How Registries can be used to improve trans-national care
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- Colin Parrish
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1 How Registries can be used to improve trans-national care Initial Funding FP6, 100,000 Euros per annum EuroCareCF Post FP6 Follow up support: 100,000 Euros per annum Unrestricted Grants: Pharma Blue areas: ECFS Registry Dr Anil Mehta has no conflicts or disclosures to declare:
2 Registries Used To COMBAT Disparities in Health Outcomes Origins of the common cystic fibrosis (CF) gene mutant KEY FACT 1: this only happened once, in 1 baby and yet today we have 1:60 carriers in Europe Patterns if you inherit 2 mutants i.e. the CF Population KEY FACT 2: Lack of universal screening at birth, Cost to Europe in lost Parental Productivity Use of Registry to influence policy Die with dignity in full publicity, not silently Gather the best evidence, through registries (Lancet)
3 This baby was a super-survivor against common childhood killers Common Mutation in the cystic fibrosis (CF) gene KEY FACT 1: Only once in human history was a baby was born with 3 adjacent DNA base pairs missing in 1 gene on 1 chromosome 7 Patterns of double carriers i.e. the CF Population KEY FACT 2: Lack of universal screening at birth, Cost to Europe in lost Parental Productivity How can patients fight back against injustice? Die with dignity in full publicity, not silently
4 ATC ATC TTT GGT GT T Ile Ile Phe Gly Val base pairs lost on chromosome 7 in a single gene cftr Fibrogenicum - carrier Baby Fibrogenicus Baby Fibrogenica ATC ATT GGT GT T Ile Ile Gly Val BCE DF508, Phe508del K -10K -2K CE Deaths: Smallpox Diarrhoea Pneumonia TB Malaria Protection? 25% 25% populate the next 100% With an excess number of Phe508del 75% (3 in 4 children died before 6 years of age i.e. no gene transmission) AMAZINGLY TODAY: 1 in 60 Europeans carry this protective chromosome
5 Over generations, the CF F508del-CFTR gene carriers became enriched F508del DF 508 CFTR Picture from DN Sheppard (Bristol) F508del Fibrogenicum s Offspring Out survive Fellow babies FROM 1 INFANT CHILD F508del En passant 1:60 Healthy EU-carrier Citizens Today All offspring inheriting two copies when carriers mated died for years
6 Every ~4000 th baby born pays an early death price EUROPEAN INCIDENCE ~1:4000 WHO Finland 25,000 Turkey <10,000 Sweden 7,300 Poland 6,000 Northern Ireland 5,350 Russian Federation 4,900 Denmark 4,700 Estonia 4,500 Norway 4,500 Netherlands 3,650 Greece 3,500 Spain 3,500 Germany 3,300 Czech Republic 2,833 United Kingdom 2,600 Italy 2,438 France 2,350 Switzerland 2,000 Scotland 1,984 Ireland 1,800 USA 3,500 Percentage of Patients More than 40,000 EU citizens Patients in 5-year Age Groups y 5-10y 10-15y 15-20y 20-25y 25-30y 30-35y 35+y 14 Age Groups Surely, a debt is owed by the member states : From the population entry of a protective gene on chromosome 7 that has kept so many Europeans healthy for thousands of years
7 Patients in 5-year Age Groups Patients in 5-year in 5-year Age Age Groups Groups Percentage of Patients Country A Percentage of Patients Percentage of Patients Country C y 5-10y 10-15y 15-20y 20-25y 25-30y 30-35y 35+y Age Groups y 5-10y 10-15y 15-20y 20-25y 25-30y 30-35y 35+y Age Groups 0-5y 5-10y 10-15y 15-20y 20-25y 25-30y 30-35y 35+y Age Groups Patients in 5-year Age Groups Patients in 5-year Age Groups Percentage of Patients Country B 0-5y 5-10y 10-15y 15-20y 20-25y 25-30y 30-35y 35+y Age Groups Percentage of Patients Country D 0-5y 5-10y 10-15y 15-20y 20-25y 25-30y 30-35y 35+y Age Groups FP6: EurocareCF brought this data to the EU Through a simple quantitative Registry McCormick et al Lancet 2010
8 Interpreting the CF profile of Europe Common Mutation in the cystic fibrosis (CF) gene KEY FACT 1: this only happened once, in 1 baby and yet today we have 1:60 carriers in Europe Divergent patterns of these doubly inherited mutations KEY FACT 2: Lack of universal screening at birth, Does it matter if a child with CF turns up already damaged? Registries again give us an answer How can patients fight back against injustice? Die with dignity in full publicity, not silently Gather the best evidence, through registries (Lancet)
9 Australian experience Newborn screening, yes 75% alive Dijk FN, et al. Improved survival in cystic fibrosis patients diagnosed by newborn screening compared to a historical cohort from the same centre. Archives of disease in childhood. 2011;96(12): No screening 50% Alive 25 years later
10 If 1500 children were kidnapped: Headline News 12% Pre-school Patients in 5-year Age Groups Percentage of Patients % ~1500 Missing pre-school i.e. no newborn screen y 5-10y 10-15y 15-20y 20-25y 25-30y 30-35y 35+y First school Teenage children Age Groups ~ yr 5-10 yr yr yr yr yr yr >35 yr Total
11 Does it cost less not to screen In years 1-7? Newborn screening, yes 75% alive No screening 50% Alive 25 years later
12 100 babies $500 screened >$25,000 p.a. $500-$5000 If unscreened 50:50 split In costs Per-Patient annual cost in US Dollars Sims et al Lancet 2007 Cover Feature Per-Patient annual cost in US Dollars
13 Registries Used To Measure Disparities in Health Outcomes Origins of the common cystic fibrosis (CF) gene mutant KEY FACT 1: this only happened once, in 1 baby and yet today we have 1:60 carriers in Europe Patterns of double carriers i.e. the CF Population KEY FACT 2: Lack of universal screening at birth, Cost to Europe in lost Parental Productivity Can we use this Registry Data to influence policy? How can our experience help you in your goals?
14 How did we get the data? The old way NO EPR patients attended for full day assessment - Annual Review Results handwritten, summary dictated by Consultant and then typed by secretaries.delay Clinic letters and discharge summaries dictated and typed Standard data forms to get the data into analytic audit Excel spread sheet in Registry/Audit
15 In EPR system introduced in Adult CF Unit: Dr Daniel Peckham s new way I N T E G R A T I O Electronic patient record system N Clinical audit programme Improved standards of patient care and outcomes Increased service efficiency
16 Daniel Peckham s key foundations EPR AUDIT Code & structure Defining terms in Snomed CT Talking same language Linking EPR systems Quality, Safety, Better Care
17 Seminar Room all WRs done using EMIS MDT office shared space with full access to EMIS Clinic rooms Seacroft and St James s The Adult ward all the Team use EMIS to run the ward
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19 Daniel has entered the lion s den : his Future??? Leeds CF services moving from PCS to EMIS WEB 5/2014. Testing web for General respiratory medicine / Bronchiectasis / TB / Asthma / PCD: Multi disease platform TODAY AS I SPEAK: Trial in Manchester and Trial in Sheffield Data retrieval and data transfer now much easier.
20 Qu how many of your CF patients have arthritis and what is the pattern of inflammation? Answer 5 min 35 patients 6 Rheumatoid 29 CF related Arthritis Sex distribution Age distribution Any genotype or phenotype data available for export.
21 FP6: value for money Whatever disease you work on AT AN EU Level: Web-based software Open source Flexible add-on modules Easy interface EU level SOLVED: data entry, transmission, error reporting and data extraction European Data Protection compliant Remote Robust Transparent management standards publically available
22 ECFS working with the SME Open App
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24 The vision needs 3 steps 1 Data-Ethics (New Regulations) De-identification Software 2 Research-ready Data SAFE Re-assembly 3 The future Is here
25 In summary by building such Data Safes Good Data : Policy : EU Health An ancient debt is owed by healthy European Taxpayers That debt can be affordably repaid Screen at birth, give every 4000 th baby a chance Make best practice the normal practice, trans-nationally Registry based evidence base published in Lancet ( ) New EPR software now being rolled out Integrate audit with care with EPR but code carefully This is transformational science from DNA/genetics to Politics and health care:
26 EuroCareCF SKILL MIX TO BUILD CF-SAFE IS READY We have assembled a team who know how to anonymise the data Two SMEs who know data linkage and project management ECFS as a support network (through screening and genetics) H2020, application submitted..pending CF-Safe as a virtual tool i.e. with Cloud-safe Analytics See Findacure.org and
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28 We now have hundreds of SNOMED-CT codes No history of pseudomonas infection Pseudomonas screen negative Intermittent pseudomonas infection Chronic pseudomonas infection Pseudomonas aeruginosa - mucoid strain Pseudomonas aeruginosa - non mucoid strain No history of burkholderia cepacia complex infection Intermittent burkholderia cepacia complex infection Chronic burkholderia cepacia complex infection Burkholderia cepacia complex screen negative Burkholderia gladioli Burkholderia cepacia complex status Burkholderia cepacia (Burkholderia cepacia complex genomovar I) From Peckham et al 2014 J Cyst Fibrosis
29 We want to capture all screen positive Cf children ALBANIA ESTONIA ICELAND LITHUANIA LUXEMBOURG MACEDONIA SLOVENIA (SCOTLAND) BULGARIA DENMARK HUNGARY IRELAND NORWAY SERBIA CZECH R SLOVAKIA SWEDEN SWITZERLAND GREECE NETHERLANDS PORTUGAL FRANCE GERMANY ENGLAND ITALY POLAND ROMANIA SPAIN UKRAINE
30 EU Commission Commentary MEHTA et al J CF, 2010 FREE FOR DOWNLOAD
31 How will we know that the CF care money is well spent: Turn patients into tax payers 30%
32 100 Eur Respir J :522-6.Data from the UK 1989 Males Females Born in children diagnosed with CF, Very few die in the UK, France etc over first decade i.e. less than 5% by 15 years
33 Measuring success Potential Tax payers Children
34 Go to stored blood spot cards Literature on incidence Neonatal screening for cystic fibrosis is beneficial even in the context of modern treatment: 2 months of age is latest to start therapy CDC Atlanta, J Pediatrics: Volume 147, Issue 3, Supplement, Pages S42-S46, September 2005 CDC Atlanta/WHO/Australia Many papers: Michael and Philip Farrell
35 You need fewer drugs for the same outcome If you screen at birth.. Sims et al The Lancet, Volume 369, Issue 9568, Pages , 2007 : % FEV1/FVC UNSCREENED Clinical Diagnosis IF WE USE LUNG DISEASE AS AN OUTCOME Drug number intensity $4500 Screened Diagnosis
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39 Can we quantify the drug costs: Lancet 2007? Admissions to hospital (Wilcken & Chalmers Lancet 1985) COHORT MEAN HOSPITAL DAYS UNSCREENED, no MI, born n= (range 0-112) UNSCREENED, no MI, born n= (range 0-240) SCREENED, no MI, born n= (range 0-20) SCREENED, no MI, born n= (range 0-31) MECONIUM ILEUS, Screened and unscreened, born 1978 to 1983 n=16 16 No admissions: Unscreened 15/48 (31%) screened 24/34 (71%) p < Admission > 21d: Unscreened 20/48 (42%) screened 1/34 (3%) p< Slide from Bridget Wilcken, Australia
40 All Europe patients ALL CF 98% can be diagnosed by 15 years PROVIDED healthcare is good 44% ommon Type 2% turn up as adults
41 If any EU health care system is able to diagnose CF (and you don t screen) and if that system can maintain their health Percentage of Patients 16 Patients in 5-year Age Groups FIVE THOUSAND CF Patients for each middle 5yr Bin % % 0% % % y 5-10y 10-15y 15-20y 20-25y 25-30y 30-35y 35+y First school Teenage children Age Groups ~ yr 5-10 yr yr yr yr yr yr >35 yr Total
42 IF WE HAD SCREENING AT BIRTH, they could get care At their nearest CF centre, or cross-border care if not available % change in CF population size from previous decade <10 10-<20 20-<30 30-<40 Rising population Falling population 40-<50 All CF 50-<60 60-<70 70-<80 % change in Fdel508/Fdel508 CF population size from previous decade New EU Members In <10 10-<20 20-<30 F508del / F508del Child-CF type Western Europe, Established Member states 30-<40 40-<50 50-<60 60-<70 70-<80 Age in years Age in years Lancet Mar 20; doi: /S (09) Podcast Lancet 2010: March 20 Evidence for any Government To see and challenge
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