Understanding Harm (& Value)

Author: Carl Davies

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Fresh off the back of my last blog, there is another discussion regarding what constitutes harm in a healthcare setting taking part as somewhat of a national conversation.  Discussion is focused around the contextual definition, and specifically related to overt and obvious acts that lead to harm. However, something that is closely linked to understanding harm, and therefore truly understanding it, is concerned with what it truly means to add value.  This is because of the opportunity cost of delivering no- or low-value i.e. funding spent on something providing low value, can no longer be spent on something that provides high value.

One of the most interesting points of discussion is about whether something causes harm if it is not directly harmful.  For example, how do we specifically quantify (and therefore make someone accountable for) harm caused by delays, inappropriate financial spend or even perpetuation of unhelpful beliefs in patients that leads to them making poor behavioural changes?  This is complex, and worthy of discussion in more detail than can be presented here.

A discussion on harm in healthcare perhaps should start with the oft quoted Hippocratic Oath (commonly paraphrased as ‘first do no harm’)

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, it is perhaps helpful to shift the conversation to the question of ‘what is best value?’ as this may answer many of the points raised in the ongoing National discussion/conversation.

There has been, for decades, an ongoing battle between clinical excellence and financial prudence or indeed the need to improve quality whilst delivering savings. Many a clash between Chief Finance Officers and Clinical Quality Leads have resulted in the untimely disappearance of quality improvement initiatives or cost improvement 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 conversations 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)”.

This need to balance an obvious organisational tension is not however with its deeper complexities. 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.

This is important because it suggests that there is a limit to how effective you can be, and that striving for perfection after to you have reached that limit doesn’t mean that you deliver the benefit you hope it will or get the returns you might hope for from your resource investment.  

Overkill

Many clinicians often believe that we (or service development projects) must provide the highest level of clinical quality to be of most value to the system.  In other words, they often focus on the perfect service for a certain population and then expand this out to a population without such complex needs. The risk then is demanding higher standards for a population that neither needs, nor can we afford, for us to provide.  Opportunity cat becomes important here, since over investment for one population may lead to under-investment elsewhere. That is, a pursuit of high-quality in one place, if not balanced effectively against need, could in fact cause harm elsewhere in the system.

“Standards of care” is key here and many governing bodies use these to try and determine the appropriate level of care for patients. However, whether they are guilty of failing to achieve the balance described above is for another blog or even research topic.  The risk is that many clinicians and participants that set standards often associate highest standards with more.  As a result, standards become no more than a ivory tower list of ideals that neglect consideration of the complexities required in delivering value. Often then supported by performance or quality metrics, these directing system behaviour towards outcomes that may not be in the best interests of the larger number of patients. We often end up with “too much” in some places, which inevitably leads to “too little” in others.  How we truly define, measure and monitor quality is therefore important.

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.  To put this 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 and opens the door to hidden harm.

If one service can provide “less” in terms of input (and therefore cost) and still achieve the preset “standards of goodness” (output/outcomes – or even go beyond), one must ask why is there a need to demand higher standards of quality and who is it that is driving this? Particularly, given that it will ultimately provide no further benefit, but incur significant additional cost.  Simply put, we must then question “is it in fact ‘harmful’ to continue to provide ‘more’ if there is no measurable long-term benefit to doing so, and we use valuable resource doing so that now cannot be invested where it is needed”?  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 NHS Atlas 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.”

“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“

“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.  Equally, they may also cause direct harm because they are not the most appropriate choice, but both clinician and patient find this preferable to doing nothing. It feels counter-intuitive that doing nothing for a patient is a better choice than doing something. However, this is undoubtedly true. 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 in many cases become addicted to them.  The response from many prescribers 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 right ethical, moral and financially acceptable 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. Sadly, the intrinsic desire to help when we see suffering blinds us from the unintended, and more complex, consequences. As a result we view “more” or “doing something” as better value and more clinically valid than doing nothing despite evidence to the contrary.  As the old saying goes, ‘when you hold a hammer, everything looks like a nail’.  

All of us, whether clinicians or managers, have a duty to ensure we provide the best value for patients.  Not only because we have a duty to the tax payer to ensure it, but we have a duty to patients themselves to ensure that we directed funding where it can provide the most benefit. 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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