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Rare registration The importance and possibilities in ......Ask questions and receive answers Find...
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Hanne Hove, consultant in Pediatrics
Head of the Raredis Database
Centre of Rare Disease
Rigshospitalet, Copenhagen
Rare registrationThe importance and
possibilities in securing registration of rare diseases
Why bother…• Registration, counting, evaluations, is
equally important for all disorders/diagnosis and disease groups. Rare or not
• Basic for ec. resources (money flow, capacity, dimensions and further investment.
• Think of fat ”epidemy”/ diabethes/HIV
• More common diseases have focused interested in prevalence and incidense
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Rare disorders have extra challenges
• For just being rare or ultrarare– No ICD 10 coding
• Hard to get a correct diagnosis – time delay
• No or little knowlegde of follow-up/key features/ health indicators (Regionernes fælles pulje)
Registration challenges
• Lack of unique and identical registration –same diagnosis have diffent diagnoses codes
• Different manifestations/clinical symptoms/age at manifestations lead to different registrations/diagnosis
• Many clinicians have limited knowledge of rare disorders – patients are not being registered
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Goal
• Systematic national registration of main and associated diagnosis of rare patients
• Registrations of complications, effective treatment/quality of life
• Enable patients to add own data to existing data files
Health platform: a new danish registration
• New era with the implemation of a new and advanced it-system: Sundhedsplatformen alias Health platform
• Diagnose and patient oriented
• Patient´s own registration
• Easy to mark rare diagnosis that is shown in all patient contacts
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The Health Platformmeans better treatment
New common digital solution at all hospitalsin the Capital Region of Denmark and Region Zealand
The Health Platform – in brief
• All hospitals in eastern part of Denmark are introducing the Health Platform by 2017. Both staff and patients will have access
• One common digital solution for using data and communications
• A new all-in-one patient medical record
• Work routines will change, improving the course of the treatment
• Easier for patients and relatives to take an active part in their treatment
• Lays the foundations for treatment at an international top level.
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The Health Platform in Eastern Denmark
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The Health Platform means working together
• Two regions with a total of 2.5 million citizens
• 12 hospitals
• 44,000 employees in the regions will be using the system
• 46 municipalities can be (partly) linked up to it
• 400 people involved in the project organisation
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Implemented in 1,100 hospitals
New work routines –
This is more than just a new IT system or new medical records
A new way to organise the work
Prepared for the past two years
Work routines, courses of treatment and guidelines are standardised, so that staff all have the same approach
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Vision for the Health Platform
To make things easier for the patient
To make things easier for the health professionals
To make it easier to optimise quality and efficiency in hospitals
To make it easier to do it well...
BETTER COURSES OF TREATMENT
• Results returned faster from blood tests, scans and X-rays
• Avoidance of double examinations, except for medical reasons
• Staff will receive reminders – examples:
– results will not be overlooked
– allergies will not be overlooked
– patients will receive the correct medications
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INVOLVEMENT OF PATIENTS
Easy access to their own health data
Increased dialogue with staff
Patients can book and cancel appointments for selected examinations
Patients can type in their own data and save a trip to the hospital
- and save time for the staff
In ‘My Health Platform’ patients can
Read their own medical records
Ask questions and receive answers
Find guidance for patients
See the results of tests
See appointments at the hospital
See a list of visits and admissions
Enter blood pressure and pulse details
Be alerted about new record entries
Answer questionnaires ahead of appointments
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To be introduced gradually from May 2016 until the end of 2017
Time HOSPITAL
21.05. 2016 Herlev and Gentofte Hospitals
05.11. 2016 The Rigshospital (at Blegdamsvej and in Glostrup)
18.03. 2017 Nordsjællands Hospital, Amager Hospital, Hvidovre Hospital and Bornholms Hospital
20.05. 2017 Bispebjerg and Frederiksberg Hospitals and Mental Health services in the Capital Region
23.09 2017 The hospitals in Nykøbing Falster, Næstved, Slagelse and Ringsted
18.11. 2017 The hospitals in Køge and Holbæk and Region Zealand Psychiatry
Finance: investing in better healthEUR 94 million allocated to the Health Platform by Region Zealand. The Capital Region of Denmark expects to spend EUR 286 million This includes...
EUR 139 million for acquisition and support of the system
EUR 147 million for internal costs; e.g. training and instruction.
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RAREDIS
Nordic collaboration between craniofacial teams
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RAREDIS• Raredis is a Nordic database
for rare diseases supportedby the Nordic Council of Ministers & The Norwegian Directorate of Health
• Today represented by Copenhagen
• Other participating centres: Aarhus, Helsinki, Oslo, Odense
Raredis Principles• We study selected rare diseases
‐ Describe epidemiology, diagnosis, natural course and existing treatment, Investigate effect of treatments
‐ Act as a resource to identify RD patients suitable for projects
• Diseases that are so rare one nationwide register is not sufficient and too common to necessitate a (pan‐)European project
• Diseases that will benefit from long‐time follow‐up
• Future: Genetic disease for which treatments will become available
• One database for all rare diseases• Core data = ID, age, sex, ICD10
• Petals
• Specific to the diagnosis
• Specific to a project
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General principles for Raredis• We have created the framework for a Nordic registry (legal, technical)
• Every institution own their data and may publish separately
• Raredis does not own the database
• The Nordic countries (governments) do not own the database
• Collaborators can apply to a board (representatives of all contributing countries for the use of Raredis data (on a project basis)
CORE data
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PETALS Diagnosis specific data
PETALS Project specific data
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Raredis Principles (cont)Present projects
• Intervention projects – prospective, long term
• Scaphocephaly (premature fusion of sagittal suture in the skull ) project
• 130 patients / 18 months
• Prospective evaluation of treatment effects – different centres use different operation techniques
• Complex craniosynostoses
• ~200 patients in Denmark and Norway (centralized treatment) ‐Several genetic subgroups
• Study natural course and effect of surgery (retrospective)
• Evaluation of new treatment (operation techniques)
• White matter
• Registration and follow‐up of children with characteristic changes on MRI of brain
• DiGeorge/22q11
• Registration PhD project
Database of RD patients
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Database of RD patientsRaredis
overgrowth syndroms 43complex chromosomale syndroms 157
complex syndroms with psychomotor delay 252hereditary connective tissue 521harmatomatous disease 825craniofacial syndroms 543
skeletal dysplasia 172
hereditary skin diseases 25
total excl. metabolic diseases 2500
My thoughts on future developments ‐ Raredis
• ”Data flow should be from local database to the central database”
• What about data flow from the Nordic database to European databases for rare diseases (diagnosis and/or project specific databases)
• Preparing for back transfer of data from the database to the patient/institution• Aim: Identify patients suitable for theraputic trials
• Therapies may become independent of diagnosis, may become mutation class specific (e.g. therapy for nonsense mutations)
• In Raredis – contact via the submitting centre
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How do we connect existing data sources (genotype‐phenotype)?
Building on existing scientificenvironments and infrastructure
RAREDIS National databases starting with (clinical) phenotype – now expanding with genotype data
Databases with results of (diagnostic) nextgeneration sequencing
Why bother…
• indeed it’s about time to get involved and secure rare registrations. Data of all aspects from basic registrations to soft data such as quality of life – should be systematically registered for all disorders/diagnosis and disease groups …
• being rare brings an extra challenge – but knowledge is power
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The successful implementation is challenging
• Things take time ‐ Probably at least a 5 year perspective is needed
• General registration need dedicated resources at each center (secretarial support)
• Research initiatives must be managed by dedicated staff (phd‐students or similar)
• The initiatives must be based on existing initiatives and existing databases instead of starting new
• One real challenge is defining good projects
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Future developments
• Adding more diagnoses – project based
• Legal and political aspects:
• Nordic council 2010: Expert committee to report on how Nordic collaboration on highly specialized treatment may lead to improved quality in each country
• And how this may benefit the rare diseases
• 2012: Report prioritized 5 items including nordic registries for highly specialized treatment
Future developments (cont)
• Subcommittee report on registries – databases
• Lists existing Nordic registries (n=8)
• Recommending two Nordic databases as pilots• Injuries to the spinal cord
• Prothesis for ankle and wrist
• Model (to be determined): Either expansion of existing local‐national registries or the Nordic datase for rare diseases
• Both models build on existing research environments and infrastructure – databases are regarded as an essential part of a scientific collaboration within the health service (bottom up)
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My thoughts on future developments ‐ Raredis
• ”Data flow should be from local database to the central database”
• Petal: Standardized Phenotype data
• ICD10, Orpha#, MIM, other?
• Human phenotype ontology?
• Petal: Standardized Genotype data
• HGDV format or similar
Databases of standardized Genotype data exist for groups of RD patients
Data originally collected for health service reasons (diagnostic activity)
• Genomic variation databases expanding into gene single gene variation detection by next generation sequencing
• Decipher, Ecaruca, ISCA
• Large projects aiming at collecting both genotype and phenotype
• UK: the DDD‐project
• DDD=deciphering developmental disorders
• Computer tools for automatic funneling of data from local to central databases is in development
• Microarray – Cartagenia used by 120 labs – module to share data and export to central databases
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Necessary modernisation on a well tested system
A new system is necessary, because the old one is out of date
The Health Platform was selected through a public tender
American Epic submitted the strongest offer – based on functionality, economy, implementation, collaboration and technology etc.
The Epic solution is in use in 1,110 hospitals in the US, Europe and elsewhere
The Health Platform brings four major improvements
BETTER COURSES OF TREATMENT
INVOLVEMENT OF PATIENTS
EASIER WORK ROUTINES
BETTER PLANNING AND SUPPORT FOR DECISIONS
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EASIER WORK ROUTINES
No need to log in to multiple systems and type in the same data in different places Less duplicated work means more focus on the patient
Doctors can easily type in patient data: dictations are avoided, with improved patient security and leads to more efficient treatments
Staff will have mobile units with the Health Platform so they can
- act on new results - respond to questions and wishes
BETTER PLANNING and SUPPORT FOR DECISION MAKING
For selected diagnoses, there will be treatment packages– patients will be treated faster, at a uniform high level
It will be easier to extract data so that management has an overview of re-admissions, beds available, and possible improvements in quality– citizens get more quality and health for their money
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The Health Platform will enable staff to
Manage general documentation of treatment and care
Manage requisitions and results, e.g. lab tests and X-rays
Manage patient administration and bookings for surgery
Manage medication processes
Transfer data directly from selected medicotechnical
equipment to the Health Platform
Access relevant data for research
Form a better overview of re-admissions
and vacant beds
Staff must change their work routines
44,000 users have to be trained
Courses of treatment are delayed. Staff work more slowly
Step-by-step introduction – staff are always beginners with some dissatisfaction
The Health Platform will be extended gradually – some functions will not be available at the start.
Staff and patients must be prepared for ‘work in progress’ and major changes
A complex process of change over several years
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We help each other along the way
20 % from hospitals with earlier implementation
Example: Distribution of super-users
60 % from the implementing hospital
20 % from hospitals awaiting implementation
A broad outline of the plan for implementation
Cut over
Training
Readiness assessments
Preparations for ready to Go-live
24/7 support Post live
Go live– 1 year + 8 months
Follow-up on application
The hospitals prepare for a year before the actual start
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Benefits from the Health Platform
Professional quality
FinancePatients’
perception of quality
Examples of benefits•Fewer bed-days & readmissions per course•Fewer outpatient visits per course •Fewer examinations per course •Fewer errors in medication per course •More efficient diagnosis and treatment•Records kept more efficiently•More patients’ questions answered•More patients feel that staff have studied their records.
Profits of EUR 108 million annually after full implementation
Modernisation will place the hospitals at top level The Health Platform will replace as many as 30 older IT systems
Hospitals’ use of technology in treatment is ranked internationally on a scale from 1 to 7. Today, Danish hospitals are rated at 5.3
The Health Platform will bring the hospitals up to level 6.
HIMSS 2015Scale 1-7
HIMSS: Healthcare Information and
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Collaboration with the primary sector
It will be possible for GPs, consultants and home nurses to see records, too
In spring 2017 a pilot project will be carried out with a municipality and a psychiatric home. A decision will then be made whether to offer the system to the primary sector
The Health Platform is linked to the Danish e-Health Portal at www.sundhed.dk
High level of data security
Staff will be able to access the necessary data in order to treat the patient
Staff access to data is vital in order to provide coordinated, high quality treatment
Patients are entitled to refuse to allow health details to be retrieved
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Communications must:
be credible and balanced
be understandable for patients, relatives and citizens
create understanding of changes and disruptions.
An important principle in communications:we are honest about advantages and disadvantages
Four main focal points in our communications
Users All employees
Patients and relatives
External stakeholders
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Raredis Principles (cont)
• Establish stable, fully functional networks of collaborating researchers
• This is essential to secure the full support for the Raredis effort from all the relevant scientific groups in the Nordic countries
• Raredis language = English
• Avoiding problems of translation
General principles (cont)
• Data collection is in the health service
• Web based manual entry
• Automatic data transfer from local hospital database to Nordic database (Oslo only)
• Data flow should be
• (from the health service to)
• the local database to
• the central database