Allergic rhinitis: how can evaluate disease control? Presented by Theerapan Songnuy, MD. March15, 2013

1. Theerapan SongnuyM.D.

2.  Introduction
 Clinical assessment
 Strength & Weakness of guideline
 How can we develop the new guideline
 Conclusion

3.  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.

4. Clinical & Experimental Allergy 2011; 42: 186-207

5.  Impact on sleep
 Mood
 Social functioning
 Work/school performance
 Health-related quality of life
 Direct health care costs
 Indirect socio-economic costs
Nathan 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.

6.  Underestimated by patients & physicians
 Poor levels of satisfaction reported by patients
 WHO : ARIA guideline
 Physicians 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;

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9.  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

10.  The national cross-sectional study
 Representative 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

11.  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

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

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

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

15.  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

16.  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

17. 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

18.  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

19. 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.

20. 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

22.  To describe the second phase of CARAT project, final
version of the CARAT questionnaires
 To evaluate its cross-sectional internal consistency &
validity

23.  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

24.  Fifteen allergy or respiratory OPD
 Hospital-based setting in the Portugese regions of
Norte, Centro, Lisboa, Alentejo & Acores
 Time frame : last trimester of 2008
 Aged 18-70 years old
 Was diagnosed as asthma and allergic rhinitis
 At least 6 months of follow up at the clinic

25.  The Asthma Control Questionnaires ( 5)
 Visual analogue scales ( 3) : airway symptoms,
bronchial symptoms, & nasal symptoms
 EuroQol Questionnaires ( EQ-5D)
 Medical evaluation : rhinitis severity & control
asthma severity & control, known allergy,
current medication, judgment for treatment

26.  Descriptive statistics
 Item 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

27.  Ten-question questionnaires
 Time frame within previous 4 weeks
 Seven 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
questions
 The range ( from 0-30 )
 Zero means complete absence of control

28.  Internal consistency by Cronbach’s alpha
 Concurrent validity by Spearman’s correlation
coefficients between its factors and
control assessment instrument & physician’s
assessment
 A 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
assessment
 Scatter plots used for showing correlations

30. (cont)
(cont)

35.  CARAT 10 questionnaires has high internal
consistency & construct validity
 Useful to compare groups in clinical studies
 Limitation : the lack of objective test such as lung
function test

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

38.  Prospective observational study
 First semester of 2009
 Two visits, 4 to 6 weeks apart
 Patients from 4 allergy OPDs of central hospital in
Portugal
 Aged from 18-70 years old
 Medical diagnosed as asthma & AR
 At least 6 months of follow up
 Self-administered questionnaires

39.  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

41. (cont)
(cont)

48.  CARAT 10 has adequate test-retest reliability
 Adequate responsiveness
 Longitudinal validity
 Confirming high internal consistency &
concurrent validity
 Can be used in clinical study & clinical practice
to compare groups & individuals over time

49.  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 AR
 Keys 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

50. Thank You Very Much

59. Patient 2010; 3 (2): 91-99

60.  No existing tools focusing on measuring symptom
control in AR or NAR
 Initial phase of development of a patient-
completed instrument
 RCAT : Rhinitis Control Assessment Test
 The final RCAT intend to be a brief, easy to
administer & patient-friendly questionnaires
Patient 2010; 3 (2): 91-99

61.  To identify concepts to be measured
 To develop initial questionnaires to be tested
further in the next phase of development
Patient 2010; 3 (2): 91-99

62.  Three phase of RCAT development
1. Item generation & cognitive testing
( qualitative)
2. Item reduction & preliminary cross-sectional
psychometric validation
3. Longitudinal validation study
Patient 2010; 3 (2): 91-99

63.  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
 -

64.  Concept to be measured:
- Draft questionnaires was conducted based on
literature review & focus group data
- Four allergist, three otolaryngologist, & three
primary physician discuss questionnaires

65.  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)

66. Patient 2010; 3 (2): 91-99

67. ( cont)
Patient 2010; 3 (2): 91-99

68. Patient 2010; 3 (2): 91-99

69. Patient 2010; 3 (2): 91-99

70. Patient 2010; 3 (2): 91-99