[PPT] - The approach to building a disease registry: the EUBIROD Project and PowerPoint Presentation

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The approach to building a disease registry: the EUBIROD Project and the ICHOM Diabetes Standard Set

Fabrizio Carinci

T e c h n i c a l C

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d i n a t

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f

t h e E U B I R O D N e t wo r k Adjunct Professor of Biostatistics, University of Bologna, Italy Visiting Professor, University of Surrey, UK

fabrizio.carinci@unibo.it

www.eubirod.eu www.hirs- research.eu/eubirod.html

Implementing Outcomes-based Healthcare

Crowne Plaza Brussels - Le Pa lace 18th October 2018

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Objectives

Overview of outcomes measurement in diabetes and refmections upon the barriers and enablers to building a pan-European diabetes registry

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Why do we need health information in Europe?

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To provide broader and faster access to an ever increasing amount of information of critical importance to researchers working in the public interest

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To make policy makers accountable for the results obtained by the EU legislation and National policies

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To evaluate adherence to evidence-based guidelines

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To set achievable targets for quality of care and outcomes, taking into account the costs and benefjts of different alternatives

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To share best practices and avoid common mistakes

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To benchmark the effect of local policies and health services

rganization against different alternatives, using standardized criteria



To avoid drawing conclusions from random variation, which is more critical in countries that have a smaller population and a limited number of cases for any problem investigated

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O E C D H e a l t h a t a G l a n c e 2 1 7

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Policies are assessed using information that is not available on a routine basis !

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OECD Health System Performance Framework 2015

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Diabetes in Europe: which international comparisons are routinely available today?

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Certainly not enough to monitor action and planning of prevention measures and health care for people with diabetes in Europe

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General data on diabetes prevalence (total number of people in diabetes at a specifjc point in time), poor data on incidence (how many new cases per year)

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Few indicators calculated from administrative data sources (e.g. hospital data), prone to bias due to fjnancing mechanisms (e.g. DRGs)

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No indicators on intermediate and terminal outcomes (those that really matter for people with diabetes)

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Prescription of hypertensive and Lower extremity amputations in diabetes, 2015

Source: OECD Health at a Glance 2017

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Why do we need a EU infrastructure for diabetes information?

 To monitor actions and plan accordingly USING MORE GRANULAR

DATA OF CLINICAL RELEVANCE

 Diabetes is a valid model for complex multidimensional and

longitudinal monitoring of chronic diseases:

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General data on diabetes prevalence (total number of people in diabetes at a specifjc point in time), poor data on incidence (how many new cases per year)

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Summary results on selected indicators calculated from administrative data sources (e.g. hospital data), prone to bias due to fjnancing mechanisms (e.g. DRGs)

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No indicators on intermediate and terminal outcomes (those that really matter for people with diabetes)

 Does relevant information exist? YES,but is stored in different silos

(networks) and/or dispersed at the national or even sub-national level!

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Diabetes Registers in Europe

BARRIER

HIGH QUALITY INFORMATION … but...

 Heterogeneous  Fragmented  Heavily Regulated  Serving local interests  Skeptical about sustainability of regular international

comparisons

 Hard to share data on a regular basis  Mainly available in national language only

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PERSON CENTRED HEALTH SYSTEMS

ENABLER

At the OECD Health Ministerial 2017, Health Ministers from around the globe:

 committed to realize person-centre health

systems

 expressed their interest to measure person

reported outcomes and costs for each individual with a specifjed target condition (fundamental prerequisite for Value-based Health Care)

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Numerator

Denominator

DATA

(LINKAGE)

INDICATOR

What do we need to measure for person- centred value-based health care ?

QUALITY OF CARE COST HEALTH

time

admission event contacts

BARRIER

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ENABLER Structure of a population- based disease register

Allows collecting a range of measures in a rigorous manner!

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But different types of models for data collection may bias the results...

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Different data sources may lead to very different results...

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Survey of diabetes data sources in Europe

Source: EUBIROD Network 2017

Instrument: Questionnaire including structured items on: Description; Scope of information; Governance; Technical Infrastructure; Outputs. Data collection system: REDCap open source research server, hosted in Slovenia Timeframe: August-September 2017 Preliminary Taxonomy

A. Population-based Registers. Croatia,

Sweden, UK-Scotland

B. National Audits and surveillance
systems. Belgium, Germany, UK-England
C. National databases for quality
indicators. Israel, Latvia
D. Different types and levels of data
sources. Cyprus, Hungary, Israel, Italy,

Malta, Poland, Romania, Slovenia

How to merge approaches?

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S h a r e d E v i d e n c e

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S y s t e m

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, D i a b e t e s R e s e a r c h a n d C l i n i c a l P r a c t i c e 7 4 ( 2 6 ) S 2 1 5 – S 2 1 9

ENABLER

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EU BIRO and EUBIROD projects

EU DG-SANCO co-funded public health projects BIRO project (2005-2009) “ t

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s y s t e m” EUBIROD project (2008-2012) “ t

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t h e B I R O s y s t e m i n 2 E u r

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n t r i e s ” BRIDGE-HEALTH (2015-2017) T a s k 8 . 2 : “ t

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Joanneum Research, Austria

International Diabetes Federation (IDF), Belgium Scientifjc Institute of Public Health, Belgium National Institute of Public Health, Croatia University of Zagreb, Croatia Ministry of Health, Cyprus Adult National Diabetes Register,Denmark University of Debrecen, Hungary Ministry of Health, Israel Serectrix, Italy Ministry of Health, Latvia University of Malta, Malta NOKLUS, Norway Silesian University of Technology, Poland Telemedica Consulting, Romania University of Ljubljana, Slovenia IDIBAPS, Spain Foundation for Care Information, The Netherlands University of Dundee, UK University of Surrey, UK

 Sharing:  Information  Best practices  Tools  Methods  Creating Opportunities for:  Targeted Research Partnerships  Direct Involvement with EU/International

Organizations

 Building together:  Global platform for diabetes monitoring

Coordinating Centre

http://www.hirs-research.eu/eubirod.html

A lasting coalition for brainstorming, debate, research and development projects!

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System. F

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Region. A

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Statistical Object. E l e me n t

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a d i s t r i b u t e d i n f

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s y s t e m c a r r y i n g e s s e n t i a l d a t a i n t h e f

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i n t e r e s t Data source. U n i t wi t h i n a r e g i

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BIRO glossary

...the foundations developed together

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Conduct a Privacy Impact Assessment Review your problem: construct an evidence-based framework 1 1 Describe the data structure of your network Specify your data dictionary Identify the best information system architecture Agree on reporting targets: specify report templates Design and implement all software Analyse data and disseminate results Transfer technology Evaluate, improve and update

The BIRO approach

2 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 10 10

...the general framework

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Privacy by design

Di Iorio CT et al. Privacy Impact Assessment in the design of transnational public health information systems: the BIRO project, J

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M e d i c a l E t h i c s , 2 9 3 5 : 7 5 3

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t e n t / 3 5 / 1 2 / 7 5 3

Result of the BIRO Delphi panel: best alternative identified to balance privacy protection and information content

BIRO = Best Information through Regional Outcomes Designed and implemented to report on quality of care and outcomes in diabetes in Europe

ENABLER

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ENABLER

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ENABLER General Software for Federated Analysis

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Successful Road Test EUBIROD Report (2012)

8/2/2012: New BIRO Release 2.1.12 15/2/2012: Collection of statistical objects 21/2/2012: EU Draft Report from 18 countries (N=79 indicators) 13 Days from Software Release to Online Publication of the results ! 1/3/2012 Project Ends SUSTAINABILITY: DIABETES INFORMATION NOT INCLUDED AS A TOPIC IN EU PROGRAMS SINCE THEN!

ENABLER BARRIER

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S t a n d a r d S e t

n

D i a b e t e s I C H O M 2 1 7

2

1 8 ENABLER

** - Research fellows * - Working Group Co- chairs

MASSIMO MASSI BENEDETTI (HIRS)
FABRIZIO CARINCI (University of Bologna)

APDP, Nova Medical School Lisbon

Western Diabetes Institute, Western University of

Health Sciences

Behavioral Diabetes Institute, University of California
Loyola University Maryland
The Keck School of Medicine of the University of

Southern California University Hospital Zürich

National institute of Public Health Slovenia,

University Medical Centre Ljubljana

University Medical Centre Ljubljana

Instituto Nacional de Ciencia Médicas y Nutrición University of Yaounde I

Imperial College London Diabetes Centre, Abu Dhabi
National Health Insurance Company Daman
University of Cape Town
Postgraduate Institute of Medical

Education and Research Patient representative Patient representative Patient representative

O’Brien Institute for Public

Health

UK Patient representative
Bournemouth University

Diabetes Center Mergentheim ICHOM Research fellow ICHOM Research fellow

National University of

Singapore

28 19 4 >10 Countries represented Patients across 3 continents Working Group members led by 2 co-chairs Profjles: Patient advocacy, Primary care, Endocrinology, Psychology, Nursing, Public Health, Insurance, Health policy, Biostatistics

International Diabetes Federation Aalborg University and Aalborg University Hospital The Hebrew University of Jerusalem

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S c

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t h e s e t

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June Jul Aug Sept Nov Jan Mar April June Working Group Process Launc h Call T1a Call 1 Outcome domains Call 2 Outcome defjnitions Call 3 Finalising defjnitio ns + PROMs search Call 4 PROMs Call 5 Case- mix domains Call 6 Case-mix defjnitions Call 7 StSet Publicatio n wrap-up Call 8 Review and transition to implement ation Standar d set launch T2a Literatur e review Patient Input External Input Research & propose scope Literature review of

utcome domains and defjnitions combining type 1 and

type 2 diabetes Literature review of risk factor domains and defjnitions for type 1 and type 2 diabetes Persons with diabetes advisory groups for type 1 and type 2 diabetes Outcome validation survey Open review period Key: T1a/ b: Type 1 diabetes core group meeting T2a/ b: Type 2 diabetes core group meeting Full Working Group meeting

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A g r e e d s p e c i f i c a t i

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t i n e m

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i t

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i n g : t h e I C H O M D i a b e t e s D a t a D i c t i

n

a r y SAMPLE ITEMS

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O v e r v i e w

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Category Outcomes included Reporting source

Patient-reported outcomes Psychological Wellbeing Patient-reported outcome measure Diabetes Distress Depression Diabetes Control Glycaemic control Provider Acute Events Diabetic Ketoacidosis Provider and Patients Hyperglycaemic Hyperosmolar Syndrome Hypoglycaemia Chronic Complications Micro- and Macrovascular complications Provider and Patients Nervous System Complications T reatment Complications Health Services Financial barriers to treatment Provider and Patients Healthcare Utilisation Survival Vital Status Provider

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D e l i v e r i n g t h e f i n a l p r

d

u c t : t h e I C H O M S t a n d a r d S e t

n

D i a b e t e s

http://www.ichom.org/medical-conditions/diabetes/

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T i m e t

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r

g

r e s s t

g

e t h e r n

w

?

http://www.hirs-research.eu/eubirod.html

E N A B L E R B A R R I E R E N A B L E R B A R R I E R E N A B L E R

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C

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 Diabetes registers are increasingly recognized by EU Member States as a

necessary solution to monitor and improve outcomes across Europe. However, there is still a lack of coordination for international comparisons

 Novel approaches for privacy enhanced rigorous data collection have

been successfully trialled in the BIRO and EUBIROD projects. Meanwhile, the federated architecture has been recognized as a viable and effective general solution by other EU projects.

 The release of the ICHOM standard set for diabetes underpins the

creation of a pan-European diabetes register that can use standardized information for multiple stakeholders wishing to apply value-based health care

 The sustainability of the register is paramount to match key goals with

the actual capacity of measuring targets on a routine basis, in the interest

f people with diabetes