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ILD Working Group Meeting

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Respiratory Effectiveness Group Interstitial Lung Disease (ILD) Working Group Meeting, held in London during the ERS 2016 Congress.

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ILD Working Group Meeting

  1. 1. INTERSTITIAL LUNG DISEASE WORKING GROUP MEETING CHAIR: Luca Richeldi DATE: Tuesday September 6th TIME: 10-11.30am VENUE: Hotel Novotel London Excel, Western Gateway, London ROOM: Board Room –  Global Characterisation of ILD Diagnostic practice –  Missed Diagnostic Opportunities in IPF
  2. 2. Agenda •  Global Characterisation of ILD Diagnostic Practice o Identifying Participant Sites •  Missed diagnostic opportunities in IPF: retrospective cohort study: o Results Summary
  3. 3. Attendees (RSVPs) Confirmed •  Carole Youakim •  Claudia Valenzuela •  Keertan Dheda (now meeting at 4pm) •  Luca Richeldi •  Maria Molina Molina •  Lurdes Planas •  Pilar Ortega •  Simon Walsh •  Steven Nathan (changed to tentantive) •  Toby Maher (changed to tenatntive) •  Ggiovanni Ferrara •  Vincent Cottin •  Aileen Wang •  Camilo Roa •  Paolo Spagnolo •  David Price •  Paola Rottoli •  Sergey Adveev •  Zuo Jun Xu •  Klaus-Uwe Kirchgaessler (supporter) •  Demosthenes Bouros •  Arata Azuma •  Mariano Maezzi •  Antonio Morais •  Andrew Worsfold •  Alison Chisholm •  Thao Le Dial ins •  Camera Corte (yes) •  Ivan Rosas (possibly) •  Kevin Brown (improbable - time zone issue) •  Andrew Wilson (probable) •  Mike Rosenblyth (supporter) (improbable - timezone issue) Tentative •  Fernando Martinez •  Kevin Flaherty •  Mark Jones •  Martin Kolb •  Ulrich Costabel
  4. 4. GLOBAL ILD DIAGNOSTIC CHARACTERIZATION STUDY
  5. 5. Background (I) •  REG’s focus is real-life research o  Raising the quality and profile of real-life research methodologies o  Using real-life research to address unmet research needs and address gaps in the evidence base •  Efficacious IPF therapies resulted interest in a need to better understand the reality of ILD diagnostic practice to optimise treatment outcomes •  Initial concept – utilise the REG ILD Working Group network to conduct a diagnostic agreement study: o  Discussion around variability in diagnostic agreement within ILD. o  Would a range of MDTs within this network agree on the diagnoses if given the same set of “test cases”
  6. 6. Background (II) •  Questions when designing the agreement study: o  What would be appropriate definition of an MDT? o  What would be the right case mix for inclusion? o  What does real-life diagnostic practice look like? •  There is limited knowledge of how diagnosis takes place outside specialist centres •  As a precursor to evaluating agreement, it’s necessary to understand how ILDs (in particular IPF) are diagnosed in routine care
  7. 7. Agreement Study: Phase I Outputs •  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 Phsae II and future research: o  The Phase II diagnostic agreement/accuracy study o  Future ILD and IPF research (RCT and real-life studies)
  8. 8. 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.
  9. 9. Timeline & Status ATS 2015: first working group meeting, Denver (developed proposal June–Aug) ATS 2016: reviewed draft questionnaire (Updated June; ethics secured June; Global leads invited July/August) ERS, Sept 2015: shared study protocol with working group and potential supporters (Funding secured Oct–Dec 2015)
  10. 10. Timeline & Status ATS 2015: first working group meeting, Denver (developed proposal June–Aug) ATS 2016: reviewed draft questionnaire (Updated June; ethics secured June; Global leads invited July/August) ERS, Sept 2015: shared study protocol with working group and potential supporters (Funding secured Oct–Dec 2015) Application prepared June Approval secured July 24th Obline questionnaire
  11. 11. Timeline & Status ATS 2015: first working group meeting, Denver (developed proposal June–Aug) ATS 2016: reviewed draft questionnaire (Updated June; ethics secured June; Global leads invited July/August) ERS, Sept 2015: shared study protocol with working group and potential supporters (Funding secured Oct–Dec 2015) ERS, Sept 2016: utilise the working group network to identify participant sites & support language translation
  12. 12. Centre Recruitment: principles (I) •  Centre Inclusion: Not restricted to expert / specialist centres; a broad a range of different diagnostic settings will be included •  Objective: The study will help to characterise and describe range and variation in diagnostic practice •  Local Expertise: Local experts will guide participation in their country to ensure a range of relevant healthcare settings / centres are included •  Descriptive study: No conclusions about practice approach prevalence (e.g. what is ‘usual practice’) will be made, i.e.: o  A range of centers in each country is required to reflect the variation in practice within each country o  The selection of participating centers does not need to be representative of practice in that country, overall
  13. 13. Cascade Approach •  Regional Leads will be asked to: o  Provide country lead names •  Country leads will be asked to to: o  Advise as to translation requirements o  Support translation(s) (personally, or nominate colleague) o  Forward to a number of ILD Centres known to them •  Participating centres will be asked to: o  Complete the questionnaire o  Send it to other centres in their network
  14. 14. We are here Cascade Recruitment STEP 1 ACTIONS: CO-PIs Actions Identify Regional Leads / Experts in key global areas: (i) Continental Regions (ii) BRIC Countries STEP 2 ACTIONS: Regional & BRIC Country Leads Identify National Leads or (BRIC) sub-country leads STEP 3 ACTIONS: National & Area Leads (i)Confirm & support language translations (ii) Complete the questionnaire (iii) Send the questionnaire to (e.g.) 10 national ILD centres STEP 4 ACTIONS: ILD Centre Leads (invited at Step 3) (i) Complete the questionnaire (ii) Send the questionnaire to members of their community network
  15. 15. International Roll Out •  Regional/Continent & National (BRIC) Leads: o  Contacted (July); o  Briefed & Confirmed (August) To guide participant centre engagement around the world REGIONAL LEADS GLOBAL REGION CONTACT NAME BRAZIL IVAN ROSAS RUSSIA SERGEY ADVEEV INDIA ZARIR UDWADIA CHINA ZUO JUN XU NORTH AMERICA FERNANDO MARTINEZ KEVIN FLAHERTY EUROPE LUCA RICHELDI SIMON WALSH SOUTH & CENTRAL AMERICA IVAN ROSAS MIDDLE EAST CAROLE YOUAKIM AFRICA KEERTAN DHEDA ASIA-PACIFIC ARATA AZUMA (JAPAN / ASIA) TAMERA CORTE (AUSTRALIA / NEW ZEALAND)
  16. 16. Example approach – Latin America •  Registry efforts in recent years have identified lead contacts for most countries in Latin American (except Bolivia) and Central American •  Each national lead can be contacted and asked how they would envisage contacting their national peers e.g.: o  What resources would they use to identify participants and email addresses, o  How many contacts they have o  How they would recommend we contact those centres) •  Invitations can then be sent to a number (e.g. 20-50) of centres in each country along with the questionnaire link and a cover note outlining the broad objectives of the study •  Turnaround should be relatively rapid and feasible within the proposed 2-month data collection period •  Translation will be important, especially in Brazil, but should be a minor effort to implement
  17. 17. Identification of Country Leads & Participants Help us to: – Identify National Leads – Translate the questionnaire
  18. 18. Translations •  Local language translations will be offered as: o  Necessary in some countries o  Desire standardization of approach across all countries (i.e. translate for all not some) •  Translation support required: o  Preliminary translations can be provided for the following languages, but review and tailoring will be required by a native speaker: –  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 –  Test (in Italian) suggests preliminary translation is ~80% accurate –  Text will be provided in a Word Document that can be edited / corrected o  Where a preliminary translation is not possible; a native speaker must be identified to support •  Questions are clear and straight forward, so forward translation only will be sufficient
  19. 19. IDENTIFYING OPPORTUNITIES FOR EARLIER DIAGNOSIS OF IDIOPATHIC PULMONARY FIBROSIS IN ROUTINE CARE IN THE UK: A HISTORICAL CLINICAL COHORT STUDY A STUDY BY THE RESPIRATORY EFFECTIVNESS GROUP’S INTERSTITIAL LUNG DISEASE WORKING GROUP PRINCIPAL INVESTIGATOR: Prof. Luca Richeldi STUDY REFERENCE: REG-RES1510
  20. 20. Realities of Current IPF Diagnosis 1 2 1. British Lung Foundation: https://www.blf.org.uk/Page/IPF-Patient-differential-diagnosis-of-COPD. (Last accessed February 2016); 2. NHS Choices Pulmonary Fibrosis (idiopathic) (http://www.nhs.uk/conditions/pulmonary-fibrosis/pages/introduction.aspx) (Last accessed February 2016) Figure reproduced from the Inspiration: Idiopathic Pulmonary Fibrosis (IPF) Report February 2016; produced by Action for Pulmonary Fibrosis, BLF and Boehringer Ingelheim (BI)
  21. 21. Look back to move forwards •  Time to look upstream…: o  What happens to patients in the lead up to their diagnosis o  Are opportunities for earlier diagnosis being missed in primary care o  How can non-specialists be supported to help identify potential IPF and earlier referral to specialist care…? •  Identify common patterns (trends) in healthcare resource utilization (HRU) and identify potential “red flags” to to aid earlier diagnosis Diagnosis & potential treatment IPF Management Pre- diagnosis
  22. 22. REG ILD WG Study Aims •  With a view to identifying potential opportunities for earlier referral to specialists and (ultimately) earlier diagnosis of IPF, the study aims to: 1.  Characterise the clinical features of patients at the time of their IPF diagnosis 2.  Evaluate patients’ patterns of HRU in the years preceding their IPF diagnosis 3.  Develop optimum code lists for IPF database research, i.e. variation in 1 & 2 for sensitive versus specific code lists
  23. 23. Collaborators Steering Committee •  Luca Richeldi: University of Southampton, Southampton, UK •  David Price: University of Aberdeen, Aberdeen, UK •  Carlo Vancheri: University of Catania, Catania, Italy •  Christopher Ryerson: University of British Columbia, Vancouver Canada •  Ian Glaspole: Alfred Hospital, Melbourne, Australia •  Ganesh Ragu: University of Washington, Washington, USA •  Kevin Flaherty: University of Michigan Medical School, Ann Arbor, MI, USA •  Vincent Cottin: Claude Bernard Lyon University, Lyon, France •  Toby Maher: National Institute for Health Research (NIHR) Clinician Scientist and Physician on the Interstitial Lung Disease Unit, Royal Brompton Hospital, London, UK •  Andrew Wilson: Norwich Medical School, University of East Anglia, Norwich, UK •  Alan Kaplan: Family Physician Airways Group of Canada, Ontario, Canada •  Martin Kolb: McMaster University, Hamilton, Ontario, Canada •  Simon Walsh: ‎Consultant Thoracic Radiologist at Kings College Hospital, London, UK REG Research Leads •  Alison Chisholm: Chief Scientific Officer, REG, UK •  Anjan Nibber: Researcher, REG, UK •  David Price: REG Founder
  24. 24. Design & data source Design •  Historical follow-up study using electronic medical records and linked questionnaire data from the Optimum Patient Care Research Database (OPCRD) Data source •  The Optimum Patient Care Research Database (OPCRD) is a UK primary care database available to REG: o  Quality-controlled, longitudinal, primary-care database o  Contains anonymous data from ≥550 UK general practices & ~2.5 million patients o  Captured via the OPC asthma and COPD clinical review service –  Respiratory “enriched” database o  Ethical approval for medical research
  25. 25. Study duration & design Study Period: 10-year period (2005–2015) Evaluation Period: will consist of: •  An index date at which patients receive their IPF diagnosis •  Characterisation period: 2-10 years continuous EMR pre diagnosis •  Where available, exploratory outcome period to evaluate time to death Historical evaluation of healthcare resource utilisation Period 2-10 years Index date, i.e. date of: •  Primary analysis: specific IPF diagnosis •  Secondary analysis: broad IPF diagnosis (exploratory analysis of time to death) Evaluation of clinical characteristics at time of diagnosis Post IPF diagnosis
  26. 26. Patient eligibility: inclusion criteria •  A diagnostic (Read) code for IPF o  Specific* IPF Read code o  Broad* IPF Read code •  Diagnosed with IPF between 2005 and 2015 •  ≥2 years’ continuous clinical records in the years immediately preceding their index diagnosis •  Aged ≥40 years or older at index date * Code lists defined on next slide
  27. 27. IPF Read Codes Reviewed by working group members from primary & secondary care and prior experience of IPF research within UK EMRs: Read Code Read Term H563.00 Idiopathic fibrosing alveolitis H563.12 (including: H563.11) Cryptogenic fibrosing alveolitis (Hamman - Rich syndrome) H563z00 Idiopathic fibrosing alveolitis NOS H563300 Usual interstitial pneumonitis H563.13 Idiopathic pulmonary fibrosis XE0Yb Idiopathic pulmonary fibrosis X102v Usual interstitial pneumonitis H563z Idiopathic fibrosing alveolitis NOS H563100 Diffuse pulmonary fibrosis H563200 Pulmonary fibrosis Broad primary analysis Specific primaryanalysis
  28. 28. Patient eligibility: exclusion criteria •  Comorbid*: o  Connective tissue disorder (CTDs) o  Allergic alveolitis o  Sarcoidosis o  Pneumoconiosis o  Asbestosis No additional exclusion criteria will be applied to ensure the study population includes the broadly heterogeneous patient population treated in routine primary care in the UK *Read Code ever during the observation period
  29. 29. Characterization at IPF Diagnosis Patients will be stratified by broad vs specific IPF code and characterized in terms of: •  Demographics •  Lifestyle factors •  Comorbidities: Respiratory, Other •  Obstructive lung disease (OLD) pharmacotherapy in the year preceding index date •  Symptom severity (mMRC) •  Lung function (FVC, FVC %pred, FEV1, FEV1/FVC) •  Obstructive lung disease characteristics: o  COPD GOLD status o  Blood eosinophilia (≥0.5 x 109/ L)
  30. 30. Outcomes: trends in HRU •  Consultations: o  Lower respiratory (LR) consultations o  LR Consultation resulting in a course of antibiotic drugs (on the same day) o  LR Consultation resulting in a course of oral steroids (on the same day) •  Hospitalisations (in-patient attendances) with a code for a: o  LR complaint on the same day o  LR complaint within 14 days •  Chest X-ray / radiology •  Cough •  Therapies o  Prescriptions for antibiotics o  Prescriptions for oral steroids: –  Acute –  Maintenance •  Emergency Room / Accident & Emergency (A&E) attendances coded for a: o  LR complaint on the same day Longitudinal trends in HRU preceding IPF diagnosis: •  10-year annual trends •  2-year quarterly trends (last 2 years before diagnosis)
  31. 31. RESULTS (SUMMARY / ANALYSIS ON-GOING)
  32. 32. Flow Diagram
  33. 33. Clinical features of patients at the time of their IPF diagnosis In this routine care IPF population from the UK: •  Demographics o  Mean age: 72-73 years o  Men accounted for 62-65% of the population o  Approximately 1/3 were never smokers; 2/3 current or ex-smokers •  Comorbidities o  13-25% had obstructive lung disease (13-15% asthma; 19-25% COPD) o  Approximately 50% of patients: –  Had cardiovascular disease (46-53%) –  Consulted for cough (40-52%; ~10% in the 2 years preceding IPF diagnosis) •  Respiratory therapies o  18-26% of patients received ≥1 prescription for SABA in the year preceding IPF diagnosis o  Prescribing of all other obstructive lung disease therapies (ICS, LABA, LAMA, combinations) was low (<10%)
  34. 34. Patterns of HRU in the years preceding their IPF diagnosis •  All markers of respiratory HRU increased annually over the 10-years and quarterly within the last 2 years leading up to patient’s IPF diagnosis: o  Primary care events –  LR consultations, LR antibiotics and oral steroids (acute and maintenance) o  Secondary care attendances –  Hospital admissions, Out patient department attendances, Accident & emergency attendances o  Other: –  Cough events, Chest X-rays, Incidence of pneumonia
  35. 35. Code lists: specific vs broad •  Compared with patients with a “specific” IPF diagnostic code, those with a “broad” diagnostic label were similar in terms of their: o  Demographic presentation at the time of diagnosis o  Escalating trends in HRU in the years preceding IPF diagnosis o  Lung function: Similar mean(SD) FVC: 3.1(6.8) vs. 2.5(0.9) (p=0.405) •  Comorbidities broad IPF patients had: o  Similar burden of: –  Chronic respiratory conditions (incl. asthma; excl COPD); heart failure, rhinitis, bronchiectasis, eczema, osteoporosis, cerebrovascular disease, sleep apnoea, depression and anxiety o  Higher burden of : –  COPD, cardiovascular disease, ischaemic heart disease, Hypertension, diabetes, myocardial infraction, GERD,CKD, lung cancer, cough •  Drug usage: broad IPF patients had higher use of short-acting bronchodilator therapy in the year preceding IPF diagnosis (26 vs 18%)

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