According to medical literature, “guidelines are intended to inform clinical practice and uphold consistent standards, rather than replace the knowledge and skills of clinicians or the wishes of patients.”
Guidelines in medical practice are often cited both by both parties in medical negligence claims. They will use them as evidence of what may seem to be appropriate treatment, and yet their status can be ambiguous. Treatment may depart from guidelines and often has to, and they remain only guidelines of recommended practice as opposed to procedures that must be strictly adhered to. But the question lies in when it is reasonable to depart from them.
There are a number of different types of medical guidelines:
- the NICE guidelines which are created and endorsed by the National Institute for Health and Care Excellence
- Regulatory guidelines which may be set by the GMC or Royal Colleges
- Local guidelines which are set by the local commissioning groups or hospital trusts
NICE guidelines are “evidence-based recommendations for health care in England”. Some recommendations are made with more certainty than others, where there is strong evidence to support them and there is a clear benefit to a patient, but even where the benefits of a recommendation are less certain, NICE say they should be considered.
The General Medical Council (GMC) good medical practice guide states that doctors and clinical staff “must be familiar with guidelines and developments that affect your work”, be they national, regulatory or local.
Departing from guidelines may be acceptable and reasonable in particular circumstances, but in doing so any clinician would need to note why that decision to depart from the guideline was made and to include the patient in his or her decision making.
NICE states that “health and social care professionals are actively encouraged to follow our recommendations to help them deliver the highest quality care… our recommendations are not intended to replace the professional expertise and clinical judgement of health professionals, as they discuss treatment options with their patients.'
However, to simply be ignorant of a guideline, as the GMC good medical practice guide suggests, is no defence to not following it or involving the patient in the decision to depart from it.
This was brought home in one of Shoosmiths’ Principal Associates Sarah Corser’s cases involving a child who suffered cerebral palsy as a consequence of a lack of oxygen at birth due to a delayed delivery.
In 2004, New Cross Hospital in Wolverhampton had reviewed its own local maternity department guidelines. These ensured that in this busy general hospital, the maternity department, which had only one specialist obstetric operating theatre and one other large room that could be used for assisted deliveries, had a local guideline as to how to deal with simultaneous emergencies within the department. These guidelines included specifically that 0.25mg terbutaline should be administered subcutaneously to a labouring woman who is waiting for a Caesarean section for foetal distress to protect the baby from the stress of the ongoing uterine contractions.
During a very busy evening on the maternity unit, when more than two simultaneous emergencies were occupying the theatres in the department, a mother was admitted in labour with her baby in fetal distress. She needed a Caesarean section, but contrary to the hospital’s own admirably sensible guideline, no steps were taken to slow her contractions and buy the baby precious time. No reason was given either in the notes or in evidence at trial as to why the guideline was not even considered and the child’s mother was not involved in the decision not to follow the guideline.
She has emphatically stated that if discussions with her had taken place she would have asked for the treatment as stated in the guideline to give her baby the very best chance: “If my doctor had told me about the guideline even if there were some potential risks to me, I would have accepted the treatment as I would have been giving my baby the chance to be born a healthy baby.” Tragically this never happened, and the baby was born with severe brain damage.
Sarah Corser states: “Training and knowledge of guidelines are so important. The hospital in this case had very sensibly put in place a guideline to prevent just what happened to my client from occurring. It is very possible that the clinicians involved that evening in the maternity team were simply ignorant of it, which had devastating consequences.”