The importance of registries in 4 questions

15 Nov
Kayla Smith

In this AQuAS blog post we’ll continue talking about registries. Last month Jorge Arias focused on registry collaboration between clinics and researchers, and at the beginning of the year we touched on the same topic during interviews with Olga Martínez and Xavier Mora, where the focus was on arthroplasties and new materials used in protheses. A few years ago, in 2015, we celebrated 10 years of the Catalan Arthroplasty Register (RACat), managed and coordinated by the Agency for Health Quality and Assessment of Catalonia (AQuAS). In that post, Olga Martínez and Laia Domingo discussed the experience of the registry as a whole, in terms of history and function.

We’ll start today’s post with the importance of registries.

1. What do we mean by ‘registry’?

A registry is a collection of standardized information that can range from patient diagnoses, outcomes, procedures, diseases, device performance, among other aspects, and uses this data to evaluate specific outcomes for predetermined clinical, scientific, or research purposes.

More concisely, a registry collects standardized information, to be used for a specific purpose, about patients who share a condition or certain characteristics. Patient registries have existed for decades, with the first arthroplasty registries, in the Nordic region, making their debut in the 1970s: the Swedish Hip Arthroplasty and the Swedish Knee Arthroplasty Registers, in 1975 and 1979, respectively, followed by the Finnish Arthroplasty Registry in 1980.

This post will focus specifically on implant registries and their importance at the local, national, and international levels, though other types of registries exist.

2. Why are they important?

Registries are of vital importance for a number of reasons.

In terms of the health sector, since a standardized set of data is collected, a registry enables health professionals and researchers to make systematic comparisons across multiple datasets and traverse geographic locations. Healthcare personnel are kept abreast of other variables that different registries take into account and they can draw conclusions based on the experiences of others. Registries can facilitate professional development while simultaneously bringing clinical practices, outcomes, and possible areas of improvement to light.

With this data, we can highlight best practices, using previous outcomes as a guide, as well as glean important information, quickly, if a need arises for implant recalls.

A brief example focuses on Poly Implant Prothèse (PIP) breast implants, which were made in France from a cheaper, industrial-grade silicone that was not approved for medical use. The implants were rupturing twice as frequently as the industry average and causing health problems in thousands of women.

Following this occurrence, the NHS created and implemented a register, The Breast and Cosmetic Implant Registry (2016), for patients in England with breast and other cosmetic implants that allows them to be traced quickly and efficiently, should any similar safety concerns arise.

3. Strengths and barriers of international registries?

Registries are not only important when keeping track of information at the local or national levels, they are also extremely helpful in an international context as techniques and methods can be easily shared among countries.

However, certain barriers can play a part in international data access. Recent changes in European law, specifically in terms of patient data protection, could have effects on international registries.

According to an expert with the Dutch Arthroplasty Register (LROI), these laws, introduced in May 2018, could be detrimental to registries whose national regulations are flexible and who are now forced to adapt to more rigid regulations.

In terms of the personnel involved in international registries, whether they are stakeholders, policy makers, healthcare professionals, or others, they have to keep abreast of potential barriers resulting from encompassing multiple countries as well as other regulatory aspects at the regional, state, and European levels to ensure correct implementation and functioning of the registry itself.

Experts from two international registries, the Nordic Arthroplasty Register Association (NARA) and the International Collaboration of Breast Registry Activities (ICOBRA), have both stated that multiple countries, and thus multiple jurisdictions, participating in a single registry could prove difficult, given that the registry as a whole is obliged to function using the regulations imposed by the strictest country.

Though there could be a few barriers to international registries, they continue to be a fountain of useful information. They facilitate advancement in knowledge, processes, and data regarding types of implants to use and/or avoid.

4. What can this knowledge do for AQuAS?

Registry implementation, long-term functionality, and best practices are of great importance to AQuAS, who created and is in charge of the RACat, the Catalan Arthroplasty Register.

The RACat currently collects information on hip and knee arthroplasty procedures from 53 out of 61 health centers in the Integrated Healthcare System of Public Healthcare Network of Catalonia (SISCAT), and is on the cusp of including shoulder arthroplasty procedures.

Given the breadth and depth of existing knowledge in the international community, AQuAS, and those involved closely with the RACat, are interested in the information available in terms of best practices for implementation and sustainability, as well as the types of variables that other registries collect.

With the ability to follow in the footsteps of registries that are already well established, AQuAS, the Catalan health system, and the international community as a whole, can improve the care given to their respective populations.

Post written by Kayla Smith.

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 …)

Analysis of research data in health: opportunities within reach

9 Feb
Xavier Serra-Picamal
Xavier Serra-Picamal

The generation and storage of data is omnipresent nowadays. The costs have fallen drastically and the health sector is not alien to this. To illustrate this, it is worth having a look at the following graph created by the National Institutes of Health about the human genome, which shows the evolution of the cost of sequencing a genome:Cost per genome

As can be seen, since 2007, the cost of sequencing a genome has fallen dramatically. Having one’s own genome sequenced is now possible and in the future it may become commonplace. Bearing in mind that a copy of the human genome is made up of aproximately 3 million base pairs (3 million adeninines, thymines, citosines or guanines arranged sequentially in 23 chromosomes ) it is easy to infer that, also within this field, the quantity of data generated in the coming years will be massive.

This tendency is repeated in other areas of health care: among other, clinical history data in electronic format, medical imaging, primary care data or that of drug consumption are obtained and stored in registries, in general, structured and interlinked. The potential of this data for carrying out research in order to provide better health care is notable, in the way of faster and more accurate diagnoses, improved therapeutic approaches and a better management of the system.

To analyse the challenges and opportunities at a European level, a work session organised by the Directorate-General for Research and Innovation of the European Commission was held in Luxembourg with representatives from AQuAS. The points discussed have been gathered in the article Making sense of big data in health research: Towards an EU action plan, published in the Genome Medicine magazine and of open access. As explained in the article, using this information to provide better healthcare is a challenge but a great opportunity at the same time.

Making sense of big data in health research

Nevertheless, a big effort is required to transform this data into knowledge and specific actions. However much the costs of generating and storing data may drop, the management of information, its interpretation, and the generation of knowledge needs considerable investment and resources. This means having adequate information systems as well as the economic and human resources so that the data can be treated efficiently and the protection of individual rights guaranteed. In addition, the participation, commitment and effective communication of all the agents of the system is needed (including the scientific community, patients, citizens, the administration, and so on) to guarantee that this data is used efficiently, responsibly and that it promotes research which is efficient and of quality.

Catalonia, because of the size of its population, the fact that it has an integrated health system and the work done over many years, is well positioned to be able promote the reuse of health data for research. At an international level, some comparable projects exist and new projects exist with the goal of integrating and consolidating data from different sources, with some very ambitious and attractive programmes. The  PADRIS Programme, presented last 12 January, aims to centralise and make the data generated in health available to researchers in research centres in Catalonia and universities so as to provide better healthcare with a maximum guarantee in security and privacy. The work to be done is considerable. The resources needed too. The opportunities to provide better research and better healthcare are within reach.

Post written by Xavier Serra-Picamal, researcher at the Karolinska Institutet (Sweden).

* TERMCAT (the centre for terminology in the Catalan language) has recently dealt with the question of how to say data scientist in Catalan. The subject is very much a current issue!