NOAC’s – AQuAS Blog

Reusing health data: oral anticoagulants and cerebral haemorrhages

23 Nov

Last September, the 35^th 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.

Elderly person with stroke: integrated care from the acute phase to the return home

9 Dec

Stroke has a high incidence, a growing prevalence and is the pathology with the second highest impact in the world in terms of disability among adults. Despite important advances in acute stroke management, which have led to a progressive decrease in acute stroke deaths, in terms of residual disability, stroke continues to have an extremely high impact on survivors, their families, their caregivers and on society in general.

Evidence shows that the approach to patients throughout the process of care in stroke, from the acute phase to the rehabilitation phase, needs to be multidisciplinary since patients have multiple health care and social needs which require a strong coordination between the different levels of healthcare. However, the tendency is still to organise conferences and congresses focused on only one speciality or level of healthcare.

On the other hand, and in self-criticism, even though stroke is one of the main reasons for using intermediate or long-term healthcare services, this sector almost never takes part in the decision making process of stroke care organisation. Neither does it do much research in stroke and in general, tends to put little thought into improving knowledge in treatments or in innovating the organisation of services compared to, for example, other conditions such as thighbone fractures.

This is why the Parc Sanitari Pere Virgili organised a monothematic symposium on 27 October, two days before the World Stroke Day. It focused on the treatment and management of stroke in elderly people from a different perspective: we traced the trajectory from the “needle” of the thrombolysis in the acute phase, passing through rehabilitative care and “reablement” in the post-acute phase, to the transition back to home life, describing the care given to patients especially, but not forgetting the attention caregivers need.

The presentations reflected and reinforced the need for a multidisciplinary approach in all phases of stroke. As an added value, in all cases the speakers not only combined recommendations derived from literature with their own practical healthcare experience but also provided data from their own research or innovation projects, in many cases with data published recently.

Among the speakers there was a varied representation from very different disciplines which included neurologists, geriatricians, physiotherapists, occupational therapists, speech therapists, social workers, a health economist and the representative of the stroke patients association who chaired a roundtable.

Some of the items that were highlighted most strongly during the symposium were:

The large amount of increasingly more accurate data available on all phases of stroke management. In Catalonia, this data is being provided by the Results Centre, which encourages transparency and allows for benchmarking thereby facilitating a reduction in variability and the sharing of best practices.
Despite improvements in the treatment of acute stroke patients using mechanical thrombectomy together with systemic thrombolysis, 40% of patients are left with a considerable disability as a consequence of stroke. This “glass half-full” should therefore encourage more to be done in terms of acute stroke management, and also in post-acute care which is still vital.
In acute care, age should not be a discriminating factor. This is in line with the concept that chronological age does not correspond necessarily to biological age and that two elderly people of the same age can have a totally different “functional potential” (a concept which in practice in the field of geriatrics is understood as meaning more or less “frail”).
Advances have not only been made in acute care but also in the field of primary and secondary preventive care. Accordingly, the development, the approval of and the use of NOACs (new oral anticoagulants) have been a determining factor since they offer an alternative for those patients where traditional anticoagulants are not a therapeutic option.
The rehabilitation prognosis is multifactorial. A recent proposal stemming from a multi-centre Catalan study led by our hospital and published recently, is based on a simple algorithm which incorporates the social factor (presence of the caregiver) together with the severity of the stroke (using the NIHSS score), functional status (according to the Barthel index) and cognitive function (a result of the Rancho Los Amigos scale). This allows patients to be classified in three levels of rehabilitation complexity, but who might evolve differently, with different needs for intervention, both in the rehabilitation process and regarding their return home.
Integrated interventions in geriatric rehabilitation can be home-based for certain patients as an alternative to a hospital admission. This model, deeply rooted in England and which has proven to be beneficial, is producing good results in our context in different pathologies including stroke. Innovative formulas such as “Comprehensive Home-based Hospitalisation” have, in our context, come about from the alliance between home-based geriatric care teams (doctor, nurse and social worker) and those of home-based rehabilitation (rehabilitation doctor, physiotherapist, occupational therapist and speech therapist).
In terms of physiotherapy, treatments should be more standardised and their efficacy demonstrated. During the symposium, interesting evidence was presented on the control of the trunk and its importance throughout the rehabilitation process in stroke.
Dysphagia is a very prevalent risk condition in patients who have suffered a stroke. Different proposals of scales for assessment at the bedside were shown which can be applied by nurses, reserving the speech therapist’s intervention for the most complex cases which require a more specialised assessment.
In rehabilitation, the support from the ICT (“telerehabilitation” which patients can receive following the instructions and programme configuration of the physiotherapist) allows treatments to be extended in time and intensity along with face-to-face treatment.
Working with caregivers is important. Apart from guiding them within the system, the availability of support groups for exchanging personal experiences, for a social worker, for example, could have an impact on the adaptation of the caregiver to the new situation. To this effect, an innovative experience was developed in our centre with a high degree of acceptance by patients and their families.
Continuity in the recovery process is key and the integration of health and social services guarantees an added value. The pilot “Return Programme” in the city of Barcelona, the result of the alliance between the Catalan Health Service and the City Council of Barcelona was presented. It allows for the direct activation of social services, from acute care and long-term care hospitals so that patients can receive the necessary aid when they return home and thus avoid unnecessary and dangerous delays.

In summary, much progress has been made in the treatment of stroke, especially in the acute phase, but innovation is also being carried out in the successive phases and the symposium showcased different experiences which have been implemented in our context. Drawing conclusions from the symposium, the take home messages are that a comprehensive view of the entire process is key, as well as an integrated and coordinated approach between the different levels of healthcare and social services. On the other hand, more research needs to be carried out especially in the post-acute and chronic phases resulting from the disease and this poses a challenge because of the difficulty in designing and implementing complex interventions where designs such as standard clinical trials are not the solution.

Post written by Marco Inzitari (@marcoinzi) and Laura Mónica Pérez, Parc Sanitari Pere Virgili, Barcelona.