REG Adherence Working Group Meeting 26/09/15

DATE: SATURDAY SEPTEMBER 26TH
VENUE: Wyndham Apollo Hotel, Amsterdam
ROOM: Boardroom
TIME: 13.00–14.30PM
CHAIR/WORKING GROUP LEAD:
Eric van Ganse: PharmacoEpidemiology Lyon (PEL)
Respiratory Medicine, Croix Rousse University Hospital, Lyon, France
UMR CNRS 5558, Claude-Bernard University, Lyon, France
ADHERENCE WORKING
GROUP MEETING

Alexandra Dima, Faculty of Social and Behavioural Sciences,
University of Amsterdam, Amsterdam, The Netherlands
Bidirectional Adherence Study Update

The study
• Title: Exploring the bidirectional relationship between
database markers of asthma treatment adherence and
asthma-related outcomes
• Research team:
REG collaborators RiRL [data extraction]
Gene Colice (Lead Investigator)
David Price
Alexandra Dima
Hilary Pinnock
Iain Small
Cynthia Rand
Michelle Eakin
Janet Holbrook
Miguel Román Rodríguez
Eric van Ganse
Randy Brown
Alison Chisholm
Julie von Ziegenweidt
Utrecht University [Phase I]
Ellen Koster
Patrick Souverein
NIVEL [Phase II]
Marcia Vervloet

Study design
• Dataset: Optimum Patient Care Research Database
(OPCRD)

Inclusion / Exclusion criteria
• Inclusion Criteria:
• 3 years of continuous records (1 prior & 2 after IPD)
• Physician-diagnosed asthma ≥ 1 year prior to IPD
• Aged ≥6 years at IPD (i.e. ≥5 years at time of diagnosis)
• First ICS prescription at IPD via MDI or DPI
• On active asthma therapy (≥ 2 prescriptions for ICS and/or
SABA at different points during each outcome year)
• Exclusion Criteria:
• Any prescriptions for LABA, combination ICS/LABA
therapy, and/or LTRA during the baseline year
• Received maintenance oral steroids during
baseline year

Measures
• ICS adherence
• Asthma outcomes:
• Moderate-to-severe exacerbations
• Risk domain asthma control
• Overall asthma control
• Treatment stability
• Prescription-derived mean daily SABA dosage
• Prescription-derived controller to total asthma meds ratio
• Covariates:
• At IPD: age, gender, BMI, smoking status, device type, ICS
dosage, ICS drug, asthma duration, comorbidities, etc.
• Prior to baseline: any ICS prescription

Analyses
• Phase I: Feasibility evaluation

Analyses
• Phase II: Longitudinal evaluation
o Cross-lagged panel models
o Hierarchical longitudinal models

ICS adherence
• The new consensus-based taxonomy
Vrijens et al. 2012
DOI: 10.1111/j.1365-2125.2012.04167.x

CMA I & II
CMA I method CMA II method
Characteristic No. of
patient
s
No. of
episode
s
Adherence%
(mean, SD)
Adherence
≥ 80%
No. of
patien
ts
No. of
episodes
Adherence%
(mean, SD)
Adherence
≥ 80%
Full 2-year follow-up period
90 day gap * 13 922 24 924 88.9 (12.9) 78.8%
Sensitivity analysis for permissible gap:
30 day gap 13 922 38 339 97.3 ( 4.5) 99.0%
182 day gap 13 922 18 603 79.7 (19.4) 55.3%
Follow-up period by time interval, using 90 day gap:
0-12 months 13 922 18 337 89.0 (14.8) 76.1%
12-24 months 12 419 14 309 89.1 (15.6) 75.6% 12 419 14 218 87.2 (16.7) 71.4%
0-6 months 13 922 14 623 90.2 (15.5) 77.9%
6-12 months 10 828 10 942 92.1 (15.0) 82.7% 10 828 10 938 87.3 (18.4) 72.0%
12-18 months 10 635 10 752 92.4 (14.5) 83.5% 10 635 10 744 87.2 (18.2) 71.5%
18-24 months 11 267 11 759 90.3 (15.7) 78.4% 10 444 10 552 87.5 (18.4) 72.7%
0-8 months 13 922 15 732 89.6 (15.5) 76.7%
8-16 months 11 479 12 041 89.9 (15.8) 77.5% 11 479 12 000 87.0 (17.5) 70.8%
16-24 months 11 267 11 759 90.3 (15.7) 78.4% 11 267 11 723 87.4 (17.9) 72.2%

Variation in adherence – 2yrs, 90-day gap

Variation in adherence – 6-mo intervals

Asthma control
• Moderate-to-severe exacerbations
o Asthma-related hospitalizations / ED attendance
– Asthma A&E or hospits
– COPD/respiratory-related/generic hospits +
Lower_respiratory_consultation (excl: lung function
test)
 Lower Respiratory read codes (incl. asthma, COPD, LRTI)
 Asthma/COPD review codes (excl: monitoring letter codes)
 Lung function, asthma monitoring
o OCS prescriptions
! If within 1 week – 1 event

Asthma control
• Risk domain asthma control
o No moderate-to-severe exacerbations
o No AB + evidence of respiratory review (± 7days)
– Lower_respiratory_consultation
– Any additional respiratory examinations, referrals, chest
x-rays or events
o Asthma-related outpatient attendance
• Overall asthma control
o + SABA dose ≤200mcg salbutamol / ≤500mcg terbutaline
• Treatment stability
o + no add-on therapy / 50% dose increase

Asthma control
• Individual elements
Number of patients per 1 yr (N=13922)
Baseline yr FU yr 1 FU yr 2 All FU
Asthma hospit 46 (0.4%) 101 (0.7%) 85 (0.6%) 164 (1.2%)
COPD hospit 5 (<0.1%) 12 (<0.1%) 10 (<0.1%) 22(0.16%)
Resp hospit 39 (0.3%) 106 (0.8%) 91 (0.7%) 175(1.26%)
≥ 1 OCS Rx event 1207 (8.7%) 2392 (17.2%) 1969 (14.1%) 3473(25%)
≥ 1 rAB Rx event 1272 (9.1%) 1913 (13.7%) 1699 (12.2%) 2982(21.4%)
Any of the above 5229(37.6%)
Max per person per year – 10 OCS & 7 rAB events
Max per person per 2yrs – 19 OCS & 11 rAB events

Next steps for AC markers
• Read codes & computation procedure for each
marker – to clarify details?
• Are hospitalizations less recorded in OPCRD?
• To merge different types of events OR consider
outcomes individually (e.g. OCs)?

Next steps
• Phase I – finish report & paper (end October)
o + ICPE & ERS posters; ESPACOMP oral presentation
• Phase II – 6 months planned after end of Phase I

Alexandra Dima, Faculty of Social and Behavioural Sciences,
University of Amsterdam, Amsterdam, The Netherlands
ASTRO-LAB Model of Asthma
Adherence Determinants

https://prezi.com/md6w9_noynia/asthma-model-of-care-11-june-2015/

Alison Chisholm, REG
Barcelona Adherence Expert
Panel Meeting May 2015:
update

Meeting Rational: develop a roadmap for
Respiratory Adherence Research*
Rationale:
• To promote consistency and
comparability of results across
studies and improve the efficiency
and value of adherence research
findings, there is a need to consider
the:
o Current priorities in adherence
research
o Methods used to measure
adherence
o Taxonomy employed in
conceptualizing adherence
behaviours and determinants.
*International Expert Panel Meeting organised by the Respiratory Effectiveness Group with the
support of Teva Pharmaceutical Industries Ltd
The Challenge:
• There is no single determinant of non-
adherence to respiratory therapies
• There is no ‘one-size-fits-all’ intervention to
improve adherence in the eyes of healthcare
professionals and payors.
• Interventions need to be tailored to the
individual needs of each patient.

Barcelona Meeting Panel Members
Chair:
David Price: REG Chairman, Academic Centre of Primary Care, University of Aberdeen, UK
Panel Members:
• Aji Barot: Patient Connect Service Limited,
Surrey, UK
• Richard Costello: Royal College of
Surgeons, Ireland and Beaumont Hospital,
Dublin, Ireland
• Alex Dima: Amsterdam School of
Communication Research ASCoR, University of
Amsterdam, Amsterdam, The Netherlands
• Michelle Eakin: Division of Pulmonary and
Critical Care Medicine, Department of Medicine,
Johns Hopkins School of Medicine, Baltimore,
Maryland
• Juliet Foster: Clinical Management Group,
Woolcock Institute of Medical Research,
University of Sydney, Sydney, Australia
• Jonathan Grigg: Asthma UK Centre for
Applied Research, Centre for Paediatrics,
Blizard Institute, Queen Mary, University of
London, London, UK
• Job van Boven: Department of Pharmacy,
Unit of Pharmaco-Epidemiology &
PharmacoEconomics University of Groningen,
Groningen, The Netherlands
• Thys van der Molen: Primary Care
Respiratory Medicine, University of Groningen,
Groningen, The Netherlands
• Dermot Ryan: Clinical Strategic Advisor at
Optimum Patient Care; EAACI Primary Care
Lead and Research Fellow at University of
Edinburgh, UK
• Bernard Vrijens: Department of Biostatistics
and Medical Informatics, University of Liège,
Liège, Belgium

Agenda: presentations
Session I: “Adherence – What Is It?”
Taxonomy – how do we currently describe adherence in chronic diseases Bernard Vrijens
Understanding adherence within the process of asthma care: the Astrolab model Alexandra Dima
Implications of delivery (mode of delivery) on adherence Thys van der Molen
Adherence challenges in children and the effect on outcomes Jonathan Grigg
Adherence challenges in older populations and the effect on outcomes Richard Costello
Inherent adherence challenges within health system Michelle Eakin
Implications of adherence on health economic outcomes Job van Boven
Session II: “Adherence – How Do We Measure It?”
Measurement of adherence within respiratory RCTs and observational studies Bernard Vrijens
Patient-reported adherence: how to optimize data quality Alexandra Dima
Technology-based approaches to adherence monitoring
Michelle Eakin &
Richard Costello
Session III: “Adherence – How Can We Improve It?”
Role of the clinician in optimizing adherence Dermot Ryan
Role of the pharmacist in optimizing adherence Aji Barot
Interventions with proven effect and potential for scaling up to real-life clinical settings Juliet Foster
System & Payer-driven solutions Michelle Eakin

Meeting Output
Adherence-themed Special Issue of JACI:
In Practice
• Editorial
• 5 papers
1. Terminology / Taxonomy
2. Determinants of Adherence – the
ASTRO-LAB Model
Focus on patient determinants
3. Delivery route & implementation
4. Age & cognition
Focus on HCP- and Payer
determinants
5. The role of the health system, cost-
effectiveness & scalability & health
care professionals
Publication dates:
• Online early Q1 2016
• Special Issue September
2016

Special Issue Overview (I)
Paper Working Title Co-authors
Status & approx.
submission date
Editorial
Introduction to main themes of the
special issue
David Price & ?
• Alison Chisholm to draft
• Additional authors TBC
• Draft to be informed by
content of Papers 1-5
Paper 1
What we mean when we talk about
adherence in respiratory medicine
Bernard Vrijens; David Price; Alex
Dima; Michell Eakin; Juliet Foster;
Job van Boven; Marjin de Bruin;
Eric van Ganse
• Alison Chisholm to draft;
• Vrijens et al
• Full author order TBA.
• Submission mid November
Paper 2
Moving towards a complete map of
medication adherence determinants
within asthma – the ASTRO-LAB Model
Alex Dima; Marjin de Bruin; Eric
van Ganse + ASTRO-LAB
colleagues
• Alexandra Dima to draft
• Draft underway.
• ASTRO-LAB to agree
author order
Paper 3
Patient-level adherence determinants –
Wanting, but unable – the role of inhaler
technique and mode of delivery
David Price; Thys van der Molen;
Victoria Carter & iHARP
Collaborators
• Victoria Carter liaising with
iHARP collaborators
• Full iHARP author list TBC.
Paper 4
7 stages of man – the role of age and
cognition on medication adherence
Richard Costello; Michell Eakin;
Jonathan Grigg; Juliet Foster;
Dermot Ryan
• Richard Costello to draft
• Costello et al?
Paper 5
Freedom within a framework – the role
of the healthcare system on medication
adherence
Job van Boven; Juliet Foster;
Michell Eakin; Aji Barot; Dermot
Ryan
• Job van Boven to draft
• van Boven et al?

Special Issue Overview (I)
Paper Working Title Co-authors
Status & approx.
submission date
Editorial
Introduction to main themes of the
special issue
David Price & ?
• Additional authors TBC
• Draft to be informed by
content of Papers 1-5
Paper 1
What we mean when we talk about
adherence in respiratory medicine
Bernard Vrijens; David Price; Alex
Dima; Michell Eakin; Juliet Foster;
Job van Boven; Marjin de Bruin;
Eric van Ganse
• Alison Chisholm to draft;
• Vrijens et al
Paper 2
Moving towards a complete map of
medication adherence determinants
within asthma – the ASTRO-LAB Model
Alex Dima; Marjin de Bruin; Eric
van Ganse + ASTRO-LAB
colleagues
• Alexandra Dima to draft
• Draft underway.
• ASTRO-LAB to agree
author order
Paper 3
Wanting, but unable – the role of inhaler
technique and mode of delivery
David Price; Thys van der Molen;
Victoria Carter & iHARP
Collaborators
• Victoria Carter liaising with
iHARP collaborators
• Full iHARP author list TBC.
Paper 4
7 stages of man – the role of age and
cognition on medication adherence
Richard Costello; Michell Eakin;
Jonathan Grigg; Juliet Foster;
Dermot Ryan
• Richard Costello to draft
• Costello et al?
Paper 5
Freedom within a framework – the role
of the healthcare system on medication
adherence
Job van Boven; Juliet Foster;
Michell Eakin; Aji Barot; Dermot
Ryan
• Job van Boven to draft
• van Boven et al?
Selected by the Journal Editors as CME papers within the Issue.
Requirements:
• Authors write a short (5 question) multiple-choice exam to accompany
their article
• Complete a AAAAI Information Document for each CME activity

Manon Belhassen & Eric Van Ganse, PharmacoEpidemiology Lyon (PEL)
Respiratory Medicine, Croix Rousse University Hospital, Lyon, France
UMR CNRS 5558, Claude-Bernard University, Lyon, France
“Lyon Adherence Projects”

ADHERENCE IN ASTHMA :
OVER 20 YEARS, FROM FIELD
STUDIES TO COMPUTERIZED
DATA

TODAY, THANKS TO
NATIONAL CLAIMS DATA:
CMA, PERSISTENCE &
TYPOLOGIES

A. Measurement of adherence proxies to anti-
asthma inhaled steroids in French Claims Data
o Primary objective : The main objective was to provide, in
patients treated by given ICs packagings, reference values for
the proportion of days covered during a 12-month period for the
corresponding ICs packagings
o Secondary objective: The secondary objective was to provide
in newly-treated patients reference values for 12-month
persistence to ICs molecules
o Study design:
– An initial historical cohort of ICS-treated asthma patients
– Specific cohorts were then specifically identified from this initial
cohort for each studied dimensions of adherence (CMA,
persistence)
o Data source: EGB (French claims data)

o Inclusion criteria: “new treatment episodes”
o ≥ 3 canisters of the same molecule of ICs consecutively
dispensed between 2007 and 2013 according to the following
rules:
– Dispensed at 2 or 3 different dates
– The time-interval between the first and the third dispensed
canisters will not exceed 120 days (for this computation a
canister was assumed to last 60 days)
– Age 6-40 years at the date of the first dispensed ICs canister
(older patients were excluded)

o CMA
Children
Teenagers
Children&
Teenagers
Women
Men
Adults
Total
N 1,606 538 2,144 1,667 1,285 2,952 5,096
Mean CMA in
% (σ)
58.3
(28.5)
56.1 (28.7) 57.7 (28.6) 51.4 (28.4)
52.7
(28.5)
52.0
(28.4)
54.4
(28.6)
24% of patients had a CMA ≥ 80%
Mean CMA=54.4%

o 12 months non-persistence
Drug classes Children
Teenager
s
Children
&
Teenagers
Women Men Adults TOTAL
Any ICs molecule
314/404
(77.7%)
95/115
(82.6%)
409/519
(78.8%)
379/462
(82.0%)
237/302
(78.5%)
616/764
(80.6%)
1,025/1283
(79.9%)

B. TYPOLOGIES OF TREATMENT
BEFORE HOSPITALIZATION
• Subjects:
o >=3 dispensations of asthma-related medications
during any 12-month window from 2006 to 2013
o Aged between 6 years and 45 years
o Within this cohort, we selected patients who
experienced asthma-related hospitalization defined as
a hospital discharge with asthma (J45 and J46 ICD-
10 codes)

• Typologies:
o Based on recorded drug dispensations, subjects were
categorized on exposure to ICS alone, LABA alone or FDC of
LABA+ICS, in the 12 months before asthma-related
hospitalization
o Cluster and discriminant analyses. Ward’s minimum-variance
hierarchical clustering method was performed using an
agglomerative (bottomup) approach and Ward’s linkage
o At each generation of clusters, samples were merged into larger
clusters to minimize the within-cluster sum of squares or to
maximize the between-cluster sum of squares.

• 20,633 asthma patients : 301(0,45%) with
hospitalization for asthma
• 3 typologies:
o Cluster 1 : 176 patients (58,5%):
– Few treatments!
o Cluster 2 : 108 patients (35,9%) :
– Regular FDC therapy
o Cluster 3: 17 patients (5,7%) :
– Free Combinations IC + LABA (unbalanced)

CONCLUSIONS
• Hospitalization is “the” outcome of interest, if
power allows it
• Interest to “view” (Dutch method, ie graphs)
patterns of use of therapy
• Clustering?
• Determinants?... Answer = PROs + linkage with
computerized datasets
• Interventions? … close/quick/effective
interaction with asthma patients is needed…

Future Projects & Activities
What next for the Group…?

Adherence-related questions in
respiratory research
• Dose management – real-time data transfer (IT),
and effective self-care (patient empowerment)
• Health care professionals – their role in adherence
in respiratory care (and alternatives?)
• Continuity of regular ICS use – changing beliefs of
patients and practitioners (paradigm shift)
• Technology in adherence – how can we optimize
data use for research and clinical purposes

REG Adherence Working Group Meeting 26/09/15

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