The importance of values in evidence-based medicine

The importance of values in evidence-based medicine – free full-text  /PMC4603687/ – Oct 2015

This is a long well-thought-out article about the current model of evidence-based medical care that we have to live with. I think the meat of the matter is in these two paragraphs:

The world as we think it ought to be is the world of values. Different people will have different values, and it is very hard to resolve value-based disagreements on the basis of scientific evidence. But values are ever present.

Despite the caricature of the passionless objective (often male) scientist in a white coat, the questions scientists decide to ask, the methods they select, and the way they interpret results are chosen through a filter of often unacknowledged and subconscious values.  

Abstract

Background

Evidence-based medicine (EBM) has always required integration of patient values with ‘best’ clinical evidence.

It is widely recognized that scientific practices and discoveries, including those of EBM, are value-laden.

But to date, the science of EBM has focused primarily on methods for reducing bias in the evidence, while the role of values in the different aspects of the EBM process has been almost completely ignored.

Discussion

In this paper, we address this gap by demonstrating how a consideration of values can enhance every aspect of EBM, including:

• prioritizing which tests and treatments to investigate,
• selecting research designs and methods,
• assessing effectiveness and efficiency,
• supporting patient choice and
• taking account of the limited time and resources available to busy clinicians.

Since values are integral to the practice of EBM, it follows that the highest standards of EBM require values to be made explicit, systematically explored, and integrated into decision making.

Summary

Through ‘values based’ approaches, EBM’s connection to the humanitarian principles upon which it was founded will be strengthened.

Excerpts from the full-text article continue below:

Background

The strong (and perhaps necessary) focus on technical procedure – how to do ‘robust’ research, how to synthesise data from primary studies, how to apply the findings in practice – has created the impression that EBM and its underpinning methodologies are concerned exclusively with matters of fact in an objective scientific environment, with confounders and bias either eliminated or carefully controlled for.

the methodological rules of EBM, and the research that underpins them, are laden with largely unacknowledged values.

Yet for years, this aspect of EBM was given relatively little systematic attention in the movement’s main writings, textbooks, and courses.

However the importance of values extends beyond the point-of-care decision with an individual patient. Values infuse evidence (in all sciences) at many levels. EBM, like all science, is necessarily value-laden.

Not only is eliminating values from the scientific method – in general and the EBM process in particular – impossible, but in trying to do so, researchers may introduce new (mostly covert and unacknowledged) biases.

Interestingly, values were at the very heart of EBM when the movement began. Cochrane’s original argument was all about doing medicine that was in patients’ interests.

Using unbiased evidence was by definition beneficent because medical interventions are risky and using the best evidence offers patients protection both from medical incompetence and the (at times) overblown claims of Big Pharma.

EBM has positioned itself as the guarantor of not doing harm; to do anything other than EBM is tantamount to maleficence.

Ironically, much of the recent backlash against EBM has been on the grounds that things have gone too far and that the slavish following of ‘evidence based’ guidelines poses threats to patients.

Discussion

What are values?

Science aspires to be about the world as it is; values are about the world as it ought to be.

Science seeks to get as close to the reality of the world as possible.

However…

What scientists are able to observe should not be confused with truth.

Contrary to popular assumption, then, neither essences nor truth are the territory of science and EBM. The world of empirical science is the world as it appears to be, revealed through our (imperfect) observational apparatus and methods.

Different values underpin different priorities and different kinds of ethical judgements.

The EBM and guidelines movements have sometimes been accused of ideological behaviour – that is

• of imposing a narrow, rule-based and overly technical approach to clinical practice and research;
• of seeking to control language;
• of suppressing dissent; and
• of dismissing alternative framings of problems and solutions.

We believe that EBM has made significant progress in recent years (although evidence that EBM itself has had any positive benefit is notoriously lacking).

This surprised me because, like everyone else, I just assumed that scientifically supported treatments would be more effective and that standardization would streamline medical care and reduce its expense.

The reference given is a printed book by Gøtzsche PC: Deadly medicines and organized crime: How Big Pharma has corrupted healthcare: Radcliffe Publishing Ltd; 2013.

From the Wikipedia entry for this book:

“The book documents activities by major pharmaceutical companies that include corruption, fraud, bribery, and omission of data to market their products. While all drugs have side effects not all have benefits. The influx of money by pharma undercuts regulation, education, and scientific integrity. Gøtzsche makes proposals on how to improve the situation.”

Many of its leading protagonists now argue for a more interdisciplinary stance that accommodates values and seeks to combine these with best evidence to achieve such goals as compassionate, patient-centred care and science for the public good

The value questions in evidence based medicine

Values have a critical influence in all aspects of EBM. Below we consider some key elements in turn.

1. The role of values in deciding which questions to ask

If medical science is defined purely in terms of commercially viable innovations tested in randomised trials, there will be less funding available to be spent (and less political will to spend it) on preventive non-drug interventions and public health measures such as food labelling or the walkability of the built environment.

These choices are the consequences of values held by key actors in the system – particularly the perspective that health is best delivered through measures that also generate innovation and wealth.

Here, he finally mentions the “elephant in the room”: financial incentives.

Ever since financiers bought up most of our healthcare goods and services and turned them into a huge corporate “healthcare industry”, profit seems to inform and guide all policies in the US these days.

Such an approach to the funding of scientific research may be a far cry from the disinterested pursuit of the greater societal good.

An alternative perspective places greater value on equity, justice and fairness – and emphasises the potentially negative consequences of innovation and profit.

…both sides are expressing values, not making logical deductions from neutral evidence.

2. The role of values in selecting methods for identifying and appraising research evidence

So despite the considerable efforts that have gone into methodological refinements of the RCT for example, trials may still reveal a skewed version of biomedical science.

I’ve been complaining about this for years: Opioids Blamed for Consequences of Chronic Pain.

Their design means they are a controlled experiment, oriented to generating an average result in an unconfounded population sample removed from the messiness of real life.

The technical method is pristine, but the degree to which the findings might apply to the atypical patient (e.g. with multi-morbidity or complex circumstances) and/or the atypical service setting (e.g. the hospital without a rapid-access chest pain clinic or the general practice whose ECG machine is broken) requires judgements that the science does not supply.

The epistemic consequence of taking a population or sub-population approach and looking at average results in these populations opens up a gap between the empirical evidence generated in the trials and the needs of individual patients.

Although the rhetoric of EBM argues for the importance of the individual patient, the failure to note that the choice of methods has profound consequences for the generation of data means that the significance of this gap is systematically overlooked

3. The importance of patient values in clinical decision-making

EBM advances have mostly aimed at methods for reducing bias in clinical trials and systematic reviews, with very little effort being spent investigating methods to elicit patient values, and how to integrate them into clinical decisions.

Decisions about which treatments to offer from among a range of available alternatives are value laden.

Yet treatment decisions are often made by standardized decision trees, which assume the values of the patient are clear and predictable.

The vast majority of evidence-based guidelines are derived from research into a single disease state. However, many people and most of those aged over 75 have more than one condition.

Multiple guidelines may be applied, suggesting multiple medications and other interventions. The net result can be a degree of polypharmacy which becomes both burdensome, potentially dangerous, and non evidence-based – since patients with multi-morbidity are almost invariably excluded from clinical trials.

Most preventive interventions carry only a small chance of benefit for the individual and patients may decide that this is insufficient to justify the taking of regular medication indefinitely – especially if they have previously experienced significant side effects from medication.

Careful attention to the hopes, aspirations and values of each individual patient will result in very different treatment decisions.

4. The importance of clinician values in prioritising (so-called) evidence-based tasks

The concerns of patients in the clinical setting are the focus of work by Values-Based Medicine (VBM) researchers, who explain how to integrate patient and practitioner values into clinical decision-making.

5. Values in the broader sense – is EBM delivering on its promise?

From the outset, EBM has been dominated by questions of efficiency and value for money.

Utilitarianism is premised on the view that actions are good insofar as they maximize benefit for the greatest number.

This is not necessarily congruent with what is in the best interest of an individual patient.

Utilitarians believe that the greatest health gain for the greatest number is efficient and that whilst some will not benefit as a consequence of the methods used to determine allocation, this is a price worth paying for the greater good (and morally the best approach because it is the most efficient).

A competing view proposes that equity should be paramount and that it is unjust and unfair that there are winners and losers as a consequence of whatever method of resource allocation is used.

The drive to improve efficiency (to achieve the greatest health benefit for the greatest number) leads to inequities since not all treatments can be provided for all people and an a priori judgement has been made about which treatments will be funded on the basis of the principles of efficiency of national resource allocation.

Efficiency can be unfair because not everyone individually will get what is right or appropriate for him or her. The cost utility approach tends to have little or no impact on patterns of need in the population or on health inequalities and at the very least reinforces the status quo.

The task of the clinician is to engage with the needs and values of each individual patient. Within any consultation, the moral obligation of the professional is to do his or her best for that particular patient and so the values of clinicians inevitably become primarily deontological

This value-based commitment of the clinician to the individual patient is poorly understood and little appreciated by those policymakers whose priorities are situated at the population or societal level, and vice versa.

Conclusions

EBM has generated substantial advances in methodology that have allowed us to

• distinguish between helpful and harmful treatments,
• identify the major problems with publication bias, and
• surface and address industry conflicts of interest.

Unfortunately, the predominance of technical progress has also served to support the myth that EBM is value neutral.

The focus on technical methodologies has obscured the equally important issue of values and, in turn, the way values impinge on judgements and the processes of interpretation of all steps in the EBM process..

Until EBM reconnects with its values and allows that its purpose is to extend human capabilities within a constrained environment, it will remain open to the accusation that it has lost its soul and come adrift from its founding humanitarian principles.

It’s easy to assume to EBM only requires a person to believe in science, but a closer and deeper investigation shows that while EBM is useful “on paper”, it ignores almost all factors of the individual patient, the individual doctor, their relationship, and the interaction between them.

Those are the logically fuzzy, value-laden human factors that may (I suspect) have more power over a patient’s welfare than any amount of EBM.