Theerapan SongnuyM.D.

Allergic Rhinitis: How can we evaluate disease control?

IntroductionClinical assessmentStrength & Weakness of guidelineHow can we develop the new guidelineConclusion

Outlines

Allergic rhinitis : - Highly prevalence - Chronic disease

Katelaris CH et al. Prevalence and diversity of allergic rhinitis in regions of the world beyond Europe and North America. Cli Exp Allergy 2012, 42: 186-207.

Introduction

Clinical & Experimental Allergy 2011; 42: 186-207

Impact on sleepMoodSocial functioningWork/school performanceHealth-related quality of lifeDirect health care costsIndirect socio-economic costsNathan RA. The burden of allergic rhinitis. Allergy Asthma Proc 2007,

28: 3-9.

Meltzer EO, Bukstein DA. The economic impact of allergic rhinitis and current guidelines for treatment. Ann Allergy Asthma Immunol 2011; 106: S12-16.

Disease Burden

Underestimated by patients & physiciansPoor levels of satisfaction reported by patients

WHO : ARIA guidelinePhysicians are not aware of this tool

No single definition of “ disease control” Variables & severity threshold vary from one method

to another

Valovirta E, Myrseth SE, Palkonen S. The voice of the patients: allergic rhinitis is not a trivial disease. Curr Opin Allergy Clin Immunol 2008; 8: 1-9.

American Academy of Otolaryngic Allergy Working Group on Allergic Rhinitis, Marple BF, Fornadley JA, Patel AA, Fineman SM, Fromer L, Krouse JH, Lanier BQ, Penna P. Demoly P, Concas V, Urbinelli R, Allaert FA. Spreading and impact of the World Health Organization’s Allergic Rhinitis and its impact on asthma guidelines in everyday medical practice in France. Ernani survey. Clin Exp Allergy 2008;

38: 1803-1807.

Challenging on Allergic Rhinitis

jkllll

To determine the spreading level of the WHO-ARIA guidelines among physicians ( familiar with and use in practice)

To determine the influence of WHO-ARIA on medical practice ( comparing treatment offered to patients)

Clinical and Experimental Allergy. 2008;38: 1803-1807

Aims

The national cross-sectional studyRepresentative physician was randomly selected

Within 15 days, each doctor had to include the first three AR patients in clinic

Patients aged 18-65 years old both male & female

Exclude only patient who prior engaged in a clinical trial or another epidemiology study

Clinical and Experimental Allergy. 2008;38: 1803-1807

Methods

Physician completed a questionnaires -Socio-professional profile - Knowledge of the WHO-ARIA guidelines - Practical use of guidelines

Patients data also completed by physician - Socio-demographic - Clinical symptoms - Treatment modalities - Effect on daily life

Clinical and Experimental Allergy. 2008;38: 1803-1807

Methods

Clinical and Experimental Allergy. 2008;38: 1803-1807

Clinical and Experimental Allergy. 2008;38: 1803-1807

Clinical and Experimental Allergy. 2008;38: 1803-1807

ARIA guidelines are widely known by physician especially by ENT physicians

The ARIA knowledge improves diagnosis & follow-up of AR

But neither enhances further examination of asthma, nor guides primary treatment

Conclusion

By analogy with GINA in asthma:

- Daily & nocturnal symptoms - Impairments in social, physical, professional, or educational activities - Respiratory function monitoring - Events related to exacerbations

Demoly P et al. Assessment of disease control in allergic rhinitis. Clinical and Translational Allergy. 2013 ; 3: 7

Measurement of Control in AR

Pascal Demoly, Moises A Calderon, Thomas casale, Glenis Scadding, Isabella Annesi-Maesano, Jean-Jacques Braun, Bertrand Delaisi, Thierry

Haddad Olivier Malard, Florence Trebuchon, & Elie Serrano

Clinical and Translational Allergy. 2013; 3: 7

Assessment of Disease Control in Allergic Rhinitis

Assess the strengths & weaknesses of the ARIA classification

Review published proposals for the modification of ARIA

Review tools for determining disease control in AR

- Data from MEDLINE, Embase, & Cochrane Library, up until

- May 2012

Aims

1. Easy to apply 2. Patient-centered 3. Emphasizes the existence of severe allergic rhinitis 4. Correlated with disease-specific quality of life, sleep quality, work productivity, & visual analogue scale scores

Clinical and Translational Allergy. 2013; 3: 7

Bousquet J et al. Severity and impairment of allergic rhinitis in patients consulting in primary care. JACI 2006; 117: 158-162.

Strengths of the Current ARIA Severity Classification

1. Based on “yes”/ “no” answer to 4 questions, this lead to little guidance on patient management

2. Some duplication among questions

3. “Mild” patients unlikely to seek treatment 4. “Moderate-severe” patients form a heterogeneous

group

5. Poor uptake by physicians 6. Not extensively applied by physicians even those who

are aware of the classification

7. Does not take account of past & present treatments

Clinical and Translational Allergy. 2013; 3: 7

Weaknesses of the Current ARIA Severity Classification

To describe the second phase of CARAT project, final version of the CARAT questionnaires

To evaluate its cross-sectional internal consistency & validity

Aims

CARAT : The Control of Allergic Rhinitis and Asthma Test Self-administered questionnaire to measure the

degree of AR & asthma in adult patients with a previous diagnosed of these diseases

The three phases of CARAT: 1. Constructed an assessment tool 2. Cross-sectional study to evaluate internal

consistency, factor structure, & concurrent validity 3. Longitudinal study to assess reproducibility,

predictive validity, & responsiveness

Introduction

Fifteen allergy or respiratory OPDHospital-based setting in the Portugese

regions of Norte, Centro, Lisboa, Alentejo & Acores

Time frame : last trimester of 2008Aged 18-70 years oldWas diagnosed as asthma and allergic rhinitis At least 6 months of follow up at the clinic

Setting & Participants

The Asthma Control Questionnaires ( 5)Visual analogue scales ( 3) : airway

symptoms, bronchial symptoms, & nasal symptomsEuroQol Questionnaires ( EQ-5D)Medical evaluation : rhinitis severity &

control asthma severity & control, known allergy, current medication, judgment for treatment

Data Collection

Descriptive statisticsItem reduction: - To decrease redundancy of questions - Apply an exploratory factor analysis - Perform internal factor analysis - Item redundancy defined as - response over 90% in a single category of a variables - cross-loading ( > 0.3 in more than one factor) - low item-total correlation ( < 0.4) - increased Cronbach’s alpha if the item was deleted

Statistic Analysis

Ten-question questionnaires Time frame within previous 4 weeksSeven questions address the frequency of symptoms ( Ex. Sleep impairment, activity limitation

et al.)The 4-point Likert scales ( 0-3 )The questionnaire’s score was the sum of all questionsThe range ( from 0-30 ) Zero means complete absence of control

CARAT 10

Internal consistency by Cronbach’s alphaConcurrent validity by Spearman’s correlation coefficients between its factors and control assessment instrument & physician’s assessmentA priori predictions for the correlation coefficient of

the new version with others Control measurement : 0.6-0.8 with ACQ5, 0.6-0.8 with symptom VAS, 0.4-0.6 with physician’s

assessmentScatter plots used for showing correlations

Evaluation of CARAT 10

(cont)(cont)

CARAT 10 questionnaires has high internal consistency & construct validity

Useful to compare groups in clinical studiesLimitation : the lack of objective test such as

lung function test

Conclusion

To prospectively assess: - The test-retest reliability - Responsiveness - Longitudinal validity of CARAT 10

Aims

Prospective observational studyFirst semester of 2009Two visits, 4 to 6 weeks apartPatients from 4 allergy OPDs of central

hospital in PortugalAged from 18-70 years oldMedical diagnosed as asthma & ARAt least 6 months of follow upSelf-administered questionnaires

Setting & Participants

Each visit ; patients had to fill: - CARAT 10 - ACQ5 - VAS : airway symptoms pulmonary symptoms nasal symptoms - Lung function test - FVE, FEV1, PEF, FENO50 - Medical evaluation

Data Collection

(cont)

(cont)

CARAT 10 has adequate test-retest reliabilityAdequate responsivenessLongitudinal validityConfirming high internal consistency & concurrent validityCan be used in clinical study & clinical

practice to compare groups & individuals over

time

Conclusion

Even though, ARIA classification of AR severity is useful, it is not optimal guide for daily practice, especially in patients already on therapy

We should develop measuring control in ARKeys challenge for any instrument would

focus on physician awareness, uptake & application

Measurement s for disease control must be reproducible, quick, easy to perform,& focus on disease’s impact in daily life

Summary

Thank You Very Much

Patient 2010; 3 (2): 91-99

No existing tools focusing on measuring symptom control in AR or NAR

Initial phase of development of a patient- completed instrumentRCAT : Rhinitis Control Assessment TestThe final RCAT intend to be a brief, easy to administer & patient-friendly

questionnaires

Why ?

Patient 2010; 3 (2): 91-99

To identify concepts to be measured To develop initial questionnaires to be tested further in the next phase of development

Aim

Patient 2010; 3 (2): 91-99

Three phase of RCAT development 1. Item generation & cognitive testing ( qualitative) 2. Item reduction & preliminary cross-

sectional psychometric validation 3. Longitudinal validation study

Methods

Patient 2010; 3 (2): 91-99

Concepts to be measured: - PubMed review since 1990 - Four focus groups - Aged > 18 years - Reside in San Diego, Raleigh (NC, USA) - Self-reported being diagnosed with rhinitis by physician - Had symptoms in the past 12 months - Conducted by clinical psychologist

-

Methods

Concept to be measured: - Draft questionnaires was conducted based

on literature review & focus group data - Four allergist, three otolaryngologist, &

three primary physician discuss questionnaires

Methods

Questionnaires testing & refining: - Cognitive interviews in Chicago,

Philadelphia, Raleigh - Aged > 18 years - Self-reported diagnosed AR - Previous AR symptoms in the past 12 months - Identify some problems ( instruction, item

wording, response option)

Methods

Patient 2010; 3 (2): 91-99

( cont)

Patient 2010; 3 (2): 91-99

Patient 2010; 3 (2): 91-99

Patient 2010; 3 (2): 91-99

Patient 2010; 3 (2): 91-99