NUI Galway - NUI Galway · NUI Galway - NUI Galway ... Title __
Professor Anthony O’Regan Consultant Physician Galway ... · • `’ILD Group” meeting • 1st...
Transcript of Professor Anthony O’Regan Consultant Physician Galway ... · • `’ILD Group” meeting • 1st...
Professor Anthony O’ReganConsultant Physician
Galway University HospitalIrish Thoracic Society Interstitial Lung Clinical Advisory Group
1st DataReported
ASMNov 2017
• `’ILD Group” meeting
• 1st Site Ethics Approval
• First Data Entered
• Registry Nurse
2014
Jan2016
• ITS ILD Group proposes Registry
• CFRI (Godfrey Fletcher & Ed McKone)
• Pharma: Unrestricted Grant
2015
• ILD Group Registry Proposal
• OpenApp Meeting
• Data Sheets approved at ITS ASM
• Ethics Application Test Site (GUH)
• Registry Built (OpenApp)
Sept2016
• Site 2 Ethics Approval
• Multidisciplinary Steering Committee established: • Decision to focus on IPF• Amendments to ethics, data sheets, & site folders
• Meeting OpenApp
• Site 3-5 Ethics Approval
• Committee Meeting
• More Amendments!!!
• Meeting OpenApp
• Service Fees agreed
Jan-Apr2017
• Site 6 Ethics Submitted
• Final Registry Sign off
• All Sites Ethics Amendments
Sept2017
XXXLimerick Regional Hospital
Galway UniversityHospital
Cork University Hospital
Adelaide & MeathHospital
Mater Hospital
St Vincent’s Hospital
– Objectives:• 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
• Integrate with International Registries / Groups
• Broaden focus to general ILD (overtime)
– Embed & Resource Governance
• Steering Group / Protocols / Audit Structure
– Ensure a National Registry using Specialist Centres
– Ensure reliable Data Collection
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: Prof. A O’Regan, Galway University Hospital, Galway.Vice-Chair: Dr. Michael Henry, Cork University Hospital, Wilton, Cork.Secretary: Ms. Suzanne McCormack, CEO, Irish Thoracic SocietyCNS Rep: Ms. Bernadette Bowen CNS; Ms Lindsay BrowneExternal: Dr. Colin Edwards, CEO, Merlin Consulting Ltd., Dublin.Member : Ms. Carita Bramhill, St. Vincent’s University Hospital, DublinMember: Ms. Nicola Cassidy, Irish Lung Fibrosis Association, Dublin
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
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
!The!Irish!Thoracic!Society!(ITS)!Interstitial!Lung!Disease!Registry!of!Ireland!!
!!
Information!for!Patients!You$are$being$invited$to$take$part$in$a$project$to$develop$a$patient$registry$(the$Irish$Thoracic$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$take$part$because$you$have$Idiopathic$Pulmonary$Fibrosis.$It$is$important$that$you$read$the$following$information$about$why$the$registry$is$taking$place$and$what$it$entails,$before$you$decide$whether$or$not$to$take$part.$$Please$read$the$following$information$carefully$and$discuss$it$with$others$if$you$wish.$You$are$also$free$to$ask$us$any$questions$you$may$have$or$to$clarify$anything$you$may$not$understand.$Do$take$the$time$to$decide$whether$or$not$you$wish$to$take$part$in$this$project.$!What!is!the!ITS!Interstitial!Lung!Disease!Registry!of!Ireland?!The$ITS$Interstitial$Lung$Disease$Registry$collects$and$analyses$information$relating$to$health$and$wellbeing$of$people$with$ILD$including$Idiopathic$Pulmonary$Fibrosis$in$Ireland.$Information$relating$to$the$prevalence,$incidence$and$treatment$of$idiopathic$pulmonary$fibrosis$will$be$stored$in$the$registry.$The$information$is$held$on$a$secure$and$confidential$computer$database.$The$development$and$maintenance$of$the$registry$is$led$by$the$Irish$Thoracic$Society$with$support$from$Boehringer$Ingelheim$Ireland.$$Why!have!an!Interstitial!Lung!Disease!Registry??!Since$Interstitial$Lung$Disease,$which$includes$Idiopathic$Pulmonary$Fibrosis,$affects$a$relatively$small$number$of$people,$by$creating$this$registry,$we$can$compile$information$to$advance$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$Idiopathic$Pulmonary$Fibrosis.$!What!information!is!kept!in!the!ITS!Interstitial!Lung!Disease!Registry!of!Ireland??!The$information$collected$will$resemble$that$collected$in$a$general$doctor$or$hospital$visit:$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.$$$Do!I!have!to!take!part?!It$is$your$decision$to$take$part$or$not$take$part$in$the$Interstitial!Lung!Disease!Registry?.$Your$care$will$not$be$affected$in$any$way$if$you$choose$to$not$take$part.$If$you$do$decide$to$take$part,$you$will$be$given$this$information$sheet$to$keep$and$will$be$asked$to$sign$a$consent$form.$$$Can!I!change!my!mind!later?!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$
The$Irish$Thoracic$Society$Interstitial$Lung$Disease$Registry$of$Ireland$(ILDRI)$
!
!
CONSENT$FORM$
This!purpose!of!this!registry!and!consent!
form!has!been!explained!to!me.!I!have!
read,!or!had!read!to!me,!this!consent!
from.!!I!have!had!the!opportunity!to!ask!
questions!and!all!my!questions!have!
been!answered!to!my!satisfaction!
I!believe!I!understand!what!will!happen!if!
I!agree!to!be!part!of!this!registry.!
I!understand!that!I!can!withdraw!from!
this!registry!at!any!time!
I!freely!and!voluntarily!agree!to!be!part!
of!this!registry,!though!without!prejudice!
to!my!legal!and!ethical!rights.!!
I!have!received!a!copy!of!this!agreement!
and!I!understand!a!copy!will!be!kept!by!
the!principal!investigator!at!this!study!
site.!
Name!Principal!Investigator!!
___________________________!Name!
Hospital!Site!
___________________________!!
ILD!Registry!Office:!!
Prof.!Anthony!O’Regan,!Irish!Thoracic!
Society,!Brookfield!House,!Brookfield!
Terrace,!Blackrock,!Co!Dublin!
!
!
!
!
!
Interstitial!Lung!Disease!Registry!of!Ireland,!!
Irish!Thoracic!Society,!!
Brookfield!House,!Brookfield!Terrace!
Blackrock!
Co!Dublin!
Participants*Name:*
Participants*Date*of*Birth:*
Signature*of*Participant:*
Date:*
*
Name*of*consentor:*
Signature*of*consentor:*
Relationship*to*participant:*
Date:*
Statement$of$Investigators$responsibility:$I!have!explained!the!nature,!purpose,!procedures,!benefits,!risks!of!
alternatives!to,!this!registry.!I!have!offered!to!answer!any!questions!and!
fully!answered!such!questions.!I!believe!that!the!participant!understands!
my!explanations!and!has!freely!given!informed!consent.!*
Signature*of*physician:*
Date:*
The!original!consent!form!should!be!placed!in!the!participants!medical!
records,!one!copy!may!be!given!to!the!participant,!and!one!copy!kept!by!the!
principal!investigator!at!the!study!site.!.!*
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)
Registry Comparison UK 2013-17
UK Ireland
Incidence (prevalence) 6000/yr (25-32000) 400/year (1-2000) estimate
Data Capture 9785-6% of new cases / yr3% of all cases
155??6-12% of cases
New diagnosis?
Age 72 72
Gender (male) 76% 69%
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
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)