development of experience with allergic rhinitis nasal spray questionnaire (earns-q): a...

1
415 Reliability of the Food Allergy Quality of Life Questionnaires (FAQLQs) for Children, Teenagers and Adults B. M. J. Flokstra-de Blok 1 , J. L. van der Velde 1 , A. DunnGalvin 2 , J. N. G. Oude Elberink 3 , B. J. Vlieg-Boerstra 1 , E. J. Duiverman 1 , J. P. Schouten 4 , J. O. Hourihane 2 , A. E. J. Dubois 1 ; 1 Department of Pediatrics, University Medical Center Groningen, University of Groningen, Groningen, THE NETHERLANDS, 2 Department of Paediatrics and Child Health, Univer- sity College, Cork, IRELAND, 3 Department of Internal Medicine, Univer- sity Medical Center Groningen, University of Groningen, Groningen, THE NETHERLANDS, 4 Department 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 Nasal Spray Questionnaire (EARNS-Q): A Questionnaire to measure Experience and Preference with Nasal Sprays R. Stanford 1 , A. A. Dalal 1 , B. Crawford 2 , M. S. Bayliss 2 , J. Lim 1 , E. Phil- pot 1 ; 1 GlaxoSmithKline, RTP, NC, 2 Mapi 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 Rhinitis M. Blaiss 1 , L. Simmons 2 , E. Meltzer 3 , K. Sheth 4 , J. Boyle 5 ; 1 University of Tennessee Health Science Center, Germantown, TN, 2 Ar- kansas Children’s Hospital, Little Rock, MD, 3 Allergy and Asthma Med- ical Group and Research Center, San Diego, CA, 4 Lafayette Allergy and Asthma Clinic, Lafayette, IN, 5 Schulman, 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 Life Questionnaire For Adults With Type I Latex Allergy (Quolla) A. Losada 1 , C. Saa 2 , A. Muriel 3 , E. Garcia 4 , M. Lazaro 5 , M. Dieguez 1 , B. De La Hoz 1 ; 1 Allergy department. Hospital Ramon y Cajal, Madrid, SPAIN, 2 Bioestadistic department. Hospital Ramon y Cajal, Madrid, SPAIN, 3 Bio- estadistic department. Hospital Ramon y Cajal, Madrid, SPAIN, 4 AEPNAA, Madrid, SPAIN, 5 Clinica 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 J ALLERGY CLIN IMMUNOL FEBRUARY 2008 S108 Abstracts SUNDAY

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Page 1: Development of Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q): A Questionnaire to measure Experience and Preference with Nasal Sprays

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