Implementation Science and new HTA regulation: two very different subjects

31 Oct

The implementation of improvements, changes in procedures, the introduction of good practices in specific health contexts and the new regulation regarding the assessment of health technologies, respectively, are subjects on the agenda at the AQuAS. Today, we will look at them in broad terms and in the future we will delve into them in more detail from this space.

To learn more about “implementation science” or “research implementation” we held a workshop at the headquarters of AQuAS with Laura J. Damschroder, an expert consultant in implementation science and researcher in the United States.

From her talk we highlight the idea of building collective knowledge and identifying the barriers and facilitators in implementation, the time factor and the value of assessment.

It is also important to know the theoretical and conceptual framework of implementation and the “basics” of implementation science which is useful for any project being implemented, as is designing and following an adequate plan of action.

 

The workshop proceeded by looking at different examples of the implementation of good practices in the context of REDISSEC, the Health Services Research on Chronic Patients Network.

It all stems from the annual meeting of this network held in Madrid last week at the Instituto de Salud Carlos III, in which the idea of organising this workshop was put forward in order to bring some of the contents of the meeting closer to the Catalan context, with the participation of the AQuAS, the Hospital del Mar, and the Fundació Avedis Donabedian.

In terms of the AQuAS, three talks were given on projects in which implementation research is being done, with a different perspective in each case:

  • Quality standards in implementation by Vicky Serra-Sutton from the European project on dementia Act on Dementia Joint Action. The AQuAS team involved in this project was in fact given a mention this week at the Alzheimer Europe Conference which was held in Barcelona
  • The transfer of good practices and impact assessment by Elisa Poses-Ferrer from the European Project CHRODIS PLUS on chronicity
  • The assessment of projects for improvement in integrated care by Jillian Reynolds from the European project SUSTAIN on integrated care for older people.

Regarding the Hospital del Mar, we heard a talk by Maria Sala on the personalisation of screening for breast cancer and regarding the Fundació Avedis Donabedian, we heard a talk by Carola Orrego and Marta Ballester, who brought reflections on aspects of improvement and lessons learnt in implementation.

This workshop was a good opportunity for speakers and attendees to share experiences and knowledge.

Moving on to the second subject.

In terms of the new European HTA regulation, which is in its final stages of discussion in the European Parliament, Iñaki Imaz, from the Instituto de Salud Carlos III in Madrid gave a seminar which we were able to follow live at the AQuAS.

It was very interesting for many reasons. Situations were contextualised that justify the need for health technology assessment (HTA) as a starting point, which is always present in our context.

The emphasis was also placed on the complexity of assessment and the different possible scenarios (or levels). On the other hand, aspects being discussed regarding the proposal for legislation which would allow for, among other objectives, joint clinical assessment at a European level, were commented on in detail.

The seminar can be found on the following link:

Imaz I. The future of health technology assessment in Europe. Regarding the proposal for regulation passed by the European Parliament. Madrid: Agency for Health Technology Assessment. Instituto de Salud Carlos III, 30 November, 2018.

Talking about HTA in Europe, a lot has been done (more than 30 assessments available within the framework of EUnetHTA), there is work in progress and, above all, there is the desire for all to gain in terms of confidence, guarantees, transparency and the sustainability of health systems. What is especially sought after is to avoid duplicities and to share knowledge and methodologies.

We will keep track of all these subjects.

The arthroplasty registry of Catalonia and the collaboration between clinicians and researchers

25 Oct
Jorge Arias

Establishing collaborations with different research projects driven from the arthroplasty registry of Catalonia (RACat) reveals the importance of the relationships and communication between professionals who manage and analyse data on the one hand and clinicians on the other.

A registry is a data base with a huge potential. The RACat, both in the number of cases registered and in the way data is used, is a very powerful research tool which needs the collaboration between clinicians and researchers. It concerns two visions, both equally necessary and complementary.

Today, we interview Jorge Arias, a researcher that works at the RACat who is involved in different research projects driven by the registry itself at the AQuAS.

Do clinicians and researchers speak the same language?

Yes and no. Even though we are usually in it together, we do not have the clinical experience to be able to fully interpret results and propose sufficiently precise studies which reflect the reality of clinical practice. Clinicians, on the other hand, are often not used to the different analyses used so that collaboration becomes a key element to obtain results of interest.

How do you solve this?

By speaking, of course.

Who decides what statistical analyses are done?

I would say that the researcher directs things but in practice it doesn’t happen quite like this. In some ways, the analysis is determined by the data itself and the objective that is established.

Let me explain. Depending on what one wants to investigate, to achieve the greatest possible precision the analysis needs to be “pre-defined”, in some way or another, so to speak. It is true that there is always scope for innovation and you almost always need to choose (from among several approaches to the problem) the most appropriate one. But in my opinion, in most cases the type of analysis is determined, as I mentioned before, by the aim of the research and the data available.

What are you working on at the moment?

At a Catalan level, we are starting a relatively new line of work in our environment in collaboration with the Hospital de Sant Rafael. It is related to the assessment of results according to the annual volume of procedures (arthroplasties in our case), and we are pleased with the interest which the project seems to be generating.

When you talk of interest, what are you referring to?

In this case, we are referring to the fact that we presented our results at the congress Sociedad Española de Cirugía Ortopédica (SECOT) (Spanish Society for Orthopaedic Surgery) and several

hospitals have since contacted us showing their interest in collaborating in this line. We feel this is very important.

Could you point out any other experience?

Yes. We are also involved in comparing results based on specific models of prosthesis, in comparing a “more general” type of implant, bone cements and in analysing the possible influence of comorbidity in surgical results.

In terms of patients, how do you incorporate their views or experiences?

Although the patient is at the centre of all the projects mentioned, in particular I would like to highlight the projects related to those known as “PROMS”, Patient Reported Outcome Measures. These results are particularly interesting because it is in fact the patient who rates the surgical results in terms of, for example, pain and improvement in life quality.

Focusing on the idea of collaboration, I would like to highlight what I think is a particularly relevant project. We began it with clinicians at the University of Exeter in the United Kingdom by “looking for” the questionnaires we could include in the registry, but seeing that the most used questionnaires in other registries were not available in our context we decided to take the initiative and adapt them ourselves.

In addition, in the following weeks, we hope to obtain a “direct” product from this project in collaboration with the University of León and the University of Oviedo, respectively, because I am in fact right now working with them to pilot one of these questionnaires on the quality of life, more specifically the HOOS, Hip disability and Osteoarthritis Outcome Score.

What do all these experiences have in common?

Without doubt, collaboration.

In your opinion, what influence can this collaboration have?

Collaboration in any field of science is basic and necessary in order to obtain results with real practical implications which in the end improve some important aspect.

We have spoken of collaboration at a clinical-researcher level but I guess we should talk of the need for this collaboration at all levels; that is, not only with clinicians but also with patients, managers and even the industry.

The subject is vast but focusing on the clinician-researcher collaboration, I would like to end by saying that from the RACat we encourage and are delighted to work with health professionals with foresight and clinical experience that want to collaborate with us. And, it goes without saying, us with them.

EIT Health, a knowledge and innovation community in Europe

18 Oct

The EIT Health consortium includes a total of 144 leading companies, universities and research centres from across 14 European countries whose aim is to develop ecosystems of innovation in health and also to generate new ideas in business, support start-ups and involve students in the range of programmes driven by EIT Health.

The Spanish hub was formally created on 31 July, 2015, and its headquarters is located in the Parc Científic in Barcelona. The EIT Health Spain is made up of entities in the areas of research, education and business creation from 5 regions (Catalonia, Madrid, Valencia, the Basque Country and Andalusia). The AQuAS is one of the associated members of EIT Health and is part of the Spanish hub, EIT Health Spain.

Why did all this come about?

In 2008, the European Union created the European Institute of Innovation and Technology, an independent EU body to promote innovation and entrepreneurship in Europe via the “KIC”, Knowledge and Innovation Communities in different disciplines.

There are several very different communities: EIT Climate-KIC, EIT Health, EIT Digital, EIT RawMaterials, EIT InnoEnergy and EIT Food.

However, we put the focus on the health community. The mission of EIT Health is to enhance the competitiveness of European industry while also improving the quality of life of citizens and the sustainability of public health systems.

In practice, all this translates into calls which EIT Health makes annually in order to finance innovative projects where proposals can be presented that meet the requirements of the European Institute of Innovation and Technology.

In addition, EIT promotes networking and training activities aimed at its members to develop new projects and establish synergies which favour innovation in health.

What role does the AQuAS play within the EIT Health framework?

The AQuAS began participating in this community of knowledge and innovation in 2016 with a Big Data in health training programme as part of the Summer School.

In 2017, the Co-Creating Innovative Solutions for Health project (CRISH) was launched. It is an educational programme that brings all the stakeholders together – including patients and caregivers – with the aim of learning how to participate, co-create and co-design top research projects and innovative projects in healthcare through patient experience, responsible research and innovation.

It is important to point out that this project has been running over the last two years by means of combined training with the aim of providing knowledge, skills and tools on patient experience methodology, responsible research and innovative components, entrepreneurship elements and reciprocity and co-design methods. All in all, the aim is to foster a better collaboration among disciplines and specialities so as to anticipate and jointly address emerging trends in health and ageing.

Another project initiated in 2017 was the Health Movement project with the aim of creating an ecosystem of the community’s stakeholders to help people lead a healthy lifestyle, adhere to treatments and receive personalised attention by means of Social Impact bonds, a financing instrument, a subject which we will delve into deeper on another occasion on this blog.

During 2018, new health technology assessment projects have been initiated. Examples are the ApneaBand project, where a protocol will be designed with which to assess the implementation of an innovative device to detect and measure sleep apneas and the LiverScreen project in which a new, cheap, fast and non-invasive method used to diagnose cirrhosis at an early stage will be assessed.

In short, there are a lot of innovative projects in the pipeline with which to continue learning and adding value.

Post written by Marcel Olivé and Gemma Cabré.

Publications of proximity with visibility

11 Oct

Annals de Medicina is a journal of the Academy of Medical Sciences and Health in Catalonia and the Balearic Islands. It is published quarterly in Catalan but is now done so exclusively in its electronic version since 2012. It offers articles of dissemination, debate and synthesis related to aspects of health and the local health environment with a diverse, open and independent spirit.The AQuAS collaborates with the magazine in creating awareness of projects and initiatives in a section called “Trials and evidence”. If we ask ourselves about the value of this collaboration we can highlight the importance of publishing top scientific articles in Catalan and also its distribution at a country level among members of the Academy.

On the other hand, it goes without saying that being an open publication means there are no restrictions in making oneself known to all readers who might be interested, including citizens, patients, health professionals and those in other sectors.

Articles written by authors at the AQuAS are the result of a desire and a commitment to share knowledge with the citizenry and health professionals.

Today we speak with the people in charge of Annals de Medicina, Xavier Bofill and Marta Gorgues.

How long has the magazine Annals de Medicina been around?

The first issue of the journal dates back to 1907 (although between 1878 and 1879 some issues were published as “Anales de la Academia y Laboratorio de Ciencias Médicas de Cataluña”.) Over time, there have been several interruptions which have marked the different stages of the journal. The last time it was relaunched was in 1998 and it has been running ever since.

In a few words, how would you define Annals de Medicina?

Close proximity, committed and diverse. Close proximity, in the sense that it deals with subjects of our most immediate environment; committed, as it is about current problems; diverse, because of the variety of sections it is made up of.

What added value does the journal provide society with in your opinion?

It is a source of rigorous information on a wide range of subjects related to health and it is of open access to all; it is written in Catalan; it enables professionals in our area to explain their work and to share experiences; it revisits old texts that we should keep in mind; it pays tribute to medical personalities of our own.

Could you point out similar journals?

All journals have their role to play. In the same way that Annals de Medicina is the Academy’s magazine, we could highlight the importance for all organisations to have a journal of their own (or in a similar format) which serves as the mouthpiece of their institution.

One of the novelties of the magazine’s website is that the most downloaded articles can be consulted.

If you would like to see the history of collaborations of the AQuAS in the Annals de Medicina journal, below is a list of the most recently published articles:

Any 2018

Health Research and Innovation System (SARIS): an example of responsible and transforming assessment

Public purchase of innovation as an instrument to facilitate the adoption of innovation within the health sector based on value

An opportunity to exchange good practices in chronic care at a European level: the JA-CHRODIS project

Any 2017

Socioeconomic inequalities in health and the use of public health services by the Catalan population

Guidelines for the standardisation of pharmacological treatments

Indicators to assess the process of care in arthroplasties: getting closer to Nordic countries

Applying qualitative methodology in assessing health services and the promotion of health

Any 2016

Assessing home-based hospitalisation: an analysis of the situation in Catalonia in the period 2010-2014

Effects of the economic crisis on the health of the people of Catalonia. Territorial analysis

Decisions about health are taken by twos

Any 2015

The participation of citizens and patients: a question of rights and duties

The use of health data as a driving force to change the health system

The audits in stroke in Catalonia. The evolution of care quality in the period 2005-2013

The methodology of variations in medical practice

Any 2014

Help tools to take clinical decisions in Catalonia

Can value be added to clinical practice “by omission?” Unnecessary clinical actions and what the Essencial project provides

Transparency and benchmarking: The Results Centre of the Catalan health system

The previous articles can be consulted on the journal’s website.

Post written by Marta Millaret (@MartaMillaret).

A double challenge: HTA and a new proposal for European regulation

4 Oct
Mireia Espallargues

Today we interview Mireia Espallargues, Doctorate in Medicine and specialised in Preventive Medicine and Public Health.

We would like you to tell us a little about the latest news related to the assessment of health technologies given that a lot has been said in 2018 about a proposal for European regulation regarding this.

In fact, on October 1, this proposal for regulating HTAs was debated in the European Parliament following the usual procedure which in this case included the European Council and the European Commission‘s Committee for Environment and Health, as well as other committees which also gave their opinion; and a vote was taken very recently.

Before getting into the subject, the big question is; what is health technology assessment?

It is not a question that I can answer with any kind of rigour in a few lines. Basically, it has to do with assessing different types of health technologies in a systematic way using a multidisciplinary approach.

Talking about “health technologies”, at present we have very different ones: starting with drugs, medical equipment or devices, surgical procedures, diagnostic tests, health products, and even models of care and organisation, or technologies based on ICTs such as Apps and portable devices – ‘wearables’ – and I am leaving out some ….

What is their purpose?

This is precisely the crux of the matter: it is about finding the way to use all this knowledge for taking the best possible decisions about their use or application in health policies, in management, in clinical practice and by people themselves.

To give some background, HTA is the English acronym used to refer to Health Technology Assessment and in the beginning it was a more restrictive concept than it is today because it centred on large equipment and in general, “hospital-based” technologies so to speak. Later, over time, the HTA concept has broadened in response to present day needs and this includes chronic care and mHealth, to give two very different but very current examples.

It is about knowledge in constant evolution. In fact, the assessment of health technologies and the organisms or agencies which do it, such as the AQuAS, have evolved. They have done so using knowledge to respond to the challenges in assessing new technologies, innovations and needs at any given time. In our context we could talk about ageing and chronicity, variations in clinical practice, transparency and accountability, the availability of data – big data and real world data – and its analysis.

It seems complicated. When your children ask you about where you work, how do you explain it?

I tell them that we investigate whether new treatments or those that are already being applied serve a purpose, whether it is worth spending money to improve health (or not so much), and whether there are different options available and also to know which one might be the best.

But it seems that all this may be very far removed from what a person might find in their everyday lives. Can you give me a practical example?

All assessment projects are practical examples. There is always a need for knowledge about a health situation or a disease, certain options (of treatment or interventions to be done, for example in prevention or in the design of programmes for care in chronicity) and there are always aspects to bear in mind: What are the benefits for the patients, what are the risks and what are the costs of the best option possible? What is the most recent research available (the latest articles published)? What are the patient’s preferences? Can everyone have access?

Is all this regulated by law?

What is being sought, precisely, is to regulate by law the way in which the European Union should cooperate at a state, country and regional level in this matter; at this stage, in aspects specifically related to new drugs and health products. The regulatory process is still being defined. It started last January when the proposal was made public, drawing from all the collaborative work done previously at a European level between health technology assessment agencies/bodies and following an extensive public consultation to gather the different views.

What can you tell us about this HTA regulatory proposal?

I think it is important to point out that it is precisely that, a proposal still under discussion where agreement will need to be reached between the two co-legislators (the European Parliament and Council) so it can be adopted in 2019 after which a three-year period will begin to start applying it, and then there will be another three-year period of transition for member states to begin participating. It is very much a current topic and we have no choice but to move forward despite its complexity but we must still wait a little before assessing how it is all going, especially to clarify doubts and dissipate any qualms that it might be generating.

What aspects would you highlight?

Firstly, I would highlight that in general terms, I think it is a good proposal, debatable and which can be fine-tuned in some aspects but it has been ambitious in seeking the maximum rather than the minimum (reflecting the results of the public consultation) and, for the first time in the European Union, laying the foundations to regulate this cooperation which has clearly been a need for some time.

I think it is a proposal that seeks to promote the use of common procedures and methodologies in health technology assessment and to ensure its quality; to promote collaborative assessment between European countries, avoiding duplicities and inconsistencies and guaranteeing the efficient use of resources; to promote the design of a common agenda for assessment and to improve business predictability. In short, more and better health technology assessment, not duplicated, and the same for everyone.

However, the proposal has also generated controversy and criticism for not being very clear in certain aspects especially that referring to the obligation of using reports of health technology assessment which are drawn up jointly. While this obligation may have been interpreted as an infringement of competences, it is also true that the obligation makes reference to using health technology assessment reports which have been drawn up jointly in each of the countries when necessary so as to avoid duplicating work already done.

What implications are at stake?

In Spain, there is experience in networking within the framework of RedETS and at a European level the EunetHTA network has the challenge of moving forward together despite the fact that some countries do not participate yet or have only recently joined.

When we talk of a joint – and unique – report of assessment (or joint clinical assessment) we are talking about assessing the efficacy/effectiveness and safety of a particular technology compared to its possible alternatives (other treatments for the same thing), using tools for comparison and variables in result which are agreed upon between assessment agencies at the design stage of a project (the protocol), including the target population and other methodological aspects. All this, based on the scientific evidence available.

It would then be the responsibility of each country to contextualise or adapt this assessment to each health system based on the evaluation of impact on other aspects or dimensions that will depend a lot on the situation and resources of each environment. This could be things like budgetary efficiency and impact, organisational impact, or ethical, social and legal aspects. This would lead to the capacity of formulating some recommendations for taking decisions at different levels (appraisal). But this original spirit of the proposal does not seem to have been very well explained or remains unclear and some states have expressed their disagreement.

Other relevant actors in this field, such as the pharmaceutical industry or manufacturers of health products, have a slightly different point of view. The pharma-industry has a generally positive opinion and believes that steps in the right direction are being taken although they feel that the industry’s participation in the process may be weakened and also feel that certain aspects of its implementation need to be discussed. The other industry directly affected is that of health products which, even though it shares the objectives of the new regulation, it sees the proposal as being very ambitious and difficult to apply and very much thought of for drug assessment and not so much for the other technologies that are markedly different (in how they are introduced on the market, how they are assessed, etc…). In addition, it comes at a time when the regulations for health products have just been updated and it will be a matter of seeing how much both sets of regulations align with each other.

Would you be willing to state your position with regards the aims of the proposal?

It must be said that this method of working jointly is not all plain sailing. This is why I think the structure of the governance bodies needs to be very clearly defined and there must be a guarantee of participation by all regional and national agencies without a discrimination of influence, both in production and also in the representative bodies as well as in funding.

The proposal for new regulation only makes reference to the assessment done in evaluating the possible introduction of technologies (including emerging technologies). I think it would be advisable to widen the field of action to assessments whose aim is to increase an appropriate usage or to give support in taking decisions to divest in inappropriate technologies.

Another subject that I consider relevant is that even though the spirit of the regulation constantly makes reference to transparency, the guarantees to avoid conflicts of interest are not sufficiently specified.

I think it will be necessary to have a common plan of assessment requiring intense coordination. I see the importance of moving forward in consolidating a structure of coordination so that a permanent activity is guaranteed, and also that participating states take reports into consideration. It will not be easy to go from a voluntary collaboration (at present within the EunetHTA network) to a mandatory one with 28 member states and their diverse regions which might have competences in health transferred, but possible it is. At this stage, less needs to be done to bring the discussion of the proposal to a close and to improve those aspects which lack clarity or are controversial.