Geriatric anesthesia is a thing. The average age of people getting surgery is increasing. Anesthesiologists and surgeons feel that with new techniques and approaches they can perform surgery on patients at ever older ages, patients who they previously would have excluded from surgery.
One of the key advances in geriatric anesthesia is the use of spinal anesthesia, a form of regional anesthesia that also includes epidurals and peripheral nerve blocks. When older adults experience a hip fracture, there’s a growing consensus that spinal anesthesia offers superior outcomes compared to general anesthesia.
It’s surprising therefore, to talk with Mark Neuman about the results of his randomized trial in NEJM, which finds essentially no difference between general anesthesia and spinal. Importantly, as a primary outcome Mark selected walking ability based on feedback from older adults – this is the outcome our patients care about most. But he finds no difference in primary outcome or secondary outcomes, including (surprisingly) delirium.
We break down potential reasons, with thoughtful commentary from Liz Whitlock and Cindy Hsu, two anesthesiologists with experience caring for older adults with hip fracture. Liz is a friend of the pod and researcher who we interviewed previously about “pumphead.” Cindy is…my wife. She also helps me out with the accompaniment on piano as it’s tough for me to play guitar with a broken clavicle. Thank you dear wife! We had fun learning to play/sing Drivers License by Olivia Rodrigo. Ah…teen angst…the angst!!!
Eric: Welcome to the GeriPal Podcast. This is Eric Widera.
Alex: This is Alex Smith.
Eric: And Alex, I see somebody with you and I see a couple other people on the Zoom. Who do we have with us today?
Alex: Yes. Today we are delighted to welcome Mark Neuman, who is the Horatio C. Wood Professorship of Anesthesiology at the University of Pennsylvania Perelman School of Medicine. Welcome to the GeriPal Podcast, Mark.
Mark: Thank you. I’m so excited to be here.
Alex: And we’re delighted to welcome back to the GeriPal Podcast, Liz Whitlock, who’s assistant professor of anesthesiology and perioperative care at UCSF. Welcome back, Liz.
Alex: And we’re delighted to welcome Cindy Hsu, who is an anesthesiologist at Kaiser Oakland Medical Center, and she’s my wife.
Cindy: Thank you, husband. [laughter]
Eric: Cindy. Thanks for joining us. I see we’re next to a piano. So we must be playing a song that’s on a piano. So before we get into the topic of geriatric anesthesiology, Mark, I think you have a song request.
Mark: Yeah, I’m just interested in hearing anything by Olivia Rodrigo, if you have it.
Eric: Why Olivia Rodrigo?
Mark: Because she’s my daughter’s favorite singer. My two daughters love Olivia Rodrigo and everything I do is just an effort to look cool in front of them. So if you could make me cool, that’d be great.
Eric: Nothing is cooler than being on the GeriPal Podcast. So this is going to be the highlight right here. [laughter]
Alex: And thank you very much to Cindy for helping out by accompanying me on piano. As we mentioned in the last podcast, I broke my clavicle biking, so it’s tough to play the guitar. Thank you to my good wife. This is Drivers License, by the way.
Liz: So sad. [laughter]
Mark: Really felt it.
Alex: Thank you.
Liz: That’s what the kids are listening to nowadays? Oh golly.
Eric: I like it when guests challenge Alex.
Alex: Over one billion Downloads on Spotify. Over one billion, and it’s only been out a short time. She’s big, big deal.
Mark: Big deal.
Liz: Really resonated.
Eric: Are about half of those downloads your daughters? [laughter]
Alex: Your daughters are still about 10 years away from driving, right Mark?
Mark: Yeah. Hopefully, yeah.
Alex: Actually, our son is in the process of driving. He drove us around Tahoe. A deer jumped in front of the car in front of him.
Cindy: Not in the car.
Alex: While we were driving. Yeah, getting a driver’s license. Scary time for parents too.
Eric: Well today we’re not talking about driver’s license in older adults, we’re actually talking about geriatric anesthesia, a little bit about types of anesthesia, great New England Journal of Medicine study that we’ll have links to on our podcast show notes, on GeriPal.org, I Don’t even remember our website anymore, that Mark did. So a lot to talk about. I’m wondering before we get into all of these topics, Mark, how did you get interested in this as a topic, especially like anesthesia in older adults and outcomes?
Mark: Thanks Eric. When I finished my anesthesia residency, I was always interested in doing research and interested in public health and health policy research. And when I was an anesthesia resident, I started to learn about hip fracture patients and discovered that this is a population of patients that is very large. It’s over a quarter a million people each year in the United States that break their hips. It’s mostly older adults and the outcomes after hip fracture that people experience can be really severe. A large number of people die in the year after hip fracture and a large number of people lose independence if they were living independently prior to fracture.
Mark: So I felt that this was a population that could benefit from work to focus on improving outcomes and on understanding how to deliver care better. And as an anesthesiologist, most people who have hip fracture undergo surgery. So these are folks who I was taking care of in the operating room. And so since about 2008, for about the past 12 and a half years, I’ve been interested in studying hip fracture and recovery from hip fracture from several different angles. This topic of spinal verse general has been sort of right in our backyard since it’s what I do clinically as an anesthesiologist. But I see it as part of this story about trying to understand what determines outcomes for people and what things we might be able to do to make them better.
Eric: And Liz, we had you on a earlier podcast about pump head, and we listened to you a little bit about how you got interested in geriatric anesthesiology, mainly focused on like CABG and PCIs. I’m wondering when you’re thinking about this topic, in particular hip fractures in older adults and the role of the anesthesiologist and what types of interventions we should be doing, how did you get interested in this and are you interested in this?
Liz: So I’m an observational researcher and the paper we discussed earlier was observational research. And there was tons of cool observational research on whether spinal was better for older adults undergoing hip fracture surgery versus general anesthesia. There’s some important hypotheses about inflammation and general anesthetics being potentially causal for adverse long-term outcomes, including delirium. Maybe if we just avoid all of that, maybe if we give you the awesome pain control that you get with neuraxial, with a spinal, maybe older adults will do better. And so people did this in databases, Mark did this in a database, and looked at whether someone had gotten a spinal or gotten a general anesthetic and how their long term or intermediate term outcomes were. And generally, pretty much across the board, if you got neuraxial anesthesia for your hip fracture surgery, you were likely to do better. And so that’s cool, but there’s a problem with observational data and that’s unmeasured confounding. It’s a boring term, but it’s something that a randomized trial needs to try and address.
Eric: Yeah. So when we were thinking about the topic of regional versus general anesthesia, I heard we’re using a lot more regional anesthesia. Cindy, I’m wondering from your perspective in an integrated health system like Kaiser, have you seen a shift in what you’ve been doing or what your colleagues have been doing as far as the types of anesthesia used?
Cindy: I would say we’ve always stressed regionally anesthesia when possible. I’ve been practicing at Kaiser now for 13 years, finished my residency about a year or two years before that. And we’ve always preferred to do spinal anesthesia for hip fractures. We’ve always preferred to do regional anesthesia when it’s possible, unless there is some other contraindication.
Eric: And why is that?
Cindy: I think all the things that Liz mentioned, we’ve always touted the benefits of regional anesthesia, lower risk of delirium, fewer systemic medications. There have been all sorts of studies, spinal and epidural anesthesia being related to lower blood loss, maybe decreased blood clots, improved pain control after mobility, maybe decreased need for opioids and therefore all the benefits related to that. So a lot of reasons. So we’ve always, as long as I’ve been practicing and as long as I was a resident, preferred to do regional anesthesia, neuraxial anesthesia.
Eric: And Mark, is this part of the reason that you decided to take on this subject?
Mark: It is. As Liz mentioned, I started my career doing retrospective data studies. And we found in our retrospective studies that it looked like people who had gotten spinal did better. But as Liz mentioned, there was one problem, which was that when you look in data retrospectively, the patients are being selected into one or another kind of anesthesia. It’s really hard to know if the differences in outcomes have to do with what the patients are like versus the treatment they’re getting. That’s one problem. But there’s another problem that we discovered as we move through these different retrospective studies, which is that the kinds of outcomes you get to look at in retrospective studies are just the outcomes that happen to be available in whatever database you’re working with.
Mark: And for us, for me, as somebody who cared about trying to move the story on hip fracture and what can make it better forward, I felt there was a gap of studies that looked at outcomes that were meaningful to patients above and beyond just what was happening in the hospital. So really the only, only way to get at that was to go out and do our own study. And in our study, what we focused on was the outcome that patients themselves and their caregivers and their loved ones told us was important, which was recovery of function. So our main outcome that we looked at was at two months after fracture, were you able to walk again independently, and had you survived to that point to get there? We also looked at delirium and a couple of other things, but that was our main outcome and it’s what we heard from patients mattered to them.
Eric: Let’s talk about the New England Journal study real quick, because our audience probably hasn’t read it yet. So this was right a randomized control trial of spinal versus general anesthesia for older adults undergoing hip fracture surgery, right? Surgery for a hip fracture, not just a hip replacement.
Mark: No. We only included people who’d come in with broken hips and you had to be age 50 or older to be in our study.
Eric: Okay. And then just for our audience, can you just give us a one sentence, what is general versus spinal anesthesia?
Mark: Liz, do you want to do that?
Liz: Sure, yeah. With general anesthesia, I promise you will be asleep. I’m going to use medications to take away your consciousness. And in fact, you’re going to be so unconscious that I’m going to have to control your breathing somehow. That’s kind of how I think of general anesthesia. No consciousness, controlled breathing. The alternative that Mark was studying, was neuraxial anesthesia, where we put a little bit of medicine in the spinal canal and it basically puts your whole body to sleep from about the nipples down. And you don’t feel anything down there for a few hours, long enough to conduct a surgery. And then what we do in terms of your consciousness is kind of optional. So you can have just the spinal anesthetic and no extra medicine. So the only medicine you get for your surgery may just be the medicine that goes in the spinal canal. You’re totally awake, you hear everything that’s going on. Some people are not comfortable with that. So we can also give additional medicines to make you sleepy or more relaxed. But you breathe on your own.
Eric: Yeah. And Mark, in this study, spinal versus general, did they get that extra medicine to make them more sleepy, in addition to the spinal?
Mark: Yeah. Most patients got some sedation in our study. The way we set this up was as a pragmatic trial. And when we say a pragmatic trial, we’re trying to study these treatments as they’re used in practice. Both spinal and general have been around for more than a hundred years. The stories behind both of them are actually kind of fascinating from a historical perspective. But in clinical practice, people typically get some sedation with spinal anesthesia. Often, patients have concerns about hearing what’s going on in operating room, like Liz said. For hip fracture patients in particular though, there’s another thing which is that it actually can hurt to position someone for the spinal block. You actually have to be able to get access to somebody’s back. And you can just imagine if you have a broken hip, turning somebody from lying flat on their back up to their side with unfixed fracture can be quite painful. So almost everybody with hip fractures, although there are some ways to do it without sedation, practically speaking, people almost always get something at least for the block and usually additional medicine in the operating room.
Eric: And what are those additional medicines? Are we using benzos?
Mark: What we saw in our study is about a third of patients got benzodiazepines, and it was usually about two milligrams. There were some people who got ketamine for positioning and a number of patients got propofol. If you look at the amounts that people got, it was a modest amount, consistent with what we used for procedural sedation. And we asked all of our providers to keep track of the sedation levels and target arousability to voice or tactile stimulus. And about 85% of the patients were able to hit that target. But again, it was a very large study across 46 centers, hundreds of different clinicians. There was naturally some variability in the sedation regimens.
Eric: And were you also looking at pain medications too?
Mark: We tracked that. We actually are writing a paper right now that will look at pain scores after surgery and report that. We actually tracked pain medication usage every day after surgery. It was actually a huge amount of work and it was based on a suggestion we got from one member of our DSMB who thought it’d be a really good idea. And so we did that. We worked really hard. I ended up being very grateful that we did it because the study is going to be very interesting. But along the way, it was very stressful. Alex, do you know who that member of the DSMB might have been?
Alex: Was that me?
Mark: It was you.
Alex: It was me?
Liz: No memory of this.
Alex: Apologies for the stress. [laughter]
Mark: It’s okay, it was worth it in the end.
Eric: Before we get into the results, one of the populations that I always think about the dangers of hip fractures and general anesthesia is people with cognitive impairment. Were people with cognitive impairment included in this study?
Mark: Yeah. People who had cognitive impairments were eligible to be in this study, if we could either obtain informed consent from the patient themselves, or if they had a healthcare proxy who could provide informed consent on their behalf. There were a few sites that did not permit proxy consent, but almost all of them did. And we worked pretty hard to screen and try to enroll people with cognitive impairment. It was a challenge to be honest, not just because of the complexity of consent in this population, but also because of the reluctance of patients and family members often to involve loved ones in research who may have been in a difficult time in their lives.
Eric: Yeah. I see though, you still had over 10% had dementia in this study. I’m also struck by the fact that the eligible patients were over 50, but the median age was close to 80, which tells you a little bit about the population and the importance of this for people who care for older adults.
Mark: Yeah. And that’s pretty close to what we’d expect for a typical population of people with hip fracture in the United States and Canada.
Cindy: I was just going to say that I was glad that you were able to enroll so many patients with cognitive impairment because I feel like that’s such a high percentage of the number of hip fractures that we see and you have to exclude those patients.
Mark: Thank you.
Alex: And also kudos for choosing a patient-centered outcome. Our GeriPal listeners will love this, that you chose this inability to walk as a part of your primary outcome composite with death. And I want to ask you before we get to what you found, what did you think you would find in advance? Mark, what did you think you would find? And Liz, if you didn’t see this study, what do you think you’d find? And Cindy, what do you think you’d find? Mark, starting with you.
Mark: I really did think that we would find that spinal anesthesia was better than general anesthesia for most of our outcomes. I especially thought we’d find a difference in delirium. I thought we had a good chance to find a difference in the actual primary outcome, but the delirium outcome I thought there would be more there.
Alex: Yeah. And Liz?
Liz: I want to answer the question after.
Alex: After? Okay. Cindy?
Cindy: Well just kind of going back though, to not finding a difference with delirium, I agree, I really thought there would be a difference. Do you think that those medications that the patients were getting for sedation either before the spinal was placed, for the spinal placement or during surgery, do you think that those medications would’ve had an impact on delirium if you were able to study-
Eric: Let’s talk about that. But first, just for the audience who may have not read this paper, what did you actually find here? I know we’ve alluded to it already.
Mark: So what we ended up finding was that the outcomes were in our main outcomes, our primary and our secondary outcomes, almost exactly the same by group. 18.5% of patients who had spinal either died or were unable to walk in 60 days, and 18% of people in general died or were unable to walk. So pretty much the same numbers. Death was almost exactly this same, 3.9% versus 4% in each group. The delirium rate was 20 and a half percent for spinal versus 19.7% for general. And the length of stay in the hospital, and we looked at it by country because we had patients who were enrolled in Canada and patients who were enrolled in the US, they have different lengths of stays because of how they use healthcare. It was exactly the same in each group, six and six in Canada, and three and three in the US.
Mark: I should mention, we looked at a number of exploratory outcomes, so in hospital complications. Those were very low rates by and large. They were pretty infrequent events. There were a number that were more common with general anesthesia. So we saw more ICU utilization after general anesthesia. We saw more pneumonias after general anesthesia, more acute kidney injury, more postoperative transfusions, but these were all relatively low rates. We didn’t even do statistical hypothesis testing on these. They’re really pretty much exploratory outcomes. But we did notice numerically different rates. But by 60 days, the differences had sort of shaken out and none of these differences were big enough to really change even somebody’s length of stay in the hospital. So all in all, it looked like at least looking at 60 days, outcomes were pretty similar.
Eric: So really no difference between two groups. Then going to Cindy’s question, was this because is this really general versus spinal anesthesia or is this general versus spinal anesthesia plus some benzos? Thoughts on that.
Mark: This is a great example of comparing a pragmatic trial to what we call an explanatory trial. I think what we represented in this trial is the way people typically use spinal anesthesia in practice. When you look at the care people received in our study, which was done at 46 hospitals, private hospitals, academic hospitals, seven hospitals in Canada, this was the typical anesthesia that people get for hip fracture. I think the answer is that given typical anesthesia, that’s spinal anesthesia, which usually involves some sedation as used in practice, it doesn’t seem like there’s a difference. Is it possible that there’s a variety of spinal anesthesia or a way of doing it that might result in better outcomes? Possibly. We can’t answer that question here. And in fact, you could actually ask that question about any study. But for that’s more the province of explanatory trials versus pragmatic. So we’re talking about usual practice.
Mark: I will say there has been pretty good research looking at this exact question. So one of our colleagues, named Fritz Sieber who’s at Hopkins, did a beautiful randomized trial that was published in JAMA Surgery a few years ago, actually looking at hip fracture patients who’d had spinals and randomizing them to higher or lower sedation levels. And in fact, there was no difference in delirium with higher or lower sedation. I guess one could pose the question, what if you had no sedation at all? I think practically speaking, that’s not really in the realm of typical practice for most patients. I think if you were to drop in on a typical hospital in the United States and look at their records, it would be extremely rare except perhaps for certain patients who maybe… I think there are maybe certain special scenarios where this could occur. It would be extremely uncommon to see a spinal done with no sedation at all, but something we wanted to explore.
Liz: Most of the time patients say, “Do whatever you want. I just want to be asleep.” And we say, “Well, but you’ll kind of be asleep with the spinal.” And you go, “Oh, well, I’ll do what I can. I’ll be right here.” People are really anxious about the idea of being awake during a surgical procedure. And so we do have rare patients who are really motivated and say they want to avoid all psychoactive medications. That can be done, but it is not the typical expectation of a patient coming in, in our health system, which is not necessarily the case in other parts of the world.
Eric: Yeah. Liz, did the results surprise you?
Liz: I learned about Mark’s results at our major national meeting that was in October and there was anesthesiologists all over the place. And I would go up to ones that I knew, “Did you hear? What did you think of this?” I’m mostly research, but most of these people were mostly clinical. And they said, “Oh yeah. Oh no, of course there’s no difference.” And I was like, “What do you mean?” Did we misread the room and design this trial. Everyone seemed not surprised by the findings. And I feel like a lot of the research community was really surprised. We thought that spinal was going to make a big difference, particularly in the delirium outcome. And to find no difference and to fairly conclusively find no difference. It’s not like Mark’s confidence intervals were humongously wide. No, this question’s relatively well answered, that common practice, there’s not a difference. I kind of was in the maybe no difference camp, but you got to do the study. I didn’t have anything to base that on except an emotional feeling and some confounded observational studies.
Eric: Do you think it’s going to change practice at all or people are just going to do what they’re going to do?
Liz: So I think yes.
Eric: Yes, it’s going to change practice or yes they’re going to do what they’re going to do?
Liz: It changes the way I think about it because there definitely had been this kind of milieu that the right thing to do is a spinal. And we’ve already kind of alluded to some reluctance patients have on pursuing a spinal anesthetic. Maybe one week before I went to the ASA and found out about these results, I took care of an early eighties patient who had a hip fracture. Totally independent, still working, fell, had a hip fracture. It was 9:30 at night by the time we had enough nursing staff and surgeon availability and an operating room to do it in. And she needed to have her hip fixed. And I said, “Well, we have these two options, all the way to sleep and spinal.”
Liz: And she said, “Oh, I don’t think I really want to.” And I said, “But the spinal, we think maybe it’s better.” And she said, “Oh, but I don’t.” She doesn’t want to get into position, getting up there in a position so that I can find the spinal space and put the medicine in. And then she didn’t really want to be awake during the procedure. And I said, “Well, no, I can help you. I can give you medicine.” Ultimately, we decided to do it as a general anesthetic because she just had reservations about the many parts that are involved in having a spinal anesthetic. You show up for surgery, your default assumption is often general anesthesia. We did it, she was fine and I was like, “Oh my gosh, have I done something bad to this very functional woman who had a lot to get back to. Did I, the anesthesia provider, should I have talked her into it more?” And I was really relieved to find out, probably not.
Eric: Cindy, from the community practice standpoint, do you think it’s going to change practice at all?
Cindy: This will be interesting to see. I’m curious to get back to work and talk to all of my colleagues about what they think. And it is so ingrained in our training and our thinking that I would say for some surgeries, we kind of always do general anesthesia, for some it’s kind of whatever the page wants. And for some surgeries it’s regional anesthesia all the way, like C-sections. It’s just kind of naturally thought of, oh, hip fracture, spinal, no question unless there’s some contraindication. So I’ll be curious to see how things shake out with this study.
Alex: Mark, what are you hearing?
Mark: I hear both groups. There’s a community of folks in anesthesiology that are very focused on regional anesthesia and there are a lot of strongly held opinions about benefits of regional anesthesia. I’ve heard some perspectives that people say this doesn’t align with what I think or what I see, and I’m not going to change practice based on it. I’ve heard others voice opinions more along the lines of what Liz has said. For me, I’ll tell you, what I think important about this trial is less whether we choose spinal or general more often or less often, frankly, but that we use it as an opportunity to think about how we’re talking about these choices with our patients. And for me, the special thing about a trial like this is it introduces a degree of transparency into what pros and cons may exist for certain medical decisions.
Mark: When something is a purely kind of insider technical decision, I control all the information, “Oh, I’ve seen this before. This is what I do in my practice. This is how I do it.” You’re sort of beholden to my opinion, right? I think that the clinicians in the mix here have a very important role to play in guiding individual choice because after all, not every patient’s the average patient. There may be patients out there who really could benefit from spinal anesthesia and we don’t have enough data to look at every single possible sub group. But overall, now we’re happy to be able to say, Cindy, Liz, I can go out into practice and internists and geriatricians who do consultations and say there was a study, it enrolled 1600 patients. On average, the patient looked like the typical hip fracture patient. And it looked like the choice of spinal versus general wasn’t consequential by 60 days. And that at least gives patients a little more power in terms of making their own decisions, if that’s what they want.
Eric: I think in a lot of medicine we’ve also learned that there’s the patients who can make decisions, but usually decisions are made also on other factors, like reimbursements. Is there a difference as far as reimbursement or quality indicators, the other things that move decisions in particular ways?
Mark: Anesthesiologists don’t get paid differently depending on whether they do general or spinal anesthesia. So it doesn’t really impact reimbursement that way. In certain practices, anesthesiologists may have to pay for their supplies and there might be considerations like that. But in general, I think it’s considered to be largely a wash between the two. And I don’t think that there are current major quality measures in this space that talk about neuraxial anesthesia as a quality measure. I think that it’s down to patients, what family members want and believe for their loved ones, and then also, what the habits are of clinicians. When we look across hospitals, there’s a wide variation and use of these techniques, and hospitals develop signatures of what they like to do.
Eric: Liz, I got a question for you. You hang out with a lot of us geriatricians. Why should we care about this subject, spinal versus regional? This is an interesting topic for an anesthesiologist to banter about, but I’m not going to do anything with this.
Liz: Well, we’re nerdy about the details of our profession. But there’s not a New England Journal paper that doesn’t have implications, I think, for a broader group of people. And in this case, it’s really important to know, for example, the delirium outcome I found very compelling. We’re really concerned that there are things that we anesthesiologists are doing, perioperatively, that cause delirium. We know delirium is associated with a lot of adverse later outcomes. And if we’re causing delirium intraoperatively, we’d like to know about it.
Eric: What do you think about that, Mark?
Mark: My hope is that anybody who’s taking care of older adults with hip fracture in the hospital is at least familiar with our findings because they may get asked questions. There are preoperative consultations that are often done by geriatricians and internists, families may have questions. And I know that there are folks who are non-anesthesiologists, who might be in internal medicine or geriatrics, who have their own beliefs and opinions. I know this because I sometimes read it in their consult notes, “Please avoid general anesthesia” or “Regional anesthesia is preferable.” I hope that this kind of work can inform those kinds of assessments. And again, help to create a degree of dialogue between the specialties about how to really improve outcomes for patients. Taking care of hip fracture patients is the ultimate team sport in medicine. To help people recover well, you need so many folks involved. And I think the more we can communicate about what the pros and cons are of the treatment options that are out there, the better.
Alex: As a member of the DSMB for this study, I was privileged to witness the extraordinary efforts that you went to in order to make this trial happen. And kudos to you and your study team, the large study team, for conducting such a large complicated trial and enrolling so many patients. And I wonder if you could share with us what lessons you’ve learned about trials? Keeping in mind that our audience is overwhelmingly clinicians, not researchers. But for example, one thing that Cindy noticed in reading the trial results two minutes before we did the podcast, was that 90, like 89% of participants were white. How can we recruit more diverse, older adults, people with dementia, non-English speaking patients? What lessons did you learn from conducting this trial?
Mark: I think it’s a great question. One thing to point out is that, and you may know this, the demographic of hip fracture patients in the United States, for reasons I don’t understand or never heard explained well, are overwhelmingly white. Only about three or 4% of hip fracture patients nationally, based on the Medicare data I’ve seen are black. We were able to [inaudible 00:35:17] 8% black patients into our sample, which is still not representative of the population of US adults, all told. But for hip fracture, that was quite a relatively high number. We did okay with other groups as well. But it is a challenge. I think that recruitment for clinical trials of even standard care interventions like spinal versus general anesthesia, is always a big challenge because what you deal with is people’s own preferences.
Mark: You need to find folks who are willing to allow that decision to be made on their behalf by our randomization algorithm and clinicians who are willing to put that kind of trust in the study as well. These are important decisions that people make. These aren’t thoughtless decisions. And when you’re talking about doing randomized trials, the more consequential the decision is, the more impactful it is ultimately for practice, right? But it’s also a harder study to do because there’s actually real stuff at stake. And it’s not to diminish the complexity of doing any trial, really any trial is hard. But in some ways, if we were doing a trial of something where there really wasn’t that much at stake in the decision, it would be an easier trial to recruit for potentially. One thing we heard from a number of people is that they didn’t want to be involved in research just in general. I think distrust in the health system and distrust in research is real, and it really does affect the trials we do. And that’s something that as society, I think we have to work on.
Mark: The last thing I’d say, this is separate for enrollment, is that this is all about trade offs. As you saw Alex, going through this with us, our design of our trial was entirely built around the practicalities of getting this thing done at this big scale, which was ultimately driven by trying to look at this particular outcome. You need a certain number of patients to get it done. If you’re trying to do a trial at that level, you have to be willing to trade off certain things. And so there are features like, for example, this sedation question, that was something that we negotiated with our sites on and we decided, well, this is our plan. This is what’ll work for our team. You can only ask for so much when you’re asking of people to do this thing for you.
Alex: Yeah. Last question for me is to Liz. And you think a lot about cognitive outcomes of major surgeries, and we have some hint of what might happen from the delirium outcome, but wondering if there are reasons to be concerned about long term cognitive outcomes from spinal versus general? And you may have thoughts on that, Mark may have thoughts on that.
Liz: Well, you’ll have to remind me, Mark, are you looking at a later cognitive outcome or the delirium was the neurocognitive outcome that you chose?
Mark: We did a brief cognitive screen called the short blessed test. It’s a six item orientation memory test. And we are collecting that out to one year. That data’s complicated though, because we’re doing it all by telephone. And as you can imagine, doing cognitive screening by telephone is not the same as being able to do it in person, for example. Another one of these trade offs we made to be able to do our study. So we’ll have some data on that, but it’ll be presented with certain limitations and caveats.
Liz: Yeah. So knowing that Mark is actually studying this, I’m not sure I really want to hazard to guess as to what he is going to find since I’ll be easily proven wrong, potentially. But I think it’s really persuasive that delirium wasn’t different between the groups. I’m relieved he collected that as an outcome. There’s a lot of hypotheses that delirium may causally or may drive later cognitive decline. And so since he didn’t find a difference in delirium, I’m optimistic that, assuming there’s a causal relationship between delirium and later cognitive decline which we don’t know yet, maybe there will be equivalent cognitive outcomes between the groups. If you don’t find equivalent cognitive outcomes between the groups, that’s an even more interesting finding that would need to be chased down.
Eric: Yeah. Well, I want to be mindful of time. Liz, Mark, and Cindy, thank you very much for joining on this podcast. But before we end, maybe Cindy and Alex, we can get a little bit more of Driver’s License.
Alex: Little bit more Driver’s License.
Eric: The teen angst Alex sincerely coming out.
Alex: That was fun. Pretty different from usual folksy request. [laughter]
Eric: I heard the other option was Taylor Swift.
Cindy: This was better.
Alex: This is better.
Eric: All right. Mark, Liz, Cindy, thanks for joining us on the GeriPal Podcast.
Cindy: Thanks so much.
Liz: Thank you.
Mark: Thank you so much. It was wonderful to come.
Eric: Archstone Foundation, thank you for your continued support. And to all of our listeners, thank you for supporting the GeriPal Podcast. Goodbye everybody.