Allergic rhinitis: how can evaluate disease control?

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Allergic rhinitis: how can evaluate disease control?

Presented by Theerapan Songnuy, MD.

March15, 2013

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Allergic rhinitis: how can evaluate disease control?

  1. 1. Theerapan SongnuyM.D.
  2. 2.  Introduction Clinical assessment Strength & Weakness of guideline How can we develop the new guideline Conclusion
  3. 3.  Allergic rhinitis : - Highly prevalence - Chronic diseaseKatelaris 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. 4. Clinical & Experimental Allergy 2011; 42: 186-207
  5. 5.  Impact on sleep Mood Social functioning Work/school performance Health-related quality of life Direct health care costs Indirect 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.
  6. 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 anotherValovirta 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;
  7. 7. jkllll
  8. 8.  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
  9. 9.  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
  10. 10.  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
  11. 11. Clinical and Experimental Allergy. 2008;38: 1803-1807
  12. 12. Clinical and Experimental Allergy. 2008;38: 1803-1807
  13. 13. Clinical and Experimental Allergy. 2008;38: 1803-1807
  14. 14.  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
  15. 15.  By analogy with GINA in asthma: - Daily & nocturnal symptoms - Impairments in social, physical, professional, or educational activities - Respiratory function monitoring - Events related to exacerbationsDemoly P et al. Assessment of disease control in allergic rhinitis. Clinical and Translational Allergy. 2013 ; 3: 7
  16. 16. Pascal Demoly, Moises A Calderon, Thomas casale, Glenis Scadding, Isabella Annesi-Maesano,Jean-Jacques Braun, Bertrand Delaisi, Thierry HaddadOlivier Malard, Florence Trebuchon, & Elie Serrano Clinical and Translational Allergy. 2013; 3: 7
  17. 17.  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
  18. 18. 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 scoresClinical and Translational Allergy. 2013; 3: 7Bousquet J et al. Severity and impairment of allergic rhinitis in patients consulting in primary care. JACI 2006; 117: 158-162.
  19. 19. 1. Based on “yes”/ “no” answer to 4 questions, this lead to little guidance on patient management2. Some duplication among questions3. “Mild” patients unlikely to seek treatment4. “Moderate-severe” patients form a heterogeneous group5. Poor uptake by physicians6. Not extensively applied by physicians even those who are aware of the classification7. Does not take account of past & present treatments Clinical and Translational Allergy. 2013; 3: 7
  20. 20.  To describe the second phase of CARAT project, final version of the CARAT questionnaires To evaluate its cross-sectional internal consistency & validity
  21. 21.  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
  22. 22.  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
  23. 23.  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
  24. 24.  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
  25. 25.  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
  26. 26.  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
  27. 27. (cont)(cont)
  28. 28.  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
  29. 29.  To prospectively assess: - The test-retest reliability - Responsiveness - Longitudinal validity of CARAT 10
  30. 30.  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
  31. 31.  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
  32. 32. (cont)(cont)
  33. 33.  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
  34. 34.  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
  35. 35. Thank You Very Much
  36. 36. Patient 2010; 3 (2): 91-99
  37. 37.  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
  38. 38.  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
  39. 39.  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
  40. 40.  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 -
  41. 41.  Concept to be measured: - Draft questionnaires was conducted based on literature review & focus group data - Four allergist, three otolaryngologist, & three primary physician discuss questionnaires
  42. 42.  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)
  43. 43. Patient 2010; 3 (2): 91-99
  44. 44. ( cont)Patient 2010; 3 (2): 91-99
  45. 45. Patient 2010; 3 (2): 91-99
  46. 46. Patient 2010; 3 (2): 91-99
  47. 47. Patient 2010; 3 (2): 91-99

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