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.

Josep Gómez, María Bodí

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)

 

Shall we go an extra mile? The IMIM and IDIBELL place the patient at the centre of research

24 Jan
Maite Solans Domènech

Research impact assessment studies show that to achieve more impact on society the participation of ‘people that can provide value’ is an important factor. What these studies show us is that making key actors participate in the long process of research can improve the efficacy of its application and its impact on society. In the conference which AQuAS organised on Participation in Research last April 4, Derek Stewart, very much involved in Patient and Public Involvement and Engagement at the NIHR Nottingham Biomedical Research Centre, told us that participation provides different perspectives to research. In addition, Derek Stewart explained that “while patients have the opportunity to configure the future and make sense of what is happening to them in their day to day, researchers have the opportunity to legitimate what they do and make their results visible.”

So what have we learnt from all this? Firstly, that there is diversity of participation in research with a wide range of ways of interaction that are inserted in the different levels of the research process. Secondly, that despite individual idiosyncrasies, a global and shared approach is needed to avoid contradictions and to take advantage of mutual learning. Thirdly, that a commitment is needed on the part of all the different institutions and the research community in order to favour participation in research and to have an impact on society. This is why a Work Group on Participation in Research has been created, (#SomRecerca). Under the initial coordination of AQuAS, different health research institutions have come together to promote actions, agents or strategies that facilitate participation and that foster more awareness of the research community. The principles that accompany this group are based on mutual support and the acceptance that diversity and different realities exist within each context.

The first step taken by this group has been to hold conferences in two institutions (IMIM and IDIBELL), last 22 and 23 of January, under the title Shall we go one step further? Placing the patient at the centre of research. These conferences have been a good opportunity to present experiences that were already on the go within the institution itself which place the patient at the centre of research.

The conferences have made the different experiences stemming from individual motivations worthwhile, of researchers or users themselves, and they have been inspirational as examples of where one can start. The patient has been placed at the centre of research in these experiences: to obtain resources, to generate ideas, to prioritise research or to be a part of the research team, among others.

And more specifically, actions have been proposed that help develop the participation of patients which provides value in research:

  • Informing patients of the research that is being carried out in institutions; that is, bringing research closer to citizens
  • Communicative skills of the researcher towards a non-scientific audience
  • Effective communication channels between patients and researchers, be they via an associative network or via other activities or means of communication such as conferences with patients, etc…
  • Support for all those involved in participation: of recruitment, of time, of resources, between researchers or with a guide.
  • Stable work groups that include the participation of different profiles (basic and clinical researchers, assistants, managers and patients) so as to identify needs, come up with ideas or make proposals, for example.

In short, the synergies between patients and researchers must be sought out in those cases where value can be provided. It is not always and easy path but one which makes a whole lot of sense.

Post written by Maite Solans Domènech.

Antisuperbugs: 3 million euros for technological innovation in the prevention of resistance of microorganisms to antibiotics

31 May

The healthcare market is one of the areas with the greatest purchasing impact in the public and private sector in Spain with a business turnover of 71 billion euros annually. It is a very complex market where the formulas used for purchasing both consumer goods and drugs, and services depend on the centres themselves. However, they also depend on the local regulations of suppliers, autonomous regions as well as state and community legislation.

This complexity does not only make it impossible for companies to make their products or services available to procurers but it is also often the interested parties in the purchasing that see the inclusion of these produces in their centre and their accessibility to their staff as a truly impossible mission.

And this is a whole lot more difficult when it comes to incorporating new technologies that meet the real needs of professionals.

In a panorama where investment in research and development is at its lowest point in recent decades, having a pre-commercial public procurement project subsidised by the European Union with 3 million euros is a big opportunity for companies that can offer their R+D services to create innovation which responds to the real needs of professionals.

An innovative public procurement project is an approach to innovation based on demand, where a group of procurers combine their resources to share risk in a joint R+D effort in the industry to provide solutions to needs which are not being met by the market. In the case of our project, it would be an ICT solution aimed at the early detection of microorganisms resistant to antibiotics (superbugs) in a healthcare environment, the Antisuperbugs project, coordinated by Jean Patrick Mathieu of the Agency for Health Quality and Assessment of Catalonia (AQuAS).

Antisuperbugs team (from left to right): Kristina Fogel, Sara Bedin, Maren Geissler, Dag Ilver, Benian Ghebremedhin, Jean Patrick Mathieu, Enric Limon, Gonçalo de Carvalho, Gemma Cabré, Esther Arévalo

The consortium coordinated by the AQuAS, an expert institution in the definition and execution of public procurement projects in innovation in Spain, consists of 6 contracting authorities (the Catalan Institute of Oncology IDIBELL (ES), Hospital Mútua of Terrassa (ES), Sheffield Teaching Hospitals NHS Foundation Trust (UK), Helios Kliniken (DE), Universitaetsklinikum Aachen (DE) and Autonomous Province of Trento (IT)), and two expert institutions in their area of research at RISE ACREO (SE) and Sara Bedin (IT).

Enric Limon of the VINCat Programme (Surveillance of Infections) of the CatSalut, principal researcher of the project, sees having a detector of microorganisms resistant to antibiotics as a business opportunity for a company.  In the United States, Asian and European Union markets, solutions are being sought that will make it possible to have a rapid detection system that activates early detection mechanisms. The resistance of certain microorganisms to antibiotics is creating a situation of alarm across the world to which the World Health Organisation (WHO) itself has drawn attention, estimating a figure of 50 million deaths in the years to come if adequate measures are not taken. The successful tendering companies will not only have access to funding but also receive the support of hundreds of professionals from six European institutions at the highest level in research and a potential market in a first phase of hundreds of hospitals and healthcare centres interested in purchasing a solution that they themselves have helped create.

Gonçalo de Carvalho, expert biologist in resistances at the Catalan Institute of Oncology, explains the need for this project to consider the possibility of creating new modules that when applied to the technologies themselves enable new detections to be made which makes purchasing them even more attractive to health institutions by adapting them to their own needs.

The tender which will be opened to companies in the next few months forms part of the Pre-Commercial Public Procurement programmes funded within the European Commission’s H2020 framework of reference. All the information regarding the Antisuperbugs project and the tendering options are available on the website of the project.

Interested companies can access the questionnaire of the open call of the market.

There is also the option for companies to offer their availability by putting in a tender as a consortium.

Post written by Jean Patrick Mathieu, Enric Limon and Gonçalo de Carvalho.

Altmetrics: complementary metrics focused on the article

19 Apr
Ernest Abadal

The traditional system in assessing the quality of a scientific publication (a journal article, for example) has fundamentally been based on the calculation of the citations it generates. In an article published in Science (1995), Eugene Garfield (1925 – 2017) proposed a citation index as a system that would help authors find articles on a subject. It was a great innovation without doubt. Later, with the creation of the Institute for Scientific Information (today the Web of Science) and the Journal Citation Reports, this system became very prominent and centred its work on the assessment of journals because it helped authors decide in which journal to publish (based on the impact factor calculated for each one).It is a system that has been criticised from the humanities and social sciences and also because it does not focus on the article itself but instead gives the reference value to the journal in which it is published (and presupposes that an article should “inherit” the journal’s impact factor).

From 2010, people started talking about altmetrics, a set of indicators (for example, how often an article is shared, its re-dissemination, the comments it has generated, mentions (likes), etc…) that measure the presence of a publication in social and academic networks, which complement citation indexes considerably. Altmetrics, therefore, assess the repercussion of an article itself and not that of a journal as a whole (the way impact factors do, for example).

At present, several scientific editors have taken this information into consideration. One of the first examples was the journal PLOS, followed by Nature and others. Its use has also spread to data bases (e.g. Scopus) and to academic networks (e.g. ResearchGate). The altmetric data that accompany an article tend to have the sections that appear in figures 1 and 2, even though there can be small differences depending on the programme used (ImpactStory, PLUM, Article Level Metrics, altimetrics.com, etc…).

Figure 1.

Figure 1. Example of the altmetrics of an article in PLOS

And so we can see that it is not only the statistics of presence in social networks that are included (mentions, blogs, etc…) but also the use of data (visualisations and downloads) as well as the citations of an article (in Scopus, CrossRef, PubMed, GoogleScholar, etc…). We are talking about very complete quantitative information for the reader and also for the author of the article.

Figure 2. Example of the altmetrics of an article in Nature

In the case of Nature (figure 2) there is also a graphic representation in the form of a circle or “ring” in which each colour is a type of channel (twitter, blogs, facebook, wikipedia, etc…), where a contextualised percentage is given in relation to articles which are similar in age and it also indicates its precise presence in the general media (“news articles”) and scientific blogs.

Let us do a quick assessment of altmetrics. Their main strengths lie in the fact that they measure the impact of publications beyond academic circles, strictly speaking, that they can be applied to all types of documents (be it an article, a book or a doctoral thesis), that the results are immediate (there is no need to wait for the annual value of the impactor factor) and that they focus on the article (and not on the journal).

In terms of their weak points, it should be said that the indicators need to be collected very quickly (they are very volatile), that it is difficult to compare the indicators between each other (which is of more value, a retweet or a “like”?), that there is great difficulty in the normalisation and homogeneity when collecting data (which does not occur in the case of citations) and that different measuring tools produce different results (e.g. ImpactStory or Altmetrics).

Altmetrics, therefore, help to measure the impact of a specific publication in social networks. This is why we should define them as complementary metrics rather than alternative metrics. In contrast to the traditional impact factor – which is applied to a journal – altmetrics are centred on the article and this is a significant innovation. Despite them having some weak points they are in a consolidation phase and have long-term potential.

From a researcher’s perspective, it is clear that at present publishing an article in a journal is not enough and one needs to be fully involved in its dissemination in social networks (especially Twitter, blogs, etc…) and also in academic networks (Researchgate, Mendeley, etc…) so as to give visibility to the contents published. In this new scenario, altmetrics are fundamental because they are able to measure this impact in networks and offer authors (and readers) a general view of the dissemination of their publications.

Post by Ernest Abadal, Faculty of Library and Information Science, University of Barcelona.

Nurses in Barcelona adopt the culture of dialogue to define their professional future

5 Apr
Glòria Novel and Núria Cuxart

Asking ourselves questions, reformulating questions, rethinking the way we want to be, what we need and how we want society to know and see us. This is, without doubt, a difficult exercise to carry out as individuals but it is even more difficult to do this as a profession.

Agreeing with each other is by no means easy. Training, method and a desire to do so is needed. Having these premises clear, we initiated the RESET project at the Official College of nurses of Barcelona (COIB).

Guided by the company Diàlegs, specialised in mediation in health, we initiated an unprecedented process of participation in the nursing profession during which we went out into the territory to find out what the concerns, needs, wishes, complaints and proposals of nurses in the province of Barcelona were.

The process lasted the whole of 2017, after which our corporation was given the commission to develop the strategic lines on which the college members of Barcelona want us to work along with thousands of ideas that they would like to process.

The difficulty of the project was considerable. Apart from the geographical distances that existed and the difficulties in getting nurses involved, there was the added difficulty of coming up with a dynamic that had to be participative so as to facilitate environments of conversation, discussion and consensus among the hundreds of female and male nurses who have different professional realities and therefore varying priorities.

The Diàlegs company took on the challenge of making it possible by means of a process lasting 12 months during which participative methodologies were used to define the profession as it is today and that of the desired future. The framework for the project was based on the principles, values and methodologies of mediation, which led to a broad and necessarily inclusive view of the differences and susceptibilities of the nursing community.

The RESET project was carried out in three different stages: in the first stage, open debates were set up in circles of group discussion. The circles enabled a comprehensive collection of very valuable data which formed the basis on which to develop the following stages that consisted of two days of consensus: one to agree on the diagnosis of the situation the profession finds itself in now and another to define the future, with the aims and lines of action to be developed.

As a result of these three stages of the RESET project, 52 group discussion circles with 925 participants were set up, that is, with people who participated one or more times. 3,762 ideas were collected as well as some proposals for the future, with nine thematic areas and 65 lines of action decided on by agreement. The level of satisfaction was very high and the participants showed a high level of interest in continuing in the project, repeating participations in the three stages.

It must be said that the key to the success of the process was the large number of people that committed themselves to the project right from the start. We are referring to what we called the Driving Group made up of 208 people (with representatives from all over the territory, all positions and susceptibilities) who worked from the start both in the co-design of specific aspects as well as in the diffusion, organisation of group discussion circles and participation in the events for consensus.

Beyond the results of the RESET project, which are, in the end, a commitment to change with implications for the upcoming years, we still have much to learn and this can no doubt be extrapolated to the professional disciplines in health in which we are organised through colleges. We need to continue asking ourselves questions both in and out of the college organisations to positively drive change and development in all the aspects which bring us together as professionals. Continuity in the culture of dialogue is one of the most important challenges that came out of this fascinating process. This was the message that the nurses who worked in the Reset Project gave us. Therefore, from the COIB, this is our commitment.

Post written by Núria Cuxart Ainaud, director of programmes at the COIB, and Glòria Novel Martí, founding director of Diàlegs.

Towards research in nursing with a (greater) impact

15 Mar
Núria Radó

What is it that makes a particular research have an impact on society beyond the strictly academic and which is truly transformative? Can a whole series of actions be planned in the way that one follows a cooking recipe which leads directly to the desired social impact? Unfortunately, the answer is no. The impact is multifactorial and depends on so many different elements and actors that it is difficult to establish a formula to guarantee it.

However, having said that, the fact that there is research which has a particular social impact does not mean that it is a totally random phenomenon and that there is no way of predicting, facilitating or promoting it. Years ago, from the Research Assessment group at the Agency for Health Quality and Assessment of Catalonia (AQuAS), and with the help and complicity of the International School on Research Impact Assessment, ISRIA, we identified a series of facilitators with regards the impact of research.

A fundamental facilitator is people, and the values, culture and capacity of leadership they have. Two identical results of research can have different impacts if the capacity of leadership, drive and will to get beyond academic impact is different. But this is still not enough. The strategy, organisation, collaborations and openness that institutions have will be a great facilitator or barrier for the researchers that have carried out the research.

Finally, both people and institutions will need two indispensable elements in order to aspire to having an impact: on the one hand, a close and effective communication with the different social actors that can play a role in transferring the results of research, and on the other, an approach focused on the participation of all these key players.

To paraphrase Confucius when he said “explain it to me and I will forget, show me and maybe I will remember, involve me and I will understand”, it is all about involving all the necessary actors to bring about a real change and make research transformative.

It is in this context that SARIS (Catalan acronym) came into being, the Assessment System of Research and Innovation in Health. It is a strategic tool which emerged from the PERIS (Strategic Plan for Research and Innovation in Health 2016-2020) with the aim of assessing the research carried out in health in Catalonia from the perspective of always wanting to facilitate and influence so that it has an impact beyond academia. To do this, the motivation and involvement of actors has been defined as a key factor for its development.

Last November, we started a series of participative sessions with nurses who were selected from the PERIS 2017 call in which a line of intensification of nursing professionals was financed.

It is important to emphasise that launching this line with nursing research makes full sense for three reasons: on the one hand, one of the thematic priorities of the PERIS is clearly that of “the development of clinical and translational research which facilitates the growth of scientific and technological knowledge, putting special emphasis on primary care agents and research in nursing”. In addition, the PERIS 2017 nursing fund has been the first to come to an end and it was appropriate to address ourselves to them first and foremost.

Last but not least, the conditions in which nursing research is carried out, with patients and their recovery as its central goal, makes it especially appropriate to ensure that this research has a direct impact on health. Hence, it is important that the research done in nursing be capable of demonstrating the impact that this group of professionals has because it can give it a comparative advantage with regards other biomedical disciplines. Indeed, nursing research is intrinsically translational.

Therefore, the first session centred on identifying the influential actors and in empowering the nurse to carry out an effective communication which amplifies the productive interactions needed to transform the results obtained into benefits for a better and improved health for patients.

We would like to express our deepest gratitude to the nurses for their participation (readiness and motivation) who attended of their own free will and in their time off work ensuring thus that the session was a success. This demonstrates that from the AQuAS we have leverage to give support to those researchers who are motivated to driving the impact of their research.

At present, we are preparing other sessions that will enable mutual learning between researchers and the assessment agents at the AQuAS.

Post written by Núria Radó Trilla (@nuriarado).

Jornada SARIS: Participación en recerca Barcelona, April 4th 2018.

Medical information in the press and the doctor-patient relationship

15 Feb
Gaietà Permanyer

For years, I have been under the impression of not having a clear idea of how information related to the complex world of medicine and health should be disseminated in the daily news media, both of the science that it is based on and of the difficulties and dilemmas in applying it in practice.

I have repeatedly refused offers, with only rare exceptions, to write texts on these subjects in newspapers or books of a non-professional nature: I had serious doubts of how to transmit this knowledge to the public at large. Looking back critically on these reservations I have had, I think they have been related to the paternalism inherent in the medical training received by the professionals of my generation: the fear that the public will make an incorrect interpretation and come to abhorrent conclusions of the facts disseminated, an audience with little knowledge on the theoretical foundations and subtleties of these facts, which are only accessible with proper professional training. Indeed, experience has shown me that these reservations were indeed justified.

However, at the same time, I have witnessed the growth of citizens’ autonomy, now widely acknowledged, and their right to take “informed decisions”. This position, which has come to define the 21st Century as “the patients’ century”, acknowledges their right to know relevant professional data so as to be able to take accurate decisions autonomously; it has an undeniable foundation but if we are to avoid that this leads to the proliferation of distorted facts it will require a rigorous preparation and an absence of spurious interests on the part of those divulging information. Ideally, these informants should contribute to “health literacy” in a way that is balanced, objective and unemotional.

The tension between these two conceptions of health information goes in parallel with that which exists between two extreme views of the doctor-patient relationship: the classical paternalistic one (“the doctor knows better than anyone what is best for a patient and their decision must be accepted”) and that of the “informed consumer” with autonomous decisions. The other extreme of this corresponds to an “imminent revolution” in which it would be the very well-informed patient, (basically as a result of the spread of refined computer technology) that would take the most important decisions concerning themselves.

Personally, like many others, I prefer a more balanced approach: that corresponding to the “interpretative” and “deliberative” models of the doctor-patient relationship, in which the experience and knowledge of the former interact with the latter respecting their autonomy.

I think that this dilemma runs parallel to the medical information found in daily news media: on the one hand, there is the social demand to inform citizens of current advances so they know their options or opportunities as “informed consumers”; on the other, there is the temptation to fuel the emotions (triumphalism or fear) of the reader who is untrained by offering them information which is largely uncritical, lacks rigour or is insufficient, with the risk of a biased, distorted or exaggerated interpretation. The more or less unreal notions that some informants may have on medical and health problems (common, alas, among many professionals) can be transmitted like this directly to the citizen and to their emotions and desires.

In the case of news related to medical advances and innovations, I would like citizens to know what expectations these novelties raise, maybe now within their reach, and the magnitude or relevance of the problem that can be lessened or resolved, and that this be done by using a rigorous and prudent terminology so that citizens can also create their own opinion on the solidity or temporariness of an innovation, and of the related uncertainties and limitations: not only of the benefits that they can provide them with but also of the undesired, uncomfortable or harmful side effects they might produce, and whether they are in anyway frequent or probable. In other words, I would not like the main aim of this information to be that of creating hope or fear in the reader, or give them the idea in a triumphal tone that in the wonderful world of science, the war against disease has claimed a new victory, especially at the hands of local researchers.

I have recently taken part in an analysis of the news published in the daily press in Catalonia on medical innovations.

Even though some well-documented news described in sufficient detail was found that could provide balanced information to the reader in this analysis, in many other cases the information was one-sided or not very thorough and was devoid of facts related to questionable aspects of the innovation and their risks. It resulted in a biased message which often tended to induce optimism in the reader rather than educate them in the knowledge of the pros and cons of the medical innovations.

At a time when there is a call for a user’s well-informed autonomy, I would be delighted if healthcare culture and the attitude of the news media did not amount to a paternalistic doctor-patient relationship. In this regard, there is no doubt that much still needs to be done.

Post written by Gaietà Permanyer Miralda. Emeritus physician. Unit of Epidemiology, Cardiology Service. Hospital Vall d’Hebron, Barcelona.

Hip and knee arthroplasty: What prosthesis did you say I would get? (part two)

1 Feb
Olga Martínez, Xavier Mora

We continue the interview with Olga Martínez expert at the Catalan Arthroplasty Register (RACat) and Xaxier Mora, specialist in traumatology and orthopaedic surgery with a Master in biomaterials.

The aim of today’s post is to know a little more about prostheses and the biomaterials used in arthroplasties.

With this post and the previous one, we have wanted to present the opinions of these two professionals.

Are all prostheses the same?

Xavier: No, because each patient is different. Therefore, the orthopaedic surgeon will recommend one type of prosthesis or another, depending on the extent to which the bone is affected, the patients’ age, associated diseases and the daily activity of a the patient.

Olga: At present, there are different types of prosthesis on the market in terms of design, materials used in their manufacture and the way they are anchored to the bone. There are prostheses that range from replacing only a part of the joint to more complex joint replacements in situations where bone damage is extensive.

As a user of the health system, to which hospital should I go to receive the best prosthesis?

Xavier: One cannot talk about better or worse prostheses because all prostheses used for implants have to follow a standardised procedure according to specific international standards, such as those of the American FDA and the European CE seal of approval, for materials that will be implanted in humans. In the same way, hospitals in Catalonia are certified to be able to carry out this type of surgery.

Olga: The prostheses which are commercialised in Catalonia meet the international standards of quality and public hospitals base their choices of prostheses on the scientific evidence available. This is allows them to select those with the best results according to arthroplasty registries, using recommendations from different institutions such as the NICE (National Institute of Healthcare and Clinical Excellence) and the ODEP (Orthopaedic Data Evaluation Panel).

Olga: In addition, the new European legislation passed in 2016, regarding implants used in health, aims to increase the supervision of the industry by implementing stricter norms and regulations including the obligation of clinical assessment, while at the same time fostering innovation in this field.

Who does the research into the best materials available and what factors are taken into account?

Olga: These days, the research of new materials and manufacturing techniques as well as the design and improvement of new prosthetic implants is a multidisciplinary process. The contributions of orthopaedic surgeons are especially important together with studies in joint biomechanics and surgical technique. In Catalonia there are research centres in biomaterials such as Leitat and the Technical University of Catalonia (UPC).

Olga: From the AQuAS we have written up and published short reports on biomaterials (polyethylene, cements and ceramics and metals) aimed at professionals that work in services of orthopaedic surgery and traumatology, with the aim of updating their knowledge.

Reports available in Catalan:

Xavier: Nowadays, when manufacturing new materials, the interaction between the surface of a biomaterial and the bone is taken into account more and more often, so that bone cells can consider an implant as part of its own structure and thereby avoid the prosthesis from moving about because this is one of the biggest problems in getting an implant to function well.

How have materials evolved since the first prostheses to the present day?

Olga: The discovery of new materials and/or the progress made both in terms of manufacturing techniques and the knowledge gained in the biomechanics of the human body have influenced the design of prostheses over time.

Xavier: The first experiences in joint implants date back to the 20s of last century. One of the first attempts at replacing the surface of the head of the hip was done by manufacturing a metal socket or dome (Smith-Petersen).

Xavier: In the last 20 years, many important advances have been made regarding the use of new biomaterials, much safer and of greater resistance to wear, thus extending the life of an implant in a biological environment such as the human body. Together with metallic biomaterials, these days ceramic biomaterials are used with good results in relation to their integration in bone tissue.

Xavier: On the other hand, research in 3D technology has paved the way for a more precise surgery, and in the future it will be possible to manufacture more personalised implants.

Xavier and Olga: We both agree that we are getting closer and closer to having a prosthesis that is for life.

Hip and knee arthroplasty: What prosthesis did you say I would get? (part one)

25 Jan
Olga Martínez, Xavier Mora

Today, we interview Olga Martínez expert at the Catalan Arthroplasty Register (RACat) and Xavier Mora, specialist in traumatology and orthopaedic surgery with a Master in biomaterials. They are two professionals involved in arthroplasties, a subject of great impact among a large sector of the population. We focus on aspects of recommendation and prognosis related to the pathology and on the value of registries for quality care.

In what cases is an arthroplasty intervention recommended?

Xavier: The most important surgical indication to carry out a knee or hip arthroplasty is arthrosis. Advanced arthrosis has a considerable social impact with a loss of life quality for the person affected due to pain, a loss of personal autonomy and an increase in dependency. In addition, the loss or reduction in mobility can worsen existing diseases such as diabetes or heart diseases. It is in these situations when an arthroplasty is recommended which will reduce pain and improve joint mobility.

Olga: In our field, according to the data from the Conjunt Mínim de Dades dels Hospitals d’Aguts (Minimum Set of Data from Acute Care Hospitals) and the Catalan Arthroplasty Register (RACat), the main reason for an intervention in knee and also hip arthroplasties is arthrosis. In the case of the hip, femoral neck fractures are the second cause for arthroplasty recommendation.

It seems that there are more and more people who undergo arthroplastic surgery each day to implant a prosthesis. Is this a fact?

Xavier: Yes, around 9,6% of the Spanish population suffer from this disease to some degree, a percentage that increases up to 33,7% among people aged between 70 and 80. With the ageing of the population, it is evident that there will be an increase in the number of people who could be candidates for arthroplastic surgery in the future. In the context of Catalonia, if we do a simulation with 2026 as the time horizon, based on data from the Idescat, the population aged between 15 and 39 will decrease while the population of 40 to 64 will increase (227,000 people and 330,000 people respectively).

Olga: At present, knee arthrosis has a prevalence of 10,2% and that of the hip is around 5%, more frequent among women, even though the data vary between one study and another.

The AQuAS, the Agency for Quality and Health Assessment of Catalonia, has been managing the Catalan knee and hip arthroplasty registry (prosthesis) for many years. What purpose does a registry like this have?

Xavier: The aim of all orthopaedic surgery is the survival and good functioning of a prosthesis and in consequence, the improvement in the quality of life of patients. Although a prosthetic implant undergoes strict manufacturing procedures before being used and follows a rigorous surgical technique during surgery, the functional results in a patient need to be assessed via follow up sessions from the time they receive an implant. To this effect, arthroplasty registries can help detect models of prosthesis with a malfunction, both in the short and long term, and identify the patients who have received these implants.

Olga: This is what happened a few years ago with the ASR model, a hip prosthesis that some publications and registries, such as the National Joint Registry, pointed out due to an unusual increase in the rate of revisions. This motivated an international health alert and a protocol was adopted to monitor patients.

Olga: One of the first prosthetic failures that prompted the creation of registries was that of the 3M Capital Hip, a hip prosthesis introduced in 1991 in the United Kingdom as an inexpensive prosthesis. After six years and more than 4,600 prosthesis implants, the risk of undergoing a revision was considered to be 4 times higher than that expected with the added difficulty of the traceability of the implants as no registry existed at a national level.

Olga: The Registry for Arthroplasties of Catalonia created in 2005, an epidemiological tool of surveillance in the Catalan Health System, stemmed from the collaboration between the AQuAS, CatSalut and the Catalan Society of Orthopaedic Surgery and Traumatology.

Are there other similar experiences of registries of this type in other countries?

Olga: Sweden (1975) and Finland (1980) were the first countries to push for a national registry of arthroplasties of a demographic nature.

Olga: At present, many countries have implemented this tool, be it in Europe, America, Oceania, etc… with different territorial coverage, but with a common aim: to be a valid instrument in assessing arthroplasty procedures and implants used.

As a patient or as a family member of a person that suffers from joint arthrosis, what is the message that you would like to get across based on your experience?

Xavier: The first consultation that a patient has is always because of the pain they are experiencing in the hip or knee joint when walking, going up or down stairs, getting up from a sitting position in a chair, having difficulty to put on shoes, etc. The aim of treatment should be to eliminate pain by using medication, doing physical exercise and physiotherapy that help improve 95% of patients. An arthroplasty intervention should only be considered as a last therapeutic resort. In this context, shared decisions between professionals and patients are very important too when talking about arthroplasties. We should all ask ourselves whether the best option to reduce this pain is to implant a prosthesis.

Does a patient go back to normal routine life after an arthroplasty intervention?

Xavier: After a surgical intervention and once the period of functional recovery has come to an end, a normal lifestyle can begin, due to the disappearance of pain and an improvement in joint mobility. In certain cases, constraints will be limited to intense activity that could overburden the joint.

(To be continued …)

Open access depredatory journals

7 Dec
Joan MV Pons

As soon as it has been published and identified with an email address, it will not come as a surprise to receive a lot, but I mean a lot, of emails that often invite one to publish in what are apparently scientific journals (by name), to participate in congresses or conferences on subjects that seem of interest or to join as a member of some board of editors. These emails come in constantly and which I always mark as junk mail so as not to waste more time on them.

And it is true that this type of business, which is purely that, has proliferated in recent times largely due to the inherent zeal of the human species for lining one’s pockets, but also perhaps because of the great proliferation of researchers and research institutes. There is a lot of money at stake and it is well-known, that with minimal effort, one ends up publishing anything that one desires. If editors of journals in the past strived for readers and subscribers, now in addition to these open access journals, what they are looking for are columnists, people who publish in their pages …. in exchange for a small (and not so small) fee. There is no need to talk about the advantages of these open access journals and how some of them have attained a pretty high impact factor within a short period of time. Here the impact factor is a correct measure because it gives an approximation of the citations the articles receive which are published in these journals; it is a mistake, we know, to use the impact factor of the journal as an approximate measure or substitute (proxy or surrogate) for the value of an article.

Jeffrey Beal, a librarian, is the person who introduced this term and who elaborates and updates a list of journals periodically that can fit in to this  typology. According Wikipedia’s definition, those considered as predatory journals are those open access publications that stem from a business model based on the exploitation of open access publications by means of charging a publishing fee to the authors without providing the editing and publishing services of journals considered as legitimate (be they open access or not). Beall’s List up to December 2016 – a good sample of how Wikipedia updates itself in some subjects – had some 1,155 journals included.

The same universal cybernetic encyclopaedia provides a series of associated characteristics with this type of predatory journal (also hunters, that hunt to survive).

Post written by Joan MV Pons