What exactly is Clinical Risk?
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ISB 0129
10 December 2013, by , in Blog, No comments

We often find ourselves trying to explain what we mean by terms like ‘risk’ and ‘clinical risk’. There are many definitions and it’s important for us to remain consistent, especially when we communicate across organisational boundaries.

Ask the average person and they’ll probably say that risk is ‘the chance of something bad happening’ – or something similar. That seems like a reasonable starting point, a link between an adverse event and an understanding that an occurrence of that event is something less than inevitable. But that’s not the full story; consider the following description of two fictitious adverse events:

“1 in 500 patients were accidentally administered double the prescribed dose of Paracetamol”

“1 in 500 patients were accidentally administered double the prescribed dose of Heparin”

Thus in each case an individual had a one in a 500 chance of being given double the correct dose of a drug. With the layman’s definition above, the risk should be the same should it not?

The pharmacology in this situation tells a different story. Receiving double the intended dose of Paracetamol as a single event is unlikely to cause most patients harm. On the other hand, receiving double the dose of Heparin could have serious clinical implications. The potential outcomes are therefore different.

The missing piece is therefore the concept of Severity, a measure of how detrimental the adverse event is to the wellbeing of an individual. This is consistent with the ISB 0129 / 0160 definition of Clinical Risk as being the “Combination of the severity of harm to a patient and the likelihood of occurrence of that harm.”

One could argue that this is not a definition of Clinical Risk at all but rather a means of its evaluation. Personally my preferred definition of Clinical Risk is “the chance of a patient being harmed to a stipulated extent”. It neatly and concisely brings together the concepts of an adverse outcome, likelihood and severity.

To add to the confusion a little, the term Clinical Risk seems to have different meanings whether it takes the definite or indefinite article. We may find ourselves saying, “We have identified a clinical risk here” or “Truncating the text in this screen is a clinical risk”. Indeed the ISB 0129 / 0160 standards themselves use the term in a manner which is occasionally contrary to its definition. Some might even be tempted to use awkward statements such as “The clinical risk of the clinical risk is Medium. If we intend Clinical Risk to mean a potentially harmful scenario it may be wise to consider using an alternative and more specific word altogether, for example, hazard, cause or trigger.

In Clinical Risk Management, terminology is important and what term could be more important than Clinical Risk itself? We should encourage the correct and consistent use of language in our projects and take the time to help our contributors and stakeholders to do the same.

Dr Adrian Stavert-Dobson is the Managing Partner of Safehand, independent consultants in clinical risk management, and the author of Health Information Systems: Managing Clinical Risk.

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