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Adherence Working Group 2017

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Adherence Working Group Presentation at ERS 2017

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Adherence Working Group 2017

  1. 1. Adherence Working Group Meeting CHAIR: Job van Boven DATE: Saturday 9th September 2017 TIME: 10.50–11.30 VENUE: Melia Milano Hotel, Via Masaccio 19, Milan, Italy
  2. 2. Agenda 1) Update on the current project ‘Improve understanding of the bi- directional causality relationship between asthma outcomes and adherence’. 2) Ideas for future projects - Are they still relevant, feasible, valid and a priority 3) New REG projects that include an adherence component 4) Any new project ideas?
  3. 3. 1) Update on current project Improve understanding of the bi-directional causality relationship between asthma outcomes and adherence
  4. 4. 1) To what extent and in what context adherence may be considered an asthma outcome, or/and a predictor of asthma outcomes. i.e. What is the impact of adherence, and change in adherence, on asthma outcomes, and vice versa?. 2) Clinically meaningful adherence and outcomes thresholds will be explored by treating them as continuous variables and estimating linear/nonlinear relationships and meaningful cut-off points. Aims
  5. 5. Phase I study has been published in JACI Souverein et al. (2017) J Allergy Clin Immunol Pract. 5(2): 448-456
  6. 6. Phase 2. Adherence - outcomes Rx1 Rx2 Gap: 60 days 50 days Interval: 110 days Adherence: 45.5% 50 days Gap: 100 days Rx3 50 days Interval: 50 days Adherence: 100% Interval: 100 days Adherence: 0% New approach – per-prescription-interval Note: possible carry-over not illustrated in this figure
  7. 7. Select homogeneous intervals to be most accurate in estimating bidirectional relation adherence – asthma control Focus on variation in implementation: - exclude gap intervals (0% adherence) (15%) - exclude intervals with 100% adherence (60%) (+ sensitivity analyses performed with binary 0/rest & 100/rest)  Include only intervals with range of adherence (4-99.6%) 94,498 intervals (10,472 patients)  24,102 intervals (7,501 patients) - control: 11,509 (92.7%) of intervals with RDAC=1; 5,882 (56.2%) patients with RDAC=1 during follow-up - adherence: 65.2% (SD=19.7) Phase 2. Adherence - outcomes
  8. 8. Interval level SABA overuse within interval (ref=no) 0.98 (0.75-1.27) SABA overuse lagged (ref=no) 0.96 (0.75-1.22) Adherence within interval 1.01 (1.00-1.01)** Adherence lagged 1.00 (1.00-1.00) Patient level Age 1.00 (0.99-1.00) Gender (ref=female) 1.58 (1.34-1.87)*** BMI (ref=underweight (<18.5)) normal (18.5-25) 1.08 (0.57-2.07) overweight (25-30) 1.08 (0.56-2.09) obese (≥30) 0.90 (0.46-1.77) Smoking history (ref=current) none 1.47 (1.15-1.89)** former 1.61 (1.18-2.19)** Deprivation (ref=Q1 most affluent) Q2 1.21 (0.83-1.77) Q3 1.26 (0.84-1.88) Q4 1.27 (0.85-1.90) Q5 (most deprived) 1.08 (0.70-1.66) Diagnosed with (ref=no) rhinitis 0.74 (0.45-1.21) allergic rhinitis 1.02 (0.74-1.39) hay fever 0.99 (0.69-1.44) gastroesophageal reflux 0.68 (0.41-1.12) COPD 0.52 (0.35-0.78)** other respiratory diseases 0.33 (0.10-1.05) Asthma duration 1.00 (1.00-1.01) CCI (ref=low (≤4)) 0.65 (0.50-0.85)** Type of ICS device (ref=DPI) MDI 0.87 (0.61-1.24) BAI 1.48 (0.57-3.90) Doses in the device 1.00 (0.99-1.00)* Daily dose 1.07 (1.00-1.15)* Phase 2: adherence - outcomes
  9. 9. Same Occurrence of ≥1: (ref=no) Asthma-related hospitalizations -0.20 (12.0) Respiratory-related hospitalizations -8.40 (11.2) Asthma-related hospitalizations & emergency visits -3.0 (15.3) Prescriptions of acute OCS -5.0 (9.0) Prescription of antibiotics -1.77 (0.64)** Asthma-related outpatient visits -2.32 (1.17)* Moderate to severe exacerbations 3.04 (8.99) SABA overuse (ref=no) -6.68 (0.42)*** -6.69 (0.42)*** Risk domain asthma control (ref=no) 2.18 (0.46)** Previous Occurrence of ≥1: (ref=no) Asthma-related hospitalizations 0.41 (10.4) Respiratory-related hospitalizations -2.80 (9.55) Asthma-related hospitalizations & emergency visits 1.86 (12.5) Prescriptions of acute OCS -6.32 (7.77) Prescription of antibiotics -0.97 (0.64) Asthma-related outpatient visits -1.34 (1.19) Moderate to severe exacerbations 6.21 (7.79) SABA overuse (ref=no) -1.22 (0.44)** -1.21 (0.44)** Risk domain asthma control (ref=no) -0.25 (0.46) … (continued) Phase 2: outcomes – adherence Interval level
  10. 10. …(continued) Patient Age 0.07 (0.01)*** 0.07 (0.01)*** Gender (ref=female) 0.25 (0.36) 0.27 (0.36) BMI (ref=underweight (<18.5)) normal (18.5-25) -1.15 (1.28) -1.10 (1.28) overweight (25-30) 0.59 (1.31) 0.65 (1.32) obese (≥30) 0.16(1.37) 0.20 (1.37) Smoking history (ref=current) none -0.74 (0.58) -0.73 (0.58) former -1.01 (0.71) -1.00 (0.71) Deprivation (ref=Q1 most affluent) Q2 0.94 (0.88) 0.91 (0.88) Q3 2.05 (0.91)* 2.02 (0.91)* Q4 0.51 (0.91) 0.46 (0.91) Q5 (most deprived) 0.96 (0.98) 0.93 (0.98) Diagnosed with (ref=no) rhinitis -0.72 (1.10) -0.74 (1.10) allergic rhinitis -0.11 (0.64) -0.12 (0.63) hay fever -2.63 (0.79)*** -2.62 (0.79)*** gastroesophageal reflux 0.33 (1.22) 0.33 (1.2) COPD 2.75 (1.10)* 2.59 (1.10)* other respiratory diseases 1.35 (3.32) 1.30 (3.32) Asthma duration -0.00 (0.02) -0.00 (0.02) CCI (ref=low (≤4)) 0.12 (0.65) 0.12 (0.65) Doses in the device 0.13 (0.0)*** 0.13 (0.0)*** Daily dose -3.88 (0.15)*** -3.87 (0.15)*** Phase 2: outcomes – adherence Patient level
  11. 11. Phase 2 – preliminary conclusions • Control is weakly associated with higher adherence during the same interval between 2 prescriptions • No lagged effects of adherence on control • Lower adherence is associated with antibiotic use, outpatient visits, and reliever overuse in the same interval • No lagged effects of control (markers) on adherence. Reliever overuse in preceding interval is predictive of lower adherence in the next
  12. 12. Phase 2 – limitations • The control-related event could have happened at the beginning, middle or end of the interval – adherence is assumed stable across the interval  moderator variable time of event within interval? • 100% and 0% adherence intervals are artificially defined based on pre-defined permissible treatment gap and by censoring at the end of the 2-year period.  gap may be too short? • No separation of variance between- and within-patient levels  person-centering may clarify effects?
  13. 13. Phase 2 – next steps • Results to share with scientific committee for interpretation • Discussion of possible publication of findings • Different methodological approaches to test in the future: o Selection of subsamples (type of ICs, >2000 only) o Solutions for considering both persistence and implementation o Testing of different permissible gap values
  14. 14. 2) Current ideas for future studies • Using Pharmacy data to validate adherence measures calculated using UK Prescribing data • Technology-based pragmatic trial grant that would provide an online video inhaler training service. Are they still relevant, feasible, valid and a priority?
  15. 15. 3) New REG projects that include an adherence component 1) Device optimisation for improved adherence and outcomes (Novartis funded study) 2) Child age dependent changes in adherence and associated outcomes. (Child Health WG)
  16. 16. Device optimization for improved adherence and outcomes (Novartis funded study) Phase 1 - Develop a standard setting piece by means of a Delphi exercise to identify and detail what all new types of technologies must do/gather in order to deliver relevant and necessary information. Phase 2 - Study design that could be used to test all new technologies/ combination of technologies. Development of a digital algorithm to predict/detect exacerbations.
  17. 17. Possible questions to address include - How does adherence change with a child’s age? - What outcomes are associated with different adherence patterns/phenotypes? - What predicts a change in year-on-year adherence? Many of these questions will be relevant to adults with asthma and other chronic respiratory conditions, and a multidisciplinary and pan–REG approach could be very productive and lead to improved patient care. Child age dependent changes in adherence and associated outcomes. (Child Health WG)
  18. 18. 3) Any new project ideas? REG research needs that involve adherence- NEED 7. To improve understanding of medication adherence behaviours (including inhaler device challenges) in respiratory and allergic airways disease, their implications on clinical and health economic outcomes and optimised management options NEED 1. To characterise current routine care disease epidemiology and burden for respiratory, allergic and obstructive airways disease outcomes NEED 2. To characterise current routine care prescribing practices (diagnostic and management) and their implications for respiratory and allergic airways disease outcomes
  19. 19. REG special Adherence issues JACI in P 2016
  20. 20. REG special Adherence issues JACI in P 2016
  21. 21. Prioritisation • Are the previous project ideas still: o Relevant? o Feasible? o Valid? o A priority? • How do we set priorities in adherence? • How to we ensure these priorities are pursued? • What are the two most important projects to push forwards?

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