The top 5 failures to disclose risk at informed consent

Tagged Audit, Checklist, complaints, Patient experience, SurgicalPerformance; Posted 11 years ago

In most countries, doctors have a duty to explain the possibility of surgical risks and possible complications before surgery to patients. In the vast majority these conversations go well; patients understand that we do not prepare her for bad things likely to happen; as surgeons/gynaecologists we simply need to comply with law and disclose those risks.

I went to the literature and searched what risks should be disclosed by the doctor as part of the consenting process. There is one very interesting paper by Bismark and colleagues (availabale as a free paper). They examine disagreements between patients and doctors about whether a particular risk ought to have been disclosed.

The findings were rather interesting: First, three quarters of disputes between doctors and patients were about patients’ allegations that a particular risk was not explained or disclosed by the doctor.

Secondly, the triggers that drove patients into litigation were five types of (unexpected or undisclosed) adverse outcomes. If any one of those five outcomes eventuated, but the doctor did not mention the possibility of it occurring prior to surgery – the risk of conflict was very high. Those five adverse outcomes were:

• The need of further surgery
• Chronic pain
• Impaired vision or hearing
• Poor cosmetic result
• Infertility or sexual dysfunction

Let’s think about it for a moment: If I am a patient and sign up for surgery, hoping that it would improve my life and then …. I need to live with permanent damage, such as constant pain. I certainly wouldn’t be happy! All the above outcomes refer to very important quality of life domains, more so than temporary incapacity.

As doctors we need to be very careful to correctly estimate what impact surgery may have on these important quality of life outcomes.

As a standard operating procedure I do inform all my patients about the possible need of conversion from laparoscopy to open surgery (which I am well aware because of my ongoing self-audit). I always inform my patients about a risk of visceral injury of bowel, bladder and ureter (again, I have those numbers broken down for all major procedures at hand).  I also add that (in the very unlikely event) that his injury is not diagnosed immediately it may require further surgeries to fix the problem.

The issue of chronic pain is important. We sometimes operate on patients who specifically request a hysterectomy or oophorectomy for chronic pelvic pain. I might explain that the medical condition may be the cause for the pain and the pain might disappear after surgery; depending on the individual patient that probability might be high. However, the pain might persist or recur unexpectedly, which indicates that the uterus, the ovary, or the endometriosis etc. did not cause the pain. The search for the cause of the pain will start all over again and since all gynaecological causes have been ruled out during surgery, I will not lead those investigations. That is hard to accept for some patients. Fortunately, in the vast majority of cases, the pain does disappear permanently after surgery. Most patients comment that they would have had their surgery much sooner, would they only have known.  

In our profession we hardly ever deal with issues about hearing or vision loss and (thanks to laparoscopic surgery) we also have hardly anything to do with poor cosmetic outcomes. If a patient had surgery previously and I see keloids from previous surgery in a scar, I inform patients that they might tend to form keloids by their own constitution. Most patients are not aware of it and grateful for the information.

Infertility and sexual dysfunction does affect gynaecologists very much. Sometimes this is the very reason why women see us. As gynaecologists we need to be super-sensitive to those issues. If infertility is a real possibility (risk of 1% or higher) it needs to be disclosed. The risk of Asherman’s syndrome after a curette is commonly understated. While I have never come across it knowingly, apparently its incidence is somewhere up to 25%.  Think of vulval surgery and the possibility of disfigurement. Think of bilateral ovarian endometriomas – we remove one ovary completely and there is only one other ovary left.  

Where from here?

1. Gynaecologists should not use standard hospital consent forms that only generically refer to risks associated with surgery. These forms don’t assist a conversation between the patients and doctor. I developed my own consent form and asked for approval by the medical executive in my private hospital, which was supported and approved.

My consent form summarises the conversation I have with my patient. It specifies the circumstances of my patient’s surgery. It also refers to my patient information sheet that I will use for almost every consenting process. In my practice this is a standard operating procedure; both forms are in every of my patient charts. If I don’t adhere to my protocol I will make a note of it.

2. The Bismarck study highlights deficits where doctors are often not aware that surgery has the potential to impact on long-term quality of life. Wherever a risk of further surgery, chronic pain, impaired vision or hearing, poor cosmetic result, infertility or sexual dysfunction – lets talk about it.

One of the most common reasons for not disclosing a risk is that the risk was considered too small. Do we know what the incidence of this or that event is in our practice? Do we measure? Most doctors don’t, but increasingly this will be a requirement for all of us.

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