clinical evidence – AQuAS Blog

Improving the quality of healthcare in intensive care units. The PADRIS programme in the Tarragona Datathon 2018 (part two)

14 Feb

Today we continue the interview with Maria Bodí (@mariabodi23), doctor at the Intensive Medicine Service, and Josep Gómez (@JosepGomezAlvarez), doctor in Biotechnology at the Hospital Universitari de Tarragona Joan XXII, experts in clinical management and aspects of quality and safety in healthcare.

In your opinion, what are the conclusions of the so-called Real World Data studies which were carried out using real data in terms of benefits and risks related to patient safety?

Benefits? Everything. Information derived from a real healthcare environment is necessary to take decisions. Randomised clinical trials which have defined the effectiveness and safety of therapeutic interventions have served till now as a Gold Standard of the best scientific evidence. But they are very costly, and what is more, they are aimed at very selective groups of patients. Studies and analyses derived from the real world, known as Real World Data, mean it is possible to know the effectiveness and safety of interventions in groups of patients which are usually excluded from trials (pregnant women, older people, patients with many comorbidities who are the majority, etc…).

There is a series of limitations and obstacles that prevent Real World Data from substituting clinical trials. On the one hand, legal and ethical aspects and those concerning the guarantee of the quality of data. On the other, it is not possible to accept the bias that there is when not randomising Real World Data. Before taking decisions, we need to ensure that there are no confusing factors.

Real World Data complements the information obtained from clinical trials in routine clinical practice.

Some weeks ago we received the visit of Lucian Leape in Barcelona, author of the extremely famous book “To Err is Human”. We were fortunate to be able to listen to him in a talk at AQuAS – were you able to listen to him?

No, unfortunately we were not able to attend. It is a pity because we were told that it was a good review of what we have learnt in the past two decades in the field of clinical safety and that some good recommendations were made for the future.

In your opinion, what contributions did the To Err is Human report, published 20 years ago, make?

It revolutionised the field of safety. It was a paradigm shift which is still in place today.

The To Err is Human report denounced the thousands of deaths in the United States resulting from adverse events which could have been avoided! People who were dying in hospitals for reasons unrelated to the disease for which they had been admitted. The most important thing is that those events, those deaths, could have been avoided. Better training, better work organisation, knowing and analysing risks and teamwork, among other factors, have been shown to be key elements that contribute to reducing the amount of events and their severity.

What impact has the PADRIS programme had on your day to day?

In 2016, MIMIC-II was published, a huge set of de-identified data of ICU patients of the Harvard Medical School. It was created and has been maintained by researchers at the Massachusetts Institute of Technology. They published this dataset with the aim of democratising research. The idea is that after attending a training course on the treatment of data for research, you are certified as a practising researcher and you sign a document of usage: ultimately, to enable a researcher to have access to a large data base to carry out research. In addition, it encourages researchers to share the code (data processing methodology) that they have applied to data to obtain the results they publish. Altogether, it makes studies more transparent and repeatable which in turn increases the excellence of scientific production.

As a result of our experience in extracting data from the clinical information system to develop our management tool of the unit, we took on the challenge of generating our own data base to carry out research. Once created, we contacted the PADRIS programme so they could advise us regarding data anonymisation protocols and methodologies to get access to the programme in order to carry out research. They showed great interest in our project at all times and they helped us see it to fruition and thus the role of the PADRIS programme was decisive in making the Datathon Tarragona 2018 possible. We are in fact still in contact with them to define future strategies about how to make this data available for research projects without infringing any data protection law and how to broaden the database with data from other ICUs in the Catalan territory.

If you could make a recommendation to other researchers who wish to do research, what would it be?

We recommend they collaborate with experts in other fields, especially those related to data and statistical technology. We are now reaching a level of sophistication and volume of data that obliges us to work in multidisciplinary teams in order to make the most of data and to understand it the best we can. The datathons are a great example of this; the role of the clinician is decisive in defining aims and in validating the results that appear when cutting edge algorithms are applied by data scientists. At the same time, the role of data scientists is also decisive when suggesting and applying complex methodologies which are far removed from traditional statistics applied within a clinical context.

What professional challenge would you like to succeed with in 2019?

The ultimate professional challenge for 2019 is the same as each year: improving the care given to patients which are admitted to an ICU. To achieve this, we have some very specific challenges in our unit. On the one hand, to continue developing our tool to exploit data which enables us to analyse processes and the results obtained in our day to day and in this way become aware of where we need to place our attention to make improvements. On the other hand, taking advantage of the secondary use of data to carry out research and to generate algorithms for automatic learning which are able to help a doctor take the most accurate and appropriate decisions based on the profile of each disease.

(You can read the first part of this interview here)

What are we doing about low-value medical practices?

8 Feb

The aim of the Essencial Project is to improve the quality of healthcare by providing professionals with evidence that is useful for them to make informed decisions in their day to day work.

What is special about this project is that this is done by identifying routine low-value practices in the health system and by using a strategy aimed at avoiding these practices.

Cari Almazán, the person in charge of this project, responds to questions in an interview.

What is the Essencial Project?

It is a project of the Department of Health of Catalonia led by the Agency for Health Quality and Assessment of Catalonia (AQuAS – its Catalan acronym), in which researchers from the AQuAS, health professionals, scientific societies and the Advisory Board of Patients participate. Each and every one, in their role, work with a clear objective: improving the quality of healthcare using a very specific strategy to identify low-value practices and thereby provide information to professionals to help them avoid doing all the things they do which do not offer any health benefits to the patient.

What is a low-value practice?

In usual medical practice, there are known routines that do not offer any benefit to the patient and it is difficult to understand why these occur but it is even more difficult to try and avoid them. In all likelihood there is a resistance to change and we need to spend a lot of time explaining what this project is about.

How does the Essencial Project work?

It works at different levels and we try to be systematic and transparent. This involves a line of work which includes: identifying low-value practices, finding knowledge (the evidence), informing about and implementing the project.

If a routine does not offer any benefit to the patient, why is it followed?

This is precisely what we ask professionals in primary care, among many other things. The comments “because we have always done it like this” or “because it is a request of the patient” are frequent. There is a certain tendency to want to feel we are being useful, a human one I would say. Both the professional and the patient feel better but on occasion, there is evidence which indicates that this “feeling better” is not accompanied by any benefit for the patient. This is what needs to be explained very carefully.

What role does the Essencial Project have in the day to day activity of a health professional and that of a potential patient?

There are many projects aligned with the initiative to improve the quality of healthcare. In this context, the Essencial Project is a tool of the health system to help health professionals make decisions. The Essencial Project thus aims to be useful to the health system and professionals. In addition, for a potential patient, knowing about this project can also help contribute to their understanding of why a health professional does not recommend a certain diagnostic test or treatment.

I am unsure as to whether the project is aimed at professionals or at citizens.

The Essencial Project is aimed at the entire population. On the one hand, it is aimed at professionals to provide them with this tool, but also at citizens. Why not? Whether citizens want this information is another thing altogether.

Do citizens show an interest in having all this information available to them?

We don’t know, we should ask them. We know of experiences where it is not clear that the information which is given is the information that citizens want but at the AQuAS we believe that sharing knowledge and methodology is an exercise in responsibility.

Who chooses the recommendations?

Cari: They are chosen in collaboration with the different scientific societies. Right now, there is a participative process on the go to prioritise low-value clinical practices in the framework of the Third Conference of Care in Sexual and Reproductive Health. In the Essencial Conference 2017 subjects for recommendation were prioritised based on the participation of the professionals that attended the conference. The idea is that it is the professionals themselves who identify when and where practices of this sort occur.

Who creates the contents of the Essencial Project?

The contents that accompany each recommendation are the result of the participation of many expert professionals in different disciplines. These contents are then validated. In terms of the videos, professionals at the AQuAS along with health professionals produce these which explain the key idea of each recommendation in the first person in an informative manner.

What would you highlight of the Essencial Project?

That we offer every recommendation, the chance to collaborate with health professionals, a bibliography and files for patients in a systematic way. This last idea of files for patients is a subject which we will delve into more deeply shortly from the agency. Perhaps, what I would say is most important here is that all this forms a part of a commitment to bring the culture of assessment and the culture of Choosing Wisely at all levels closer to everyone: the citizenry, professionals and the health system.

To drip or not to drip (and thus, ship); that is the question!!

14 Dec

The proof given in 2015 of the efficacy of a mechanical thrombectomy in patients suffering from a severe ischemic stroke caused by a large vessel occlusion in the brain represents a change of paradigm because it forces us to reconsider the organised systems of care for people suffering from a severe stroke.

These models of organisation, or systems of stroke code as they are known in our environment, started being developed at the end of the 90s and beginning of the year 2000 in response to the evident difficulties observed in accessing intravenous thrombolytic therapy, a highly time dependent treatment, eminently due to the delay of the arrival of patients at emergency services.

Rightly, these difficulties were overcome by developing organised systems of care where a protocol was established for the rapid transfer of these patients to specially designated and previously alerted hospitals equipped to manage these cases expertly.

Recently, we have scientific evidence that establishes that a mechanical thrombectomy is the new therapeutic standard in the case of strokes caused by large vessel occlusion in the brain, clinically more severe, where the effect of intravenous thrombolysis is very limited (30% maximum rates of revascularisation). A mechanical thrombectomy, however, is a highly specialised and complex treatment that needs to be undertaken as quickly as possible in centres with advanced technology to guarantee adequate results.

This recentralising tendency in carrying out endovascular treatment contrasts with the decentralisation which was done in its day to ensure an adequate access to thrombolytic therapy which by nature needs to be administered in the first 4,5 hours after the onset of symptoms. This is why nowadays we talk about a change of paradigm to refer to the obsolescence of the models in stroke care developed in the era of thrombolysis, now that we are fully in the thrombectomy era.

The situation today is even more complex if we bear in mind what the mechanical thrombectomy trials established: that endovascular therapy was better than medical treatment, including intravenous thrombolysis. As a result, the current standard of care establishes that, with patients having no contraindications for thrombolytic treatment, this care must be given as soon as possible before a thrombectomy.

In urban metropolitan areas, mostly served by hospitals with the capacity of carrying out both treatments, the translation of the results of trials to clinical practice does not pose a problem.

However, the question is: what needs to be done when there is a stroke in one of the areas primarily covered by centres without endovascular capacity? Should we hold the patient back in the nearest stroke hospital, and in this way prioritise intravenous thrombolysis, even if by taking this decision we are in fact delaying the arrival of the patient at the tertiary stroke centre, the only one with the capacity of carrying out a thrombectomy? Or should we transfer these patients directly to the tertiary stroke centre with the understanding that a thrombectomy is the only valid therapeutic option in these cases, even if this means delaying or disregarding intravenous thrombolysis?

This is, in fact, the controversy between the “drip-and-ship” model which prioritises thrombolysis, and the “mother-ship” model which adopts the opposite approach and defends the direct transfer to a tertiary hospital where the entire process of care can be performed: from an ultra-rapid diagnosis to whatever type of reperfusion treatment.

If that weren’t enough, one must bear in mind that these models are based on the prehospitalisation selection of patients strongly suspected of having a stroke but without confirmation or diagnosis, nor of the subtypes of stroke, ischemic or haemorrhagic.

At present, we do not have the necessary evidence to prioritise the transfer of patients with acute stroke following either the “drip-and-ship” or the “mother-ship” protocol and this is why the RACECAT (NCT02795962) is being carried out in Catalonia since the beginning of 2017 which aims to provide answers to this controversy.

This study has been made possible thanks to the effort of a large number of health professionals: from those in charge of prehospital care (SEM/112), specially trained in the use of the RACE scale (a scale to assess the gravity of stroke and, therefore, those cases with a higher probability of having a large vessel occlusion and susceptible to being treated with mechanical thrombectomy), to the people in charge of care in each of the 26 hospitals in the stroke code network in Catalonia. Would you like to know more? Then you must watch this video.

The RACECAT trial is being carried out at present and in a couple of years, the evidence obtained from this study will allow us to modify the circuits of care in the case of a serious stroke code and so be able offer the greatest clinical benefit to these patients.

Post written by Sònia Abilleira.

The speed and relevance of assessing health products

5 Oct

The European market of health products has been widely affected by the sudden emergence of a new legislative framework with the new regulations (2017/745 and 2017/746). The subtle difference between directive and regulation is paramount, they say, but we’ll leave that for another occasion. This new framework in the field of health products is characterised among other things by:

A stricter control of high risk health products (for example, certain implantable products)
The strengthening of rules of clinical evidence by including a coordinated procedure at a European level for the authorisation of multicentre clinical research.
The reinforcement of requirements and the coordination between European countries regarding controls and after sales aspects.

In this context of important changes, the assessment community is also clearly active. Thus, on 19 June this year, there was a panel on health products at the international meeting of Health Technology Assessment HTAi, where a new and innovative Italian programme for health products was presented.

The programme, explaining the work carried out over several years in terms of definition and its pilot phase, includes three work packages: appraisal, methodology and monitoring. In another panel closely related to the previous one, in the field of methodology, the presentation of the categories to decide on what to invest in and what to disinvest win clearly stood out.

When talking about monitoring and collecting information, an example that stood out was the debate on the need for early assessments given that the life cycle of a health product tends to be short.

The significant increase in new products available and all the work objects previously mentioned are some of the things that position the importance of specific assessment in health products.

The importance of the assessment of health products is, therefore, undeniable. In the joint production work package of EUnetHTA JA3, in which AQuAS is participating, as many or more assessments of “other technologies” (health products, health interventions,…) have been planned as of the known assessments of drugs. In a sense, the numbers of one or other necessity are matched. The importance of the assessment of “other technologies” was in fact reflected in the HTAi annual meeting in a presentation by Wim Goettsch, director of EUnetHA.

The identification and prioritisation of products to be assessed (the Horizon Scanning system), as well as the balance between innovation and divestment, are also extensively discussed subjects and under continuous debate. Thus, in the REDETS network (in which the AQuAS is also actively participating) and with the leadership of Avalia-T, a public access tool was identified that helps in approaching this subject: the PriTec.

Assessment, therefore, can help directly in the use, management and sustainability of different health systems. In conclusion, new opportunities are provided for improving decision making in the area of health products and some of them will come through demonstrating efficiency by means of the adequate use and definition of health technology assessments (HTA).

Post written by Emmanuel Giménez.

Crisis, inequalities and policies: proposed intinerary

7 Sep

Unfortunately, inequalities in health are still an issue today including in our country. The crisis of recent years has once again put the spotlight on this subject.

This is why we propose an itinerary taking us through the different texts which we have published on the subject in this blog and, in particular, we invite you to read the original texts which are mentioned here in more depth, a large proportion of which have been elaborated at the AQuAS.

In September of last year, Luis Rajmil reflected on social inequalities in child health and the economic crisis in this post placing the concepts of equality, equity and reality on the agenda for discussion.

“At present, there is enough accumulated information that shows that life’s course and the conditions of prenatal life as well as life during the first few years are very influential factors in the health and social participation of an adult to come.”

At a later date, the Observatory of the effects of the crisis on the health of the population published its third report but prior to that, a post was published with a collection of individual thoughts and reflections on this subject by Xavier Trabado, Angelina González and Andreu Segura focussing on, respectively, the effects of the crisis on the mental health of people, the coordination of different mechanisms in primary and specialised care, the urgency for community health actions and the need to engage in intersectoral actions.

“It is urgent to put community health processes into action; processes in which the community is the protagonist, which constitute the shift from treating an illness to a bio-psycho-social approach which gives an impulse to intersectoral work in a network with local agents, with who there is the shared aim of improving the community’s well-being. Based on the needs detected and prioritised in a participatory way and with the local assets identified, these processes activate interventions based on evidence which are assessed”

In this other post, Cristina Colls presented an interesting case of the application of scientific evidence to political action which occurred with the revision of the socio-economic dimension of the formula for allocating resources to primary care.

“Social inequality leads to an unbalanced distribution of the population in a territory, concentrating the most serious social problems in certain municipalities or neighbourhoods having higher needs for social and health services than other territories. In this context, more needs to be done where needs are greater if the aim is to guarantee equality in the allocation of resources”

Finally, the most recent post was written by Anna García-Altés and Guillem López-Casanovas. It is a text that provides food for thought based on the latest report published from the Observatory of the Health System of Catalonia on the effects of the crisis on the health of the population.

“Understanding the mechanisms by which social inequalities have an impact on the health of the population, so as to know how best to counter or neutralise them, in any place and at any time, is an issue that must still be addressed by our social policies”

We hope that you this very short itinerary through these texts, initiatives and analyses that aim to be useful in tackling inequalities has been of interest.

Post written by Marta Millaret (@MartaMillaret)