AND PROCESS OF THE INTERVIEW TO THE PATIENT 
 “We would like to talk to you about your experience of living with nasal polyps, particularly the 
symptoms  you  experience  and  how  having  nasal  polyps  may  impact  you.  This  part  of  the 
interview will take approximately 55‐minutes.” 
 “We  would  also  like  to  obtain  your  opinion  of  a  number  of  questionnaires,  including  their 
relevance to nasal polyps and your understanding of their content. This part of the interview will 
take approximately 60‐minutes.” 
 When we’re finished with the interview, you will receive a payment of $200 to thank you for your 
time and your participation in the interview.”  
REASSURE THE PATIENT OF CONFIDENTIALITY 
 “Your name and contact information will remain with Adelphi Values and will only be accessible 
to researchers directly involved with this project. Any information you provide will be reported in 
a way that protects your privacy by avoiding any mention of your name or other information that 
could identify you. 
AUDIO‐RECORDING THE INTERVIEW 
 “The interview today will be audio‐recorded to enable us to pay careful attention to what you say 
and to make certain we accurately capture the information that you provide to us during the 
interview. After the interview the audio‐recording will be transcribed (written out).” 
 “An  anonymized  recording  or  written  version  of  the  interview  may  be  shared  with  the  study 
sponsor. This means that we will take any information out of the interview that might identify 
you, like names or places, and any data that you provide will be assigned an ID number.” 
 “Please try to speak relatively loudly so that your comments can be heard and are clear on the 
recordings.” 
 “Please be honest in your responses and don’t be afraid to voice any opinions. We want to know 
about your experience and opinions, not those of your doctor or anyone else.” 
 “If you do not understand a question, please ask for the question to be repeated and explained.” 

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 IMPORTANT: “If you find any of the questions difficult to answer, please let me know. You do not 
have to answer any questions you do not want to. You may leave the interview at any point and 
you may decline to answer any question.” 
At this point, turn on the audio‐recorder and ask the patient the following questions: 
 “Do you agree to participate in this interview?” 
 “Do you agree to have this interview audio‐recorded?” 
 “Do you have any questions at this point?” 
 
 

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4. Concept  elicitation:  exploration  of  the 
patient  experience  of  nasal  polyps  (55 
minutes) 
 Nasal polyp symptoms (35 minutes)  
 “This  is  the  first  section  of  the  interview  where  I  will  ask  you  general  questions  about  your 
experience of having nasal polyps.” 
[Note  to  the  interviewer]:  First  ask  the  participant  how  they  refer  to  their  condition  and  use  this 
terminology in place of ‘nasal polyps’ throughout the interview. 
5. When you talk to your family or friends about your nasal condition, how do you refer to it? 
What do you call it? Is it ok to use this term throughout the interview? 
[Interviewer]:  Enter term/s used______________________________ 
 “We are now going to talk about the symptoms that you experience as a result of your nasal 
polyps.” 
6. Tell me about your experience of nasal polyps. 
7. Tell me about the symptoms that you experience related to your nasal polyps. 
[Note  to  the  interviewer]:  List  down  every  symptom  that  the  patient  mentions  spontaneously  as  a 
symptom that they experience. You can use the ‘symptom table’ below to record symptoms that the 
patient mentions spontaneously. If the symptom is not on the list, please write it down.  
 SYMPTOM LIST 
Symptom 
Tick if mentioned spontaneously () 
Congestion  
Runny nose  
Nasal swelling  
Loss of smell  
Change in smell 
Nose bleed 
Post‐nasal drip/throat mucus  
Nasal pain 
Nasal pressure  
Sneezing 
Visible polyps  

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Symptom 
Tick if mentioned spontaneously () 
Mucus/catarrh  
Nasal tightness  
Sinus blockage  
Sinus inflammation  
Sinus infections  
Difficult breathing  
Wheezing  
Cough  
Head/facial pressure  
Headache  
Dizziness  
Dry throat/mouth  
Loss of taste  
Distorted voice  
Ear congestion  
Illness and infection  
Patient mentioned symptoms not currently in list:
 
 
 
 
 
[Note to interviewer]: Now ask the participant the following questions about each sign/symptom that 
they mentioned spontaneously. Allow the participant to answer spontaneously at first and only probe 
further if the participant is having difficulty discussing his/her experience or hasn’t previously mentioned 
the probed topics. Please note that the probes are to be used as a guide and they may not all need to be 
asked. 
 
 
 
 
 

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[Note to interviewer]: For each symptom mentioned ask the following questions: 
Symptom description 
 
How would you describe this symptom? How does it make you feel? 
 
Tell me about any additional words you use to describe this symptom, 
if at all. 
Frequency 
 
How often do you experience this symptom? 
 
Does the frequency vary/has it changed over time?  Please tell me about 
this. 
 
Does the frequency vary in the daytime versus the nighttime? Tell me 
about that.  
 
Is it a constant symptom or does it come and go? Tell me about that. 
Severity 
 
How would you describe the severity of this symptom? 
 
Does the severity vary/has it changed over time? Please tell me about 
this? 
 
Does the severity change in the daytime versus the nighttime? Time me 
about that 
 
How would you describe mild, moderate and severe [insert symptom]? 
Duration 
 
How long does this symptom typically last for? 
 
Does the duration vary/has it changed over time?  Please tell me about 
this. 
Impacts 
 
How does this symptom affect you in your daily life? 
 
How bothersome is this symptom for you? Please tell me more about 
that. 
o Physically? 
o Doing your daily/usual activities? 
o In doing things/relationships with family or friends? 
o Emotionally? 
o At school/work? 
Worsening / 
Improvement  
 
Tell me about anything that makes this symptom worse. 
 
Tell me about anything that makes this symptom better. 
Relation to other 
symptoms 
 
Do you experience this symptom on its own or at the same time as other 
symptoms? Please tell me more about that. 
[TO  INTERVIEWER]  Please  probe  on  those  symptoms  in  the  ‘symptom  list’  above,  that  were  not 
spontaneously  mentioned  by  the  participant.  Please  assess  relevance  of  the  symptom  first.  If  the 
participant  experiences  the  symptom  in  question  please  ask  the  additional  questions  detailed  in  the 
table above. 
8. Have you ever experienced any of the following symptoms as part of your nasal polyps? 
 
9. Are  there  any  other  symptoms  of  nasal  polyps  not  already  discussed  that  you  have 
experienced? Please tell me about them. 
 

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10. Which of the symptoms that you described are the worst? Why? 
 
11. Which  of  the  symptoms  that  you  described  do  you  experience  most  frequently/least 
frequently?  
 
12. Which of the symptoms that you described are most bothersome/least bothersome to you? 
Why? 
 
13. Can you tell me about anything that makes your nasal polyp symptoms better? 
 
Medication? 
 
Coping strategies/lifestyle changes? 
 
14. Can you tell me about anything that makes your nasal polyps worse? 
 
Does this affect specific symptoms or do your symptoms worsen equally? Tell me about this. 
 Living with nasal polyps (10 minutes) 
 “We are now going to talk about what it is like to live with nasal polyps.”  
15. Tell me what it is like to live with nasal polyps on a daily basis.  
 
How does nasal polyps affect you in your daily life?  
 
Tell me what a good day is like with your nasal polyps. Tell me what a bad day is like with 
your nasal polyps.  
 
Are there any things that you are not able or find difficult to do because of nasal polyps? 
 
Are there any things that you have to do differently because of nasal polyps? Please tell me 
about this. 
 
Which symptoms of nasal polyps have had the biggest impact on your life? Tell me why. 
 
16. In what ways, if at all, has nasal polyps affected you physically? 
 
How has nasal polyps affected the physical activities you do? Please tell me about this. 
 
Do the physical impacts vary or change over time? (E.g. frequency, severity, duration). 
 
Which symptom(s) of your nasal polyps has the biggest impact on you physically? Why? 
 
Tell me about anything you do to cope with/manage the physical impacts of nasal polyps 
(e.g. have you made any changes to your life to accommodate these physical impacts?) 

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17. In what ways, if at all, has nasal polyps affected your sleep? 
 
Has nasal polyps affected your sleep quality? Tell me about that.  
 
Has nasal polyps affected how much sleep you can get in in a night? Tell me about that 
 
Which symptom(s) of your nasal polyps has the biggest impact on your sleep? Why? 
 
Tell me what you do to cope with the sleep impacts caused by your nasal polyps.  
 
18. In what ways, if at all, has nasal polyps affected you emotionally/psychologically? 
 
Tell me about any emotional impacts you experience as a result of nasal polyps. 
 
Do the emotional impacts vary or change over time? (E.g. frequency, severity, duration). 
 
Which symptom(s) of your nasal polyps has the biggest impact on you emotionally? Why? 
 
Tell me about anything you do to cope with/manage the emotional impacts of nasal polyps 
 
19. In what ways, if at all, has nasal polyps affected you in doing things with family and friends? 
 
Has nasal polyps affected your participation in social activities? Tell me about that 
 
Which symptom(s) of your nasal polyps has the biggest impact on your social life? Why? 
 
Has nasal polyps affected your relationships with family/friends? Tell me about that 
 
Which symptom(s) of your nasal polyps has the biggest impact on your relationships with 
others? Why? 
 
20. In what ways, if at all, has nasal polyps affected your work activities? 
 
How do the nasal polyp symptoms that you discussed affect your work activities?  
 
Is there anything that you find challenging at work due to the nasal polyp symptoms that you 
experience? Please tell me about this.  
 
Have you ever had to take time off work because of your nasal polyps? Please tell me about 
this. 
 
Which symptom(s) of your nasal polyps has the biggest impact on your work activities? Why? 
21. In what ways, if at all, has nasal polyps affected you financially? 
 

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 Treatment/surgical experiences (10 minutes) 
22. How  easy  or  difficult  was  it  to  choose  to  have  surgery?  Tell  me  about  the  things  you 
considered in making your decision. 
 
When  deciding  whether  to  have  nasal  polyp  surgery,  which  symptom(s)  were  those  you 
wanted to be reduced the most by surgery?  
23. Tell me about your experience of having nasal polyp surgery? 
 
What effect did surgery have on your symptoms and any impacts you experienced? 
 
How did having the nasal polyp surgery impact your life?  
 
What were the positives of having surgery (if any)? 
 
Were there any negatives or drawbacks of having surgery? 
 
Would you choose to have additional surgeries to remove your nasal polyps? Why/why not? 
 
24. How have the treatments that you have taken for your nasal polyps impacted your life (if at 
all)? This may include prescribed, over‐the‐counter and alternative treatments. 
 
What was good about these treatments? 
 
What was bad about these treatments?  
 
25. If you were to take a treatment for your nasal polyps, what would make you think that it was 
worth taking?  
 
How would the symptoms that you experience have to change? 
o What change would you like to see in the severity of your symptoms? (probe on the 
percentage decrease i.e. 50% less or 70% less) 
‐ 
What is the smallest change that you would be happy with? 
o What change would you like to see in how often you experience symptoms?  
‐ 
What is the smallest change that you would be happy with? 
o What change would you like to see in the length of time that your symptoms last for? 
‐ 
What is the smallest change that you would be happy with? 
o What change would you like to see in how bad your symptoms get? 
‐ 
What is the smallest change that you would be happy with? 
o How important is no longer experiencing symptoms at all? 
o Which symptoms would be most important to you to treat? Why? 
o How would these changes affect your life?  

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26. Is  there  anything  else  you  would  like  to  tell  me  about  your  nasal  polyps  that  we  haven’t 
already discussed? 

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27. Think  aloud  cognitive  debriefing  (60 
minutes) 
[TO INTERVIEWER] Ask the participant to read aloud the instructions, each item and the responses they 
choose for each questionnaire. After the participant has responded to each item ask the participant the 
corresponding questions in the table below. Ask the participant to complete all of the questions.   
 “For each instruction and question of each of the following questionnaires, I want you to read it 
out loud, and tell me what you are thinking when you are answering. Please tell me any thoughts 
or opinions you have on the instructions and questions as you read them and tell me why you 
selected the answer you did.” 
 “After  you  respond  to  each  question  I  am  going  to  ask  you  some  questions  about  each 
instruction/item. These will be about your understanding of the item and its relevance to your 
experience with nasal polyps. Additionally, I will ask you about the response options you selected 
for each assessment and what it would mean to you to select a different response option.”  
 “You may decline to answer any question” 
 “The questions I ask may be a bit repetitive, but they are important so that we can see how you 
understand each question.” 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[TO INTERVIEWER] 

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Interviewer instructions 
 
You may need to keep reminding the participant to read and think aloud. Please have 
the patient read aloud the response they have chosen so this can be recorded. 
 
If the participant has difficulty reading a particular item, offer to read it for them and 
make a note of this.  
 
Make sure you are non-judgmental in your tone when probing. If the participant 
hesitates when answering, use one or more of the following probes, or similar questions 
to elicit comments from them. Please feel free to vary which ones you ask for each 
questionnaire item – rather than going through each one in rote fashion and getting one 
word answers. Not every probe has to be used for every item/participant.  
 
Asking why: if appropriate, probe further by asking the participant why they have 
answered the interview question in that way. 
 
If the patient has chosen to skip a question remember to ask why they have chosen to 
do so.  
 
If the patient has chosen “0” or “not applicable” option for any question ask why they 
have made this selection  
o 
Was the question not relevant? (e.g. they do not experience this symptom) 
o 
Is the question relevant, although they might not be currently experiencing this 
symptom? 
 
Wherever possible, please make brief notes in the empty boxes provided for each item 
to summarize: 
 
How the question was understood by the participant? 
 
Was the concept relevant to the participant? 
 
How easy/difficult was it for the participant to choose their answer? 
 
Why did they choose the answer they did? [please record their answers in the box 
below] 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
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 Cognitive debriefing of the SNOT‐22  
Understanding 
Relevance 
Recall period 
Response Options 
[INSTRUCTION 1] Below you will find a list of symptoms and social/emotional consequences of your rhinosinusitis. We would like to know more about these 
problems and would appreciate your answering the following questions to the best of your ability. There are no right or wrong answers and only you can 
provide us with this information. Please rate your problems as they have been over the past two weeks.  Thank you for your participation. Please do not 
hesitate to ask for assistance if necessary.  
In your own words, what is this 
instruction asking you to do?  
What does “social/emotional 
consequences” mean to you? 
What does “rhinosinusitis” mean to 
you? 
What does “problems” in relation to 
your condition mean to you?  
 
What does “over the past two weeks 
mean to you”? 
How easy or difficult is it to remember 
your symptoms over the last two 
weeks?  
Do you think that it is appropriate to 
answer questions about your nasal 
polyps thinking back to the past 
two weeks? Tell me about that. 
 
[INSTRUCTION 2] Considering how severe the problem is when you experience it and how often it happens, please rate each item below on how “bad” it is by 
selecting the number that corresponds with how you feeling using this scale.  
In your own words, what is this 
instruction asking you to do? 
What does “severe” mean to you? 
What does “how bad” mean to you? 
What does “how often it happens” 
mean to you? 
What does “corresponds with how 
you are feeling” mean to you? 
Based on your experience of nasal 
polyps, do you think that how bad 
your symptoms are (severity) and 
how often you experience a 
symptom (frequency) can be 
assessed at the same time? 
Are they the same or different? Why? 
 
How would you describe:  
“No problem”  
“Very Mild Problem” 
“Mild or Slight Problem” 
“Moderate Problem” 
“Severe Problem”  
“Problem as bad as it can be” 
 
[QUESTION 1] Need to blow nose  
What does “need to blow nose” mean 
to you?  
Would you use any other words to 
describe this symptom? 
 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “need to 
blow nose” separately, rather than 
together? Why? 
What time frame were you thinking 
about when answering this 
question? 
Was it easy or difficult to remember 
over the past 2 weeks? 
Did you think about both how bad the 
symptom is and how often you 
experience it? Why/Why not? 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
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Relevance 
Recall period 
Response Options 
What would your severity based and 
frequency based scores be? 
[QUESTION 2] Nasal blockage  
What does “nasal blockage” mean to 
you?  
Would you use any other words to 
describe this term? 
Is “nasal blockage” the same or 
different to “need to blow nose”? 
Why?  
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “nasal 
blockage” separately, rather than 
together? Why? 
What would your severity based and 
frequency based scores be? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[QUESTION 3] Sneezing  
What does “sneezing” mean to you?  
Would you use any other words to 
describe this term? 
 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “sneezing” 
separately, rather than together? 
Why? 
What would your severity based and 
frequency based scores be? 
 
How easy or difficult was it for you 
answer this question? 
What change in score would make a 
difference to you and why? 
[QUESTION 4]: Runny nose  
What does “runny nose” mean to 
you? 
Would you use any other words to 
describe this term? 
Is “runny nose” the same or different 
to “a need to blow nose”? Why? 
Is “runny nose” the same or different 
to “nasal blockage”? Why? 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “runny 
nose” separately, rather than 
together? Why? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
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Relevance 
Recall period 
Response Options 
What would your severity based and 
frequency based scores be 
[QUESTION 5] Cough 
What does “cough” mean to you? 
Would you use any other words to 
describe this term? 
 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “cough” 
separately, rather than together? 
Why? 
What would your severity based and 
frequency based scores be? 
What time frame were you thinking 
about when answering this 
question? 
Was it easy or difficult to remember 
over the past 2 weeks? 
Did you think about how bad the 
symptom is and how often you 
experience it? Why/Why not? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[QUESTION 6] Post‐nasal discharge  
What does “post‐nasal discharge” 
mean to you?  
Would you use any other words to 
describe this term? 
Is “post‐nasal discharge” the same or 
different to “runny nose”? Why? 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “post‐nasal 
discharge” separately, rather than 
together? Why? 
What would your severity based and 
frequency based scores be? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[QUESTION 7] Thick nasal discharge 
What does “thick nasal discharge” 
mean to you?  
Would you use any other words to 
describe this term? 
Is “thick nasal discharge” the same or 
different to “runny nose”? Why? 
Is “thick nasal discharge” the same or 
different to “post‐nasal 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “thick nasal 
discharge” separately, rather than 
together? Why? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 

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Recall period 
Response Options 
discharge”? Why? 
What would your severity based and 
frequency based scores be? 
[QUESTION 8] Ear fullness 
What does “ear fullness” mean to 
you?  
Would you use any other words to 
describe this term? 
 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “ear 
fullness” separately, rather than 
together? Why? 
What would your severity based and 
frequency based scores be? 
 
 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[QUESTION 9] Dizziness  
What does “dizziness” mean to you?  
Would you use any other words to 
describe this term? 
 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “dizziness” 
separately, rather than together? 
Why? 
What would your severity based and 
frequency based scores be? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[QUESTION 10] Ear pain 
What does “ear pain” mean to you?  
Would you use any other words to 
describe this term? 
Is “ear pain” the same or different to 
“ear fullness”? Why? 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “ear pain” 
What time frame were you thinking 
about when answering this 
question? 
Was it easy or difficult to remember 
over the past 2 weeks? 
Did you think about how bad the 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 

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Response Options 
 
separately, rather than together? 
Why? 
What would your severity based and 
frequency based scores be? 
symptom is and how often you 
experience it? Why/Why not? 
 
[QUESTION 11] Facial pain/pressure  
What does “facial pain” mean to you?  
What does “facial pressure” mean to 
you?  
Is “facial pain” the same or different 
to “facial pressure”? Why? 
Would you use any other words to 
describe these terms? 
Where on the face do you think 
about? Full face or specific areas? 
Tell me about that. 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Do you think that it’s appropriate to 
assess facial pain and pressure in 
one question? Why/why not? 
Would your scores be different if you 
were asked to rate “facial pain” 
and “facial pressure” separately? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “facial pain” 
and “facial pressure” separately, 
rather than together? Why? 
What would your severity based and 
frequency based scores be for 
each? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[QUESTION 12] Decreased sense of smell/taste  
What does a “decreased sense of 
smell” mean to you?  
What does a “decreased sense of 
taste” mean to you?  
Would you use any other words to 
describe these terms? 
 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Do you think that it’s appropriate to 
assess decreased sense of smell 
and taste in one question? 
Why/why not? 
Would your scores be different if you 
were asked to rate “decreased 
smell” and “decreased taste” 
separately?  
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
GK7818A v3_0 
Page 85 of 131 
15th May 2017 
Understanding 
Relevance 
Recall period 
Response Options 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “decreased 
sense of smell” and “decreased 
sense of taste” separately, rather 
than together? Why? 
What would your severity based and 
frequency based scores be for 
each? 
[QUESTION 13] Difficulty falling asleep  
What does difficult falling asleep 
mean to you?  
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “difficulty 
falling asleep” separately, rather 
than together? Why? 
What would your severity based and 
frequency based scores be? 
What time frame were you thinking 
about when answering this 
question? 
Was it easy or difficult to remember 
over the past 2 weeks? 
Did you think about how bad the 
impact is and how often you 
experience it? Why/Why not? 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[QUESTION 14] Wake up at night  
What does waking up at night mean 
to you?  
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “waking up 
at night” separately, rather than 
together? Why? 
What would your severity based and 
frequency based scores be? 
 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
GK7818A v3_0 
Page 86 of 131 
15th May 2017 
Understanding 
Relevance 
Recall period 
Response Options 
[QUESTION 15] Lack of a good night’s sleep  
What does “lack of good night’s sleep 
“mean to you?  
Is “lack of good night’s sleep” and 
“waking up at night” the same or 
different? Why? 
Is “lack of a good night’s sleep” and 
“difficulty falling asleep” the same 
or different? Why? 
 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “lack of 
good night’s sleep” separately, 
rather than together? Why? 
What would your severity based and 
frequency based scores be? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[QUESTION 16] Wake up tired  
What does “wake up tired” mean to 
you?  
 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of “waking up tired” 
separately, rather than together? 
Why? 
What would your severity based and 
frequency based scores be? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[QUESTION 17] Fatigue  
What does fatigue mean to you? 
Would you use any other words to 
describe this term? 
Is “fatigue” and “waking up tired” the 
same or different? Why?  
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “fatigue” 
separately, rather than together? 
Why? 
What would your severity based and 
frequency based scores be? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
GK7818A v3_0 
Page 87 of 131 
15th May 2017 
Understanding 
Relevance 
Recall period 
Response Options 
[QUESTION 18] Reduced productivity  
What does “reduced productivity” 
mean to you? 
Would you use any other words to 
describe this term? 
 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “reduced 
productivity” separately, rather 
than together? Why? 
What would your severity based and 
frequency based scores be? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[QUESTION 19] Reduced concentration  
What does “reduced concentration” 
mean to you?  
Would you use any other words to 
describe this term? 
Is “reduced concentration” the same 
or different to “reduced 
productivity”? Why?  
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “reduced 
concentration” separately, rather 
than together? Why? 
What would your severity based and 
frequency based scores be? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[QUESTION 20] Frustration/restless/irritable  
What does “frustration” meant to 
you? 
What does “restless” mean to you?  
What does “irritable” mean to you? 
Would you use any other words to 
describe these words? 
Are these terms the same or 
different? Why?  
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate “frustration”, 
“restlessness” and “irritability” 
separately? What scored would 
they be? 
Would your score be different if you 
were asked to rate the severity 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
GK7818A v3_0 
Page 88 of 131 
15th May 2017 
Understanding 
Relevance 
Recall period 
Response Options 
and frequency of your 
“frustration” separately, rather 
than together? Why? 
What would your severity based and 
frequency based scores be? 
[QUESTION 21] Sad 
What does “sad” mean to you?  
Would you use any other words to 
describe this term? 
Do you experience this as part of your 
nasal polyps? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “sadness” 
separately, rather than together? 
Why? 
What would your severity based and 
frequency based scores be? 
 
 
What time frame were you thinking 
about when answering this 
question? 
Was it easy or difficult to remember 
over the past 2 weeks? 
Did you think about how bad the 
impact is and how often you 
experience it? Why/Why not? 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[QUESTION 22] Embarrassed  
What does “embarrassed” mean to 
you?  
Would you use any other words to 
describe this term? 
Do you experience this as part of your 
nasal polyps? 
? 
Why did you choose an answer of [X]? 
Would your score be different if you 
were asked to rate the severity 
and frequency of your “sadness” 
separately, rather than together? 
Why? 
What would your severity based and 
frequency based scores be? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
GK7818A v3_0 
Page 89 of 131 
15th May 2017 
General feedback on SNOT‐22 
 We would also like to have your feedback on the questionnaire overall.  
28. What do you think of the questionnaire in general? 
 
What did you like/dislike about the questionnaire? 
 
What did you find easy/difficult 
29. Are there any symptoms or impacts that you experience due to your nasal polyps that you feel are missing from the questionnaire?  
30. Do you have any further comments about this questionnaire that we haven’t already discussed?  

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
GK7818A v3_0 
Page 90 of 131 
15th May 2017 
 Cognitive debriefing of VAS scales 
Understanding 
Relevance 
Recall period 
Response Options 
[NASAL OBSTRUCTION VAS]‘Please rate your nasal obstruction at its worst over the previous 24 hours’  
[SCALE] 0 (none) – 100 (as bad as you can imagine)  
What does “nasal obstruction” mean 
to you?  
Would you use any other words to 
describe this term? 
What does “at its worst mean to 
you”? 
“What does “over the previous 24 
hours mean to you”? 
What does “0 none” mean to you? 
What does “100 as bad as you can 
imagine none” mean to you? 
 
Do you experience this as part of your 
nasal polyps? 
Please mark your answer on the line. 
What number from 0‐100 does this 
line represent? 
Does the severity of your nasal 
obstruction differ over 24 hours?  
What time frame were you thinking 
about when answering this 
question? 
Was it easy or difficult to remember 
over the past 2 weeks? 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[NASAL DISCHARGE VAS] ‘Please rate your nasal discharge at its worst over the previous 24 hours’  
[SCALE] 0 (none) – 100 (as bad as you can imagine) 
What does “nasal discharge” mean to 
you?  
Would you use any other words to 
describe this term? 
Do you experience this as part of your 
nasal polyps? 
Please mark your answer on the line. 
What number from 0‐100 does this 
line represent? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
GK7818A v3_0 
Page 91 of 131 
15th May 2017 
Understanding 
Relevance 
Recall period 
Response Options 
[MUCUS IN THROAT VAS]‘Please rate the feeling of mucus in the throat at its worst over the previous 24 hours’  
[SCALE] 0 (none) – 100 (as bad as you can imagine) 
What does “mucus in the throat” 
mean to you?  
Would you use any other words to 
describe this term? 
 
Do you experience this as part of your 
nasal polyps? 
Please mark your answer on the line. 
What number from 0‐100 does this 
line represent? 
Does your experience of mucus in 
throat change in severity over 24 
hours? 
What time frame were you thinking 
about when answering this 
question? 
Was it easy or difficult to remember 
over the past 2 weeks? 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
[LOSS OF SMELL VAS] ‘Please rate your loss of smell at its worst over the previous 24 hours’  
[SCALE] 0 (none) – 100 (as bad as you can imagine) 
What does “loss of smell” mean to 
you? 
 
Do you experience this as part of your 
nasal polyps? 
Please mark your answer on the line. 
What number from 0‐100 does this 
line represent?  
Does your experience of loss of smell 
change in severity over 24 hours? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
 
[FACIAL PAIN VAS] ‘Please rate your facial pain or pressure at its worst over the previous 24 hours’  
[SCALE] 0 (none) – 100 (as bad as you can imagine) 
  
Do you experience this as part of your 
nasal polyps? 
Please mark your answer on the line. 
What number from 0‐100 does this 
line represent? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 

Date:   /    / 2017      Center Number:   /___/___/     Participant N°: /___/___/     
          MM       DD      
GK7818A v3_0 
Page 92 of 131 
15th May 2017 
Understanding 
Relevance 
Recall period 
Response Options 
[OVERALL VAS SYMPTOM SCORE] ‘Overall, please rate your nasal polyps symptoms at their worst over the previous 24 hours’  
[SCALE] 0 (none) – 100 (as bad as you can imagine) 
What does “overall symptoms” mean 
to you? 
Do you prefer the wording of this 
question, or the previous 
question? Why?   
Do you experience this as part of your 
nasal polyps? 
Please mark your answer on the line. 
What number from 0‐100 does this 
line represent? 
 
How easy or difficult was it for you 
answer this question? Why? 
What change in score would make a 
difference to you and why? 
 
General feedback on VAS scales 
 We would also like to have your feedback on the VAS scales overall.  
31. What do you think of the scales in general? 
 
What did you like/dislike about them? 
 
What did you find easy/difficult? 
32. Any further comments about the VAS scales?  
 

 
 
 
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33. General  feedback  on  real‐time  data 
capture  
[TO INTERVIEWER] The following section should only be asked to participants if they have taken part in the real‐time 
data capture task in addition to the interview. 
 “I would now like to ask you some question about your experience of completing the real‐time data capture 
task 
34. Overall how did you find the app task? 
 
What did you like/dislike? 
 
What did you enjoy? Was there anything you did not enjoy? 
 
Did you find the app easy or difficult to use? Tell me about that. 
 
Did you find it easy or difficult to submit your responses? Tell me about that. 
35. Was it easy or difficult to fit this into your daily routine? Tell me about that. 
36. Please tell me about your experience of downloading the app?  
 
Was this easy or difficult? Tell me about that. 
 
What did you think of the instructions you were provided with to download the app? 
37. What did you think of the types of tasks you were asked to complete? Tell me about that. 
38. What  did  you  think  of  the  ways  in  which  you  could  respond  to  tasks?  (e.g.  video  recording,  audio 
recording, photographs and text) 
 
Was there a response method that you preferred? If so, why? 
 
Were there any response methods that you did not choose? Tell me about that. 
39. What did you think of the number of task you were asked to complete? 
 
Were there too many/too few? 
 
On average, how long did each task take you to complete?  
40. Is there anything you’d change about the app task at all to make it better?  
41. How did you find completing the app task before/after your interview? 
 
Would you have preferred to take part in the app task before/after your interview instead? Why? 
Tell me about that. 
 
Would you have answered any of the app tasks/questions differently had you completed the app 
exercises before/after your interview instead? 
 
THANK THE PARTICIPANT FOR HIS/HER PARTICIPATION 
Finally I would like to thank you for taking part in this interview and sharing your experiences.  If this discussion has 
given you any concerns about your condition or treatment please contact your doctor. 
 

 
 
 
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Appendix 8: Questionnaires for use in cognitive debriefing interview 
 
 
 
 
QUESTIONNAIRES 
 
This document contains a number of questionnaires for you to complete, 
during your telephone interview with Adelphi Values about your nasal polyps.  
Within this document you will see a series of images of the questionnaire in 
electronic format, designed for use on a smartphone. Although you will see 
the questionnaire in this format you will be required to provide your answers 
on paper in this document by checking the relevant answer. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IMPORTANT: This document is for use DURING your telephone 
interview ONLY. Please do not complete any of the questionnaires 
inside this document until you are told to do so during your 
telephone interview.  
Please keep this document and the pre-paid mail return envelope 
safe until your telephone interview.  
Following the telephone interview, please mail this document to 
MedQuest (recruitment agency), using the pre-address and pre-paid 
mail envelope that has been provided.  
 

 
 
 
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Questionnaire 1: SNOT 22 
CCI - This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by third party copyright
laws and therefore have been excluded.

 
 
 
 
 
CONFIDENTIAL  
 
 
Copyright 2016 the GlaxoSmithKline group of companies. All rights reserved. 
Unauthorized copying or use of this information is prohibited. 
 
Questionnaire 2: Visual Analogue Scales  
Instruction: For the following questions you are asked to rate your symptoms on a scale from 0 to 100. 
At the start of each rating scale you will see a single line (cursor). In electronic form on a smartphone 
form you would be asked to slide this line to a place on the 0‐100 line that represents your answer.  
 
Using a pen/pencil please mark on the 0‐100 line using vertical line (|)where you would move the line 
(cursor) to  that represents your answer. 
 
 
A 
Question and response  
Please write which 
number out of 100 
your line 
represents 
 
 
 
 
 
 
 
 
 

 
 
 
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B 
 
Please rate your nasal discharge at its worst over the previous 24 hours.  
 
 
 
 
 
 

 
 
 
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C 
 
Please rate the feeling of mucus in the throat at its worst over the 
previous 24 hours.  
 
 
 
 
 
 

 
 
 
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D 
 
Please rate your loss of smell at its worst over the previous 24 hours.  
 
 
 
 
 
 

 
 
 
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E 
 
Please rate your facial pain or pressure at its worst over the previous 24 
hours.  
 
 
 
 
 
 

 
 
 
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F 
 
Overall, please rate your nasal polyps symptoms at their worst over the 
previous 24 hours.  
 
 
 
 
 
Thank you for completing these questionnaires 
Please put this completed document into the provided pre‐addressed and pre‐
paid envelope, and mail it back to MedQuest.  
 
 
 
 
 
 
 
 
 
 
 
 
Appendix 9: Example real-time data captures questions/tasks 
Example task/question 
Comments/Rationale 

 
 
 
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Example task/question 
Comments/Rationale 
Introductory task/orientation to 
the device 
“Using video or audio, please 
describe your experience of living 
with nasal polyps.” 
 
Prior to commencing the formal app tasks/questions, in order 
to orient the participant to the device and the response 
modalities it is recommend that we include an introductory 
task for completion by the participants. 
Nasal polyp description task 
“Please provide a written 
description of how you would 
describe nasal polyps to someone 
who had never heard of the 
condition.” 
 
In addition to understanding the patient experience of nasal 
polyps, additional value could be gained by getting patient to 
provide written description of their nasal polyps as if they 
were describing to someone who doesn’t know what nasal 
polyps are. 
Assessment of global severity of 
nasal polyps 
“Please rate the severity of your 
nasal polyps today at their worst.” 
 
Asking questions such as these, on a daily basis will allow the 
day‐to‐day variability of the global severity of nasal polyps to 
be reported. 
 
Responses to this daily question could be collected in a 
number of ways: 
o 
Categorical response options (e.g. No symptoms through 
to Very severe) 
o 
Numerical response scale (NRS) 
o 
Implementation of the overall symptom VAS as intended 
for the Phase III trial. Due to variability in each 
participant’s screen size of their personal smart phone 
and the limitations of the app platform it won’t be 
possible to measure the VAS score as you would on paper 
or as would be on a provisioned electronic device. Here 
we would ask the participant to provide a response using 
a slider option (outlined in the table above) and also ask 
the participant to provide in a free text box the number 
the slider position represents. 
Assessment of global impact of 
nasal polyps 
“Please rate how much your nasal 
polyps affected your usual activities 
today” 
 
As per global severity assessment, asking questions such as 
these, on a daily basis will allow the day‐to‐day variability of 
the global impact of nasal polyps to be reported. 
 
As described above, categorical, NRS or VAS a VAS sliding 
response scale could be used to respond to this task. In the 
case of the sliding scale VAS, a text box will also be provided 
for the patient to coordinate their sliding scale response to a 
number. . 
Assessment of day in the life with 
nasal polyps 
“During the study period we would 
 
Participants would be asked to complete this question/task 
once or twice during the study period. Because this main study 
uses telephone interviews, questions such as these, using 
video/audio responses, will allow patients to give a more 

 
 
 
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Example task/question 
Comments/Rationale 
like to understand your experience 
of nasal polyps over one full day. 
You can choose any day during the 
10-day period you would like 
complete this task. On your chosen 
day we would like you think about 
what you experienced, how it 
affected you and how you felt. You 
are encouraged to submit as many 
video or audio responses as you 
like as you move through your day.  
This may include submitting a 
response first thing in the morning 
to explain your experience of nasal 
polyps through the night (e.g. how 
you slept”. 
You could submit responses 
throughout your day as you go 
about your usual activities, 
explaining your experience of nasal 
polyps and how it affects you. 
You could also submit a response in 
the evening before bed describing 
your day’s experience with nasal 
polyps. 
These are just suggestion and you 
can submit any responses that you 
feel documents your experiences 
that day” 
 
detailed description of their symptom and daily life 
experiences with nasal polyps and allow the researchers at AV 
further insight into their experience of the disease.  

 
 
 
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Example task/question 
Comments/Rationale 
Assessment of treatment 
experiences 
“Please take a photo(s) of the 
medications or remedies you use 
for your nasal polyps and provide a 
short text caption/description about 
what is shown in the photo(s and 
what it means to you).” 
“Using video, audio or text response 
please describe which of these 
treatments (if any) you used today?  
What are the benefits you have 
seen today from these treatments? 
Is there anything you have disliked 
about your treatments today?” 
 
Treatments and surgical experiences and decisions for nasal 
polyps was discussed in both the qualitative literature and the 
patient blogs reviewed as part of an earlier nasal polyps 
literature review for GSK, and is included in the preliminary 
conceptual model. It is suggested that further detail regarding 
treatments and surgical decisions for nasal polyps is investigated 
using the app task. 
Capturing feelings/emotions 
“During the 10-day period take 
photos of things that describe your 
experience of nasal polyps that day 
and how you felt. You can submit as 
many photographs as you like. For 
each photo submitted please 
provide a short text 
caption/description about what is 
shown in the photo and what it 
means to you.” 
“For each photo provided, please 
rate the importance of this 
photograph to you?” Why did you 
give it this number?  
 
A technique that has been utilised successfully in other AV 
studies is the implementation of creative exercises. Here, 
patients could be fielded creative question to ‘take a photo 
that best describes your feelings towards your nasal polyps 
today, and use the caption to explain why you chose this 
photo’. Again, this requires patient to consider their condition 
and experience of it differently and may allow for interesting 
insight. As part of this process patient could be asked to rank 
the importance of the photos submitted using a sliding scale. 
Ranking criteria could be discussed and drafted with input 
from GSK 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Appendix 10: Adverse event form 
 
 
 
 
 
 
 
 
 
Agency/Project details  
Activity type: Epidemiology 
  Health Outcomes 
 
Project no./Activity ID: 
Project title: 
Agency name: 
Contact name: 
Address: 
 
Country: 
Tel. no: 
Fax no: 
E-mail: 
 
Safety information 
Event no: 
Respondent ID: 
When did the agency identify the safety information (day:month:year)? 
What GSK product is the safety information about? 
What indication (condition) was the product used for? 
Dose used: 
Lot/Batch no: 
Expiry date: 
Describe the safety information disclosed during the research (include any verbatim text): 
 
 
 
 
 
 
 
 
 
 
 
 
 
GSK Global Adverse Event, Pregnancy Exposure, and Incident Reporting Form for  
Epidemiology and Health Outcomes Studies 
To be completed in English  
 
Please send completed form to GSK within 24 hours of identifying the safety information via fax or e-mail to: 
Global CMG GCSP    
 or 
 
  
PPD
PPD

 
 
 
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Information about the reporter (respondent) who disclosed the safety information 
Reporter:    Consumer 
          Doctor 
           Nurse 
          Pharmacist 
           Other (specify):  
Which country does the reporter live in? 
Did the reporter consider the event was possibly related to the product use?    Yes 
        No 
        
Unknown 
 
Is the reporter willing for GSK’s safety team to contact them to discuss further?    Yes 
        No 
 
If No, please complete just the reporter fields above. If Yes, please provide contact details below.  For an HCP 
it is their contact details; for a patient it is their doctor’s contact details: 
Name:  
Address: 
Tel. no / E-mail: 
 
Information about the patient (person) or groups who used the product (may be the reporter or someone 
else) 
Gender: Male 
 Female 
 
Unknown 
   
Individual/Multiple Patients: Individual 
  Multiple 
   
Age: 
If Multiple state number if known: 
Initials: 
Other (date/year of birth, patient ID, etc): 
Was the patient pregnant when using the product?    Yes 
        No 
        Unknown 
  
 
Agency signature and date: