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What is the legal status of guidelines and protocols in the management of patients?

Adherence to current clinical guidelines of commonly accepted practice is generally a complete defence to a claim in medical negligence.

Guidelines are established by national organisations such as the National Institutes for Health and Clinical Excellence (NICE) in the UK, special interest groups such as in gastroenterology or general surgery and may be produced as a matter of local policy in an individual institution. The intention is to promote best practice from a meta-analysis of available evidence such as found in a Cochrane Review, which is an analysis of a relevant database related to a specific condition.

Guidelines are not intended to be exclusive but rather provide a solid foundation on which to base clinical practice.

Their standing in legal matters is therefore the subject of debate. Medical evidence is usually generated from the results of clinical trials and is therefore based on a statistical analysis which never gives an absolute answer but rather, what is the “most likely” answer within statistical guidelines ie to around 95% certainty. This means there are certainly outliers in any such analysis, which indicates that a small number of patients may not respond or respond adversely to “routine” management. The more experienced the medical practitioner, the more likely they are to have seen and managed such outlying cases.

Guidelines therefore cannot be absolute, and management of a particular case may vary in specific circumstances based on the previous experience of the medical practitioner. However, in a legal situation, where guidelines are in place, any deviation needs to be explained in a logical way by a “reasonably, respectable and responsible” body of opinion and it is this that may be tested in court. Therefore, it is up to the defendant in a medical negligence action to logically explain their choices and behaviour when they deviate from accepted guidelines and policies.

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