Reusing health data: oral anticoagulants and cerebral haemorrhages

23 Nov
Rosa Maria Vivanco

Last September, the 35th scientific meeting of the Spanish Epidemiological Society (SEE in Spanish) took place in Barcelona.

The AQuAS presented the impromtu roundtable “The reuse of health data for research: how, when and what is expected from the PADRIS programme in Catalonia.”

At this roundtable, moderated by Mireia Espallargues and Ramon Roman, the attendees were informed of what the PADRIS programme consists of (Public Data Analysis for Health Research and Innovation Programme in Catalonia) and some results were presented, such as those that derive from the study we are carrying out at the IMIM (Medical Research Institute of the Hospital del Mar), with the support  of the Catalan Stroke Program, on the link between the use of oral anticoagulants and cerebral haemorrhages.

Cerebral haemorrhages are the second most frequent type of stroke in the world, with an incidence of 48 cases per 100,000 inhabitants per year (Global Burden Disease 2010). The most frequent cause is high blood pressure.

As with other causes, it points to the use of anticoagulant drugs and old age. High blood pressure is a risk factor which is being detected the earliest and which is being controlled more efficiently in recent years in high income countries, and thus it is estimated that associated cases of cerebral haemorrhages will decrease.

By contrast, it is foreseeable that due to the ageing of the population and the increase in the prescription of anticoagulants to prevent stroke at a primary and secondary stage, cerebral haemorrhages associated to these other risk factors will increase.

On the other hand, new oral anticoagulants have appeared on the market (known as direct action) which, according to clinical trials, offer similar efficacy and improved safety features over the anticoagulants that there have been till now, known as vitamin K dependent.

These results, however, need to be verified in habitual clinical practice.

This is the context in which it is so necessary to have a programme available with the characteristics of the PADRIS programme.

What can we get out of it?

To know, by using population data, among other elements, the incidence of cerebral haemorrhages over the last 10 years, their association with the use of these drugs, both dependent vitamin K coagulants and the new oral anticoagulants, whether the tendency of the prescription has changed, whether the new oral anticoagulants are associated to a lower risk of cerebral haemorrhages as studies seem to indicate, what segment of the population is most affected and even to be able to make estimates for the years ahead.

In the case of our study, the preliminary results that we presented show a tendency for a greater prescription of new oral anticoagulants and a stabilisation of the number of cerebral haemorrhages in recent years. To be able to give more definitive results, more analyses need to be done and we continue working because this is what the complexity of managing data requires.

Making the most of our experience, we feel we are in a position to offer a series of advice to any research group that is considering putting in a request to the PADRIS programme for health data.

One must bear in mind the characteristics of the registries and the data bases from which health information is obtained: namely, that the data obtained is administrative data, with the limitations that this entails, and that technical personnel do not speak the same language as research personnel.

This is why we consider it necessary to have the figure of an interlocutor or mediator that enables the research group and technical and administrative personnel “to understand each other” and that via the feedback from both sides, the group can benefit from the numerous opportunities that the PADRIS programme offers.

In our case, thanks to the Catalan Stroke Program, we were able to push ahead with the project and we hope to be able to publish our results soon and provide society with the corresponding benefits.

Post written by Rosa Maria Vivanco, researcher at the Neurovascular Diseases Research Group of  at IMIM.

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