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Format 2016: how to get asthma control: from PubMed to the tricks of the trade.

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Format 2016: how to get asthma control: from PubMed to the tricks of the trade.

  1. 1. How to get Asthma Control: from PubMed to the Tricks of the Trade Attilio Boner University of Verona, Italy attilio.boner@univr.it  Introduction  Establishment of a partnership  The problem of adherence  Effective use of devices  Written action plans  Effective use of controller medications  Effective use of quick-relief medications  Environment control  Oxidative stress reduction and diet  Addressing co-morbidities  Monitoring the child asthma  Summary and Conclusions
  2. 2. Asthma Control General Considerations Guidelines for asthma management have evolved considerably during the last decade, from treatment recommendations based on the level of asthma severity to the current emphasis on achieving full asthma control. •National Asthma Education and Prevention Program Coordinating Committee. Expert Panel Report 3 (EPR3): Guidelines for the Diagnosis and Management of Asthma. 2008. http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm Date last accessed: December 18, 2012. Date last updated: 2008. •British Thoracic Society Scottish Intercollegiate Guidelines Network. British Guideline on the Management of Asthma: a national clinical guideline. Thorax 2009;63(Suppl. 4):i1–21. Asthma control is defined as the extent to which the various manifestations of asthma are reduced or removed by treatment. •Reddel HK, Taylor DR, Bateman ED, et al. An official American Thoracic Society/ European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med 2009;180:59–99.
  3. 3. An official American Thoracic Society/ European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Reddel HK, Am J Respir Crit Care Med 2009;180:59–99. Asthma control includes 2 components: 1. The level of clinical asthma control, which is gauged from features such as symptoms and the extent to which the patient can carry out activities of daily living and achieve optimum quality of life, and 2. The risk of future adverse events including loss of control, exacerbations, accelerated decline in lung function, and side-effects of treatment.
  4. 4. P R E S E N T F U T U R E
  5. 5. refers to the difficulty in controlling asthma with treatment (i.e. the activity of the underlying disease state) Asthma Severity and Control Asthma severity and control are related but not interchangeable concepts Asthma control refers to the extent to which asthma symptoms or associated features are alleviated by treatment asthma severity Reddel HK, Am J Respir Crit Care Med 2009;180:59–99. Taylor DR, Eur Respir J 2008;32:545–554.
  6. 6. Bronchial biopsy specimens before and after repeated inhaled methacoline challenge. Panels A and C respiratory epithelium before the challenges. Biopsy specimens immunostained with an antibody to collegen type III (in Panels A and B). Panels B and D respiratory epithelium 4 days after the challenges. Biopsy specimens stained with peridic acid-Shiff to detect goblet cells (in Panels C and D). Effect of bronchoconstriction on airway remodeling in asthma. Grainge CL. N Engl J Med. 2011;364(21):2006-15
  7. 7. Progression of Irreversible Airflow Limitation in Asthma: Correlation with Severe Exacerbations. Matsunaga K, J Allergy Clin Immunol Pract. 2015;3(5):759-764. annual rate of decline in post-bronchodilator FEV1 (mL/year) -10 – -10 – -20 – -30 – -40 – -50 – -60 - exacerbation numbers 0 1 ≥2 -13.6 mL/year -41.3 mL/year -58.3 mL/year P < 0.01 P < 0.0001 128 patients with asthma 3-year follow-up
  8. 8. Trajectories of lung function during childhood. Belgrave DC, Custovic A. Am J Respir Crit Care Med. 2014;189:1101-9. birth cohort, specific airway resistance (sRaw) at age 3 (n = 560), 5 (n = 829), 8 (n = 786), and 11 years (n = 644). wheeze phenotypes (no wheezing, transient, late-onset, and persistent) atopy phenotypes (no atopy, dust mite, non-dust mite, multiple early, and multiple late). wheezers who experienced exacerbation had significantly poorer lung function (higher sRaw) than children who never wheezed.
  9. 9. Lung-Function Trajectories Leading to Chronic Obstructive Pulmonary Disease. Lange P, N Engl J Med. 2015;373(2):111-22. BACKGROUND: Chronic obstructive pulmonary disease (COPD) is thought to result from an accelerated decline FEV1 over time. Yet it is possible that a normal decline in FEV1 could also lead to COPD in persons whose maximally attained FEV1 is less than population norms.
  10. 10. Of the 332 persons with COPD at the end of the observation period 60 – 50 – 40 – 30 – 20 – 10 – 0 48% 52% FEV1 before 40 years of age ≥80% and had a rapid decline in FEV1 thereafter, of 53±21 ml per year* <80% low FEV1 in early adulthood and a subsequent mean decline in FEV1 of 27±18 ml per year* *P<0.001 for the decline participants in 3 independent cohorts stratified according to lung function [FEV1 ≥80% (n=2207) or <80% (n=657) of the predicted value) at cohort inception (mean age of patients, approximately 40 years] and the presence or absence of COPD at the last study visit. we then determined the rate of decline in FEV1 over time among the participants according to their FEV1 at cohort inception and COPD status at study end. Follow-up: 22 years. Lung-Function Trajectories Leading to Chronic Obstructive Pulmonary Disease. Lange P, N Engl J Med. 2015;373(2):111-22.
  11. 11.  82 children (6-11 years) and 725 adolescent/adult patients ≥12 years (TENOR study).  Follow-up: 24 months. in Children with Consistently Very Poorly Controlled Asthma OR for 6.4 HOSPITALIZATION, ED VISIT, or CORTICOSTEROID BURST 7 – 6 – 5 – 4 – 3 – 2 – 1 – 0 Consistently very poorly controlled asthma increases risk for future severe asthma exacerbations. Haselkorn T, J Allergy Clin Immunol. 2009;124(5):895-902.
  12. 12. The Poorly Explored Impact of Uncontrolled Asthma O’Byrne, CHEST 2013;143:511  Poorly controlled asthma adversely affects children’s cardiovascular fitness, while children with well-controlled asthma perform at the same level as their peers.  Children with uncontrolled asthma also have a higher frequency of obesity than children with controlled asthma.  Children with poorly controlled asthma are more likely to have learning disabilities compared with those with good control.
  13. 13. The Poorly Explored Impact of Uncontrolled Asthma O’Byrne, CHEST 2013;143:511  Adults patients with asthma are at greater risk for depression.  Poorly controlled asthma increases the risks of severe asthma exacerbations following upper respiratory and pneumococcal pulmonary infections.  Lastly, the risks of uncontrolled asthma during pregnancy are substantially greater than the risks of recommended asthma medications.  Treatments to maintain asthma control are the best approach to optimize maternal and fetal health in the pregnancies of women with asthma.
  14. 14. The aim of treatment of asthma is: 1) to control symptoms, 2) to restore full physical and psychosocial functioning, 3) to eliminate interference with social relationships and quality of life. The goals of asthma treatment To reach these goals, people with asthma (including children and their parents) must at least: 1) be able to use prescribed drugs in the proper manner to prevent or control symptoms, 2) identify and avoid the triggers that cause symptoms, 3) develop or maintain family and other necessary social support, 4) communicate effectively with healthcare providers.
  15. 15. The aim of treatment of asthma is: 1) to control symptoms, 2) to restore full physical and psychosocial functioning, 3) to eliminate interference with social relationships and quality of life. The goals of asthma treatment To reach these goals, people with asthma (including children and their parents) must at least: 1) be able to use prescribed drugs in the proper manner to prevent or control symptoms, 2) identify and avoid the triggers that cause symptoms, 3) develop or maintain family and other necessary social support, 4) communicate effectively with healthcare providers. The failure to see management by patients as a behavioural process based largely on an individual's ability to self regulate may lead to inefective asthma control despite optimal therapy prescription
  16. 16. Attilio Boner University of Verona, Italy attilio.boner@univr.it  Introduction  Establishment of a partnership  The problem of adherence  Effective use of devices  Written action plans  Effective use of controller medications  Effective use of quick-relief medications  Environment control  Oxidative stress reduction and diet  Addressing co-morbidities  Monitoring the child asthma  Summary and Conclusions How to get Asthma Control: from PubMed to the Tricks of the Trade
  17. 17. Management of chronic disease by practitioners and patients: are we teaching the wrong things? Clark NM, BMJ 2000;320:572-5. The patient should be the primary manager of chronic disease, guided and coached by a doctor or other practitioner to devise the best therapeutic regimen. The practitioner and patient should work as partners, developing strategies that give the patient the best chance: 1) to control his or her own disease and 2) to reduce the physical, psychological, social, and economic consequences of chronic illness. patient
  18. 18. Bandura’s Social Cognitive Theory: Determinants of Improved Self Regulation Mastery experiences (practice opportunities) Social modeling (watching others succeed) Social persuasion (from a trusted source) Psychological response (decreased stress)
  19. 19. + + =
  20. 20. Self Regulation Self regulation is the process of: It is a means by which patients determine what they will do, given: 1) observing, 2) making judgments (evaluations), and 3) reacting realistically and appropriately to one's own efforts to manage a task. 1) their specific goals, 2) social context, and 3) their perceptions of their own capability. Clark NM, BMJ. 2000;320:572-5 the patient
  21. 21. Self Regulation Self regulation is the process of: It is a means by which patients determine what they will do, given: For example, a child with asthma who wants to play football 1) their specific goals, 2) social context, and 3) their perceptions of their own capability. i. thinks drugs will help and so uses them preventively, ii. takes a reliever drug when exercising strenuously, iii. seeks moral support from his friends and coaches, iv. uses other strategies that enable him to reach his personal goal. v. he learns which strategies are effective through self regulation. Clark NM, BMJ. 2000;320:572-5 1) observing, 2) making judgments (evaluations), and 3) reacting realistically and appropriately to one's own efforts to manage a task.
  22. 22. Motivational interviewing derives from Prochaska and DiClemente’s transtheoretical model of change. This model explains behavioral change as a process in which individuals pass through 5 stages: 1) precontemplation, 2) contemplation, 3) preparation, 4) action, 5) maintenance. Transtheoretical therapy: toward a more integrative model of change. Prochaska, JO. Psychotherapy: Theory, Research & Practice, 1982;19:276
  23. 23. Motivational interviewing offers an alternative response to ambivalence.  struggles with ambivalence as a normal part of the process of change and that  patient motivation and readiness to change are not static traits, but rather dynamic states that can be greatly influenced by interactions between provider and patient. N O R M A L OVERCOMING AMBIVALENCE
  24. 24. PRINCIPLES OF MOTIVATIONAL INTERVIEWING: creating the conditions for change • Express empathy. • Avoid argument. • Develop a discrepancy. • Roll with resistance. • Support self-efficacy. Non-smoking twin Twin who smokes 3 cigarettes per day
  25. 25. “the change only depends on me”). “I have absolutely no influence on asthma change,” Higher risk of poor control Asthma patients' perception of their ability to influence disease control and management Laforest L, Ann Allergy Asthma Immunol 2009;102:378 Internal locus of control OR = 2.68
  26. 26. There are 2 types of patient needs to be addressed during the medical interview: Physicians’ communication and parents’ evaluation of pediatric consultations. Street RL. Med Care. 1991;29:1146 cognitive (serving the need to know and understand) and affective (serving the emotional need to feel known and understood). “understand” “be understood”
  27. 27. Active listening is a specific communication skill which involves: - giving free and undivided attention to the speaker, - placing all of one’s attention and awareness at the disposal of another person, - listening with interest and appreciating without interrupting - concentrating on everything the person is conveying, both verbally and nonverbally (body language). Active listening More than just paying attention Robertson, Aust Fam Physicians 2005;34:1053 in out
  28. 28. Active listening is a specific communication skill which involves: - giving free and undivided attention to the speaker, - placing all of one’s attention and awareness at the disposal of another person, - listening with interest and appreciating without interrupting - concentrating on everything the person is conveying, both verbally and nonverbally (body language). This is a rare and valuable commitment, as most discussions involve competition for a space to speak. Active listening More than just paying attention Robertson, Aust Fam Physicians 2005;34:1053 in out
  29. 29. emotions play a part in the process of medical care in 3 interrelated ways: EMOTIONS AND THE MEDICAL CARE PROCESS First, both physicians and patients have emotions. Second, both physicians and patients show emotions, Third, both physicians and patients judge each other’s emotions.
  30. 30. Nonverbal Sensitivity of Physicians element nonverbal index: -facial expressivity -frequency of smiling; -eye contact and nodding, -body lean -body posture -tone of voice It seems likely that physicians’ nonverbal behavior significantly influences patients’ likelihood of deciding for or against recommended treatment options.
  31. 31. Three elements of communication – and the "7%-38%-55% Rule“ Mehrabian (1971) Silent messages. Wadsworth, Belmont, California. •there are basically three elements in any face-to-face communication: 1) words, 2) tone of voice and 3) body language. These three elements account differently for the meaning of the message: - Words account for 7% - Tone of voice accounts for 38% and - Body language accounts for 55% of the message. 2
  32. 32. Enabling Effective Child Participation Parents and children themselves are more satisfied and adherence to the treatment regimen is enhanced. when the child is addressed in information gathering and in the creation of the treatment plan.
  33. 33. Children 7 years and older are: 1) more accurate than their parents in providing health data that predicts future health outcomes, although 2) they are worse at providing past medical histories. Enabling Effective Child Participation
  34. 34. Children's contributions to pediatric outpatient encounters. van Dulmen AM. Pediatrics. 1998;102:563-8 21 consulting pediatricians videotaped a total of 302 consecutive outpatient encounters. Children's contributions to the outpatient encounters 5 – 4 – 3 – 2 – 1 – 0 4% only
  35. 35. Children's contributions to pediatric outpatient encounters. van Dulmen AM. Pediatrics. 1998;102:563-8 21 consulting pediatricians videotaped a total of 302 consecutive outpatient encounters. Children's contributions to the outpatient encounters 5 – 4 – 3 – 2 – 1 – 0 4% only Always talk with the child !
  36. 36. Adolescents’ Roles in Health Care Communication and Decisional Authority Leveton Pediatrics 2008;121:e1441 Adolescents must receive understandable information: 1) to enable an understanding of the condition, 2) what to expect with various tests and treatments, 3) the range of acceptable and practical alternative care plans, 4) likely outcomes of each option.
  37. 37. The tolerant model of decision making 1) addresses potentially harmful decisions by giving weight to the adolescent’s decision, 2) with the proxy taking the role of: - educator, - discussant, - challenger, and - shared decision maker. Adolescents’ Roles in Health Care Communication and Decisional Authority Leveton Pediatrics 2008;121:e1441
  38. 38. The tolerant model of decision making 1) addresses potentially harmful decisions by giving weight to the adolescent’s decision, 2) with the proxy taking the role of: - educator, - discussant, - challenger, and - shared decision maker. Adolescents’ Roles in Health Care Communication and Decisional Authority Leveton Pediatrics 2008;121:e1441 the adolescent’s decision should not be overrided but discussed. X X
  39. 39. Oral communication strategies for health care providers Table II Health literacy and asthma Rosas-Salazar C, JACI 2012;129:935-42 10 out of 100 instead of 10%
  40. 40. Oral communication strategies for health care providers Table II Health literacy and asthma Rosas-Salazar C, JACI 2012;129:935-42 10 out of 100 instead of 10%
  41. 41. Learning from tragedies: clinical lessons from the Climbié report. Marcovitch H. Qual Saf Health Care 2003 ;12:82–3. “doctors [should be taught] how to write [so] that readers will understand” Trick of the Trade from Lord Laming “UK Secretary of State for Health” who has carried out child protection review
  42. 42. Attilio Boner University of Verona, Italy attilio.boner@univr.it  Introduction  Establishment of a partnership  The problem of adherence  Effective use of devices  Written action plans  Effective use of controller medications  Effective use of quick-relief medications  Environment control  Oxidative stress reduction and diet  Addressing co-morbidities  Monitoring the child asthma  Summary and Conclusions How to get Asthma Control: from PubMed to the Tricks of the Trade
  43. 43. •The term adherence is often used interchangeably with compliance and is preferred by some as it acknowledges the patient’s role as a partner in the decision-making process. Tilson HH. Adherence or compliance? Changes in terminology. Ann Pharmacother 2004; 38: 161-2 •Adherence is defined as “the extent to which a person’s behaviour – taking medication, following a diet, and/or executing lifestyle changes –corresponds with agreed recommendations from a healthcare provider. World Health Organization. Adherence to long-term therapies: evidence for action [online]. Available from URL: http://www.emro.who.int/ncd/Publications/adherence_report.pdf Haynes R, Taylor D, Sackett D. Compliance in health care. Baltimore: The Johns Hopkins University Press, 1979. Definition
  44. 44. non-adherence can be as high as 32–56% Robinson DS, Eur Respir J 2003; 22: 478–483. Heaney LG, Thorax 2003; 58: 561–566. Gamble J, Respir Med 2011; 105: 1308–1315. Poor inhaler technique is also common and should be addressed Bracken M, Arch Dis Child 2009; 94: 780–784. . If non-adherence is present, clinicians should empower patients to make informed choices about their medicines and develop individualised interventions to manage non-adherence. Gamble J, Respir Med 2011; 105: 1308–1315. Non-adherence to treatment should be considered in all difficult-to-control patients Non-Adherence to Treatment
  45. 45. Adherence to therapy Bush A, Eur Respir Mon 2011;51:59-81 Doctors are notoriously poor at predicting which patients take treatment, and parents frequently overestimate adherence. Useful tools include: 1) measurement of serum medication levels (prednisolone and theophylline); 2) obtaining a list of prescriptions supplied (collecting a prescription does not guarantee adherence, but failure to collect guarantees non-adherence); Warner JO. BMJ 1995;311:663–666. 3) assessment of whether there is a supply of easily accessible in-date medication in the home.
  46. 46. Adherence to therapy Bush A, Eur Respir Mon 2011;51:59-81 Other adherence issues to be addressed include: 4) whether the child is supervised (often quite young children are left unsupervised by the carers); Orrell-Valente JK, Pediatrics 2008;122:e1186–e1192. 5) whether the child and family have an age-appropriate drug delivery device that is being used properly. Repeated education in the use of medication devices is frequently required. Kamps AW, Pediatr Pulmonol 2000;29:39–42. “It is, of course, one thing to identify poor adherence and quite another to address it.”
  47. 47. Adherence to therapy Bush A, Eur Respir Mon 2011;51:59-81 Other adherence issues to be addressed include: 4) whether the child is supervised (often quite young children are left unsupervised by the carers); Orrell-Valente JK, Pediatrics 2008;122:e1186–e1192. 5) whether the child and family have an age-appropriate drug delivery device that is being used properly. Repeated education in the use of medication devices is frequently required. Kamps AW, Pediatr Pulmonol 2000;29:39–42. “It is, of course, one thing to identify poor adherence and quite another to address it.” !
  48. 48.  Adherence estimated from electronic prescription and pharmacy fill records.  Patients were considered to be adherent if ICS use was ≥ 80% of prescribed.  Health Locus of Control scale was used to assess five sources (God, doctors, other people, chance, and internal). OR for medication adherence in patients’ who had a stronger belief that God determined asthma control 1.0 – 0.5 – 0.0 0.68 0.89 African American White Asthma medication adherence: the role of God and other health locus of control factors. Ahmedani BK, Ann Allergy Asthma Immunol. 2013;110(2):75-9.
  49. 49. Parents accompanying 150 children aged 3–9 years with asthma attending asthma clinics. OR FOR SOUTH ASIAN PARENTS COMPARED TO WHITE 0.30 3.19 TO GIVE PREVENTERS DRUG TO CONSIDERES DRUG MORE HARM THAN GOOD 3.50 – 3.00 – 2.50 – 2.00 – 1.50 – 1.00 – 0.50 – 0 Parental attitudes towards the management of asthma in ethnic minorities.Smeeton NC, Arch Dis Child. 2007;92:1082-7.
  50. 50.  351 children with asthma.  Parents of study participants completed the Asthma Numeracy Questionnaire. Low parental numeracy (1 cp 25 mg = 5 cp 5 mg) OR for visits to the ED or urgent care for asthma 1.77 2.0 – 1.5 – 1.0 – 0.5 – 0.0 p=0.04 Parental Numeracy and Asthma Exacerbations in Puerto Rican Children Rosas-Salazar C. Chest 2013;144:92-8
  51. 51.  351 children with asthma.  Parents of study participants completed the Asthma Numeracy Questionnaire. OR for visits to the ED or urgent care for asthma 1.77 2.0 – 1.5 – 1.0 – 0.5 – 0.0 p=0.04 Parental Numeracy and Asthma Exacerbations in Puerto Rican Children Rosas-Salazar C. Chest 2013;144:92-8 Trick of the trade: “speak as you eat” Low parental numeracy (1 cp 25 mg = 5 cp 5 mg)
  52. 52. ADHERENCE TO ALLERGEN AVOIDANCE ADVICE % P A T I E N T S U S I N G C O V E R M A T T R E S S 40 - 30 - 20 - 10 - 0 17 % 39 % 0 % Without formal education program Eggleston ARRD 1992;145:213 With usual clinic based education effort Korsgaard ARRD 1982;125:80 With a computer education program Huss JACI 1992;89:836
  53. 53. Adherence with Inhaled Corticosteroids typically ranging from 30% to 70%, but on average lower than 50% 1) Rand CS. Adherence to asthma therapy in the preschool child. Allergy. 2002;57 Suppl 74:48–57. 2) Jentzsch NS, Camargos PA, Colosimo EA, Bousquet J. Monitoring adherence to beclomethasone in asthmatic children and adolescents through four different methods. Allergy. 2009 Oct;64(10):1458–62 3) Bender BG, Bender SE. Patient-identified barriers to asthma treatment adherence: responses to interviews, focus groups, and questionnaires. Immunol Allergy Clin North Am. 2005;25(1):107–30. 4) Milgrom H, Bender B, Ackerson L, Bowry P, Smith B, Rand C. Noncompliance and treatment failure in children with asthma. J Allergy Clin Immunol. 1996;98(6 Pt 1):1051–7. These rates may even be an overestimate of true adherence in the general population, as study participants are likely to increase their medication use as a manifestation of knowing they are being observed (the Hawthorne effect) Desai M, Curr Allergy Asthma Rep 2011;11:454 Studies assessing adherence to ICS in children and adolescents consistently demonstrate poor rates of adherence.
  54. 54. Adherence with Inhaled Corticosteroids typically ranging from 30% to 70%, but on average lower than 50% 1) Rand CS. Adherence to asthma therapy in the preschool child. Allergy. 2002;57 Suppl 74:48–57. 2) Jentzsch NS, Camargos PA, Colosimo EA, Bousquet J. Monitoring adherence to beclomethasone in asthmatic children and adolescents through four different methods. Allergy. 2009 Oct;64(10):1458–62 3) Bender BG, Bender SE. Patient-identified barriers to asthma treatment adherence: responses to interviews, focus groups, and questionnaires. Immunol Allergy Clin North Am. 2005;25(1):107–30. 4) Milgrom H, Bender B, Ackerson L, Bowry P, Smith B, Rand C. Noncompliance and treatment failure in children with asthma. J Allergy Clin Immunol. 1996;98(6 Pt 1):1051–7. These rates may even be an overestimate of true adherence in the general population, as study participants are likely to increase their medication use as a manifestation of knowing they are being observed (the Hawthorne effect) Desai M, Curr Allergy Asthma Rep 2011;11:454 Studies assessing adherence to ICS in children and adolescents consistently demonstrate poor rates of adherence. compliance is significantly less of an issue for ‘as required therapy’ with β-agonists, compared with regular therapy with corticosteroids.
  55. 55. Adherence with Inhaled Corticosteroids typically ranging from 30% to 70%, but on average lower than 50% 1) Rand CS. Adherence to asthma therapy in the preschool child. Allergy. 2002;57 Suppl 74:48–57. 2) Jentzsch NS, Camargos PA, Colosimo EA, Bousquet J. Monitoring adherence to beclomethasone in asthmatic children and adolescents through four different methods. Allergy. 2009 Oct;64(10):1458–62 3) Bender BG, Bender SE. Patient-identified barriers to asthma treatment adherence: responses to interviews, focus groups, and questionnaires. Immunol Allergy Clin North Am. 2005;25(1):107–30. 4) Milgrom H, Bender B, Ackerson L, Bowry P, Smith B, Rand C. Noncompliance and treatment failure in children with asthma. J Allergy Clin Immunol. 1996;98(6 Pt 1):1051–7. These rates may even be an overestimate of true adherence in the general population, as study participants are likely to increase their medication use as a manifestation of knowing they are being observed (the Hawthorne effect) Desai M, Curr Allergy Asthma Rep 2011;11:454 Studies assessing adherence to ICS in children and adolescents consistently demonstrate poor rates of adherence. If β2-agonists frequently very likely the child is not taking ICS or he has a poor technique !
  56. 56. Background: A validated tool to assess adherence with inhaled corticosteroids (ICS) could help physicians and researchers determine whether poor asthma control is due to poor adherence or severe intrinsic asthma. Objective: To assess the performance of the Medication Adherence Report Scale for Asthma (MARS-A), a 10-item, self-reported measure of adherence with ICS. Permission to use it should be obtained by requests to Rob.horne@pharmacy.ac.uk. Score: Alaways =1, Often=2, Sometimes=3, Rarely=4, Never=5 Assessing the validity of self-reported medication adherence among inner-city asthmatic adults: the Medication Adherence Report Scale for Asthma CohenJL. Ann Allergy Asthma Immunol 2009;103:325-31 ICS
  57. 57. Self-reported Medication Adherence How often do you do the following: 1) Alaways 2) Often 3) Sometimes 4) Rarely 5) Never High self-reported adherence was defined as a mean MARS score of ≥4.5 Assessing the validity of self-reported medication adherence among inner-city asthmatic adults: the Medication Adherence Report Scale for Asthma CohenJL. Ann Allergy Asthma Immunol 2009;103:325-31
  58. 58. Self-reported Medication Adherence How often do you do the following: 1) Alaways 2) Often 3) Sometimes 4) Rarely 5) Never High self-reported adherence was defined as a mean MARS score of ≥4.5 Ask the patients to tell you the name of the drugs. Ask the patients to bring their drugs and the spacer at each visit. Assessing the validity of self-reported medication adherence among inner-city asthmatic adults: the Medication Adherence Report Scale for Asthma CohenJL. Ann Allergy Asthma Immunol 2009;103:325-31
  59. 59. Poor or non-adherence to treatment Adolescents are at risk reduced adherence to treatment smoking, illicit drug use a higher risk of fatal episodes of childhood asthma. are common risk taking behaviours ERS/ATS Guidelines, ERJ 2014;43:343-373 X X
  60. 60. Hedlin G, E. RJ 2010;36:196-201 Psychological risk factors are prominent in children and young adults who subsequently die of asthma. Strunk RC, JAMA 1985;254:1193–1198. Bergström SE, Respir Med 2008;102:1335–1341. Similarly, in near-fatal asthma episodes in children, the children also showed significant denial, psychosocial pathology and delay in seeking treatment. Martin AJ, Pediatr Pulmonol 1995;20:1–8. lack of concordance with prescribed medication due to psychosocial factors in chaotic families, influence asthma control. Non-Adherence: Psychosocial Issues
  61. 61. Most well trained professionals adopt a practical tactic that processes through an ongoing assessment and negotiation of the various components of the treatment. A contractual approach to improving adherence Michaud Arch Dis Child 2004;89:943 There are clues for improving adherence in general and the adherence of adolescents with a chronic disorder such as asthma,
  62. 62. Most well trained professionals adopt a practical tactic that processes through an ongoing assessment and negotiation of the various components of the treatment. A contractual approach to improving adherence Michaud Arch Dis Child 2004;89:943 There are clues for improving adherence in general and the adherence of adolescents with a chronic disorder such as asthma, tricks of the trade: 1) “I have done the same thing when I was young so I do understand you …and I like you but I cannot agree”. 2) “If you have questions or doubts this is my phone number”.
  63. 63. OR for uncontrolled asthma Low maternal education Parental concerns about potential adverse consequences of medication 2.0 – 1.5 – 1.0 – 0.5 – 0 1.6 1.6 Uncontrolled asthma at age 8: The importance of parental perception towards medication Koster ES. Pediatr Allergy Immunol 2011;22:462-8  Uncontrolled asthma at age 8 in children participating in the PIAMA birth cohort study.  Uncontrolled asthma defined as: ≥3 items present in the past month:  1) day-time asthma symptoms,  2) night-time asthma symptoms,  3) limitations in activities,  4) rescue medication use,  5) FEV1 < 80% predicted and  6) unscheduled physician visits because of asthma.
  64. 64. OR for uncontrolled asthma Low maternal education Parental concerns about potential adverse consequences of medication 2.0 – 1.5 – 1.0 – 0.5 – 0 1.6 1.6 Uncontrolled asthma at age 8: The importance of parental perception towards medication Koster ES. Pediatr Allergy Immunol 2011;22:462-8  Uncontrolled asthma at age 8 in children participating in the PIAMA birth cohort study.  Uncontrolled asthma defined as: ≥3 items present in the past month:  1) day-time asthma symptoms,  2) night-time asthma symptoms,  3) limitations in activities,  4) rescue medication use,  5) FEV1 < 80% predicted and  6) unscheduled physician visits because of asthma. Talk also about treatment side-efffects
  65. 65. The Madison Avenue effect: How drug presentation style influences adherence and outcome in patients with asthma Clerisme-Beaty EM. JACI 2011;127:406-11  99 participants.  Randomized to placebo or montelukast in conjunction with a presentation mode that was either neutral or designed to increase outcome expectancy.  Adherence monitored electronically over 4 weeks. 4.0 OR for good adherence (≥80% prescribed doses) 4.0 - 3.0 – 2.0 – 1.0 – 0.00 Presentation mode designed to increase outcome expectancy
  66. 66.  99 participants.  Randomized to placebo or montelukast in conjunction with a presentation mode that was either neutral or designed to increase outcome expectancy.  Adherence monitored electronically over 4 weeks. 4.0 OR for good adherence (≥80% prescribed doses) 4.0 - 3.0 – 2.0 – 1.0 – 0.00 Presentation mode designed to increase outcome expectancy The use of an enhanced presentation aimed at increasing outcome expectancy may lead to improved medication adherence. The Madison Avenue effect: How drug presentation style influences adherence and outcome in patients with asthma Clerisme-Beaty EM. JACI 2011;127:406-11
  67. 67. Attilio Boner University of Verona, Italy attilio.boner@univr.it  Introduction  Establishment of a partnership  The problem of adherence  Effective use of devices  Written action plans  Effective use of controller medications  Effective use of quick-relief medications  Effective control of inflammation  Oxidative stress reduction and diet  Addressing co-morbidities  Monitoring the child asthma  Summary and Conclusions How to get Asthma Control: from PubMed to the Tricks of the Trade
  68. 68. Role of inhaler competence and contrivance in ‘‘difficult asthma’’ Mark L. Everard, Paediatric Respiratory Reviews 2003;4:135–142 Failure to deliver drug effectively to the lungs is the most common cause of referrals with ‘‘uncontrolled asthma’’. This may be due to: 1) poor regime Compliance or 2) poor device Compliance lack of Competence (the inability to use a device effectively) and/or Contrivance (knowing how to use a device effectively but choosing to use it in a non-effective way ). the healthcare professional must be aware of the: 1) principles underlying aerosol delivery 2) aspects of patient behaviour. more difficult to address.
  69. 69. Role of inhaler competence and contrivance in ‘‘difficult asthma’’ Mark L. Everard, Paediatric Respiratory Reviews 2003;4:135–142 Failure to deliver drug effectively to the lungs is the most common cause of referrals with ‘‘uncontrolled asthma’’. This may be due to: 1) poor regime Compliance or 2) poor device Compliance lack of Competence (the inability to use a device effectively) and/or Contrivance (knowing how to use a device effectively but choosing to use it in a non-effective way ). the healthcare professional must be aware of the: 1) principles underlying aerosol delivery 2) aspects of patient behaviour. more difficult to address. ‘‘spacer disuse’’, omitting to use the spacer because it is inconvenient, is one of the most common forms of contrivance. X
  70. 70. Contrivance with holding chamber-Spacer 100 prescribed 65–73% will use Studies in children and adults suggest that 65–73% of patients prescribed an HC for use when administering regularly use their pMDI alone. Everard ML. Thorax 2000;55:811–814. Shim C. Am J Respir Crit Care Med 2000;161:A320
  71. 71. Contrivance with holding chamber-Spacer 100 prescribed >85% will use Studies in children and adults suggest that 65–73% of patients prescribed an HC for use when administering regularly use their pMDI alone. Everard ML. Thorax 2000;55:811–814. Shim C. Am J Respir Crit Care Med 2000;161:A320 ‘‘spacer disuse’’ had fallen to <15% suggesting that addressing the issue in clinic can have a major impact on this potential reason for therapeutic failure. Everard ML, Ped Respir Rev 2003;4:135
  72. 72. Physician knowledge in the use of canister nebulizers. Kelling JS,. Chest . 1983;83:612-614 . 55 house officers and non-pulmonary attending staff from the Department of Medicine were interviewed individually. Each physician was handed a placebo canister and asked a series of standard questions regarding the recognition, assembly, and correct inhalation technique of the device. % participants correctly performing more than 4 of the 7 steps felt to constitute a correct inhalation maneuver. 50 – 40 – 30 – 20 – 10 – 0 40% only!
  73. 73. % patient with difficulty in Problems patients have using pressurized aerosol inhalers Crompton GK. Eur J Respir Dis Suppl 1982;119:101 -6 51% Co-ordinating aerosol release with inspiration Release of aerosol into the mouth caused a halt of inspiration 60 – 50 – 40 – 30 – 20 – 10 – 0 12% 24% Inspiration was achieved through the nose with no air being drawn in through the mouth  Use of pressurized aerosol inhalers  1173 out-patients X Freon effect
  74. 74. Nasal inhalation as a cause of inefficient pulmonal aerosol inhalation technique in children Pedersen S, Allergy 1983;38:191-194  71 children were given careful instruction in aerosol inhalation technique.  Inhalation technique was assessed as being efficient when a child achieved an increase of more than 19% in FEV1 10 min after taking 2 puffs of terbutaline (each puff= 0.25 mg). 11.3 % children efficient in inhalation technique after instruction 5-7 >7 Age (years) 100 – 80 – 60 – 40 – 20 – 0 37% 80% Inhalation through the nose after actuation into the mouth accounted for about 50% of treatment failures, with the problem being more frequent in the younger age group.
  75. 75. Nasal inhalation as a cause of inefficient pulmonal aerosol inhalation technique in children Pedersen S, Allergy 1983;38:191-194  71 children were given careful instruction in aerosol inhalation technique.  Inhalation technique was assessed as being efficient when a child achieved an increase of more than 19% in FEV1 10 min after taking 2 puffs of terbutaline (each puff= 0.25 mg). 11.3 % children efficient in inhalation technique after instruction 5-7 >7 Age (years) 100 – 80 – 60 – 40 – 20 – 0 37% 80% When this error was corrected about 83% of the children were efficient in the technique. Trick of the trade
  76. 76. The adequacy of inhalation of aerosol from canister nebulizers. Shim C. Am J Med 1980;69:891-4  30 patients hospitalized with asthma.  Taught the correct technique. % patients that, when retested, had reverted to the old incorrect technique 50% 50 – 40 – 30 – 20 – 10 – 00 -
  77. 77. The adequacy of inhalation of aerosol from canister nebulizers. Shim C. Am J Med 1980;69:891-4  30 patients hospitalized with asthma.  Taught the correct technique. % patients that, when retested, had reverted to the old incorrect technique 50% 50 – 40 – 30 – 20 – 10 – 00 - Patients should be taught repeatedly until they learn the correct technique and retain it !
  78. 78. Contributory Factors: Non-Adherence to Treatment Hedlin G, E. RJ 2010;36:196-201 Very young children are frequently and inappropriately left to take their asthma medication unsupervised. Orrell-Valente JK, Pediatrics 2008; 122: e1186–e1192. Finally, repeated checking of inhaler technique is important. we learn: 10% of what we read 20% of what we hear 30% of what we see 50% of what we see and hear 70% of what we say 90% of what we say and do
  79. 79. Contributory Factors: Non-Adherence to Treatment Hedlin G, E. RJ 2010;36:196-201 Very young children are frequently and inappropriately left to take their asthma medication unsupervised. Orrell-Valente JK, Pediatrics 2008; 122: e1186–e1192. Finally, repeated checking of inhaler technique is important. 1) Please read 2)Please do Trick of the trade
  80. 80. % increase 30 minutes post salbutamol inhalation 70 - 60 - 50 – 40 – 30 – 20 – 10 – 0 18 asthmatic children FEV1 FVC Mouthpiece (MP) versus Facemask (FM) For Delivery of Salbutamol in Children With Asthma Exacerbation. Kishida M. J Asthma 2002;39:337-9 MP FM MP FM 56.4% 28.9% 34.4% 7.5% * p<0.05 * *
  81. 81. % increase 30 minutes post salbutamol inhalation 70 - 60 - 50 – 40 – 30 – 20 – 10 – 0 18 asthmatic children FEV1 FVC Mouthpiece (MP) versus Facemask (FM) For Delivery of Salbutamol in Children With Asthma Exacerbation. Kishida M. J Asthma 2002;39:337-9 MP FM MP FM 56.4% 28.9% 34.4% 7.5% * p<0.05 * * Trick of the trade: train the child to use the mouthpiece as soon as possible
  82. 82. How to use an MDI with a spacer
  83. 83. How to use an MDI with a spacer …………spray 1+1 (2) spruzzi al mattino …………spray 1+1 (2) spruzzi alla sera
  84. 84. How to use an MDI with a spacer Tira su, tira su, tira su ……………………………………………… … tira su.
  85. 85. Inhaled corticosteroids for asthma: impact of practice level device switching on asthma control. Thomas M, BMC Pulm Med 2009; 9: 1. 2 – 1 – 0 1.92 in the switched cohort OR for unsuccessful treatment p < 0.001 2-year retrospective matched cohort study used the UK General Practice Research Database to identify practices where ICS devices were changed without a consultation individually matched with patients using the same ICS device who were not switched. Asthma control over 12 months after the switch compared with controls
  86. 86. Instruct the patient to recognize the effect by the color of the device
  87. 87. Attilio Boner University of Verona, Italy attilio.boner@univr.it  Introduction  Establishment of a partnership  The problem of adherence  Effective use of devices  Written action plans  Effective use of controller medications  Effective use of quick-relief medications  Environment control  Oxidative stress reduction and diet  Addressing co-morbidities  Monitoring the child asthma  Summary and Conclusions How to get Asthma Control: from PubMed to the Tricks of the Trade
  88. 88. WAPs should include not only instructions in case of deterioration but importantly recommendations for daily management, which remains the most effective means to prevent exacerbations in children. Use of WAPs should be tested for their efficacy, not only in improving patient compliance and asthma control, but also for improving healthcare professionals’ adherence to recommendations and dispensing of the WAP. Ducharme FM, Curr Opin Allergy Clin Immunol. 2008;8(2):177-88 Definition of written action plan (WAP)
  89. 89. Written action plans for asthma: an evidence-based review of the key components. Gibson GP. Thorax 2004;59:94-9. Individualised complete written action plans must contain each of the following four components of an action plan: – when to increase treatment (action point); – how to increase treatment; – for how long; – when to seek medical help. a level of symptoms or lung function 70–85% of the personal best or pred. PEF value
  90. 90. Written action plan symptom-based vs PEFR 4 studies (355 ch) Written action plan use significantly: 1) Reduced acute care visits, 2) Reduced missed school days, 3) Reduced nocturnal awakening, 4) Improved symptom scores. Systematic review of randomized controlled trials examining written action plans in children: what is the plan? Zemek RL, Arch Pediatr Adolesc Med 2008; 162:157–163. 1) Charlton I, BMJ.1990;301:1355. 2) Wensley D, AJRCCM. 2004;170:606. 3) Letz KL, Ped Asth All Immunol. 2004;17:177. 4) Yoos HL, Ann All Asth Immunol. 2002;88:283
  91. 91. A Low-Literacy Asthma Action Plan to Improve Provider Asthma Counseling: A Randomized Study Yin H S, Pediatrics. 2016;137:e20150468
  92. 92. A Low-Literacy Asthma Action Plan to Improve Provider Asthma Counseling: A Randomized Study Yin H S, Pediatrics. 2016;137(1):e20150468  119 providers were randomly assigned (61 low literacy, 58 standard)  Physicians at 2 academic centers randomized to use a low-literacy or standard action plan to counsel the hypothetical parent of child with moderate persistent asthma (regimen: -Flovent 110 μg 2 puffs twice daily, -Singulair 5 mg daily, -Albuterol 2 puffs every 4 hours as needed) 90 – 80 – 70 – 60 – 50 – 40 – 30 – 20 – 10 – 00 % providers more likely to use times of day (eg, Flovent morning and night) 100 - 96.7% p<0.001 51.7% The low-literacy plan Standard plan
  93. 93. A Low-Literacy Asthma Action Plan to Improve Provider Asthma Counseling: A Randomized Study Yin H S, Pediatrics. 2016;137(1):e20150468  119 providers were randomly assigned (61 low literacy, 58 standard)  Physicians at 2 academic centers randomized to use a low-literacy or standard action plan to counsel the hypothetical parent of child with moderate persistent asthma (regimen: -Flovent 110 μg 2 puffs twice daily, -Singulair 5 mg daily, -Albuterol 2 puffs every 4 hours as needed) 90 – 80 – 70 – 60 – 50 – 40 – 30 – 20 – 10 – 00 % providers recommend spacer use (eg Albuterol) 83.6% p<0.001 43.1% The low-literacy plan Standard plan
  94. 94. A Low-Literacy Asthma Action Plan to Improve Provider Asthma Counseling: A Randomized Study Yin H S, Pediatrics. 2016;137(1):e20150468  119 providers were randomly assigned (61 low literacy, 58 standard)  Physicians at 2 academic centers randomized to use a low-literacy or standard action plan to counsel the hypothetical parent of child with moderate persistent asthma (regimen: -Flovent 110 μg 2 puffs twice daily, -Singulair 5 mg daily, -Albuterol 2 puffs every 4 hours as needed) 90 – 80 – 70 – 60 – 50 – 40 – 30 – 20 – 10 – 00 % providers using explicit symptoms (eg, "ribs show when breathing," ) 100 - 54.1% p<0.001 3.4% The low-literacy plan Standard plan OR=33.0
  95. 95. Empowering the child and caregiver: yellow zone Asthma Action Plan. Dinakar C, Curr Allergy Asthma Rep. 2014;14(11):475. 100% lung function Symptoms’ perception
  96. 96. Empowering the child and caregiver: yellow zone Asthma Action Plan. Dinakar C, Curr Allergy Asthma Rep. 2014;14(11):475. 100% lung function Symptoms’ perception The yellow zone 2 weeks
  97. 97. Empowering the child and caregiver: yellow zone Asthma Action Plan. Dinakar C, Curr Allergy Asthma Rep. 2014;14(11):475. Yellow Zone Strategies: Repetitive use of inhaled SABA (from 2 to 4 puffs to 6 to 10 puffs based on the severity of the episode) Scheduled dosing step-up: increasing total ICS dose per 24 h (e.g., quadrupling or higher doses of ICS) Dynamic dosing step-up: ICS along with reliever SABA use ICS-LABA-adjustable maintenance dosing (AMD) ICS ≥ 4 X
  98. 98. Attilio Boner University of Verona, Italy attilio.boner@univr.it  Introduction  Establishment of a partnership  The problem of adherence  Effective use of devices  Written action plans  Effective use of controller medications  Effective use of quick-relief medications  Evironment control  Oxidative stress reduction and diet  Addressing co-morbidities  Monitoring the child asthma  Summary and Conclusions How to get Asthma Control: from PubMed to the Tricks of the Trade
  99. 99. Quantifying the proportion of severe asthma exacerbations attributable to inhaled corticosteroid nonadherence. Williams LK, J Allergy Clin Immunol 2011;128:1185–91. 298 asthmatics ICS adherence estimated from electronic prescription and fill information changes in ICS adherence over time and effect of this changing pattern of use on asthma exacerbations (need for oral corticosteroids, an asthma- related emergency department visit, or an asthma-related hospitalization) % asthma exacerbations 30 – 20 – 10 – 00 - attributable to ICS medication non-adherence. 24%
  100. 100. Quantifying the proportion of severe asthma exacerbations attributable to inhaled corticosteroid nonadherence. Williams LK, J Allergy Clin Immunol 2011;128:1185–91. 298 asthmatics ICS adherence estimated from electronic prescription and fill information changes in ICS adherence over time and effect of this changing pattern of use on asthma exacerbations (need for oral corticosteroids, an asthma- related emergency department visit, or an asthma-related hospitalization) 0.61 patients with adherence > 75% of the prescribed dose vs patients with adherence ≤25% HR for asthma exacerbations 1.0 – 0.5 – 0.0
  101. 101. Trends in preventive asthma medication use among children and adolescents,1988-2008. Kit BK, Pediatrics. 2012;129:62e69. a cross-sectional analysis of preventive asthma medication (PAM) use 2499 children aged 1 to 19 years with current asthma data from the National Health and Nutrition Examination Survey (NHANES) during 3 time periods: 1988-1994, 1999-2002, and 2005-2008. PAMs included inhaled corticosteroids, leukotriene receptor antagonists, long- acting β-agonists, mast-cell stabilizers, and methylxanthines compared to white children aOR of PAM use in 0.5 1.0 – 0.5 – 0.0 non-Hispanic black Mexican American 0.6
  102. 102. Trends in preventive asthma medication use among children and adolescents,1988-2008. Kit BK, Pediatrics. 2012;129:62e69. a cross-sectional analysis of preventive asthma medication (PAM) use 2499 children aged 1 to 19 years with current asthma data from the National Health and Nutrition Examination Survey (NHANES) during 3 time periods: 1988-1994, 1999-2002, and 2005-2008. PAMs included inhaled corticosteroids, leukotriene receptor antagonists, long- acting β-agonists, mast-cell stabilizers, and methylxanthines aOR of PAM use in 12 to 19 year olds 0.5 1.0 – 0.5 – 0.0 compared to 1-11 years old children
  103. 103. Low Rates of Controller Medication Initiation and Outpatient Follow-Up after Emergency Department Visits for Asthma. Andrews AL, J Pediatr 2012;160:325  Retrospective cohort study.  ED visit for asthma.  3435 patients aged 2-18 yrs. 40 – 30 – 20 – 10 – 0 % children who had a prescription for ICS after the ED visit & attended a follow-up appointment. 5.2%
  104. 104.  Retrospective cohort study.  ED visit for asthma.  3435 patients aged 2-18 yrs. 40 – 30 – 20 – 10 – 0 % children who had a prescription for ICS after the ED visit & attended a follow-up appointment. 5.2% Children with asthma seen in the ED have low rates of ICS use & outpatient follow-up. Prescribe ICS in the ED and organize a follow-up visit. Low Rates of Controller Medication Initiation and Outpatient Follow-Up after Emergency Department Visits for Asthma. Andrews AL, J Pediatr 2012;160:325
  105. 105.  Retrospective cohort study.  ED visit for asthma.  3435 patients aged 2-18 yrs. 40 – 30 – 20 – 10 – 0 % children who had a prescription for ICS after the ED visit & attended a follow-up appointment. 5.2% Children with asthma seen in the ED have low rates of ICS use & outpatient follow-up. And call the patient if he is not presenting to the follow-up visit. Low Rates of Controller Medication Initiation and Outpatient Follow-Up after Emergency Department Visits for Asthma. Andrews AL, J Pediatr 2012;160:325
  106. 106. Dose Response of Inhaled Corticosteroids in Children With Persistent Asthma: A Systematic Review Zhang L. Pediatrics 2011;127:129-38  Systematic review and meta-analysis  Randomized controlled trials comparing ≥2 doses of ICSs  children 3-18 years with persistent asthma.  To compare moderate (300–400 μg/day) with low (≤200 μg/day BDP-equivalent) doses of ICSs. There was no significant difference between moderate and low doses of ICSs in terms of efficacy
  107. 107. Dose Response of Inhaled Corticosteroids in Children With Persistent Asthma: A Systematic Review Zhang L. Pediatrics 2011;127:129-38  Systematic review and meta-analysis  Randomized controlled trials comparing ≥2 doses of ICSs  children 3-18 years with persistent asthma.  To compare moderate (300–400 μg/day) with low (≤200 μg/day BDP-equivalent) doses of ICSs. There was no significant difference between moderate and low doses of ICSs in terms of efficacy Reduce the ICS dose after 3 months of well controlled asthma. Use the lowest ICS dose that maintains asthma under control.
  108. 108. Daily vs. intermittent inhaled corticosteroids for recurrent wheezing and mild persistent asthma: a systematic review with meta-analysis. Rodrigo GJ. Respir Med. 2013;107(8):1133-40. 7 trials with a minimum of 8 weeks of daily ICS (daily ICS with rescue SABA during exacerbations) vs. intermittent ICS (ICS plus SABA at the onset of symptoms) 1367 participants RR for asthma exacerbations 0.96 daily vs. intermittent ICS 1.0 – 0.5 – 0.0
  109. 109. Daily vs. intermittent inhaled corticosteroids for recurrent wheezing and mild persistent asthma: a systematic review with meta-analysis. Rodrigo GJ. Respir Med. 2013;107(8):1133-40. Pooled relative risk for percent asthma free days Pooled relative risk for percent recue medications If the child/parents have good perception of symptoms you can use intermittent strategy. If not, use the daily strategy.
  110. 110. The risk of asthma exacerbation after stopping low-dose inhaled corticosteroids: A systematic review and meta-analysis of randomized controlled trials Rank MA. J Allergy Clin Immunol. 2013;131(3):724-9.  7 trials with a mean follow-up of 27 weeks RR for an asthma exacerbation in patients who stopped ICSs 2.35 P <0.001 3 – 2 – 1 – 0 compared with those who continued
  111. 111. The risk of asthma exacerbation after stopping low-dose inhaled corticosteroids: A systematic review and meta-analysis of randomized controlled trials Rank MA. J Allergy Clin Immunol. 2013;131(3):724-9.  7 trials with a mean follow-up of 27 weeks RR for an asthma exacerbation in patients who stopped ICSs 2.35 P <0.001 3 – 2 – 1 – 0 compared with those who continued Provide the parents with a symptom diary and organize a follow-up spirometry within a month if you stop treatment
  112. 112.  182 children (6 to 17 yrs of age), who had uncontrolled asthma while receiving 100 µg of fluticasone twice daily;  16 weeks: 250 µg of fluticasone twice daily (ICS step-up), 100 µg of fluticasone plus 50 µg of a long-acting beta-agonist twice daily (LABA step-up), or 100 µg of fluticasone twice daily plus 5 or 10 mg of a leukotriene- receptor antagonist daily (LTRA step-up). Step-up Therapy for Children with Uncontrolled Asthma Receiving Inhaled Corticosteroids Lemanske NEJM 2010;362:975 Relative probability of best response vs LTRA step-up 1.6 P=0.004 2 – 1 – 0 LABA step-up
  113. 113. Relative probability of best response vs ICS step-up 1.7 P=0.002 2 – 1 – 0 LABA step-up Step-up Therapy for Children with Uncontrolled Asthma Receiving Inhaled Corticosteroids Lemanske NEJM 2010;362:975  182 children (6 to 17 yrs of age), who had uncontrolled asthma while receiving 100 µg of fluticasone twice daily;  16 weeks: 250 µg of fluticasone twice daily (ICS step-up), 100 µg of fluticasone plus 50 µg of a long-acting beta-agonist twice daily (LABA step-up), or 100 µg of fluticasone twice daily plus 5 or 10 mg of a leukotriene- receptor antagonist daily (LTRA step-up). 2X
  114. 114. Pairwise comparisons of the three step-up therapies Step-up Therapy for Children with Uncontrolled Asthma Receiving Inhaled Corticosteroids Lemanske NEJM 2010;362:975
  115. 115. Pairwise comparisons of the three step-up therapies Step-up Therapy for Children with Uncontrolled Asthma Receiving Inhaled Corticosteroids Lemanske NEJM 2010;362:975Always maintain a certain degree of uncertainty and evaluate objectively the effects of your choices Oxford University
  116. 116. OR for receiving ≥6 prescription for SABA every year 2 - 1 – 0 1.8 A retrospective observational study comparing rescue medication use in children on combined versus separate long-acting β-agonists and corticosteroids Elkout H. Arch Dis Child. 2010;95:817-21 In children reiving LABA+ICS vs LABA & ICS  40 primary care practices for the years 2002–6  10 454 children with received at least one prescription for asthma medication +
  117. 117. OR for receiving ≥6 prescription for SABA every year 2 - 1 – 0 1.8 A retrospective observational study comparing rescue medication use in children on combined versus separate long-acting β-agonists and corticosteroids Elkout H. Arch Dis Child. 2010;95:817-21 In children reiving LABA+ICS vs LABA & ICS  40 primary care practices for the years 2002–6  10 454 children with received at least one prescription for asthma medication + Only prescribe fixed-dose LABA-&-ICS combination deevices!
  118. 118. Loss of asthma control in pediatric patients after discontinuation of long-acting Beta-agonists. R O'Hagan A, Pulm Med. 2012;2012:894063. 54 children with moderate-to-severe persistent asthma after switching from combination (ICS/LABA) to monotherapy with ICS. mean followup of 10.7 weeks % children with loss of asthma control leading to addition of leukotriene receptor antagonists, increased ICS, or restarting LABA. 40 – 30 – 20 – 10 – 0 37%
  119. 119. Loss of asthma control in pediatric patients after discontinuation of long-acting Beta-agonists. R O'Hagan A, Pulm Med. 2012;2012:894063. 54 children with moderate-to-severe persistent asthma after switching from combination (ICS/LABA) to monotherapy with ICS. mean followup of 10.7 weeks % children with loss of asthma control leading to addition of leukotriene receptor antagonists, increased ICS, or restarting LABA. 40 – 30 – 20 – 10 – 0 37% Provide the parents with a symptom diary and organize a follow-up spirometry within a month if you stop treatment
  120. 120. Pre-treatment by omalizumab allows allergen immunotherapy in children and young adults with severe allergic asthma Lambert N, Pediatr Allergy Immunol. 2014;25:829-832 Asthma control and therapeutic level for the four periods. SCIT, Subcutaneous allergen-specific immunotherapy; BDP, Equivalent of beclomethasone dipropionate; LAT, Long-acting theophylline.
  121. 121. Pre-treatment by omalizumab allows allergen immunotherapy in children and young adults with severe allergic asthma Lambert N, Pediatr Allergy Immunol. 2014;25:829-832 Asthma control and therapeutic level for the four periods. SCIT, Subcutaneous allergen-specific immunotherapy; BDP, Equivalent of beclomethasone dipropionate; LAT, Long-acting theophylline. Consider the opportunity to start immunotherapy in a child on omalizumab treatment.
  122. 122. Attilio Boner University of Verona, Italy attilio.boner@univr.it  Introduction  Establishment of a partnership  The problem of adherence  Effective use of devices  Written action plans  Effective use of controller medications  Effective use of quick-relief medications  Environment control  Oxidative stress reduction and diet  Addressing co-morbidities  Monitoring the child asthma  Summary and Conclusions How to get Asthma Control: from PubMed to the Tricks of the Trade
  123. 123. Asthma Guidelines recommend early treatment of asthma exacerbation as ‘‘key in management’ Reddel HK, Am J Respir Crit Care Med. 2009;180:59-99 Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. 1) earlier recognition of an impending exacerbation 2) coupled with earlier augmentation of treatment at home to avoid therapy delays A strategy to reduce exacerbations might be: Parents report a vast number of symptoms observed in their children before an exacerbation. •Beer S, Arch Dis Child. 1987;62:345-8. •Rivera-Spoljaric K, J Pediatr 2009;154:877-81, e4. •Yoos HL, J Pediatr Health Care 2005;19:197-205. •Garbutt J, Ann Allergy Asthma Immunol 2009;103:469-73.
  124. 124. 134 children with bronchial asthma Mean age 7.0 years (range 1-5-14 years). A standardised questionnaire recording the symptoms that preceded the attack of asthma completed by the parents. Prodromal features of asthma Beer S, Arch Dis Child 1987;62:345 % children with prodromal symptoms and/or signs 70.4% 80 – 70 – 60 – 50 – 40 – 30 – 20 – 10 – 0 (95/134)
  125. 125. 134 children with bronchial asthma Mean age 7.0 years (range 1-5-14 years). A standardised questionnaire recording the symptoms that preceded the attack of asthma completed by the parents. Prodromal features of asthma Beer S, Arch Dis Child 1987;62:345 % children with prodromal symptoms and/or signs 70.4% 80 – 70 – 60 – 50 – 40 – 30 – 20 – 10 – 0 (95/134) Respiratory symptoms (cough, rhinorrhoea, and wheezing). Behavioural changes (irritability, apathy, anxiety, and sleep disorders). Gastrointestinal symptoms (abdominal pain and anorexia). Others: fever, itching, skin eruptions, and toothache.
  126. 126.  Parents of children (n=101) 2 to 12 years old with asthma exacerbations that required urgent care in the past 12 mo.  Telephone questionnaires to describe antecedent symptoms and signs of asthma exacerbations noticed by parents and to learn when and how parents intensify asthma treatment. Respiratory symptoms 24% % Signs and Symptoms Preceding Exacerbations Cold Behaviour change Other nonspecific symptoms 80 – 70 – 60 – 50 – 40 – 30 – 20 – 10 – 0 29% 43% 79% Detection and home management of worsening asthma symptoms. Garbutt J. Ann Allergy Asthma Immunol 2009;103:469
  127. 127. Cough Treatment was Most Often Intensified When the Parent Noticed Shortness of breath Wheeze 60 – 50 – 40 – 30 – 20 – 10 – 0 55% 54% 25%  Parents of children (n=101) 2 to 12 years old with asthma exacerbations that required urgent care in the past 12 mo.  Telephone questionnaires to describe antecedent symptoms and signs of asthma exacerbations noticed by parents and to learn when and how parents intensify asthma treatment. Detection and home management of worsening asthma symptoms. Garbutt J. Ann Allergy Asthma Immunol 2009;103:469
  128. 128. Cough Treatment was Most Often Intensified When the Parent Noticed Shortness of breath Wheeze 60 – 50 – 40 – 30 – 20 – 10 – 0 55% 54% 25%  Parents of children (n=101) 2 to 12 years old with asthma exacerbations that required urgent care in the past 12 mo.  Telephone questionnaires to describe antecedent symptoms and signs of asthma exacerbations noticed by parents and to learn when and how parents intensify asthma treatment. Detection and home management of worsening asthma symptoms. Garbutt J. Ann Allergy Asthma Immunol 2009;103:469 Cold is not considered an allarming sign by parents !
  129. 129. Nonrespiratory symptoms before loss of asthma control in children. Newton L, JACI Pract 2013;1:304  Caregivers of children aged 2 to 11 years with asthma.  Diary cards daily for 16 weeks during cold and flu season.  Likert scale from 1 to 5 (3 represented baseline or usual; 1 or 2, less than usual; and 4 or 5, more than usual).  Multiple nonrespiratory (NR)  Upper respiratory (UR) signs and symptoms.  Mood changes (MC)  Lower respiratory tract (LR).  Loss of asthma control (LOC) Percentage of days with a nonusual symptom before and during a LOC episode (≥2 consecutive days with LR symptoms)
  130. 130. Nonrespiratory symptoms before loss of asthma control in children. Newton L, JACI Pract 2013;1:304  Caregivers of children aged 2 to 11 years with asthma.  Diary cards daily for 16 weeks during cold and flu season.  Likert scale from 1 to 5 (3 represented baseline or usual; 1 or 2, less than usual; and 4 or 5, more than usual).  Multiple nonrespiratory (NR)  Upper respiratory (UR) signs and symptoms.  Mood changes (MC)  Lower respiratory tract (LR).  Loss of asthma control (LOC) Percentage of days with a nonusual symptom before and during a LOC episode (≥2 consecutive days with LR symptoms) changes in behavior (moody, irritability, tension) and appearance (dry skin, eye swelling, sunken eyes) can be present 3 days before an exacerbations
  131. 131. Difficulty in obtaining peak expiratory flow measurements in children with acute asthma. Gorelick MH, Pediatr Emerg Care 2004;20:22-6. 65% 70 – 60 - 50 - 40 - 30 – 20 – 10 – 0 % of children aged 5 to 18 years able to complete PEF or FEV1 during an exacerbation456 children (age 6-18 years old) treated in a pediatric ED for an acute exacerbation of asthma PEFR in all children age ≥ 6 years among children < 5 years, these maneuvers were almost impossible
  132. 132. Brown Asthma Visual Analogue Scale Pictorial visual analogue scale for rating severity of childhood asthma episodes. Fritz J. Asthma 1994;31:473 None A tiny A little Some Quite Alot Very much at all bit a bit terrible ALB Trick of the trade for extimating the child of perception an asthma exacerbation at home of the child
  133. 133. Criteria for categorizing the severity of asthma exacerbations Camargo CA, J Allergy Clin Immunol. 2009;124(2 Suppl):S5-14
  134. 134. Criteria for categorizing the severity of asthma exacerbations Camargo CA, J Allergy Clin Immunol. 2009;124(2 Suppl):S5-14 1,2,3,4,5,6,7,8,9,10,….
  135. 135. Criteria for categorizing the severity of asthma exacerbations Camargo CA, J Allergy Clin Immunol. 2009;124(2 Suppl):S5-14
  136. 136. Mechanism of reduced blood pressure during inspiration During inspiration the increased negative intrathoracic pressure causes increased right sided venous return to the right atrium and, subsequently, to the right ventricle during diastole. This causes an increase in right ventricular filling pressures because of increased volume and stretch, leading to a bulging of the intraventricular septum towards the left ventricle, thus decreasing the left ventricular size and filling volume due to this protrusion. Thus, there is a subsequently decreased left sided stroke volume and therefore a lower systolic blood pressure. + > 20 mm Hg+
  137. 137. •Severe pulsus paradoxus can easily be palpated in the radial, brachial, or femoral pulses as a weakening or disappearance of the pulse during inspiration (which is usually best observed by watching the rise and fall of the abdomen). •With a sphygmomanometer, the blood pressure is measured in the standard fashion except that the cuff is deflated more slowly than usual. •During deflation, the first Korotkoff sound is audible only during expiration, but with further deflation additional Korotkoff sounds are clearly heard throughout the respiratory cycle. The difference between the systolic pressure at which the first beats are heard and the pressure at which all beats are heard is the size of the pulsus. Trick of the trade measurement of pulsus paradoxus
  138. 138. ED MANAGEMENT OF ASTHMA EXACERBATIONS Camargo CA, J Allergy Clin Immunol. 2009;124(2 Suppl):S5-14 Dosages of drugs for asthma exacerbations ≤ 12 years of age
  139. 139. Caregivers of 82 children with asthma aged 4 to 14 yrs, presenting to the ED with an asthma exacerbation; Home albuterol use was measured using a structured interview guide. 70 – 60 – 50 – 40 – 30 – 20 – 10 – 0 Inappropriate Appropriate Home albuterol use for the current asthma exacerbation was 68% 56/82 32% 26/82 Inappropriate home albuterol use during an acute asthma exacerabtion Clayton K, Ann Allergy Asthma Immunol 2012;109:416 69% (39/56) Undertreating Only 5% overtreating
  140. 140. Caregivers of 82 children with asthma aged 4 to 14 yrs, presenting to the ED with an asthma exacerbation; Home albuterol use was measured using a structured interview guide. 70 – 60 – 50 – 40 – 30 – 20 – 10 – 0 Inappropriate Appropriate Home albuterol use for the current asthma exacerbation was 68% 56/82 32% 26/82 Reasons for incorrect home albuterol use included:  no spacer (17 pts),  overtreating (3 pts),  overreacting (5 pts),  using a controller medicine for quick relief (6 pts). 69% (39/56) Undertreating Only 5% overtreating Inappropriate home albuterol use during an acute asthma exacerabtion Clayton K, Ann Allergy Asthma Immunol 2012;109:416
  141. 141. Caregivers of 82 children with asthma aged 4 to 14 yrs, presenting to the ED with an asthma exacerbation; Home albuterol use was measured using a structured interview guide. 70 – 60 – 50 – 40 – 30 – 20 – 10 – 0 Inappropriate Appropriate Home albuterol use for the current asthma exacerbation was 68% 56/82 32% 26/82 In addition, most children in the entire study population used an albuterol MDI (52%) but were giving only 2 puffs (63%) instead of 4-6-8 puffs suggested by Guidelines 69% (39/56) Undertreating Only 5% overtreating This finding suggests some concern about the use of albuterol at home!!!!!!! Inappropriate home albuterol use during an acute asthma exacerabtion Clayton K, Ann Allergy Asthma Immunol 2012;109:416
  142. 142. Nota informativa importante concordata con l’Agenzia Italiana del Farmaco (AIFA) ottobre 2014 Paragrafo 4.1 Indicazioni terapeutiche Broncovaleas soluzione da nebulizzare 5mg/mL è indicato nel trattamento del broncospasmo nei pazienti di età superiore ai 2 anni… Paragrafo 4.2 Posologia e modo di somministrazione Bambini da 2 a 12 anni: il dosaggio iniziale deve basarsi sul peso corporeo (da 0.1 a 0.15 mg/Kg per dose), con successiva titolazione fino al raggiungimento della risposta clinica desiderata. La dose non deve mai eccedere i 2.5 mg 3 o 4 volte al giorno per nebulizzazione: Peso corporeo (KG) Dose (mg) Volume di soluzione (mL) N° gocce 10-15 1.25 0.25 5 gtt > 15 2.5 0.5 10 gtt Cordiali saluti Valeas SPA
  143. 143. Nota informativa importante concordata con l’Agenzia Italiana del Farmaco (AIFA) ottobre 2014 Paragrafo 4.1 Indicazioni terapeutiche Broncovaleas soluzione da nebulizzare 5mg/mL è indicato nel trattamento del broncospasmo nei pazienti di età superiore ai 2 anni… Paragrafo 4.2 Posologia e modo di somministrazione Bambini da 2 a 12 anni: il dosaggio iniziale deve basarsi sul peso corporeo (da 0.1 a 0.15 mg/Kg per dose), con successiva titolazione fino al raggiungimento della risposta clinica desiderata. La dose non deve mai eccedere i 2.5 mg 3 o 4 volte al giorno per nebulizzazione: Peso corporeo (KG) Dose (mg) Volume di soluzione (mL) N° gocce 10-15 1.25 0.25 5 gtt > 15 2.5 0.5 10 gtt Cordiali saluti Valeas SPA ?
  144. 144. Safety of Continuous Nebulized Albuterol for Bronchospasm in Infants and Children Katz RW, Pediatrics 1993;92:666-9 incidence of cardiotoxicity 19 infants (mean age 20.7 ± 3.8 months) who receive continuous nebulized albuterol (CNA) for bronchospasm. ADM=admission Dose of albuterol during continuous nebulization.
  145. 145. The Dilemma of Albuterol Dosing for Acute Asthma Exacerbations in Pediatric Patients Arnold Chest 2011;139:472 For moderate- severity exacerbations, six (60%) of 10 completing the question reported using CNA doses that exceed current expert guidelines.  Nebulized albuterol doses recommended by expert consensus guidelines for exacerbations in children ≤ 12 yrs of age are “ 0.15-0.3 mg/kg up to 10 mg every 1-4 hours as needed, or 0.5 mg/kg/hour by continuous nebulization.”  Continuous nebulized albuterol (CNA) dose (10 mg/h = 2 mL Broncovaleas sol 0.5%).  We administered an Internet-based questionnaire to respiratory care directors of the Child Health Corporation of America.
  146. 146. Trick of the trade with MDI use in acute asthma Only half of patients regularly used a holding chamber with their MDI. Scarfone R, Pediatrics. 2001;108:1332e1338. Multiple studies have demonstrated the effectiveness of albuterol delivery using a holding chamber with an MDI when compared with using an MDI alone. Brown PH, Thorax. 1990;45:736e739. Lipworth BJ. Thorax. 1995;50:105e110. Newman SP, Thorax. 1984;39:935e941. Selroos O, Thorax. 1991;46:891e894. Camargo CA, JACI. 2009;124(2 Suppl):S5-14
  147. 147. Beta-agonists through metered-dose inhaler with valved holding chamber versus nebulizer for acute exacerbation of wheezing or asthma in children under 5 year of age: a systematic review with meta-analysis Castro-Rodriguez JA. J Pediatr 2004;145:172-7 6 trials (n=491) OR for hospital admission in MDI+spacer vs nebulizers 0.42 ALL PATIENTS 0.27 PATIENTS WITH MODERATE-SEVERE EXACERBATIONS 1.00 – 0.75 – 0.50 – 0.25 – 0
  148. 148. Holding chambers (spacers) versus nebulisers for beta- agonist treatment of acute asthma. Cates CJ, Cochrane Database Syst Rev. 2013 Sep 13;9:CD000052 1897 children and 729 adults 39 trials: 33 from emergency room and community settings, 6 trials on inpatients with acute asthma Relative Risk of hospital admission for spacer versus nebuliser 1.0 – 0.5 – 0 0.94 0.61 to 1.43 Adults Children 0.71 0.47 to 1.08
  149. 149. Holding chambers (spacers) versus nebulisers for beta- agonist treatment of acute asthma. Cates CJ, Cochrane Database Syst Rev. 2013 Sep 13;9:CD000052 1897 children and 729 adults 39 trials: 33 from emergency room and community settings, 6 trials on inpatients with acute asthma Relative Risk of hospital admission for spacer versus nebuliser 1.0 – 0.5 – 0 0.94 0.61 to 1.43 Adults Children 0.71 0.47 to 1.08 The mean duration in the ED for children given nebulised treatment was 103 minutes, and for children given treatment via spacers ≤33 minutes
  150. 150.