development of experience with allergic rhinitis nasal spray questionnaire (earns-q): a...
TRANSCRIPT
J ALLERGY CLIN IMMUNOL
FEBRUARY 2008
S108 Abstracts
SU
ND
AY
415 Reliability of the Food Allergy Quality of Life Questionnaires(FAQLQs) for Children, Teenagers and Adults
B. M. J. Flokstra-de Blok1, J. L. van der Velde1, A. DunnGalvin2, J. N. G.
Oude Elberink3, B. J. Vlieg-Boerstra1, E. J. Duiverman1, J. P. Schouten4,
J. O. Hourihane2, A. E. J. Dubois1; 1Department of Pediatrics, University
Medical Center Groningen, University of Groningen, Groningen, THE
NETHERLANDS, 2Department of Paediatrics and Child Health, Univer-
sity College, Cork, IRELAND, 3Department of Internal Medicine, Univer-
sity Medical Center Groningen, University of Groningen, Groningen,
THE NETHERLANDS, 4Department of Epidemiology, University Medi-
cal Center Groningen, University of Groningen, Groningen, THE
NETHERLANDS.
RATIONALE: The Food Allergy Quality of Life Questionnaire Child
Form (FAQLQ-CF), Teenager Form (FAQLQ-TF) and Adult Form
(FAQLQ-AF) were recently developed within EuroPrevall, a multi-centred
study of food allergy in Europe. The primary aim of this study was to
evaluate the test-retest reliability of the FAQLQ-CF, -TF and -AF. In
addition, test-retest reliability of the Food Allergy Independent Measure
(FAIM), a questionnaire used to assess construct validity, was assessed.
METHODS: One-hundred-and-one patients (31 children, 34 teenagers
and 36 adults) were included and completed the self-administered FAQLQ
and FAIM twice with a 10-14 day interval. The intraclass correlation
coefficient (ICC), Lin’s Concordance correlation coefficient (CCC) and
Bland-Altman plots were used to assess test-retest reliability.
RESULTS: Test-retest reliability was excellent for the FAQLQs with ICCs
and CCCs above 0.907, 0.975 and 0.951 for the FAQLQ-CF, -TF and -AF,
respectively. Bland Altman plots showed that the mean differences (MD)
of measurement 1 and 2 were close to zero; 0.05, -0.05 and 0.15 for
FAQLQ-CF, -TF and -AF, respectively. Test-retest reliability was good for
the FAIM-CF, -TF and -AF with ICCs and CCCs above 0.869, 0.853 and
0.754, respectively. Bland Altman plots showed that the MDs were close to
zero; -0.08, 0.05 and -0.07 for FAIM-CF, -TF and -AF, respectively.
CONCLUSIONS: The FAQLQs and the FAIM may be considered
reliable. The FAQLQs are not only excellent tools for group comparison
studies, but also for monitoring individual patients over time.
Funding: This work was funded by the EU through the EuroPrevall project
(FOOD-CT-2005-514000).
416 Development of Experience with Allergic Rhinitis NasalSpray Questionnaire (EARNS-Q): A Questionnaire tomeasure Experience and Preference with Nasal Sprays
R. Stanford1, A. A. Dalal1, B. Crawford2, M. S. Bayliss2, J. Lim1, E. Phil-
pot1; 1GlaxoSmithKline, RTP, NC, 2Mapi Values, Boston, MA.
RATIONALE: Sensory attributes of an intranasal spray (INS) may affect
willingness to adhere to such therapies in patients with allergic rhinitis
(AR), with greater compliance linked to favorable experiences with and
preference for that INS. A patient-based assessment was developed to
assess overall experience and preference with INSs.
METHODS: EARNS-Q development consisted of three phases: concept
elicitation and content testing; psychometric validation; and conceptual
framework (CF) confirmation. A literature-based CF informed the mod-
erator guide for focus groups (FGs) among 66 AR patients. Content
confirmation and saturation was documented in FGs involving an addi-
tional 87 patients. The hypothesis was that patients’ experience with
different attributes of two products is evaluated and determination made on
preference for one over the other based on those attributes. Iterative data
collection, analysis, and theory development continued until the concep-
tual framework was well-developed and saturation/information-redun-
dancy was reached.
RESULTS: 153 patients identified 14 items most related to overall
experience to nasal sprays. Items contained attributes related to sensory
perceptions, device characteristics, efficacy, and delivery/spray character-
istics. Recall period was tied back to the medications respondents were
currently taking. Two likert-type response continua were applied to each
attribute - one assessing patient experience on attribute; second assessing
product preference on that attribute.
CONCLUSIONS: The hypothesized process of a patient drawing a
conclusion of preference for one product over another, on the basis of
experience with both, is reflected in EARNS-Q. The EARNS-Q has
potential to inform clinicians and pharmaceutical product developers about
the likely adoption of and adherence to INS therapy.
Funding: GlaxoSmithKline
417 Sleep Impairment in Adult and Children With Allergic RhinitisM. Blaiss1, L. Simmons2, E. Meltzer3, K. Sheth4, J. Boyle5;
1University of Tennessee Health Science Center, Germantown, TN, 2Ar-
kansas Children’s Hospital, Little Rock, MD, 3Allergy and Asthma Med-
ical Group and Research Center, San Diego, CA, 4Lafayette Allergy and
Asthma Clinic, Lafayette, IN, 5Schulman, Ronca and Bucuvalas, Inc.,
Silver Spring, MD.
RATIONALE: Allergic rhinitis (AR) is associated with a range of
symptoms including nasal congestion, itching, sneezing, runny nose, and
difficulty sleeping. Ineffective control of these symptoms can affect
performance, productivity, and the overall feelings of AR sufferers.
METHODS: We compared symptoms of AR obtained from 2 national
telephone surveys of adults and children conducted between January 2006
and April 2007: Pediatric Allergies in America, a national survey of parents
of 500 children aged 4 to 17 years with AR, and Allergies in America,
a national survey of 2,500 adults with AR.
RESULTS: Adults (22%) and children (15%) reported lack of sleep on
most days or every day during the worst month of their allergies.
Approximately one third of children reported difficulty in getting to sleep
(32%) or lack of a good night’s sleep (29%). Among regular activities
impaired by allergy symptoms, sleep interference was the most frequently
reported by children (40%). A higher percentage of adults compared with
children reported frequently feeling miserable (29% versus 15%), irritable
(26% versus 20%), and tired (44% versus 22%), manifestations that may be
related to lack of sleep.
CONCLUSIONS: Compromised sleep quality and quantity are trouble-
some symptoms in adults and children with AR. A comparison of sleep
impairment and associated symptoms from the 2 national surveys suggests
that somewhat more adults report sleep impairment and manifest adverse
symptoms related to sleep impairment than children. However, because
figures for children are reported by parents, sleep impairment in children
may be underrepresented in this survey.
418 Primary Validation Of The Spanish Version Of Quality Of LifeQuestionnaire For Adults With Type I Latex Allergy (Quolla)
A. Losada1, C. Saa2, A. Muriel3, E. Garcia4, M. Lazaro5, M. Dieguez1, B.
De La Hoz1; 1Allergy department. Hospital Ramon y Cajal, Madrid, SPAIN,2Bioestadistic department. Hospital Ramon y Cajal, Madrid, SPAIN, 3Bio-
estadistic department. Hospital Ramon y Cajal, Madrid, SPAIN, 4AEPNAA,
Madrid, SPAIN, 5Clinica Alergoasma, Salamanca, SPAIN.
RATIONALE: Allergy to rubber latex has become increasingly recog-
nised as an important health issue since eighties. Aim of the study was to
validate the spanish version of quality of life questionnaire for adults with
type I latex allergy (Quolla).
METHODS: Aim of this pilot study was the transcultural adaptation into
Spanish of the original English version of the questionnaire. This study was
carried out in two phases: first one, to translate and validate the Spanish
version, and the second one, to asses the reliability. To achieve the first
objective, latex allergic patients were selected consecutively. Those
patients completed Quolla-A and SF-12 tests. For the second objective,
same group of patients answered Quolla-B (Quolla-A in wich questions
were ordered differently) four days apart. Validation phase is being
performed now in a higher sample size.
RESULTS: 25 latex allergic patientes were included. 23 out of the 25
(92%) returned both questionnaires. Median age was 41 years (minimum
20, maximum 59). 19 patients (82.6%) were female. Quolla score is from 0
to 40. Median Quolla-A score was 4, and for Quolla-B was 5. Patients spent
to answer the questionnaire from 1 to 15 minutes (median 4 minutes). Test-
retest reliability, measured as agreement in placing into 5 severity