Consent Script for Stroke Thrombolysis

Hello, my name is Dr. Prudence. I need to speak to you urgently about the current situation.

We have performed a brief assessment of your father and it appears that he is having a stroke. This is a very serious situation. There are a number of causes for a stroke but a common one is where the blood supply to a part of his brain has been blocked by a clot. Currently, he is in the CT scanner to determine if this is the problem. I want to reassure you that there is nothing that you have done today that could have prevented this situation occurring because often the underlying problem has been going on for years.

Now I need to talk to you about a treatment that may be offered in selected cases. This is something that has been around now for 20 years. However, despite this there still remains some controversy about its treatment. We propose that we administer a drug that is a powerful blood thinner that may dissolve the clot, restore circulation and reduce the damage to part of his brain. The downside is that it may induce severe or even life-threatening internal bleeding. If that bleeding occurs in the brain itself, your father may be further disabled. The fact is regardless of what we do some damage has already occurred, we know that 1 in 4 patients after a stroke will not survive beyond one year and only 1 in 4 regain complete independence.

Previously there was no immediate treatment to be given for stroke and the focus was mainly on reducing complications, preventing another stroke and rehabilitation. Now despite this treatment being used many times in the past, it remains controversial for four reasons. This where it gets complicated with some fairly confronting statistics and I want you to listen carefully.

1) Firstly, unlike many emergency treatments that we perform in this hospital, the chances of making someone better with it versus making them is almost roughly equal. 1 in 22 of symptoms becoming better. 1 in 17 of symptoms become worse. Nothing else we do in medicine has such a small margin between benefit and risk.

2) Secondly, this treatment has not been shown to improve the overall chances of survival from stroke. Remember again that on average 1 in 4 patients do not survive their stroke after 12 months. The statistics show that every person’s life that is saved by this treatment, one person will die from it. We do not know which of those two people your father will be.

3) Thirdly, the statistics I mention to you are averages. Although one thing that may improve his chances is early treatment, there is no proven method to reduce the risks to the patient. Despite ongoing research for 20 years we have not been able to identify people who are more likely to benefit from the treatment. But there are a number of factors that increase the risk such as old age and already being on blood thinners.

4) Fourthly, there is still a chance your father’s condition can still improve without treatment over the next few days and even months or years given good rehabilitation to a point where he can return to independent living. Although 1 in 4 are independent is the quoted figure. It varies from as high as 4 in 5 for minor strokes to 1 in 5 for major strokes.

I have now just given you a whole range of statistics that you may need to digest for a while. But the reason I give them to you is to show you why clinicians are still so divided about this therapy.

So in summary

1) The risk benefit balance is not strongly in favour of one or the other
2) The average chance of saving his life is equal to that of killing him
3) He still has a change of getting improving without this treatment
4) We will do the utmost to reduce his risk of treatment complications but we can’t improve on the known statistics.

In all of these mind boggling statistics we will also need your response as soon as the diagnosis has been confirmed after the CT scan. Unfortunately we are under time pressure to administer the treatment if you agree with it. In other words, you will have the next 15 minutes to come up with a decision. Since your father is not in a state to respond, you will need to answer on his behalf. Although, you may not have discussed this situation specifically before, I want to you to seriously consider what he would have wanted if this had occurred.

My final comments are that as you wrestle about the possibility of your father being disabled for life is that we also know that the majority of stroke survivors when asked months later are glad they are alive despite their disability. Beyond the treatment we have discussed that is only helpful in a small fraction of patients, there has been a lot of progress we have made in overall stroke care and less riskier treatments that has improved outcomes for our patients. This is something also that you may also need to consider.

For the time being we will wait for the scan to be completed and I will return to check if you have any further questions before making a decision.