This document summarizes a presentation about the European Cystic Fibrosis Patient Registry (ECFSPR). The ECFSPR collects data from over 23 countries and 220 hospitals/centers to measure and compare aspects of cystic fibrosis treatment. It aims to encourage new treatment standards and provide data for research. The presentation discusses the OpenApp software developed for the registry, which allows different countries and centers to participate through a shared or customized system while protecting patient data. Features like error reporting and flexible reporting are highlighted.
Chandrapur Call girls 8617370543 Provides all area service COD available
From Patient Encounter to European Registry
1. EHI Live Birmingham NEC
6th Nov 2013
From Patient Assessment to
European Registry
European Cystic Fibrosis Experience
Mel McIntyre
EHI Live 6th Nov 2013
2. About OpenApp
•Software development and support focused on
healthcare, patient assessments, quality assurance,
spatial analysis and planning.
•Deliver solutions on Open Source technologies, Python,
Postgresql, Linux, Django, Zope.
•Cloud delivered Patient Assessment Platform for Clinical
Programs
•Teaming with IBM and DSS Inc Florida USA to bring VistA
to Europe
EHI Live 6th Nov 2013
3. European Cystic Fibrosis Patient Registry - ECFSPR
The ECFS Patient Registry’s aim is to measure,
survey and compare aspects of cystic fibrosis and its
treatment in the participating countries,
•encouraging new standards of dealing with the
disease,
•providing data for epidemiological research
•identifying special patient groups suitable for
multi-centre trials.
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4. 23 countries - approx 220 hospitals/cf centres
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5. Goals for the software
•Make it easy for countries and centres to participate
oAccomodate countries with existing CF Registry software and
countries and centres with no existing software
oAccomodate countries with strict data protection
interpretations
oAllow countries and centres to extend the core data model to
collect ‘more’ data and transfer or share data
oNo barriers to participation - low or no costs
•Make it easy for doctors/providers to participate
oProvide feedback on patient and centre preformance
oEasy as possible for doctors to complete patient assessments
oAccurate summary process
oExtend towards a richer encounter - labs, meds, other
1.
EHI Live 6th Nov 2013
6. OpenApp goals
•Build a platform that can serve more clinical
programmes
oCurrently building Irish National Joint Registry and
one other Clinical Program
•Integrate easily with external systems - PAS, Lab,
Surgery, et al
•Underpin with clinical data models (OpenEHR, EN
13606) and Clinical Tems and Ternilologies (SnomedCT,
ICD, ATC, )
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7. Three types of Registry Participants
Use
European
System
Centres and/or Countries who will use the
ECFSPR software system to generate the Patient
Annual Summary record and submit to the
European Registry Database
Use Own
Centres and/or Countries who have their own
System
means of developing the Annual Summary
submission and will submit a file once per year to
be included in the European Registry Database
Own instance
Austria
Bulgaria
Greece
Israel
Latvia
Portugal
Serbia
Spain
Slovenia
Switzerland
Belgium
Czech Republic
Denmark
France
Germany
Italy
Hungary
Moldova
Russia
Slovakia
Sweden
UK
Centres and/or countries who will
manage their own instance/server
of Europe
running the ECFSPR software and will
System
submit a file once per year to be included
in the European Registry Database
EHI Live 6th Nov 2013
Ireland
Holland
8. Software system components
Core
Data
C
• Registration
• Demo
graphics
• Diagnosis
• Duplicate
and sharing
mgmt
Patient
Identifcation
File accessible only
from within the Centre
network
Patient Identification
Name,
DOB, Other
Patient
Centre Id
Encounter
Data Entry
En
• Data Entry
• L1 - Field
validation
• Patient
Identification
• Offline data
collection and
synchronisation
• Centre specific
styling
• Centre level
reporting
Annual
Summary
Process
AS
• Each Centre has
it’s own data
tables
• Each country has
it’s own database
• Data import or
Excel upload
• Level 1 and 2
validation
• Error highlighting
and correction
• Error over-rides
• Add country
specific field
additions
• Country level
reporting
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Annual
Return AR
Verification
• Download
Country and/or
Centre returns
• Upload error
reports for
Centre
attention
• Mark data as
complete
Patient Id
Consent management
User Management
Network and
Application Security
European
Registry
Database
• Fixed reports
• Reporting tools
and charts
• Data Export
• Mutation
management
• Other tables
9. Software deployment . . with error reporting
ECFSTracker
Partition within European
System
Austria, Slovenia, Greece . . .
Core
Encounter
C Data Entry En
Data
Own System
UK, Germany, France . .
Annual
Return
Centre
Country
Annual
ASSummary AR
Process
ETL
Spain
UK
Holland
AR
Own copy of ECFSTracker Software
Ireland
Core
Data
C
Encounter
Data Entry
En
Annual
Summary
Process
AS
EHI Live 6th Nov 2013
Annual
Return AR
Verification
European
Registry
Database
10. Data protection . .
1.Patient identification only in Centre/Hospital
o Label encryption process under control of
the hospital
2.Only de-identified data managed in ECFS
Registry
EHI Live 6th Nov 2013
11. Patient Identification
Hospital - Centre
Country Registry
European Registry
Hospital MRN
File accessible only
from within the
Centre network
Patient Identification
Name,
DOB, Other
Patient
Centre Id
Centre Patient Id
Name
Date of Birth
HASH - Name/DOB
National Reg Id
National Reg Id
National Centre Id
National Centre Id
National Reg Id
European Reg Id
European Reg Id
European Country or
Centre Id
European Country or
Centre Id
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12. Patient Identification - two methods
We use a Labels File to associate the
patients real name with the CFRI Identifier
1.Hospital hosts the Labels File on a web
server only accessible from within the
hospital network and only accessed by
the CF application
2.CFRIReg or ECFSTracker hosts the
Encrypted Labels File and only the
hospital can retrieve and decrypt with a
hospital controlled password.
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13. Extending the Data Collected
- Adding fields at Country level . . .
•Locally defined fields can be added to the
Annual Summary at Country level and reflected
in the Centre’s Encounter Data Collection Form
•Fields are not mandatory at Centre level - you
don’t have to use them
•Visibility of fields and form layout can be
customised at Centre level
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16. Data Quality Control - Spec
Level 1: data control through input masks and validation rules at input level.
This is to prevent a user to put in really faulty data e.g. FEV 15 litre; validation rules,
e.g. FEV1 <= FVC or e.g. a user fills in: sterile or normal flora in sputum, then the
pseudomonas and other should become grey and impossible to choose;
Level 2: automatic data control of the whole set before saving.
A user should have the possibility to input partial data, after leaving the internet it
should be possible to continue the same patient later. Once a patient is complete, the
user clicks the button ¡§make this registration complete¡¨. From that moment on, there
should be a control of missing values, incompatible combinations of data, data
coherence etc. to give the user the possibility to correct the errors.
Summarising:
•
•
•
•
•
Automatic data-coding control;
Automatic control of miscalculations;
Automatic control of missing values or values outside the allowed range;
Automatic control double entries, e.g. records that are doubled by mistake;
Automatic data-coherence controls (according to a list that will be provided).
Level 3: once everything is in order, data are admitted to the general working
database where level 3 validation is done (many of these items will be done manually
by statisticians).
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17. Error reporting from Level 3 Validation (Statistician) . . .
•Set of tools for use by CF Registry Statistician
•Based on Annual Return of Annual Summaries on
a Centre or Country basis
•All Centre or Country data available to download
•Upload of Error Reports by Statistician
•Errors are posted back to appropriate Centre and
specific fields highlighted for correction
•Error over-ride available
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18. Error Reporting Module - Spec
• Prevents the user from entering/modifying the data when the procedure
is started;
• The user should receive notification of the errors present in their
database;
• Each error should be accompanied by a short explanation of the nature
of the error;
• The user should be automatically directed to the page where the errors
are present;
• The wrong values should be clearly evident (either by highlighting the
field or by writing it in a different colour;
• All the fields that do not need correction should be blocked (i.e. the user
should not be allowed to modify them);
• After the errors have been corrected, the software should re-carry out all
the usual and agreed data-quality controls;
• If the correction of one error generates another error in the database,
then the software should notify the user and the user should be directed
to the page where the new error is found, the user should be allowed to
modify the relevant fields
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20. Reporting . .
Data protection
• Same reporting facilities available at Centre, Country,
Europe
• Reporting permissions
o USER and Centre Administrator at Centre only
o Country Coordinator ALL CENTRES in that Country
o European Coordinator can see all Centres and Countries
• PIVOT Table for Ad-Hoc reports
o What variables to expose - still under discussion
o Counts and Proportions (Yes/Total Records) as report
type
• Fixed Reports for Centre
• Fixed Reports for Patient
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24. Planned for Irish CFR - Shared Enhanced Encounter Mgt
John Doe
DOB 12 Oct 1997
CFRI Id - 12345
12 Main St, Athy, Co
Kildare
Patient Summary
• Some indicators
• Complications
• Patient report
Hospital Data
• Lab test results
• Inpatient encounters
Medications
• Current
• History
Patient Schedule
• Clinic dates (assessments)
• Other
Key Clinical Indicators
Patient
reports
•
•
•
•
•
Hospital MRN
Next of Kin
Referring GP etc
Treating Consultant
Other provider
Data
input
Visualisation
EHI Live 6th Nov 2013
25. Technologies used
1. PostgreSQL database
2. Django wep app framework
3. Indivo PCHR - we used the Indivo design
pattern but have removed the code as we
use more Provider than Patient control
4. Lots of Javascript - D3, Flot, JQuery