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.

Indicators for assessing care for chronicity

10 Nov

In a previous post we discussed the advantages of using indicators in the assessment of health services. At AQuAS we have been applying indicators to assess different care processes and areas, with care for patients suffering from chronic conditions being one of the principal areas of interest in terms of new care models and programs assessment. Interventions in the field of care for chronicity are extremely complex given that by their very nature, they tend to involve multiple actors and many different levels of care concurrently, as well as different elements utilising therapeutic instruments and technology with very variable intensity. Moreover, their effectiveness is often linked to contextual factors, making it difficult to attribute an outcome to a particular component of the program. So, given this level of complexity, the question remains, why should we be using indicators in this area? The answer is that these indicators may provide us with several benefits compared to other assessment approaches, such as:

  • Incorporating professional opinion and consensus
  • The possibility of including structural and procedural indicators allows us to obtain an understanding of the environment and the reality in which the initiative is being implemented
  • Providing a type of assessment that is more accessible and understandable for professionals
  • Greater simplicity and speed in evaluation and obtaining results
  • Possibility of defining standards
  • Allowing comparisons to be established and objectifying trends
  • Identifying successful characteristics and factors that can define which models are most effective, for which groups of chronic patients, in what context and at what cost

The first project in which AQuAS began using quality of care indicators for assessing chronicity got underway in 2012 with the commission by the Program for Prevention and Care for Chronicity (PPAC) to define a set of indicators to assess the quality of integrated care programs for chronicity within the health sector, where an ‘integrated program’ is understood as those programs involving the coordinated participation of different levels of care. Following the methodology described in the previous post (review of literature, establishing a theoretical framework and expert opinions) a total of 18 indicators were obtained, mainly from intermediate and final results, which experts considered relevant and feasible for assess these types of programs and which are currently being implemented (see table 1 and web).

Table 1: Indicators assessed as relevant and feasible for evaluating integrated care programs for chronicity

indicadors-2-en-1

From this experience, AQuAS developed a proposal for indicators, published recently to, assess chronic care as part of the strategy for tackling chronicity within the National Health System. As a result of this work, a set of indicators considered to be crucial for evaluation emerged, which included several previously prioritized indicators which are repeated such as polymedication, avoidable readmissions and hospitalisations, but which incorporates new factors which are more closely associated with the patients’ experience, such as the assessment of the patients’ and carers’ quality of life, or patients’ lifestyles (see Table 2).

Table 2: Proposal for prioritized indicators for promoting more uniform measurement of the entire National Health System for evaluating of chronicity care strategies

indicadors-2-en-2

Later, from 2014 onwards, the Catalan Institute of Healthcare and Social Services (ICASS – Dpt. Social Welfare and Family) and the PPAC (Health Dept.), commissioned extensive work to be carried out in evaluating collaborative social and health care models in Catalonia. These models not only consider the different levels of care in the health system but also include social services, a crucial aspect in caring for patients in this category. The objectives of the project were to outline the organization and operations of these collaborative experiences, identify barriers and facilitators, propose a conceptual framework for assessment and define a set of well-founded indicators based on feedback from participants and the expertise acquired from previous assessment studies. The proposed indicators continue to take into account traditional indicators while consolidating assessment that includes the views of those involved, not just the patient, but also the caregivers and professionals, and placing special emphasis on the evaluation of the coordinated actions of healthcare and social services, for example considering the avoidance of duplicate processes or carrying out joint social and healthcare initiatives.

We must also highlight in this line of work the efforts undertaken by the ITES FORUM (Forum of innovation, transformation and excellence in health and social services) to define a joint health and social services evaluation framework with a proposal of indicators (line L6) and in which AQuAS is also involved jointly with professionals from different fields. The Forum is a tool to facilitate the necessary conceptual debate required for transforming existing social services and healthcare in favour of a new model of integrated care.

Finally, and to continue discussing the area of assessing the integration of health and social services, since 2015 AQuAS has been involved in the Horizon2020 SUSTAIN (Sustainable tailored integrated care for older people in Europe) project. This European project aims to compare, assess and implement strategies to improve integrated care experiences aimed at non-institutionalized elderly individuals, in other words, those living in their own homes. The project has an additional goal, which is to seek to ensure that the best integrated care initiatives in this area are applicable and adaptable to other European health systems and regions. The project involves seven European countries working simultaneously on the basis of the definition and implementation of a set of indicators pending definition, tailored to this type of population and integrative approach.

Indicators, therefore, are useful tools for assessing an area as large and as complex as chronicity and they can be applied from a broader or narrower perspective, in other words, taking into account not only the different levels of care in the health system, but also including social services. The results obtained from the implementation of these indicators will provide professionals with objective criteria regarding the quality of their interventions, by facilitating the identification of the strengths of chronic care programs, as well as areas with scope for improvement.

Post written by Noemí Robles, Laia Domingo i Mireia Espallargues. Àrea d’Avaluació, AQuAS.

Broadening perspectives in health service assessment

8 Sep
Vicky Serra-Sutton
Vicky Serra-Sutton, sociologist PhD

What lies behind a significant volume of hospital readmissions? What makes a service present a good healthcare praxis? What obstacles are there when changing to a healthcare model such as in major out-patient surgery which encourages patients to go home on the same day as their operation? Do managers and nursing staff have the same opinion about what efficiency is in an operating theatre? What is the perception of professionals of the possible benefits of people-centred attention?

Do we all see a dragon?

Drac

Reality is complex and therefore approaches are needed which facilitate the interpretation and understanding of that reality. With qualitative research, places can be reached otherwise unattainable when using other methodological aproximations. When answering questions like those we asked ourselves previously, a truly qualitative approach is required. We need to make the approach using an adequate and credible technique to validate the process of all those involved and  to ensure precision in results as is done in quantitative research but not forgetting that we need to be critical and independent in the analysis made.

We will briefly outline the evolution of the qualitative approaches in the context of the assessment of health services. A reflection on the usefulness of qualitative techniques  in the assessment of health services or medical technologies is not a new one and you can find a series on this subject in the British Medical Journal of 1995 and in the Health Technology Assessment report of 1998.

bmj-1995-eng

Health assessment agencies have given great importance to questions about the scientific evidence available when talking about the efficiency and safety of treatments and biomedical interventions of a clinical nature. Randomized controlled trials and systematic reviews are considered to be the reference standards for causal atributions of the benefits of an intervention for the improvement in the health status of patients.

Society has evolved and the needs of the system adapt to this. We formulate new questions related to the preferences and expectations of users facing treatment and how different professionals contribute to providing better results in patient health care. One must bear in mind that when assessing the benefits and results of attention given,  many factors come into play.

In this context, the paradigm of evidence based medicine and the supposed superiority of quantitative approaches and of some study designs above others, have created obstacles in the application of qualitative research. In this sense, the letter to the editors of the British Medical Journal signed by more than 70 researchers of reference for giving their support to qualitative research is clear proof of this remaining obstacle.

bmj-2016-eng

Questioning the efficacy of a medical drug cannot be answered using a qualitative approach but we can broaden the scope of questions that we pose ourselves.

For example, we can consider asking ourselves questions, among others, about the preferences of patients, the perception of the benefits of a medical drug, the expectations or opinion of professionals that prescribe it or the possible reasons for a low adherence of the medical drug.

Another scenario could be that of a patient with osteoarthritis who has undergone a knee replacement (arthroplasty) and who is being attended by several professionals such as the primary care doctor, the traumatologist surgeon, the anaesthetist, the nurse, the physiotherapist and other professionals if the patient has other comorbidities. That patient has certain preferences and expectations which need to be understood and then give the health care to cover those needs, which can go beyond the mere surgical procedure.

With qualitative research we develop a discourse, texts, opinions and perceptions of people, communities, with images, perspectives, ideologies and complexities. We must guarantee rigour and that the photograph and interpretation of reality that we make remain valid and coherent for the research group and the populaton or group of people that we are assessing.

The application of qualitative techniques has been on the rise using interviews, semi-structured questionnaires, field notes, focus or discussion groups to gather the opinion of different groups of professionals and users.

From my point of view, there are three examples which can be of great use to know the approach and the process in carrying out an assessment of services with a qualitative approach:

  1. Opinions, experiences and perceptions of citizens regarding waiting lists
  2. Job satisfaction or productivity, a study exploring the opinions of different professional profiles regarding the efficiency of operating theatres
  3. What opinion do professionals have of the benefits of an integrated attention in the United Kingdom?

Avoiding the classic metrics means being able to measure in an alternative or complementary way by combining different approaches be they qualitative or quantitative. I find the introduction to qualitative research we find in René Brown’s TED talk the power of vulnerability. This qualitative researcher recommends we measure that which is apparently unmeasurable and go more in depth into the complex phenomenon of vulnerabilty.

We broaden perspectives by understanding the reality from within, by bearing in mind the multiple existing points of view to improve that which is disfunctional or by identifying better practices to spread them. We can measure what we want to measure. It will be necessary to adapt the approach to the context and audiences and to continue progressing to show with rigour and practice the usefulness of qualitative approaches.

We continue learning. This time, it has been at the Congrés Iberoamericà de Recerca Qualitativa en Salut (in Twitter #IICS2016) held in Barcelona, 5-7 September. The Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS) and the Agència de Salut Pública de Catalunya (ASPCAT) shared the stand to explain their experiences.

2016 Congreso Iberoamericano de Investigación Cualitativa en Salud
Santi Gómez Santos (AQuAS/ASPCAT), Dolors Rodríguez Arjona (ASPCAT), Mireia Espallargues (AQuAS), Vicky Serra-Sutton (AQuAS)

Post written by Vicky Serra-Sutton (@vserrasutton), sociologist PhD in AQuAS.

Indicators for the health services assessment

4 Feb

What are indicators and how to set them?

In the clinical evaluation field, specifically for health care, an indicator in an instrument used to measure or assess specifici aspects of quality of care, and ultimately, the improvement of quality: assessment to improve.

The methodology used for creating or developing health indicators is distinct in that it combines different methodologies. In the first place, when elaborating indicators, the standard and most recommended procedure is to begin with a conceptual framework of reference, as this provides the premise for reflecting aspects of assessment, dimension, attributes, key areas of care specific to the field of study, as well as the target population. Moreover, the process of defining indicators takes into consideration two sources: scientific evidence experience and expert opinion.

A literature review enables authors to take into consideration scientific evidence and experience in the use of the indicator. A review of the scientific evidence ensures the validity of both the construct, (the indicator measures the intended target), as well as the guidelines (there is close correlation between an indicator and the outcome or another measure considered the gold standard). In addition, previous experience in the application of an indicator provides some basis as to its acceptability or use thereof. Generally, users find an indicator helpful if variations in the values it presents are ​​due to changes in the quality of care, and vice versa.

As far as expert opinion is concerned, it is important to highlight the advantages to using consensus methods during the process of identification and selection of indicators, a highly participative course of action. In general, the process is based on a consensus-centred approach (i.e., a group of professional experts which may, in addition, incorporate opinions from a group of patients and users), which is subsequently extended to a larger body of associated groups. Thus, the involvement of a significant number of participants in reaching a consensus on indicators reinforces the embeddedness of the assessment strategy and collective responsibility, furthering the eventual adoption and implementation of the indicators.

Figure 1. Combination of methodologies for developing indicators

Methodologies Developing Indicators

How to implement indicators?

Once the indicators have been defined, there are several different approaches to their implementation. These include performance analysis and comparison between units of analysis, or benchmarking, whether this refers to organizations, centres, services, teams or professionals. The first approach seeks to analyse the relationship between health outcomes (in quantity and quality) and the resources utilized, in other words, the value of health care. The objective is to identify the gap between what might be achieved using existing technology and resources (efficiency, the maximum achievable potential), and what is actually being achieved (effectiveness), adjusted due to the available resources and other variables which impact the outcome.

Figure 2. An example of mapping indicators used to analyse performance. In this case, the graph maps the ratio of observed/expected cases for the indicator subject to the study for Basic Healthcare Areas (ABS, as per the Catalan acronym).

Mapping

Source: Metodologia dels atles de variacions en la pràctica mèdica del SISCAT. Atles de variacions del SISCAT, número 0. Barcelona: Agència de Qualitat i Avaluació Sanitàries de Catalunya. Departament de Salut. Generalitat de Catalunya; 2014.

Finally, if the process is taken to the next level, we find ourselves in the realms of benchmarking, which allows us to make a comparative assessment. Basically, this involves using any product, service or work process within an organisation and which manifest best practises in the area of interest and using it as “comparator” or benchmark. The objective of this process is to transmit information regarding best practices and their implementation.

Figure 3. Sample mapping of an indicator used to make comparisons between units of analysis (benchmarking)

Comparisons

Source: Metodologia dels atles de variacions en la pràctica mèdica del SISCAT. Atles de variacions del SISCAT, número 0. Barcelona: Agència de Qualitat i Avaluació Sanitàries de Catalunya. Departament de Salut. Generalitat de Catalunya; 2014.

Post written by Mireia Espallargues, Noemí Robles and Laia Domingo.