Evaluating outcomes in European cystic fibrosis patients with access to their health records

Using registries to innovate and directly impact patient careAbi Jackson, PhDResearch Fellow Cystic Fibrosis Registry of Ireland

4th October 2016

BackgroundCystic fibrosis (CF) is an inherited condition that affects many body functions such as breathing, digestion, and reproduction. It is a lifelong condition for which there is no cure. The symptoms and severity of CF vary from person to person. Better treatment strategies have helped to improve the length and quality of life of people with CF. CF registries gather information on all aspects of a patients condition. They act as information storehouses for infection and treatment statistics. Detailed analysis of this information can yield significant findings about the most effective treatments for CF. It is through these analyses that better management of CF may be achieved.

Using registries to drive innovationPeople with CF are using registries to drive health innovation and impact care

1,300 consented93% of people with CFPermission granted to access hospital records: 400 data elements per person per yearInnovative collaborationsInnovative health technologies

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Innovative collaborations (1)With international academic researchers Enhanced disease knowledge potentially influencing care practices e.g.

CF-related liver disease study:- knowing when & how to screen for liver disease

CF newborn CF screening study:- evaluate benefits of early detection and intervention

CF genetic study:- understanding the function of the CF gene product, correlating clinical symptoms with mutations

CF survival estimation:- better prognostic information, international comparisons, raises new issues e.g. independent living

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Innovative collaborations (2) With the pharmaceutical industry*

Evaluate new medicines in real-world settings (known as pharmacovigilance)

Clinical trials conducted on relatively small number of patients with a specific profile for a limited length of time

Allows identification of adverse eventsTracks how patients respond to particular medicines over timeComplies with EU regulation for new medicinesCan assist regulators assess whether approvals can be expanded to other patient groupsassess whether expectations underpinning decision by healthcare payer to reimburse are being met

* Patient-identifiable data is never shared with pharma. Data analysis performed in-house

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Innovative technologiesSoftware platform upgrade 2015Secure, electronic, web-basedCare encounter-based reportingAccessible by CF consultant(s)Reporting moduleCommon platform with European CF Registry (>40,000 patients)

Preliminary study: CF Patient/Parent surveyPerspectives on patient electronic access to registry health records (HR): an Irish-Slovene online survey

Ireland*Sep 2015Slovenia*Nov 2015

N 147 (12 % 1)N 41 (44 % 1) 1 % of IE/SI patients in European CF RegistryHome internet accessInterested in on-line HR access100

18 yrsCurrently keeping HR on paperCurrently keeping HR in own electronic database

0%

979986885856713 18 yrsSlide c/o Dr Uros Krivec presented at the European CF conference, 2016

Ireland Slovenia

*With thanks to CF Ireland & CF Association of Slovenia

Evaluating outcomes in European cystic fibrosis patients with access to their registry recordsA randomised control trial of a Registry patient portalLead PI: Dr Abi Jackson, CFRI

Mr Godfrey Fletcher, CFRIDr Ed McKone, UCD & SVUHDr Gerardine Doyle, UCDProf Cecily Kelleher, UCDIE, DE & SL site investigators

www.cfview.eu CF Registry patient portal

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www.cfview.eu

Your CF data on your phone See your data in a listOr on a chartA simple interfaceRegistry patient portal

www.cfview.eu

Patient participation

Study started?No. of participants(% of people needed) Dublin, IE100 (100%)Dublin, IE 25 (63%)Dublin, IE11 (92%)Dublin, IE14 (88%)Dublin, IE25 (89%)Galway, IE 11 (92%)Limerick, IE28 (100%)Cork, IE56 (100%)TOTAL270 (96%)

No. of patients needed in Ireland : 280

Aarhus, DenmarkOctober-Ljubljana, SloveniaDecember-

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will cfview have an impact on patient care? Areas under investigationPatterns of usage by participantsClinical outcomesUsage of health servicesHealth literacyPatient-reported quality of lifeCost of care

Comparing outcomes in participants with access to CF View and educational videosA randomised control trial

ConclusionsPatients can drive health innovationParticipate in your registryParticipate in research

People with CF are having a direct impact on their own care!Sharing information that can be used for future-proofing CF services Development of new tools which may aid self-management of their condition Monitoring of the safety and effectiveness of CF medicationsContributing to improved clinical decision making

acknowledgements

Congratulations IPPOSI on your 10th birthday Special thanks to: CF Registry participants & their parents

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