Development of a questionnaire to assess experience and preference of intranasal corticosteroids in patients with allergic rhinitis

Abstract

Background: Allergic rhinitis affects 10%–20% of the US population. Its chronic nature, combined with patients' perceptions of safety/efficacy, administration, and sensory attributes of nasal sprays (corticosteroids), impact patient adherence to therapy. The purpose of this study was to develop a measure of experience with and preference for corticosteroid therapy for treatment of allergic rhinitis. Methods: Questionnaire development was conducted through qualitative research includ-ing concept elicitation and content testing in 153 patients with allergic rhinitis. Patient focus groups (n = 66), in conjunction with content confirmation and saturation in additional groups (n = 87), provided research data. A literature-based conceptual framework was incorporated into the interview guide. An iterative process of data collection, analysis, and theory development yielded the conceptual framework. Results: Consistent comments from the focus groups combined with those from cognitive debriefing interviews led to the incorporation of 14 finalized attributes into the Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q) items. Between the first and second cognitive debriefing interviews, researchers revised the EARNS-Q for retesting. Face and content validity tests indicated that the items, responses, and instructions were understood by study participants. The EARNS-Q is comprised of two modules that measure patient experi-ence with nasal sprays (experience module), and patient preference for a nasal spray relative to another (preference module). Conclusion: The EARNS-Q accurately measured patient experience with and preference for nasal sprays used in treating allergic rhinitis. A potential application of this questionnaire may be as a patient-reported outcomes endpoint in clinical trials of intranasal corticosteroids in patients with allergic rhinitis.

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Development of a questionnaire to assess
experience and preference of intranasal
corticosteroids in patients with allergic rhinitis
http://dx.doi.org/10.2147/PROM.S19195
Bruce Crawford1
Richard h stanford2
Audrey Y Wong1
Anand A Dalal2
Martha s Bayliss1
1Mapi Values, Boston, MA, UsA;
2glaxosmithKline, Research Triangle
Park, nC, UsA
Correspondence: Bruce Crawford
Mapi Values, Arco Tower 12F, 1-8-1
shimomeguro, Meguro, Tokyo
153-0064, Japan
Tel +81 03 5436 2070
Fax +81 03 5436 2071
email bruce.crawford@mapivalues.com
Background: Allergic rhinitis affects 10%–20% of the US population. Its chronic nature,
combined with patients’ perceptions of safety/efficacy, administration, and sensory attributes
of nasal sprays (corticosteroids), impact patient adherence to therapy. The purpose of this
study was to develop a measure of experience with and preference for corticosteroid therapy
for treatment of allergic rhinitis.
Methods: Questionnaire development was conducted through qualitative research includ-
ing concept elicitation and content testing in 153 patients with allergic rhinitis. Patient focus
groups (n = 66), in conjunction with content confirmation and saturation in additional groups
(n = 87), provided research data. A literature-based conceptual framework was incorporated into
the interview guide. An iterative process of data collection, analysis, and theory development
yielded the conceptual framework.
Results: Consistent comments from the focus groups combined with those from cognitive
debriefing interviews led to the incorporation of 14 finalized attributes into the Experience
with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q) items. Between the first and
second cognitive debriefing interviews, researchers revised the EARNS-Q for retesting. Face
and content validity tests indicated that the items, responses, and instructions were understood
by study participants. The EARNS-Q is comprised of two modules that measure patient experi-
ence with nasal sprays (experience module), and patient preference for a nasal spray relative
to another (preference module).
Conclusion: The EARNS-Q accurately measured patient experience with and preference for
nasal sprays used in treating allergic rhinitis. A potential application of this questionnaire may
be as a patient-reported outcomes endpoint in clinical trials of intranasal corticosteroids in
patients with allergic rhinitis.
Keywords: EARNS-Q, allergic rhinitis, intranasal corticosteroid, patient preference, experience,
questionnaire development
Introduction
Allergic rhinitis is a highly prevalent and chronic condition that affects an estimated
10%–20% of the US population.1–4 According to the National Center for Healthcare
Statistics, up to 40 million people have allergic rhinitis and generate an estimated
$2.7 billion in both direct and indirect costs.1,5,6 Allergic rhinitis is also associated
with daily life burden, including 52.5 symptomatic workdays and 3.6 workdays
missed each year, and 2.3 hours of unproductive work for every symptomatic day.
The resulting annual economic burden on employers is calculated to be an average
of $593 per patient.7
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Crawford et al
Regular prophylactic use of intranasal corticosteroids is
recommended for long-term management of the symptoms of
allergic rhinitis.8–11 Despite the guidelines, the practical issues
around patients’ treatment compliance may significantly
impact the success of therapy; patients’ acceptance and/or
satisfaction with their treatment may also play important
roles in compliance. Recent studies have shown that patient
perceptions of intranasal corticosteroids are influenced by the
efficacy and safety of an agent, ease and comfort of adminis-
tration, and by sensory attributes.12,13 Because of the chronic,
long-term nature of allergic rhinitis, adherence to therapy is
difficult and may result in inadequate disease control. Accord-
ing to the Allergies in America survey, most patients (61%)
stopped their prescribed intranasal medication because of its
attributes rather than allergic rhinitis itself. Patients reported
lack of efficacy (37%), diminished effectiveness over time
(35%), lack of 24-hour relief (32%), and side effects (25%)
from the medication as reasons why they discontinued treat-
ment.14 Mahadevia et al reported that patients’ willingness to
adhere to physician advice would significantly improve with
more favorable sensory attributes.15
Therefore, it is important to have sound measurement
of the concepts of experience and preference for allergic
rhinitis therapy to track patients’ acceptance of therapies and
to optimize treatment outcomes. Thus, a project to develop
(and validate) measures of experience with and preference for
allergic rhinitis therapies was undertaken. The results of the
qualitative research that comprised the development phase of a
promising instrument, ie, the Experience with Allergic Rhinitis
Nasal Spray Questionnaire (EARNS-Q), are presented here.
Methods
Preference
Preference can be defined as the action that a patient would
choose in a particular medical situation at a particular time,
given a set of alternatives.16–18 Hypothetically, a patient’s experi-
ences with attributes of different products is evaluated (“A” in
Figure 1), and they make a determination about a preference
for one product over the other (with respect to those attributes,
“B” in Figure 1). In addition, the patient’s preference for one
product over the other can be evaluated using a single “global
preference” item, which hypothetically reflects his or her
consideration of all attributes, experience, and preferences in
a single expression of product preference. These hypothesized
relationships are illustrated in Figure 1. A thorough review of
the preference literature in allergic rhinitis demonstrates that
the most appropriate method is direct assessment of preferences
among medications by using questionnaires.19
Development and validation
of the eARns-Q
In order to evaluate whether the EARNS-Q is a valid measure to
assess experience and preference of intranasal corticosteroids in
allergic rhinitis patients, a qualitative and quantitative research
methodology was implemented for its development and psy-
chometric validation. This development approach followed
guidelines described in the US Food and Drug Administration
(FDA) patient-reported outcomes guidance document.20 The
development and validation program included three major
phases, ie, qualitative research to determine concepts of
importance to patients, development of a draft instrument,
and patients’ comprehension of the items (methodologies 1, 2,
and 3), quantitative evaluation of the validity of each module
of the EARNS-Q, and qualitative research to guarantee repre-
sentation of allergic rhinitis patients from low socioeconomic
circumstances. The development phase of the EARNS-Q
is summarized in Figure 2. Phases 2 and 3 are reported in a
separate paper.
Patient samples and analytic procedures
Methodology 1: Focus groups for concept elicitation
and item generation
The goal of this phase was to elicit patients’ experiences with
nasal sprays for the treatment of allergic rhinitis. This process,
described as concept elicitation, was performed in a US focus
group consisting of 10 allergy sufferers who previously used
or were currently using nasal sprays to alleviate allergy, and
recruited through a newspaper advertisement. Patients with a
wide representation of demographic characteristics (eg, age,
gender, and social status) were invited to participate in the
study. Inclusion criteria included patients aged 18–65 years
and a confirmed diagnosis of allergic rhinitis (perennial,
vasomotor, or seasonal). Exclusion criteria included a
diagnosis of a life-threatening condition.
The focus group utilized a structured discussion guide.
Patients were invited to share recollections of their condi-
tion and treatment history, followed by discussions aimed
at eliciting nasal spray attributes.
Focus group interview data were tape-recorded and tran-
scribed, and coding schemes were developed and iteratively
refined to translate descriptions of patient characteristics
into thematic trends for data analysis using grounded theory
methods.21
Guided by the verbatim patient comments in the focus
group, a set of items was developed that reflected the allergic
rhinitis-related patient concerns, while ensuring item clarity
and interpretability. Thus, all major areas of concern that

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Development of questionnaire in allergic rhinitis
had been voiced by patients were represented in the initial
instrument. The questionnaire was subsequently reviewed by
a researcher and expert in psychometric analysis (who was not
involved in the initial development) to search for potentially
problematic item content. The questionnaire was divided
into two modules, ie, an experience module and a preference
module which investigated patient preference of medication,
because conceptually, preference is linked to the patients’
experience with medication and ratings of its attributes.
The experience module was designed to capture patients’
evaluation of specific characteristics of nasal sprays, and
was intended for use after patients’ respective treatment
administration. It consisted of two questions that examine the
attributes, ie, to rate their experience on each attribute and to
capture their importance. The rationale for this approach was
to investigate developing an importance-weighted rating of
each attribute, such that attributes deemed more important
would receive greater weight.
The preference module addressed the comparison of two
products, and established the study participant preference for a
product based on individual product attribute (and offered the
choice of a neutral category in the event of no clear preference).
It was specifically developed for use at the end of a crossover
study in which participants receive each study treatment in a
random order during the trial, and features a global preference
item, which is supported by individual preference domains.
Methodology 2: Cognitive debriefing interviews
Cognitive debriefing aims to verify the comprehensiveness
and patient understanding of a questionnaire, as well as its
clinical applicability and acceptability. A series of individual
interviews (n = 5) with allergic rhinitis sufferers, who had
been prescribed a nasal spray, was conducted after the
first draft of the experience module was developed. These
interviews examined whether the draft questionnaire was
appropriate to measure the target population (who were treat-
ment candidates). The identical inclusion/exclusion criteria
from methodology 1 were applied to the target population.
The interviews lasted about 2 hours and comprised a
two-step process. The first step followed an open-ended,
exploratory format that allowed patients to express spontane-
ously what attributes should be included in the questionnaire
(spontaneous elicitation). Patients were then asked to
comment systematically on the content and relevance of the
questionnaire (cognitive debriefing).
Transcription, coding, and analysis by grounded theory
methods proceeded as in methodology 1, with the addition
of a saturation grid to document the adequacy of the sample
size to yield consistent and stable results.
Responses from the cognitive debriefing section of the
interviews were reviewed and patterns and inconsistencies
in patient perceptions were identified. Items that patients
found difficult to understand and/or interpret were rephrased.
Overall preference
Preference domain 1Preference domain X
Preference 1Preference 2Preference 14Preference 13
Greater experience
1
Greater experience
2
Greater experience
13
Greater experience
14
Experience
(t1)
Experience
(t2)
Experience
(t1)
Experience
(t2)
Experience
(t1)
Experience
(t2)
Experience
(t1)
Experience
(t2)
. . . . . . . . . . .
. . . . . . .
A
B
Figure 1 Operationalization of preference elicitation.

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Crawford et al
Ten additional interviews were conducted, following the
same methodology, to ensure that the modifications were
well understood.
Methodology 3: Focus groups testing
the concept of “experience”
The content of the EARNS-Q experience and preference
modules was explored in four focus groups (n = 41) of aller-
gic rhinitis patients, with a focus on the meaning of the term
“experience”. Data captured patients’ evaluation of specific
characteristics of nasal sprays, and was intended for use after
patients’ respective administration of the products. The same
recruitment criteria and methods as in methodology 1 were
utilized for this phase of the development.
Results
Results from methodology 1: Concept
elicitation
The mean age of study participants was 43 (range 30–50)
years. Most patients were female (70%), and a majority
(70%) of participants had achieved a college or a graduate
degree. The remaining patients had a diploma or attended
some high school. Patients who participated in the focus
groups were diagnosed with allergies for an average of nine
(range 0–28) years prior to the focus groups.
Results from the analysis of qualitative data from the ini-
tial focus group revealed key attributes that were consistently
reported by study participants (Table 1).
Certain attributes identified by patients were beyond the
scope of the concept of interest. The excluded attributes
were weight of the product, ease of use in the elderly, price
or financial issues, and size of the bottle/frequency of refill.
Note that the impact of price/financial issues as an attribute
could not be determined in an industry-sponsored trial where
the sponsor covers the cost of therapy. The first draft of the
questionnaire included an experience module (illustrated in
Figure 3) and a preference module.
A four-point Likert scale was selected for the experience
module because it was easily understood, offered response
choices that discriminate between respondents’ perceptions,
Initial Item
development
#1. Item-elicitation
#2. Cognitive
debriefing interviews
(1st and 2nd draft of the
EARNS-Q Modules)
Content
testing
#3. 4 Focus
groups for
testing the
concept of
“experience”
Psychometric
validation
#4.
Experience
module
#5.
Preference
module
Theoretical
model
confirmation
#6. 6 Focus
groups with
adequate
representation
of racial/ethnic
groups
#7. 2 Low
SES/
education
focus groups
for content
testing
n = 10
n = 41
n = 121
n = 89
n = 55
n = 15
n = 15
Number of
patients
ActivityMethodology
#8. 2 Low
SES/education
focus groups
for cognitive
debriefing
n = 17
Dates for each
phase
March 2004
May 2004
November
2004
October
2006
June 2005–
January 2007
January
2007
January
2007
Figure 2 Allergic Rhinitis nasal spray Questionnaire: qualitative and quantitative research phases.
Abbreviations: eARns-Q, experience with Allergic Rhinitis nasal spray Questionnaire; ses, socioeconomic status.

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Development of questionnaire in allergic rhinitis
Table 1 experience with Allergic Rhinitis nasal spray
Questionnaire attributes
Attributes consistently mentioned
in patient focus groups
Final EARNS-Q attributes
Ability to deliver the same doseAbility to deliver the same
dose
Comfort of the nose tip
ease of operation
Ability to deliver the right
dose
Ability to assess how much
medication is left in the bottle
Leakage (nose or throat)
Efficacy
smell
Onset of action
Aftertaste
symptom relief
Burning
Mist
ease of transport
size/comfort of the nose tip
ease of operation
Ability to deliver the right dose
Bottle transparency
Absorption by the nose (leakage)
Efficacy (how well it worked)
smell
Onset of action
Aftertaste
symptom relief
Abbreviation: eARns-Q, experience with Allergic Rhinitis nasal spray
Questionnaire.
and was readily interpretable. A “neutral” category was
not required, and an even number of options was offered.22
Responses to the preference model were collected on five-
point Likert scales.
Results from methodology 2: Cognitive
debriefing interviews
The mean age of the interviewed patients was 38 (range
20–72) years. Seventy-three percent of the study population
was female. Sixty percent of the population worked either
full-time or part-time, and 27% were full-time or part-time
students. Participants had been diagnosed with allergies for
an average of 15 years prior to the focus group, ranging from
8 months to 60 years.
All patients found the attributes in the questionnaire rel-
evant, and the most important characteristics were that the
nasal spray worked (ie, it treated their allergies), and that it
was convenient (ie, easy to carry, easy to use). Participants
thought the questionnaire was of a proper length, comprehen-
sive, informative, and consistent (data not shown).
Because study participants did not have comparative
products (on hand) during debriefing, researchers instructed
them to imagine their current nasal spray for their allergies
as “product A” and others as “product B”. However, some
patients had difficulty because they were unable to imagine
a comparison of two products without actual sprays being
present. Nevertheless, all patients found the instructions
clear and had no difficulty understanding them. They did not
suggest rewording them, and the study participants indicated
overall that the answer choices were clear, detailed, and
appropriate for the questions (data not shown).
Between the first and second cognitive debriefing inter-
views, researchers revised the EARNS-Q for retesting, as
an iterative, qualitative-research process. The rationale
(summarized in Table 2) was determined by comparing com-
ments from the initial focus group with those from the first
round of cognitive debriefing. The relevance/importance of
three items from the initial focus group (eg, convenience of
the bottle [transport], direction of the spray [straight line or
mist], and intensity of the spray) were supported and added
to the questionnaire.
The second set of interviews consisted of a thorough
review of the revised questionnaire in 10 patients. When asked
for their overall opinion of the questionnaire, three patients
indicated it was thorough and consistent, while six believed
it was too long. Study participants believed that the question-
naire was easy to understand (n = 8), easy to answer (n = 9),
and comprehensive (n = 10). Although a majority of the ques-
tions were easily understood and relevant, some items were
perceived as having awkward wording or seemed irrelevant.
Consistent comments discerned from the initial focus group
combined with that from cognitive debriefing interviews led
to 14 finalized attributes in the EARNS-Q (Table 1).
Results from methodology 3: Testing
the concept of “experience”
Subjects judged “experience with nasal sprays” to be the
most suitable term that summarized their opinions about nasal
sprays; they noted that the term was broad and not leading.
Experience included efficacy, side effects, form of administra-
tion, onset and duration of action, convenience, ease of use,
and comfort. Patients also indicated a connection between
experience and preference. Moreover, because the preliminary
content of the instrument encompassed only the wording/
elements mentioned in these focus groups (described in detail
above), the responses from the focus groups corroborated the
ability of the EARNS-Q to capture relevant attributes of nasal
sprays for patients with allergic rhinitis.
The participants’ spontaneous responses to questions
regarding their likes/dislikes with nasal sprays confirmed the
findings of the initial focus group, as well as the first set of
item elicitation/cognitive debriefing interviews. Saturation
was achieved (data not shown), such that the subjects’
responses to the interviews remained consistent across all
items, and items were similar to those reported in other
preference studies.17