“Me sube la melatonina”

28 Jun
Joan MV Pons

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
Ion Arrizabalaga

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
Elisa Poses Ferrer

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.

Specialised health training and indicators to measure the quality of teaching

7 Jun
Alicia Avila

To work as a specialist in the health system -in any speciality in medicine, pharmacy, psychology, nursing or other- not only do you need to have a university degree but also the corresponding specialist qualification. To get it you need to pass the selective test traditionally known as the MIR in Spain (national specialisation examination) for specialist doctors, PIR for psychologists, FIR for hospital pharmacists, to give some examples and which has been done annually for more than 30 years. The training of specialists in the Health System is done in public and private health centres and teaching venues, previously accredited, to which professionals have access once they have passed the selection process, in rigorous order of registration.

The allocation of chosen places for this year recently finalised and the residents took up their places at the end of May. The specialist health press has made use of all kinds of headlines, commenting on the results of autonomous communities, the most sought after specialties by residents or the best positioned centres. Nevertheless, not all the comments that have been published, sometimes too hastily, contain an accurate and rigorous analysis. The ability of centres to attract teaching staff in Catalonia has not regressed nor changed much in recent years; the hospitals and teaching centres most sought after in Family and Community Care by new residents are still the same at a state level.

Why is it important to be an attractive teaching centre for residents? Obviously, because all centres aspire to have the students with the best marks, not only for the prestige that this has or for the base of knowledge they have shown to have, but also because of the possibility of retaining them and contracting them at the end of their residency. The lower the mark in the MIR, the greater the chances are of abandoning a speciality and in practice a significant number of foreign residents are seen as having greater difficulties for future employment.

To promote the intrinsic and perceived quality in specialised training given to residents, the Department of Health of the Generalitat de Catalunya has implemented a Management Plan of Teaching Quality and within this, a set of structural, procedural and results indicators related to the places offered, which have been published in a report since last year at the Central de Resultats (Results Centre, Catalan Health System Observatory) under the auspices of the AQuAS.

Furthermore, a survey of satisfaction is carried out with all residents in Catalonia which has had an effective participation of 76% this year and which offers complementary information to that of the Plan of Quality. Both instruments, beyond the fact of generating transparency and information regarding a healthy specialist training, make it possible to benchmark different centres with the aim of achieving greater competitivity and improved teaching in Catalonia.

Ultimately, guaranteeing profiles of excellence of specialist health professionals is the permanent aspiration of the Health Authority via a learning process based on supervised and mentored practice to attain the necessary professional skills to offer a safe and high quality practice. In this way, the health system will be capable of training better specialists to meet the needs of the population in health.

Post written by Alícia Avila, Assistant Director-General of Professional Planning and Development. Health Department.