This document summarizes the agenda and attendees for an IPF/ILD working group meeting. The meeting will discuss developing and providing feedback on a questionnaire to characterize diagnostic practices for interstitial lung disease globally. Next steps that will be discussed include identifying national leads, translating and adapting the questionnaire for different regions, disseminating the questionnaire through working group networks, and addressing any missing global regions. The goal is to understand real-world diagnostic practices to inform the design of a future study on diagnostic agreement for IPF.

1. 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

2. 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)

3. 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

4. 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

5. 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).

6. 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)

7. 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.

8. 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.

9. 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.

10. 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)
!

11. 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

12. 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.

13. 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

14. Alison Chisholm (REG) & Sherry Danese (Outcomes
Insights)
Questionnaire Development

15. 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

16. 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

17. 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

18. 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

19. REG Survey
Please refer to accompanying survey pdf circulated with these minutes for
the list of questions and question-by-question feedback

20. Luca Richeldi Chair & Group Discussion
Next Steps

21. 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…?

22. 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 LeadContinent 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

23. Study Design Summary
Global Steering Committee
Approval / adaption of
global methodology
Continent / Regional Lead Continent / Regional LeadContinent 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

24. 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

25. 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

26. 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

27. Regional Tailoring (II)
• Other tailoring required?
• Mode of delivery – e-survey sufficient?

28. 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 LeadContinent 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

29. 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

30. 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)
!

31. 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

32. Pause for discussion…
• Feasibility of proposed timelines?
• Next steps…