WHY AND HOW TO REALIZE AND IMPLEMENT DIABETES REGISTERS

1. BIRO Academy 2nd Residential Course In Collaboration with the IDF Science Task Force Brussels 23-25 January 2011 WHY AND HOW TO REALIZE AND IMPLEMENT DIABETES REGISTERS Prof. Massimo Massi Benedetti Project Leader EUBIROD EU Consortium www.eubirod.eu

2. Evidence base on Diabetes in Europe • Diabetes affects about 50 million people in the European Union. Up to 50% of cases are currently undiagnosed • There is an explosion in prevalence of Type 2 diabetes: EU rate 7.5%. +16% is the predicted growth by 2025 • Diabetes kills as many people worldwide as does AIDS and leaves countless others crippled with complications causing heart attacks, strokes, kidney disease, blindness and amputation • Diabetes is expensive, costing the European Union 50 billion euros per year. Treating complications is much more expensive than treating properly the disease itself. National healthcare expenditure is 2.5-15% • Standards of healthcare vary widely across the Union and, of those individuals treated for the disease, a considerable number receive sub optimal care

3. EU Action on Diabetes • St. Vincent Declaration in 1989 first created awareness of Diabetes and set targets for achieving results • 2004: the EU Health Council stressed the importance of a coordinated European Strategy for diabetes • 2006: Austria made Type 2 Diabetes a key health priority during its EU presidency • February 2006: at the European Conference on Prevention of type 2 Diabetes EU policy recommendations were established • April 2006: The European Parliament urged the European Commission and the European Council to make the care and prevention of Diabetes a priority and to develop a European wide strategy to tackle the disease • June 2006: recommendations for Diabetes EU policy were included in the Health Council Conclusion and formally adopted by the Ministers of Health of the EU countries’

4. EU Policy in Diabetes • In order to face Diabetes it is fundamental to recognize present policy gaps and to put in place comprehensive strategies to collect and analyze comparable epidemiological evidence • European Union cannot deal with diabetes effectively until reliable and comparable data on the disease become available • This needs : • cooperation among all member states • the establishment of a standard dataset • the development of appropriate information technology for the analysis of the data and the dissemination of the results

5. EU policy recommendations for Diabetes • EU: • to prioritise diabetes • to promote best practice through exchange between Member States • to facilitate European diabetes research and ensure wide dissemination of results • to establish common criteria for collection and reporting of diabetes information • to encourage development of national prevention programs • Member States: • to improve collection and reporting of diabetes epidemiological and economic data • to develop National Diabetes Plans and Screening Programs • to develop Primary and Secondary Prevention Programs • to develop comprehensive diabetes training of healthcare professionals • to adopt a multi-disciplinary approach to managing diabetes

6. WHO and UN Policy on Diabetes World Health Assembly resolutions WHA42.36 of 19 May 1989 on the prevention and control of diabetes mellitus • WHA57.17 of 22 May 2004 on a global strategy on diet, physical activity and health • United Nations A/61/L.39/Rev.1 General Assembly Resolution • Sixty-first session A/RES/61/225 20 December 2006 on World Diabetes Day

7. UN Summit on NCDs: 19 September 2011

8. Diabetes Registry: Rationale Diabetes has a growing relevant effect on Quality of life of the affected individuals, on the social structure and on the economies worldwide Need for action has been formally and strongly recommended by the major international institutions: WHO and UN, plus a number of regional and national institutions: EU, GCC, etc. The recommended action is to be focused on prevention of the disease by multi-factorial intervention and on prevention of its complications through early diagnosis and delivery of effective and comprehensive diabetes care. The need to monitor the evolution of the disease in its various dimensions  and to monitor the quality of care has been identified as the prerequisite for efficient planning and implementation of efficacious preventative programmes of diabetes and its complications. Appropriate instruments to fulfil the recommendations for intervention on diabetes are to be made available Diabetes registries are to be considered the backbone and the necessary platform for any action to be undertaken

9. Diabetes Registry: Targets (1) • to provide robust and timely information on Epidemiology of diabetes and its complications; • to monitor the evolution of the disease and its complications in relation to time, interventions, conditions and changes of the environment; • to evaluate the quality of care delivered to people with diabetes; • to estimate the cost of the disease; • to estimate the cost-effectiveness of the interventions • to provide a solid platform for diabetes shared care • to provide an essential tool for diabetes research

10. Diabetes Registry: Targets (2) The gathered information is to be made available, as appropriate and with the due restrictions, in suitable format to be used by: • National and international policy makers • Health care policy makers • Health care administrators • Health care deliverers • Research institutions • People affected by diabetes • The public domain

11. Diabetes Registry: Strategy (1) • The Registry for diabetes needs to be a flexible instrument able to evolve with the evolution of needs, knowledge,  technologies and according to the available resources (economical, cultural, structural). • The original design of the registry needs to satisfy such concept to allow for production of information of progressively increasing complexity as a function of its evolution. • The evolution of the registry needs to guarantee the coherence of the information throughout the time • In any part of the world the design and the evolution of the registries are heavily influenced by the local prevailing culture and processes for the delivery of diabetes care which need to be taken into consideration, but need to be made compatible with an advanced diabetes registry. • It is to be accepted and taken into consideration that factors outside the Health Care System might interfere with the evolution of the diabetes registry (i.e. the overall communication infrastructures, etc)

12. Diabetes Registry: Strategy (2) • It is consolidated experience that unrecognised and unexpected barriers con jeopardize the success of the diabetes registry. • A detailed preliminary and careful system analysis is to be carried out in order to prevent such risk. • Functions of the registry which might not be permitted by unsolvable barriers need to be abandoned or kept in hold until solutions are identified. • If a vital function for the registry cannot be satisfied it will be necessary to halt the project until a solution is found.

13. Diabetes Registry: Strategy (3) • The planning and the implementation of the registry is a powerful instrument for standardizing the quality of diabetes care in the involved environment. • The diabetes registry can be successful only if all the relevant stakeholders are involved in its planning and in its realization according to their institutional roles. • In consideration that the diabetes registry is an ongoing indefinite term activity, formal procedures need to be adopted to prevent any negative influence by the more or less frequent natural turnover of the different stakeholders (Politicians, administrators, professionals)

14. Diabetes Registry: Strategy (4) • The collection of data needs to be based on Information Technology and electronic medical records. Manual input of the data has proven to be the main reason for failure of diabetes registries. • The diabetes registry needs to be based on perspective information. The download of already existing information has proven to be ineffective due to lack both of standardization and finalisation • The collection of data needs to be based on routine clinical practice and to be done automatically without interfering with the usual routine activity nor producing any adjunctive work load to the clinical settings. • The production of data in standard electronic format is to be adopted for securing effective interfacing of the different electronic medical records with the registry data base • The evolution of the registry and the completeness of the data are directly dependent by the capacity of the diabetes care network to produce information. • A strong policy for the adoption of electronic medical records in routine clinical practice in the diabetes care settings is to be heavily promoted and supported.

15. Diabetes Registry: Strategy (5) • The diabetes registry needs to be able to accept data produced by the different electronic medical records adopted in the various public and private clinical settings • Provided that the adoption of identical medical electronic records in the different settings is a non viable option, standardization of the communication procedures is a must. • Relevant data resident in administrative data bases are to be considered for transfer and inclusion in the diabetes registry.

16. Diabetes Registry: Strategy (6) • A comprehensive and specific system for the analysis of the information is to be tailored to fulfil the targets of the registry. • A precise model to make the information available to the interested constituencies, as appropriate, is to be defined and implemented taking advantage of advanced communication technologies. • An explicit policy for structured data protection is to be adopted and implemented since the beginning.

17. Clinical settings Criteria Guidelines Scientific evidence Epidemiological models Classification system Data Relational Database Linked structures Management Analysis Planning Administration System for analysis Reports Statistical models Citizens Shared Care Risk factors Diagnosis Procedures Treatments Outcomes Design for Multilevel outputs