Patient Satisfaction and Sensory Attributes of Nasal Spray Treatments for Allergic Rhinitis
Conditions: Allergic Rhinitis
Sponsor: Community and Patient Preference Research Pty Ltd

 
 
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Collaborative Research Study Protocol Template 
 
[Protocol Cover Page] 
 
 
 
PROTOCOL TITLE: 
 
 
TREATMENT ATTRIBUTE SATISFACTION WITH (RYALTRIS®) INTRANASAL NASAL 
SPRAY FOR ALLERGIC RHINITIS 
 
PRS PROTOCOL IDENTIFICATION NUMBER: 20210902_2 
 
 
VERSION NUMBER: Version 3.0 
 
 
DATE: 14 October 2021 
 
 
 
 

 
 
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TABLE OF CONTENTS 
 
 
1. 
RELEVANT CONTACT INFORMATION 
 
2. 
LIST OF ABBREVIATIONS 
 
3. 
INTRODUCTION 
 
4. 
BACKGROUND 
 
5. 
INVESTIGATIONAL PRODUCT 
 
6. 
STUDY SETTING 
 
7. 
STUDY: PATIENT SATISFACTION AND SENSORY ATTRIBUTES OF NASAL SPRAY 
TREATMENTS FOR ALLERGIC RHINITIS 
 
 
A.  Objectives 
 
B.  Study Design 
 
C.  Study Population 
                 1. Description of study population 
                 2. Recruitment of subjects 
 
     3. Inclusion criteria 
 
     4. Exclusion criteria 
 
D.  Study Procedure 
 
    1. Study treatment/intervention  
 
    2. Satisfaction and importance of treatment attributes measurement 
 
    3. Assessment of safety 
 
    4. Duration 
 
    5. Subject withdrawal 
 
    6. Investigational product accountability 
 
    7. Compliance/adherence 
 
E.  Endpoints 
 
    1. Primary endpoints 
 
F.  Data Collection and Monitoring 
 
    1. Data collection 
 
    2. Data monitoring 
 
G.  Statistical Methods and Analysis 
 
    1. Sample size and statistical power 
 
    2. Statistical methods 
 
    3. Deviations including missing data 
 
8. 
PROTECTION OF HUMAN SUBJECTS 
 
 
A.  Informed Consent 

 
 
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9. 
ADVERSE EVENT MANAGEMENT 
 
10. 
STATEMENT OF CONFORMANCE 
 
11. 
DISSEMINATING AND COMMUNICATION OF RESULTS 
 
 
A.  Publication Plans 
 
12. 
REFERENCES 
 
 
 

 
 
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1. 
RELEVANT CONTACT INFORMATION 
 
Principle Investigator: 
Name: Simon Fifer, PhD, MAppliedStats, B.Ec 
Title: Dr. 
Address: Level 20, 25 Bligh Street, Sydney NSW 2000    
Contact telephone number(s): +61 403 862 091 
Email: simon.fifer@cappre.com.au 
 
Co-Investigator (if applicable): 
Name: Lili Toh, B.PsycSc 
Title: Miss. 
Address: Level 20, 25 Bligh Street, Sydney NSW 2000    
Contact telephone number(s): +61 452 551 409 
Email: lili.toh@cappre.com.au 
 
2. 
LIST OF ABBREVIATIONS 
 
ACIP 
Advisory Committee on Immunization Practices 
AE 
Adverse Event 
AMSRS 
Australian Market and Social Research Society 
AR 
Allergic Rhinitis 
BWS 
Best-Worst Scaling 
CaPPRe 
Community and Patient Preference Research 
EC 
Ethics Committee 
HCP 
Health Care Professional 
HREC 
Human Research Ethics Committee 
ICH 
International Committee on Harmonisation 
PAR 
Perennial Allergic Rhinitis 
SAE 
Serious Adverse Event 
SAR 
Seasonal Allergic Rhinitis 
 
 
3. 
INTRODUCTION 
 
 
Allergic rhinitis (AR) is a highly prevalent disease, affecting more than 4.6 million Australians 
(Australian Institute of Health and Welfare, 2019). Intranasal corticosteroids (INCS) +/-  
intranasal antihistamines (INAH) are recommended as first-line therapy for AR [ASCIA AR 
Clinical Update (allergy.org.au)]. Patients may often differentiate intranasal treatments based on 
sensory attributes (Meltzer et al., 2008). Application of patient preferences when selecting INCSs 
could improve adherence to treatment (Meltzer et al., 2005). 
 
4. 
BACKGROUND 
 

 
 
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Olopatadine hydrochloride and mometasone furoate monohydrate (RYALTRIS®) is a fixed dose 
combination nasal spray containing an isotonic aqueous white homogenous suspension in a 
metered dose manual spray unit. It is indicated for the treatment of symptoms associated with 
allergic rhinitis and rhinoconjunctivitis in patients 12 years of age and older and marketed in 
Australia by Seqirus. Allergic rhinitis will be described to participants as “allergic rhinitis (hay 
fever or other year-round allergies)” in the studies below as stated according to the RYALTRIS® 
Consumer Medication Information (CMI). 
 
There is currently no patient satisfaction data for RYALTRIS® nasal spray. To address this 
knowledge, this research seeks to examine patients’ satisfaction and importance of treatment 
attributes for AR nasal sprays from two brands (RYALTRIS® vs. DYMISTA®). The research 
objectives are outlined below. 
 
5. 
INVESTIGATIONAL PRODUCT 
 
 
Olopatadine hydrochloride and mometasonefuroate monohydrate (RYALTRIS®) is a fixed dose 
combination nasal spray containing an isotonic aqueous white homogenous suspension in a 
metered dose manual spray unit. It is indicated for the treatment of symptoms associated with 
allergic rhinitis and rhinoconjunctivitis in patients 12 years of age and older and marketed in 
Australia by Seqirus. 
 
No investigational  product is being supplied.  
 
 
6. 
STUDY SETTING 
 
Data will be collected through an online survey platform, Forsta Plus.  
 
The site location is: 
Community and Patient Preference Research (CaPPRe) 
Level 20, 25 Bligh Street, Sydney NSW 2000 
 
7. 
STUDY: PATIENT SATISFACTION AND SENSORY ATTRIBUTES OF NASAL 
SPRAY TREATMENTS FOR ALLERGIC RHINITIS 
 
A. 
Objectives 
 
To understand AR patients’ level of satisfaction with RYALTRIS® compared to 
DYMISTA® nasal spray based on various treatment attributes. In addition, CaPPRe 
recommends exploring the importance of each sensory attribute to AR patients, thus 
enabling a much more comprehensive evaluation of true satisfaction with treatments. 
 
The key objectives of this research are: 

 
 
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• 
To understand patient satisfaction and importance with various treatment attributes 
of the RYALTRIS® nasal spray 
• 
To compare overall satisfaction for various treatment attributes of RYALTRIS® 
with the DYMISTA® nasal spray 
 
B. 
Study Design 
 
To directly compare patient satisfaction with 2 different AR nasal sprays, an 
observational, non-interventional, cross-sectional study design with 2 independent 
samples was chosen. Participants will complete an online survey involving a Best-
Worst scaling (BWS) task to determine satisfaction and importance index for sensory 
attributes.  
 
The suggested treatment attributes are informed by a range of previous studies, 
including those conducted by Meltzer et al 2005 and Price et al 2020, and 
methodology from CaPPRe’s own work in developing indices for importance and 
satisfaction of treatment attributes using BWS. 
 
C. 
Study Population 
 
1. Description of study population 
 
The primary population will be patients with moderate to severe SAR or PAR with or 
without conjunctivitis in Australia who have been initiated on RYALTRIS® or 
DYMISTA® in that last 12 months. 
 
The expected sample size is between 200 to 400 patients. 100-200 patients initiated on 
RYALTRIS® and 100-200 patients initiated on DYMISTA® nasal spray in the last 
12 months.  
 
2. Recruitment of subjects 
 
The main recruitment channel will be through the engagement of online panel 
companies that specialise in patient population and healthcare provider samples. 
Online panel companies will contact their list of panel members via email to invite 
them to participate in the study. Convenience sampling will be used to recruit 
participants into the study; participants will opt-in after hearing about the study. 
Interested panel members will be directed to the survey link where they will answer a 
number of screening questions that will determine their eligibility before the main 
survey (e.g., Prescribed treatment by doctor for AR and identifying treatment with a 
fixed dose combination (Ryaltris or Dymista)). Recruitment of 100-200 patients 

 
 
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initiated on RYALTRIS®, and 100-200 patients initiated on DYMISTA® nasal spray 
in the last 12 months will take approximately 2 weeks to complete.  
 
Upon commencing the survey, participants will be provided a study information sheet 
and consent form before continuing to the rest of the survey. The study information 
sheet will contain contact details of the CaPPRe project manager to assist participants 
with any queries or provide additional information. Participants will have the option 
of saving/printing the participant information sheet and consent form to retain a copy 
for their records. Participants will read the Participant Information Sheet and the 
Consent Form online and check a box to indicate they have read the information and 
agree to participate. 
 
3. Inclusion criteria 
 
AR patients (moderate-to-severe SAR or PAR) with or without conjunctivitis who 
meet the following criteria will be offered the opportunity to participate in the study: 
 
• 
Patients above 18 years old 
• 
Fluent in English 
• 
Patients initiated on RYALTRIS® or DYMISTA® nasal spray in the last 12 
months and currently using treatment 
• 
Willing and able to provide consent to participate 
 
4. Exclusion criteria 
 
Potential participants will be excluded if they: 
 
• 
Have reported a loss of taste and/or smell related to COVID-19 (or other medical 
condition) 
• 
Are employed by a pharmaceutical company (to avoid conflict of interest) 
• 
Are employed by a vaccine company (to avoid conflict of interest) 
• 
Do not have access to the internet (to ensure validity of the data) 
• 
Are unable to read and understand English (to ensure validity of the data) 
 
D. 
Study Procedure 
 
1. Study treatment/intervention 
 
Participants would have already initiated treatment on a RYALTRIS® or 
DYMISTA® AR nasal spray in the last 12 months before completing the survey and 
currently be using treatment. 

 
 
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2. Satisfaction and importance of treatment attributes measurement 
 
Treatment attribute satisfaction and importance will be assessed using Best Worst 
Scaling (BWS).  Importance of the items will also be measured to create an overall 
satisfaction index between 0-100 (satisfaction weighted by importance). 
 
The BWS exercise involves showing participants a series of scenarios that include a 
subset of attributes from a master list (in this case, treatment attributes of AR nasal 
sprays). Patients will be asked to review scenarios and choose what is most satisfied 
and least satisfied, and most important and least important to them in each. An 
example of a BWS choice task is shown below in Figure 1. 
 
Figure 1. Example of a BWS choice task from a survey   
(NOTE: this is an example only and does not reflect the final choice task) 
 
 
 
BWS is a survey technique developed in the 1980s by Professor Jordan Louviere to 
overcome measurement issues with traditional scale-based research. BWS takes 
advantage of an individual’s ability to reliably identify extremes (‘best’ and ‘worst’) 
in a set of three or more items, with respect to a continuum, such as satisfaction 
(Louviere et al., 2015). BWS studies are routinely used in health to identify patient 
preferences and prioritisation (Mühlbacher et al., 2016) 
 

 
 
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BWS is preferred over traditional methods, including rating scales, ranking, and 
paired comparisons, due to the following reasons: 
• 
Simple and intuitive for participants to complete 
• 
No scale biases 
• 
Ability to handle a large number of items  
• 
Scores demonstrate greater discrimination among items and between groups of 
respondents than traditional scale methods 
• 
Scores can be estimated for individual respondents 
 
The Directors of CaPPRe have all worked directly with Professor Louviere over many 
years at the Centre for the Study of Choice (CenSoC) and The Institute for Choice 
(I4C) and understand the advantages and disadvantages of BWS very well. BWS 
measures all items on a common scale which can be used to evaluate the relative 
hierarchy of any domain versus another domain. 
 
BWS scores are a relative measure and cannot be used to build an index for 
comparison between individuals without an absolute anchoring point. Our research 
implements an anchoring process to rescale scores so they can be directly compared – 
we refer to this as anchored best-worst scaling (ABWS).  
 
The questionnaire below (see Figure 2) was developed by Melzer et al 2005 to 
measure patient preferences for intranasal corticosteroids in patients with AR. This 
questionnaire has been adapted for use to determine satisfaction with and importance 
of treatment attributes of AR nasal sprays. 
 
Figure 2. Questionnaire measuring patient preferences for intranasal corticosteroids 
(Melzer et al.) 
 

 
 
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3. Assessment of safety 
 
There are no specific safety assessments, however, all respondents will be made aware 
at the start of the survey that their responses may potentially raise adverse events 
requiring reporting. Any AEs received spontaneously should be reported directly to Seqirus 
at AE.Reporting@Seqirus.com. They will be asked to consent to being contacted by 
Seqirus in this instance and to provide their personal email address to facilitate this 
contact. All personal contact details will only be used for the purposes specified and 
will kept separate from the survey data. All observed adverse events related to, 
Seqirus products (Adverse Drug Reactions, Serious Adverse Drug Reactions, product 
complaints, and other safety findings, pregnancy, lactation) in routine clinical practice 
will be documented in accordance with Seqirus requirement documents (e.g., Standard 
Operating Procedures [SOPs]). 
 
Adverse reactions will be reported according to the Seqirus requirements. Patients will 
be advised about reportable events and provide consent (example survey text below): 
 
Reportable Events 
You are about to enter an online research survey. Different patients sometimes 
respond in different ways to the same products, and some side effects may not be 
discovered until many people have used a product over a period of time. For this 
reason, we are now required to pass on to (INSERT NAME), who is a manufacturer of 
medicines, details of any reportable events (side effects, situations that could affect 
the safety of a medicine, or product complaints) related to their own products that are 
mentioned during the course of market research. Although this is an online research 

 
 
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survey and how you respond will, of course, be treated in confidence, should you raise 
a reportable event, where you, or someone you know, experienced a reportable event 
or became ill after using one of (INSERT NAME) products, we will need to report this, 
so that they can keep the knowledge of the safety profile of their medicines up to date. 
You may be contacted to provide further information about this side effect. However, 
you have the choice to remain anonymous and choose not to be contacted if you so 
wish. You will be asked to provide your preference on this further below. 
 
4. Duration 
 
The online survey including the BWS exercise will take approximately 20 minutes to 
complete.  
 
5. Subject withdrawal 
 
Participants may withdraw at any time they wish, including prior to commencement of 
the survey or during survey completion. All data generated up to the time of voluntary 
discontinuation (withdrawal of consent) and the reason(s) for discontinuation, if 
available, will be recorded. Patients who choose to withdraw consent will no longer be 
contacted for follow up information. 
 
6. Investigational Product Accountability 
 
Any identified AEs will be reported in line with Seqirus requirements. 
 
7. Compliance/adherence 
 
Ongoing internal monitoring to ensure compliance of the study will be conducted by 
the principle and co-investigators. The progress of the study (sample achieved) will be 
monitored regularly (at least twice a week).  
 
All adverse reactions related to Seqirus products (Adverse Drug Reactions, Serious 
Adverse Drug Reactions, product complaints and other safety findings, pregnancy, 
lactation) in routine clinical practice will be documented in accordance with Seqirus 
requirement documents (e.g., Standard Operating Procedures [SOPs]). 
 
Adverse reactions will be reported according to the Seqirus requirements. Patients will 
be advised about reportable events and provide consent. 
 
E. 
Endpoints 
 

 
 
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1. Primary endpoint 
 
The primary study endpoint is the overall index score from the BWS exercise, to 
reflect satisfaction and importance of treatment attributes of the RYALTRIS® and 
DYMISTA® nasal spray.  
 
2. Secondary endpoints 
 
Secondary study endpoints are the domain scores from the BWS exercise (i.e., relative 
ranking scores for each of the domains; satisfaction and importance). 
 
F. 
Data Collection and Monitoring 
 
1. Data collection 
 
Participants can complete the online survey by accessing a survey link online via 
mobile, desktop computer, laptop or standard sized tablet. At the beginning of the 
survey, participants will be asked to review the study participant information sheet 
and provide consent.  
 
The 20-minute online survey will include: 
• 
Patient demographics (e.g., Age, Gender, Location) 
• 
Symptoms (mild, severe, moderate) 
• 
Brief diagnosis and treatment history (SAR/PAR with or without conjunctivitis) 
• 
Current treatment 
             a) Duration 
             b) Initiation: Doctor or self-managed 
 
• 
A Best-Worst scaling task to determine the overall satisfaction index for treatment 
attributes 
 
2. Data monitoring 
 
Ongoing internal monitoring to ensure compliance of the study will be conducted by 
the principle and co-investigators. The progress of the study (sample achieved) will be 
monitored regularly.  
 
All adverse events related to observed Seqirus products (Adverse Drug Reactions, 
Serious Adverse Drug Reactions, product complaints, and other safety findings, 
pregnancy, lactation) in routine clinical practice will be documented in accordance 
with Seqirus requirement documents (e.g., Standard Operating Procedures [SOPs]). 

 
 
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Adverse events will be reported according to the Seqirus requirements. Patients will 
be advised about reportable events and provide consent. 
 
Statistical Methods and Analysis 
 
1. Sample size and statistical power 
 
The expected sample size is 100-200 moderate to severe SAR/PAR patients initiated 
on RYALTRIS® nasal spray in the last 12 months and 100-200 patients initiated on 
DYMISTA® AR nasal spray in the last 12 months. Traditional power calculations are 
not applicable to the design of BWS studies. The experimental designs used (BIBD 
and Youden designs) allow for individual level estimation of scores. A sample size of 
100-200 patients per treatment provides appropriate precision, balanced against 
recruitment constraints.  
 
 
2. Statistical methods 
 
The data from the quantitative survey will be cleaned and restructured for analysis 
using R statistical software 
 
Best Worst Scaling analysis  
Standard BWS scores cannot be used to build an index that is comparable between 
groups of participants because the scores represent a relative ranking. CaPPRe have 
developed a new method to convert these scores from relative to absolute measures 
which can be combined to form an index An index will be built to measure the overall 
satisfaction with the sensory attributes. The index is a combined score of the BWS 
domains, accounting for both satisfaction and importance, and ranges from 0 to 100. 
Index scores will be compared using an analysis of variance (ANOVA). 
 
The BWS exercise yields scores reflecting the relative hierarchy of each domain vs 
another domain (e.g., cost versus efficacy). The BWS scores for each item are 
calculated by finding the difference between the number of times it was chosen as 
most satisfied / important and least satisfied / important, and then dividing it by the 
total number of times it appeared throughout the exercise. 
 
 

 
 
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Furthermore, the BWS scores are mapped onto a scale ranging from 0 (“Not satisfied at 
all”/”Not important at all”) to 10 (“Completely satisfied”/”extremely important”) 
describing the level of satisfaction and importance. These rescaled scores allow direct 
inference of how satisfied/important each individual domain is, rather than just their 
relative ranking. 
 
Best-Worst Scaling (BWS) scores range from -1 to 1 and represent the relative 
ranking (ordering) of the domains. 
• A negative score indicates the domain was chosen as worst more often than best 
• A positive score indicates the domain was chosen as best more often than worst 
• A zero score indicates the domain was chosen as best and worst an equal number of 
times OR 
was never chosen. 
 
Rescaled scores range from 0 to 10 and represent the individual level of satisfaction 
and importance experienced. The scale was labelled at each extreme as follows: 
• 0 = “Not satisfied at all”/”Not important at all” 
• 10 = “Completely satisfied”/”Extremely important” 
 
In analysing the BWS results, consideration will be given as to whether there are any 
respondent specific characteristics that might influence preferences, such as whether 
demographic factors or previous experience with treatments impacts on preferences. 
Rescaled scores for each domain will be compared using a multivariate analysis of 
variance (MANOVA). 
 
Treatment background and demographic questions 
 
Descriptive statistics will be provided for the demographic component of the survey. 
The analysis and reporting of the data will be conducted at a total sample or segment 
level with participant anonymity protected. 
• 
the mean, median, standard deviation, minimum and maximum will be reported 
for numeric variables, and 
• 
the frequency and percentage will be reported for categorical variables. 
Where deemed appropriate, the results for some variables will be displayed visually 
through a suitable graph. Any missing data resulting from a participant selecting 
“prefer not to answer” will be treated as a separate category within each variable. The 
level of significance used will be 5% (p < .05). 
 
3. Deviations including missing data 
 
No deviation from the protocol will be implemented without the prior review and 

 
 
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approval of the HREC except where it may be necessary to eliminate an immediate 
hazard to a study subject.  In such case, the deviation will be reported to the HREC as 
soon as possible. Any protocol deviation will be reviewed and dealt with as an 
amendment to the current protocol where necessary. 
 
Each participant’s response will be individually assessed to determine the validity and 
sincerity of their responses based on the cohesion of their open text responses and the 
overall time they took to complete the survey. Any responses found to fail the 
assessment process will be excluded from the analysis. 
 
8. 
PROTECTION OF HUMAN SUBJECTS 
 
Ethics approval for this study is being sought via the Bellberry Human Ethics Committee, 
Australia. The review and approval ensure the study will be conducted according to the non-
interventional design and to protect the rights of the participants including data protection, 
participant privacy, sponsor’s interest. 
 
All ethical considerations as outlined in Chapter 4 of the National Statement on Ethical Conduct 
in Human Research have been considered and will be applied to the conduct of the research, as 
outlined in the Participant Information Sheet and Participant Consent Form. 
 
It is important to note that this is a research project, not an interventional clinical trial. The 
researchers from CaPPRe, in conducting this study, will act in accordance with the procedures as 
set out in the ethics approval. Researchers conducting this study also comply with the Australian 
Market and Social Research Society (AMSRS) Code of Professional Behaviour and Medicines 
Australia Code. These Codes have been developed to protect the interests of people who agree to 
participate in research studies. In addition, individual members of the AMSRS are bound by a 
Code which covers both the ethical requirements and standard conditions of conducting and 
reporting market and social research.  
 
The research will also adhere to the relevant Australian standards on scientific credibility 
(including but not limited to related standards and processes for pharmacovigilance), as 
applicable and their regulatory standards providing assurance that the rights, safety, and 
wellbeing of people participating in market research studies are protected and that the study data 
are credible and responsibly reported. This market research study protocol has not been submitted 
to any other ethics committees. 
 
CaPPRe considers this research to be a low-risk survey-based project. The project is expected to 
take approximately 8 months from start of fieldwork to final completion. Ongoing internal 
monitoring to ensure compliance of the study will be conducted by the principle and co-
investigators. The progress of the study (sample achieved) will be monitored regularly (at least 
twice a week). 
 

 
 
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If the study takes longer than 8 months, a progress report will be submitted to Bellberry via e-
protocol detailing compliance of the study with the approved protocol, consent procedures and 
documentation, outcome of the research, and security of records. A final report detailing the 
above with also be submitted at study completion. Any protocol deviations will be reported to 
Bellberry within 14 days of the event. 
 
In relation to maintenance and security of records, all data is stored in a secure encrypted 
environment that can only be accessed by CaPPRe personnel. 
 
Confidentiality 
 
CaPPRe respects and understands participant privacy. By providing consent, the participant 
agrees to us collecting and using personal and health information they have provided for the 
research study. Any information obtained in connection with the research project that can identify 
the participant will remain confidential. Participant personal details will not be forwarded to any 
other parties, nor will they be contacted by CaPPRe for anything other than the research study 
unless they choose to do so. Participant information will only be used for the purpose of this 
research project and it will only be disclosed with their permission, except as required by law. 
 
Data de-identification 
 
The data collected in this research will be de-identified by segmenting the dataset into two, one 
containing participants’ names and contact information (stored in Excel) and the other containing 
the data to be used for analysis (using R software) and reporting with a de-identified participant 
ID. The first dataset containing participant personal information will be held securely by CaPPRe 
only and stored in Australia. The personal details of participants will not be forwarded to any 
other parties, nor will they be contacted by CaPPRe for anything other than this research project 
unless they choose to be. All responses are treated with the strictest confidentiality. CaPPRe 
alone will know which people have participated and their responses. No individual data will be 
available to anyone other than CaPPRe. Seqirus will be provided with a report of the findings 
containing only combined de-identified data. The research data will be kept for a period of five 
years. 
 
Data storage and access 
 
All responses collected by CaPPRe are treated with the strictest confidentiality. The data will be 
stored in a secure encrypted environment in the cloud that only CaPPRe can access. Any data 
collected will be used for the purpose of this research study only. 
 
A. 
Informed Consent 
 
Participants will be provided with both a Participant Information Sheet and Consent Form for the 
survey prior to participating in this study. In addition, CaPPRe is available at any time to answer 
any questions prior to or during the study.   
 
9. 
ADVERSE REACTION MANAGEMENT 
 

 
 
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All respondents will be made aware at the start of the survey that their responses may potentially 
raise adverse reactions and will be asked for their consent for their doctor to be contacted by 
Seqirus in this instance as well as for their personal email address to facilitate this contact. All 
personal contact details will only be used for the purposes specified and kept separate from the 
survey data.  
 
All adverse reactions related to observed Seqirus products (Adverse Drug Reactions, Serious 
Adverse Drug Reactions, product complaints, and other safety findings, pregnancy, lactation) in 
routine clinical practice will be documented in accordance with Seqirus requirement documents 
(e.g., Standard Operating Procedures [SOPs]). 
 
Adverse reactions will be reported according to the Seqirus requirements. Patients will be advised 
about reportable events and provide consent (example survey text below): 
 
You are about to enter an online research survey. Different patients sometimes respond in 
different ways to the same products, and some side effects may not be discovered until many 
people have used a product over a period of time. For this reason, we are now required to pass 
on to (INSERT NAME), who is a manufacturer of medicines, details of any reportable events 
(side effects, situations that could affect the safety of a medicine, or product complaints) related 
to their own products that are mentioned during the course of market research. Although this is 
an online research survey and how you respond will, of course, be treated in confidence, should 
you raise a reportable event, where you, or someone you know, experienced a reportable event or 
became ill after using one of (INSERT NAME) products, we will need to report this, so that they 
can keep the knowledge of the safety profile of their medicines up to date. You may be contacted 
to provide further information about this side effect. However, you have the choice to remain 
anonymous and choose not to be contacted if you so wish. You will be asked to provide your 
preference on this further below. 
 
10. 
STATEMENT OF CONFORMANCE 
 
This study will be conducted in compliance with the protocol approved by the Bellberry Human 
Ethics Committee, Australia.  No deviation from the protocol will be implemented without the 
prior review and approval of the HREC except where it may be necessary to eliminate an 
immediate hazard to a study subject.  In such case, the deviation will be reported to the HREC as 
soon as possible. 
 
 
11. 
DISSEMINATING AND COMMUNICATION OF RESULTS 
 
A. 
Publication Plans 
 
The results will be disseminated through articles submitted for publication in peer reviewed 
international journals, as well as oral and poster presentations at national and/or international 
conferences. Publication or presentation of the overall research study results requires prior 
written or verbal approval of CaPPRe. 
 
The project will have a dedicated research project manager and technical lead as well as access to 

 
 
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methodological and strategic expertise. All technical aspects, including the BWS experimental 
design, programming of the survey, development of the BWS model and statistical analysis are 
managed in-house directly by CaPPRe staff. 
 
Community and Patient Preference Research (CaPPRe) is a consultancy group committed to 
meaningful research, leading to better engagement and understanding of community and health 
consumer needs. CaPPRe is an independent company committed to high quality choice 
modelling.  CaPPRe will have full responsibility for designing all materials for this study which 
will be reviewed and approved by Seqirus prior to fieldwork commencing. 
 
Key CaPPRe research staff (and their responsibilities) are shown in the table below. 
Table 2: Research staff and their responsibilities 
Research Staff 
Main Roles and Responsibilities 
Dr Simon Fifer 
- 
Project Oversight 
- 
Technical lead 
o Experimental Design 
o Scripting and programming 
o BWS modelling and analysis 
- 
Report and dashboard review 
- 
Journal paper development 
Lili Toh 
- 
Project Management 
- 
Survey design 
- 
Statistical analyses 
- 
Dashboard development 
- 
Journal paper development 
 
The project will take approximately 8 months to complete. Based on the estimated timeframe and 
pending ethics approval the research fieldwork is anticipated to commence in September 2021 
with completion of the project estimated around December 2021. 
 
Table 3. Project timeline 
 
Milestone 
Planned date 
Start study preparation  
August 2021 
Start of data collection - Quantitative research component 
September 2021 
End of data collection  
December 2021 
Finish analysis modelling, report and dashboard preparation 
 January 2022 
Journal publication preparation  
February 2022 
 
 
12. 
REFERENCES 
 

 
 
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Australian Institute of Health and Welfare 2019. Allergic rhinitis ('hay fever'). Cat. no. PHE 257. 
Canberra: AIHW. Viewed 01 May 2020, https://www.aihw.gov.au/reports/chronic-respiratory-
conditions/allergic-rhinitis-hay-fever/contents/allergic-rhinitis 
 
Meltzer, E.O., Bardelas, J., Goldsobel, A. et al. A Preference Evaluation Study Comparing the 
Sensory Attributes of Mometasone Furoate and Fluticasone Propionate Nasal Sprays by Patients 
with Allergic Rhinitis. Treat Respir Med 4, 289–296 (2005) 
Meltzer EO, Garadi R, Laforce C, Chadwick SJ, Berger WE, Gross G, Edwards MR, Crenshaw 
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