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Informed consent 

The Health Service Ombudsman, Ann Abraham issued a report last week highlighting that the root of most complaints against trusts and health authorities was due to lack of communication and insufficient informed consent. Lesley Herbertson, head of clinical negligence at Alexander Harris, talks to Veronica Cowan...

A report out last week by the Health Service Ombudsman, Ann Abraham, criticised trusts and health authorities and highlighted two particular issues: lack of communication; and failure to obtain informed consent. "Failures of communication are at the root of many of the complaints and claims that The Medical Protection Society (MPS) assists doctors with each year", according to a spokesman.

This reflects the experience of Lesley Herbertson, head of clinical negligence at Alexander Harris: "A number of people contact us about poor communication, but whether they develop into a negligence case on informed consent depends on a number of issues. There have been initiatives to tackle the way doctors seek consent. The National Institute for Clinical Excellence has devised specific guidelines, but it is clear doctors are not abiding by them, and this would make it easier to prove negligence in a consent case".

Consent is needed for all physical examinations, and the patient must be capable of giving consent, be sufficiently informed to make a considered decision and it must be voluntary. So what would be the implications of failure to get consent? "Technically, it could be a battery - depending on what occurred - but one would tend to plead negligence, unless what was done was totally outside what was consented to", Ms Herbertson said, adding: "Any damages would depend on what happened and the effect, but the difficult issue is causation. The patient might say s/he would not have gone ahead, but proving this can be the most difficult area".

The MPS spokesman notes: "Consent is part of an ongoing process, and is not just a signature on a piece of paper but the result of proper dialogue between doctor and patient. It is essential that patients feels they are in a position to make genuine choices rather than are being led towards a decision that the doctor thinks is preferable." Ms Herbertson agrees, and confirms that medical paternalism can still affect consent: "We had a case in which the doctor thought an anal sphincter repair was appropriate, but did not tell the patient about the pros and cons because he thought it was the right way forward but the patient thought it would be simple removal of skin tags". 

She added that in another case the consent form referred to removal of the ovaries, but the patient had indicated to the doctor previously that this should only be done if necessary. "None of the prior conversation appears on the consent form but doctors try and rely on the letter of the form".

The Ombudsman referred in particular to failures of communication between medical and nursing staff and with patients and their carers. In today's healthcare system, which involves an extended team, is this a complicating factor? Ms Herbertson believes it is: "Healthcare professionals come under a lot of different heads, with multi-disciplinary teams looking after individuals, and often no proper co-ordination of treatment. The team may not be properly used, she said, instancing a case she is currently running; "A lady requested a double mastectomy because of a family history of breast cancer, which the surgeon performed. We are arguing that he should have first made sure she was counseled by a geneticist, a psychologist and a second breast surgeon, given the devastating effect of such a procedure".

The doctor who has ultimate responsibility for the care of the patient should ensue proper consent is obtained according to Ms Herbertson. The Ombudsman upheld the complaint of a lady who underwent a number of unsuccessful operations to reduce urinary leakage, agreeing she had not been given the opportunity to give informed consent to two of them, and was not warned about potential complications. 

The Ombudsman's clinical assessor advised that the more operations a patient has, the more risk there is of complications arising, and the specific complications suffered - excessive bleeding and a worsening of her symptoms - would be known risks for such a patient. Her consent was obtained on three occasions by different junior doctors, and the Ombudsman concluded that the consultant was responsible for ensuring she was provided with sufficient information to enable her to make an informed choice either directly, or indirectly through trained junior staff.(03/04/03)

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