 This is Donna Prosser, Chief Clinical Officer here at the Patient Safety Amendment Foundation. Today, we're going to talk about the topic of informed consent and what that means, both to patients and families, as well as to clinicians and administrators. And so we're so excited to be joined today by Dr. John James. He's a leading patient safety advocate, and you may know him from his work, a new evidence-based estimate of patient harms associated with hospital care. And that's the paper back in 2013 that estimated that between 200 and 400,000 people die every year due to preventable medical error. So thank you so much, John, for joining us. So glad to have you here today. Well, thank you, Donna. I always appreciate a chance to help out. Great. I wonder if we can just talk real briefly about informed consent. Like, what is informed consent? Why does it matter? That's actually a very important question. It is the opportunity for a patient and clinician to interact and for the clinician to ensure that he or she is optimizing patient care based on patient preferences. Shared decision-making tends to be a subset of informed consent. On the patient side, it's their chance to ask important questions based on the homework they've done and their worries and concerns. And in case I forget, I want to say at this point, the patient should always cast their questions in terms of, I'm worried that I am not going to make the best decision for my own care because I don't get all the information I really need. You don't want to cast it in terms of, I don't trust you, doctor. That is not the way to do it. I'm a warrior and I want my worries taken care of. So informed consent is the time when critical elements come together that have the potential to optimize the patient's care. You want to talk a little bit about the ethical principles behind that? And you think about where we've been the last several centuries. We've been very paternalistic in healthcare. So can you talk a little bit about the ethical principles behind why patients should be part of that decision-making process? Well, the primary principle is called autonomy. It means that we each assume beings to determine what happens to our bodies. And so the idea is that nobody interferes with our body without our permission and in the case of medicine, our informed permission. The other perhaps a little less critical but still in the mix are beneficence. There should be something beneficial and what is done for the patient and there should be non-maleficence. That means harmful things done to the patient that should not have been done. And that's pretty rare in medicine. But we read stories periodically of unethical doctors, very small minority doctors, that intentionally do things to patients that they know are wrong. So it's all those things, autonomy, beneficence and non-maleficence. Now I know your background was at NASA in the past. What made you get interested and involved in the topic of informed consent and patient safety? Well, I came to patient safety because of what happened to my son in 2002 in Waco. He had collapsed and was cared for for five days in a couple of hospitals in his college town. And things just don't go well. He died as a result of medical errors and I was shocked and I was very ill-prepared in terms of informed consent to help him through his process. And looking back I realized his informed consent process was terrible. And while I spent years trying to change the system, I've learned in the past few years that what's really important and doable is to change how much patients know about the informed consent process. So they can really get it. I remember my son's fear-mongering was used. His cardiologist told him a frightening story, the Pete Marovitch story that I won't go in here, but it scared him. And then it turned out I found out a long time later one of the key things before invasive procedures was to do a cardiac MRI. While they did that, it was never properly done. And a radiologist much later told me that. So his informed consent was very unethical part of his care. And so in the past few years I've tried to become a champion of sorts of improving informed consent. Well, I'm so very sorry to hear that about your son, but we're grateful for the work that you've produced in patient safety as a result. I wonder if you can tell us a bit about what's happening today? I know we've been talking a lot about improving patient safety over the past 20 years and that includes conversations about improving informed consent. So what are the current gaps that we still have now in this process? I think perhaps 15 to 20 years ago, the concept of shared decision making began to enter into the picture of informed consent. By that is meant that a conversation occurs between the clinician that's going to do a potentially invasive procedure and the patient. The patient voices their preferences. They may have a huge fear of surgery or they may have a huge fear of infection or just a lot of these, their preferences for their care. And that has to be matched up with the options they have for taking care of whatever problem they may have. And it applies even to screening because a lot of screening is done on people that don't understand the downside of screening, for example, for cancer. I think it's hard to characterize the whole system within the US. I believe there's islands of excellence that really do share decision making well. But I think across the country, there's a lot of places where hospitals and clinicians that are stressed there do not really fully engage in shared decision making. It takes some time. It takes a lot of listening and that's a barrier. So we kind of have this bright light of shared decision making and we need to begin to pursue it as the backbone of informed consent. Well, very well said. What recommendations do you have for clinicians and administrators and what they can do better in improving their own practice? Clinicians and administrators. Okay. So one of the pushbacks for a more complete informed consent shared decision making process is clinician time. I really think that especially highly trained nurses, nurse practitioners and physicians assistants and so on could get more involved in the informed consent shared decision making process and get the patients prepared to effectively engage in those processes. For example, are there decision aids available for the situation the patient is in that are well vetted, not a sales job, but really good decision aids? You know, what are their concerns about cost? Do they have concerns about alternatives? Kind of work some of those questions and then have a more efficient shared decision making with a clinician that's actually going to do a potentially invasive procedure and even one of the questions and I've heard this from some MDs say, hey, I was going to have this critical surgery and I went to the local good hospital and they didn't tell me what I found out, which was that over here at, let's say Mayo Clinic or somewhere, they're doing a progressive new procedure that has virtually no side effects on its own. So he went there, he got the procedure and it was great. So there's always the question, does your institute, your hospital have the capability to give me the best treatment that I need? So there's a lot of interplay here and of course, clinicians don't really want to send you to a hospital somewhere unless they really, really have to. That's true. Now how about for patients and families that are currently dealing with these issues in the hospital or even for the general public that might not know that this is such an issue, what recommendations would you have for them to help to navigate this process more safely? Okay, let me, I think that's an important question. I'm going to put some background to a little bit. So there's two kinds of informed consent basically, state by state. About half the states have what's called a clinician-centered informed consent. That means doctors have decided what the patient should do for a given procedure. The other half of the states have what's called a reasonable person stand. That means, okay, we should tell that patient what we think a reasonable person should know before having a stent stuck in or something. By the way, by all of this is about non-emergency procedures. It's an emergency informed consent that's set aside. Anyway, so who says what a reasonable patient wants to know? Interestingly, in my state of Texas, which is a reasonable person's standard for informed consent, a bunch of doctors and malpractice defense lawyers are setting the standards for what a reasonable patient should know. We're trying to fix that. We don't think that does not make it a reasonable patient informed consent. It's really the doctor thing. Now, so I decided a couple of years ago, maybe we should ask the country, if you will, do a survey. What does a reasonable patient want to know? And I did a paper published in BMJ Open in 2019 in which I had surveyed with my colleagues the national population through SurveyMonkey and we asked them questions about what people want to know. And I was amazed at the strength of which people wanted to know things if they knew to ask. This is things like, what are all my options and the risks and benefits of each? What about off-label drugs or black box label drugs? Yes, they want to know if they're going to be given any of those. They want to know about decision aids. They want to know cost. They want to know exactly who's going to give the procedure or do the procedure. And the scenario I painted was in a training hospital. So, you know, people have to do first surgeries. And I'm okay with that, but it has to be rigorously overseen. And the people want to know that. They want to know how to make entries in their medical records. And especially they want to know what the outcomes are, even if things go well. I mean, am I going to have to do this for a month or two? Or what am I going to have to do? What do I expect even when things go well? And of course, what happens when things don't go well? So, there's so much information that a patient needs to come in prepared to ask about. And in any other situations, like there's subsets like patients with cancer. How effective are these drugs you're going to give me and what are the side effects? I have a 92-year-old friend who's got pancreatic cancer. And when he looked at the treatment and the possible outcomes, forget it. And he's done fine for a year and a half walking around with his pancreatic cancer. No treatment. So it's very important that the patients get prepared to deal with these things. Long answer. Sorry about that. No worries. No worries. That was exactly what, you know, what folks need to hear. You know, we need to be as transparent as we can be. So that people have the information that they need to make the right decisions. Absolutely. And I might say there was a paper published in 2020 by Erica Spatz MD and her colleagues. And the same journal mine was, BMJ Open. And she asked the question, well, she had set up a 20-point quality evaluation scale for how well documented informed consent is in hospitals. She queried 25 hospitals, 100 records each. Of the 20 points, the average score was four and a half. Eight of the hospitals scored two or less in this 20-point quality scale. So based on the documentation that actually is present in hospital records, we have a long ways to go with informed consent. We have a very long ways. So, and I think with patients pushing the issue and clinicians welcoming the dialogue, we can make progress. Wow. Well, thank you so very much for joining us today. This was excellent information. And I look forward to having continued discussions with you in the future as we continue to evolve patient safety in hospitals. Well, thank you, Donna. I appreciate your interest for sure. Excellent. We'll have a great day. Uh-huh. You too. Bye-bye.