Allergic rhinitis: how can evaluate disease control?
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Transcript of Allergic rhinitis: how can evaluate disease control?
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
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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