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REG IPF / ILD Working Group Meeting

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REG ILD Working Group Meeting 140516 San Francisco

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REG IPF / ILD Working Group Meeting

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 14. Alison Chisholm (REG) & Sherry Danese (Outcomes Insights) Questionnaire Development
  15. 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. 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. 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. 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. 19. REG Survey Please refer to accompanying survey pdf circulated with these minutes for the list of questions and question-by-question feedback
  20. 20. Luca Richeldi Chair & Group Discussion Next Steps
  21. 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. 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. 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. 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. 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. 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. 27. Regional Tailoring (II) •  Other tailoring required? •  Mode of delivery – e-survey sufficient?
  28. 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. 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. 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. 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. 32. Pause for discussion… •  Feasibility of proposed timelines? •  Next steps…

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