Professor Anthony O Regan Consultant Physician Galway University Hospital Irish Thoracic Society Interstitial Lung Clinical Advisory Group
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1 Professor Anthony O Regan Consultant Physician Galway University Hospital Irish Thoracic Society Interstitial Lung Clinical Advisory Group
2 2014 ` ILD Group meeting 1 st Site Ethics Approval First Data Entered Registry Nurse ITS ILD Group proposes Registry CFRI (Godfrey Fletcher & Ed McKone) Pharma: Unrestricted Grant Jan ILD Group Registry Proposal OpenApp Meeting Data Sheets approved at ITS ASM Ethics Application Test Site (GUH) Registry Built (OpenApp) Sept 2016 Site 3-5 Ethics Approval Committee Meeting More Amendments Meeting OpenApp Service Fees agreed Site 2 Ethics Approval Multidisciplinary Steering Committee established: Decision to focus on IPF Amendments to ethics, data sheets, & site folders Meeting OpenApp Jan-Apr 2017 Site 6 Ethics Submitted Final Registry Sign off All Sites Ethics Amendments Sept st Data Reported ASM Nov 2017
3 Objectives: Galway University Hospital Clinical Features & Prognosis of IPF in Ireland Framework to evaluate management of IPF Develop reliable datasets to advocate for patient care Promote Research in IPF Limerick Integrate with International Registries / Groups XXX Regional Hospital Broaden focus to general ILD (overtime) Embed & Resource Governance Steering Group / Protocols / Audit Structure Ensure a National Registry using Specialist Centres Cork University Hospital Ensure reliable Data Collection St Vincent s Hospital Mater Hospital Adelaide & Meath Hospital
4 Reality of Capturing Data on Clinical Sites Lesson 1 Feasible focused Data Sets All Interstitial Diseases vs Specific Disease (IPF) Establish Clinical Advisory / Steering Group buy in Prioritise Specific Aims & Objectives Chair: Vice-Chair: Secretary: CNS Rep: External: Member : Dublin Member: Prof. A O Regan, Galway University Hospital, Galway. Dr. Michael Henry, Cork University Hospital, Wilton, Cork. Ms. Suzanne McCormack, CEO, Irish Thoracic Society Ms. Bernadette Bowen CNS; Ms Lindsay Browne Dr. Colin Edwards, CEO, Merlin Consulting Ltd., Dublin. Ms. Carita Bramhill, St. Vincent s University Hospital, Ms. Nicola Cassidy, Irish Lung Fibrosis Association, Dublin
5 Reality of Capturing Data on Clinical Sites Lesson 1 Feasible focused Data Sets All Interstitial Diseases vs Specific Disease (IPF) Establish Clinical Advisory / Steering Group buy in Prioritise Specific Aims & Objectives
6 Reality of Capturing Data on Clinical Sites Lesson 2 Simplify Process of Data Collection Protocols & Site Folders (NCT registry) Clear Guidelines on Consent & Data Storage Facilitate Data Collection & Entry Proforma ILD Nurse IRISH THORACIC SOCIETY ILD REGISTRY CONTENTS PAGE 1. Contact list 2. Delegation log 3. Site personnel Curriculum Vitae 4. Protocol 5. Ethics: A) Application B) Amendments C) Ethics Correspondence 6. Patient Information Leaflet and Consent Form 7. Staff Training Log 8. Recruitment Log 9. Note to File 10. Correspondence 11. Education Literature 12. Auditing TheIrishThoracicSociety(ITS) InterstitialLungDiseaseRegistryofIreland The$Irish$Thoracic$Society$Interstitial$Lung$Disease$Registry$of$Ireland$(ILDRI)$ CONSENT$FORM$ InformationforPatients You$are$being$invited$to$take$part$in$a$project$to$develop$a$patient$registry$(the$Irish$Thoracic$ Thispurposeofthisregistryandconsent Society$Interstitial$Lung$Disease$Registry$of$Ireland)$for$people$with$Interstitial$Lung$ Disease$ (ILD)$which$includes$Idiopathic$Pulmonary$Fibrosis$(IPF).$You$are$being$invited$to$formhasbeenexplainedtome.Ihave take$part$ read,orhadreadtome,thisconsent because$you$have$idiopathic$pulmonary$fibrosis.$it$is$important$that$you$read$the$ following$ from.ihavehadtheopportunitytoask information$about$why$the$registry$is$taking$place$and$what$it$entails,$before$you$decide$ questionsandallmyquestionshave whether$or$not$to$take$part.$ beenansweredtomysatisfaction $ IbelieveIunderstandwhatwillhappenif Please$read$the$following$information$carefully$and$discuss$it$with$others$if$you$wish.$ You$are$ Iagreetobepartofthisregistry. also$free$to$ask$us$any$questions$you$may$have$or$to$clarify$anything$you$may$not$ understand.$ Do$take$the$time$to$decide$whether$or$not$you$wish$to$take$part$in$this$project.$ IunderstandthatIcanwithdrawfrom thisregistryatanytime WhatistheITSInterstitialLungDiseaseRegistryofIreland? Ifreelyandvoluntarilyagreetobepart The$ITS$Interstitial$Lung$Disease$Registry$collects$and$analyses$information$relating$ to$health$ ofthisregistry,thoughwithoutprejudice and$wellbeing$of$people$with$ild$including$idiopathic$pulmonary$fibrosis$in$ireland.$ Information$ tomylegalandethicalrights. relating$to$the$prevalence,$incidence$and$treatment$of$idiopathic$pulmonary$fibrosis$will$be$ stored$in$the$registry.$the$information$is$held$on$a$secure$and$confidential$computer$ database.$ Ihavereceivedacopyofthisagreement andiunderstandacopywillbekeptby The$development$and$maintenance$of$the$registry$is$led$by$the$Irish$Thoracic$Society$ with$ theprincipalinvestigatoratthisstudy support$from$boehringer$ingelheim$ireland.$ site. $ WhyhaveanInterstitialLungDiseaseRegistry?? NamePrincipalInvestigator Since$Interstitial$Lung$Disease,$which$includes$Idiopathic$Pulmonary$Fibrosis,$affects$a$relatively$ Name small$number$of$people,$by$creating$this$registry,$we$can$compile$information$to$ advance$ HospitalSite education$and$facilitate$research$on$the$disease.$by$analyzing$the$data$we$collect,$ we$will$be$ better$able$to$see$what$actions$are$successful$and$how$treatments$affect$different$ people.$ From$there,$doctors$can$better$help$contribute$to$the$quality$of$care$of$persons$with$Idiopathic$ ILDRegistryOffice: Pulmonary$Fibrosis.$ Prof.AnthonyO Regan,IrishThoracic WhatinformationiskeptintheITSInterstitialLungDiseaseRegistryofIreland?? Society,BrookfieldHouse,Brookfield The$information$collected$will$resemble$that$collected$in$a$general$doctor$or$hospital$ visit:$ Terrace,Blackrock,CoDublin demographics,$height,$weight,$pulmonary$function$tests,$respiratory$cultures$and$any$other$ tests$carried$out.$the$registry$will$also$store$information$on$any$drugs$taken$or$treatments$ given$as$well$as$any$complications$that$arise.$$ $ DoIhavetotakepart? It$is$your$decision$to$take$part$or$not$take$part$in$the$InterstitialLungDiseaseRegistry?.$Your$ care$will$not$be$affected$in$any$way$if$you$choose$to$not$take$part.$if$you$do$decide$ to$take$part,$ you$will$be$given$this$information$sheet$to$keep$and$will$be$asked$to$sign$a$consent$ form.$$ $ InterstitialLungDiseaseRegistryofIreland, CanIchangemymindlater? IrishThoracicSociety, If$you$agree$to$take$part$in$the$Interstitial$Lung$Disease$registry,$you$may$choose$to$withdraw$at$ any$point$in$the$future$without$providing$a$reason.$any$information$stored$on$you$ will$then$be$ BrookfieldHouse,BrookfieldTerrace Blackrock CoDublin Participants*Name:* Participants*Date*of*Birth:* Signature*of*Participant:* Date:* * Name*of*consentor:* Signature*of*consentor:* Relationship*to*participant:* Date:* Statement$of$Investigators$responsibility:$ Ihaveexplainedthenature,purpose,procedures,benefits,risksof alternativesto,thisregistry.ihaveofferedtoansweranyquestionsand fullyansweredsuchquestions.ibelievethattheparticipantunderstands myexplanationsandhasfreelygiveninformedconsent.* Signature*of*physician:* Date:* Theoriginalconsentformshouldbeplacedintheparticipantsmedical records,onecopymaybegiventotheparticipant,andonecopykeptbythe principalinvestigatoratthestudysite..*
7 Reality of Capturing Data on Clinical Sites Lesson 3 Working with Patient Organisations Irish Lung Fibrosis Association (ILFA) Irish Lung Health Alliance Seek input & Provide Patient Updates Develop Audit Structures (data protection)
8 Registry Comparison UK UK Ireland Incidence (prevalence) 6000/yr ( ) 400/year (1-2000) estimate Data Capture % of new cases / yr 3% of all cases Age Gender (male) 76% 69% 155?? 6-12% of cases New diagnosis? Smoker (Ex) 70% 58% Female data FHx 7% 19% Higher MDT 92% 80% lower Definite 42% New verson Biopsy 13% 10% (44% if cryobx) similar FVC (50-80%) 57% (<50%: 4%) 52% (<50%: 2%) similar DLCO (36-55%) 47% (<36%: 24%) 52% (<36% 26%) similar Anti-fibrotic 45% 72% NICE
9 Thank you Suzanne McCormack Steering Group Bridget Mulholland (ILD Nurse) OpenApp Cystic Fibrosis Registry Godfrey Fletcher & Ed McKone Boehringer Ingelheim (John Barron) Roche Pharmaceuticals (Denise Eggleston)
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