General – Page 3 – AQuAS Blog

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

4 Oct

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.

Person-centred (especially) care

23 Aug

Person-centred care is increasingly the focus of discussion these days, that which incorporates the preferences, circumstances and values of patients. It is also about results related to the life quality of people and clinical variables. This is the guiding theme of the journey we propose today in this summer post. We hope it is inspiring.

Johanna Caro reflected on the challenges faced by the Essencial project and low-value practices, from Quebec (where the international congress, Preventing Over-diagnosis, was held last year).

Johanna Caro reflexionava des del Quebec (on es va fer l’any passat el congrés internacional Preventing Overdiagnosis) sobre els reptes del projecte Essencial i les pràctiques de poc valor.

“Patients are also important decision makers in relation to their needs and in the demand for certain health services. Hence, the project must be accompanied by a communications strategy aimed not only at patients but also at citizens in general”

Cari Almazan was only recently interviewed, in fact, in relation to the Essencial project.

“In usual medical practice, there are known routines that do not offer any benefit to the patient and it is difficult to understand why these occur but it is even more difficult to try and avoid them”

Assumpció González Mestre highlighted the strengths of the patient and expert caregiver programmes (Pacient Expert Catalunya and Cuidador Expert Catalunya, respectively).

“This type of learning programme among equals manages to improve the quality of life of people which find themselves in the environment of a disease in the context of chronicity in Catalonia, be it as patients, as caregivers or both things together”

Gaietà Permanyer – already mentioned several days ago within the context of research and the press, reflected from her experience as a physician on the information which reaches the general population.

“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 21^st Century as “the patients’ century”, acknowledges their right to know relevant professional data so as to be able to take accurate decisions autonomously”

Felip Miralles i Joan Escarrabill situated us in the process of preparing the XPatient congress which is being held this September and which is based on an innovative vision to foster the empowerment of the patient and caregiver.

“Hi ha moltes estratègies per identificar les necessitats no cobertes dels pacients i dels seus cuidadors”

Finally, Montse Moharra placed value on the importance of language and communication in order to successfully facilitate access to information in a clear and understandable way.

“There is a growing need, therefore, to provide this (medical information) within a comprehensible format which includes the need to ensure that the medical message a patient receives is effective.”

We have a lot of challenges on top of many other challenges, both old and new, in an ever changing world. These challenges add to the limitations but also the opportunities within a health system, to those of the process in disease and those of the entire population.

HTA connections

9 Aug

In our blog at AQuAS, we have spoken about the European EUnetHA project, of the arthroplasty registry of Catalonia, of the paradigm shifts in acute stroke care and of melatonin.

Let us begin with EUnetHA, a European project made up of different institutions working towards joining forces and methodologies to avoid duplicities with the aim of providing, adapting and sharing useful knowledge for health systems. When we speak of HTA, we are basically speaking about assessment.

Emmanuel Giménez highlighted that in a world of constant change a robust system is needed in terms of method which is at the same time agile and which can adapt to the speed of innovations.

“The identification and prioritisation of products to be assessed (the Horizon Scanning system), as well as the balance between innovation and divestment, are also extensively discussed subjects and under continuous debate”

Marta Millaret focused on the aspect of communication and dissemination in a project because although doing is important, explaining and sharing what is being done is equally so.

“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”

We continue with the Arthroplasty Registry of Catalonia, a tool of the health system with an impact on a large part of the population.

In an interview with Olga Martínez and Xavier Mora, aspects of the suitability and prognosis of arthroplasties were discussed, and in particular, they shed light on the value of registries.

“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”

Precisely this summer, two reports from the AQuAS have been published thanks to the registries.

We wanted more so we held a second interview with Olga Martínez and Xavier Mora. On this occasion, we put the spotlight on the materials used in making prostheses.

“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”

Moving on to another subject. Knowledge advances, which has implications in medical practice. An example is this text by Sònia Abilleira which shows a paradigm shift forcing one to rethink organised systems of care for people with acute stroke.

“This recentralising tendency in carrying out endovascular treatment contrasts with the decentralisation which was done in its day to ensure an adequate access to thrombolytic therapy which by nature needs to be administered in the first 4,5 hours after the onset of symptoms”

To finish this journey, a 100% current topic: melatonin. Joan MV Pons shared his thoughts after an assessment report.

“New physiological actions of this hormone are discovered every day which means that it almost acquires the quality of a “miraculous molecule” due to its ubiquity and the number of activities in which it takes part (antioxidant, neuro-protector, anti-cancerous, immunomodulation, etc..).”

What do these initiatives, all so different from each other, have in common? The answer is assessment. Wherever, with the will to identify, analyse and use knowledge of better quality using the best methodology available while considering the context in all its complexity. This is no mean feat!

Gender issues: here and now

2 Aug

One of the editorial lines of the AQuAS blog is on gender. In recent years, we have had the collaborations of Mercè Piqueras shedding light on the silenced contributions of some women in science with the example of Nettie Maria Stevens (Who discovered the Y chromosome?), of Esther Vizcaino with a call for the involvement of all of society (men and women) in subjects of equality, of Paula Adam with the initiative to include gender in research impact assessment and of Dolores Ruiz-Muñoz bringing to light what happens with women (in biomedical research) and the famous glass ceiling.

What else have we published on gender? Since last summer we have put the emphasis on a more practical approach (apparently) from a health profession perspective and on a more theoretical approach (apparently) within a conceptual framework and related to public policies.

The first approach emerges from several concerns and events in the media which alerted us and we found it interesting to do a group exercise with Núria Rodriguez-Valiente, Marc Fortes and Mercè Salvat that generated an inspiring conversation about nursing and gender. The result was a very enriching text which is an invitation to question multiple elements of daily life based on a very specific case.

El primer enfocament sorgeix de diverses inquietuds i esdeveniments en mitjans de comunicació que ens van alertar i vam trobar interessant fer un exercici en grup amb Núria Rodríguez-Valiente, Marc Fortes i Mercè Salvat que va generar una conversa inspiradora sobre infermeria i gènere. El resultat va ser un text molt ric, que és una invitació al qüestionament de múltiples elements de la vida quotidiana, a partir d’un cas molt concret.

“Why the term caregiving is associated with women in our society, why this care does not have nor has had social recognition when opinion is favourable in the processes of health-illness, how the men who have chosen this profession experience it and finally, how it would be possible to “deconstruct” this social and cultural construct”

The second approach emerges from the sum of different initiatives having a clearly informative purpose. Iria Caamiña laid down the basics about gender from the perspective of public policies in the context of health. It is a dense and solid text which shows the ground that has been covered (available, public, within reach of everybody) and which stated that although the journey has begun, there is still a long way to go.

“The media systematically show us examples of the persistence of discriminatory situations for women such as the gender wage gap, the lack of women in managerial positions and the violence towards women, among other things. These situations are a result of our social construct which is still based on an androcentric model where man is placed at the centre, as a reference of values and of the view of the world while at the same time subordinating women and rendering them invisible”

All these different and complementary perspectives, despite still needing to be explored further and considered, all form part of our daily lives in society. What is more, they affect us and explain where we come from, who we are, where we are and where we want to go.

The concept of “gender mainstreaming” means incorporating the perspective of gender in all policies and actions by a government, an entity or an institution; in a health system and in assessment too.

We recommend reading this document by the catalan Health Department:

A guide for the introduction of the gender perspective in health planning

The impact of research in retrospect

26 Jul

It was last autumn, with cooler temperatures than this mid summer’s, that we published some interesting reflections by Ramon Gomis on biomedical research in Catalonia mentioning the CAPRIS programme (Advisory Board in Research and Innovation Policy) and the ICREA programme (Catalan Institute of Research and Advanced Studies).

These questions marked the start of a powerful reflection by Núria Radó about nursing research where the aspects of participation and impact of research were combined (multifactorial), and where the aspect of involvement came into play. All of this in the context of SARIS (The Health Research and Innovation Assessment System) and PERIS (Strategic Plan for Research and Innovation in Health 2016-2020).

Doing research and publishing on this research are actions which often go hand in hand, be it in scientific contexts (articles, communications at congresses) or in informative contexts (the traditional media or social networks).

In this study we saw an analysis of the critical tone of news about medical innovations published in the daily written press. These are the generous reflections by Gaietà Permanyer on the reservations of a doctor when publishing in newspapers or books of a non-professional nature, of the concepts of patient autonomy, of informed decisions and health literacy, and of how everything fits together, to ideally arrive at balanced information in non-specialist media.

We continue highlighting publications. However, we are now focusing on scientific publications and the impact that can be derived from two very different but inspiring subjects:

On the one hand we saw the phenomenon known as “the sleeping beauties of science” thanks to Joan MV Pons and the case of a discovery (published) by Francis Mojica (25 years ago) which has been key in the development of the CRISPR genome editing technique..

“Sleeping Beauties is also said of those scientific articles which seem to go by unacknowledged until someone comes to their late rescue and gives them the recognition they deserve”

On the other hand, two days before the start of spring, we had the collaboration of Ernest Abadal from Newcastle who explained the altmetrics and the strengths and weaknesses of systems (traditional and not so traditional) in the assessment of the quality of a scientific publication.

“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”

The aspect of involvement also comes up here:

“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 and also in academic networks so as to give visibility to the contents published”

We end this journey on the assessment and impact of research with Ion Arrizabalaga with the challenge of measuring involvement in this context.

“Participation of the actors in research is a key element in research to transform and generate impact in society”

If you would like to read more about participation and research, we recommend reading these two documents published at AQuAS:

How we adapt medical language to improve communication with patients

12 Jul

What is special about the recommendations for patients and the Essencial project, one of the projects of the Agency for Health Quality and Assessment of Catalonia (AQuAS)?

There is a greater and greater demand to have access to clear and more readily understandable information in health by patients. There is a growing need, therefore, to provide this within a comprehensible format which includes the need to ensure that the medical message a patient receives is effective. This will in turn facilitate the conversation between both parts and will improve a patient’s understanding of their diseases, treatment options or possible side effects and will most likely also have an impact on empowering patients to be more actively involved in taking decisions related to their treatment.

The use of medical terminology is one of the factors, among others, which impedes an effective communication between professionals in health and patients. This could be due to a low level of understanding in health which we call “literacy” or perhaps as a result of the complexity of the specialised medical terminology itself which stems from a wide range of clinical specialities. These use specific terminology and we often find terms used in other fields of expertise such as pharmacy or biology.

It is most likely too that one of the reasons why medical information is not successfully transmitted is due to the amount of terminology found in a text which may not easily be understandable to the patient. Moreover, with the progress of medicine itself new terminology is constantly being introduced – some is modified and some terms are discarded. Therefore, the variation in terminology and the use of overlong sentences, the density of unexplained terminology, the use of acronyms, symbols or abbreviations are some of the barriers that complicate understanding.

The Essencial project, which has been drawing up recommendations to avoid unnecessary clinical practices for five years, started to adapt information for patients in 2014 and at present there are a total of twenty-two recommendations for patients available in Catalan and Spanish. These are a clear example of how medical terminology is adapted so that clinical recommendations can better be understood by patients and reach them effectively. For this reason, a process is followed to adapt the language to make a text easier to read and this also applies to its content, format and graphic images thus ensuring that documents for patients meet minimum reading requirements. The communication group of the Patient Advisory Council that designed the format of the documents and regularly validates the content also participates in this process.

The ultimate aim, therefore, is to make medical language more accessible to patients so that the message is effective bearing in mind the linguistic, cognitive and cultural barriers that may impede the information from being understood adequately.

Post written by Montse Moharra.

The XPatient congress in search of current and innovative proposals in the area of patient experience

5 Jul

The XPatient Barcelona congress, which this year holds its 3^rd edition on September 20 in the CaixaForum Barcelona, concerns itself with innovative initiatives taking place in several contexts: in patient and caregiver empowerment, in the co-creation of healthcare with patients and in technology at the service of users. This has been done via a call for participation, or Call4Projects, which was open till last 25 June and received 73 projects, a figure considered a success in participation.

This event, organised by the technological centre Eurecat and the Hospital Clínic, together with the help of the XPA Barcelona community of practice (Patient Experience) – of which AQuAS has been a member since its beginning – has become the main meeting point in Catalonia for patients, family members and healthcare professionals as well as the different actors involved in healthcare. This is where they present and debate on the best initiatives for improving the quality of life of people and users, an area where technology plays a key role as facilitator of new models of healthcare.

In the words of the head eHealth at Eurecat, Felip Miralles, “we want an XPatient Barcelona congress which is increasingly more active, interactive and participative and which consolidates itself as ambassador for the best initiatives, methods and technologies having a focus and impact on improving patient experience.”

Joan Escarrabill, physician at the Hospital Clínic, points out that “the starting point to assess patient experience is to not make any assumptions” and stresses that “there are many strategies to identify the needs of patients and their caregivers which are not covered.”

The proposals selected from the participative process, Call4Projects, will be presented during the congress in September either in a speech or in the exhibition space at the event.

Post written by Eurecat (@Eurecat_news), Centre Tecnològic de Catalunya.

“Me sube la melatonina”

28 Jun

Well, let’s say that in Juan Luis Guerra’s merengue song (1990), it was bilirubin that was on the rise:

Me sube la bilirrubina
¡Ay! Me sube la bilirrubina
Cuando te miro y no me miras
¡Ay! Cuando te miro y no me miras
Y no lo quita la aspirina
¡No! Ni un suero con penicilina
Es un amor que contamina
¡Ay! Me sube la bilirrubina

It is evident that it is something difficult to treat, but who cares, it could also have been serotonin, dopamine or noradrenaline. After all, love alters everything and things would rhyme just the same. Whatever the case, if there is one thing that should best be avoided, it is a rise in bilirubin, because one can end up jaundiced or, as they said in the past, with an excess of bile.

What is true is that melatonin starts increasing in all of us when it begins to get dark, before going to sleep, following a circadian rhythm set by our hypothalamic biological clock. The pineal gland, where Descartes thought there was a connection between the mind and the body, where he placed the soul, segregates this hormone that induces sleep and thus, works better when restful sleep eludes us, that is, when there is a delay in the onset of sleep.

New physiological actions of this hormone are discovered every day which means that it almost acquires the quality of a “miraculous molecule” due to its ubiquity and the number of activities in which it takes part (antioxidant, neuro-protector, anti-cancerous, immunomodulation, etc..).

Melatonin, which is mostly obtained synthetically, is marketed as a drug (prolonged-release tablets of 2 mg) and as a nutritional or dietary supplement (doses of less than 2 mg). This difference, we are talking about 0.02 mg, is in itself a little surprising and even more so bearing in mind that there is only one drug with melatonin but on the other hand, there are numerous supplements that contain melatonin (on its own or in combination with other products). The requirements, in one case or another, are very different. While there are countries in which melatonin is marketed on its own or as dietary supplements, in others it is only found as a drug which requires a doctor’s prescription, and in Europe both situations exist. In Spain, a medical prescription is needed but it is not a publicly funded drug and as a supplement, as mentioned before, there is a wide range of products.

As a drug, it is authorised by the European Medicines Agency (EMA) in people aged 55 or over and in treating primary insomnia for a limited period of time. The EMA considers that melatonin is effective albeit with a small effect size in a small fraction of the population but with a more favourable safety profile than other hypnotic drugs.

It is known that as one gets older the secretion of this hormone decreases and yet all clinical practice guidelines or recommendations in the approach to insomnia primarily advise sleep hygiene measures followed psychological interventions. Nevertheless, the data of pharmacological consumption shows an increase in prescriptions of hypnotic drugs and sedatives, especially those derived or related to benzodiazepines.

The EMA has asked for more studies on melatonin at a paediatric level despite the fact that there is data which seems favourable in children with an attention-deficit hyperactivity disorder or with autistic spectrum disorder where sleep hygiene and psychological interventions have failed.

The report “Exogenous melatonin in the treatment of sleep disorders: efficacy and safety” drawn up by the AQuAS talks of these and other related subjects, mentioning the wide range of para-pharmaceutical products that contain melatonin.

As a dietary supplement or a drug, there are unequal demands by regulatory agencies in Europe (food safety, drugs) in terms of its authorisation for marketing. It is a known fact that the variability in the quality of a product, its formulation, dosage and combinations in supplements and so on, in part explain the heterogeneity between studies observed in some meta-analyses, also contained in the report.

Post written by Joan MV Pons.

Taking another step forward: Can we measure the participation in research of the agents of the system?

21 Jun

In recent years, the idea that the participation of the actors in research is a key element in research to transform and generate impact in society has been insisted on repeatedly. For those who are still a little unsure of this statement, studies in the assessment of the impact of research demonstrate the idea. They emphasise the participation of professionals, patients and the remainder of the actors of the system throughout the entire process of research during which the effectiveness of research in reaching society is improved.

Hence, the AQuAS, in collaboration with the Fundación Bancaria “a Caixa”, considered it necessary for the systems of assessment to be involved too if we want research to have a greater impact. With this objective, and a great contribution from Maite Solans and Paula Adam, the first monographic on Responsible Research of the SARIS (Assessment System of Research in Health) was presented. As a result of reviewing the existing international literature, 47 indicators were identified that measure the activities and participation of the actors in research institutions.

The indicators identified cover a large part of the research ‘process’, and they have been grouped in six aspects – training, governance, resources, activity, dissemination, and primary results. This allows us to see how the different actors in the system can be involved during the entire process of research (planning, execution and translation).

Figure 1. Aspects in the process of research

However, we need to be cautious! On the one hand, the proposed indicators can be useful to stimulate and open up the reflection on how to monitor the activities carried out in research institutions in relation to the participation of the actors of the system. On the other hand, it must be pointed out that an indicator must be used responsibly by taking into consideration their context, incentives and the distortions that a measure can provoke. Experts in measures and indicators in science know very well that the research fabric and the research system change their behaviour according to what is being measured, ‘you get what you measure’, said Cyril Frank, chairman of the panel on the impact of research in health of the Canadian Academy of Health Sciences (CAHS).

Referring to participation in research, the question of measure is even more complex because it is still in its infancy. As Derek Stewart said, director of Patient Involvement of Nottingham Biomedical Research Centre and speaker at the SARIS session where this monographic was presented:

“One of the greatest challenges of measures is that ‘inputs’ are often measured – the number of people that participate, the number of groups that have been called or who have been talked to or the number of studies in which patients participate. It is about carrying out actions that add value, that help provide knowledge for solutions for patients”

Derek Stewart’s reflections during the preparation of his conference can be found on his blog ‘Making a difference’.

Indicators should help to answer specific questions based on each situation and need, and this is why it is essential to assess their relevance and feasibility within their context. The concept of relevance refers to the proximity of an indicator to a need and specific question that we pose; for example, what is the real value of the participation which an indicator measures? The concept of feasibility refers to how easily available and affordable data is when constructing an indicator.

As can be seen in Figure 1, among the indicators found in the literature there is a large number that are relevant, which was to be expected because they are recommended by very prestigious entities. Nevertheless, their feasibility in our environment is low in the majority of cases which means that although we have identified several indicators with limitations, none are fully recommendable.

Figure 3. Feasibility vs Relevance of the 47 indicators

Therefore, bearing in mind the context of research in Catalonia, at AQuAS we have catalogued the indicators as follows:

27 indicators as not recommendable for use
20 indicators with limitations
No indicator as being fully recommendable

Our findings allowed us to learn a valuable lesson: before defining indicators or measuring the participation in research, we must first explore what is done in our environment and so by first analysing what is feasible we can then decide what the most relevant actions are.

The success of assessment systems depends on the acceptance of their processes and results among those in charge of taking decisions and the research communities which are being assessed. The challenge, thus, is to understand what is done in practice in our environment based on the guide which the indicators in the international literature have provided us with.

Let us continue!

Post written by Ion Arrizabalaga.

(Post published jointly in the AQuAS blog and the blog of CaixaCiència)

mHealth assessment at HIMSS Europe 2018: success stories and new challenges

15 Jun

Last 27, 28 and 29 of May, Sitges hosted the annual congress of Healthcare Information and Management Systems Society (HIMSS) Europe & Health 2.0, an event centred on digital health and innovation in telemedicine. The congress received hundreds of professionals from around the world who shared their experiences in mHealth and people’s health, integrated care, value added strategies, big data, data analysis and real world data.

The characteristic feature of the congress was the focus of activities and presentations on the action and participation of all stakeholders involved in the health sector. It was also about facilitating the creation of strategic networking, about research and about the funding of projects.

AQuAS had a noteworthy participation with a presentation by Toni Dedeu at the “ETC Map of Excellence” session within the framework of the European Telemedicine Conference.

The adoption of the 2.0 solutions among health professionals from a disruptive perspective was also a lively debate which is still ongoing after the congress. How do we involve professionals?

To continue. In the field of assessment, the conference “Assessing Telemedicine Solutions” was focused on examples of European eHealth in which the assessment of technology was a key piece in the implementation of digital strategies in health.

On the one hand, representatives of the Odense University Hospital of Denmark outlined an innovative strategy to reduce hospital stays of premature new-born babies and to improve their weight gain and family experiences by using video conferences and digital support in the management of data.

On the other hand, the company Kaia Health presented a mobile application aimed at people with chronic obstructive pulmonary disease, monitoring both adherence to medication and the degree of day to day sedentary lifestyle. The factors for success most discussed during the session were, on the one hand, the collection of continuous and systematic feedback of patients, family members and professionals and on the other, the continuous and cyclical improvement technology.

As challenges, the conference speakers highlighted the assessment of economic impact and the impact on health as well as the design of strategies to guarantee the use of mobile technologies and applications by patients.

This confirms that it is becoming increasingly necessary to have a European framework of assessment in mHealth that provides an assessment framework of impact and a roadmap to improve the satisfaction of users beyond mere technological validation and certification of quality.

AQuAS has been developing a theoretical model of mHealth assessment, published in the JMIR mHealth and eHealth journal and at present it is in a second phase with the aim of transforming this theoretical framework into a practical model.

An exercise in consensus will soon be done by using the Health Consensus tool to agree on indicators of assessment and several focus groups to get to know of the qualitative assessment of patients, professionals and other parties involved in eHealth technologies.

It is estimated that this framework of assessment will be ready at the end of the year to respond to the present day needs of assessing the impact on users and their satisfaction of new health technologies.

The next European HiMSS congress, programmed for the 7 and 18 October, 2018, in Potsdam, Germany, will in fact be dedicated to discussing the social and economic impact of health technologies.

The annual congress (equivalent to that held in Sitges) will take place next year in Finland. You can take note in your diaries: Helsinki, 11-13 June, 2019, HIMSS Europe 2019 & Health 2.0 2019.

Post written by Elisa Poses Ferrer.