Endometriosis Foundation of America 2014
Societal perceptions and ethical imperatives in the decision-making for the treatment in of fertility and pain: incomplete procedures, misrepresentation, ethics in IVF issues
- David Keefe, MD
Dr. Victor Gomel: Next is Dr. David Keefe, “Societal Perceptions and Ethical Imperatives in the Decision Making for the Treatment of Infertility and Pain: Incomplete Procedures, Misrepresentation, Ethics and IVF Issues, so, a big title!
We are going to get the abridged version of that title “Decision Making and the Treatment of Endometriosis Related Pain” because in 20 minutes, just before lunch I wanted to make sure that we could get you out on time.
I want to add my thanks to Dr. Gomel and Dr. Seckin for another very successful endometriosis meeting. It is my second appearance here and I really enjoy the collegiality, the science, the advocacy that gets all rolled up into one. I also want to congratulate Drs. Guidice and Mettler for their awards, their Harry Reich Awards, awarded while you are still very much alive and for their tremendous contributions to the field. Dr. Guidice has been a role model not only for those interested in and committed to studying endometriosis but in our own field. One who most adeptly brings the bench to the bedside in a really special way that is for the better of all involved. And Dr. Mettler who has been a pioneer in the field of assisted reproduction as well as minimally invasive surgery. Well deserved honors indeed.
So I am going to just focus that large bite into a smaller one, which is essentially developing a framework to balance the benefits and the risks in the treatment of severe endometriosis. And then underline the importance of one of the ethical principles that Dr. Chervenak outlined for us, the patient autonomy in the process of clinical decision making and do this all in the framework of a case, a specific case that will allow us hopefully to individualize the process.
How many here are involved in the treatment of deep endometriosis, many of you are actually involved in dissections. So this would be a very I am sure familiar case of a 32-year-old with chronic pelvic pain, stage IV endometriosis. It was diagnosed and treated by her gynecologist with lysis of adhesions, fulguration, some excision mainly of the endometrioma that was kind of a straightforward component of this bigger case. And then post-operatively place some continuous oral contraceptive pills. But the pain really has persisted. She has got 5/10 deep dyspareunia, she has dyschezia and actually some rectal bleeding as well. It worsens pre-menstrually when she does cycle off the pill. A digital exam reveals in fact that she has a tender nodular area in her rectal mass. An MRI suggests rectovaginal involvement with infiltration and sigmoidoscopy, in fact, confirms this. She has failed non-steroidal anti-inflammatories and she wants to preserve her childbearing potential.
A number of options: she is in your office, she has failed conventional treatment. You could treat her medically, you could treat her surgically or you could present both and discuss the pros and cons. How many would recommend A? How about B? How about C? How many people here, raise your hands, would offer both and then allow her to be active in the process? Everybody has to vote, so, C, okay. I am going to try to emphasize the importance of this element of autonomy. As we know surgery, in fact, is highly effective, much of it developed by people in this room, especially rectovaginal endometriosis can be incredibly debilitating and conventional approaches are not as effective. However, surgery can relieve symptoms 70 percent of the time and you can see the work by Falcone and others have emphasized up to 99 percent of the time one has pain related symptoms relieved by the surgery and as well, sexual functioning, particularly the deep dyspareunia.
This is a highly effective treatment that was developed by many people in this room but at the same time, the complications that are associated with it beg a thorough discussion of them. In the process of your analysis, your discussion with the patient, we are going to discuss not only the potential benefits but also the potential risks. This includes, depending of course on your approach, shaving of the lesions, as opposed to resection of that segment or even segmental resection, can have anywhere from six percent up to 30 percent risk of significant complications including bleeding, fistulas, anastomotic leaks if there is a segmental resection and others have shown that there can be stenosis in the anastomosis, bowel fistulas and milder symptoms such as constipation and so on. How do we help the patient reconcile these two really disparate sides of the strategies that we are talking about?
One is you could quote surveys. These are populations. These are where people have been surveyed after the procedure to determine on average what were the effects of the balance of both the intervention and the potential for complications on the quality of life. This has been done by a number of groups. Moshe Baum’s group has looked at the various quality of life surveys after procedures and found in fact a significant improved quality of life as have a number of other groups suggesting that on balance the surgical intervention assuming the medical intervention was tried and failed or there was a direct pass to go and surgery was tried initially, suggesting that on balance the average population scores this as a beneficial approach.
However, if it is the patient, the specific patient, involved, the average suddenly may not be as relevant. There is a kind of joke among statisticians if statisticians tell jokes they tell the joke of two statisticians that were going to Africa to go hunting together and they are in the blind and all of a sudden they are surprised by a tiger that careens around the corner. It is just about to leap upon them and one statistician armed with his gun says, “Hey, you shoot one foot to the right of him and I’ll shoot one foot to the left and we’ll get him right between the eyes”.
What is important to know is that the average does not exist for the individual, right? This is the challenge we have moving from the scientist to the clinician we need to deal with the individual in front of us and certainly it is very powerful to know the average, to know the mean, the trends of populations but we have to individualize this, both because that patient may be the exception, she may be the outlier. And also the process of decision making is itself part of the therapy. We know that when misadventures happen when things occur that were not fully expected that the ability to have at least been exposed to this is very important. I think Dr. Chervenak’s wonderful story of the case at New York Hospital so many decades ago was so important not only because it laid the foundation but it still happens today where patients at least feel that they were not informed that they did not truly understand. The process of the discussion itself is the therapy. Before I was an OBGYN I practiced psychiatry for six years and did therapy. A very important part of that is the voyage, the way the patient arrives where she is going to arrive and that is the essence of resolution the struggle. This is not a novel concept. We had a wonderful introduction with Dr. Chervenak’s overview.
Let us talk about the process of informed consent. As you know it is very critical to discuss not only the specific recommendation you may have but also alternatives. Let us say in this case the patient had tried and failed the medical – I think that is pretty straightforward. Probably most of us would have at least attempted a medical approach first or non-surgical approach. The next component that is so important is to convey this in an understandable and at the same time non-directive manner. It is important as we do this to walk that fine razor’s edge between providing too much information and not enough. You want to think of the information like a dose of a drug. It needs to be appropriate and what is that? It depends. It depends on the patient, it depends on her adaptive style, it depends on her level of interest, her background. The best indicator for it is not reading or necessarily looking again at population studies of how to provide informed consent but use the patient as your feedback. And particularly the eyes, the eyes, and the face will tell you where she is at this point and as well if her significant others there, the partner. The hegemony of the mean is used to refer to the emphasis on averages, which can be what we call in psychotherapy as resistance. It allows you not to have to think about something you really need to think about. To say on average most people that have very invasive, aggressive, heroic surgery on average will not have a complication prevents the active discussion of the possibility that she may have it.
What you will find is that many of us are a little hesitant to go too far into it for fear the patient may be scared away from the procedure that she or he needs. The paradox is the opposite. When she is already thinking about this most likely she is already gone online and so for you to be with her emotionally speaking, to make contact, to be looking at the eyes, to be looking at the body language, to be looking at the fact that I guarantee you will be the most assuring and comforting approach to her so that she is most likely to get that surgery that she needs.
I find that discussing representative cases, cases I once knew, is very powerful. Yes, it is not good science but we are not talking now about science. We are talking about an experience. Someone is about to go on a voyage and you have been there before. You are the jungle guide, you have been through there. You know where the mosquitoes and the quicksand are. Parables are very powerful most religions have parables, the Old Testament, the New Testament, the Koran. There are many examples of the power of a story, the narrative. They should be told in a neutral fashion, a brief fashion and not random. They should be chosen to illustrate the point. They are much more powerful than the P value.
The other thing that is very helpful is analogies. I am sure many of you already practice these so I am probably preaching to the choir but analogies are very helpful. I always say to my patients there is nothing that I do that I cannot explain based on an analogy to food, sports or a car, so pick a category. It may vary. It is very helpful when people find out what they do because they will be able to understand certain things better than others.
The other component of this that is exceptionally important is to ask the patient after she has heard a variety of different concerns but which ones most concern her because that can help lead the discussion but most importantly it can help her feel that you are listening. Active listening is very important. We are always told “just listen”, well, as we know with seeing patients every 15 minutes a pre-op patient every half an hour we do not have a lot of time just to listen, actively listen and a very rapid way to get the patient the most bang for the buck so to speak from time is to ask her which of these most hits her, most concerns her.
You do need to leave sometime. This whole thing is going to pay off in multiples. You want to spend time now rather than in the courtroom. Anybody who has been involved in that game knows that system gets paid by the hour. And it is tremendously, tremendously time to consume and invasive and not very productive for most patients although I am not opposed to it. It is what it is but.
Some surgeons ask the patient to explain back what they heard and I would like a moment to ask you with your very extensive experience to share some of your approaches to this. But I would like to hear what you think about that. It depends on how you ask it. If somebody asks, I just had a little more surgery on my face; I have a little skin cancer. I am sure you will not feel so sorry for that surgery when you realize I got it as an exchange student living in Brazil when I was in my teens. I deserve every basal cell cancer I have earned. The doctor asked me to explain back what he had just said. It feels a little bit like the…we got in the third year of medical school. But some of it – I would like to hear how you do this, how you phrase it, the tone of your voice and see if you find it productive or not. I feel a little contrived. I am a little worried about inherently that imbalance of power that exists in the dyad between doctor and patient at all times and especially in the surgical setting. We are trying to redress that balance at the time of the consent so that we can elicit these concerns by asking what they have heard. I just find myself it…a bit this imbalance and shuts off a subsequent discussion. But again, I am very eager to hear from you in a moment, we have a lot of expertise and experience in this room.
I am sure we have all got the following, “Well, what would you do doc? What would you do if you were in my situation?” And so, I would like to hear as well what do you say? Because I will bet there is not a person in this room that cares for patients that have not been posted that question “Doc if you were in my situation what would you do?” I would like to hear what you say.
I would like to hear also how you convey the benefits as well as the risks of treatment in your practice. Do people feel comfortable at this point sharing what you do because you have done this? A lot of you are wrestling with this there is no right answer. There is no right answer I guarantee you. Anybody feel comfortable with answering, discussing, let us say your patients say “What would you do doc?” How do you address that?
Audience Member: Dr. Keefe you are absolutely right patients all the time ask the same questions…session. I spend about like you do probably the way you are describing it about 30 to 45 minutes in informed consent because we have been bitten twice…twice so I spend that time and I…informed consent. This is one of the questions invariably asked.
