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HEALTH OUTCOMES STUDY PROTOCOL - QUALITATIVE RESEARCH UNIQUE IDENTIFIER HO-16-16285/ 206455 FULL TITLE Trelegy: Qualitative Interviews and Discrete Choice

Experiment(s) Evaluating the Perceived Benefits of the Features of Trelegy Ellipta (single inhaler triple therapy) Treatment in the UK, US and Germany

ABBREVIATED TITLE Trelegy: Qualitative Analysis & DCE FINAL PROTOCOL APPROVED SPONSORSHIP GSK DIVISION Pharma BUSINESS UNIT Research & Development DEPARTMENT VEO STUDY ACCOUNTABLE PERSON CONTRIBUTING AUTHORS

ASSET ID 18345

GSK ASSET Vilanterol + fluticasone furoate + umeclidinium (Trelegy Ellipta)

INDICATION Chronic Obstructive Pulmonary Disease (COPD)

REVISION CHRONOLOGY: Version Date Document Type Change(s) since last version Original n/a

PPD

Description: Trelegy: Qualitative Analysis & DCE Unique Identifier: HO-16-16285/ 206455 SPONSOR SIGNATORY Melanie Schroeder (Afisi Ismaila) 02/12/2016

Senior Line Manager Fleur Chandler Head VEO Respiratory, R&D Value Evidence & Outcomes

Date

2

PROTOCOL SYNOPSIS Unique Identifier HO-16-16285/ 206455

Abbreviated Title Trelegy: Qualitative Analysis & DCE

GSK Product Vilanterol + fluticasone furoate + umeclidinium (Trelegy Ellipta)

Rationale For patients at higher risk of exacerbation, treatment with all three

classes of medication (i.e. LABA, LAMA, and ICS) is recommended.

However, currently this approach is limited by the unavailability of an

inhaler device capable of combining all three medication classes, and

patients are forced to use at least two inhalers in triple therapy (e.g.

Relvar & Incruse). GSK wishes to explore the potential utility of

Trelegy Ellipta, a single inhaler containing all three classes. An

important step in determining the viability of such a device is to

understand the needs of patients with COPD. To this end, there is a

need qualitatively to explore and understand why patients with COPD

may benefit from a single inhaler device combining three medication

classes, and to quantify the relative importance of the benefits that

therapy single inhaler triple therapy may offer, thus allowing

differentiation from other treatment options. Additionally, there is a

need to assess and rank patient burden in COPD, focusing on

symptoms, life impact and treatment preferences. The study was

modeled after study HO-15-15503 (Evaluating the Impact, Benefits

and Preferences of Relvar Ellipta in Patients with COPD and asthma)

which was approved at PRC on January 4, 2016. This study would be

conducted in the US, UK and Germany.

Objectives (Primary, Secondary)

The main aim of this project is to evaluate and translate relevant

attributes of Trelegy Ellipta into patient experienced benefits, and to

quantify those preferences in terms of patients’ trade-offs and WTP.

The objectives of the study are thus:

1. To elicit the preferences, priorities and treatment goals of

3

patients with COPD for inhaled treatments.

Related to the above, to determine the key relevant attributes of COPD treatment;

2. To estimate the relative importance of each attribute;

3. To estimate the overall preference value of different

treatment approaches based on an assumed combination of

specific attribute levels, expressed as WTP and odds ratio

(OR).

Study Design This study will elicit the preferences of patients with COPD for inhaled

treatments using a Discrete Choice Experiment (DCE) methodology in

the UK, US and Germany. Following recommended best practice in

DCE design (Hauber et al., 2016), to incorporate contextual factors

that are likely to influence preferences, a separate DCE will be

developed for each market to best reflect market specific differences

in, for example, cost attributes to inform willingness to pay (WTP).

This is a mixed methods study with a qualitative phase and a

quantitative DCE phase. The qualitative phase will inform the

development of the online DCE surveys, which will be used for the

quantitative phase. The study will be conducted in four stages: 1)

Qualitative concept elicitation and DCE development, 2) DCE

development, 3) DCE piloting and testing, 4) Conducting of the DCE.

1) Qualitative concept elicitation and DCE development

• Up to 30 one-to-one telephone interviews and 3 in-person

focus group discussions with up to 5 patients with COPD will

be conducted across the three markets, the UK, US and

Germany to identify disease burden, life impact, and priorities

in terms of symptoms and treatment effect and goals. Both

telephone interviews and focus groups will last up to 60

minutes.

4

2) DCE development

• The attributes and levels and the draft DCE survey will be

developed using information obtained from the qualitative

phase.

3) DCE testing and piloting

• Testing: Up to 18 cognitive interviews, 6 per market specific

DCE survey, will be conducted with patients with COPD to

explore the saliency of the choice of attributes and assess

whether the attributes are understandable, meaningful and

comprehensive. A final DCE will be developed.

• Piloting: The DCE will be piloted with up to 60 patients with

COPD, 20 per market specific DCE survey, to refine the

underlying design and ensure that information is collected in

an efficient way to enable the statistical analysis to be as

precise as possible.

4) Conduct of the DCE

• Up to 450 patients with COPD, 150 per market, will complete

the DCE online to allow assessment of the relative importance

of treatment attributes and priorities.

Documents pertaining to the stages 2 and 3 will be developed and

submitted as appendices to the protocol and processes as protocol

amendments as the project progresses. These include the draft and

final DCE surveys and Informed Consent Forms (ICFs) for the DCE

pilot/testing. Some of these would be developed and refined based

on results of stage 1.

Study Population and Sampling Methods

Patients with COPD (up to N=573) from the UK, US and Germany will

be recruited by Global Perspectives, a specialist recruitment agency,

through the recruiter’s proprietary patient database, consumer

recruiter networks, medical recruiter networks, support groups and

nurses, as well as patient key opinion leaders (networkers) and Social

5

media (if required). Participants will be screened according to

following inclusion/exclusion criteria:

• Inclusion criteria:

o Diagnosis of COPD, self-reported

o ≥40 years of age

o Moderate to severe COPD with a COPD Assessment

Test (CAT) score of ≥10 or a Modified Medical

Research Council (MMRC) Dyspnea Scale score of ≥2 at

enrollment

o Currently prescribed and receiving one of the following

treatment types:

ICS/LABA

LABA/LAMA

ICS/LABA/LAMA (Triple therapy)

LAMA

o Currently resident in either the UK, US or Germany

o Adequate written and oral fluency in language of

country of residence

o Willing and able to understand the objective of the

study and provide informed consent

o Has access to the internet (Cognitive interviews and

DCE survey only)

• Exclusion criteria

o Has taken part in any other stage of this study.

o Subjects with a current diagnosis of asthma (including

ACOS).

o Any co-morbidity that would inhibit the ability to

provide informed consent or allow participation in a

telephone of face-to-face interview.

Data Source Qualitative interview and focus group audio recordings and

6

transcripts and interviewer notes, as well as electronically captured

CAT/MMRC, demographic, and DCE survey data.

Data Analysis Methods • Qualitative concept elicitation data

Qualitative concept elicitation interview and focus group recordings

will be transcribed verbatim. Transcripts will be analysed using a

qualitative software tool, MaxQDA. Thematic analysis (in accordance

with Braun and Clarke, 2006) will be used as it provides a rigorous

and transparent qualitative analysis approach. A codebook will be

created based on the interview guide and themes emerging from the

data. The analysis will explore the themes identified in the codebook.

• DCE development

Analysis is not required for the development of the DCE.

• Cognitive interview data

Interviewer notes will be treated as the primary source of cognitive

interview data. These notes will be entered into an analysis grid. The

analysis grid will be reviewed for any revisions or amendments that

may be required to the DCE to improve attribute saliency and

participant comprehension. Cognitive interviews will be audio

recorded for backup and reference purposes.

• Quantitative data

Demographic data will be summarised using descriptive statistics

(e.g., mean, standard deviation, frequencies). CAT responses will be

scored according to the user guide (GSK, 2012), with scores indicating

disease severity. Demographic and CAT data will be used to describe

and, for the DCE, stratify the sample.

To guide the DCE analysis, a SAP will be developed with input from

GSK. Analysis of choice data will be based on the random utility

framework, with the specific model (e.g., conditional logit, random

effects probit, mixed logit,) chosen as appropriate both for the

design features of the DCE and the desired depth of analysis. The aim

7

of the DCE analysis will be to explore the impact of each attribute

(independent variable) on the participants’ choices (dependent

variable) about their therapy. The coefficients obtained from the logit

model will provide an estimate of the relative strength of treatment

attributes in influencing treatment choice.

Sample Size and Power Sample sizes and power for each study stage are:

1) Qualitative concept elicitation (N=45)

• N=10 telephone interviews in each of the UK, US and

Germany with patients with COPD

• N=1 focus group with up to 5 patients with COPD in

each of the UK, US and Germany

• Qualitative concept elicitation sample sizes are

determined according to data saturation, i.e., when no

new themes or concepts emerge during interviews.

Data saturation will be assessed using a saturation grid

and can typically be reached in as few as 15 interviews,

therefore a total qualitative sample of 45 patients is

expected to be more than adequate to reach data

saturation for all three markets. If saturation is not

reached, the option to increase the sample number

will be discussed and arranged subject a study change

order.

2) DCE development

• No participants are required for this phase.

3) DCE testing and piloting (N=78)

• Testing: N=6 telephone cognitive interviews with

patients with COPD in each of the UK, US and

Germany. This sample size is expected to provide

adequate data on the saliency and comprehension of

the DCE attributes.

8

• Piloting: N=20 patients with COPD in each of the UK,

US and Germany will complete the DCE. This sample

size is expected to be large enough to estimate model

priors and develop a d-efficient design for the final

DCE.

4) Conduct of the DCE (N=450)

• N=150 patients with COPD in each of the UK, US and

Germany

• The sample size was determined with reference to the

ISPOR Task Force publication (Johnson et al.,. 2013)

which demonstrated that precision of parameter

estimates increases rapidly at sample sizes less than

150 and then flattens out at around 300 observations.

With a sample size of N=450, separate analysis in each

of the three countries (N=150 each) could be

conducted and various more data-demanding models

(e.g. mixed logit model) could be estimated.

Limitations i. Participants will be asked to self-report their COPD diagnosis

and a clinician diagnosis will not be included. A detailed

screening script (including the CAT and MMRC scale) has been

developed to control for any misrepresentation.

ii. Use of consumer and medical recruitment networks could

create selection bias as these patients may have previously

volunteered or expressed interest in participating in research,

which could create selection bias. The use of other

recruitment channels, such as support groups, nurses, patient

key opinion leaders and social media, may also be used to

minimize any selection bias.

iii. Patients with severe COPD may not be able or willing to travel

to take part in a focus group, which could limit the range and

9

type of patients in focus groups. Severity and demographics

will be monitored at screening, with the aim of achieving a

broad patient sample in line with the inclusion criteria.

iv. The DCE will be hosted online only, which could be limiting for

older patients with COPD or those who not have access to the

internet. This is unlikely to impact recruitment because

multiple recruitment methods will be used. However, if

recruitment is slow or patients do not have access to

complete the DCE online, the possibility for subjects to

complete the DCE via paper will be discussed and integrated

in to the study.

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TABLE OF CONTENTS

Table of Contents 1. INTRODUCTION/BACKGROUND .......................................................................................................... 14

2. OBJECTIVES ......................................................................................................................................... 15

2.1. Primary ............................................................................................................................................ 15

2.2. Secondary ........................................................................................................................................ 16

3. RESEARCH METHODOLOGY ................................................................................................................ 16

3.1. Study Design.................................................................................................................................... 16

3.2. Study Population ............................................................................................................................. 17

3.2.1. Eligibility Criteria ............................................................................................................................. 17

3.2.1.1. Inclusion Criteria ..................................................................................................................... 18

3.2.1.2. Exclusion Criteria ..................................................................................................................... 18

3.2.2. Sampling .......................................................................................................................................... 18

3.3. Data Source / Data Collection ......................................................................................................... 19

3.3.1. Endpoints ........................................................................................................................................ 20

3.4. Sample Size / Power Calculations ................................................................................................... 20

3.5. Hypotheses ..................................................................................................................................... 22

4. DATA ANALYSIS CONSIDERATIONS ................................................................................................. 22

5. LIMITATIONS ................................................................................................................................... 24

6. STUDY CONDUCT, MANAGEMENT & ETHICS .................................................................................. 24

6.1. Ethics Committee/IRB Approval ..................................................................................................... 24

6.2. Informed Consent ........................................................................................................................... 25

6.3. Data Protection ............................................................................................................................... 25

6.4. Personally Identifiable Information (PII) ......................................................................................... 25

6.5. Adverse Event (AE), Pregnancy Exposure, and Incident Reporting ................................................ 26

7. EXTERNAL INVOLVEMENT ............................................................................................................... 26

7.1. Third Party Supplier ........................................................................................................................ 26

7.2. External Expert/Health Care Professionals (Consultants & Research PIs) ...................................... 27

8. REFERENCES .................................................................................................................................... 28

Appendix A Screening Questions ................................................................................................................ 30

Appendix B Qualitative Interview Informed Consent Form ........................................................................ 33

Appendix C Sociodemographic Form .......................................................................................................... 41

Appendix D Focus Group Informed Consent Form ..................................................................................... 46

Appendix E Adverse Event Reporting Form ................................................................................................ 54

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Appendix F Qualitative Interview Guide ..................................................................................................... 56

Appendix G Focus Group Discussion Guide ................................................................................................ 64

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ABBREVIATIONS AE Adverse Event ACOS Asthma-COPD overlap syndrome CAT COPD Assessment Test COPD Chronic Obstructive Pulmonary Disease DCE Discrete Choice Experiment GOLD Global initiative in chronic Obstructive Lung Disease GSK GlaxoSmithKline ICF Informed Consent Form ICS Inhaled Corticosteroids IRB Institutional Review Board LABA Long-Acting Beta-Adrenoceptor Agonist LAMA Long-Acting Anti-muscarinic Agent MMRC Modified Medical Research Council NHS National Health Service OR Odds Ratio PII Personally Identifiable Information SABA Short-Acting Beta-Agonist SAP Statistical analysis plan WHO World Health Organisation WTP Willingness to Pay

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1. INTRODUCTION/BACKGROUND

Chronic obstructive pulmonary disease (COPD) is a leading source of morbidity and mortality

globally. The 2010 update of the Global Burden of disease cited the number of people

worldwide currently known to suffer from COPD as 328 million, with a slight predominance of

men (168 million men vs. 160 million women) (WHO 2015). Currently, COPD is cited by the

WHO as the third commonest cause of death globally (WHO 2015). Additionally, COPD is

associated with an impairment of disease-specific health status (Wilke 2015), with this

impairment likely to deteriorate over time.

Currently, three main classes of inhaled treatment for COPD exist: Beta2-adrenergic agonists

(which may be short (SABA) or long (LABA) acting), long-acting muscarinic acetylcholine

receptor antagonists (LAMA), and inhaled corticosteroids (ICS) (Calverley 2015). The present

GOLD (Global initiative in chronic Obstructive Lung Disease) recommendations for drug therapy

in COPD suggest a combination of these agents depending on the severity of COPD (GOLD

2015). For patients at higher risk of exacerbation, treatment with all three classes of

medication (i.e., LABA, LAMA, and ICS) is recommended. However, currently this approach is

limited by the unavailability of an inhaler device capable of combining all three medication

classes, and patients are forced to use at least two inhalers in triple therapy (e.g., Relvar &

Incruse). The aim of this study is to explore the potential utility of a device containing all three

groups of compound (LABA, LAMA, and ICS), called single inhaler triple combination or Trelegy

Ellipta.

It is hypothesized that single inhaler triple therapy will result in patient benefits over the

existing available triple therapies. This includes greater efficacy, convenience, and ease of use

from managing a single inhaler device versus dual devices with differing administration

techniques or frequency of dosing. Overall this may lead to greater productivity and the ability

to conduct various activities that may otherwise not have been possible. However, other

attributes and associated benefits may arise during the course of this research that are

unknown or difficult to predict at this stage, such as lower anxiety levels, reluctance to switch

14

due to familiarity with current therapy or the opinion that they would receive reduced

medication levels with one inhaler as opposed to two.

An important step in determining the viability of such a device is to understand the needs and

want of patients with COPD. To this end, there is a need qualitatively to explore and

understand why patients with COPD may benefit from a single inhaled device combining three

medication classes, and to quantify the relative importance of the benefits that single triple

therapy may offer, thus allowing differentiation from other treatment options.

In order to understand the needs and want of patients with COPD qualitative interviews and

focus groups will be conducted to explore patient burden in COPD, focusing on symptoms, life

impact and treatment preferences. Additionally, these interviews and focus groups will inform

the construct of a Discrete Choice Experiment (DCE). A DCE is a quantitative method that allows

analysts to elicit the relative strength of patient preference for the attributes of a treatment or

product. The method also allows us to understand the relative importance of attributes with

respect to each other, and how this impacts on how patients determine their choices (Bridges

et al., 2011; Johnson et al., 2013). The importance of attributes can be expressed as an Odds

Ratio (OR); willingness to pay (WTP) can be estimated when a price attribute is included.

Attribute levels can be bundled together as a profile and compared against other profiles again

in terms of OR and WTP.

2. OBJECTIVES

The main aim of this project is to translate relevant attributes of Trelegy Ellipta therapy into

patient experienced benefits, to quantify the relative importance of these benefits for COPD

patients. The objectives of the study are thus:

2.1. Primary

• To elicit the preferences, priorities and treatment goals of patients with COPD

for inhaled treatments.

• Related to the above, to determine the key relevant attributes of COPD

treatment;

15

2.2. Secondary

• To estimate the relative importance of each attribute;

• To estimate the relative appeal of different treatment approaches based on an

assumed combination of specific attribute levels, expressed as a probability of

choosing one treatment over another.

3. RESEARCH METHODOLOGY

3.1. Study Design

This study will elicit the preferences of patients with COPD for inhaled treatments using a DCE

methodology in the UK, US and Germany. According to recommended best practice, a separate

DCE will be developed for each market to account for market specific differences in, for

example, cost attributes to inform willingness to pay (WTP).

This is a mixed methods study with a qualitative phase and a quantitative DCE phase. The

qualitative phase will inform the development of the online DCE surveys, which will be used for

the quantitative phase. The study will be conducted in three stages: 1) Qualitative concept

elicitation, 2) DCE development, 3) DCE piloting and testing, 4) Conduct of the DCE.

In the first stage, qualitative concept elicitation telephone interviews (N=10 per country) and in-

person focus groups (N=1 each with 5 patients per country) will be conducted with patients

with COPD to explore treatment effectiveness, symptoms, quality of life, and features of

treatment that are important to them. Data from the patient interviews and focus groups, and

feedback from GSK, experts and relevant literature, will inform the development of the

attributes that will be used in the DCE surveys. Data from the patient interviews and focus

groups, and feedback from GSK, experts and relevant literature, will inform the development of

the attributes that will be used in the DCE surveys. Specifically, the data will allow us to select

the key attributes considered to be most important to patients with COPD when making

treatment choices. The evidence is also used to assign the most appropriate number and range

of levels for each attribute. In conjunction to this, the properties of the DCE design will be

decided (e.g. labelled or unlabelled, alternative choices etc.) and the choice sets constructed

using the Ngene software. Ngene is now widely used in the academic community by economists

16

in transport, health and environment specifically for the capacity it provides to develop optimal

and statistically efficient designs for choice experiments. It possesses an extensive range of

features and outputs and will therefore allow the DCE to be designed with any number of

choice situations, alternatives, attributes and attribute levels (Choicemetrics, 2011). The Ngene

software will determine when and how often particular attribute level values should be shown

to the respondents in the DCE, as well as how the attribute levels are matched up to create the

hypothetical treatment profiles. Ngene will also be used to confirm the total number of choice

sets each participant will be presented in the survey (the total number of choice sets shown to

each participant in the DCE is dependent on the number of attributes and attribute levels to be

included, but it is likely to be around 16-18 choice sets per participant). In the second stage,

draft versions of the DCE surveys will first be tested with participants in cognitive interviews. Up

to six patients with COPD in each of the UK, US and Germany will be asked to complete and

provide feedback on the surveys. This will allow exploration of the saliency of the attribute

choices and assess whether the attributes are understandable, meaningful and comprehensive.

The surveys will be modified according to the participant feedback obtained. Next, the modified

DCEs will be piloted with up to 20 patients with COPD in each country to refine the underlying

design and ensure that information is collected in an efficient way to enable the statistical

analysis to be as precise as possible. If changes are not required after pilot testing, the DCE pilot

data will be included in the final analysis.

In the third stage, 150 patients with COPD (or 130, if no changes to the survey are made

following piloting) in each of the UK, US and Germany will complete the online-only market

specific DCE surveys.

3.2. Study Population

3.2.1. Eligibility Criteria

The eligibility criteria are designed to ensure a representative sample of patients with COPD

who may be receiving any combination of dual or triple therapy treatment. The COPD

Assessment Test (CAT) and Modified Medical Research Council (MMRC) scale will be

administered as part of screening to measure and monitor disease severity of the sample and

17

will be completed by all recruited patients taking part in the qualitative interviews, focus

groups, DCE pilot phase and full DCE survey.

3.2.1.1. Inclusion Criteria

All patients must meet the following inclusion criteria in order to be eligible to participate in the

study:

• Diagnosis of COPD, self-reported

• ≥40 years of age

• Moderate to severe COPD, indicated by a CAT score of ≥10 or MMRC score of ≥2

• Currently prescribed and receiving one of the following treatment types:

o ICS/LABA

o LABA/LAMA

o ICS/LABA/LAMA (Triple therapy)

o LAMA

• Currently resident in the UK, US or Germany.

• Adequate written and oral fluency in language of country of residence

• Willing and able to understand the study and provide informed consent

• Has access to the internet (Cognitive interviews and DCE survey only)

3.2.1.2. Exclusion Criteria

Patients meeting the following exclusion criteria will not be eligible for this study:

• Has taken part in any other stage of this study

• Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are

eligible if they have a current diagnosis of COPD).

• Any co-morbidity that would inhibit the ability to provide informed consent or allow

participation in a telephone of face-to-face interview.

3.2.2. Sampling

The study will utilise convenience sampling. Patients with COPD (N=573) from the UK, US and

Germany will be recruited by Global Perspectives, a specialist recruitment agency, through 18

using the following channels in each market: in Germany: recruiter's own patient database,

patient Key Opinion Leaders (KOLs; networkers), social media (if required); the UK: consumer

recruiter network, medical recruiter network, support groups and nurses; and in the USA: the

recruiters proprietary patient database.

3.3. Data Source / Data Collection

• Qualitative concept elicitation

Potential participants diagnosed with COPD for the telephone interviews will be screened by

the recruiter to ensure eligibility (Appendix A). Eligible participants will be asked to review the

informed consent form (ICF), and provide consent electronically online, or written, for

participating in the individual interviews (Appendix B). Demographic data (Appendix C) will be

collected by the interviewer over the telephone before the interview begins.

Patients participating in focus groups will have been screened by the recruiter to ensure

eligibility and will be asked to review the ICF and provide written consent (Appendix D), and

complete the demographic form (Appendix C) in person prior to the start of the discussion. The

ICF asks for the participants consent to follow up on adverse events (AEs) related to any

medicine manufactured by the study sponsor that may be identified during the

interviews/discussions, as well as the reporting of these to the study sponsor (Appendix E).

Telephone interviews and focus groups will last for up to 60 minutes and be conducted by

experienced, trained interviewers from ICON (UK/US) or Global Perspectives (Germany). Focus

groups will be conducted in-person at a suitable facility. The interviews will be conducted

according to the approved individual interview guide (see Appendix F) and focus group guide

(Appendix G), with the flexibility of allowing the interviewer to adapt the questioning for each

individual participant.

The interviews and focus groups will be audio-recorded and transcribed verbatim, participants

will be informed before recording begins. Following the completion of each interview/focus

group, participants will be reimbursed for their time.

• DCE development

The attributes and levels and the draft DCE survey will be developed using information

obtained from the qualitative phase.

19

• Testing of DCE surveys

Cognitive interviews will be conducted to evaluate general readability of the market specific

DCE surveys and item comprehension. Potential participants will be emailed study information

and a URL to study screening questions (Appendix A) to ensure eligibility. If eligible, Participants

will be asked to review the ICF (to be submitted as an amendment to the protocol as the study

progresses) and provide consent electronically; and subsequently requested to complete the

survey and demographic form online immediately before participating in the cognitive

interviews. The interviews will last for up to 60 minutes and be conducted over the telephone

by experienced, trained interviewers from ICON (UK/US) or Global Perspectives (Germany). The

interviews will be conducted according to the approved cognitive interview guide (to be

submitted as an amendment to the protocol as the study progresses) and participants will

review the survey at the time of the interview. The interviews will be audio recorded for backup

and reference purposes with interviewer notes acting as the primary source of data.

Interviewer notes will be analysed using an interview grid to evaluate the information gathered

and determine whether revisions to the survey are required before piloting. Following the

completion of each interview, participants will be reimbursed for their time.

• Piloting and conduct of the DCE

Potential participants will be emailed study information and a URL to study screening questions

(Appendix A) to ensure eligibility. If eligible, participants will be presented with the online ICF

(to be developed and included as an amendment to the protocol as the study progresses) and

asked to check box to indicate consent prior to starting the survey. The data collected in the

online survey will include demographic data and the main DCE. Following the completion of the

online survey, participants will be reimbursed (£50 UK/$50 US/€50 Germany).

3.3.1. Endpoints

This is not applicable as a DCE survey has no endpoints per classical definitions; the resultant

data from a DCE produces treatment stated choices.

3.4. Sample Size / Power Calculations

Sample sizes and power for each study stage are:

20

1) Qualitative concept elicitation (N=45)

• N=10 telephone interviews in each of the UK, US and Germany with patients

with COPD

• N=1 focus group with up to 5 patients with COPD in each of the UK, US and

Germany

• Qualitative concept elicitation sample sizes are determined according to data

saturation, i.e., when no new themes or concepts emerge during interviews.

Data saturation will be assessed using a saturation grid and can typically be

reached in as few as 15 interviews, therefore a total qualitative sample of 45

patients is expected to be more than adequate to reach data saturation across

the three markets. If saturation is not reached, the option to increase the sample

number will be discussed and arranged subject a study change order.

2) DCE development

• No participants are required for this phase.

3) DCE testing and piloting (N=78)

• Testing: N=6 telephone cognitive interviews with patients with COPD in each of

the UK, US and Germany. This sample size is expected to provide adequate data

on the saliency and comprehension of the DCE attributes. If participants

experience considerable difficulty in completing the draft DCE and multiple

changes are required, additional rounds of cognitive interviews will be discussed

and incorporated according to a change order of the project.

• Piloting: N=20 patients with COPD in each of the UK, US and Germany will

complete the DCE. This sample size is expected to be enough to derive estimate

model priors and develop a d-efficient design for the final DCE.

4) Conduct of the DCE (N=450)

• N=150 COPD patients in each of the UK, US and Germany

• The sample size was determined with reference to the ISPOR Task Force

publication (Johnson et al., 2013) which demonstrated that precision of

parameter estimates increases rapidly at sample sizes less than 150 and then

flattens out at around 300 observations. With a sample size of N=150, separate

21

analysis in the three countries could be conducted and various more data-

demanding models (e.g. mixed logit model) could be estimated with results also

compared across countries.

3.5. Hypotheses

It is hypothesized that Trelegy Ellipta will result in patient benefits and be preferred over the

existing available triple therapies.

4. DATA ANALYSIS CONSIDERATIONS

• Qualitative concept elicitation data

Qualitative concept elicitation interview and focus group recordings will transcribed verbatim.

The analysis will begin with a careful review of the interview transcripts by members of the

project team. This initial review of the transcripts will ensure comprehensiveness and accuracy

of the transcripts, correct any missing or incorrect information, remove participant names and

identifying information and begin to identify themes. Transcripts will be analysed using a

qualitative software tool, MAXQDA. Thematic analysis (in accordance with Braun and Clarke,

2006) will be used as it provides a rigorous and transparent qualitative analysis approach, which

is well suited to qualitative patient reported outcomes research (Kerr et al., 2011). Data

saturation is expected to be reached after approximately 15 interviews and will be assessed

using a documented codebook approach and saturation tables (Kerr et al., 2010) providing

important documentary evidence of the rigor of the qualitative methods. A codebook will be

created based on the interview guide and themes emerging from the open-ended data. The

analysis will explore the themes identified in the codebook.

• Cognitive interview data

Interviewer notes will be treated as the primary source of cognitive interview data. These notes

will be entered into an analysis grid. The analysis grid will be reviewed for any revisions or

amendments that may be required to DCE to improve attribute saliency and participant

comprehension. Cognitive interviews will be audio recorded for backup and reference

purposes.

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• Quantitative data

Demographic data will be summarised using descriptive statistics (e.g., mean, standard

deviation, frequencies). CAT responses will be scored according to the user guide (GSK, 2012),

with scores used to describe and stratify the sample by disease severity.

A statistical analysis plan (SAP) will be developed with input from GSK to guide the DCE data

analysis. This will be based on the random utility model, with the specific model (e.g., mixed

logit, random effects binary probit, logit, conditional logit) chosen as appropriate for the design

of the DCE. The aim of the DCE analysis will be to explore the impact of each attribute

(independent variable) on the participants’ choices (dependent variable). The coefficients

obtained from a logit model will provide an estimate of the odds ratios (ORs) of preference for

treatment attributes.

In a nutshell, the data analysis of DCE data can identify a range of useful information on the

factors that influence the preferences for treatment:

i. the relative importance of different attributes: which attributes are important and how

important one attribute is in comparison with another attribute;

ii. how individuals trade between different attributes (how much of one attribute they are

willing to give up for improvements in another);

iii. how much an individual would be willing to pay for improvements in treatment attributes;

iv. the probability of individuals choosing a treatment with specified attributes.

v. The extent to which different individual characteristics (age, gender, severity of illness)

influence the strength of these preferences

Finally, the data may be used to test other subgroup hypotheses, with potential further

hypotheses developed with input based on feedback from the clinical experts. Interaction

analyses of specific patient characteristics with specific attributes will be used to test these

hypotheses. In addition, the identification of patient groups with specific preferences or values

may be explored with the use of latent class models, where patient preference depends on

their membership of the latent class as well as on perceived utility.

Additional exploratory analyses may also be conducted to describe and explore the health of

patients, according to scores on the CAT/MMRC scales, across the sample and relevant

subgroups.

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5. LIMITATIONS

Some limitations of the study, and plans to minimize their potential impact, are as follows:

i. As participants are recruited by an agency, they will be asked to self-report their

diagnosis and a clinician diagnosis will not be included. In order to control for any

misrepresentation, a detailed screening script has been developed.

ii. Some participants will be recruited through consumer and medical recruitment

networks. These patients may have previously volunteered, or expressed interest, in

participating in research, which could create selection bias. The use of other recruitment

channels, such as support groups, nurses, patient key opinion leaders and Social media,

may also be used to minimize any selection bias.

iii. Patients with severe COPD may not be able or willing to travel to take part in a focus

group. This could limit the range and type of patients in focus groups. Nevertheless,

severity and demographics will be monitored at screening, with the aim of achieving a

broad patient sample in line with the inclusion criteria.

a. If the project were to use other recruitment channels, e.g. clinical site

recruitment it would require appropriate ethics approval in each market,

including NHS approval in UK and would add significantly to the scope of this

project. Likewise, a limitation to this method would remain that severe COPD

patients would be under represented using this approach, as they would be

harder to reach and perhaps less interested in participating in the survey.

iv. The DCE will be hosted online only. This could be especially limiting for older patients

with COPD, or patient who not have access to the internet. However, this is unlikely to

impact recruitment due to the use of multiple recruitment methods used.

6. STUDY CONDUCT, MANAGEMENT & ETHICS

6.1. Ethics Committee/IRB Approval

As this research is defined as market research, ICON will not submit the study for local ethical

approval in each market. The study protocol and all study materials will be submitted for review

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by Salus Institutional Review Board (IRB) in Texas, USA. This review will suffice for approval in

all countries in the study.

6.2. Informed Consent

Informed consent will be obtained from all participants prior to study initiation. Written

information will be given to the participants explaining the details of the study (including the

purpose of the interview, the types of questions that will be asked and who will have access to

the data collected). Participants will be required to indicate they have read and understood the

terms of the study and wish to participate, before any data will be collected. Informed consent

will be collected online for all stages of the study, except the focus group where written

consent will be taken in person before the focus group is conducted. The option to complete

written consent will also be given to subjects taking part in the qualitative interviews who do

not have access to the internet. In addition to the electronic consent taken online, patients

taking part in interviews will be asked to also provide verbal consent at the start of the

interview, once recording has begun.

6.3. Data Protection

All data collected in this study will be strictly confidential in accordance with all appropriate

legislation. Access to the participant files will not be permitted to anyone other than the study

staff and auditors. Only the study staff involved in data collection will know the identity of the

participants. Study staff will be instructed to maintain complete confidentiality of all collected

data.

6.4. Personally Identifiable Information (PII)

Patient files will be kept on secure servers (or any physical copies in a locked file cabinet). The

study report will not contain any patient identifying information. Participants will be assigned a

unique participant number to ensure confidentiality and anonymity. Interview transcripts will

be identified by this unique participant number and any PII associated with the individual will

be removed.

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6.5. Adverse Event (AE), Pregnancy Exposure, and Incident Reporting

All members of the project research team at ICON PRO involved in data collection and all third

parties involvement in recruitment have completed adverse event (AE) training (“Adverse Event

Reporting for Health Outcomes research activities using interview and / or elicitation methods”)

required by the study Sponsor prior to commencing the study.

This study is a low interventional and has no direct clinical site involvement. As such the study

presents minimal risk. However, if during the recruitment or study participation an AE is

reported and suspected to be associated with the use of one of the study Sponsor’s products

this will be reported as per the GSK PV training by the interviewer/moderator to the study

Sponsor within one working day (but no later than three calendar days after date of receipt if

information is received, e.g. during a weekend or on public holidays). (Appendix E).

• Study-specific PVP monitoring process – ICON will comply with GSK standard procedures, as

described in the training provided.

• Safety-specific roles – Study responsible personnel: (GSK, SAP);

(GSK, GOA); (ICON, Project Manager); and (ICON, Project Director).

• Reporting process and timelines – As per GSK AE training. GSK has provided the standard AE

collection form (Appendix E), which ICON and all third party suppliers will use.

• Frequency of data review, Interim & final study reports – AEs collected at the time of interview

will be reported within 24 hours as per GSK training. A second review of AEs will be completed at the

time of transcript review and a summary included within the transcript report.

• Reconciliation process – Will be completed in line with per “Adverse Event Reporting for Health

Outcomes research activities using interview and / or elicitation methods” training.

7. EXTERNAL INVOLVEMENT

7.1. Third Party Supplier

ICON Clinical Research UK Ltd

Project director:

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Project manager:

100 Park Drive

Milton Park

Abingdon, Oxon

OX14 4RY

Global Perspectives Ltd

Director:

17 Bayliss Road

Wargrave

Berkshire

RG10 8DR

7.2. External Expert/Health Care Professionals (Consultants & Research PIs)

Herrn Prof. consulted through GSK compliance hub.

Prof. Dr. med.

We have also consulted with GSK employed clinical experts, and

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8. REFERENCES Braun V and Clark V (2006). Using thematic analysis in psychology. Qualitative Research in

Psychology, 3, 77-101

Bridges J, Hauber A, Marshall D, Lloyd A, Prosser L, Reiger D, Reed Johnson F, Mauskopf J

(2011) Conjoint Analysis Applications in Health—a Checklist: A Report of the ISPOR Good

Research Practices for Conjoint Analysis Task Force. Value Health 14(4):403-413

Calverley P, Vlies B. A rational approach to single, dual and triple therapy in COPD. Respirology

2015; Nov 26. doi: 10.1111/resp.12690. [Epub ahead of print.]

Choicemetrics (2011). Ngene 1.1. User manual and reference guide. The cutting edge in

experimental design.

Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis,

Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2015.

GSK (2012) COPD Assessment Test: Expert guidance on frequently asked questions (user guide).

Hauber AB, González JM, Groothuis-Oudshoorn CGM, Prior T, Marshall DA, Cunningham C,

IJzerman MJ, PhD2, Bridges JFP. Statistical Methods for the Analysis of Discrete Choice

Experiments: A Report of the ISPOR Conjoint Analysis Good Research Practices Task Force.

Value in Health Volume 19, Issue 4, June 2016, Pages 300–315

Johnson, F. R., Lancsar, E., Marshall, D., et al., (2013) Constructing experimental designs for

discrete-choice experiments: report of the ISPOR Conjoint Analysis Experimental Design Good

Research Practices Task Force. Value in Health. 16, 3-13.

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Kerr C, Nixon A, Acaster S, Flood E (2011). Fit for purpose, rigourous methodology for

qualitative research supporting patient reported outcome (PRO) selection and development:

The way forward. Poster Presentation (1049/376) ISOQOL 18th Annual Conference. October 26-

29.

Kerr C, Nixon A, Wild D (2010). Assessing and demonstrating data saturation in qualitative

inquiry supporting patient-reported outcomes research. Expert Rev. Pharmacoecononmics

Outcomes Res. 10 (3), 269-281.

Wilke S et al. One-year change in health status and subsequent outcomes in COPD. Thorax.

2015; 70(5): 420-5.

World Health Organisation. The top 10 causes of death. 2014.

http://www.who.int/mediacentre/factsheets/fs310/en - accessed 30th November 2015.Wilke

2015

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Appendix A Screening Questions Identifier: ___________________________________________

Date of screening (day/month/year): ________________________________

Screener: Please complete the following questions to determine patient eligibility for the study.

Introductory script:

I am calling you from [name of association] to you see if you may be interested in taking part in

a study by ICON Clinical Outcomes Assessments to explore how COPD affects the everyday lives

of patients with COPD. ICON is a research company interested in finding out how patients with

COPD perceive their condition and how it affects the kind of things they can and cannot do.

ICON also want to learn about particular likes and dislikes patients have of the treatment they

are currently taking. The study would involve patients with COPD being invited to [please

specify a or b as appropriate]:

a) Take part in a focus group, lasting up to 60 minutes, to discuss their experience of living

with COPD, the kind of treatment they receive and how it affects them.

b) Take part in a one to one telephone interview, lasting up to 60 minutes, to discuss their

experience of living with COPD, the kind of treatment they receive and how it affects them.

If you are eligible for the study and are interested in taking part I will send you some further

information about the study.

Today, I would like to ask you some questions to see if you are eligible to take part. Answering

the questions does not commit you to taking part.

Do you have a few minutes to answer some questions about this today? All of the info you

provide will be kept confidential and only shared with members of the study team.

[If ‘no’, ask if there is another time. If ‘yes’ proceed to the next question’]

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1. Are you currently living in the UK, US or Germany?

If yes, continue

If no, not eligible - discontinue

2. Are you aged 40 or over?

If yes, continue

If no, not eligible - discontinue

3. Have you been diagnosed with COPD?

If yes, continue

If no, not eligible - discontinue

4. Are you currently receiving treatment for COPD?

If yes, continue

If no, not eligible - discontinue

5. Please describe the treatment you are currently receiving.

…………………………………………………………………………………………………………………………………………

…………………………………………………………………………………………………………………………………………

……………………………………………………………………………………………………………………

6. [Question 6 only: Not to be read out, it is in the opinion of the investigator] Does the

patient have adequate oral fluency in English/German?

If yes, continue

If no, not eligible - discontinue

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7. If you are interested, this study will involve [please specify a or b as appropriate]:

a) A telephone interview in the next couple of weeks, this will take up to 60

minutes and you will be reimbursed (£45 UK/$75 US/€60 Germany) for your

time.

b) Attending a focus group discussion in [TBC] on [##/##/2017], this will take up to

60 minutes and you will be reimbursed (£75 UK/$100 US/€90 Germany) for your

time and travel.

8. Do you agree to us sending the information you have provided today and your contact

details to the study team at ICON? They will send you further information.

If yes, continue

If no, offer the following telephone number at ICON if they wish to discuss

further:

Contact Details:

Title (Mr/Ms/Mrs/Miss/Dr/etc.): _____________________________________

Name: ________________________________________________________

Primary telephone number: ________________________________________

Secondary telephone number:______________________________________

Address:_______________________________________________________

______________________________________________________________

______________________________________________________________

Email address:__________________________________________________

Any notes about availability/preferences for contact or interview time:

______________________________________________________________

______________________________________________________________

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Appendix B Qualitative Interview Informed Consent Form

AN AGREEMENT TO BE IN A RESEARCH STUDY

INFORMED CONSENT DOCUMENT – Qualitative Interview

Sponsor: GlaxoSmithKline (GSK)

City and State: London, UK

Protocol Number and Title: 0018-0780: Qualitative Interviews and Discrete Choice

Experiment(s) Evaluating the Perceived Benefits of the

Features of Single Inhaler Triple Ellipta Treatment (HO-16-

16285)

Principal Investigator: PhD

Project Manager: BSc

Study Research Associates: MSc

BSc

Address of Study Site(s):

UK

Contact Telephone Number:

(09:00 - 17:30 GMT Monday-Friday)

Principal Investigator email address:

You are invited to take part in an interview study. Before you decide to take part in this study,

you should read this document. This document, called an Informed Consent Document, explains

the study. Please ask as many questions as needed so that you can decide if you want to be in

the study. Participation is voluntary, and you are free to choose whether or not you would like to

participate.

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PURPOSE OF THE STUDY

You have been asked to take part in this study to understand how COPD and your treatment

affects your everyday life. ICON is a research company working for GSK, a pharmaceutical

company developing therapies for COPD, will be paying ICON,(a contract research organisation)

to conduct this study. We are conducting this research to find out how you perceive your COPD

and how it affects the kind of things that you can and cannot do. We also want to learn about

your experience of the COPD treatment you take at the moment, how you feel about it and

whether you have any needs or preferences that are not met by your current treatment.

WHAT WILL HAPPEN DURING THE STUDY

If you choose to participate in this study, a telephone interview will be scheduled with you at a

time that is convenient for you.

During the interview you will be asked to provide some basic information about yourself (e.g.,

age, gender and occupation) and asked questions about your COPD. The interview questions will

be about the impact of living with COPD, the kinds of symptoms you experience, how you

perceive your quality of life, your current treatment and your treatment preferences and

priorities.

All interviews will be audio recorded and you will be told in advance of when the audio recording

is started. Any information that is likely to identify you will be removed from the recording before

we analyse the data and we will not include any information that is likely to identify you when we

report the results of this study. If you do not want the interview to be recorded, you will

unfortunately not be able to take part in this research study.

Your interview will last for approximately 60 minutes and you will be given the opportunity to

take a break approximately halfway through.

You must be honest with the study staff in order to participate in this study.

SCOPE OF THE STUDY AND NUMBER OF PARTICIPANTS

Up to 30 participants, male and female, ages 40 and older with COPD are expected to be

interviewed over the telephone over the next few weeks across the UK, US and Germany. We will

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also hold a focus group discussion in each country with up to 5 participants (who will not be

interviewed on an individual basis) with COPD in each session. The information provided from all

participants will be combined together and used to develop a survey. The survey will be used in a

larger study to further explore your preferences about your inhaled COPD therapy . The study will

be completed by the end December 2017.

POSSIBLE RISKS AND DISCOMFORTS

As this study does not involve medication in any way, there are no risks of side effects. It is

possible that you may find it difficult, or feel emotional, when talking about COPD and how it

affects your life. However, you do not have to answer any questions that you do not want to

answer. You are also free to end the interview at any time without giving any reason. Please let

the interviewer know if you do not want to answer a question or want to stop the interview. If

you become tired or out of breath during the interview, please let the interviewer know and you

will be able to take a break.

NEW FINDINGS

You will be contacted if there is a change to the way the research will be performed that might

influence your willingness to continue study participation.

POSSIBLE BENEFITS OF THE STUDY

The information you provide will help us learn about the experiences of people with COPD. As

there is no treatment provided during the study there is no direct benefit to you, however, you

may value the opportunity to share your experiences with others.

PAYMENT FOR BEING IN THE STUDY

You will receive £45.00/$75.00/€60.00 by [cash, cheque or Amazon voucher – TBC per country],

which will be posted to you following the interview (this should be within 2 weeks of the

interview). If you leave the study once the interview has begun but before it has finished, you will

still be paid in full for your time.

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ADDITIONAL COSTS

There are no costs to you associated with participating in this study; a free dial in number will be

provided to you or the interviewer will call you directly on the number you provide.

IN CASE OF RESEARCH-RELATED INJURY

You must tell the study staff if you feel you have been injured as a result of participating in this

study. No form of compensation is offered for a research-related injury.

ALTERNATIVES TO PARTICIPATION

Because this study is for research only, you can choose not to take part in this research study.

RELEASE OF RESULTS AND PRIVACY

Records of you being in this study will be kept private. Contact details that you have provided

and signed consent forms will be kept securely and separate from the study data you provide

(linked by a study number only). If information from this study is published or presented at

scientific meetings, your name and other personal information will not be used. Information

relating to your personal details, such as name, address, and telephone number, will only be

seen by ICON staff or those helping with recruitment. The following people will have access to

the collated and anonymized interview data:

• ICON (Study coordinators)

• GSK (Study sponsor)

• Salus IRB

• Recruitment agency

• Other country or local regulatory agencies

You may, by written notice to the principal investigator, cancel your authorization to use or

disclose your personal information at any time.

If you withdraw your authorization, the information collected up to that time may still be used to

preserve the scientific integrity of the study. By signing this consent form, you authorize these

uses and disclosures of your personal information. If you do not authorize these uses and

disclosures, you will not be able to participate in the study.

36

During the study should any adverse events be reported in relation to the study Sponsors

products, ICON Clinical Outcomes Assessments are required to report this to the study Sponsor

using their official reporting documents.

LEGAL RIGHTS

You do not lose any legal rights by signing this consent document.

WHOM TO CONTACT

You may contact the principal investigator at the phone number or email address listed on the

first page of this consent document for:

• answers to questions, concerns, or complaints about this research study

• information about study procedures.

You may contact Salus if you:

• would like to speak with someone unrelated to the research,

• have questions, concerns, or complaints regarding the research study, or

• have questions about your rights and welfare as a research participant.

Salus IRB

2111 West Braker Lane, Suite 400

Austin, TX 78758

Or you may email:

Or you can call: between 8:00 AM and 5:00 PM Central Time

If you would like additional information, you may visit Salus’ website at www.salusirb.com.

Salus has approved this study and this informed consent document. Salus is a group of scientific

and non-scientific people who review, and approve or disapprove research involving people by

following the federal regulations. This group is also required by the federal regulations to do

periodic review of ongoing research studies. 37

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If you have any questions or concerns about your health please contact your personal doctor.

LEAVING THE STUDY

Taking part in this study is your choice. You may choose either to take part or not to take part in

the study. You have the right to leave this study at any time. If you do not want to be in the

study, there will be no penalty to you, and you will not lose any benefits to which you are

otherwise entitled.

If you wish to leave this study, please call or email the principal investigator using the phone

number or email address listed on the first page of this consent document.

If you withdraw from the study, no new data about you will be collected for study purposes.

The principal investigator will inform you whether they intend to either: (1) retain and analyse

any data relating to you that has already been collected up to the time of your withdrawal; or

(2) honour your request that the investigator destroy the your data or that the investigator

exclude your data from any analysis.

Your part in this study may be stopped at any time and for any reason without you being asked.

The following people can stop your participation and/or the study itself:

• ICON (Study coordinators)

• GSK (Study sponsor)

• Salus IRB

• Recruitment agency

• Other country or local regulatory agencies

If you do not follow the study procedures or there are any conditions or circumstances that may

jeopardize your welfare or the integrity of the study then you may be taken out of the study.

AGREEMENT TO BE IN THE STUDY

This consent document contains important information to help you decide if you want to be in

this study. If you have any questions that are not answered in this consent document, please ask

the person explaining this document or one of the study staff.

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By consenting to participate you agree that you have been given a copy of all pages [insert

number of pages] of this consent document.

You have had an opportunity to ask questions and received satisfactory answers to all your

questions about this study.

You understand that you are free to leave the study at any time without having to give a reason

and without affecting your medical care.

You understand that information relating to your personal details, such as name, address, and

telephone number, will only be seen by ICON staff or organisations helping with recruitment.

Salus IRB and GSK (study sponsor) will not have access to these details.

You understand that anonymized amalgamated survey or interview data will only be seen by

ICON, GSK or Salus IRB staff.

[VARIABLE TEXT:

For paper ICF:

You understand and agree to the following statement:

I understand that the agency is required to pass on to their client, who is a

manufacturer of medicines, details of any side effects related to their own

products that are mentioned during the course of this Health Outcomes research

activity. Although what is mentioned in the research study will, of course, be

treated in confidence, should a side effect that I, or someone I know, is raised the

agency will need to report this, so that they can learn more about the safety of

their medicines. I understand what I say will, of course, be treated in confidence.

IF YOU DO NOT AGREE WITH THE STATEMENT ABOVE, YOU SHOULD NOT SIGN THIS

INFORMED CONSENT DOCUMENT.

Printed Name of Adult Participant

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Signature of Adult Participant Date

Printed Name of Person Explaining Informed Consent Document

Signature of Person Explaining Informed Consent Document Date

Please sign and date. Return one copy of the signed and dated consent form in the stamped

addressed envelope provided.]

For online ICF: AGREEMENT TO BE IN THE STUDY Please check you agree with the points below:

This study has been explained to me in a language I understand

I understand that I have the right to withdraw at any time

I understand that if an adverse event is identified this will be sent by ICON Clinical Research to the study sponsor

Select ‘Yes’ below if you agree to participate in the study. By selecting this option you DO NOT waive any of your legal rights.

Yes, I agree to participate in the study No, I do not agree to participate in the study

Please click the ‘Click to Print This Page’ button to print or save a copy of this screen for your own records

END OF VARIABLE TEXT]

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Appendix C Sociodemographic Form Participant ID:_________________ Date of screening:_______________________

This form asks you to provide some background information about yourself. These questions

help us to describe the group of people who take part in the study. Please answer the following

questions:

1. What is your age? __________________ Years

2. What is your gender? Male

Female

Transgender Male

Transgender Female

Other

Prefer not to say

3. What is your racial/ethnic background?

[VARIABLE TEXT:

UK ONLY

White

British Any other white background (please provide details) _________________

Mixed/multiple ethnic groups

White and Black Caribbean White and Black African White and Asian Any other mixed/multiple ethnic background (please provide details)

_________________

Asian/Asian British

Indian Pakistani Bangladeshi Any other Asian background (please provide details) _________________

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African/Caribbean/Black British

African Caribbean Any other Black background (please provide details) _________________

Chinese or Chinese British

Chinese Any other Chinese background (please provide details) _________________

Other ethnic group

Middle Eastern Any other ethnic background (please provide details) _________________

US ONLY

3. What is your race? (Please check all that apply)

White or Caucasian Black or African American Asian American Indian or Alaska Native Native Hawaiian or Other Pacific Islander Other

4. Are you Hispanic or Latino? (A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.)

Yes No

GERMANY ONLY

White

German Any other white background (please provide details) _________________

Mixed/multiple ethnic groups

White and Black Caribbean White and Black African White and Asian

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Any other mixed/multiple ethnic background (please provide details) _________________

Asian/Asian British

Indian Pakistani Bangladeshi Any other Asian background (please provide details) _________________

African/Caribbean/Black British

African Caribbean Any other Black background (please provide details) _________________

Chinese or Chinese British

Chinese Any other Chinese background (please provide details) _________________

Other ethnic group

Middle Eastern Any other ethnic background (please provide details) _________________

END OF VARIABLE TEXT]

4. Which of the following best describes your main activity?

Employed full time Employed part time

Student Seeking work

Unemployed Retired

Self-employed Stay at home

Other ______________________

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5. What is your highest level of education?

No formal qualifications

Left school at age 16 with qualifications

Left school at age 18 with qualifications

Technical/ vocational qualifications from a college or job

Completed university

Other ___________________________

6. What is your current marital status?

Single

Partnership

Married

Divorced/ separated

Widowed

Other ______________________________

7. Are you a smoker?

Yes Former smoker No

8. Are you a pet-owner?

Yes Formerly owned a pet No

9. When were you diagnosed with COPD?

___________________________________

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10. What medications are you taking currently for COPD?

Medication Name Date began medication

(month & year)

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

Can you please state other prescribed medications you are taking and for what reason?

Medication Name Condition

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Appendix D Focus Group Informed Consent Form

AN AGREEMENT TO BE IN A RESEARCH STUDY

INFORMED CONSENT DOCUMENT – FOCUS GROUP

Sponsor: GlaxoSmithKline

City and State: London, UK

Protocol Number and Title: 0018-0780: Qualitative Interviews and Discrete Choice

Experiment(s) Evaluating the Perceived Benefits of the

Features of Single Inhaler Triple Ellipta Treatment (HO-16-

16285)

Principal Investigator: PhD

Project Manager: BSc

Study Research Associates: MSc

BSc

Address of Study Site(s):

UK

Contact Telephone Number:

(09:00 - 17:30 GMT Monday-Friday)

Principal Investigator email address:

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INTRODUCTION

You are being invited to take part in a focus group discussion. Before you decide to take part in

this study, you should read this document. This document, called an Informed Consent

Document, explains the study. Please ask as many questions as needed so that you can decide if

you want to be in the study. Participation is voluntary, and you are free to choose whether or not

you would like to participate.

PURPOSE OF THE STUDY

You have been asked to take part in this study to understand how COPD and your treatment

affects your everyday life. ICON is a research company working for GSK, a pharmaceutical

company developing therapies for COPD, will be paying ICON,(a contract research organisation)

to conduct this study. We are conducting this research to find out how you perceive your COPD

and how it affects the kind of things that you can and cannot do. We also want to learn about

your experience of the COPD treatment you take at the moment, how you feel about it and

whether you have any needs or preferences that are not met by your current treatment.

WHAT WILL HAPPEN DURING THE STUDY

If you choose to participate in this study a member of the ICON research team will invite you to

take part in a focus group discussion with up to 5 participants to share your experiences of COPD.

Before the discussion begins you will be asked to fill out a demographic form, which asks for

some basic information about yourself (e.g., age, gender and occupation), and a short survey to

assess the severity of your COPD. During the discussion the interviewer/moderator will ask

some questions about the impact of living with COPD, the kinds of symptoms you experience,

how you perceive your quality of life, your current treatment and your treatment preferences

and priorities. The questions are designed to help guide the discussion and you do not have to

share any information with the group that you do not want to share.

The discussion will be audio recorded and you will be told in advance of when the audio recording

starts. Any information that is likely to identify you will be removed from the recording before we

analyse the data and all information will be anonymised when we report the results of this study.

47

We may use some quotes in advertising or support material that will be made available to people

who have not directly worked on this study, however, the quote will be anonymous and we will

not include any information that would identify you in any way. Short video clips of the focus

group may be used and reviewed by people who work for study Sponsor but are not directly

involved in this study, however the video recording will not be made publicly available and will

not be seen by anyone other than those who are directly involved with this study or work for the

study Sponsor. Your contact details or any personal information will not be made available to

anyone other than the recruitment agency or people involved with recruitment that work for

study Coordinator. If you do not want the interview to be recorded, you will unfortunately not

be able to take part in this research study.

The focus group will last for approximately 60 minutes you will be given the opportunity to take a

break approximately halfway through.

You must be honest with the study staff in order to participate in this study.

SCOPE OF THE STUDY AND NUMBER OF PARTICIPANTS

We are holding up to three focus group discussions, one in each of the UK, US and Germany. Up

to 5 participants with COPD will participate in each focus group and they will be male and female,

ages 40 and older. We will also interview approximately 30 participants with COPD over the

telephone, up to 10 in each of the UK, US and Germany. The information provided from all

participants will be combined together and used to develop a survey. The survey will be used in a

larger study to further explore your preferences about your inhaled COPD therapy . The study will

be completed by the end of December 2017.

POSSIBLE RISKS AND DISCOMFORTS

As this study does not involve medication in any way, there are no risks of side effects. It is

possible that you may find it difficult, or feel emotional, when talking about COPD and how it

affects your life. However, you do not have to answer any questions that you do not want to

answer. You are also free to leave the discussion at any time without giving any reason. If you

become tired or out of breath during the discussion, you are free to leave to take a break.

48

NEW FINDINGS

You will be contacted if there is a change to the way the research will be performed that might

influence your willingness to continue study participation.

POSSIBLE BENEFITS OF THE STUDY

The information you provide will help us learn about the experiences of people with COPD. As

there is no treatment provided during the study there is no direct benefit to you, however, you

may value the opportunity to share your experiences with others.

PAYMENT FOR BEING IN THE STUDY

You will receive £75.00/$100.00/€90.00 in [cash, cheque, bank transfer or amazon vouchers –

TBC per country] which will be given to you at the end of the focus group. If you leave the group

once the discussion has begun but before it has finished you will still be paid in full for your time.

ADDITIONAL COSTS

There may be some travel costs associated with attending the focus group. The focus group will be

held in [TBC]. The payment you will receive at the end of the focus group is intended to cover

travel costs as well as your participation in the study. No additional payments will be made to

cover travel expenses.

IN CASE OF RESEARCH-RELATED INJURY

You must tell the study staff if you feel you have been injured as a result of participating in this

study. No form of compensation is offered for a research-related injury.

ALTERNATIVES TO PARTICIPATION

Because this study is for research only, you can choose not to take part in this research study.

RELEASE OF RESULTS AND PRIVACY

Records of you being in this study will be kept private. Contact details that you have provided

and signed consent forms will be kept securely and separate from the study data you provide

(linked by a study number only). If information from this study is published or presented at

49

scientific meetings, your name and other personal information will not be used. Information

relating to your personal details, such as name, address and telephone number, will only be

seen by ICON staff or those helping with recruitment. The following people will have access to

the collated and anonymized interview data :

• ICON (Study coordinators)

• GSK (Study sponsor)

• Salus IRB

• Recruitment agency

• Other country or local regulatory agencies

You may, by written notice to the principal investigator, cancel your authorization to use or

disclose your personal information at any time.

If you withdraw your authorization, the information collected up to that time may still be used to

preserve the scientific integrity of the study. By signing this consent form, you authorize these

uses and disclosures of your personal information. If you do not authorize these uses and

disclosures, you will not be able to participate in the study.

During the study should any adverse events be reported in relation to the study Sponsors

products, ICON Clinical Outcomes Assessments are required to report this to the study Sponsor

using their official reporting documents.

LEGAL RIGHTS

You do not lose any legal rights by signing this consent document.

WHOM TO CONTACT

You may contact the principal investigator at the phone number or email address listed on the

first page of this consent document for:

• answers to questions, concerns, or complaints about this research study

• information about study procedures.

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You may contact Salus if you:

• would like to speak with someone unrelated to the research,

• have questions, concerns, or complaints regarding the research study, or

• have questions about your rights and welfare as a research participant.

Salus IRB

2111 West Braker Lane, Suite 400

Austin, TX 78758

Or you may email:

Or you can call: between 8:00 AM and 5:00 PM Central Time

If you would like additional information, you may visit Salus’ website at www.salusirb.com.

Salus has approved this study and this informed consent document. Salus is a group of scientific

and non-scientific people who review, and approve or disapprove research involving people by

following the federal regulations. This group is also required by the federal regulations to do

periodic review of ongoing research studies.

If you have any questions or concerns about your health please contact your personal doctor.

LEAVING THE STUDY

Taking part in this study is your choice. You may choose either to take part or not to take part in

the study. You have the right to leave this study at any time. If you do not want to be in the

study, there will be no penalty to you, and you will not lose any benefits to which you are

otherwise entitled.

If you wish to leave this study, please call or email the principal investigator using the phone

number or email address listed on the first page of this consent document.

If you withdraw from the study, no new data about you will be collected for study purposes.

The principal investigator will inform you whether they intend to either: (1) retain and analyse

any data relating to you that has already been collected up to the time of your withdrawal; or

(2) honor your request that the investigator destroy the your data or that the investigator

exclude your data from any analysis.

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PPD

PPD

Your part in this study may be stopped at any time and for any reason without you being asked.

The following people can stop your participation and/or the study itself:

• ICON (Study coordinators)

• GSK (Study sponsor)

• Salus IRB

• Recruitment agency

• Other country or local regulatory agencies

If you do not follow the study procedures or there are any conditions or circumstances that may

jeopardize your welfare or the integrity of the study then you may be taken out of the study.

AGREEMENT TO BE IN THE STUDY

This consent document contains important information to help you decide if you want to be in

this study. If you have any questions that are not answered in this consent document, please ask

the person explaining this document or one of the study staff.

By consenting to participate you agree that you have been given a copy of all pages [insert

number of pages] of this consent document. You have had an opportunity to ask questions and

received satisfactory answers to all your questions about this study.

You understand that you are free to leave the study at any time without having to give a reason

and without affecting your medical care.

You understand that information relating to your personal details, such as name, address, and

telephone number, will only be seen by ICON staff or organisations helping with recruitment.

Salus IRB and GSK (study sponsor) will not have access to these details.

You understand that anonymized survey or interview data will only be seen by ICON, GSK or

Salus IRB staff.

52

You understand and agree to the following statement:

I understand that the agency is required to pass on to their client, who is a

manufacturer of medicines, details of any side effects related to their own products

that are mentioned during the course of this Health Outcomes research activity.

Although what is mentioned in the research study will, of course, be treated in

confidence, should a side effect that I, or someone I know, is raised the agency will

need to report this, so that they can learn more about the safety of their medicines.

I understand what I say will, of course, be treated in confidence.

IF YOU DO NOT AGREE WITH THE STATEMENT ABOVE, YOU SHOULD NOT SIGN THIS

INFORMED CONSENT DOCUMENT.

Printed Name of Adult Participant

Signature of Adult Participant Date

Printed Name of Person Explaining Informed Consent Document

Signature of Person Explaining Informed Consent Document Date

You will be given a signed and dated copy of this informed consent document to keep.

53

Appendix E Adverse Event Reporting Form

Agency/Project details

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 Reporting Form for Health Outcomes Research Activities

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:

For POM & OTC products CMG GCSP Reports from Americas: or Reports outside of Americas: or

For Vaccine products CMG VCSP Reports from USA & Canada: or Reports outside USA & Canada: or

54

PPD PPDPPD PPDPPD PPD

PPD PPD

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:

55

Appendix F Qualitative Interview Guide

Instructions to the participant

• Thank you for your interest in this study and agreeing to take part in the interview today.

• My name is ______. I am a researcher from ICON, a health research company.

• The purpose of this study is to understand how COPD affects your everyday life. We are

interested in the kinds of compromises and changes you have to make to your lifestyle

because of your COPD and your treatment for it. We are also interested in finding out

how you perceive COPD and how it affects the kind of things that you can and cannot do.

We also want to learn about your experiences of the COPD treatment you take at the

moment, how you feel about it and whether you have any needs, preferences or goals

that are not met by your current treatment.

• We will be conducting approximately 30 interviews with participants diagnosed with

COPD. The results of these interviews will be used to develop a survey investigating

treatment preferences of people diagnosed with COPD.

• All the information you provide today will be used for the purpose of this research project

only. We may publish the results of these interviews but all the information you provide

will be anonymous. This means that we will not mention you by name or include any

information that is likely to identify you, such as the town you live in, names of hospitals

or clinicians or the work that you do.

• There are no right or wrong answers and you do not have to answer any questions you

don’t want to. We are interested in your thoughts and opinions.

• I am not a medical expert; my role here is to ask questions and fully understand your

answers.

• This interview will last up to 1 hour. If needed I will give you the opportunity to take a

break approximately halfway through but please let me know if you need a break at any

other point.

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• As mentioned on the consent form, I will be audio-recording this interview for reference

purposes. Please try to speak clearly so that we can hear all of your comments and don’t

miss any important information. I will let you know as soon as I switch the recorders on.

• Before we begin, do you have any questions about the study or about the consent form?

[Interviewer: Allow time for response]

• When I start the recording, I will need to give a couple of study reference numbers.

• I will now start the recorders.

[Begin recording]

• This is study number 0018-0780.

• This is interview number _____.

• Today’s date is _____.

• To confirm, do I have your permission to record the interview?

Symptoms

1. When were you formally diagnosed with COPD?

2. How is your condition at the moment?

3. What are the main symptoms that you experience with COPD? [Probe into any of the

symptoms below which have not already been mentioned by participant.]

• Shortness of breath

• Coughing

• Coughing up mucus (can change colour/thickness during exacerbation)

• Wheezing

• Chest tightness, pain or pressure

• Trouble sleeping

• Frequent chest infections

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4. Which symptom concerns you the most?

a) Why?

5. Which symptoms do you experience the most frequently?

6. Which symptoms are the least frequent?

HRQL

7. How does COPD affect your everyday life? [Probe into any impacts below which have not

already been mentioned by participant.]

• Physical activities – ability to exercise, climbing stairs, walkable distance

• Social life - ability to visit family and socialise with friends, join social clubs

• Hobbies – ability to do all desired activities

• Sleep – effect of COPD on sleep, ability sleep through the night

• Psychological – depression, fear of exacerbations

8. What are the reasons why you cannot do [insert activity]? [Probe: physical restrictions of

COPD or psychological (e.g. fear of exacerbation, worried or embarrassed about taking

medication)]

9. How have these impacts changed over time since you were diagnosed?

a) When did you first notice [insert activity] was becoming more difficult to do?

b) How did the change start?

c) How does this make you feel?

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Current Treatment

We are now going to talk about the treatments that you currently take for your COPD. These

can either be long-term treatments which are taken primarily to prevent a recurrence of your

symptoms, or short-term rescue/relief treatments which you take when your symptoms may

have become particularly bad, this often referred to as a flare or an exacerbation of symptoms.

First I would like to find out about your long-term/preventer medication.

10. How do you feel about using your current long-term/preventer medication?

a) How do you feel about the way it controls your COPD symptoms?

b) What do you like about your current medication?

c) What do you dislike about your current medication?

d) Have you ever been on a different type of treatment than your current one?

[Probe for oral tablet, inhaler, other]

i. How does it compare? [Probe: dosage frequency, symptom free period, side

effects, taste, ease-of-use]

11. Do you feel that you current medication works well to manage your COPD symptoms?

a) Do you ever worry about your medication not working?

i. Why?

12. How often has your doctor told you that you should take the treatment? [If the participant

takes more than one treatment, ask for all].

13. At times, some people miss taking their medication as often as their doctors has told them

to take it, for a range of different reasons. Have you ever missed taking your preventer

medication?

a) [If Yes:] How often do you miss taking your medication? What are the reasons

you have missed taking your medication?

b) Does taking your medication affect your daily routine? [Probe for: Differences

59

between weekdays and weekends, during holidays].

c) Are there any times that you are more or less likely to miss a dose?

14. Are there any features of your medication that affect how you take your medication?

[Probe for taste, side effects].

15. How often do you or your doctor discuss your treatment and how it is going for you?

a) How do you feel about how often you have these discussions?

b) Considering your current situation, how willing to switch to a new therapy would

you be?

i. What would influence your willingness to switch?

16. Next I want to discuss your reliever/rescue medication. Do you ever need to use a

reliever/rescue medication?

a) How often do you need it? [Probe: frequency, e.g. daily, weekly, monthly, every 3

months]

b) Can you describe the kinds of situations when you typically need rescue

medication?

c) How well does the rescue medication work to manage your symptoms?

d) How quickly does your treatment take effect, i.e. you have relief of symptoms?

17. Overall, do you have any other concerns about your medication(s)? [Probe for potential

side effects, becoming tolerant, how often they need to take the medication, picking up

infections].

[If not already done so, ask participant if they would like to take a break. Pause recorders if

necessary – inform participant if/when recorders have been stopped and restarted]

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Treatment Preferences

Now I would like to ask you about how important different aspects of COPD treatment are to

you if you had a range of treatments to choose between.

18. How important is it that your inhaler is easy to use?

a) Is your current inhaler(s) easy to use?

b) How long does it take to use each time you take your treatment?

i. How do you feel about this?

19. How important is treatment effectiveness to you?

a) What does ‘effective treatment’ mean to you?

b) How long do you have relief from your symptoms (i.e. no shortness of breath or

difficulty in breathing) when you use your current treatment? [Probe: hours,

days.]

c) Do you always have relief from your symptoms for the same periods of time?

i. If not, please describe.

d) Are there times during the day/week that your COPD symptoms seem better

controlled [Probe: mornings vs evenings, weekdays vs weekends]

20. How important is how often that you are supposed to take your maintenance/preventer

medication?

a) Would you prefer to take medication more or less often? Why?

b) Are there specific times of the day when you prefer to take your medication?

c) How do you feel about taking your medication in public or in front of

friends/family?

21. How important is the number of inhalers that you have to use?

a) How many inhalers do you currently need to use as part of your COPD

treatment?

b) What would be your ideal number of inhalers?

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22. How important is the speed with which you can feel the medication working?

a) How quickly can you feel your treatment take effect, i.e. you have relief of

symptoms? [Probe: Specific length of time, e.g. 15-mins, 30-mins, 1-hour]

b) How is this different for reliever and preventer medication?

23. How important is it that COPD does not disturb or wake you during the night?

a) Is your sleep impacted by your COPD? If so, how?

b) Do you ever wake up in the night needing your medication? If yes, please

describe.

i. Does your medication give you relief?

24. How important are side effects to you?

a) Do you experience any side effects due to treatment? [Probe: dry mouth,

hoarseness, sore throat/tongue, thrush, nausea, headache, skin effects,

pneumonia, tremor, other]

i. If yes, please describe [Probe: frequency, severity].

b) How do these side effects impact your daily life? [Ask for each side effect].

c) Are you anxious of side effects potentially occurring?

25. How important are exacerbations of your COPD to you?

a) Do you ever experience flares/severe attacks/exacerbations due to COPD? An

exacerbation is when your symptoms may have become particularly bad, this

often referred to as a flare or an exacerbation of symptoms.

b) Which symptoms do you experience?

c) How long do you experience them for?

d) How often do you experience an exacerbation?

e) What is the outcome of a typical attack? [Probe: calling for a doctor, need to go

to hospital, other.]

f) Has an exacerbation or hospitalisation ever led to a change in treatment?

62

g) How does an exacerbation impact you? [Probe: emotional impact, activities they

are unable to do].

h) Are you anxious of exacerbations potentially occurring?

26. How important is cost of medication/prescription to you?

a) How do you currently pay for your medication? [Probe on insurance, co-

payments]

b) Does this impact on how often you take your medication?

c) [If patient does not pay:] Would you be willing to pay for your medication? If so,

for what reasons? [Probe for ease of use, symptom control, frequency, speed of

relief, sleep, side effects etc]

d) [If patient does pay:] Would you be willing to pay more for you r medication? If

so, for what reasons? [Probe for ease of use, symptom control, frequency, speed

of relief, sleep, side effects etc]

27. So far we have discussed how easy it is to use your inhaler, treatment effectiveness, how

often you take your medication, speed of feeling relief, sleep disturbance, side effects,

exacerbations of your COPD and cost. Out of those, which three aspects do you consider

to be the most important in terms of your COPD treatment?

28. In addition to those we have discussed [list aspects again if necessary], do you think there

are any aspects that may be important and we haven’t considered? [Probe: why are they

important].

29. That’s all of my questions. Is there something else you would like to talk about in relation

to your COPD treatment and lifestyle or do you have any other questions or concluding

remarks?

Thank you for taking the time to participate in this study. Everything you have said, along with

the background questionnaire which you have already completed, will help us to understand

how COPD and its treatment is affecting you and will be very useful. I am now going to stop the

recorder. [Turn off recorder]

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Appendix G Focus Group Discussion Guide

Instructions to group

• Thank you for your interest in this study and agreeing to take part in the focus group

today.

• My name is ______. I am a researcher from ICON, a health research company.

• My colleague ______ is here to help as well.

• The purpose of this study is to understand how COPD affects your everyday life. We are

interested in the kinds of compromises and changes you have to make to your lifestyle

because of your COPD. We are also interested in finding out how you perceive COPD and

how it affects the kind of things that you can and cannot do. We also want to learn about

your experiences of the COPD treatment you take at the moment, how you feel about it

and whether you have any needs, preferences or goals that are not met by your current

treatment.

• We will also be conducting a focus group in two other countries [Germany/UK/USA –

delete as appropriate]. The results of the focus groups will be used to develop a survey

investigating the inhaler treatment preferences of people diagnosed with COPD.

• All the information you provide today will be used for the purpose of this research project

only. We may publish the results of these interviews but all the information you provide

will be anonymous. This means that we will not mention you by name or include any

information that is likely to identify you, such as the town you live in, names of hospitals

or clinicians or the work that you do.

• There are no right or wrong answers and you do not have to answer any questions you

don’t want to. We are interested in your thoughts and opinions.

• I am not a medical expert; my role here is to ask questions and fully understand your

answers.

• This discussion will last approximately 1 hour.

64

• As mentioned on the consent form, I will be audio-recording this discussion for reference

purposes. I will let you know as soon as I switch the recorders on.

• Please note there are a few group rules that will help this run smoothly:

o Please respect that everybody’s views and experiences are of value.

o Feel free to respond to each other’s comments, this is a group discussion.

However please speak one at a time, this will make it easier to follow the

recording afterwards.

o You do not have to answer a question if you feel that it is too personal or

sensitive.

o Don’t be offended if I need to move the discussion on at times, this is to make

sure we can finish on time.

o Please turn off or silence your phones, unless you are expecting an urgent call.

o Help yourselves to the refreshments provided, and feel free to leave the focus

group to use the restroom.

• Before we begin, do you have any questions about the study, focus group or consent

form? [Interviewer: Allow time for response]

• When I start the recording, I will need to give a couple of study reference numbers.

• I will now start the recorders.

[Begin recording]

• This is study number 0018-0780.

• This is focus group number _____.

• Today’s date is _____.

Instructions

1. First I would like to start by going around the group; please could you tell me your first

name and complete this sentence “My COPD is…” using one or a few words. [Proceed with

introductions]

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Symptoms

2. Can you describe the main symptoms that you experience with COPD.

Symptoms to probe for:

• Shortness of breath

• Coughing

• Coughing up mucus (can change colour/thickness during exacerbation)

• Wheezing

• Chest tightness, pain or pressure

• Trouble sleeping

• Frequent chest infections

3. Which of these symptoms are the most severe to you or affects your life the most?

HRQL

4. How does COPD or the treatments you have to take for it affect your everyday life? [Probe

into any impacts below which have not already been mentioned. Also probe for reasons they

can/cannot do things; due to physical restrictions of COPD or mental (e.g. worried or

embarrassed about having taking medication, their moods/emotions)]

• Physical activities – ability to exercise, climbing stairs, walkable distance

• Social life - ability to visit family and socalise with friends, join social clubs

• Hobbies – ability to do all desired activities

• Sleep – effect of COPD on sleep, ability sleep through the night

• Psychological – depression, fear of exacerbations

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5. What is the worst aspect of having COPD? [Can include anything including the symptoms,

HRQOL impacts, tasks or activities they find difficult or are unable to do or aspects of

treatment they do not like about their treatment].

Current Treatment

We are now going to talk about the treatments that you currently take for your COPD. These

can either be long-term treatments which are taken primarily to prevent a recurrence of your

symptoms, or short-term rescue/relief treatments which you take when your symptoms may

have become particularly bad, this often referred to as a flare or an exacerbation of symptoms.

6. How do you feel about using your current treatment? When answering please let us know

which kind of treatment you use (for example oral vs. inhaler, more than one treatment).

a. What are the main factors that you like about your current treatment?

b. What are the main factors that you dislike about your current treatment?

c. What would be the main thing(s) you would like to change about your current

treatment?

d. How often do you have to use additional medication to control your symptoms during

a flare up/exacerbation?

a. How does this affect you?

e. Considering your current situation, how willing to switch to a new therapy would you

be?

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Treatment Preferences

Now, thinking about your current medication, I would like to discuss how important different

aspects of COPD treatment are to you. [Use the following list to allow discussion and probe for

why they are important/not important].

• Inhaler ease of use

• Treatment effectiveness [Probe: What does treatment effectiveness mean to you?]

• Frequency that you are supposed to take your medication

• The number of inhalers you have to use as part of your COPD treatment

• How quickly you can feel your medication working

• Being disturbed or woken up during the night due to your COPD

• Treatment side effects

• How often you experience exacerbations

• Cost of medication/prescription

7. Do you think there are any aspects that may be important about COPD and the treatment of

COPD that we haven’t considered here today?

8. To close the focus group we will go around the group again. I would like you to imagine an

ideal treatment which would have all the best aspects in it for you and tell the group one or

two of those best aspects. This can be anything that we have discussed, or any other

aspects that come to mind.

Thank you for taking the time to participate in this study. Everything you have said, along with

the background questionnaires which you have already completed, will help us to understand

how COPD and its treatment is affecting you and will be very useful. I am now going to stop the

recorders. [Turn off recorders]. 68