Standardization – As the EUROCISS project has widely demonstrated for cardiovascular disease registries, standardised procedures for the identification of events and agreed standardised diagnostic criteria for their validation are needed, even though they are not commonly adopted yet at European level [
15]. If PBRs related to the same disease and implemented in different areas of the country adopt agreed and standardised procedures for data collection and standardised diagnostic criteria for event validation, they can be organised and integrated in a national research platform. This is the example of the cancer registries, unified in Italy under the AIRTUM organization (
http://www.registri-tumori.it/cms/), and participating to the EUROCARE Programmes (
http://cordis.europa.eu/project/rcn/46511_en.html,
http://www.eurocare.it/Eurocare6/tabid/92/Default.aspx) at European level. This process will facilitate sustainability of PBRs and their continuative implementation attracting regular funds both at national (from Ministry of Health) and European level.
PBR integration with epidemiological studies and HCUs (interoperability)
Population-based mortality registries and health interview surveys, often managed by the National Institutes of Statistics, provide information on mortality and perceived health status; morbidity registries, epidemiological research studies, such as longitudinal studies and Health Examination Survey (HESs), usually conducted by National Institutes of Public Health, provide health information on occurrence and prevalence of disease, on measured risk factors, lifestyles, and high risk conditions by standardized methods and diagnostic criteria.
In recent years, thanks to information technology, other sources of information of health current data, managed by Health Authorities (HCU databases), are routinely collected for evaluating hospitalised complications, for administrative purposes related to reimbursement of provided services, for management of health services and healthcare expenditure, and for guaranteeing equity of health care system.
To integrate these huge sources of information allows to follow-up patients over time and to perform observational studies aimed at investigating the relationship between risk factors, healthcare pathways, their possible interactions, and selected outcomes for generating evidence on quality of care and efficacy of therapeutic and assistance pathways in relation to diagnoses.
With the aim of ensuring data interconnectability (i.e., the feasibility to recognize health services supplied to a given beneficiary of health system jointly to his/her health-related characteristics through an unique personal identifier) and platforms interoperability (i.e., the capability of heterogeneous platforms of interchanging data in a way that the data from one can be recognized, interpreted, used and processed by the others [
36]), while complying legal and privacy rules, several models may be used.
A possible way is of implementing country specific research platforms able to: (i) integrate in a safe environment, data from PBRs, epidemiological studies and HCUs whose accessibility is regulated by harmonized rules in different countries; (ii) allow of extracting, storing and standardizing data deriving from different and heterogeneous sources; (iii) agree data organization by means of a protocol driven approach (i.e., extracting relevant fields, selecting records according to predefined inclusion or exclusion criteria, allowing the implementation of observational designs and statistical tools); and (iv) compare and summarize population health (incidence and survival) with healthcare indicators and evidence generated by each country according to a common protocol. Taking lessons from results of the BRIDGE project (
http://www.cuore.iss.it/eng/bridge/pdf/WP8-D8.2_Population based registries_2017-10-30.pdf), European countries are addressing along this path to verify its feasibility and potentiality including the interoperability issue in the Joint Action on Health Information-InfAct, which is about to start, funded by the European Commission (
https://ec.europa.eu/health/sites/health/files/indicators/docs/ev_20171206_conclusions_en.pdf,
http://ec.europa.eu/chafea/health/actions.html).
Ethical aspects - Population-based registries for epidemiological studies contain information about the health status of a person; this is considered sensitive data by law and therefore subject to protection. The identification of each subject in the different situations (registries or use of administrative data) has generated legal and ethical problems, given that the personal integrity (autonomy, confidentiality and privacy) of individuals has to be guaranteed. In particular, consideration shall be paid to the fundamental principles applied through norms, and the latest EU Regulation (2016/679) on the protection of natural persons [
37].
In the case of population-based registries, the principle of ‘respect for persons’ is well represented and supported by the “informed consent” of the subjects to the use of their health information (HI) for research purposes. A general ethical requirement for consent clearly implies that human subjects voluntarily permit the use of their HI in a registry, unless a specific exception to voluntary participation applies to the registry itself. One such exception is a legally mandated, public health justification for the compilation of HI. Voluntary agreement to the use of HI in a registry necessarily allows a subsequent decision to discontinue participation.
The consent given for a registry concerns, mainly, two different aspects:
- consent to create the registry by compilation of patient information;
- consent to the use of data for the purpose of the registry and for other declared purposes.
The issue related to ethical aspects, in particular the different way European countries incorporate and implement the recent EU Regulation, still represents a barrier to the implementation of PBRs at national level.