Understanding Harm (& Value)

Author: Carl Davies

Fresh of the back of my last blog, there is another discussion regarding what constitutes harm.  Discussion is focused around contextual definition, but I believe it’s something that is closely linked to what it truly means to add ‘value’ and it’s worth spending some time considering this.  One of the most interesting points of discussion is about whether it causes harm if it is not ‘directly’ harmful.  Do delays, increased financial spend, perpetuation of unhelpful beliefs etc cause harm?  Personally, I believe they do if the intention of the clinician was not to help the patient in line with ‘best practice’, but defining best practice and understanding the clinician’s intention is more complicated than a question of ‘is this treatment intrinsically harmful’ (which was the point of my last blog).

The Hippocratic Oath states:

I will follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous.”

In order to avoid doing harm, we must then be able to ascertain what is truly deleterious or mischievous.

In Of the Epidemics  Hippocrates says:

The physician must be able to tell the antecedents, know the present, and foretell the future — must mediate these things, and have two special objects in view with regard to disease, namely, to do good or to do no harm.”

In order to truly understand ‘harm’ then, I believe it is helpful to shift the conversation to the question of ‘what is best value?’ as this may answer many of the points raised in the discussion.

There has been, for decades, an ongoing battle between clinical excellence and financial prudence.  Many a clash between Director of Finance and Clinical Quality Leads have resulted in the hostile death of quality improvement initiatives and projects throughout the land.  RightCare began an approach to shift the focus away from conversations centred purely on finance or clinical excellence and encouraged all of those involved in service delivery, or quality improvement, to shift towards ‘Decisions of Value‘.  That is, to ensure they are making…

“… decisions with a clear and measurable impact on both finance (costs) and quality (care)”.

There are some extremely important considerations when you are attempting to achieve this balance.  The first is the ‘law of diminishing returns’ which suggests that there is a certain point at which the level of profit or benefit gained is less than the amount of money or energy invested.  Understanding this enables anybody starting a project , or delivering interventions, to consider what quality standards they should set and how much resource to invest.

law-of-diminishing-returns-diagram

This is important because it suggests that there is a limit to how effective you can be, and that striving for perfection doesn’t mean that you deliver the benefit you hope it will.  If we take the example of Physiotherapy and a patient with osteoarthritis of the knee,  exercise has been proven to be of significant benefit in a large percentage of that population….to a point.  Most of us would then recognise that, where conservative measures have been unsuccessful, a surgical intervention of “total knee replacement” (TKR) represents the best value for those patients.  To carry out a TKR before the patients requires one, or indeed continue with treatment that is providing no benefit when they evidence would suggest the patient would benefit from a TKR, could constitute ‘harm’.  We must be mindful of the subtleties in this when determining ‘harm’, because context is key.   What is definitely ‘harmful’ is applying electrotherapy or massage, when there is neither clinical or economical case for doing so, and the evidence is clear that ‘passive only’ approaches have no clinical basis.

Overkill

Many clinicians often believe that we (or service development projects) must provide the “highest” level of clinical quality to be of any “value” to the system.  In other words, they often become perfectionist, and begin demanding higher “standards” for a population that neither needs, nor can we afford to provide.  Anybody who knows me, knows that I do demand the highest standards of care from both myself and from others – but again it’s about providing highest standard of care that is appropriate for the needs of the patient.  Providing too much of something, just because you believe it to be the ‘right’ thing can actually be harmful.

“Standards of care” is key here.  The problem is that many clinicians often associate “highest standards” with “more“.  We often end up with “too much” in some places, which inevitably leads to “too little” in others.  The problem is therefore, not the level of perfectionism in clinicians or the fact they strive and demand the highest quality, but how and to whom they are applying their ‘highest standards’ or how we define “quality”.

Quality

Donabedian defines quality as “the degree to which a service meets pre-set standards of goodness”

Source: Donabedian A, personal communication.

This definition is important, for it suggests that in order for a service to provide quality, it must meet its “preset standards of goodness”.  Note that it does not say it must meet the “highest standard of goodness”.  That is because the level of quality is dependent on the “needs” of the patients using that service, and both those ‘needs’ and the ‘standards’ will vary depending on patient and service.  Therefore, it is perfectly acceptable to have a service that offers very little in the way of clinical expertise IF that level of clinical expertise is appropriate to meet the needs of the users of that service.  To put this even more simply, it is can be the right thing to do to offer “less” providing that “less” meets the needs of the patients.  Failure to recognise this is what leads to significant unwarranted clinical variation.  If one service can provide “less” in terms of input (and therefore cost) and still achieve the preset “standards of goodness”, why is there a need to demand “higher standards of quality” that will ultimately provide no further benefit, but incur significant additional cost.  Simply put, why is there a need to provide more if the preset standards of goodness can be achieved with less?  And is it in fact ‘harmful’ to continue to provide ‘more’ if there is no measurable long-term benefit to doing so, and use valuable resource doing so?  This very same principle can be applied to interventions chosen in clinical practice, which is why an ability to measure and demonstrate outcomes is critical.

RightCare summarise this in such a way that it is best just to take an extract straight from their Atlas of Variation Compendium (2015):

“In the second NHSAtlas of Variation in Healthcare (November 2011), the classic diagram, originated in 1980 by the late Professor Avedis Donabedian, was reproduced to show that when resources are invested in increasing amounts by those responsible for paying for healthcare, the intervention is offered to people in the population who are less severely affected.

As a result, the benefit gained from the intervention overall, flattens off (known as the Law of Diminishing Returns), whereas the amount of harm done increases in proportion to the level of investment.”

Donabedian diminishing returns

This effect occurs independent of the quality and safety of the service. Although the levels of quality and safety will influence the relative position of the two lines, they will not affect the basic relationship. As more healthcare is provided to the population, the benefits will plateau, whereas the harmful or adverse effects will continue to increase until a point of optimality is reached. If resources are invested beyond the point of optimality, the economic value of the investment for the population, including tax-payers, will decline from high to low value through zero to a negative value

Benefit vs harm

“This decrease in value has important implications for individual patients. As the amount of resource increases and treatment is offered to more individuals who are less severely affected, for each of those individuals the balance of benefit to harm associated with a single intervention, such as knee replacement, cataract surgery or the prescription of statins, also changes. In general, the magnitude of the benefit that an individual can expect will diminish, whereas the probability and magnitude of harm remains the same, and a clinical intervention can move from being necessary or appropriate to being inappropriate or futile”

Basically, there is a point at which you are providing “too much” for the needs of that individual and to continue to do so actually increases the chance of harm. Providing “too much” not only increases the risk of harm, but is also a form of “waste”.  When resources are expended for no additional benefit, they are wasted at the expense of individuals who, if used more appropriately, could have received the benefit.  This can be defined as a form of harm.  A prime example of this is opioid use in chronic pain.  They can be a useful form of intervention for “some” patients, in very specific circumstances, for limited amounts of time.  However, we have entered a period of huge ‘over use’, in which they are providing little benefit to much of the population who have become addicted to them.  The response from many GP’s is “but what other option is there, we can’t do nothing”.  To which the reply is, not only CAN you do nothing, but it is the only ethical, moral and economical option.  It is actually counter-therapeutic, a huge drain on financial resources and causing significant harm to offer opioid intervention in the majority of patients that are currently receiving them…..but clinicians view “more” as better value and more ‘clinically valid’ than doing nothing despite evidence to the contrary.

I therefore call out to all clinicians that next time you consider providing “the best quality” or “best-practice” please consider instead whether you are actually just providing ‘more’ of what you to believe to be effective, without true evidence of whether you are in fact providing the ‘greatest value’.  All of us, whether clinicians or managers, have a duty to ensure we provide the best ‘value’ for patients.  This is why robust outcome measures are key and should be the cornerstone of every decision made throughout healthcare.  We need to move away from our own personal definitions of ‘quality’ and ‘harm’, to measurable ‘value’.  Only then will we truly be able to say that the interventions we choose are ‘best practice’ or do/do not cause ‘harm’.

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