The hype over genetic tests

Implementation of a companion diagnostic in the clinical laboratory:The BRAF example in melanoma

Analytical validity is one of the three steps for any assessment of genetic tests, combined with clinical validity and clinical utility. Understanding how this process affects specific tests is not that easy.Fortunately you can find a detailed explanation of one of them:the BRAF genotype analysis in tumor tissue samples for identification of melanoma patients that can benefit treatment with BRAF inhibitors.
Once you begin to read the article you'll understand the complexity of being precise in a test. This is the reason why if specificity and sensibility is uncertain, different methodologies are needed (check Figure 1).
But how to do it?. How to set up external controls of quality?. All these issues are covered in this article, that explains what's going on in practical terms. I'm concerned if due to such complexity, all "genetic test talent" is not concentrated in one site of the organization-hospital, and many departments and services -oncology or cardiology- are developing their own genetic tests. Somebody should block this option before it is too late.

The size of the health budget

In 2015 the per capita expenditure (1,120€) will be the same as in 2006, nine years earlier (p.46). The economy follows exactly the same pattern. GDP per capita in 2014 was less than in 2006. Therefore, those that are concerned about stagnation and cutbacks, should look at statistics. The health budget is set according to political criteria, and what this amount reflects is exactly the same social effort to cover health risks as before the crisis.
Unfortunately I haven't seen this argument in any debate, up to now. It's really annoying that ideology overpowers evidence.

PS. James Buchanan blog in BMJ

PS. Robbed by the Kremlin in the WSJ.

Mandatory complementary private insurance

Compulsory private complementary health insurance offered by employers in France: Implications and current debate

It looks strange at a first glance. Why a country with statutory Social Health Insurance (SHI) has to set up a mandate to employers to buy private health insurance for their employees?. In France by 2016 all employers will have to do it, and this complementary insurance covers basically copayments in the SHI system. It is really strange, because copayments are created to reduce moral hazard, hence if somebody insures copayments, then its impact on utilization is the same as if it were no copayments in the SHI but with a high and avoidable loading fee. And, as far as this insurance is mandatory and private, then it makes no sense at all.
Each country decides politically according to the context, nothing to add, though this is a very weird case. You'll find more details in this article.

Is this the end my friend? (2)

Once upon a time there was a country with seven Schools of Medicine for 7,5m inhabitants. The needs for future physicians were estimated 8 years ago and the time goes by but somebody seems he is not aware of that. Some months ago I said that the organization of health care system as we have known it, was at their final days, now I can confirm that medical profession structure is also in the same situation.
A big and unnoticed change has occurred. In 2006, only 1,8% of resident physicians were foreigners, in 2013 this figure has jumped to 32,3% (!). Does this makes any sense?.
How is it possible that our citizens can't study medicine and we are able to open the system to foreigners without the right level of qualifications?. Who is boosting this?. I explained it in this post some years ago, here and there.
The time to disconnect is coming. Enough is enough!

The Dunning Funnel criteria for the health basket

The basic benefit package: Composition and exceptions to the rules. A case study

In the Netherlands there are four criteria to assess any benefit to be included in the health basket:

1. Care should be essential: Does the illness, disability or the care needed justify a claim on solidarity within the existing cultural context?
2. Effectiveness: Does the intervention do what it is expected to do? In other words: it is proven to be effective and evidence based.
3. Cost-effectiveness: Is the ratio between the cost of the intervention and the outcome
acceptable?
4. Feasibility: Is it feasible to include the intervention in the basic package, now and in the future?

This is known as the funnel originated by a commission report chaired by Mr. Dunning in 1991. The application of such criteria has been evolving and a recent article says that some benefits have followed a yo-yo effect, being in and out of the package for unspecified reasons. I think that it is better to have some clear principles and justify its application, than not having any.
Here we have some principles, sometimes we change them, sometimes we assess them, sometimes not and nobody knows why.

PS. The Irish  have made a recent effort of definition in this report.

The challenge of setting fair priorities

Public views on principles for health care priority setting: Findings of a European cross-country study using Q methodology

The clash between equity and efficiency is featured nowadays with hepatitis C drugs. High prices mean that access requires some kind of prioritisation. An interesting article may help to understand it:

 Resources available to the health care sector are finite and typically insufficient to fulfil all the demands for health care in the population. Decisions must be made about which treatments to provide. Relatively little is known about the views of the general public regarding the principles that should guide such decisions

The tension between equity and efficiency in the health care sector is apparent in a range of routine decisions and practices. For instance, in the prioritisation of patients on a waiting list, the aim to maximise overall health benefits from treatment may be at conflict with that of obtaining an equitable distribution of health and health care.

 Now ask yourself about the following principles to allocate health resources:

(I) “Egalitarianism, entitlement and equality of access”;

II) “Severity and the magnitude of health gains”;

(III) “Fair innings, young people and maximising health benefits”; 

(IV) “The intrinsic value of life and healthy living”; 

(V) “Quality of life is more important than simply staying alive”.

 Are you able to set a ranking? Does a general ranking of priorities always apply to all cases?. Not so easy. This is exactly what they do in the article and the results are:

Given the plurality of views on the principles for health care priority setting, no single equity principle can be used to underpin health care priority setting. Hence, the process of decision making becomes more important, in which, arguably, these multiple perspectives in society should be somehow reflected.

Let's think about the somehow...

PS. Sofosbuvir vs. NICE . And the winner is?

The satisfaction paradox and the need for a dose of realism

A paradox is a "situation that is made up of two opposite things and that seems impossible but is actually true or possible". This is exactly what is happening to satisfaction with health services in times of economic recession. Everybody would think that less budget damages satisfaction perception. What's going on is exactly the opposite. Satisfaction with health services is increasing (from 79% of people satisfied with the public system in 2006 to 88% in 2013). And this is also happening in the UK, John Appleby et al. from King's Fund say:

Overall public satisfaction with the NHS increased to 65 per cent in 2014 – the second highest level since the British Social Attitudes survey began in 1983. Dissatisfaction with the service fell to an all-time low of 15 per cent.

One interpretation of the increase in overall satisfaction for the NHS is that it is likely to reflect a vote of support for the NHS as an institution in difficult times. A lack of objective improvement in NHS services and the fact that improvements in satisfaction appear to have been driven by an 11 percentage point increase in satisfaction among Labour supporters and those without recent contact with the service, may lend weight to this analysis. This may especially be the case given that some see the NHS as currently under threat, for example from privatisation, and some feel ministers and others have been too critical of the NHS and its staff.

Official measures of performance tell a different story: NHS funding has been under increasing pressure since 2010 and there have been well-publicised performance problems with high-profile targets such as the 4-hour A&E waiting time standard and the 18-week maximum wait from referral to treatment. At the same time, the media has featured negative stories about the financial position of NHS hospitals and the need for additional investment in the service.

This context suggests a possible alternative explanation for the increase in satisfaction in 2014. We know that what drives changes in satisfaction is not straightforward – and almost certainly is never simply satisfaction with the NHS per se, for all respondents to the survey. Political beliefs, attitudes towards the government of the day, media stories and expectations of the NHS will shape people’s satisfaction.

So, while satisfaction improved in 2014, this is not necessarily synonymous with an improvement in the actual performance of the NHS, nor does it simply reflect an actual improvement in satisfaction. Nevertheless, it is clear that public satisfaction with the NHS and support for it as an institution remains high.

I suggest you have a look at the report. Satisfaction is a different dimension from performance, good point. If overall performance is based on healthy life expectancy, then the conclusion for us would be the same. We have increased healthy life expectancy all these years.

Those that complain about austerity want to forget such results. Also journalists. They don't figure out that the issue is a balanced budget and cutbacks have not been applied on an ideological foundation as some pretend. Anybody can blame over budget cuts, but immediately they would have to understand what they would do at home if their income is 7 years less than  before (2013 GDP per capita is less than those in 2006!!!). For sure they would return to an expenditure level simliar to previously,  in one way or another. Can anyone defend that these are ideological budget cuts at home?.
You can't live permanently in increasing debt, I'm satiated of cheap populism. A dose of realism is required.

PS. As you may notice, realism begins after reading the data, but you have to read them.

Stratified medicine in Europe

Stratified medicine in European Medicines Agency licensing: a systematic review of predictive biomarkers

The potential of predictive biomarkers for the development of stratified medicine has been highlighted for more than a decade. The current situation is very concrete. In Europe, EMA has accepted 49 biomarker-indication-drug combinations over 16 years, mostly used in cancer and as a predictive of drug efficacy, and in a minor scale of drug toxicity (4 cases).
These data confirm that currently the new wave of "personalised" or stratified medicine is really minor, although the investments and return expectations are huge.

Given the large body of literature documenting research into potential predictive biomarkers and extensive investment into stratified medicine, we identified relatively few predictive biomarkers included in licensing. These were also limited to a small number of clinical areas.

 Just released

Healthy behavior strategies

Healthy Behavior Change in Practical Settings

This is the article to read today. If you don't have enough time, have a look at this figure and ask yourself if you can apply it.

PS. Afterwards you may fill the questionnaire (Article 4) to check your understanding.

Psychological wellbeing and health

Subjective wellbeing, health, and ageing

What is the relationship between wellbeing and age?. This is precisely what this article tries to disentangle considering three types of subjective wellbeing:

• Evaluative wellbeing: evaluations of how satisfied people are with their lives
• Hedonic wellbeing: feelings or moods such as happiness,sadness and anger
• Eudemonic wellbeing: judgments about the meaning and purpose of life

Is it possible that positive subjective wellbeing is a protective factor for health?
Their conclusion:

Research into subjective wellbeing and health at older ages is at an early stage. Nevertheless, the wellbeing of elderly people is important, and evidence suggests that positive hedonic states, life evaluation, and eudemonic wellbeing are relevant to health and quality of life as people age. Health-care systems should be concerned not only with illness and disability, but also with supporting methods to improve positive psychological states.

Do you have any clue of how to do it?

Deciding by default

Choosing Not to Choose. Understanding the Value of Choice

The core of the application of behavioural economics to decision making on health lies in my opinion in choice architecture. I explained that 2 years ago in this post. Now Cass Sunstein is providing us with a new book that shows the details and rules for "choosing no to choose", a must read.

The choice among impersonal default rules, active choosing, and personalized default rules cannot be made in the abstract.To know which is best, both choosers and choice architects need to investigate two factors: the costs of decisions and the costs of errors (understood as the number and magnitude of mistakes). An understanding of those kinds of costs does not tell us everything that we need to know, but it does help to orient the proper analysis of a wide range of problems.
It should be obvious that a default rule can much reduce the costs of decisions. When such a rule is in place, people do not need to focus on what to do; they can simply follow the default. But a default rule can also increase the costs of errors, at least if it does not fit people’s situations; it can lead them in directions that make their lives go worse.

In approaching the underlying issues, he shows five propositions. I'm right now in the middle of the book. I can't have a final opinion, however I'm sure that this will be a key reference for the future.

Knowing what works

A systematic review of barriers to and facilitators of the use of evidence by policymakers

Evidence-based health policy should be grounded on knowledge on what works. Too often we see that policy-maker decisions' are far from that. Understanding why, is the first step to fixing it. In this article you'll find a systematic review on this topic:

The most frequently reported barriers were the lack of availability to research, lack of relevant research, having no time or opportunity to use research evidence, policymakers' and other users not being skilled in research methods, and costs . The most frequently reported facilitators also included access to and improved dissemination of research, and existence of and access to relevant research. Collaboration and relationships between policymakers and research staff were all reported as important factors.

Incentives, a modern frame (2)

Ética de los incentivos a profesionales sanitarios

Revisitng this report released 5 years ago, and comparing some statements with a former post, I can find relevant differences. Though this one is applied and the former is more general, the perspective is focused on having clear answers to specific problems. The definition, appropriateness and foundations of the argument requires deeper elaboration, in my opinion. That's why I suggest you should read the book.

Incentives, a modern frame

Strings Attached: Untangling the Ethics of Incentives

I've found extremely appealing the chapter 2 of the book "Strings Attached", it helps to understand the etimology of incentives as a word in the english language and its meaning:

For more than 250 years, starting in about 1600, the word “incentive” meant “inciting or arousing to feeling or action, provocative, exciting.” Uses cited by the authoritative Oxford English Dictionary include: “The Lord Shaftesbury . . . made an incentive speech in the House of Lords (1734),” or “This Paper is principally designed as an incentive to the Love of our Country (1713).” The last example cited of the term in this sense is dated 1866 and, like the others, it comes from an English source. Then there is a striking change. “Mr. Charles E. Wilson . . . is urging war industries to adopt ‘incentive pay’—that is, to pay workers more if they produce more.” This is the first example from the same dictionary of the use of the term in its contemporary sense, and it is an American example dated three quarters of a century later in 1943.

There is a huge gap in time, place, and meaning between the two sorts of citations, a gap that introduces several puzzles. What was happening in America when the new meaning of incentives was introduced? Why is this conception missing from the vocabulary in the seventeenth and eighteenth centuries, the very years in which the idea of a market economy was being discovered and articulated? We are accustomed to believe that our thinking about political economy rests on the work of the likes of John Locke, Bernard Mandeville, Adam Smith, David Hume, Jeremy Bentham, James Mill, John Stuart Mill, and the authors of The Federalist Papers. But with very few exceptions, “incentive” does not appear in any of their writings.

Beyond chapter 2, the whole book deserves to be read.