reg collaborators' meeting
TRANSCRIPT
Saturday May 16th, 16.30-18.00 (MST)Altitude Room; Crowne Plaza, Denver, Colorado
REG Interstitial Lung Disease Working Group Meeting
Saturday May 16th, 7.30-9.00am (MST)Altitude Room; Crowne Plaza, Denver, Colorado
Collaborators’ Meeting
AgendaTime Item Lead
7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair)
7.40–7.55 REG Research: update & call for participation David Price
7.55-8.05
Future Plans: staffing & events update
David Price, Thao Le, Alison Chisholm
• Revised staffing structure: who are your key contacts?• Working Group & Council Structure: who does what?• 2015/16 Events: when will we see you next?
o EAACI Eventso ERS Events – AGM & Council Meetingo 2016 REG Summit
8.05–8.20
Driving Quality Standards• What else should we be doing?
• ERS Vision – “Real Life Evidence”
Nicolas Roche & Group Discussion
8.20–8.35A word from REG’s Supportersinvited Industry perspectives on REG activities & real-life research priorities
REG supporters
8.35–8.50PCORI: New funding source for comparative effective researchFollowed by discussion of additional funding opportunities
Jerry Krishnan (Co-Chair)
8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion
9.00 CLOSE
Richard Martin (REG North Americas Lead)
7.30-7.40am
Welcome & Introductions
David Price (REG Chairman)
7.40-7.55am
Research & Activity Update & Call for participation
Protocol development Data extraction Phase I
(or baseline)Phase II
(or results) Publication
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2013/14 Initiated Studies
Independent risk predictors modeled; risk predictor tool in development. 1 x abstract
Characteristics that predict step-up treatment choice – published. CE outcomes manuscript in print. 3 x abstracts to date
Mapping of different adherence measures over 3 years – complete; bidirectional relationship between adherence & outcomes to commence3 abstracts to date
Analysis complete. Manuscript outline in development: “predictive quality of database outcomes”. 3 x abstracts
Analysis complete; manuscript outline reviewed by steering committee; draft paper by June
Cross-sectional analysis of comorbidities in refractory asthma patients – complete & ms written. Longitudinal analysis of comorbidities associated with os use still to be completed
Collaboration with UK Department of Health. Paper published in Lancet Respiratory Medicine
Diagnostic opportunities
Analysis complete. Manuscript in draft; paediatric abstract presented at REG Regional Summit; Full report at EAACI 2015
Protocol development
Data extraction
Phase I (or baseline)
Phase II (or results)
Publication
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COPD control
2014/15 Initiated Studies
COPD Triple Therapy Protocol developed; Seeking Funding…?
Final voting underway; publication to follow shortly
Working group meeting tomorrow to plan protocol delivery
REALISE ASIA
Longitudinal Asthma Steps. Protocol developed; Funding discussions underway
Proposal to item reduce and validate a reduced item EXACT-PRO. Funding under discussion
Supported Asthma UK to quantify prescribing “Errors” as defined by national asthma deaths registry. 1 x abstract
COPD RISK PREDITCORS: spin off of COPD eosinophils. Ms in final pre-submission stages
Pin board – funding awards
REG CORE FUNDING TO COVER TOP 2 RANKED RESEARCH STUDIES
REG CORE FUNDING TO COVER DATA EXTRACTION (ONLY) FOR
FURTHER 2 HIGHLY-RANKED STUDIES
• Voted REG 2014 Research Pinboard: #1 priority
• Lead Investigator: Jonathan Grigg• The particle size and delivery characteristics of extra-fine
hydrofluoroalkane beclomethasone [EF HFA-BDP] aerosol may be particularly relevant for young children in whom a greater proportion of airways are classified as small (<2mm in diameter)1 and airways resistance is low.
• There are evidence to suggestion that EF HFA BDP is equivalent to CFC fliuticasone (FP) in terms of efficacy and safety in adults and children (5–12 years) with mild-to-moderate asthma.2,3
• Evidence remains lacking as to the role that ICS particle size may play in the management of asthma/wheeze in younger, pre-school (<5 years) children.
1. Leach CL, et al. Eur Respir J. 1998;12:1346–1353.2. Aubier M, et al. Respir Med. 2001;95:212–220.3. Fairfax A, et al. Ann Allergy Asthma Immunol. 2001;86:575–582.
Aims & Objectives• Aim: to improve understanding of the prescribing of
guideline recommended management approaches, and their comparative effectiveness, in the routine care of UK children with wheezing illness in their early (pre-school) years.
• Phase I: a descriptive analysis of treatment patterns in children aged ≤5 years with wheezing illness
• Part II: a comparative effectiveness analysis of guideline-recommended treatment options in pre-school children newly initiating Step 2 therapies:o 3 x 2-way matched comparative effectiveness
analysis: EF ICS, NEF ICS and LTRA vs SABAo Relative benefit of EF ICS vs SABA over alternatives
Study Design
Outcome Measures:• Exacerbations• Database Asthma
control measures• Acute respiratory
events• SABA usage
• Voted REG 2014 Research Pinboard: #2 priority
• Lead Investigator: Nikos Papadopoulos; Clare Murray
• Does the addition of (oral) antibiotics to oral corticosteroids in an acute asthma exacerbation offer benefit in terms of:o Time to next unscheduled GP visit with asthma;o Time to next oral corticosteroid prescription
and use of SABA of the following 6 months?
• Stratified by antibiotic class
• Voted REG 2014 Research Pinboard: #3 priority
• Lead Investigator: Karin Lisspers on behalf of IPCRG’s UNLOCK
• Are pharmacological RCTs relevant to real life asthma populations?
• Aim: Explore to what extent are the inclusion criteria for people with asthma in RTCs representative of real life primary care populations with asthma.
• Method: Compare data from primary care asthma populations at treatment step 2/3 with those meeting the inclusion criteria for the RCTs that underpin key asthma guidelines (i.e. GINA, BTS/SIGN, CTS, AAH).
• Voted REG 2014 Research Pinboard: #6 priority
• Lead Investigator: Björn Ställberg on behalf of IPCRG’s UNLOCK
• The prevalence of comorbidities in COPD patients and their impact on the quality of life and COPD symptoms in primary care patients
• Aim: To enhance knowledge in terms of prevalence of comorbidities in COPD patients and their impact on the quality of life and on COPD symptoms in primary care patients.
• Method: Retrospective cross sectional analysis of primary care data from different countries. Analysis will include descriptive statistics, null hypothesis tests such as Chi-Square, factorial analysis of variance and predictive binary logistic regression models.
Call for participation: Checklist
• Delphi to develop an
optimum & minimum
checklist for “research-
ready” databases
o Optimum checklist
developed in Rotterdam
– wider validation
required
o Delphi item reduction
required to confirm
minimum mandatory
criteria
Events in 2015: Rotterdam & Singapore
REG 2015 Global SummitDate: 22–24 January 2015Rotterdam
REG 2015 Regional SummitDate: 25–26 April 2015Singapore
Publications in 2015• Small Airways Working Group:
o Increased Dose of ICS vs. ICS/LABA for Step-Up Therapy in Asthma1
o Differential effects of ICS in smokers/ex-smokers and non-smokers with asthma2
o Small-particle ICS as first-line or step-up controller therapy in childhood asthma3
• Child Health Working Group:o Initial step-up treatment changes in asthmatic children
already prescribed inhaled corticosteroids: a historical cohort study4
• Breathe Review:o Commissioned review following REG’s 2014
ERS Symposium: Real-world research and its importance in respiratory medicine.5
• REG 2015 Rotterdam Summit Abstract Book6
• ARCH Supplement now OPEN ACCESS
1Israel E, et al. Ann Am Thorac Soc 2015 Mar 10. [Epub ahead of print]; 2Roche N, et al. Am J Respir Crit Care Med 2015;191:960-964; 3Accepted at JACI: In Practice 23 Apr 2015; 4Price D, et al. Breathe. 2015;11:26-38; 5Accepted at Nature, Primary Care Respiratory Journal. 7 Apr 2015; 6Pragmatic and Observational Research. 2015; 6:13—38; 7Ann Am Thorac Soc. 2014;11:Supplement 2
ALL PUBLICATIONS ARE BEING POSTED ONLINE – VISIT THE WEBSITE FOR ON-GOING UPDATES &
AUTHOR GUIDELINES
Symposia activity in 2015• WAAC: April 2015 – done!
• EAACI: June 2015 – 2 x sessions:o Efficacy-based to effectiveness-
based guidelines in asthma: a paradigm shift?
o Harnessing primary care databases to unpick the complexities of allergic obstructive airway disease
• 2015 WAO & APSR session proposals – submitted!
• EAACI 2016 – session accepted
• ERS 2016: 3 x session proposals submitted
• But First…ATS symposium this Wednesday!
AgendaTime Item Lead
7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair)
7.40–7.55 REG Research: update & call for participation David Price
7.55-8.05
Future Plans: staffing & events update
David Price, Thao Le, Alison Chisholm
• Revised staffing structure: who are your key contacts?• Working Group & Council Structure: who does what?• 2015/16 Events: when will we see you next?
o EAACI Eventso ERS Events – AGM & Council Meetingo 2016 REG Summit
8.05–8.20
Driving Quality Standards• What else should we be doing?
• ERS Vision – “Real Life Evidence”
Nicolas Roche & Group Discussion
8.20–8.35A word from REG’s Supportersinvited Industry perspectives on REG activities & real-life research priorities
REG supporters
8.35–8.50PCORI: New funding source for comparative effective researchFollowed by discussion of additional funding opportunities
Jerry Krishnan (Co-Chair)
8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion
9.00 CLOSE
David Price, Thao Le, Alison Chisholm
Future Plans: staffing & events
Staffing: who does what?
John Haughney
David Price
Alison Chisholm
DavidPrice
Trevor Lambert
Nick May
Thao Le
Linh HaymanContracted as
needed
Mylee Durack
Agency providersContracted as needed
Starting June
Zoe Mitchell
When David steps down as REG Chairman, we will be looking to appoint a Chair of Council…
volunteers welcomed!
Strategic Planning
Council responsible for development of an annual strategic plan.
2015 Council Planning Meeting: 25 September 2015
REG Support & Research Funding
RESEARCH IDEA GENERATION
Working Groups Identify Research Priorities in their
respective fields of expertise
SECURING FUNDING
Nature of funding dictates future study course:• Single commercial funding source: an investigator
initiated study conducted external to REG• Non-product/brand specific grant(s): an REG
Collaboration carried by REG or in partnership with REG
REG Supporters
Non-supporter& wider
institutional grants
OR
REG develops idea in collaboration with WG / collaborators &:(i) Seeks external
support(ii) Submits for
REG Core Funding Grant
REG Grants awarded at FY end
REG Core Grants Awarded to Top Priority Ideas
(subject to available funding)
Mid October Core Grant submission
deadline
Ideas prioritised by REG Research Committee
If insufficient REG Funds, continue to look externally
Working Groups
“At a Glance”
Terms of reference drafted; initial project ideas in development
IPCRG’s UNLOCK Group
Inaugural Meeting at EAACI 2015
Well underway – first paper
accepted in April!
Inaugural Meeting in Rotterdam; Checklist
Delphi & Registry Work about to commence
Long-established, successful group, came
under REG in 2014
Still to be established
Committee Meetings Held in Rotterdam
REG/EAACI Taskforce leading current activities
Meeting 7-9am tomorrow
Inaugural meeting 4.30-
6pm today!
Pre-cursor Workshops; Second Workshop 2-
3pm today
Working Group Meeting tomorrow 4-6pm
Inaugural Meeting at EAACI 2015
Met in Rotterdam; study on-going & Expert
(Taxonomy) Meeting at EAACI 2015
Events: what’s coming next…?
BarcelonaJune 2015
First meeting of the Allergy Working Group:2-3pm June 7th, BarcelonaWorking Group Lead: Peter Hellings
First meeting of the Biomarkers Working Group:5-6pm June 7th, BarcelonaWorking Group Lead: Leif Bjermer
Adherence Expert Panel MeetingOne-day focused meeting to develop a Roadmap for Respiratory Adherence ResearchJune 11th, BarcelonaWorking Group Lead: Gene Colice
Adherence Expert Panel Meeting
• International panel of experts to review key topics within respiratory adherence research.
• Present and discuss key issuesand challenges in adherence research
• Meeting structure:o Taxonomyo Placing adherence behaviours in the context of
respiratory careo Considering specific populations and topics. o Measurement – of adherence behaviours, determinants
and capturing accurate datao Opportunities to improve adherence – scalable
interventions with proven effect
• Output: themed issue of:
Adherence Roadmap
Events: what’s coming next…?
Friday September 25th
• REG Annual General Meetingimmediately followed by…
• REG Council Meeting (2016 strategic planning)
+ further working group
meetings
Coming up… REG Summit 2016• Dovetail 2016
Summit with final ASTROLAB symposiumo Day 1:
ASTROLABo Days 2 & 3:
REG WG Meetings & Summit
• Venue: Lyon• Date: Late March /
Early April 2016 (to avoid ATS) – Thurs-Saturday:o 30 March – 2 Aprilo 7–9 Aprilo 14-16 Aprilo 21-23 April
An FP7-supported Project to investigate the safety of asthma
therapy, with a focus on adherence
ASTROLAB: Assessment of Safety of LABAs in Asthma routine Care by Combining Healthcare Databases and Direct Patient Follow-up
Compare severe exacerbations rates in patients with asthma treated by LABAs ± concomitant ICS in routine care
Astrolab Meeting Attendance: 50-100• Regulators
• Scientific societies• Patients
• Health Care Professionals• EU representatives
• Partners and Advisory Boards
Lyon April 2016!
AgendaTime Item Lead
7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair)
7.40–7.55 REG Research: update & call for participation David Price
7.55-8.05
Future Plans: staffing & events update
David Price, Thao Le, Alison Chisholm
• Revised staffing structure: who are your key contacts?• Working Group & Council Structure: who does what?• 2015/16 Events: when will we see you next?
o EAACI Eventso ERS Events – AGM & Council Meetingo 2016 REG Summit
8.05–8.20
Driving Quality Standards• What else should we be doing?
• ERS Vision – “Real Life Evidence”
Nicolas Roche & Group Discussion
8.20–8.35A word from REG’s Supportersinvited Industry perspectives on REG activities & real-life research priorities
REG supporters
8.35–8.50PCORI: New funding source for comparative effective researchFollowed by discussion of additional funding opportunities
Jerry Krishnan (Co-Chair)
8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion
9.00 CLOSE
Nicolas Roche (REG European Lead)
8.05-8.20am
Driving Quality Standards: REG/EAACI Taskforce Update
Quality initiatives: REG/EAACI Taskforce
• Review of the CER asthma literature over the last 10 years
• Focus on key PICOT questions that looking at “gaps” in the evidence
• Development of a quality assessment tool / checklist to appraise the literature
• Identify CER papers that should be considered by guideline developers
• Clarify apparent contradictions in the evidence• Identify as yet unmet research needs
What else should we be doing?• Collaborating with other societies?
AgendaTime Item Lead
7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair)
7.40–7.55 REG Research: update & call for participation David Price
7.55-8.05
Future Plans: staffing & events update
David Price, Thao Le, Alison Chisholm
• Revised staffing structure: who are your key contacts?• Working Group & Council Structure: who does what?• 2015/16 Events: when will we see you next?
o EAACI Eventso ERS Events – AGM & Council Meetingo 2016 REG Summit
8.05–8.20
Driving Quality Standards• What else should we be doing?
• ERS Vision – “Real Life Evidence”
Nicolas Roche & Group Discussion
8.20–8.35A word from REG’s Supportersinvited Industry perspectives on REG activities & real-life research priorities
REG supporters
8.35–8.50PCORI: New funding source for comparative effective researchFollowed by discussion of additional funding opportunities
Jerry Krishnan (Co-Chair)
8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion
9.00 CLOSE
Industries view on real-world research priorities
8.20-8.35am
A Word from REG’s Supporters
AgendaTime Item Lead
7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair)
7.40–7.55 REG Research: update & call for participation David Price
7.55-8.05
Future Plans: staffing & events update
David Price, Thao Le, Alison Chisholm
• Revised staffing structure: who are your key contacts?• Working Group & Council Structure: who does what?• 2015/16 Events: when will we see you next?
o EAACI Eventso ERS Events – AGM & Council Meetingo 2016 REG Summit
8.05–8.20
Driving Quality Standards• What else should we be doing?
• ERS Vision – “Real Life Evidence”
Nicolas Roche & Group Discussion
8.20–8.35A word from REG’s Supportersinvited Industry perspectives on REG activities & real-life research priorities
REG supporters
8.35–8.50New funding opportunities:North American Initiatives and Grants for Implementation Science
Jerry Krishnan (Co-Chair)
8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion
9.00 CLOSE
Jerry Krishnan (REG/ATS Liaison)
8.35-8.50am
PCORI: New funding source for comparative effectiveness research
AgendaTime Item Lead
7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair)
7.40–7.55 REG Research: update & call for participation David Price
7.55-8.05
Future Plans: staffing & events update
David Price, Thao Le, Alison Chisholm
• Revised staffing structure: who are your key contacts?• Working Group & Council Structure: who does what?• 2015/16 Events: when will we see you next?
o EAACI Eventso ERS Events – AGM & Council Meetingo 2016 REG Summit
8.05–8.20
Driving Quality Standards• What else should we be doing?
• ERS Vision – “Real Life Evidence”
Nicolas Roche & Group Discussion
8.20–8.35A word from REG’s Supportersinvited Industry perspectives on REG activities & real-life research priorities
REG supporters
8.35–8.50New funding opportunities:North American Initiatives and Grants for Implementation Science
Jerry Krishnan (Co-Chair)
8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion
9.00 CLOSE
All Collaborators & Attendees
8.50-9.00am
Open discussion: new ideas & feedback
And finally…. Join these REG events
TODAY
TOMORROW
NEXT WEEK…
Saturday May 16th, 16.30-18.00 (MST)Altitude Room; Crowne Plaza, Denver, Colorado
REG Interstitial Lung Disease Working Group Meeting
Have a wonderful ATS…
Thank you for your attention