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.

Who talks about what at EUnetHTA?

3 May
Marta Millaret

AQuAS is analysing the activities of dissemination of the EUnetHTA project, a European Joint Action comprised of 61 organisations from 29 countries and coordinated from the Zorginstituut Nederland in Holland. It is the European health technology assessment network.

Assessment, as Emmanuel Giménez talked about in this post,”can directly help in the practice, management and sustainability of different health systems” by providing the best available knowledge for taking decisions at different levels.

It is precisely on this subject that a proposal has recently been published regarding the regulation of drugs and health products within the framework of the European Commission and which is being debated and outlined for implementation.

The aim of the EUnetHTA project is to facilitate cooperation between different institutions in the field of health technology assessment to take advantage of expertise and useful knowledge to favour health systems which will consequently provide potential benefits for the health of citizens. It is about generating quality knowledge by using common methodologies in a systematic and transparent way and it is about doing this by working collaboratively and by avoiding duplicities.

AQuAS participates very actively in different work groups in the project (assessment, implementation, generation of evidence, dissemination) and today we are going to put the spotlight on the dissemination group, led by Iñaki Imaz of the Instituto de Salud Carlos III (Institute of Health Carlos III) in Madrid. This work group has the challenge of communicating more and better regarding what the EUnetTHA project is.

To do this, there are different strategies and one of these is the assessment of the dissemination itself, a task led by AQuAS. To this end, the different activities are being brought together and a first analysis has been carried out which will be repeated every four months with the idea of obtaining recommendations and specific actions.

In the first intake, almost a 100 activities have been included. 78% correspond to the activities in scientific meetings (workshops, presentations, oral communications and posters); 5% are articles in scientific publications with an impact factor in the Journal Citation Reports and the remainder (17%) are other publications, e-meetings and activity done in social networks.

This analysis will make it possible to look at who disseminates, what is disseminated and where it is disseminated as well as looking at the content and who the majority target audience is of these dissemination activities within the framework of the EUnetHTA project. The results of the first analysis will be presented at the next general assembly of the project in Cologne (Germany) at the end of the month.

We feel that it is interesting to find the way to involve all those participating in facilitating the dissemination of the project so as to achieve a more active communication of the EUnetHTA project. Involvement in dissemination means getting the people that work on a project to disseminate both their work and their project at the same time. In this way, everyone stands to gain.

Will we succeed in getting all participants more involved in the activities of dissemination? Will our assessment serve to improve things? That is to be seen.

Post written by Marta Millaret (@MartaMillaret).

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 …)

Scientific evidence and clinical practice: the case of hip prostheses in Catalonia

9 Mar
Daniel Chaverri, Miquel Pons, Luis Lobo

A total hip replacement is one of the surgical procedures which provide greatest satisfaction among patients due to the significant improvement in the quality of life they experience.

So much so, that it has been defined by some authors as the surgery of the 20th Century. It is a procedure which consists in substituting the hip joint with an artificial joint or prosthesis.

The most common reason for surgical intervention is arthrosis, a disease caused by the wear-and-tear of the cartilage which leads to a malfunction of the joint. It is especially common in older people, older than 65, who live with pain and which can limit their day-to-day activities considerably.

In today’s context of continuous technological innovations and advances and facing the enormous pressure from manufacturers, the range of prosthesis available to orthopaedic surgeons is wider than ever. This situation demands that the prostheses used have supporting scientific evidence based on clinical studies or on data from arthroplasty registries.

The legislation which regulates the commercialisation of medical devices, such as prostheses, is more lax than that which regulates drugs which means that not the same type of studies are required for their approval and in consequence, neither is the scientific evidence. In fact, this precise legislation is undergoing a review at present and a new one on this matter will soon be made available.

Several years ago, the prestigious journal BMJ (British Medical Journal) published an article in which it was highlighted that in the UK, 24% of hip prostheses used had no scientific evidence to demonstrate their clinical effectiveness.

As a consequence of that publication and applying the same methodology, at the Hospital Sant Rafael and in collaboration with the Catalan Arthroplasty Registry (RACat) of the Agency for Health Quality and Assessment of Catalonia (AQuAS), we embarked on the task of analysing what the scientific evidence was on hip prostheses used in public hospitals in Catalonia which had sent their data in to the RACat during the period 2005-2013.

We did this via a search on different platforms putting the spotlight on Orthopaedic Data Evaluation Panel (ODEP), as well as Tripdatabase, PubMed and Google acadèmic.

Following the analysis of the 18,816 acetabular or hip cups and 19,546 femoral stems (the main components of the hip prosthesis) collected in the registry, our first surprise was to observe that 123 different models of cups had been used and 138 different models of stems. In the group of participating hospitals in the RACat during the period of the study, it was seen that with many of these models less than 10 units in number of each had been used.

As these models only represent 1% of implants used, they were excluded from the study and in the end 74 models of hip cups and 75 models of femoral stems were studied.

Artroplàsties PTM

The results of the analysis, either recently published or not yet published, now at a pre-publication stage, show that less than 50% of components used had the highest level of scientific evidence in accordance with the ODEP. This top level is achieved when there are studies having 10 years at least of monitoring with a number of prostheses evaluated exceeding 500 units.

What also caught our attention was not finding any evidence for 18 hip cups or 16 femoral stems which represented, respectively, 13.56% and 9.53% of all implants carried out during this period.

Artroplàsties -taula

All scientific studies show limitations and it is not always possible to offer exhaustive results. Aware of this, and of the fact that the data in our study are the results of a research project which might not be able to reflect what the reality of public hospitals in Catalonia is in absolute terms.

We do want to stress that the task of the orthopaedic surgeon needs to be more and more regulated by evidence based medicine and this is, precisely, one of main purposes of arthroplasty registers: to carry out studies like the one we have been able to do at Hospital Sant Rafael with the aim of improving the health care of people.

Post written by Miquel Pons, Danieol Chaverri and Luis Lobo, Hospital Sant Rafael, Barcelona.