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DATE: MAY 14TH
VENUE: Westin St Francis, Union Square ROOM: Olympic Room TIME: 1:00AM-1.00PM CHAIR: Luca Richeldi, Professor of Respiratory Medicine, Chair of Interstitial Lung Disease, University of Southampton, UK
IPF/ILD WORKING GROUP MEETING
Agenda
TIME TOPIC LEAD 11.00-11.15 Study Concept / Overview Luca Richeldi
11.15-12.30 Questionnaire Development & Group Feedback
Alison Chisholm Sherry Danese
12.30-13.00
Next Steps: • Identification of National Leads • Questionnaire local translation /
adaptation • Questionnaire dissemination via the
working group network • Identifying and Addressing “missing”
global regions • Timelines
Group; Luca (Chair)
Attendees (based pre-meeting RSVPs)
• Aileen David Wang • Camillo Roa • David Price • Simon Walsh • Luca Richeldi • Toby Maher • Kevin Flaherty • Fernando Martinez • Sherry Danese • Neil Barth • Pauline Bianchi • Mike Rosenbluth • Hal Collard • Kaissa de Boer
• Arata Azuma • Shiniti Sasak • Kevin Brown • Tamera Corte • Ian Glaspole • Bruno Crestani • Vincent Cottin • Manuela Funke • Paolo Spagnolo • Mariano Mazzei • Silvia Quandrelli • Pilar Rivera • Alison Chisholm • Thao Le
Apologies • Carlo Vancheri • Michael Keane • Maria Molina Molina
Luca Richeldi (Southampton, UK) on behalf of co-Pis: Fernando Martinez (New York, USA); Kevin Flaherty (Ann Arbor, USA); Simon Walsh (Radiology; London, UK) & Jeff Myers (Pathology; Ann Arbor, USA)
Global evaluation of MDT diagnosis in the real-world
Background • A broad survey is required to establish a picture of routine
diagnostic practice.
• A two-phase study is proposed: o Phase I: First characterise diagnostic practice in different
geographical areas (in terms of composition, functionality, etc.).
o Phase II: Design a diagnostic agreement and accuracy study involving centres that reflect real-world practice (with particular interest in agreement of IPF diagnosis).
Outputs: Phase I • Characterise the ILD diagnostic process globally,
especially in countries/territories where little is currently known.
• Provide valuable insight as to current diagnostic practices to inform the robust design of Phase II.
• Develop a characterised global network of ILD centres for engagement in: o The Phase II diagnostic agreement/accuracy study o Future ILD and IPF research (RCT and real-life studies)
Outputs: Phase II
• Evaluate agreement and accuracy of ILD MDT diagnosis across a range of global sites and healthcare settings
• Identify features of current MDT diagnostic practice associated with accurate diagnosis (including the effect of bronchoscopic sampling for diagnosis)
• Produce a series of best practice recommendations to optimise the pathway to accurate ILD diagnosis for future practice.
Link with REG
• Characterising real-world clinical practice and evaluating effectiveness (not drug efficacy)
• REG has a proven track record in delivering real-world research on behalf of international stakeholder groups (to date primarily in asthma and COPD)
• REG is a not-for-profit organisation; all research funding is used in the most cost-effective way possible.
Geographical Scope
• Building on prior work,1-2 the study will include: o Dedicated and non-dedicated ILD centres o Countries within both mature and expanding
economies o All continents and key global regions.
• Of particular interest will be features of practice in Brazil, Russia, India and China (the “BRIC” countries) owing to their limited representation in previous studies and large population size.
1. Flaherty KR, et al. Am J Respir Crit Care Med 2004;170:904–910; 2. Kevin R. et al. Am J Respir Crit Care Med. 2007; 175: 1054–1060.
Design: country selection (not exhaustive)
• Inclusive approach
• All countries and participants involved in the diagnosis of ILD eligible for inclusion
• For operational feasibility the following continents, countries will be prioritised for inclusion.
Continent / Region Country Proposed Lead Collaborator
Europe
UK Luca Richeldi (Southampton) Italy Carlo Vancheri (Catania) France Vincent Cottin (Lyon) Germany Jürgen Behr (Munich) Greece Demosthenes Bouros (Athens) Russia Sergey Avdeev (Moscow) Scandinavia Elisabeth Bendstrup (Aarhus, Denmark) Belgium Wim Wuyts (Leuven) Netherlands Jan Grutters (Utrecht) Spain / Portugal Ferran Morell & Maria Molina Molina (Barcelona, Spain)
North America USA Kevin Flaherty (Ann Arbor) & Fernando Martinez (New York)
Canada Charlene Fell (Calgary) ± Chris Ryerson (Vancouver) ± Martin Kolb (Ontario)
South America Brazil
Ivan Rosas (Colombia) Argentina Chile
Asia
Japan Arata Azuma China Zuo Jun Xu (Beijing) India Zarir Udwadia (Bombay) Middle East Carole Youakim (Beirut, Lebanon)
The Philippines Camilo Roa, Aileen David-Wang Australasia Australia Tamara Corte (Sydney) Africa South Africa Keertan Dheda (Cape Town)
!
Design: site selection (I)
• Lead collaborators within the prioritised countries/regions will provide local expertise on: o Geographical distribution of diagnostic centres
o Weighting of diagnostic case load across centres.
• Through local consortia, networks and professional links, these data collection “nodes” will distribute the survey (and curate responses) within their assigned territory.*
*Industry links and the REG network will be used to engaged appropriate national leads in areas currently “unknown” to the Investigators
Design: site selection (II)
• Pragmatic - “strategic-opportunistic” - site inclusion combining: o Scalable electronic data capture
o Local expertise & broad participation invitation
o Representative range of (ultimately self-selecting) Participants.
Methodology • Expertise of survey respondent: (clinical; pathology; radiology) • Demographics of respondent site: Geographical territory
(continent, country); Practice setting: Diagnostic techniques used in practice
• Patient demographics of respondent site: Number of (IPF and ILD) patients (i) managing and (ii) diagnosing; Referral pattern of patients
• ILD patient management: self- / referred; # physicians seen during diagnostic pathway
• Approach to diagnosis employed by respondent site: specialists involved; diagnostic tools used
• Use of available therapeutics at respondent site • Process of diagnosis: use of MDT; method of seeking specialist
input
Alison Chisholm (REG) & Sherry Danese (Outcomes Insights)
Questionnaire Development
Framing points
• Objective & History – grew out of a desire to conduct an MDT Agreement Study
• Differ from previous diagnostic survey work by:
Study of MDT Practice at 10 ILD Centres
Assessment of the impact of molecular diagnostics – US
centres
Question Identification
1. Reviewed prior surveys & selected relevant questions
2. Added questions particular to this study – structure: o ‘About You’– i.e. respondent characterisation
o ‘About Your Centre’ – e.g. University or Academic hospital (or not)
o ‘About Your ILD Patients’ – e.g. Case load, Case mix, Diagnostic work up
o ‘About Your Diagnostic Practice’ – e.g. Format, Frequency, Participants ‘Your Access to Licensed IPF therapies’ – e.g. Captures potential impact of approach to access to therapy
The ‘KISS’ Approach 1. Keep It Simple and Short: to optimise completion rates, data quality
and ease of translation: o Thematically grouped questions to aid in information recall o Item reduced, e.g. removed duplicates and “nice to know” o Reduced burden on respondents: offered categorical responses
where specific numeric responses were not key o Avoid free text options to improve analyzability
2. Reviewed (and further refined) by co-PIs from a clinical perspective
3. Digitised using a customizable e-survey tool
Provisos
• To characterize current practice around the world, but importantly: o Inform the design of the diagnostic agreement study to
reflect the real-world and avoid bias: – Sites / “diagnostic formats” to include – Case mix
• To be discussed: likely required completion by physicians
REG Survey
Please refer to accompanying survey pdf circulated with these minutes for the list of questions and question-by-question feedback
Luca Richeldi Chair & Group Discussion
Next Steps
Discussion points
• Identification of National Leads • Questionnaire local translation / adaptation • Questionnaire dissemination via the working group
network • Identifying and Addressing “missing” global
regions • Timelines • Others…?
Study Design Summary
Global Steering Committee Local specialist input: (i) Regional survey adaptions (ii) Geographical distribution of diagnostic centres (iii) Case load / mix distribution by centres
Approval / adaption of global methodology
Pragmatic site recruitment:
strategic, inclusive approach
Continent / Regional Lead Continent / Regional Lead Continent Lead
X X
X
X X
X
X
X
X
X
X
National Leads
Engagement of local / regional
diagnostic teams
(dedicated ILD centres
& community based)
local consortia, network and
professional links
Continent Lead
National Leads
Engagement of local / regional
diagnostic teams
(dedicated ILD centres
& community based)
local consortia, network and
professional links
National Leads
Engagement of local / regional
diagnostic teams
(dedicated ILD centres
& community based)
local consortia, network and
professional links
National Leads
Engagement of local / regional
diagnostic teams
(dedicated ILD centres
& community based)
local consortia, network and
professional links
National Leads
Engagement of local / regional
diagnostic teams
(dedicated ILD centres
& community based)
local consortia, network and
professional links
National Leads
Engagement of local / regional
diagnostic teams
(dedicated ILD centres
& community based)
local consortia, network and
professional links
Study Design Summary
Global Steering Committee Approval / adaption of global methodology
Continent / Regional Lead Continent / Regional Lead Continent Lead
X X
X
X X
X
X
X
X
X
X
Continent Lead Local specialist input: (i) Regional survey adaptions (ii) Geographical distribution of diagnostic centres (iii) Case load / mix distribution by centres
National Leads
Geographical reach of meeting attendees
ASIA PACIFIC The Philippines • Aileen David Wang • Camillo Roa Singapore • David Price • Catherine Hutton • Shawna Tan Japan • Arata Azuma • Shiniti Sasak Australia • Tamera Corte • Ian Glaspole(remote)
EUROPE UK • Simon Walsh • Luca Richeldi • Toby Maher • (David Price)
France • Bruno Crestani • Vincent Cottin Germany • Jurgen Behr Switzerland • Manuela Funke Italy • Paolo Spagnolo Spain • Pilar Rivera • Lurdes Planas • Joan Soriano
NORTH AMERICA USA • Kevin Flaherty • Fernando Martinez • Kaissa de Boer • Kevin Brown • Ganesh Ragu
SOUTH AMERICA Argentina • Mariano Mazzei Brazil • Silvia Quandrelli Roche UK • James Mawbray Roche Global • Klaus BI • Claus Justus Genentech • Check with Thao Veracyte • Mike Rosenbluth • Pauline Bianchi • Neil Barth
Continent / Region Country Proposed Lead Collaborator
Europe
UK Luca Richeldi (Southampton) Italy Carlo Vancheri (Catania) France Vincent Cottin (Lyon) Germany Jürgen Behr (Munich) Greece Demosthenes Bouros (Athens) Russia Sergey Avdeev (Moscow) Scandinavia Elisabeth Bendstrup (Aarhus, Denmark) Belgium Wim Wuyts (Leuven) Netherlands Jan Grutters (Utrecht) Spain / Portugal Ferran Morell & Maria Molina Molina (Barcelona, Spain)
North America USA Kevin Flaherty (Ann Arbor) & Fernando Martinez (New York)
Canada Charlene Fell (Calgary) ± Chris Ryerson (Vancouver) ± Martin Kolb (Ontario)
South America Brazil
Ivan Rosas (Colombia) Argentina Chile
Asia
Japan Arata Azuma China Zuo Jun Xu (Beijing) India Zarir Udwadia (Bombay) Middle East Carole Youakim (Beirut, Lebanon)
The Philippines Camilo Roa, Aileen David-Wang Australasia Australia Tamara Corte (Sydney) Africa South Africa Keertan Dheda (Cape Town)
!
Priority Countries & Proposed National Leads
Regional Tailoring (I) Translations: • Google translate (most countries) FOLLOWED BY
National Lead review & revision to ensure appropriateness
• Translations available for: o English – UK; Esperanto; Estonian; Finnish; French; German; Greek;
Gujarati; Hebrew; Hindi; Hungarian; Italian; Japanese; Khmer; Korean; Latvian; Lithuanian; Macedonian; Mongolian; Myanmar; Norwegian; Persian; Polish; Portuguese; Romanian; Russian; Serbian; Slovak; Slovenian; Spanish (Latin America); Spanish (Spain); Swahili; Swedish; Tamil; Thai; Turkish; Ukrainian; Urdu; Vietnamese; Welsh
o Listed in protocol, but not available for auto-translation: Philippines, China
Regional Tailoring (II)
• Other tailoring required?
• Mode of delivery – e-survey sufficient?
Study Design Summary
Global Steering Committee Local specialist input: (i) Regional survey adaptions (ii) Geographical distribution of diagnostic centres (iii) Case load / mix distribution by centres
Approval / adaption of global methodology
Pragmatic site recruitment:
strategic, inclusive approach
Continent / Regional Lead Continent / Regional Lead Continent Lead
X X
X
X X
X
X
X
X
X
X
National Leads
Engagement of local / regional
diagnostic teams
(dedicated ILD centres
& community based)
local consortia, network and
professional links
Continent Lead
National Leads
Engagement of local / regional
diagnostic teams
(dedicated ILD centres
& community based)
local consortia, network and
professional links
National Leads
Engagement of local / regional
diagnostic teams
(dedicated ILD centres
& community based)
local consortia, network and
professional links
National Leads
Engagement of local / regional
diagnostic teams
(dedicated ILD centres
& community based)
local consortia, network and
professional links
National Leads
Engagement of local / regional
diagnostic teams
(dedicated ILD centres
& community based)
local consortia, network and
professional links
National Leads
Engagement of local / regional
diagnostic teams
(dedicated ILD centres
& community based)
local consortia, network and
professional links
Dissemination Plans
Pragmatic site recruitment • Strategic, inclusive approach
• Utilise: o Local consortia o Network
– Working Group – REG wider collaborator group – Supporters
o Professional links o Social Meida – LinkedIn;
• Engage both: o Dedicated ILD centres o Community based centres
Global Coverage… gaps? Continent / Region Country Proposed Lead Collaborator
Europe
UK Luca Richeldi (Southampton) Italy Carlo Vancheri (Catania) France Vincent Cottin (Lyon) Germany Jürgen Behr (Munich) Greece Demosthenes Bouros (Athens) Russia Sergey Avdeev (Moscow) Scandinavia Elisabeth Bendstrup (Aarhus, Denmark) Belgium Wim Wuyts (Leuven) Netherlands Jan Grutters (Utrecht) Spain / Portugal Ferran Morell & Maria Molina Molina (Barcelona, Spain)
North America USA Kevin Flaherty (Ann Arbor) & Fernando Martinez (New York)
Canada Charlene Fell (Calgary) ± Chris Ryerson (Vancouver) ± Martin Kolb (Ontario)
South America Brazil
Ivan Rosas (Colombia) Argentina Chile
Asia
Japan Arata Azuma China Zuo Jun Xu (Beijing) India Zarir Udwadia (Bombay) Middle East Carole Youakim (Beirut, Lebanon)
The Philippines Camilo Roa, Aileen David-Wang Australasia Australia Tamara Corte (Sydney) Africa South Africa Keertan Dheda (Cape Town)
!
Key phases & timelines Study Component Indicative
Timeline
Contracts & Funding
Signing of all contracts & necessary agreements with supporting organisations and study sponsor Q4 2015
Signing of all contracts & necessary agreements with national vendors (as required) Q1 2016
Review / Adaption of Methodology
Steering Committee review & adaption of screening methodology Q1 2016
National/regional validation and/or adaptation (including translation) of screening methodology
Q2 2016
Systematic Data Collection
Commence Q3 2016
Conclude Q4 2016
Analysis Data Cleaning & master file generation Q1 2017
Analysis: full population and stratified by region Q1 2017
Publication Draft Development Q2 2017 Final manuscript submitted Q2/3 2017
Study Phase II Protocol development for Phase II analysis* Q1-Q2 2017
Commencement of Phase II Q3 2017
!
~6-months to agree methodology &
implement regional adaptions
~6-months data collection
~3-months analysis
Publication 3-6 months post analysis sign off
Phase II to commence ≤3 months of Phase I
completion
TODAY
Pause for discussion…
• Feasibility of proposed timelines?
• Next steps…